Here are the latest stories being discussed in biopharma today:

Pharma Firms Delist Patents from Orange Book Following FTC Challenges

Following the challenge from the Federal Trade Commission concerning over 100 improperly listed patents, three pharmaceutical companies have removed their patents from FDA’s Orange Book. This comes after heightened scrutiny from FTC this year, including arguments around patents for asthma inhalers, epinephrine auto-injectors, and other drugs.

Moderna’s Facility Finds Do Not Reflect Quality and Safety Concerns

Moderna has stated that the FDA findings at its Massachusetts facility does not indicate any concerns regarding the quality and safety of their vaccines. The company’s firm stand comes after lapses in cleaning procedures and expired product were discovered in the manufacturer’s Norwood, MA, plant during an inspection.

Servier Guilty of Fraud over Mediator Weight Loss Drug

French drug company, Servier, has been ordered to pay a fine of €430 million after a court ruling found them guilty of fraud. The case revolves around their weight loss drug, Mediator, which Servier marketed while aware of its potential harms.

Calliditas Wins Approval for Steroid Treatment in Rare Autoimmune Disease

Drug development company, Calliditas Therapeutics, has secured full approval for Tarpeyo, a steroid drug in rare autoimmune disease, IgA nephropathy (IgAN). Calliditas applied for full approval in June after the drug revealed a highly significant benefit over placebo in kidney function.

FDA Delivers CRL to Merck over Chronic Cough Drug Efficacy

A complete response letter (CRL) from FDA to Merck indicates the pharmaceutical firm’s drug for chronic cough, gefapixant, failed to meet evidence of effectiveness. The decision to hand a CRL over to Merck was free of any safety issues related to gefapixant.