WILMINGTON, Del. / Mar 27, 2023 / Business Wire / Positive high-level results from the NEURO-TTRansform Phase III trial in patients with hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN) showed eplontersen met its co-primary endpoints through 66 weeks. The results were consistent with the positive 35-week findings announced in June 2022.1 At 66 weeks, patients treated with eplontersen continued to demonstrate a...Read more
Eplontersen met co-primary endpoints demonstrating sustained reduction in TTR and benefits in neuropathy and quality of life through 66 weeks 35 and 66-week data to be presented at the American Academy of Neurology (AAN) Annual Meeting in April CARLSBAD, Calif., March 27, 2023 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced positive topline results from the 66-week analysis of the Phase 3 NEURO-TTRansform...Read more
Vertex to receive non-exclusive rights to CRISPR Therapeutics’ CRISPR/Cas9 to accelerate development of potentially curative cell therapies for T1D CRISPR Therapeutics to receive $100M upfront payment plus milestone and royalty payments on potential future gene-edited hypoimmune T1D products BOSTON & ZUG, Switzerland / Mar 27, 2023 / Business Wire / Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and CRISPR Therapeutics...Read more
Expanded and advanced oncology pipeline to 20 programs in 24 ongoing clinical trials including five ongoing randomized Phase 2 clinical trials; multiple trials with registrational potential expected to be initiated in 2023 and 2024 Announced licensing agreement with OncoC4 to complement the Company’s oncology portfolio with clinical stage next-generation immune checkpoint modulator; a randomized Phase 3 trial planned to start in...Read more
WOONSOCKET, R.I. and DALLAS and NEW YORK, March 27, 2023 /PRNewswire/ -- CVS Health® (NYSE: CVS) today announced it expects to complete its acquisition of Signify Health (NYSE: SGFY) on or around March 29, 2023, subject to the satisfaction or waiver of the remaining customary closing conditions set forth in the merger agreement. The companies entered into a definitive agreement in September 2022 under which CVS Health...Read more
California’s Desert Oasis Healthcare (DOHC) implements Rimidi’s Respiratory Module for respiratory patient monitoring, based on data collected by Teva’s Digihaler® System Digihaler is the first and only smart inhaler system that can provide objective data to help patients and their doctors better support asthma management Teva and Rimidi look to expand respiratory monitoring program to additional health systems with the aim of...Read more
WILMINGTON, Del. & TOKYO / Mar 27, 2023 / Business Wire / Incyte (Nasdaq:INCY) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Pemazyre® (pemigatinib), a selective fibroblast growth factor receptor (FGFR) inhibitor, for the treatment of myeloid/lymphoid neoplasms (MLNs) with FGFR1 fusion (also known as 8p11 myeloproliferative syndrome). MLNs are a rare, aggressive group of cancers...Read more
WILMINGTON, Del. / Mar 23, 2023 / Business Wire / Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for ruxolitinib extended-release (XR) tablets, a JAK1/JAK2 inhibitor, for once-daily (QD) use in the treatment of certain types of myelofibrosis (MF), polycythemia vera (PV) and graft-versus-host disease (GVHD). The complete response letter states that the FDA cannot...Read more
A significantly higher proportion of patients with moderately to severely active ulcerative colitis treated with risankizumab achieved the primary endpoint of clinical remissiona (per Adapted Mayo Score) compared to placebo at week 12 in the Phase 3 INSPIRE induction study All secondary endpoints, including clinical, endoscopic and histologic outcomes, were met Safety results in this study were consistent with the known safety profile...Read more
Results of the M19-130 (SLEek) Phase 2 trial of upadacitinib given alone or as a combination therapy (ABBV-599) met the primary endpoint of systemic lupus erythematosus (SLE) Responder Index (SRI-4) and steroid dose less than or equal to 10 mg prednisone equivalent once per day at week 24 in patients with moderately to severely active SLE1,2 No new safety signals were identified with upadacitinib, and a similar safety profile was...Read more
Royalty Pharma has acquired an interest in PureTech’s royalty in Karuna Therapeutics’ KarXT; Royalty Pharma and PureTech will share in royalties above certain annual sales thresholds PureTech retains its current equity stake in Karuna in addition to milestone payments and 20% of sublicense revenues due to PureTech Transaction provides further non-dilutive capital for PureTech’s growing and rapidly advancing Wholly Owned Pipeline, with...Read more
