Acceptance based on results from the Phase 3 KEYNOTE-A18 trial, which showed a statistically significant and clinically meaningful improvement in progression-free survival in these patients RAHWAY, N.J. / Sep 20, 2023 / 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 accepted for priority review a new supplemental Biologics License...Read more
OSAKA, Japan & CAMBRIDGE, Mass. / Sep 20, 2023 / Business Wire / Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) resubmission for TAK-721 (budesonide oral suspension) which is being investigated for the short-term treatment of eosinophilic esophagitis (EoE), a chronic inflammatory disease that can cause damage to the esophagus.1 The...Read more
Acceptance based on results from the Phase 3 LITESPARK-005 trial, which showed a statistically significant and clinically meaningful improvement in progression-free survival compared to everolimus in patients with advanced RCC that progressed following PD-1/L1 and VEGF-TKI therapies If approved, WELIREG would provide a new, novel mechanism of action for patients with advanced RCC in need of new options RAHWAY, N.J. / Sep 19, 2023 /...Read more
NEW YORK / Sep 19, 2023 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has granted marketing authorization for LITFULO™ (ritlecitinib) to treat adults and adolescents 12 years of age and older with severe alopecia areata. LITFULO, a once-daily oral capsule, is the first medicine authorized by the EC to treat individuals as young as 12 years of age with severe alopecia areata. LITFULO is also the...Read more
This Positive Opinion Reinforces Veklury’s Strong Safety Profile FOSTER CITY, Calif. / Sep 19, 2023 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted a positive opinion for the use of Veklury® (remdesivir) to treat people with COVID-19 with mild to severe hepatic impairment. The European Commission (EC)...Read more
European Commission approves TEVIMBRA for previously treated advanced or metastatic esophageal squamous cell carcinoma (ESCC) U.S. FDA accepts Biologics License Application in first-line advanced ESCC BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass. / Sep 19, 2023 / Business Wire / BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that the European Commission (EC) has...Read more
Regulatory marketing applications for U.S. and EU under review, with plans to expand TEVIMBRA commercial presence worldwide TEVIMBRA is the cornerstone of BeiGene’s solid tumor portfolio, potentially pairing with more than 20 internal investigational assets as part of a broad, flexible combination strategy Regaining global rights furthers Company’s mission of bringing innovative, affordable medicines to more patients and addressing...Read more
Investigational VVD-130037 is highly specific, potent Kelch-like ECH Associated Protein 1 (KEAP1) activator developed for treatment of advanced solid tumors Major milestone for Vividion’s chemoproteomics innovative technology platform First-in-class clinical candidate to target cancers with activation of KEAP1-NRF2 pathway Berlin, Germany, San Diego, CA, USA, September 18, 2023 – Vividion Therapeutics, Inc. (Vividion), announced...Read more
All primary and secondary endpoints were met for second Phase 3 study (M21-310) and results were consistent with findings from first Phase 3 study (M21-309). Results support onabotulinumtoxinA as a potential treatment option for moderate to severe platysma prominence. Data will be included as part of an upcoming U.S. Food and Drug Administration regulatory submission expected near the end of the year. If approved,...Read more
BioNTech is initiating a Phase 1/2 clinical trial of the mRNA-based mpox vaccine program, BNT166 The Coalition for Epidemic Preparedness Innovations (CEPI) commits funding of up to $90 million for the development of vaccine candidates Data generated by this partnership will contribute to CEPI’s 100 Days Mission, a global effort to accelerate the development of well-tolerated and effective vaccines against future viral threats with...Read more
Yescarta Achieved a Complete Metabolic Response (CMR) of 71% at 3 Months Versus 12% Expected with Historical Standard of Care Controls Results Published in Nature Medicine SANTA MONICA, Calif. / Sep 18, 2023 / Business Wire / Kite, a Gilead Company (Nasdaq: GILD), today announced results from the Phase 2 ALYCANTE study, led and sponsored by the French collaborative group LYSA/LYSARC, for use of its chimeric antigen receptor...Read more
