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Bristol Myers Squibb Receives Positive CHMP Opinion for Reblozyl® (luspatercept) for Treatment of Adults with Transfusion-Dependent Anemia due to Low- to Intermediate-Risk Myelodysplastic Syndromes (MDS)

February 23
Last Trade: 51.66 0.33 0.64

Approval by European Commission would expand Reblozyl’s indication to include first-line treatment of anemia in adults with MDS in Europe In the pivotal Phase 3 COMMANDS study, Reblozyl nearly doubled the percentage of patients achieving primary endpoint of both transfusion independence and hemoglobin increase vs. epoetin alfa PRINCETON, N.J. / Feb 23, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced the...Read more


Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) in Combination With Chemotherapy as Neoadjuvant Treatment, Then Continued as Monotherapy as Adjuvant Treatment, for the Treatment of Resectable NSCLC at High Risk of Recurrence

February 23
Last Trade: 129.45 0.19 0.15

Opinion granted based on positive overall survival and event-free survival results from the Phase 3 KEYNOTE-671 trial First opinion to be granted for an anti-PD-1/L1 therapy in resectable non-small cell lung cancer (NSCLC) based on positive overall survival results RAHWAY, N.J. / Feb 23, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Medicines Agency’s...Read more


Regeneron Pharmaceuticals: Dupixent® (dupilumab) sBLA Accepted for FDA Priority Review for Treatment of COPD with Type 2 Inflammation

February 23
Last Trade: 981.20 16.31 1.69

Priority Review granted based on positive results from two Phase 3 trials; if approved, Dupixent would be the only biologic therapy for COPD and the first new treatment approach for this disease in more than a decade Regulatory submissions are also under review in China and Europe Dupixent is the leading biologic treatment for all five of its FDA-approved indications in new-to-brand prescriptions in the U.S. TARRYTOWN, N.Y. and...Read more


AbbVie and Tentarix Announce Collaboration to Develop Conditionally-Active, Multi-Specific Biologics for Oncology and Immunology

February 22
Last Trade: 178.09 1.34 0.76

Collaboration to leverage AbbVie's therapeutic area expertise and Tentarix's Tentacles™ platform, to develop novel multifunctional biologics against one target in oncology and another in immunology AbbVie will receive an exclusive option to acquire the therapeutic programs following candidate nomination by Tentarix NORTH CHICAGO, Ill. and SAN DIEGO, Feb. 22, 2024 /PRNewswire/ -- AbbVie Inc. (NYSE: ABBV) and Tentarix...Read more


Moderna Reports Fourth Quarter and Fiscal Year 2023 Financial Results and Provides Business Updates

February 22
Last Trade: 96.46 -2.98 -3.00

Posts fourth quarter revenues of $2.8 billion, GAAP net income of $217 million and GAAP diluted EPS of $0.55 Reports full-year revenues of $6.8 billion, GAAP net loss of $(4.7) billion and GAAP diluted EPS of $(12.33); loss primarily driven by mostly non-cash charges of $3.7 billion related to resizing and a tax valuation allowance Reaffirms 2024 expected product sales of approximately $4 billion Expects regulatory approvals for its...Read more


Regeneron Pharmaceuticals: Linvoseltamab BLA for Treatment of Relapsed/Refractory Multiple Myeloma Accepted for FDA Priority Review

February 21
Last Trade: 981.20 16.31 1.69

TARRYTOWN, N.Y., Feb. 21, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for linvoseltamab to treat adult patients with relapsed/refractory (R/R) multiple myeloma (MM) that has progressed after at least three prior therapies. The target action date for the FDA...Read more


Johnson & Johnson: TECVAYLI® (teclistamab-cqyv) biweekly dosing approved by the U.S. FDA for the treatment of patients with relapsed or refractory multiple myeloma

February 20
Last Trade: 161.84 1.39 0.87

Biweekly dosing with TECVAYLI®, the first approved BCMA-targeting bispecific antibody, provides patients with dosing flexibility HORSHAM, Pa., Feb. 20, 2024 /PRNewswire/ -- Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for TECVAYLI® (teclistamab-cqyv) for a reduced dosing frequency of 1.5 mg/kg every two weeks (Q2W)...Read more


Bristol-Myers Squibb: U.S. Food and Drug Administration (FDA) Accepts Supplemental New Drug Application for KRAZATI® (adagrasib) in Combination with Cetuximab as Targeted Treatment Option for Patients with Previously Treated KRAS G12C-Mutated...

February 20
Last Trade: 51.66 0.33 0.64

U.S. FDA has assigned a target action date of June 21, 2024 Application based on results from the Phase 1/2 KRYSTAL-1 study PRINCETON, N.J. / Feb 20, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental new drug application (sNDA) for KRAZATI® (adagrasib) in combination with cetuximab for the treatment of patients...Read more


AbbVie Unveils New Data from Robust Gastroenterology Portfolio at the 19th Congress of European Crohn's and Colitis Organisation (ECCO)

February 19
Last Trade: 178.09 1.34 0.76

A total of 17 accepted abstracts, including nine oral presentations and eight posters, reinforce AbbVie's commitment to produce a portfolio of products that aim to improve the lives of patients living with inflammatory bowel diseases (IBD) Oral data presentations include a new post-hoc analysis of clinical and endoscopic outcomes from the SEQUENCE trial comparing risankizumab (SKYRIZI®) versus ustekinumab, results from the COMMAND...Read more


European Commission Approves Pfizer’s VELSIPITY® for Patients with Moderately to Severely Active Ulcerative Colitis

February 19
Last Trade: 27.76 0.21 0.76

VELSIPITY is the first and only oral advanced ulcerative colitis therapy approved for use in patients 16 years of age or older in the EU NEW YORK / Feb 19, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has granted marketing authorization for VELSIPITY® (etrasimod) in the European Union to treat patients 16 years of age and older with moderately to severely active ulcerative colitis...Read more


AstraZeneca: Datopotamab deruxtecan Biologics License Application accepted in the US for patients with previously treated advanced nonsquamous non-small cell lung cancer

February 19
Last Trade: 65.83 1.70 2.65

Application based on results from the TROPION-Lung01 Phase III trial If approved, AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan may be the first TROP2-directed antibody drug conjugate for patients with lung cancer WILMINGTON, Del. / Feb 19, 2024 / Business Wire / AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the US for the treatment of adult...Read more


AstraZeneca: TAGRISSO® (osimertinib) demonstrated overwhelming efficacy benefit for patients with unresectable, Stage III EGFR-mutated lung cancer in LAURA Phase III trial

February 19
Last Trade: 65.83 1.70 2.65

First EGFR inhibitor and targeted treatment to demonstrate progression-free survival benefit in Stage III setting WILMINGTON, Del. / Feb 19, 2024 / Business Wire / Positive high-level results from the LAURA Phase III trial showed AstraZeneca’s TAGRISSO® (osimertinib) demonstrated a statistically significant and highly clinically meaningful improvement in progression-free survival (PFS) for patients with unresectable, Stage III...Read more