First and only biologic to demonstrate clinically meaningful and statistically significant reduction (30%) in exacerbations compared to placebo First and only biologic to show rapid and significant improvement in lung function (160 mL in FEV1) compared to placebo (77 mL in FEV1) First and only biologic to demonstrate significant improvements in quality of life and respiratory symptoms COPD is the third leading cause of death...Read more
If approved, tofersen will be the first treatment targeting a genetic cause of ALS and the next marketed Ionis-discovered antisense medicine FDA decision expected by April 25, 2023 CARLSBAD, Calif., March 22, 2023 /PRNewswire/ -- Ionis (Nasdaq: IONS) today announced the outcome of the U.S. Food and Drug Administration's (FDA) Peripheral and Central Nervous System Drugs Advisory Committee meeting on tofersen, an investigational...Read more
CAMBRIDGE, Mass., March 22, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced today the outcome of the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee meeting on tofersen, an investigational product for the treatment of superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). On the question, “Is the available evidence sufficient to conclude that a...Read more
First regulatory approval for Incyte PD-1 inhibitor based on the results of the POD1UM-201 trial Zynyz is also being studied in additional tumor types and in combination with other Incyte pipeline compounds WILMINGTON, Del. / Mar 22, 2023 / Business Wire / Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Zynyz™ (retifanlimab-dlwr), a humanized monoclonal antibody targeting programmed...Read more
NORTH CHICAGO, Ill., March 22, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) for ABBV-951 (foscarbidopa/foslevodopa) for the treatment of motor fluctuations in adults with advanced Parkinson's disease. In its letter, the FDA requested additional information about the device (pump) as part of the NDA...Read more
Approval extends Evkeeza to children aged 5 to 11 with homozygous familial hypercholesterolemia (HoFH), an inherited condition characterized by extremely high low-density lipoprotein cholesterol (LDL-C) 48% reduction in LDL-C from baseline at week 24 when Evkeeza was added to other lipid-lowering therapies in the pivotal trial TARRYTOWN, N.Y., March 22, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today...Read more
SANTA MONICA, Calif. / Mar 21, 2023 / Business Wire / Kite, a Gilead Company (Nasdaq: GILD), today announced the primary overall survival (OS) analysis results of the Phase 3 ZUMA-7 study. The results showed a statistically significant improvement for Yescarta in OS versus historical treatment, which was the standard of care (SOC) in a curative setting for nearly 30 years, for initial treatment of adult patients with relapsed/refractory...Read more
Approximately seven times as many patients aged 6 months to 5 years with severe atopic dermatitis treated with Dupixent experienced clear or almost clear skin and reduced overall disease severity compared to placebo Patients treated with Dupixent achieved rapid itch reduction as early as three weeks after start of therapy, with significant improvements at 16 weeks sustained through one year Dupixent is now a treatment option for the...Read more
BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass. / Mar 21, 2023 / Business Wire / BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, is entering a new phase as it continues to build its U.S. presence. The company announced today that the last piece of structural steel will be laid at its Hopewell, NJ campus today. This new facility will provide state-of-the-art commercial-stage U.S. biologic...Read more
SOUTH SAN FRANCISCO, Calif. / Mar 20, 2023 / Business Wire / Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced new long-term data for Evrysdi® (risdiplam) in a broad range of people aged 2-25 years with spinal muscular atrophy (SMA) from the pivotal SUNFISH study. Data confirm increases in motor function were sustained at four years and the overall rate of adverse events continued to decrease over the...Read more
BOSTON / Mar 20, 2023 / Business Wire / Karuna Therapeutics, Inc. (NASDAQ: KRTX), a clinical-stage biopharmaceutical company driven to create and deliver transformative medicines for people living with psychiatric and neurological conditions, today announced positive topline results from its Phase 3 EMERGENT-3 trial evaluating the efficacy, safety, and tolerability of its lead investigational therapy, KarXT (xanomeline-trospium) in adults...Read more