Approval is for use in myelofibrosis patients with anemia regardless of prior myelofibrosis therapy Nearly all myelofibrosis patients are estimated to develop anemia over the course of the disease, and over 30% will discontinue treatment due to anemia1,2,3 Ojjaara addresses key manifestations of myelofibrosis, namely anemia, constitutional symptoms and splenomegaly LONDON / Sep 15, 2023 / Business Wire / GSK plc...Read more
Opinion granted based on positive disease-free survival results from the Phase 3 KEYNOTE-091 trial RAHWAY, N.J. / Sep 15, 2023 / 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 for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, for the adjuvant...Read more
If approved, more than 1,200 children would be newly eligible for a medicine that could treat the underlying cause of their disease BOSTON / Sep 15, 2023 / Business Wire / Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the label extension of KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in a...Read more
The positive opinion follows the recommendation from regulators and global public health bodies to develop monovalent XBB.1.5 COVID-19 vaccines for autumn/winter 2023 vaccination campaigns Clinical trial data from research assay confirmed Moderna's updated COVID-19 vaccine showed an 8.7 to 11-fold increase in neutralizing antibodies against circulating variants, including BA.2.86, EG.5, and FL.1.5.1 variants CAMBRIDGE, MA /...Read more
Registrational assets expected to double from six to 12 over next 18 months Cell Therapy and Targeted Protein Degradation platforms offer potential to expand treatment options across multiple therapeutic areas Enhanced approach to R&D expected to drive top-tier productivity PRINCETON, N.J. / Sep 14, 2023 / Business Wire / Bristol Myers Squibb (NYSE: BMY) is today holding a Research and Development (R&D) Day in New York to...Read more
Cardiovascular and Renal Drugs Advisory Committee Voted 9:3 That the Benefits of Patisiran Outweigh its Risks for the Treatment of the Cardiomyopathy of ATTR Amyloidosis Prescription Drug User Fee Act Target Action Date is October 8, 2023 CAMBRIDGE, Mass. / Sep 13, 2023 / Business Wire / Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced the positive outcome of the U.S....Read more
Applications for Investigational Subcutaneous Administrations for Both Crohn’s Disease and Ulcerative Colitis Are Now Under Review by the FDA OSAKA, Japan & CAMBRIDGE, Mass. / Sep 13, 2023 / Business Wire / Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) for the investigational subcutaneous (SC) administration of ENTYVIO®...Read more
Company's flu vaccine, mRNA-1010, met its primary endpoint in Phase 3 trial; separate Phase 1/2 data demonstrated higher HAI titers than Fluzone HD Vaccine pipeline advancing rapidly with Company announcing the completion of RSV BLA filing (mRNA-1345), completion of adult enrollment in the Phase 3 trial of mRNA-1647, a first-in-class vaccine against CMV, and the Phase 3 trial of mRNA-1283, a next-generation COVID-19 vaccine With its...Read more
Application based on results from Phase 3 EMBARK trial, which showed XTANDI plus leuprolide reduced risk of metastasis or death by 58% TOKYO, Sept. 12, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the European Medicines Agency (EMA) has validated its Type II variation for XTANDI® (enzalutamide) for the treatment of patients with non-metastatic...Read more
SEQUENCE, a Phase 3 head-to-head study (study drug open-label and efficacy assessment blinded) compared risankizumab to ustekinumab for the treatment of adult patients with moderately to severely active Crohn's disease who have failed one or more anti-TNFs1 Risankizumab met both primary endpoints of non-inferiority for clinical remission (Crohn's Disease Activity Index [CDAI]) at week 24 and superiority of endoscopic remission at...Read more
Clinical data show robust immune responses across multiple circulating variants, including EG.5, FL.1.5.1, and BA.2.86Updated vaccine to be available in pharmacies and care settings across the U.S. in the coming days CAMBRIDGE, MA / ACCESSWIRE / September 11, 2023 / Moderna, Inc. (NASDAQ:MRNA) today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application(sBLA) for...Read more
This season’s vaccine is tailored to the SARS-CoV-2 XBB.1.5 sublineage and indicated as a single dose for most individuals 5 years of age and older Pre-clinical data show that the updated COVID-19 vaccine generates improved neutralizing antibody responses against multiple circulating Omicron-related sublineages including XBB.1.5, BA.2.86 (Pirola), and EG.5.1 (Eris), which currently accounts for the largest portion of U.S. cases1 The...Read more