AstraZeneca: TAGRISSO® (osimertinib) with the addition of chemotherapy approved in the US for patients with EGFR-mutated advanced lung cancer

February 16
Last Trade: 65.83 1.70 2.65

Approval based on FLAURA2 results which showed TAGRISSO plus chemotherapy extended median progression-free survival by nearly 9 months vs. standard of care WILMINGTON, Del. / Feb 16, 2024 / Business Wire / AstraZeneca’s TAGRISSO® (osimertinib) with the addition of chemotherapy has been approved in the US for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small...Read more


FDA Approves Xolair as First and Only Medicine for Children and Adults With One or More Food Allergies

February 16
Last Trade: 32.96 0.47 1.45

Approval is based on data from the NIH-sponsored Phase III OUtMATCH study, which showed a significantly higher proportion of food allergy patients as young as 1 year treated with Xolair could tolerate small amounts of peanut, milk, egg and cashew without an allergic reaction, compared to placebo More than 40% of children and more than half of adults with food allergies have experienced a severe reaction at least once Detailed OUtMATCH...Read more


Regeneron Pharmaceuticals: Japan First in the World to Approve Dupixent® (dupilumab) for Chronic Spontaneous Urticaria (CSU)

February 16
Last Trade: 981.20 16.31 1.69

Approval based on results from Phase 3 trial showing Dupixent significantly reduced itch compared to placebo CSU is the fifth approved indication for Dupixent in Japan and the sixth indication for Dupixent globally TARRYTOWN, N.Y. and PARIS, Feb. 16, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing...Read more


Alnylam Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Period Activity

February 15
Last Trade: 157.65 -5.16 -3.17

Achieved Fourth Quarter and Full Year 2023 Global Net Product Revenues of $346 Million and $1,241 Million, Respectively, Representing 39% Annual Growth Compared to 2022  Company Announces Updated Statistical Analysis Plan and Timing for HELIOS-B Phase 3 Study of Vutrisiran  Announces U.S. FDA Clearance to Initiate Multiple-Dosing in ALN-APP Phase 1 Study  Provides 2024 Combined Net Product Revenue Guidance of $1,400...Read more


U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for Augtyro™ (repotrectinib) for the Treatment of Patients with NTRK-Positive Locally Advanced or Metastatic Solid Tumors

February 14
Last Trade: 51.66 0.33 0.64

Application based on results from the TRIDENT-1 and CARE trials, in which Augtyro demonstrated clinically meaningful response rates If approved, Augtyro will provide a new, next-generation option for patients with NTRK-positive locally advanced or metastatic solid tumors who have high unmet medical needs The U.S. Food and Drug Administration assigned a target action date of June 15, 2024 PRINCETON, N.J. / Feb 14, 2024 / Business Wire...Read more


Vertex Pharmaceuticals: European Commission Approves First CRISPR/Cas9 Gene-Edited Therapy, CASGEVY™ (exagamglogene autotemcel), for the Treatment of Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia

February 13
Last Trade: 430.11 3.33 0.78

Over 8,000 patients 12 years of age and older with severe sickle cell disease or transfusion-dependent beta thalassemia may be eligible for treatment LONDON / Feb 13, 2024 / Business Wire / Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the European Commission has granted conditional marketing authorization to CASGEVY™ (exagamglogene autotemcel [exa-cel]), a CRISPR/Cas9 gene-edited therapy. CASGEVY is approved...Read more


Roche enters into collaboration agreement with PathAI to expand digital pathology capabilities for companion diagnostics

February 13
Last Trade: 32.96 0.47 1.45

PathAI will exclusively work with Roche Tissue Diagnostics (RTD) to develop artificial intelligence (AI) digital pathology algorithms for RTD's companion diagnostics business. The image analysis algorithms will be deployed on Roche's navify Digital Pathology platform, allowing seamless integration into pathology laboratories worldwide. The collaboration between RTD and PathAI helps advance precision medicine by bringing together...Read more


Biogen Received European Commission Approval for SKYCLARYS® (omaveloxolone), the First Therapy to Treat Friedreich’s Ataxia

February 12
Last Trade: 223.32 0.84 0.38

Friedreich’s ataxia is a rare, genetic, life-shortening, debilitating, and neurodegenerative disorder Treatment with SKYCLARYS improved patient function compared to placebo Biogen is leveraging its expertise and capabilities in rare disease to bring this groundbreaking treatment to patients CAMBRIDGE, Mass., Feb. 12, 2024 (GLOBE NEWSWIRE) --  Biogen Inc. (Nasdaq: BIIB) announced the European Commission (EC) has authorized...Read more


Gilead Sciences Expands Liver Portfolio With Acquisition of CymaBay Therapeutics

February 12
Last Trade: 73.55 0.77 1.06

Gilead Adds Seladelpar to Portfolio, a PPARδ Agonist for the Treatment of Primary Biliary Cholangitis (PBC) with FDA Priority Review and Anticipated U.S. Approval in Third Quarter of 2024  Seladelpar Phase 3 Data Demonstrates a Best-in-Disease Profile for Second-Line PBC  Acquisition Expands Gilead’s Long-Standing Commitment to Patients with Liver Diseases  FOSTER CITY, Calif. & NEWARK, Calif. / Feb 12, 2024 /...Read more


FDA Approves Takeda’s EOHILIA (budesonide oral suspension), the First and Only Oral Treatment in the U.S. for Eosinophilic Esophagitis (EoE)

February 12
Last Trade: 14.62 -0.02 -0.14

12 Weeks of Treatment with EOHILIA May Address Significant Unmet Needs of Patients 11 Years of Age and Older EoE Is a Chronic Disease That Can Significantly Impact Patients, with Esophageal Inflammation and Intermittent Symptoms of Choking and Difficult or Painful Swallowing OSAKA, Japan & CAMBRIDGE, Mass. / Feb 12, 2024 / Business Wire / Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA)...Read more


AbbVie Completes Acquisition of ImmunoGen

February 12
Last Trade: 178.09 1.34 0.76

Adds flagship antibody-drug conjugate (ADC) ELAHERE® (mirvetuximab soravtansine-gynx) for folate receptor-alpha (FRα) positive platinum-resistant ovarian cancer (PROC) to AbbVie's portfolio ImmunoGen's pipeline complements AbbVie's existing oncology pipeline with potential to be transformative across multiple solid tumors and hematologic malignancies ImmunoGen's late-stage development programs for ELAHERE provide opportunity to expand...Read more


Merck: Health Canada Approves KEYTRUDA® in combination with trastuzumab and chemotherapy, as a first-line treatment for patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma whose tumou...

