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Citing a JAMA study that found Ozempic could be profitably produced at under $5 per month, Senator Bernie Sanders on Wednesday called on Novo Nordisk to lower prices for the diabetes treatment and the weight-loss drug Wegovy.
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Keytruda can now be used in the European Union for patients with resectable non-small cell lung cancer at high risk of recurrence in combination with platinum chemotherapy, then continued as a monotherapy afterwards.
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After an initial rejection due to safety issues, followed by a dispute and deferred actions, Akebia Therapeutics on Wednesday finally won the FDA’s nod for vadadustat as a treatment for anemia caused by chronic kidney disease.
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Will the IRA’s Focus on the Pharmaceutical Industry Hurt the World’s Healthcare System Instead of...
3/28/2024
The pharmaceutical industry is facing critical attention, particularly around drug pricing and development costs. Drug development cost is about 10% of the total healthcare spend in the United States. Broader issues such as local monopolies, utilization, unit, and costs and local monopolies, poli... -
Stoke Therapeutics plans to offer up more than 5.5 million shares of its common stock following positive Phase I/IIa data for its Dravet syndrome candidate.
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Continuing 2024’s biotech initial public offering rally, Boundless Bio will debut Thursday on the Nasdaq with the proceeds used to advance its pipeline of extrachromosomal DNA cancer assets.
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To avoid overextending yourself and harming your work-life balance, how should you set and maintain boundaries at work?
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Altimmune on Wednesday said it is ending development of HepTcell, a hepatitis B candidate, following disappointing trial results as it focuses on obesity and metabolic dysfunction-associated steatohepatitis.
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Follow along as BioSpace keeps you up-to-date on the latest pharma and biotech layoffs.
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Follow along as BioSpace keeps you up to date on the latest pharma and biotech M&As, from announcements to closings.
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Larkspur Biosciences to Present New Preclinical Research on Lead Development Program Candidate, a First-in-Class PIP4K2C Protein Degrader, at AACR 2024
3/28/2024
Larkspur Biosciences, a company pioneering a new wave in cancer therapy by targeting cancer-intrinsic drivers of immune evasion, announced that it will present positive preclinical efficacy data for LRK-A, Larkspur’s novel, lead investigational therapy targeting the lipid kinase PIP4K2C, in primary human tumor samples and an in vivo model of colorectal cancer (CRC).
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Lipocine Announces Positive Week 52 Results from LPCN 1148 Phase 2 Study in Patients with Cirrhosis
3/28/2024
Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company today announced positive topline results from a Phase 2 clinical study of LPCN 1148. LPCN 1148 is an oral candidate under development for the clinical management of cirrhosis, specifically prevention of OHE recurrence and treatment of sarcopenia.
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Azura Ophthalmics to Present New Data Supporting the Potential of AZR-MD-001 to be the First Ophthalmic Keratolytic for Ocular Surface Diseases
3/28/2024
Azura Ophthalmics Ltd., a clinical-stage biopharmaceutical company developing a potential new therapeutic class of Ophthalmic Keratolytics for ocular surface diseases, today announced multiple presentations highlighting positive efficacy and safety data from Phase 2 studies of the company’s lead drug candidate, AZR-MD-001, in Meibomian Gland Dysfunction (MGD).
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Neurocrine Biosciences Announces Initiation of Phase 1 Clinical Study Evaluating Effects of NBI-1065890, a Second-Generation VMAT2 Inhibitor, in Healthy Adults
3/28/2024
Neurocrine Biosciences, Inc. (Nasdaq: NBIX), today announced the initiation of its Phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of investigational compound NBI-1065890 in healthy adult participants.
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Aurion Biotech Announces First Canadian Subject Dosed in Phase 1 / 2 Clinical Trial
3/28/2024
Aurion Biotech today announced that it has dosed the first Canadian subject in its Phase 1 / 2 clinical trial (ABA-1, CLARA) of AURN001, a cell therapy for the treatment of corneal edema secondary to corneal endothelial dysfunction.
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HUTCHMED Announces Savolitinib sNDA Accepted in China for Treatment-Naïve or Previously Treated Patients with Locally Advanced or Metastatic MET Exon 14 NSCLC
3/28/2024
HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the supplemental New Drug Application (“sNDA”) for savolitinib, in adult patients with locally advanced or metastatic non-small cell lung cancer (“NSCLC”) with mesenchymal epithelial transition factor (“MET”) exon 14 skipping alteration, has been accepted for review by the China National Medical Products Administration (NMPA).
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JenaValve Announces Publication of ALIGN-AR Pivotal Trial Results in The Lancet
3/28/2024
JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced the publication of results from the ALIGN-AR Pivotal Trial in The Lancet.
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Mustang Bio Announces Vision for CAR T-Cell Therapy Platform Expansion into Autoimmune Diseases
3/28/2024
Mustang Bio, Inc. (“Mustang”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, today announced its expansion into autoimmune diseases with MB-106, a personalized CD20-targeted, 3rd-generation autologous CAR T-cell therapy.
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AEOVIAN PHARMACEUTICALS DOSES FIRST PARTICIPANTS IN PHASE 1 CLINICAL TRIAL, STRENGTHENS LEADERSHIP TEAM AND RAISES ADDITIONAL $50 MILLION FINANCING
3/28/2024
Aeovian Pharmaceuticals, a clinical-stage biopharmaceutical company developing novel and highly selective therapeutics that potently inhibit the mTORC1 pathway, today announced that it has dosed the first cohort of participants in a Phase 1 clinical trial for its lead development candidate AV078, a first-in-class CNS penetrant selective mTORC1 inhibitor.
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C-Path Launches Clinical Trial Simulator for Duchenne Muscular Dystrophy Research
3/28/2024
Critical Path Institute's (C-Path) Duchenne Regulatory Science Consortium (D-RSC) is excited to announce the launch of a groundbreaking model-based Clinical Trial Simulator (CTS), specifically designed to improve design of efficacy studies for potential therapies for Duchenne muscular dystrophy (DMD).