First head-to-head trial of biologics in EGPA, comparing a single monthly injection of FASENRA to three injections per month of mepolizumab WILMINGTON, Del. / Sep 11, 2023 / Business Wire / Positive high-level results from the MANDARA Phase III trial showed AstraZeneca’s FASENRA (benralizumab) met the primary endpoint of the trial and demonstrated non-inferior rates of remission compared to mepolizumab in patients with eosinophilic...Read more
Data from longest reported follow-up for a Phase 3 trial with immunotherapy in metastatic non-small cell lung cancer demonstrate consistent, durable benefits of Opdivo plus Yervoy vs. chemotherapy at six years, regardless of PD-L1 expression Opdivo plus Yervoy combination more than tripled overall survival rate at six years compared to chemotherapy in patients with PD-L1 expression <1% in an exploratory analysis Updated data to be...Read more
Combination reduced the risk of disease progression by 38% versus TAGRISSO monotherapy, the current 1st-line global standard of care WILMINGTON, Del. / Sep 11, 2023 / Business Wire / Positive results from the FLAURA2 Phase III trial showed AstraZeneca’s TAGRISSO® (osimertinib) in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), compared to...Read more
AstraZeneca and Daiichi Sankyo’s ENHERTU showed objective response rates of 49% and 56% with 5.4mg/kg and 6.4mg/kg doses respectively in primary analysis ENHERTU provided a median progression-free survival of 9.9 months at 5.4mg/kg dose and 15.4 months at 6.4mg/kg dose with a median duration of response of 16.8 months seen at the 5.4mg/kg dose and not reached at the 6.4mg/kg dose Favorable safety profile confirms 5.4mg/kg as optimal...Read more
Topline Results for TAK-279 Show that a Significantly Greater Proportion of Psoriatic Arthritis Patients Achieved at Least an ACR20 Response Compared to Placebo at Week 121 Based on the Positive Results, Takeda Intends to Initiate a Phase 3 Study of TAK-279 in Psoriatic Arthritis Full Clinical Results Will be Presented at an Upcoming Medical Meeting OSAKA, Japan & CAMBRIDGE, Mass. / Sep 11, 2023 / Business Wire / Takeda...Read more
Exploratory post-hoc analysis of STELLAR shows potential of sotatercept to improve cardiovascular function Interim results from SOTERIA open-label extension study represent longest safety and efficacy analysis of sotatercept to date; safety profile of sotatercept consistent with previous studies and efficacy improvements maintained after one year of therapy Nine Merck-sponsored abstracts in PAH featured at European Respiratory Society...Read more
In Phase 1b Study, Patients Treated in First-Line Demonstrated a Confirmed Objective Response Rate of 65% THOUSAND OAKS, Calif., Sept. 10, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced exciting data from a study arm of the CodeBreaK 101 clinical trial, a Phase 1b study evaluating LUMAKRAS® (sotorasib) with carboplatin and pemetrexed in adult patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC). These...Read more
Results Show Encouraging Activity of Trodelvy in Combination with KEYTRUDA in 1L Metastatic NSCLC Across all PD-L1 Subgroups and Histologies Studied Results Support Further Investigation of Trodelvy in Combination with KEYTRUDA in 1L Metastatic NSCLC FOSTER CITY, Calif. / Sep 10, 2023 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced promising early data from the global, open-label, Phase 2 EVOKE-02 study...Read more
Results show 26 weeks of treatment with twice-daily 60 mg dose of BMS-986278 resulted in a 69% relative reduction in the rate of decline in percent predicted forced vital capacity versus placebo Treatment effect was consistent with or without background therapy and BMS-986278 was well tolerated, with rates of adverse events similar to placebo and low discontinuation rates These progressive pulmonary fibrosis findings, along with the...Read more
TARRYTOWN, N.Y., Sept. 08, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that Kathryn Guarini, Ph.D., and David P. Schenkein, M.D., have joined Regeneron’s Board of Directors effective September 8, 2023. “Today’s announcement demonstrates our strong commitment to strategic refreshment of the Board, a focus on the recruitment of new directors to complement the overall mix of skills, experience and...Read more
Milestone signifies ongoing effort to help prepare for outbreaks of Zaire ebolavirus RAHWAY, N.J. / Sep 07, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the European Commission (EC) has approved an expanded indication for ERVEBO for active immunization of individuals 1 year of age or older to protect against Ebola Virus Disease (EVD) caused by Zaire ebolavirus. The...Read more
