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The UK’s National Institute for Clinical Excellence (NICE) voted down a recommendation for Gilead Sciences’ chemotherapy drug aimed at triple-negative breast cancer, but approved Merck KGaA’s Bavencio (avelumab), which fought its way back into the agency’s good graces after stakeholders launched a letter-writing campaign and the company lowered its cost. Read More
Pfizer announced yesterday that it would acquire ReViral in a $525 million deal that will give the company ownership of ReViral’s experimental treatments for respiratory syncytial virus (RSV) infections. Read More
Despite the disappointing results, Theravance is still investigating the drug as a potential treatment for patients with multiple system atrophy. Read More
Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni outlined the center’s budget priorities in fiscal year 2023 in a webinar hosted this week by the Alliance for a Stronger FDA. Read More
Repeated COVID-19 boosters simply aren’t a practical way to deal with the shape-shifting SARS-CoV-2 virus, according to members of the FDA’s Vaccines and Related Biologics Advisory Committee. Read More
Two draft guidelines from the International Council for Harmonization (ICH) were released yesterday for public comment, one on pediatric extrapolation in clinical trials and the other on calculating compound-specific acceptable intakes. Read More
The FDA issued a final guidance yesterday for sponsors of drugs and biologics for the treatment of chronic hepatitis B that expands upon a November 2018 draft. Read More
Lundbeck’s Vyepti (eptinezumab-jjmr), a monoclonal antibody approved for the treatment of migraines, was associated with greater declines in headache frequency and days of acute headache medication use vs. placebo in people dually diagnosed with chronic migraine and medication overuse headache, the company said. Read More
Citius Pharmaceuticals claimed a topline win in its pivotal phase 3 trial of I/Ontak (E7777) in patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL). Read More