February 12
Last Trade: 129.45 0.19 0.15

Approval is based on the Phase 3 KEYNOTE-811 Trial KIRKLAND, QC, Feb. 12, 2024 /CNW/ - Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced that Health Canada has granted approval of  KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adult patients with locally advanced...Read more


Takeda Intends to Rapidly Initiate the First Global Phase 3 Trials of TAK-861, an Oral Orexin Agonist, in Narcolepsy Type 1 in First Half of Fiscal Year 2024

February 8
Last Trade: 14.62 -0.02 -0.14

Primary and Key Secondary Endpoints Were Met in Narcolepsy Type 1 Phase 2b Trial TAK-861 Was Found to be Generally Safe and Well-Tolerated Results Will be Presented at an Upcoming Scientific Congress OSAKA, Japan & CAMBRIDGE, Mass. / Feb 08, 2024 / Business Wire / Takeda (TSE:4502/NYSE:TAK) today announced positive topline results from a randomized, double-blind, placebo-controlled, multiple dose Phase 2b trial evaluating...Read more


AbbVie's VYALEV™ (foslevodopa/foscarbidopa solution) Available for the Treatment of Advanced Parkinson's Disease in Canada

February 8
Last Trade: 178.09 1.34 0.76

VYALEV is the first-and-only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of advanced Parkinson's disease (aPD) in Canada. Advanced Parkinson's disease patients now have a non-surgical treatment option that addresses an unmet need within this community. In clinical trials, patients taking VYALEV achieved the primary endpoint of a reduction in motor fluctuations and morning akinesia, as well as improvements...Read more


Merck Canada Announces Collaboration With Vector Institute To Further Advance Its Artificial Intelligence Capabilities And Drive Innovation In Healthcare

February 8
Last Trade: 129.45 0.19 0.15

KIRKLAND, QC, Feb. 8, 2024 /CNW/ - Merck (NYSE: MRK), known as MSD outside the United States and Canada, has entered into a multi-year agreement with the Vector Institute in Toronto, an independent not-for-profit corporation dedicated to advancing the field of artificial intelligence (AI) through world-class research.  This agreement will allow Merck Canada to gain access to Vector's exceptional research capabilities and...Read more


BioNTech and Autolus Announce Strategic CAR-T Cell Therapy Collaboration to Advance Pipeline and Expand Late-Stage Programs 

February 8
Last Trade: 93.97 0.40 0.43

Strategic alliance leverages manufacturing and commercial infrastructure as well as technology with the aim to advance both companies’ autologous CAR-T programs towards market, pending market authorization BioNTech secures the right to utilize Autolus’ manufacturing capacity in a cost-efficient set-up to accelerate the development of BNT211 into pivotal trials in CLDN6+ tumors BioNTech to support launch and expansion of development...Read more


AstraZeneca Full year and Q4 2023 Financial Results

February 8
Last Trade: 65.83 1.70 2.65

Strong growth and pipeline momentum with three new medicines approved since the third quarter CAMBRIDGE, United Kingdom / Feb 08, 2024 / Business Wire / AstraZeneca: Revenue and EPS summary     FY 2023   Q4 2023         % Change       %...Read more


Bristol Myers Squibb Announces Acceptance of U.S. and EU Regulatory Filings for Neoadjuvant Opdivo (nivolumab) and Chemotherapy Followed by Surgery and Adjuvant Opdivo in Resectable Non-Small Cell Lung Cancer

February 7
Last Trade: 51.66 0.33 0.64

Applications based on results from CheckMate -77T, the company’s second positive Phase 3 randomized trial with an immunotherapy-based combination for the treatment of non-metastatic non-small cell lung cancer The perioperative Opdivo-based regimen demonstrated significant improvement in event-free survival compared to neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo The U.S. Food and Drug Administration...Read more


BeiGene: Health Canada Approves BRUKINSA® (zanubrutinib) for the Treatment of Relapsed or Refractory Follicular Lymphoma

February 7
Last Trade: 155.10 1.32 0.86

BRUKINSA is the first and only BTK inhibitor approved for follicular lymphoma in Canada Follicular lymphoma (FL) is the 2nd most common type of non-Hodgkin lymphoma (NHL) This is the fifth Canadian therapeutic indication for BRUKINSA TORONTO, Feb. 7, 2024 /CNW/ - BeiGene, Ltd. (Nasdaq: BGNE) (HKEX: 06160) (SSE: 688235), a global biotechnology company, today announced it received Health Canada authorization for the use of BRUKINSA®...Read more


Gilead Sciences Announces Fourth Quarter and Full Year 2023 Financial Results

February 6
Last Trade: 73.55 0.77 1.06

Product Sales Excluding Veklury Increased Year-Over-Year by 7% for Full Year 2023 Biktarvy Sales Increased Year-Over-Year by 14% for Full Year 2023 Oncology Sales Increased Year-Over-Year by 37% for Full Year 2023 FOSTER CITY, Calif. / Feb 06, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the fourth quarter and full year 2023. “This was another strong year of revenue growth...Read more


Amgen Reports Fourth Quarter And Full Year 2023 Financial Results

February 6
Last Trade: 289.18 4.00 1.40

THOUSAND OAKS, Calif., Feb. 6, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the fourth quarter and full year 2023 versus comparable periods in 2022. "2023 was another year of performance and progress for our company," said Robert A. Bradway, chairman and chief executive officer. "Our marketed products are reaching many more patients around the world, and we anticipate more than a dozen significant...Read more


Calibr-Skaggs announces expansion of option and license agreement with AbbVie to develop novel cell therapies for solid tumors and autoimmune diseases

February 6
Last Trade: 178.09 1.34 0.76

AbbVie to maintain exclusive access to Calibr-Skaggs' switchable CAR-T (sCAR-T) platform to develop novel cell therapy candidates against solid tumor targets identified by AbbVie AbbVie also has the option to explore the applicability of Calibr-Skaggs' sCAR-T platform in autoimmune diseases Calibr-Skaggs to partner with AbbVie to support discovery of next-generation sCAR-Ts using genetic medicine-based approaches LA JOLLA, Calif.,...Read more


AstraZeneca expands US manufacturing footprint to accelerate ambitions in next-generation cell therapy discovery and development

February 6
Last Trade: 65.83 1.70 2.65

New facility in Rockville, Maryland will focus on manufacturing for critical cancer trials and launch of its commercial cell therapy platforms WILMINGTON, Del. / Feb 06, 2024 / Business Wire / AstraZeneca is investing $300 million in a state-of-the-art facility in Rockville, MD to launch its life-saving cell therapy platforms in the US for critical cancer trials and future commercial supply. More than 150 new highly skilled jobs will...Read more


GSK’s RSV Vaccine, AREXVY, Accepted Under Priority Review in US for the Prevention of RSV Disease in Adults Aged 50-59 at Increased Risk

February 6
Last Trade: 42.22 0.06 0.14

Application supported by positive results of a phase III trial showing immune response and acceptable tolerability profile in this population Adults aged 50 and above with underlying medical conditions are at increased risk for RSV disease1,2,3 GSK is the first company to file for regulatory approval to extend RSV vaccination to adults aged 50-59 at increased risk US FDA has set a Prescription Drug User Fee Act action date of June 7,...Read more