Zilebesiran Met Primary Endpoint Demonstrating Greater than 15 mmHg Reduction of Systolic Blood Pressure at Three Months of Treatment Compared to Placebo at Two Highest Single Doses Evaluated Study Met Key Secondary Endpoints Showing Consistent and Sustained Reductions of Systolic Blood Pressure at Six Months, Supporting Quarterly or Biannual Dosing Zilebesiran Demonstrated an Encouraging Safety and Tolerability Profile in...Read more
THOUSAND OAKS, Calif., Sept. 7, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the Morgan Stanley Global Healthcare Conference at 8:50 a.m. ET on Tuesday, Sept. 12, 2023. Robert A. Bradway, chairman and chief executive officer at Amgen will present at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public. The webcast,...Read more
CDC notes that the BA.2.86 (Pirola) variant may be more likely to break through existing immunity from previous vaccination or infection, highlighting the need for vaccination with an updated COVID-19 vaccine for the fall 2023 season Clinical trial data from research assay confirmed Moderna's updated COVID-19 vaccine showed an 8.7 to 11-fold increase in neutralizing antibodies against circulating variants, including BA.2.86, EG.5, and...Read more
Acceptance based on the Phase III COMMODORE 2 study, which demonstrated crovalimab achieved disease control and was well-tolerated in people with paroxysmal nocturnal hemoglobinuria (PNH) If approved, crovalimab will be the first monthly subcutaneous treatment for PNH, with the option to self-administer outside of a supervised healthcare setting Filing applications have also been accepted in the EU, China and Japan, and submissions to...Read more
CAMBRIDGE, Mass., Sept. 06, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced the appointment of Jane Grogan, Ph.D., as Executive Vice President, Head of Research effective 2 October 2023. Dr. Grogan will be a member of Biogen’s Executive Committee reporting to Christopher A. Viehbacher, President and Chief Executive Officer. “Dr. Grogan is a pioneering scientist whose groundbreaking discoveries at Genentech helped pave the...Read more
Data showed no cases of certain HPV-related high-grade disease, certain studied cancers or genital warts through 10 years for boys and girls vaccinated at ages 9-15 years RAHWAY, N.J. / Sep 05, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced new, 10-year long-term follow-up (LTFU) data published in the peer reviewed journal, Pediatrics, for girls and boys who received a...Read more
BOTHELL, Wash. & COPENHAGEN, Denmark / Sep 04, 2023 / Business Wire / Seagen Inc. (Nasdaq: SGEN) and Genmab A/S (Nasdaq: GMAB) announced today that the Phase 3 innovaTV 301 global trial in recurrent or metastatic cervical cancer patients with disease progression on or after front-line therapy who received TIVDAK® (tisotumab vedotin-tftv), compared with chemotherapy alone, met its primary endpoint of overall survival (OS). An Independent...Read more
Phase 3 innovaTV 301 confirmatory trial met its primary endpoint of improved overall survival (OS) at predetermined, independent interim analysis Trial results to be submitted for presentation at a future medical meeting Genmab and Seagen to engage in discussions with regulatory authorities COPENHAGEN, Denmark & BOTHELL, Wash. / Sep 04, 2023 / Business Wire / Genmab A/S (Nasdaq: GMAB) and Seagen Inc. (Nasdaq: SGEN) announced...Read more
ALINA data demonstrate Alecensa reduces disease recurrence in the early setting for people with ALK-positive non-small cell lung cancer (NSCLC), building on its long-established benefit in the advanced setting About half of people with NSCLC experience disease recurrence following surgery, despite adjuvant chemotherapy, therefore new treatments are urgently needed to provide the best chance for cure These data will be submitted to...Read more
THOUSAND OAKS, Calif. and DUBLIN, Sept. 1, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Horizon Therapeutics plc (NASDAQ:HZNP) today announced the entry into a consent order agreement with the Federal Trade Commission (FTC) that resolves the pending FTC administrative lawsuit. This clears the path to take the final steps to close Amgen's acquisition of Horizon. As a result of the consent order agreement, Amgen and Horizon expect that the...Read more
BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass. / Aug 31, 2023 / Business Wire / BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that the Company will participate in the Morgan Stanley 21st Annual Global Healthcare Conference on Monday, September 11th, 2023 with a fireside chat at 9:20 am ET. A live webcast of this event can be accessed from the investors section of BeiGene’s...Read more
