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Surmodics

List of Big Pharma Stocks

Company
Last Trade
Change
Volume
Shares Out
Market Cap
US$ 769.54
-0.10 -0.01
2.28M
949.31M
US$ 730.530B
US$ 123.45
-1.07 -0.86
3.21M
4.46B
US$ 550.590B
US$ 161.84
1.39 0.87
6.28M
2.41B
US$ 390.030B
US$ 129.45
0.19 0.15
4.96M
2.53B
US$ 327.510B
US$ 178.09
1.34 0.76
3.78M
1.77B
US$ 315.220B
US$ 103.90
1.10 1.07
1.11M
2.04B
US$ 211.960B
US$ 32.96
0.47 1.45
996,043
6.38B
US$ 210.280B
US$ 65.83
1.70 2.65
6.88M
3.10B
US$ 204.070B
US$ 27.76
0.21 0.76
32.48M
5.65B
US$ 156.840B
US$ 289.18
4.00 1.40
2.46M
535.92M
US$ 154.980B
US$ 48.77
0.97 2.03
1.14M
2.50B
US$ 121.930B
US$ 430.11
3.33 0.78
745,785
258.31M
US$ 111.100B
US$ 981.20
16.31 1.69
433,701
107.94M
US$ 105.910B
US$ 51.66
0.33 0.64
10.85M
2.03B
US$ 104.870B
US$ 73.55
0.77 1.06
5.56M
1.25B
US$ 91.940B
US$ 42.22
0.06 0.14
3.37M
2.03B
US$ 85.710B
US$ 14.62
-0.02 -0.14
4.71M
3.14B
US$ 45.910B
US$ 228.74
0.00 0.00
0
188.66M
US$ 43.150B
US$ 96.46
-2.98 -3.00
4.52M
381.28M
US$ 36.780B
US$ 223.32
0.84 0.38
900,915
145.36M
US$ 32.460B
US$ 7.76
-0.04 -0.51
781,727
3.93B
US$ 30.500B
US$ 93.97
0.40 0.43
489,032
237.72M
US$ 22.340B
US$ 157.65
-5.16 -3.17
1.20M
125.95M
US$ 19.860B
US$ 10.99
0.03 0.27
217,124
1.79B
US$ 19.670B
US$ 29.16
0.05 0.17
592,785
653.23M
US$ 19.050B
US$ 155.10
1.32 0.86
215,121
104.28M
US$ 16.170B

Latest Big Pharma Stock News


New England Journal of Medicine Publishes Phase III Data Showing Xolair Significantly Reduced Allergic Reactions Across Multiple Foods in People With Food Allergies

Detailed results from the NIH-sponsored Phase III OUtMATCH study showed treatment with Xolair increased the amount of peanuts, tree nuts, egg, milk and wheat that people as young as 1 year consumed without an allergic reaction The U.S. FDA recently approved Xolair as the first and only medicine for children and adults with one or more food allergies  Allergic reactions can be life-threatening and it is estimated that food-related anaphylaxis results in 30,000 medical... Read more


AstraZeneca: MANDARA Phase III data published in New England Journal of Medicine show remission is an achievable goal in eosinophilic granulomatosis with polyangiitis (EGPA) with FASENRA

FASENRA enabled patients to taper off oral corticosteroids while preventing relapses WILMINGTON, Del. / Feb 23, 2024 / Business Wire / Positive results from the MANDARA Phase III trial for FASENRA® (benralizumab) in patients with EGPA were published in the New England Journal of Medicine today,1 as the first head-to-head trial of biologics in patients with EGPA,2 and the first to demonstrate that more than half of patients achieved remission with eosinophil-targeting... Read more


Biogen’s QALSODY® (tofersen), the First Therapy to Treat Rare, Genetic Form of ALS, Received Positive Opinion from CHMP

SOD1-ALS is a devastating, uniformly fatal, and ultra-rare genetic form of ALS affecting less than 1,000 people in Europe1 With QALSODY, Biogen has advanced the role of neurofilament in the development of new medicines for ALS, with the potential to accelerate further discovery in the field CAMBRIDGE, Mass., Feb. 23, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency... Read more


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 (

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 Committee for Medicinal Products for... 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...

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 Committee for Medicinal Products... Read more


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

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 PARIS, Feb. 23, 2024 (GLOBE NEWSWIRE)... Read more


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

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 Biotherapeutics today announced a multi-year... Read more


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

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 investigational RSV vaccine for... Read more


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

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 decision is August 22, 2024. Linvoseltamab... 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

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) in patients with relapsed or refractory... 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...

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 with previously treated KRASG... Read more


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

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 Phase 3 study of risankizumab... Read more


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

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 (UC) who have had an inadequate response,... Read more


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

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 patients with locally advanced... Read more


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

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 epidermal growth factor receptor-mutated... Read more


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

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 cell lung cancer (NSCLC). The... Read more


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

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 results will be featured in a la... Read more


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

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 and manufacturing authorization... Read more


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

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 Million to $1,500 Million, in Addition... 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...

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 / Bristol Myers Squibb (NYSE: BMY)... 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...

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 for the treatment of patients... Read more


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

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 AI-interpretation and companion diagnostics,... Read more


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

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 SKYCLARYS® (omaveloxolone) for the... Read more


Gilead Sciences Expands Liver Portfolio With Acquisition of CymaBay Therapeutics

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 / Business Wire / Gilead Sciences,... Read more


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

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) has approved EOHILIA (budesonide... Read more


AbbVie Completes Acquisition of ImmunoGen

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 into earlier lines of therapy... 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...

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 unresectable or metastatic HER2... 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

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 TAK-861, an oral orexin receptor 2 (OX2R)... Read more


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

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 in sleep quality and quality of... Read more


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

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 expertise in AI and engage with its robust... Read more


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

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 program of Autolus’ lead cell... Read more


AstraZeneca Full year and Q4 2023 Financial Results

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       % Change     $m   Actual     CER1     $m &nbs... 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...

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 assigned a target action date of October... Read more


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

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® (zanubrutinib) in combination... Read more


Gilead Sciences Announces Fourth Quarter and Full Year 2023 Financial Results

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 for Gilead’s base business,... Read more


Amgen Reports Fourth Quarter And Full Year 2023 Financial Results

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 pipeline milestones in 2024." Key... Read more


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

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., Feb. 6, 2024 /PRNewswire/ -- The... Read more


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

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 be created to initially focus on... 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

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, 2024 PHILADELPHIA / Feb 06, 2024... Read more


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

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 lymphoma under the Accelerated Approval... Read more


Vertex Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results

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 clinical-stage pipeline continues... Read more


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

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 studies  Vertex plans to file for... 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

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 three-year initiative to bridge... Read more


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

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 Import Expo (CIIE) at the National... 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

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 Abecma® (idecabtagene vicleucel)... Read more


Merck Animal Health to Acquire Elanco’s Aqua Business

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 division of Merck & Co., Inc.,... Read more


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

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 collaboration. The acquisition... Read more


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

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 from the Immunology Portfolio Were... Read more


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

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 antibody designed to bridge B-cell maturation... Read more


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

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 and New Product Portfolio Revenues... Read more

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