BioNTech to receive exclusive worldwide license from OncoC4 to develop and commercialize its anti-CTLA-4 monoclonal antibody candidate, ONC-392 BioNTech and OncoC4 will co-develop ONC-392 as monotherapy or in combination with anti-PD1 in various solid tumor indications, with a randomized Phase 3 trial planned to start in 2023 BioNTech also plans to combine ONC-392 with its proprietary oncology product candidates to evaluate...Read more
WILMINGTON, Del. / Mar 18, 2023 / Business Wire / Incyte (Nasdaq:INCY) today announced new data from a Phase 2b clinical trial evaluating the safety and efficacy of povorcitinib (INCB54707), an investigational oral JAK1 inhibitor, in adult patients with extensive nonsegmental vitiligo. These data were presented today in a late-breaking oral presentation (Session: S042 – Late-Breaking Research: Session 2) at the 2023 American Academy of...Read more
WILMINGTON, Del. / Mar 18, 2023 / Business Wire / Incyte (Nasdaq:INCY) today announced new 104-week results from the pivotal Phase 3 TRuE-V clinical trial program evaluating Opzelura® (ruxolitinib) cream 1.5% in patients 12 years of age and older with nonsegmental vitiligo, a chronic autoimmune disease characterized by depigmentation of skin. These data were presented today in two late-breaking oral presentations (Session: S025 – Late...Read more
Treatment with SKYRIZI (risankizumab) demonstrated short- and long-term efficacy of psoriasis signs and symptoms (sPGA 0/1) at week 16 and week 52 in a difficult-to-treat population, with no new safety signals observed in an open-label, single-arm phase 3b study Patients with moderate to severe psoriasis previously received at least six months of treatment with secukinumab or ixekizumab with a suboptimal response, defined as a static...Read more
More than twice as many patients on Dupixent achieved clear or almost clear skin compared to placebo at 16 weeks Nearly four times as many patients on Dupixent saw a clinically meaningful reduction of itch, with improvements seen as early as one week TARRYTOWN, N.Y. and PARIS, March 18, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today presented positive results from the clinical trial...Read more
Pfizer and Astellas announce positive topline results from Phase 3 EMBARK trial NEW YORK and TOKYO, March 16, 2023 /PRNewswire/ -- Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced positive topline results from the Phase 3 EMBARK trial evaluating XTANDI® (enzalutamide) in men with non-metastatic hormone-sensitive prostate cancer...Read more
CAMBRIDGE, Mass. / Mar 16, 2023 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that at its late cycle meeting for the SRP-9001 (delandistrogene moxeparvovec) biologics license application (BLA), the U.S. Food and Drug Administration’s Office of Therapeutics (OTP) has determined that an advisory committee meeting will be held for SRP-9001 in advance of...Read more
RAHWAY, N.J. / Mar 16, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today provided an update on the open-label arm of the non-registrational Phase 2 KeyVibe-002 trial. KeyVibe-002 is evaluating MK-7684A, a coformulation of vibostolimab, an anti-TIGIT therapy, and pembrolizumab (KEYTRUDA®), Merck’s anti-PD-1 therapy, with or without docetaxel for the treatment of patients with metastatic...Read more
NEW YORK / Mar 16, 2023 / Business Wire / Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) voted 16 to 1 that available data support the safety and effectiveness of PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets) for the treatment of mild-to-moderate COVID-19 in adult patients who are at high risk for progression to severe illness. The AMDAC's...Read more
BD Vaginal Panel on BD COR™ System Tests for Multiple Common Types of Vaginitis Using Only One Swab, One Test FRANKLIN LAKES, N.J., March 16, 2023 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the BD Vaginal Panel on the BD COR™ System, a comprehensive...Read more
CAMBRIDGE, Mass., March 16, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the Court of Justice of the European Union decided in favor of Biogen, the European Medicines Agency (EMA), and the European Commission in their appeal of a General Court decision annulling the EMA’s refusal to evaluate a generic version of TECFIDERA® (dimethyl fumarate) because of TECFIDERA’s regulatory data and marketing protection....Read more
BOSTON / Mar 16, 2023 / Business Wire / Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced publication in the New England Journal of Medicine (NEJM) of results from preclinical studies and a Phase 2 study evaluating the efficacy and safety of inaxaplin (VX-147) on top of standard-of-care in people with focal segmental glomerulosclerosis (FSGS) and two APOL1 variants, a severe, rapidly progressive form of chronic kidney...Read more