The updated COVID-19 vaccine is tailored to the Omicron XBB.1.5 sublineage of SARS-CoV-2 and is recommended for individuals 6 months of age and older Recommendation is based on pre-clinical data showing that the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine generates an improved response against multiple XBB-related sublineages, including XBB.1.5, XBB.1.16, XBB.2.3, and EG.5.1 (Eris), which continue to dominate globally1 Doses...Read more
Company expects increased 2023 Reported Sales Growth of 7.0% - 8.0%, Operational Sales Growth of 7.5% - 8.5%, and Adjusted Operational Sales Growth of 6.2% - 7.2%; Figures exclude the COVID-19 Vaccine Company expects 2023 Adjusted Reported Earnings Per Share (EPS) of $10.00 - $10.10, reflecting increased growth of 12.5% at the mid-point and Adjusted Operational EPS of $9.90 - $10.00, reflecting increased growth of 11.5% at the...Read more
At day 30, approximately 90% of all study patients were satisfied with treatment resulting in a natural look and more than 80% of all study patients were satisfied with natural-looking outcomes throughout the 12-month study period for the temporary improvement in the appearance of their moderate to severe upper facial lines1 At day 30, more than half of patients experienced a notable difference in self-perceived appearance and...Read more
Approval based on progression-free survival benefit demonstrated in Phase 3 KEYNOTE-811 trial KEYTRUDA is the first immunotherapy approved in the EU for the first-line treatment of this patient population RAHWAY, N.J. / Aug 29, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination...Read more
Reblozyl is the first and only therapy to demonstrate superiority compared to an erythropoiesis stimulating agent (ESA) in MDS-related anemia based on interim results from pivotal Phase 3 COMMANDS trial, expanding approved population to ESA-naïve patients, regardless of ring sideroblast status In head-to-head study, results showed Reblozyl nearly doubled the percent of patients achieving primary endpoint of concurrent transfusion...Read more
BOSTON / Aug 29, 2023 / Business Wire / Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that E. Morrey Atkinson, Ph.D., has been appointed Executive Vice President, Chief Technical Operations Officer, Head of Biopharmaceutical Sciences and Manufacturing Operations, effective immediately. Dr. Atkinson has served as Senior Vice President of Global Commercial Manufacturing and Supply Chain since July 2020. This new role and...Read more
Results from VALOR-HCM LTE (56 weeks) demonstrated that with longer follow-up, CAMZYOS continued to reduce eligibility for invasive SRT at 56 weeks EXPLORER-LTE data (cumulative analysis up to 120 weeks) showed sustained improvements in LVOT obstruction, symptoms, and NT-proBNP levels in patients with symptomatic obstructive HCM, with no new safety signals observed CAMZYOS was recently approved in the European Union, following its...Read more
Submissions are supported by two Phase 3 clinical trials demonstrating risankizumab achieved the primary endpoint of clinical remission (per Adapted Mayo Score) and key secondary endpoints as an induction and maintenance treatment1,2 Safety results were generally consistent with the known safety profile of risankizumab, with no new safety risks observed1,2 Risankizumab is an IL-23 inhibitor being evaluated as a treatment for...Read more
Cellares to provide proof-of-concept manufacturing for a key BMS CAR-T cell therapy Cellares' proprietary Cell Shuttle is a cost-efficient, reliable, fully automated, and highly scalable manufacturing solution Bristol Myers Squibb is the latest company to join Cellares' TAP program to evaluate potential benefits in meeting patient demand, lowering process failure rates, lowering manufacturing costs, and accelerating scale-out SOUTH...Read more
Amgen is Changing the Cardiovascular Disease Treatment Landscape With New Research on Innovative Lipid Management New Olpasiran Phase 2 Data Demonstrates Continued Reduction of Lp(a) Nearly a Year After the Last Dose Amgen Convenes First LDL Awareness to Action Implementation Consortium THOUSAND OAKS, Calif., Aug. 26, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced data from the final analysis of the Phase 2...Read more
Amsterdam, Netherlands, 25 August 2023 – Novo Nordisk (NYSE: NVO) today announced results from the phase 3 STEP HFpEF trial showing that compared with placebo, once-weekly semaglutide 2.4 mg led to large reductions in heart failure-related symptoms, physical limitations and improvements in exercise function, and resulted in greater weight loss in adults with heart failure with preserved ejection fraction...Read more