Eli Lilly Reports Strong Fourth-Quarter 2023 Financial Results and Provides 2024 Guidance

February 6
Last Trade: 769.54 -0.10 -0.01

Revenue in Q4 2023 increased 28%. New Products(i) revenue grew by $2.19 billion to $2.49 billion in Q4 2023, led by Mounjaro and Zepbound. Growth Products(ii) revenue increased 9% to $5.27 billion in Q4 2023, led by Verzenio and Jardiance. Pipeline progress included FDA approval of Zepbound for adults with obesity or overweight with weight-related comorbidities and Jaypirca for chronic lymphocytic leukemia or small lymphocytic...Read more


Vertex Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results

February 5
Last Trade: 430.11 3.33 0.78

Full year product revenue of $9.87 billion, an 11% increase compared to full year 2022  Company provides full year 2024 product revenue guidance of $10.55 to $10.75 billion  CASGEVYTM approved in the U.S., Great Britain, the Kingdom of Saudi Arabia and Bahrain  Vertex on track to submit new drug applications (NDAs) to the FDA by mid-2024 for both VX-548 in Acute Pain and the Vanzacaftor Triple in CF  Broad and deep...Read more


Vertex Pharmaceuticals Announces Positive Results From Pivotal Trials of Vanzacaftor/Tezacaftor/Deutivacaftor, Next-In-Class Triple Combination Treatment for Cystic Fibrosis

February 5
Last Trade: 430.11 3.33 0.78

Treatment with the once-daily vanza triple CFTR modulator regimen met all primary and key secondary endpoints in two randomized controlled trials in people with CF ages 12 years and older  Results were more pronounced in the single-arm study in children ages 6 to 11 years, demonstrating the potential that treating early in life may prevent disease development  Vanza triple was generally well tolerated across all three...Read more


Breaking Barriers in Cancer Care: The American Cancer Society and Pfizer Announce a $15 Million, Three-Year Initiative to Bridge the Gap in Cancer Care Disparities

February 5
Last Trade: 27.76 0.21 0.76

The initiative, “Change the Odds: Uniting to Improve Cancer Outcomes” aims to enhance awareness of and access to cancer screening, clinical trials and support in medically underrepresented communities across the United States ATLANTA & NEW YORK / Feb 05, 2024 / Business Wire / The American Cancer Society (ACS) and Pfizer Inc. (NYE: PFE) today announced the launch of “Change the Odds™: Uniting to Improve Cancer Outcomes,” a...Read more


Yiviva Announces Memorandum of Understanding with AstraZeneca to Develop Platforms, Technologies, and Innovative Therapeutics through a Systems Biology Approach

February 5
Last Trade: 65.83 1.70 2.65

NEW YORK and SHANGHAI, China, Feb. 05, 2024 (GLOBE NEWSWIRE) -- Yiviva, a clinical-stage, platform biotechnology company developing systems biology medicines to treat aging-related diseases, signed a memorandum of understanding (MOU) with AstraZeneca China to establish a research and development collaboration at AstraZeneca’s Innovation Campus (iCampus) in Chengdu, China. The signing ceremony took place at the 2023 China International...Read more


Bristol Myers Squibb and 2seventy bio Share Update on U.S. FDA Oncologic Drugs Advisory Committee Meeting for Abecma in Triple-Class Exposed Multiple Myeloma Based on KarMMa-3 Study

February 5
Last Trade: 51.66 0.33 0.64

PRINCETON, N.J., & CAMBRIDGE, Mass. / Feb 05, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) and 2seventy bio, Inc. (Nasdaq: TSVT) today announced that a notice was published in the Federal Register that the U.S. Food and Drug Administration (FDA) will convene a virtual meeting of the Oncologic Drugs Advisory Committee (ODAC) on March 15, 2024, to review data supporting the supplemental Biologics License Application (sBLA) for...Read more


Merck Animal Health to Acquire Elanco’s Aqua Business

February 5
Last Trade: 129.45 0.19 0.15

Bolsters Merck Animal Health’s position in the aqua industry with comprehensive approach to ensure fish health, welfare and sustainability in aquaculture, conservation and fisheries Complements Merck Animal Health’s broad portfolio of veterinary pharmaceuticals, vaccines and technology solutions RAHWAY, N.J. / Feb 05, 2024 / Business Wire / Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a...Read more


Novo Nordisk to acquire three fill-finish sites from Novo Holdings A/S in connection with the Catalent, Inc. transaction

February 5
Last Trade: 123.45 -1.07 -0.86

Bagsværd, Denmark, 5 February 2024 – Novo Nordisk (NYSE: NVO) today announced that the company has agreed to acquire three fill-finish sites from Novo Holdings A/S (Novo Holdings) in connection with a transaction where Novo Holdings has agreed to acquire Catalent, Inc. (Catalent), a global contract development and manufacturing organisation headquartered in Somerset, New Jersey (US). Novo Nordisk and Catalent have a long-standing...Read more


AbbVie Reports Full-Year and Fourth-Quarter 2023 Financial Results

February 2
Last Trade: 178.09 1.34 0.76

Reports Full-Year Diluted EPS of $2.72 on a GAAP Basis, a Decrease of 59.0 Percent; Adjusted Diluted EPS of $11.11, a Decrease of 19.3 Percent; These Results Include an Unfavorable Impact of $0.42 Per Share Related to 2023 Acquired IPR&D and Milestones Expense  Delivers Full-Year Net Revenues of $54.318 Billion, a Decrease of 6.4 Percent on a Reported Basis and 5.9 Percent on an Operational Basis Full-Year Global Net Revenues...Read more


Regeneron Pharmaceuticals: Linvoseltamab Receives EMA Filing Acceptance for Treatment of Relapsed/Refractory Multiple Myeloma

February 2
Last Trade: 981.20 16.31 1.69

TARRYTOWN, N.Y., Feb. 02, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for linvoseltamab to treat adult patients with relapsed/refractory (R/R) multiple myeloma (MM) who have progressed after at least three prior therapies. Linvoseltamab is an investigational bispecific...Read more


Bristol Myers Squibb Reports Fourth Quarter and Full-Year Financial Results for 2023

February 2
Last Trade: 51.66 0.33 0.64

Results Reflect Continued Strength of In-Line and New Products, Pipeline Execution and Business Development Activity, Supporting Growth Momentum into 2024   Reports Fourth Quarter Revenues of $11.5 Billion; GAAP EPS of $0.87 and Non-GAAP EPS of $1.70 In-Line and New Product Portfolio Revenues Increased 9% to $9.8 Billion Reports Full-Year Revenues of $45.0 Billion; GAAP EPS of $3.86 and Non-GAAP EPS of $7.51 In-Line...Read more