BEERSE, Belgium / Mar 15, 2023 / Business Wire / The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) announced today the publication of new data in the journal Nature showing that an early-stage clinical candidate (JNJ-1802) provides strong protection against dengue in non-human primates and mice. The first-in-class antiviral, which was shown to be safe and well tolerated in a Phase 1 first-in-human clinical study, is...Read more
VYVGART is the first neonatal Fc receptor (FcRn) blocker approved in the UK for the treatment of adults living with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive 68% of anti-AChR antibody positive gMG patients treated with VYVGART were responders (n=44/65) on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale compared with 30% of patients treated with placebo (n=19/64)...Read more
Company Anticipates No Impact on U.S. and European Royalty Revenues from DARZALEX FASPRO® and SC through at least 2030 Reiterates 2023 Revenue Guidance of $815 million to $845 million and Royalty Revenue of $445 million to $455 million SAN DIEGO, March 15, 2023 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today provides an update on a decision by the Opposition Division of the European...Read more
Royalty Pharma now expects 2023 Adjusted Cash Receipts(1) (non-GAAP) to be between $2,850 million and $2,950 million, excluding contributions from future transactions NEW YORK, March 15, 2023 (GLOBE NEWSWIRE) -- Royalty Pharma plc (Nasdaq: RPRX) today announced that it has received a $475 million accelerated milestone payment from Pfizer, following the U.S. Food and Drug Administration (FDA) approval of Zavzpret (zavegepant), a...Read more
DUBLIN, March 15, 2023 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the company, along with its partners, will present five new abstracts at the American Association for Cancer Research (AACR) Annual Meeting from April 14-19, 2023. Research findings to be presented include data from company-sponsored and collaborative trials studying Zepzelca® (lurbinectedin), zanidatamab and JZP898. "The data Jazz...Read more
Novo Nordisk has been working to identify a sustainable approach to reduce insulin costs for patients that addresses changes in health policy and market shifts Lower list prices build on long-standing history of affordability initiatives already in place which can be accessed at NovoCare.com Novo Nordisk currently provides co-pay support for a number of insulin products meaning eligible patients can pay $25-35 for their insulin...Read more
New Analyses from Phase 2 and Phase 3 Extension Studies Continue to Demonstrate Sustained Improvement in Growth with no Change in Safety Profile SAN RAFAEL, Calif., March 14, 2023 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery, will present updated data demonstrating the long-term benefit of treatment with VOXZOGO® (vosoritide) and...Read more
XTANDI® (enzalutamide) plus androgen deprivation therapy (ADT) significantly delays time to PSA progression compared to placebo plus ADT Study enrolled 180 men with metastatic hormone-sensitive prostate cancer in mainland China TOKYO, March 13, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced positive topline results from the Phase 3 China ARCHES study...Read more
NEW YORK & BOTHELL, Wash. / Mar 13, 2023 / Business Wire / Pfizer Inc. (NYSE: PFE) and Seagen Inc. (Nasdaq: SGEN) today announced that they have entered into a definitive merger agreement under which Pfizer will acquire Seagen, a global biotechnology company that discovers, develops and commercializes transformative cancer medicines, for $229 in cash per Seagen share for a total enterprise value of $43 billion. The Boards of Directors...Read more
More than 20 abstracts, including one late-breaking presentation, underscore AbbVie's dedication to advancing care for dermatologic conditions NORTH CHICAGO, Ill., March 13, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced it will present more than 20 abstracts, including one late-breaking presentation during the 2023 American Academy of Dermatology (AAD) Annual Meeting, March 17-21, in New Orleans, Louisiana. "The...Read more
NEW YORK / Mar 10, 2023 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) has approved ZAVZPRET™ (zavegepant), the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the acute treatment of migraine with or without aura in adults. In its pivotal Phase 3 study, ZAVZPRET was statistically superior to placebo on the co-primary endpoints of pain freedom...Read more