Switching from Eliquis (apixaban) to rivaroxaban in Non-Valvular Atrial Fibrillation (NVAF) patients was associated with a higher risk of stroke/systemic embolism (S/SE) and major bleeding (MB) than those who continued Eliquis PRINCETON, N.J. & NEW YORK / Aug 25, 2023 / Business Wire / The Bristol Myers Squibb-Pfizer (BMS NYSE: BMY) – (Pfizer NYSE: PFE) Alliance today presented results from ATHENS, a retrospective real-world data...Read more
RAHWAY, N.J. & NUTLEY, N.J. / Aug 25, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Eisai today provided an update on the Phase 3 LEAP-010 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, as a first-line treatment for patients with recurrent or metastatic head and neck...Read more
Program plans to enroll approximately 17,000 participants across three global studies RAHWAY, N.J. / Aug 25, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the initiation of the company’s Phase 3 clinical program, CORALreef, for MK-0616, an investigational, oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, being evaluated for the treatment of adults...Read more
CAMBRIDGE, Mass. / Aug 25, 2023 / Business Wire / Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced an update on its ongoing patent infringement litigation. On March 17, 2022, Alnylam initiated litigation in the United States District Court for the District of Delaware against Moderna for patent infringement. To date, in two separate actions against Moderna, Alnylam has sought to recover...Read more
Company files legal challenge to protect timely access to medicines for orphan indications in the US WILMINGTON, Del. / Aug 25, 2023 / Business Wire / To help protect access to medicines for cancer and rare disease patients, AstraZeneca today has filed a legal challenge to critical aspects of the drug price negotiation provisions of the Inflation Reduction Act (IRA). The drug price negotiation provisions of the IRA run headlong into...Read more
ABRYSVO is the first and only RSV vaccine approved in the European Union (EU) for both older adults and for immunization of pregnant individuals to help protect their infants immediately from birth through six months of age NEW YORK / Aug 24, 2023 / Business Wire / Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has granted marketing authorization for ABRYSVO™, the company’s bivalent respiratory syncytial...Read more
First PARP inhibitor approved in Japan to demonstrate clinically meaningful benefits in combination with a new hormonal agent RAHWAY, N.J. / Aug 24, 2023 / Business Wire / AstraZeneca and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that LYNPARZA in combination with abiraterone and prednisone or prednisolone (abi/pred) has been approved in Japan for the treatment of adult patients with...Read more
This Approval Supports Veklury’s Strong Safety Profile and Makes Veklury the Only Approved COVID-19 Antiviral Treatment Across all Stages of Liver Disease FOSTER CITY, Calif. / Aug 24, 2023 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) for the use of Veklury® (remdesivir) with no dose adjustments to treat...Read more
SOUTH SAN FRANCISCO, Calif. / Aug 23, 2023 / Business Wire / Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), has been made aware of an inadvertent disclosure of the second interim analysis of the Phase III SKYSCRAPER-01 study, evaluating the investigational anti-TIGIT immunotherapy tiragolumab plus Tecentriq® (atezolizumab) versus Tecentriq alone as an initial (first-line) treatment for people with PD-L1-high locally...Read more
If approved, XTANDI would become the first and only novel hormone therapy approved in this earlier type of prostate cancer NEW YORK and TOKYO, Aug. 23, 2023 /PRNewswire/ -- Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the companies' supplemental New Drug...Read more
FOSTER CITY, Calif. / Aug 23, 2023 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its executives will be speaking at the following investor conferences: Wells Fargo Healthcare Conference Wednesday, September 6 at 11:00 am ET Morgan Stanley Annual Global Healthcare Conference on Tuesday, September 12 at 11:30 am ET The live webcasts can be accessed at the company’s investors page at investors.gilead.com. The...Read more
TARRYTOWN, N.Y., Aug. 23, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) will webcast management participation as follows: • 2023 Wells Fargo Healthcare Conference at 8:45 a.m. ET on Wednesday, September 6, 2023 • Morgan Stanley 21st Annual Global Healthcare Conference at 9:20 a.m. ET on Monday, September 11, 2023 The sessions may be accessed from the "Investors & Media" page of Regeneron's...Read more
Approval based on results from the Phase 3 CheckMate -76K trial in patients with stage IIB or IIC melanoma, in which Opdivo reduced the risk of recurrence or death by 58% versus placebo Opdivo is the only PD-1 inhibitor that is indicated as an adjuvant treatment for patients within stages IIB, IIC, III, as well as stage IV resected melanoma PRINCETON, N.J. / Aug 22, 2023 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today...Read more