Tisotumab Vedotin Marketing Authorization Application Validated by European Medicines Agency for Treatment of Recurrent or Metastatic Cervical Cancer

February 2
Last Trade: 29.16 0.05 0.17

Validation is supported by data from Phase 3 innovaTV 301 trial COPENHAGEN, Denmark / Feb 02, 2024 / Business Wire / Genmab A/S (Nasdaq: GMAB) and Pfizer, Inc. (NYSE PFE) today announced that the European Medicines Agency (EMA) has validated for review the marketing authorization application (MAA) of tisotumab vedotin, an antibody-drug conjugate (ADC), developed for the treatment of adult patients with recurrent or metastatic cervical...Read more


Regeneron Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial and Operating Results

February 2
Last Trade: 981.20 16.31 1.69

Fourth quarter 2023 revenues increased 1% to $3.43 billion versus fourth quarter 2022; excluding RonapreveTM(a)(b), revenues increased 14% Full year 2023 revenues increased 8% to $13.12 billion versus full year 2022; excluding Ronapreve(a), revenues increased 12% Fourth quarter 2023 Dupixent® global net sales (recorded by Sanofi) increased 31% to $3.22 billion versus fourth quarter 2022; full year 2023 Dupixent global net sales...Read more


Merck Announces Fourth-Quarter and Full-Year 2023 Financial Results

February 1
Last Trade: 129.45 0.19 0.15

Fourth-Quarter and Full-Year Sales Reflect Sustained Growth Across Oncology and Vaccines Fourth-Quarter Worldwide Sales Were $14.6 Billion, an Increase of 6% From Fourth Quarter 2022; Excluding LAGEVRIO, Growth Was 11%; Excluding LAGEVRIO and the Impact of Foreign Exchange, Growth Was 13% Fourth-Quarter GAAP Loss per Share Was $0.48; Non-GAAP EPS Was $0.03; GAAP Loss per Share and Non-GAAP EPS Include a Charge of $1.69 per Share for a...Read more


Ted Love, MD, Joins Gilead Sciences’ Board of Directors

February 1
Last Trade: 73.55 0.77 1.06

FOSTER CITY, Calif. / Feb 01, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced that Ted Love, MD, has been appointed to the company’s Board of Directors. Dr. Love is currently chair of the Board of Directors of the Biotechnology Innovation Organization and serves on the Boards of Directors of Royalty Pharma and Structure Therapeutics. Previously, he was the President and Chief Executive Officer of Global Blood...Read more


Takeda Announces Third-Quarter FY2023 Results; On-Track Towards Full-Year Management Guidance With Strong Momentum in Growth & Launch Products

February 1
Last Trade: 14.62 -0.02 -0.14

Two New U.S. FDA Approvals in FY2023 Q3: FRUZAQLA for Adults With Previously Treated Metastatic Colorectal Cancer and ADZYNMA for Ultra-Rare Blood Clotting Disorder cTTP Strong Commercial Execution Maximizing Value of Existing Portfolio: ENTYVIO® Pen Launched in U.S. for Ulcerative Colitis; U.S. FDA Approval Decision on Crohn’s Disease Filing Expected in early FY2024 QDENGA ® Dengue Vaccine Now Launched in 21 Countries LIVTENCITY ®...Read more


Allergan Aesthetics Releases "Decoding the Future of Aesthetic Individuality" Exploring the Power of Self-Expression

January 31
Last Trade: 178.09 1.34 0.76

 New report incorporates in-depth interviews, industry research and social listening to understand the role of individuality in the world of aesthetics  Report underpins ongoing commitment to aesthetics accessibility and inclusivity to achieve desired patient outcomes IRVINE, Calif., Jan. 31, 2024 /PRNewswire/ -- Today, Allergan Aesthetics, an AbbVie (NYSE: ABBV) company and a global leader in medical aesthetics...Read more


Novo Nordisk's sales increased by 31% in Danish kroner and by 36% at constant exchange rates to DKK 232.3 billion in 2023

January 31
Last Trade: 123.45 -1.07 -0.86

Bagsværd, Denmark, 31 January 2024  - Novo Nordisk's (NYSE: NVO) sales increased by 31% in Danish kroner and by 36% at constant exchange rates to DKK 232.3 billion in 2023 Operating profit increased by 37% in Danish kroner and by 44% at constant exchange rates (CER) to DKK 102.6 billion. Sales in North America Operations increased by 50% in Danish kroner (54% at CER). Sales in International Operations increased by...Read more


Biogen to Realign Resources for Alzheimer's Disease Franchise

January 31
Last Trade: 223.32 0.84 0.38

Company to reprioritize resources allocated to ADUHELM® (aducanumab-avwa) to advance LEQEMBI® (lecanemab-irmb) and to develop new treatment modalities Biogen committed to building a leading Alzheimer’s disease franchise to address patient needs CAMBRIDGE, Mass., Jan. 31, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced plans to reprioritize its resources in Alzheimer’s disease (AD), a strategic therapeutic area...Read more


BeiGene: Adults living with chronic lymphocytic leukemia (CLL) in Ontario and Quebec now have access, through public reimbursement, to BRUKINSA® (zanubrutinib)

January 31
Last Trade: 155.10 1.32 0.86

BRUKINSA is now listed on the RAMQ and ODB formularies. Two global Phase 3 trials in adults with CLL demonstrated superior efficacy for BRUKINSA in first line and relapsed/refractory settings. Approximately 2,000 Canadians are diagnosed every year with CLL, the most common form of leukemia in adults. TORONTO, Jan. 31, 2024 /CNW/ - BeiGene, Ltd. (NASDAQ: BGNE) (HKEX: 06160) (SSE: 688235), a global biotechnology company is pleased...Read more


BioNTech and DualityBio Receive FDA Fast Track Designation for Next-Generation Antibody-Drug Conjugate Candidate BNT325/DB-1305

January 31
Last Trade: 93.97 0.40 0.43

Designation is based on preliminary safety and efficacy data from an ongoing Phase 1/2 trial in patients with platinum-resistant ovarian epithelial cancer, fallopian tube, or primary peritoneal cancer1 Fast Track designation can facilitate the development and expedite the regulatory review of BNT325/DB-1305  Ovarian cancer is the fourth most common gynecological tumor type2 with over 300,000 cases diagnosed globally each year3;...Read more


Gilead Sciences: Kite Receives U.S. FDA Approval of Manufacturing Process Change Resulting in Reduced Median Turnaround Time for Yescarta® CAR T-cell Therapy

January 30
Last Trade: 73.55 0.77 1.06

New Median Turnaround Time from Leukapheresis to Product Release in U.S. Anticipated to be Reduced from 16 Days to 14 Days  Continues to Support Kite’s Industry-Leading Overall Turnaround Time and Reliability  Time to Treatment is a Critical Factor for CAR T-cell Therapy Patients  SANTA MONICA, Calif. / Jan 30, 2024 / Business Wire / Kite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug...Read more