RAHWAY, N.J. & KINGSTON, Ontario / Mar 10, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and the Canadian Cancer Trials Group (CCTG) today announced that the Phase 2/3 CCTG IND.227/KEYNOTE-483 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy met its primary endpoint of overall survival (OS) for the first-line treatment of patients with unresectable...Read more
Expansion includes new West Coast offices in South San Francisco, California and Seattle, Washington New offices complement existing locations in Cambridge, MA; Norwood, MA; Atlanta, GA; Bethesda, MD; and Princeton, NJ Moderna currently has offices in 17 locations worldwide Company plans to hire approximately 2,000 new employees in 2023 CAMBRIDGE, MA / ACCESSWIRE / March 10, 2023 / Moderna, Inc., (NASDAQ:MRNA) a biotechnology...Read more
SOUTH SAN FRANCISCO, Calif. / Mar 09, 2023 / Business Wire / Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 11 to 2 in favor of Polivy® (polatuzumab vedotin-piiq) in combination with Rituxan® (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of people with previously...Read more
Clinical data submitted are consistent with global data and support enfortumab vedotin as a platinum-free option in patients with locally advanced or metastatic urothelial cancer who received prior treatment with a PD-1/L1 inhibitor and platinum-based chemotherapy TOKYO and BOTHELL, Wash., March 9, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Seagen Inc....Read more
SAN DIEGO, March 9, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced today that new data from RE-KINECT™, the largest real-world, observational, multicenter study of antipsychotic-treated patients with possible tardive dyskinesia (TD), was published in the Journal of Patient-Reported Outcomes.1 The analysis assessed the effects of possible TD, defined as clinician-confirmed presence of abnormal...Read more
WILMINGTON, Del. / Mar 09, 2023 / Business Wire / Positive high-level results from a planned interim analysis of the AEGEAN Phase III, placebo-controlled trial showed that treatment with AstraZeneca’s IMFINZI® (durvalumab) in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS) versus...Read more
WILMINGTON, Del. / Mar 09, 2023 / Business Wire / Positive high-level results from the ADAURA Phase III trial showed AstraZeneca’s TAGRISSO® (osimertinib) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), a key secondary endpoint, compared to placebo in the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell...Read more
BOSTON / Mar 09, 2023 / Business Wire / Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug Application (IND) for VX-264, a stem cell-derived, fully differentiated pancreatic islet cell therapy encapsulated into a Vertex-developed, immunoprotective device with the potential to treat type 1 diabetes (T1D). The VX-264 program does not...Read more
PARSIPPANY, N.J. & TEL AVIV, Israel & HYDERABAD, India / Mar 09, 2023 / Business Wire / Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816), announced today the launch of additional strengths for the generic version of Revlimid®1 (lenalidomide capsules), in 2.5 mg, and 20 mg strengths, in the United States. The companies have...Read more
ZUG, Switzerland, March 9, 2023 /CNW/ -- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, and Medison Pharma ("Medison"), a global pharma company focused on providing access to highly innovative therapies for patients in international markets, have announced an expansion of their existing partnership to a multi-regional agreement that includes Poland, Czech Republic, Hungary,...Read more
The application is based on phase III results from the DINAMO trial showing Jardiance® (empagliflozin) tablets significantly reduced A1c (a marker of average blood sugar) versus placebo in participants aged 10-17 living with type 2 diabetes If approved, Jardiance would be the first SGLT2 inhibitor indicated for this vulnerable population RIDGEFIELD, Conn. and INDIANAPOLIS, March 8, 2023 /PRNewswire/ -- The U.S. Food and Drug...Read more
Results showed solanezumab did not slow cognitive decline in preclinical Alzheimer's disease or reduce risk of progression to symptomatic Alzheimer's disease Solanezumab targets soluble amyloid beta, and treatment did not result in clearance of brain amyloid plaque Lilly remains committed to fighting Alzheimer's disease, with plaque-clearing mechanisms such as donanemab and remternetug, both in ongoing Phase 3 trials INDIANAPOLIS,...Read more
MISSISSAUGA, ON, March 8, 2023 /CNW/ - Jazz Pharmaceuticals plc (NASDAQ: JAZZ) announced today that Vyxeos® (daunorubicin and cytarabine liposome for injection) is now included on eight additional provincial drug formularies, including British Columbia, Ontario, Saskatchewan, Manitoba, New Brunswick, Nova Scotia, Alberta, and Newfoundland and Labrador. Vyxeos is indicated for the treatment of adults with newly diagnosed...Read more
