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 statistically significant and clinically meaningful... 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 study of Ionis and AstraZeneca's... 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 (Nasdaq: CRSP) today announced that they... 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 2023 Initiated Phase 1 trials for four... 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 announced it would acquire Signify 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 assessing potential cost savings,... 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 characterized by an over-production of myeloid... 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 approve the application in its present... 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 of risankizumab, with no new safety... 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 observed for the combination therapy... 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 five clinical-stage candidates... 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 worldwide with no new treatment approaches... 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 antisense medicine for the treatment... 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 reduction in plasma neurofilament... 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 death receptor-1 (PD-1), for the... 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 review. The CRL does not request... 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 announced the U.S. Food and Drug... 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 large B-cell lymphoma (R/R LBCL) within... 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 approximately 80,000 infants and... 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 pharmaceutical manufacturing, late-stage research... 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 48-month period, reinforcing the long-term... 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 with schizophrenia. The trial met... 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 complementary modes of action with the aim... 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 Dermatology (AAD) Annual Meeting,... 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 Breaking Research: Session 1) at the... 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 Physician's Global Assessment (sPGA)... 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 assessing Dupixent® (dupilumab)... 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 (nmHSPC; also known as non-metastatic... 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 the May 29, 2023 regulatory action... 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 non-small cell lung cancer (NSCLC)... 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 vote, while not binding, will... 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 diagnostic test that directly detects... 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. With this favorable decision,... 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 disease also known as APOL1-mediated... 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 now progressing into Phase 2 clinical... 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) (p<0.0001) during the first treatment... 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 Patent Office ("EPO") regarding one... 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 calcitonin gene-related peptide (CGRP)... 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 and our partners are presenting at... 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 PLAINSBORO, N.J., March 14, 2023... 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 new observational data on disease... 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 of XTANDI® (enzalutamide) plus... 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 of both companies have unanimously... 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 data at this year's AAD conference... 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 and freedom from most bothersome... 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 advanced or metastatic malignant... 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 company pioneering messenger RNA (mRNA)... 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 untreated diffuse large B-cell lymphoma... 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. (Nasdaq: SGEN) today announced that... 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 involuntary movements, on patient health... Read more
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