COVID-19 vaccine makers are shifting gears and planning for a smaller, more competitive booster shot market after delivering as many doses as fast as they could over the last 18 months.

Although 2020 was a tough year for the biopharma industry — and most other industries as well — it appeared to rebound significantly in mid-2021. However, biotech stocks are generally getting hammered during 2022, although to be fair, the entire stock market is down.

FDA sign

Less than one month after the U.S. Food and Drug Administration raised concerns about the supplemental New Drug Application for Pfizer and Myovant Sciences’ Myfembree (relugolix), the regulatory agency extended the review period to Aug. 6. The initial approval review date was May 6.

The Janssen COVID-19 vaccine is now limited to certain individuals ages 18 and up after the U.S. Food and Drug Administration downgraded its emergency use authorization.

COVID-19, syringe needle

The first World Trade Organization meeting to discuss a draft agreement to temporarily waive intellectual property rights for COVID-19 vaccines went “very well”, its chair said on May 6.

Cigna Corp. raised the health insurer’s annual adjusted profit forecast on May 6, following a decline in COVID-related costs and no sign of pent-up demand for medical procedures that were delayed due to the pandemic.

NovoLog, Novo Nordisk

U.S. lawmakers attempting to cut the cost of insulin for more than a million Americans to $35 per month are unlikely to succeed as November elections draw near and complicate bipartisan support, health policy and political experts say.

Paxlovid

Additional reports of patients with long COVID who were helped by Pfizer Inc.’s oral antiviral treatment Paxlovid offer fresh impetus for conducting clinical trials to test the medicine for the debilitating condition, U.S. researchers said on May 5.

The U.S. Food and Drug Administration indirectly refuted Pfizer’s recommendation that it’s all right for COVID-19 patients to take another round of Paxlovid if they experience a rebound after completing the first course.

Novartis temporarily suspended the production of the company’s Lutathera and Pluvicto cancer therapies at facilities in Italy and New Jersey after potential quality issues were discovered in their manufacturing.