CAMBRIDGE, Mass., March 08, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ: BIIB) today announced that the Board of Directors has elected Caroline Dorsa as Chair of the Board of Directors, effective immediately following the Company’s 2023 Annual Meeting of Stockholders (the “Annual Meeting”), scheduled to take place on June 14, 2023. Ms. Dorsa will succeed Stelios Papadopoulos, Ph.D., who announced he would not stand for reelection to the...Read more
CAMBRIDGE, Mass. / Mar 08, 2023 / Business Wire / Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) the leading RNAi therapeutics company, announced today the appointment of Peter Kellogg to its Board of Directors. Mr. Kellogg is an accomplished industry executive with extensive global financial and strategic management experience. “Mr. Kellogg joins our Board at a pivotal moment for Alnylam as we continue on the path to achieving our P5x25...Read more
The Supplemental New Drug Application is Based on Positive Results from Global Randomized Phase 2 Study in Infants and Young Children FDA set PDUFA Target Action Date of October 21, 2023 SAN RAFAEL, Calif., March 7, 2023 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery, announced today that the U.S. Food and Drug Administration (FDA)...Read more
New test will run on Abbott's Alinity® i laboratory instrument, complementing Abbott's rapid i-STAT TBI Plasma test, cleared by the FDA in 2021 Given the significant number of Alinity i instruments in use in labs across the U.S., Abbott's lab test will make concussion testing available to more people across the country Test helps doctors evaluate patients with mild traumatic brain injury (mTBI), commonly known as concussion, by ruling...Read more
TARRYTOWN, N.Y. and PARIS, March 07, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) to treat adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) that is not adequately controlled with the current...Read more
35-week data included in the filing demonstrated a statistically significant and clinically meaningful change from baseline for co-primary and secondary endpoints compared to external placebo group Eplontersen previously granted Orphan Drug Designation for transthyretin-mediated amyloidosis FDA assigns PDUFA action date of Dec. 22, 2023 CARLSBAD, Calif., March 7, 2023 /PRNewswire/ -- Ionis Pharmaceuticals (Nasdaq: IONS) today...Read more
IRVING, Texas, March 7, 2023 /PRNewswire/ -- Caris Life Sciences®(Caris), the leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize healthcare, today announced a strategic research partnership with Incyte Corporation (NASDAQ:INCY) to augment precision medicine approaches for Incyte's oncology pipeline. Caris' unique platform combines data from whole exome...Read more
FDA Extends PDUFA Target Action Date to June 30, 2023 SAN RAFAEL, Calif., March 6, 2023 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery, today announced that it received notice this afternoon from the U.S. Food and Drug Administration (FDA) that the agency has extended review of the company's Biologics License Application (BLA) for...Read more
RAHWAY, N.J. / Mar 06, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced full results from the Phase 3 STELLAR trial, which evaluated sotatercept, Merck’s novel investigational activin signaling inhibitor biologic, in combination with stable background therapy for the treatment of adult patients with pulmonary arterial hypertension (PAH) (WHO Group 1). Sotatercept significantly...Read more
RAHWAY, N.J. / Mar 06, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from the Phase 2b clinical trial evaluating MK-0616, an investigational, once-daily oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor in adults with hypercholesterolemia. The primary objective of the study was to evaluate the percent change in low density lipoprotein cholesterol...Read more
RAHWAY, N.J. / Mar 06, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved the addition of the intramuscular (IM) route of administration to the United States Product Insert (USPI) for Merck’s MMRV family of vaccines: M-M-R®II, VARIVAX®, and ProQuad®. While these vaccines have a long history in the U.S., until now they...Read more
Abbott's world's leading1 and affordable2 integrated continuous glucose monitoring (iCGM) sensors are cleared for connectivity with automated insulin delivery (AID) systems in the U.S. Sensors also cleared for use by children as young as two years old, for use by women with diabetes who are pregnant, and for wear time up to 15 days ABBOTT PARK, Ill., March 6, 2023 /PRNewswire/ -- Abbott (NYSE: ABT) today announced that the U.S....Read more
