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Merck appears destined for another disappointment with its investigative cough suppressant gefapixant, after an FDA advisory committee almost universally panned the drug’s phase 3 data, citing an almost complete overlap of patient-reported outcomes, a 57 percent placebo response rate, and a 28 percent dropout rate related to taste disturbance, the drug’s biggest side effect. Read More
Two oncology drugs that hold the records for the longest-marketed accelerated approval cancer drugs without confirmed clinical benefit and safety profiles need shorter, more focused study in a subgroup, members of the Oncologic Drugs Advisory Committee agreed in a meeting on Thursday, expressing concerns about the sponsor’s proposal for a large phase 3 trial. Read More
A groundbreaking treatment for sickle-cell disease and transfusion-dependent β-thalassemia using the biomedical advancement of CRISPR technology has been authorized by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for patients aged 12 and over. Read More
Bayer is issuing a voluntary withdrawal of Aliqopa (copanlisib) after the PI3K inhibitor failed to meet the primary endpoint of progression-free survival in its postmarketing confirmatory trial. Read More
At first, the idea of repurposing a drug seems so logical. A reasonable person could be forgiven for thinking this is already common practice. Since safety and efficacy have been shown in order to gain FDA approval to use a drug for a specific disease, that logic goes, wouldn’t researchers check to see what other diseases might be treated using such a drug? Read More
In this edition of Quick Notes, we review recent FDA drug approvals of Zepbound for weight loss, Fruzaqla for colorectal cancer, Cosentyx for hidradenitis suppurativa, Keytruda for biliary cancer, and Stelara biosimilar Wezlana for several inflammatory diseases. Read More
In this edition of Quick Notes we tackle regulatory activity across the pond in Britain and the EU with stories on increased EMA fees, electronic product information for medicines, an updated service to help pharmaceutical companies and repurposing of a drug to help prevent breast cancer. Read More
Many pre-approval inspections that were in limbo because of the backlog during the pandemic are now going ahead and the uptick could result in more product approvals, according to regulatory attorney Cathy Burgess, a partner in the law firm Alston & Bird. Read More
In this edition of Quick Notes, we cover drug approvals for Roche’s Vabysmo for macular edema, Servier’s Tibsovo for treatment of IDH1, Coherus’ and Shanghai Junshi Biosciences’ Loqtorzi for nasopharyngeal cancer, Santhera Pharmaceuticals’ Agamree for treatment of Duchenne muscular dystrophy (DMD) and Eli Lilly’s Omvoh for treatment of ulcerative colitis. Read More