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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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Syndax Announces Completion of Enrollment in AUGMENT-101 Pivotal Trial Cohort of Patients with Relapsed/Refractory mNPM1 Acute Myeloid Leukemia
3/28/2024
Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced completion of enrollment in the AUGMENT-101 pivotal trial cohort of patients with relapsed/refractory (R/R) mutant nucleophosmin (mNPM1) acute myeloid leukemia (AML).
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REGENXBIO Announces Lancet Publication of Phase I/IIa Study Evaluating ABBV-RGX-314 as a One-Time Gene Therapy for Wet AMD
3/28/2024
REGENXBIO Inc. (Nasdaq: RGNX) today announced the publication of results from the Phase I/IIa trial evaluating the safety and tolerability of a single dose of subretinal ABBV-RGX-314 for the treatment of wet age-related macular degeneration (wet AMD).
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Ironwood Pharmaceuticals Announces Positive Results from its Phase II Exploratory STARGAZE Trial of Apraglutide in Patients with Steroid-Refractory Gastrointestinal Acute Graft-versus-Host Disease (SR GI aGVHD)
3/28/2024
Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, today announced positive, primary results up to Day 91 for its Phase II exploratory STARGAZE trial evaluating apraglutide in patients with steroid-refractory gastrointestinal acute Graft-versus-Host Disease (SR GI aGVHD).
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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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4DMT Announces Update on Regulatory Interactions and Development Path for 4D-710 for Treatment of Cystic Fibrosis
3/28/2024
4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases, today announced an update on its regulatory interactions and development path for 4D-710, an aerosolized genetic medicine for the treatment of CF lung disease.
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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).