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 Application (sBLA) seeking approval... 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 resubmission is intended to address previous... 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 / Business Wire / Merck (NYSE: MRK),... 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 first and only treatment to selectively... 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) will review the CHMP recommendation... 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 approved TEVIMBRA® (tislelizumab) as... 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 areas of high unmet need BASEL,... 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 today that it has initiated dosing... 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, onabotulinumtoxinA will be the first and only neurotoxin... 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 pandemic potential The partnership... 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 (CAR) T-cell therapy Yescarta® (axicabtagene... 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 (LSE/NYSE: GSK) today announced that the... 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 treatment of adults with non-small cell... 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 combination regimen with ivacaftor,... 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 / ACCESSWIRE / September 14, 2023 / Moderna,... 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 discuss the company’s R&D strategy... 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. Food and Drug Administration’s (FDA)... 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® (vedolizumab) for maintenance therapy... 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 partner Merck, the Company plans... 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 hormone-sensitive prostate cancer (nmHSPC;... 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 week 48 versus ustekinumab All... 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 Spikevax® for ages 12 years and above.... 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 companies are working closely with... 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 granulomatosis with polyangiitis... 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 presented and featured in the official... 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 TAGRISSO alone for patients with... 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 dose in this tumor type and reinforces... 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 (TSE:4502/NYSE:TAK) today announced positive... 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 (ERS) International Congress 202... 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 results were featured in an oral... 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 evaluating Trodelvy® (sacituzumab govi... 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 previously reported idiopathic pulmonary... 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 perspectives, and further... 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 EC’s decision follows the positive... 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 Adult Patients with Mild-to-Moderate... 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, as with other selected presentations... 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 FL.1.5.1 variants With governments... 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 other regulatory authorities around... 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 way for development of targeted... 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 three-dose regimen of GARDASIL®9 (Human... 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 Data Monitoring Committee determined... 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 today that the Phase 3 innovaTV 301... 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 health authorities globally and presented... 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 parties will jointly file stipulated... 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 website at http://ir.beigene.com, h... 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 will be ready to ship to applicable... 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 mid-point Company reduced outstanding share... 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 psychosocial well-being1 IRVINE, Calif.,... 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 with trastuzumab, fluoropyrimidine-... 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 independence and hemoglobin (Hb) increase... Read more
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