Regeneron Pharmaceuticals Announces Formation of Regeneron Cell Medicines with the Acquisition of 2seventy bio Platforms and Preclinical and Clinical Programs

January 30
Last Trade: 981.20 16.31 1.69

TARRYTOWN, N.Y., Jan. 30, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the formation of Regeneron Cell Medicines based on an agreement with 2seventy bio, Inc. to acquire full development and commercialization rights to its pipeline of investigational novel immune cell therapies, along with its discovery and clinical manufacturing capabilities. 2seventy bio employees who support the acquired...Read more


Regulatory Applications Accepted in the U.S. and Japan for Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel) in Relapsed or Refractory Follicular Lymphoma (FL) and Relapsed or Refractory Mantle Cell Lymphoma (MCL)

January 30
Last Trade: 51.66 0.33 0.64

U.S. FDA grants both FL and MCL applications Priority Review Applications based on results from TRANSCEND FL and TRANSCEND NHL 001, in which Breyanzi demonstrated clinically meaningful benefit with deep and durable responses Multiple regulatory applications underscore Bristol Myers Squibb’s commitment to advancing Breyanzi, a differentiated CAR T cell therapy, for more patients across the broadest array of B-cell...Read more


Pfizer Reports Full-Year 2023 Results and Reaffirms Full-Year 2024 Financial Guidance

January 30
Last Trade: 27.76 0.21 0.76

2023 Sets Stage for Future Growth Potential: Completed Seagen Acquisition, Creating World-Class Oncology Organization; Launched Significant Number of New Products and Indications; and Realigned Commercial Organization to Improve Focus, Speed and Execution Full-Year 2023 Revenues of $58.5 Billion Expected Decline in Comirnaty(1) and Paxlovid Revenues Drove 41% Operational Decrease in Year-Over-Year Revenues Excluding Contributions...Read more


Vertex Pharmaceuticals Announces Positive Results From the VX-548 Phase 3 Program for the Treatment of Moderate-to-Severe Acute Pain

January 30
Last Trade: 430.11 3.33 0.78

Treatment with VX-548 led to statistically significant improvement in pain compared to placebo as well as a clinically meaningful reduction in pain from baseline in both the abdominoplasty and bunionectomy randomized controlled trials  Treatment with VX-548 was also shown to be effective in the single arm study in a broad range of surgical and non-surgical pain conditions for up to 14 days  VX-548 was safe and well tolerated...Read more


Gilead Sciences and Arcus Biosciences Announce Amended Collaboration and Equity Investment

January 29
Last Trade: 73.55 0.77 1.06

Investment Reinforces Companies’ Conviction in TIGIT Pathway and Provides Opportunity to Accelerate the Anti-TIGIT Program  Additional Equity Investment of $320M, Raising Gilead’s Ownership Stake in Arcus to 33%  Amendment Provides Gilead with One Additional Seat on the Arcus Board  FOSTER CITY, Calif. & HAYWARD, Calif. / Jan 29, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) and Arcus Biosciences,...Read more


Takeda’s GAMMAGARD LIQUID® Approved by U.S. FDA for Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

January 29
Last Trade: 14.62 -0.02 -0.14

New Indication Delivers on Takeda’s Commitment to Expanding its Broad and Diverse Immunoglobulin (IG) Portfolio to Meet the Needs of People Living with CIDP Approval Supported by Phase 3 ADVANCE-CIDP Open-label Study Data Demonstrating Safety and Efficacy as an Intravenous Therapy for Adults with CIDP GAMMAGARD LIQUID [Immune Globulin Infusion (Human) 10% Solution] is the Only Intravenous IG (IVIG) Approved for the Treatment of Multiple...Read more


AstraZeneca: ENHERTU® (fam-trastuzumab deruxtecan-nxki) granted Priority Review in the US for patients with metastatic HER2-positive solid tumors

January 29
Last Trade: 65.83 1.70 2.65

If approved, AstraZeneca and Daiichi Sankyo’s ENHERTU will potentially be the first HER2-directed treatment and antibody drug conjugate to receive a tumor-agnostic indication Application based on results from DESTINY-PanTumor02 trial and supported by additional ENHERTU data Submission to be reviewed under FDA Real-Time Oncology Review and Project Orbis WILMINGTON, Del. / Jan 29, 2024 / Business Wire / AstraZeneca and Daiichi Sankyo's...Read more


Amgen: deCODE genetics - A sequence variant that increases risk of pregnancy loss

January 29
Last Trade: 289.18 4.00 1.40

REYKJAVIK, Iceland, Jan. 29, 2024 /CNW/ -- Scientists at deCODE genetics, a subsidiary of Amgen, and their collaborators from Iceland, Denmark, and the USA published a study today in Nature Structural & Molecular Biology titled "Variant in the synaptonemal complex protein SYCE2 associates with pregnancy loss through effects on recombination". While it is well established that chromosomal abnormalities...Read more


Takeda’s HYQVIA® Approved by European Commission as Maintenance Therapy in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

January 29
Last Trade: 14.62 -0.02 -0.14

HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] becomes the Only Facilitated Subcutaneous Immunoglobulin, Offering Patients an up to Once-Monthly Treatment Option At-Home or In-Office Administration Provides CIDP Patients with a Personalized Treatment Experience Approval Expands Takeda’s Portfolio of Differentiated Immunoglobulin Therapies for Patients with Neuroimmunological Disorders OSAKA, Japan...Read more


Merck’s KEYTRUDA® (pembrolizumab) Reduced the Risk of Death by 38% Versus Placebo as Adjuvant Therapy for Patients With Renal Cell Carcinoma (RCC) at an Increased Risk of Recurrence Following Nephrectomy

January 27
Last Trade: 129.45 0.19 0.15

KEYNOTE-564 is the first Phase 3 trial to demonstrate superior overall survival (OS) with adjuvant therapy compared to placebo in patients with RCC Late-breaking OS results selected for the official Press Program at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium RAHWAY, N.J. / Jan 27, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results...Read more


Bristol-Myers Squibb: Subcutaneous Nivolumab (nivolumab and hyaluronidase) Shows Noninferiority Compared to Intravenous Opdivo (nivolumab) in Advanced or Metastatic Clear Cell Renal Cell Carcinoma in CheckMate -67T Trial

January 27
Last Trade: 51.66 0.33 0.64

CheckMate -67T is the first Phase 3 trial of the subcutaneous formulation of Opdivo to evaluate and demonstrate noninferior pharmacokinetics, efficacy and safety vs. its intravenous formulation Subcutaneous nivolumab demonstrated noninferior pharmacokinetics (co-primary endpoints) and objective response rate (key powered secondary endpoint) compared to intravenous Opdivo Results from the Phase 3 CheckMate -67T trial will be presented in...Read more


European Medicines Agency Validates Type II Variation Application for PADCEV™ (enfortumab vedotin) with KEYTRUDA®(pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer

January 26
Last Trade: 27.76 0.21 0.76

Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival If approved, PADCEV with KEYTRUDA would be the first combination in the EU to offer an alternative to platinum-containing chemotherapy, the current standard of care in first-line locally advanced or metastatic urothelial cancer TOKYO and NEW YORK, Jan. 26, 2024 /PRNewswire/ -- Astellas Pharma Inc....Read more


Merck’s KEYTRUDA® (pembrolizumab) Significantly Improved Disease-Free Survival (DFS) as Adjuvant Therapy Versus Observation in High-Risk Patients With Localized Muscle-Invasive and Locally Advanced Urothelial Carcinoma After Surgery

January 26
Last Trade: 129.45 0.19 0.15

KEYTRUDA doubled median DFS as adjuvant therapy versus observation – 29 months versus 14 months – in these patients AMBASSADOR (A031501)/KEYNOTE-123 is the first positive trial for KEYTRUDA as adjuvant therapy in urothelial carcinoma RAHWAY, N.J. / Jan 26, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from the Phase 3 AMBASSADOR (A031501)/KEYNOTE-123 trial...Read more


Bristol Myers Squibb Receives Positive CHMP Opinion for CAR T Cell Therapy Abecma (idecabtagene vicleucel) in Earlier Lines of Therapy for Triple-Class Exposed Relapsed and Refractory Multiple Myeloma

January 26
Last Trade: 51.66 0.33 0.64

Recommendation for approval based on Phase 3 KarMMa-3 study in which Abecma demonstrated superiority over standard regimens, significantly improved progression-free survival and a well-established safety profile with mostly low-grade occurrences of cytokine release syndrome and neurotoxicity This is the first positive CHMP opinion in earlier lines of therapy for a chimeric antigen receptor (CAR) T cell therapy in the treatment of...Read more


New Long-Term Data for Genentech’s Vabysmo Show Sustained Retinal Drying and Vision Improvements in Retinal Vein Occlusion (RVO)

January 26
Last Trade: 32.96 0.47 1.45

Vabysmo sustained robust drying of retinal fluid, often associated with distorted or blurry vision Up to 60% of people receiving Vabysmo were able to extend treatment intervals to three or four months apart Detailed results from two global Phase III RVO studies will be presented at Angiogenesis, Exudation, and Degeneration 2024 Vabysmo is approved in the U.S. for RVO, and in more than 90 countries around the world for people living...Read more


Regeneron Pharmaceuticals: Dupixent® (dupilumab) FDA Approved as First and Only Treatment Indicated for Children Aged 1 Year and Older with Eosinophilic Esophagitis (EoE)

January 25
Last Trade: 981.20 16.31 1.69

Approval based on Phase 3 EoE KIDS trial showing a greater proportion of children taking Dupixent achieved histological remission compared to placebo Expanded indication marks second disease for which Dupixent is approved in children this young, underscoring the commitment to bringing therapies to young patients with significant unmet needs   EoE is one of five FDA-approved indications for Dupixent in the U.S. for which type...Read more


Elegen and GSK Sign Collaboration and Licensing Agreement to Further Develop Elegen’s Cell-Free DNA Production Technology

January 24
Last Trade: 42.22 0.06 0.14

Multi-year collaboration allows GSK to leverage Elegen’s cell-free synthetic DNA production technology. Agreement provides Elegen up to $35 million in near-term financial and development support and fees, in addition to sales of ENFINIA™ DNA and a potential equity investment in Elegen by GSK. SAN CARLOS, Calif. / Jan 24, 2024 / Business Wire / Elegen, a leader in DNA manufacturing innovation, today announced a collaboration and...Read more


Bristol Myers Squibb Completes Acquisition of Mirati Therapeutics, Strengthening and Diversifying Oncology Portfolio

January 23
Last Trade: 51.66 0.33 0.64

PRINCETON, N.J. / Jan 23, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that it has successfully completed its acquisition of Mirati Therapeutics, Inc.® (“Mirati”). With the completion of the acquisition, Mirati shares have ceased trading on the NASDAQ Global Select Market and Mirati is now a wholly owned subsidiary of Bristol Myers Squibb. “The closing of the Mirati transaction is a significant milestone in our...Read more


Johnson & Johnson Reports Q4 and Full-Year 2023 Results

January 23
Last Trade: 161.84 1.39 0.87

2023 Fourth-Quarter reported sales growth of 7.3% to $21.4 Billion with operational growth of 7.2%* and adjusted operational growth of 5.7%*. Operational growth excluding COVID-19 Vaccine of 10.9%* 2023 Fourth-Quarter Earnings per share (EPS) of $1.70 increasing 39.3% and adjusted EPS of $2.29 increasing by 11.7%*  2023 Full-Year reported sales growth of 6.5% to $85.2 Billion with operational growth of 7.4%* and adjusted...Read more


BeiGene Welcomes Experienced Life Sciences Executive Olivier Brandicourt to Board of Directors

January 23
Last Trade: 155.10 1.32 0.86

BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass. / Jan 23, 2024 / Business Wire / BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that Olivier Brandicourt, M.D. has been appointed to its Board of Directors. Dr. Brandicourt will join the audit committee of the Board. Dr. Brandicourt replaces Thomas Malley, who has served on the Board since 2016. “Dr. Brandicourt brings a wealth...Read more


Bristol Myers Squibb: Eight-Year Data for Opdivo (nivolumab) Plus Yervoy (ipilimumab) Continue to Demonstrate Longest Survival Benefit vs. Sunitinib Reported in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

January 22
Last Trade: 51.66 0.33 0.64

Patients with previously untreated advanced or metastatic renal cell carcinoma treated with Opdivo plus Yervoy experienced a 28% reduction in the risk of death vs. sunitinib at eight years from the start of treatment, regardless of risk group The dual immunotherapy combination showed improved survival and durable responses compared to sunitinib among intermediate- and poor-risk patients, as well as all randomized patients Updated...Read more


Bristol Myers Squibb: Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib) Demonstrates Long-Term Survival Benefits After Four Years of Follow-Up in the CheckMate -9ER Trial in First-Line Advanced Renal Cell Carcinoma

January 22
Last Trade: 51.66 0.33 0.64

Opdivo in combination with CABOMETYX reduced the risk of death by 23% in the first-line treatment of advanced renal cell carcinoma vs. sunitinib Four-year results demonstrating continued benefits with immunotherapy-tyrosine kinase inhibitor combination to be shared in an oral presentation at ASCO GU 2024 PRINCETON, N.J. & ALAMEDA, Calif. / Jan 22, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) and Exelixis, Inc. (NASDAQ:...Read more


Gilead Sciences Provides Update on Phase 3 EVOKE-01 Study

January 22
Last Trade: 73.55 0.77 1.06

FOSTER CITY, Calif. / Jan 22, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Phase 3 EVOKE-01 study did not meet its primary endpoint of overall survival (OS) in previously treated metastatic non-small cell lung cancer (NSCLC). EVOKE-01 is evaluating Trodelvy® (sacituzumab govitecan-hziy; SG) vs. docetaxel in patients with metastatic or advanced NSCLC that had progressed on or after platinum-based...Read more