TARRYTOWN, N.Y., Aug. 22, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the Biomedical Advanced Research and Development Authority (BARDA) has entered into an agreement with Regeneron to support clinical development, clinical manufacturing and the regulatory licensure process of a next-generation COVID-19 monoclonal antibody therapy for the prevention of SARS-CoV-2 infection. The agreement is...Read more
INDIANAPOLIS, Aug. 22, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced topline results from the LIBRETTO-531 study evaluating Retevmo versus physician's choice of the multikinase inhibitors (MKIs) cabozantinib or vandetanib as an initial treatment for patients with advanced or metastatic rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC). The study met its primary endpoint, demonstrating a...Read more
First and only U.S. approval of a maternal vaccine to help protect infants at birth through six months of life from lower respiratory tract disease (LRTD) and severe LRTD due to RSV FDA’s decision is based on data from the pivotal Phase 3 clinical trial in more than 7,000 pregnant individuals, and including their infants a total greater than 14,000 trial participants NEW YORK / Aug 21, 2023 / Business Wire / Pfizer Inc. (NYSE: PFE)...Read more
THOUSAND OAKS, Calif., Aug. 21, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) will review data supporting the supplemental New Drug Application (sNDA) for the full approval of LUMAKRAS® (sotorasib) for adults with previously treated locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC) at a meeting on Oct. 5,...Read more
Enrolled Patients May Continue Receiving Study Medicine Studies in Solid Tumors Unaffected FOSTER CITY, Calif. / Aug 21, 2023 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on the initiation of new patients in U.S. studies evaluating magrolimab to treat acute myeloid leukemia (AML). The FDA action follows the...Read more
Approval based on the pivotal PULSAR and PHOTON trials in which EYLEA® HD demonstrated clinically equivalent vision gains to EYLEA (aflibercept) Injection 2 mg that were maintained with fewer injections First and only treatment approved in wAMD and DME for immediate dosing at 8-week and up to 16-week intervals following three initial monthly doses TARRYTOWN, N.Y., Aug. 18, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc....Read more
CHAPLE is an ultra-rare hereditary disease that can cause potentially life-threatening gastrointestinal and cardiovascular symptoms Approval represents 10th FDA-approved medicine invented by Regeneron With the approval of Veopoz, the pre-approval inspection issues related to the aflibercept 8 mg biologics license application (BLA) have been addressed FDA action on the aflibercept 8 mg BLA is expected in the next few...Read more
Journal Of Health Care for the Poor and Underserved Supplement Details COMPASS Progress at the Halfway Mark of the Ten-Year Initiative FOSTER CITY, Calif. & NASHVILLE, Tenn. / Aug 18, 2023 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) and Meharry Medical College, one of the nation’s oldest and largest historically Black academic health science centers, today announced the publication of a new supplemental issue of Meharry...Read more
First positive Phase 3 results for WELIREG from LITESPARK-005 showed statistically significant improvements in PFS versus everolimus in these patients RAHWAY, N.J. / Aug 18, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced topline results from LITESPARK-005, the first positive Phase 3 trial investigating WELIREG, Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α)...Read more
Updated COVID-19 vaccine effectively targets EG.5, a dominant variant of concern, as well as the rapidly spreading FL 1.5.1 variant Updated vaccine expected to be available, pending approval, in coming weeks for fall vaccination season CAMBRIDGE, MA / ACCESSWIRE / August 17, 2023 / Moderna, Inc. (NASDAQ:MRNA) today announced that preliminary clinical trial data confirm its updated COVID-19 vaccine for the fall 2023 vaccination...Read more
AQUIPTA® (atogepant) is the first and only once-daily oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) in the European Union (EU) approved for the prophylaxis of migraine in adults who have four or more migraine days per month Approval is based on two pivotal Phase 3 studies that demonstrated statistically significant reduction in mean monthly migraine days with AQUIPTA compared to placebo in adult patients with...Read more
