Morning Briefing
Summaries of health policy coverage from major news organizations
European Drugmakers May Halt Some Production Amid Soaring Energy Costs; FDA Approves C. Diff Treatment
Reuters: Europe's Generic Drugmakers Say They May Cut Output Due To Energy Bills
Europe's drugmakers have warned they may stop making some cheap generic medicines because of surging electricity costs and are calling for an overhaul of the way they are priced, the latest industry to seek help as the energy crisis deepens. The generic drug industry lobby group Medicines for Europe, which represents companies including Teva, Novartis's Sandoz unit and Fresenius SE's Kabi business, on Tuesday sent an open letter to European Union member states' energy and health ministers. (Burger, 9/28)
On fecal transplants —
CIDRAP: FDA Advisers Approve Fecal Transplant Treatment For Recurrent C Difficile
Swiss biopharmaceutical company Ferring Pharmaceuticals announced yesterday that the Food and Drug Administration's (FDA's) Vaccine and Related Biological Products Advisory Committee (VRBPAC) voted in favor of the company's investigational fecal microbiota transplant (FMT)-based therapy. ... FMT therapy involves transplanting beneficial bacteria into the gut of a patient with recurrent CDI, which is traditionally treated with antibiotics. (9/23)
CIDRAP: Trial: Fecal Microbiota Transplantation Superior To Antibiotics For C Difficile
A randomized clinical trial conducted in Denmark found that, in patients with a first or second Clostridioides difficile infection, fecal microbiota transplantation (FMT) was superior to standard-of-care antibiotic treatment in achieving sustained resolution of symptoms, researchers reported last week in The Lancet Gastroenterology & Hepatology. (9/27)
In other pharmaceutical industry news —
Reuters: Biden Administration Asks Supreme Court To Reject Amgen's Repatha Patent Appeal
The Biden Administration told the U.S. Supreme Court on Wednesday that it should turn down a request by Amgen Inc to review a decision that invalidated patents on its blockbuster cholesterol drug Repatha. The U.S. Court of Appeals for the Federal Circuit correctly found that the relevant parts of the patents did not describe Amgen's inventions adequately when it ruled for Sanofi SA and Regeneron Pharmaceuticals Inc, U.S. Solicitor General Elizabeth Prelogar said. (Brittain, 9/21)
Reuters: Novartis To Take U.S. Drug Patent Case To Supreme Court
Novartis AG plans to ask the U.S. Supreme court to uphold the validity of a patent it holds on the dosing regimen for multiple sclerosis drug Gilenya after suffering a setback in a federal appeals court ruling, the Swiss drugmaker said on Wednesday. (9/22)
Reuters: Novartis To Prioritize U.S. Market, Unfazed By Drug Pricing Pushback
Swiss pharma giant Novartis said it would make growth in the United States its top geographic priority, even after laws were passed to rein in drug prices in the world's largest pharmaceutical market. (Burger and Revill, 9/22)
FiercePharma: Daiichi Sankyo Bags First Approval For Blood Cancer Drug Ezharmia
While Daiichi Sankyo has been focusing on a stable of antibody-drug conjugates, the Japanese company has won a global first in an area that Pfizer is also targeting. (Liu, 9/26)
Reuters: U.S. FDA Puts Avidity's Muscle Disorder Drug Trial On Partial Hold
Avidity Biosciences Inc said on Tuesday the U.S. Food and Drug Administration has put a hold on patient enrollment in an early-to-mid-stage trial of its drug to treat a genetic muscle disorder, sending the company's shares down over 15%.The agency put the partial hold after a serious adverse event seen in a patient during the study. (9/27)
FiercePharma: Hospira Must Wait To Launch Generic Lexiscan But Only Two Weeks
Fourteen years after it launched Lexiscan in the U.S., Astellas is trying to wring the last bit of market exclusivity it can get out of the scanning agent. (Dunleavy, 9/26)
FiercePharma: The Most Productive Biopharma Workforces Of 2021
A lot has changed since we last ranked the most productive biopharma companies with numbers from 2016. For starters, two of that year’s top 10 companies—Celgene and Allergan—are no longer independent firms. (Liu, Becker, Dunleavy, Kansteiner, and Sagonowsky, 9/26)
Bloomberg: GSK Will Be Helmed By Two Women As Drugmaker Hires Brown As CFO
GSK Plc hired Julie Brown as chief financial officer to work alongside Chief Executive Officer Emma Walmsley, putting two women in charge of the UK drugmaker -- a milestone in an industry dominated by men. (Fourcade, 9/26)