The VENTANA PD-L1 (SP263) Assay helps determine which patients with non-small cell lung cancer (NSCLC) may be eligible for treatment with Libtayo monotherapy1 based on the results of the Phase III EMPOWER-Lung 1 study. This additional approval will allow more patients with locally advanced and metastatic NSCLC broader access to the immunotherapy Libtayo. PD-L1 testing provides clinicians with essential information that helps guide...Read more
WILMINGTON, Del. / Mar 06, 2023 / Business Wire / Incyte (Nasdaq:INCY) today announced that multiple abstracts featuring data from its dermatology portfolio will be presented at the upcoming 2023 American Academy of Dermatology (AAD) Annual Meeting, held March 17-21, 2023, in New Orleans. New data from the Phase 3 TRuE-V clinical trial program evaluating the durability and long-term response (up to 104 weeks) of Opzelura® (ruxolitinib)...Read more
Confirmatory Phase 3 Clarity AD data to be evaluated by FDA in determining whether to convert accelerated approval of LEQEMBI to a traditional approval Priority Review accelerates FDA review time with a Prescription Drug User Fee Act (PDUFA) target action on July 6, 2023 TOKYO and CAMBRIDGE, Mass., March 05, 2023 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB,...Read more
New five-year data presented at American College of Cardiology Scientific Sessions (ACC.23) and simultaneously published in The New England Journal of Medicine reinforce the long-term safety and effectiveness of MitraClip for treating secondary mitral regurgitation (MR) Results show minimally invasive mitral valve repair in advanced heart failure patients reduces hospitalizations and deaths and provides durable reduction in the...Read more
Late-breaking data presented at American College of Cardiology Scientific Sessions (ACC.23) and simultaneously published in The New England Journal of Medicine demonstrate TriClip was superior to medical therapy with significant improvements in quality of life and tricuspid regurgitation (TR) Findings show TriClip, an investigational device in the U.S. to treat a leaky tricuspid valve, demonstrated safety and met the primary...Read more
WILMINGTON, Del. / Mar 03, 2023 / Business Wire / Incyte (Nasdaq:INCY) today announced that it will discontinue the Phase 3 LIMBER-304 trial following results of a pre-planned interim analysis conducted by an independent data monitoring committee (IDMC) indicating that the study is unlikely to meet the primary endpoint in the intent-to-treat patient population. The recommendation to stop the study was not due to safety. LIMBER-304 is a...Read more
High risk patients eligible for Verzenio can now be identified solely based on nodal status, tumor size, and tumor grade, regardless of Ki-67 score Approval supported by four-year data from the monarchE trial; Verzenio added to adjuvant endocrine therapy (ET) reduced the risk of recurrence by 35% compared to adjuvant ET alone Verzenio remains the first and only CDK4/6 inhibitor approved in the adjuvant...Read more
PRINCETON, N.J. / Mar 03, 2023 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has granted full Marketing Authorization for Reblozyl® (luspatercept), a first-in-class therapeutic option, for treatment in adult patients of anemia associated with non-transfusion-dependent (NTD) beta thalassemia. Reblozyl is currently approved in the European Union (EU), United States and Canada to address...Read more
PRINCETON, N.J. / Mar 02, 2023 / Business Wire / Bristol Myers Squibb (NYSE: BMY) in collaboration with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson and Johnson (Janssen) today announced the launch of the Phase 3 Librexia program studying milvexian, an investigational oral factor XIa (FXIa) inhibitor (antithrombotic). The Librexia program is unrivaled as the most comprehensive FXIa development...Read more
RAHWAY, N.J. / Mar 02, 2023 / Business Wire / AstraZeneca and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) will convene a meeting of the Oncologic Drugs Advisory Committee (ODAC) to discuss the supplemental new drug application (sNDA) for use of LYNPARZA in combination with abiraterone and prednisone or prednisolone (abi/pred) for the treatment of...Read more
DEERFIELD, Ill. / Mar 02, 2023 / Business Wire / Walgreens, in partnership with DoorDash and Uber, today announced free, Same Day Rx Delivery of medications for the prevention and treatment of HIV. This service is available to eligible patients within 15 miles of thousands of participating Walgreens retail pharmacies nationwide. “While most of the U.S. population lives within five miles of a Walgreens pharmacy, transportation remains a...Read more