TARRYTOWN, N.Y., Aug. 17, 2023 (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 odronextamab to treat adult patients with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), who have progressed after at least two prior systemic therapies. The EMA...Read more
Ahead of the fall and winter RSV season, AREXVY is now widely available in major retail pharmacies and anticipated to be covered by most Medicare and commercial insurance plans PHILADELPHIA / Aug 17, 2023 / Business Wire / GSK plc (LSE/NYSE: GSK) today announced that AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) is now available in the US at all major retail pharmacies. In June, the Advisory Committee on Immunization...Read more
The cobas® connection modules (CCM) sample conveyors system has been extended with newly developed elevator and overhead conveyor modules enabling more flexibility in lab design. CCM Vertical optimises the use of laboratory space without compromising on sample throughput of CCM up to 2,500 samples per hour. The fully modular system allows connection of different work areas in the laboratory without blocking walkways and enabling...Read more
Repotrectinib continued to demonstrate high response rates and durable responses, including robust intracranial responses, in patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer who were TKI-naïve or previously treated with one TKI and no chemotherapy Median duration of response and progression-free survival to be disclosed for the first time in the pooled Phase 1/2 population alongside updated results...Read more
FLAURA2 data reinforce TAGRISSO® as backbone therapy for EGFR-mutated advanced lung cancer in combination with chemotherapy; granted Breakthrough Therapy Designation in the US Further results for ENHERTU®, IMFINZI® and datopotamab deruxtecan showcase strength of diverse ADC and IO portfolios to address unmet needs WILMINGTON, Del. / Aug 16, 2023 / Business Wire / AstraZeneca advances its robust lung cancer portfolio and pipeline at...Read more
BOTHELL, Wash. / Aug 16, 2023 / Business Wire / Seagen Inc. (Nasdaq: SGEN) today announced that the Phase 3 HER2CLIMB-02 clinical trial of TUKYSA® (tucatinib) in combination with the antibody-drug conjugate ado-trastuzumab emtansine (Kadcyla®) met its primary endpoint of progression-free survival (PFS). Patients in the trial had unresectable locally advanced or metastatic human epidermal growth factor receptor 2-positive (HER2-positive)...Read more
Collaboration Combines Gilead’s Oncology and Inflammation Expertise and Tentarix’s Tentacles™ Platform Gilead Receives Exclusive Rights to Acquire Novel Therapies From this Collaboration FOSTER CITY, Calif. & SAN DIEGO / Aug 15, 2023 / Business Wire / Gilead Sciences, Inc. (Nasdaq:GILD) and Tentarix Biotherapeutics today announced that the companies established three multi-year collaborations leveraging Tentarix’s...Read more
Study participants include children up to and including 36 months who attend group child care and early childhood education settings located in Worcester and Cambridge WORCESTER, Mass., Aug. 14, 2023 /PRNewswire/ -- UMass Chan Medical School today announced it will begin enrolling participants at group child care and early childhood education settings in Worcester and Cambridge to examine the impact of cytomegalovirus (CMV)...Read more
The approval of ELREXFIO (elranatamab-bcmm) is based on clinically meaningful response rates and duration of response from Phase 2 MagnetisMM-3 study ELREXFIO is the first off-the-shelf (ready-to-use) fixed-dose subcutaneous BCMA-directed agent in the U.S. with the option for every-other-week long-term dosing after 24 weeks of weekly treatment Pfizer continues to advance the MagnetisMM clinical program to expand ELREXFIO into earlier...Read more
INDIANAPOLIS, Aug. 14, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced the successful completion of its acquisition of Versanis Bio. The acquisition expands Lilly's portfolio to include Versanis' lead asset, bimagrumab, which is currently being assessed in a Phase 2b study alone and in combination with semaglutide in adults living with overweight or obesity. "Combining our current incretin portfolio, including...Read more
| Company | Change | Last Trade |
|---|---|---|
| Vertex Pharmaceuticals | 1.97 0.56 | $354.28 |
| Roche | 0.55 1.55 | $35.93 |
| Bristol-Myers Squibb | 0.31 0.53 | $59.09 |
Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by rare and niche allergic and immunological diseases. Our lead program, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein in clinical development...
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