AstraZeneca: AIRSUPRA® (albuterol/budesonide) now available as the first and only FDA-approved anti-inflammatory rescue option for asthma

January 22
Last Trade: 65.83 1.70 2.65

Adults living with asthma now have an approved rescue treatment designed to treat both symptoms and inflammation to help prevent asthma attacks WILMINGTON, Del. / Jan 22, 2024 / Business Wire / AstraZeneca announces AIRSUPRA® (albuterol/budesonide), is now commercially available in the US by prescription. AIRSUPRA received FDA approval in January 2023 for the as-needed treatment or prevention of symptoms of asthma and to help prevent...Read more


BioNTech and DualityBio Initiate Pivotal Phase 3 Trial Of Antibody-Drug Conjugate Candidate BNT323/DB-1303 in Metastatic Breast Cancer

January 22
Last Trade: 93.97 0.40 0.43

The pivotal Phase 3 trial with BNT323/DB-1303 follows positive Phase 1/2 safety and efficacy data in patients with Human Epidermal Growth Factor Receptor 2 (“HER2”)-expressing advanced solid tumors with early signs of anti-tumor activity in heavily pretreated patients with HER2-low and HER2-positive breast cancer The trial is expected to enroll 532 patients with Hormone Receptor-positive (“HR+”) and HER2-low metastatic breast cancer...Read more


Bristol-Myers Squibb: Opdivo (nivolumab) Plus Yervoy (ipilimumab) Reduced the Risk of Disease Progression or Death by 79% Versus Chemotherapy in Patients with Microsatellite Instability-High or Mismatch Repair Deficient Metastatic Colorectal Cancer...

January 20
Last Trade: 51.66 0.33 0.64

First presentation of data from the Phase 3 randomized trial shows statistically significant and clinically meaningful improvement in progression-free survival with Opdivo plus Yervoy compared to chemotherapy as first-line treatment in this patient population Opdivo plus Yervoy is the first dual immunotherapy regimen to demonstrate significant efficacy benefit compared to chemotherapy as first-line treatment in MSI-H/dMMR...Read more


AstraZeneca: IMFINZI® (durvalumab) plus transarterial chemoembolization (TACE) and bevacizumab reduced the risk of disease progression or death by 23% vs. TACE in liver cancer eligible for embolization

January 19
Last Trade: 65.83 1.70 2.65

EMERALD-1 is first global Phase III trial to show improved clinical outcome for systemic therapy in combination with TACE in this setting WILMINGTON, Del. / Jan 19, 2024 / Business Wire / Positive results from the EMERALD-1 Phase III trial showed AstraZeneca’s IMFINZI® (durvalumab) in combination with TACE and bevacizumab demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of...Read more


Vertex Pharmaceuticals Announces US FDA Approval of CASGEVY™ (exagamglogene autotemcel) for the Treatment of Transfusion-Dependent Beta Thalassemia

January 16
Last Trade: 430.11 3.33 0.78

Approximately 1,000 patients in the U.S. 12 years of age and older are now eligible for this one-time treatment BOSTON / Jan 16, 2024 / Business Wire / Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the U.S. Food and Drug Administration (FDA) has approved CASGEVY™ (exagamglogene autotemcel [exa-cel]), a CRISPR/Cas9 gene-edited cell therapy, for the treatment of transfusion-dependent beta thalassemia (TDT) in...Read more


U.S. FDA Approves Takeda’s HYQVIA® as Maintenance Therapy in Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

January 16
Last Trade: 14.62 -0.02 -0.14

HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase], the Only up to Once Monthly (every 2, 3 or 4 weeks) Subcutaneous Immunoglobulin (SCIG) Infusion to Treat CIDP, Can Be Administered by a Healthcare Professional or Self-Administered after Appropriate Training Approval Based on Phase 3 ADVANCE-CIDP 1 Study Demonstrating a Statistically Significant Difference in Relapse Rate in Favor of HYQVIA Versus Placebo...Read more


Regeneron Pharmaceuticals: Dupixent® (dupilumab) U.S. Label Updated with Data Further Supporting Use in Atopic Dermatitis with Moderate-to-Severe Hand and Foot Involvement

January 16
Last Trade: 981.20 16.31 1.69

Data included from first and only Phase 3 trial specifically evaluating a biologic in this difficult-to-treat population Phase 3 trial showed more than twice as many patients treated with Dupixent achieved clear or almost clear skin and nearly four times as many had improvement in itch, compared with placebo TARRYTOWN, N.Y. and PARIS, Jan. 16, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today...Read more


FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemoradiotherapy as Treatment for Patients With FIGO 2014 Stage III-IVA Cervical Cancer

January 12
Last Trade: 129.45 0.19 0.15

KEYTRUDA is the first and only anti-PD-1 therapy approved in combination with chemoradiotherapy for these patients Approval marks third FDA-approved indication for KEYTRUDA in cervical cancer and 39th indication for KEYTRUDA in the US RAHWAY, N.J. / Jan 12, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA,...Read more


Henlius and Sermonix Announce Strategic Collaboration and Exclusive License Agreements for Novel Endocrine Therapy Lasofoxifene

January 10
Last Trade: 769.54 -0.10 -0.01

Partnership expands Henlius’ portfolio with license of exclusive China rights to develop, manufacture and commercialize lasofoxifene; Sermonix retains all other global rights Henlius to facilitate clinical development for the initiated Phase 3 MRCT (ELAINE-3) of lasofoxifene in the territory Sermonix receives upfront payment, milestone payments of up to $58M and royalties upon commercialization in the territory COLUMBUS, Ohio and...Read more


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Today's Big Pharma Gainers

 
CompanyChangeLast Trade
Regeneron Pharmaceuticals 16.31 1.69 $981.20
Amgen 4.00 1.40 $289.18
Vertex Pharmaceuticals 3.33 0.78 $430.11
AstraZeneca 1.70 2.65 $65.83
Johnson & Johnson 1.39 0.87 $161.84
AbbVie 1.34 0.76 $178.09
BeiGene 1.32 0.86 $155.10
Novartis 1.10 1.07 $103.90
Sanofi 0.97 2.03 $48.77
Biogen 0.84 0.38 $223.32
Gilead Sciences 0.77 1.06 $73.55
Roche 0.47 1.45 $32.96
BioNTech 0.40 0.43 $93.97
Bristol-Myers Squibb 0.33 0.64 $51.66
Pfizer 0.21 0.76 $27.76
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List of Big Pharma Stocks

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Cue Biopharma is developing the first-ever class of therapeutics for the treatment of cancer that mimic the natural signals, or “Cues”, of the immune system. This novel class of injectable biologics selectively engages and modulates tumor-specific T cells directly within the patient’s body to transform...

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