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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... -
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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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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To avoid overextending yourself and harming your work-life balance, how should you set and maintain boundaries at work?
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Follow along as BioSpace keeps you up-to-date on the latest pharma and biotech layoffs.
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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 M&As, from announcements to closings.
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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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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).
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Serum Detect Launches with Novel T-Cell Analysis Approach for Cancer Early Detection at AACR
3/28/2024
Serum Detect, a cancer diagnostics company, is debuting a novel and promising approach for cancer early detection at the upcoming American Association for Cancer Research (AACR) conference.
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China's National Medical Products Administration Accepts Astellas and Pfizer's Supplemental Biologics License Application for enfortumab vedotin with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer
3/28/2024
Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas") today announced that on March 27, 2024 the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the supplemental Biologics License Application (sBLA) for enfortumab vedotin with KEYTRUDA® (pembrolizumab) as a combination therapy for the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC).
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MAPLIGHT THERAPEUTICS ANNOUNCES INITIATION OF PHASE 1 CLINICAL TRIAL FOR ML-007/PAC, UNDER DEVELOPMENT FOR SCHIZOPHRENIA AND ALZHEIMER'S DISEASE PSYCHOSIS
3/28/2024
MapLight Therapeutics today announced initiation of a Phase 1 clinical trial evaluating ML-007/PAC, MapLight's extended-release fixed-dose combination formulation of the novel, investigational muscarinic agonist ML-007 and a precision-matched peripherally active anticholinergic (PAC).
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Bridge Biotherapeutics Launches a Research Collaboration with Emory University School of Medicine to Explore Combination Therapy of BBT-877 for KRAS/P53 Mutant NSCLC Patients Resistant to Anti-PD-1 Blockade
3/28/2024
Bridge Biotherapeutics (KQ288330), a South Korean clinical-stage biotech company developing novel drugs for cancer, fibrosis, and inflammation, announced a research collaboration with Dr. Jessica M. Konen's Lab at Emory University School of Medicine.
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An ActRIIA Fusion Protein Got FDA Approved for PAH Treatment
3/28/2024
On March 26th, the US FDA granted approval for Merck’s WINREVAIR™ (sotatercept-csrk), marking a significant milestone in pulmonary arterial hypertension (PAH) treatment.
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Cell And Gene Therapy CDMO Market Size to Reach USD 69.11 Bn by 2033
3/28/2024
The global cell and gene therapy CDMO Market size was valued at USD 5.90 billion in 2023 and is projected to reach USD 69.11 billion by 2033,
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Advanced Therapy Medicinal Products CDMO Industry is Rising Rapidly
3/28/2024
According to latest study, the global advanced therapy medicinal products CDMO Market size was valued at USD 6.10 billion in 2023 and is projected to reach USD 34.53 billion by 2033
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Pharmaceutical Market Size to Hit Around USD 2,832.66 Bn by 2033
3/28/2024
According to Vision Research Reports, the global pharmaceutical market size was estimated at USD 1,559.53 billion in 2023 and it is expected to surpass around USD 2,832.66 billion by 2033.