Archive for February 2022

FDA clinical holds saw a sharp increase in 2021, propelled in large part by holds on cell and gene therapy trials, according to an analysis by investment banking firm Jefferies that evaluated holds over the past 12 years. Source: Drug Industry Daily

A biologics-focused subsidiary of Bangalore, India-based Biocon is buying the biosimilars portfolio of Pittsburgh, Pa.-based Viatris for up to $3.3 billion. Source: Drug Industry Daily

Sanofi and Regeneron added another brick to their joint Dupixent franchise with more phase 3 data confirming the antibody’s benefit in eosinophilic esophagitis, a chronic inflammatory disorder that can increase the risk of esophageal cancer. Source: Drug Industry Daily

The FDA has issued a complete response letter (CRL) to Reata Pharmaceuticals, rejecting the company’s new drug application (NDA) for bardoxolone methyl for treatment of patients with Alport syndrome-related chronic kidney disease. Source: Drug Industry Daily

Viatris, formerly Mylan, has agreed to a $264 million settlement to resolve a class-action lawsuit alleging that the company, along with Pfizer, had taken part in a scheme to delay generic competition to its EpiPen allergy treatment, used to quickly administer epinephrine to treat potentially fatal allergic reactions. Source: Drug Industry Daily

Amryt Pharma received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for Oleogel-S10 for treating a rare genetic skin ailment — epidermolysis bullosa (EB). Source: Drug Industry Daily

The European Medicines Agency’s (EMA) human medicines committee gave a thumbs up to 13 new drugs, including two biosimilars and five generics, in its monthly meeting last week. Source: Drug Industry Daily

The FDA has sent Mumbai-based Macleods Pharmaceuticals a 19-page, seven-observation Form 483 outlining many issues related to the cleanliness of its manufacturing facility after an inspection in October and November of 2021. Source: Drug Industry Daily

Jardiance (empagliflozin), the type 2 diabetes and cardiovascular blockbuster developed by Eli Lilly and Boehringer Ingelheim, has expanded its indications with a new approval for reducing the risk of cardiovascular death and hospitalization in adults with heart failure and preserved left ventricular ejection fraction (LEVF). Source: Drug Industry Daily

The FDA outlined its latest thinking on patient-focused drug development in a final guidance released on Friday, including ways to gather information that can be used for trial design. Source: Drug Industry Daily