Karen Massey appointed as Chief Operating Officer, effective March 13, 2023 Keith Woods to retire and serve as Advisor on argenx Board of Directors March 2, 2023 - Amsterdam, the Netherlands — argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that Karen Massey will join argenx as Chief Operating Officer,...Read more
$173 million in fourth quarter and $401 million in full year 2022 VYVGART® (efgartigimod alfa-fcab) global net product sales FDA review ongoing for SC efgartigimod BLA with PDUFA target action date of June 20, 2023; MAA filed in Japan with approval decision expected by first quarter of 2024 ADHERE topline results continue to be expected in second quarter of 2023 Karen Massey appointed as Chief Operating Officer as part of planned...Read more
Strong Execution Drove Record Revenues in 2022 of $3.7 billion, an increase of 18% over 2021 Positioned for Total Revenue and Net Income Growth in 2023 Xywav Enters 2023 as the Oxybate Therapy of Choice and Company's Largest Product by Net Sales Enhanced Investment in R&D to Advance Pipeline towards Key Value Inflection Points in 2023 and 2024 Company is Well-Positioned to Achieve Vision 2025 DUBLIN, March 1, 2023...Read more
INDIANAPOLIS, March 1, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced price reductions of 70% for its most commonly prescribed insulins and an expansion of its Insulin Value Program that caps patient out-of-pocket costs at $35 or less per month. Lilly is taking these actions to make it easier to access Lilly insulin and help Americans who may have difficulty navigating a complex healthcare system that may keep...Read more
RAHWAY, N.J. / Mar 01, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the Phase 3 KEYNOTE-671 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, met one of its dual primary endpoints, event-free survival (EFS), as a perioperative treatment regimen for patients with resectable stage II, IIIA or IIIB non-small cell lung cancer (NSCLC). A perioperative treatment...Read more
PARSIPPANY, N.J. / Mar 01, 2023 / Business Wire / Zoetis is pleased to receive a $15.3 million grant from the Bill & Melinda Gates Foundation to further develop and integrate innovative solutions to advance veterinary care and diagnostic services that will ultimately improve livestock health and productivity in Sub-Saharan Africa. The grant will help Zoetis to expand its original African Livestock Productivity and Health Advancement...Read more
JERUSALEM, Israel, March 1, 2023 – BioNTech SE (Nasdaq: BNTX, “BioNTech”, “the Company”) announced that the Company and the Weizmann Institute of Science (“Weizmann Institute”) signed a Memorandum of Understanding (MoU). As part of this MoU, scientists from a variety of disciplines from BioNTech and the Weizmann Institute will collaborate in basic and applied research with the aim to better understand various diseases, including cancer,...Read more
FRANKLIN LAKES, N.J., March 1, 2023 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that it will present at the Barclays Global Healthcare Conference on Wednesday, March 15, 2023 at 9:00 am Eastern Time. The live webcast of BD's presentation can be accessed from the BD investor relations website, investors.bd.com. A replay of the event will be available on the...Read more
Combined Data From FOURIER and FOURIER-OLE Studies Show Earlier, Longer Use of Repatha Reduces Total CV Events Analysis From Phase 2 OCEAN(a)-DOSE Study Shows Olpasiran Markedly Reduced Lp(a) Concentration Irrespective of Baseline Level Amgen Convenes First LDL-C Action Summit to Help Improve State of Cardiovascular Disease Care in the U.S. THOUSAND OAKS, Calif., March 1, 2023 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced...Read more
| Company | Change | Last Trade |
|---|---|---|
| Regeneron Pharmaceuticals | 20.41 2.54 | $822.57 |
| Vertex Pharmaceuticals | 8.27 2.71 | $313.02 |
| Biogen | 5.38 2.03 | $270.55 |
| Amgen | 5.06 2.17 | $238.16 |
| Karuna Therapeutics | 4.77 2.71 | $180.99 |
| Jazz Pharmaceuticals | 4.17 3.03 | $141.62 |
| Novo Nordisk | 3.70 2.47 | $153.29 |
| Eli Lilly | 3.59 1.08 | $336.23 |
| Becton Dickinson | 3.47 1.47 | $239.86 |
| Zoetis | 3.40 2.11 | $164.64 |
| AbbVie | 3.01 1.94 | $158.31 |
| Moderna | 2.15 1.44 | $151.57 |
| Legend Biotech | 2.05 4.68 | $45.87 |
| Sarepta Therapeutics | 1.96 1.53 | $130.34 |
| Neurocrine Biosciences | 1.44 1.50 | $97.13 |
Cue Biopharma is developing the first-ever class of therapeutics for the treatment of cancer that mimic the natural signals, or “Cues”, of the immune system. This novel class of injectable biologics selectively engages and modulates tumor-specific T cells directly within the patient’s body to transform...
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