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The Centers for Medicare and Medicaid Services will enter talks with manufacturers to come up with a pricing and rebate scheme that will tie the gene therapies’ cost with their effectiveness.
Defender Pharmaceuticals on Tuesday did not reveal the reasons for the regulator’s rejection of its nasal gel version of scopolamine. The company is seeking a meeting with the FDA to “understand the issues.”
Here are the top companies on BioSpace with internship opportunities for graduate students.
Ascidian Therapeutics, a member of BioSpace’s NextGen Class of 2024, on Monday announced it received IND clearance from the FDA and was granted Fast Track designation for ACDN-01.
The FDA has granted Priority Review for AstraZeneca and Daiichi Sankyo’s supplemental BLA for the treatment of adult patients with unresectable or metastatic HER2-positive solid tumors.
After Tamar Bresge was diagnosed with retinitis pigmentosa at age 15, her entrepreneurial father made it his mission to help find a cure.
Excluding its COVID-19-products Comirnaty and Paxlovid, Pfizer’s revenue in the fourth quarter of 2023 grew 8%. The company projects full-year revenue in 2024 to remain about flat.
A minority of companies in the industry use personality tests in hiring. Here’s why—and how to approach the assessments.
Gilead Sciences and Arcus Biosciences have amended their collaboration agreement in an effort to accelerate an anti-TIGIT program, the companies announced Monday.
Gene therapy company Sarepta Therapeutics provided additional data for SRP-5051 in treating Duchenne muscular dystrophy patients who are amenable to exon 51 skipping.
Stringent regulation, manufacturing costs and absence of price control contribute to high GLP-1 agonist costs in the U.S. Patients could go to other countries for cheaper treatment.
After VX-548 demonstrated significant pain relief in surgical and non-surgical settings, Vertex Pharmaceuticals is preparing to file a New Drug Application for the non-opioid candidate by mid-2024.
The Centers for Medicare and Medicaid Services’ initial proposed drug price cuts, due to pharma companies by Thursday under the Inflation Reduction Act, could range from 25% to 60%, analysts told Reuters.
The persistent shortage of genuine glucagon-like peptide 1 receptor agonist products has led to an increase in fake versions, the World Health Organization warned on Monday.
On the heels of ArriVent and CG Oncology’s upsized IPOs last week, Alto Neuroscience and Fractyl Health on Monday announced their respective plans to go public.
Bristol Myers Squibb’s PD-1 inhibitor was unable to outperform the placebo arm in improving disease-free survival in renal cell carcinoma patients at high risk of relapse after surgery.
The clinical development pipeline for vaccines is broad but shallow with a large proportion of programs dedicated to COVID-19, according to a new report by industry group Biotechnology Innovation Organization.
The CEOs of J&J and Merck have finally committed to testifying before the Senate health committee regarding the high prices of drugs in the U.S. The hearing is set for Feb. 8.
The blockbuster immunotherapy secured separate late-stage victories as an adjuvant-setting treatment in renal cell carcinoma and muscle-invasive urothelial carcinoma.
The FDA’s myriad acronyms—and the differences between them—can be perplexing. BioSpace looks at the unique advantages of certain regulatory classifications for drug developers.