Since 21 October, the FDA has been on a tear in approving five new drugs (all with list prices of more than $100,000 per year) months ahead of when they were expected to be approved.

For instance, the FDA signed off on Vertex Pharmaceuticals’ Trikafta (elexacaftor/ivacaftor/tezacaftor), a new treatment for those with the most common cystic fibrosis mutation, after only three months of review and well ahead of its 19 March 2020 user fee action date.

The FDA has given Aquestive Therapeutics the green light to market Exservan, its oral film formulation of a decades-old treatment for amyotrophic lateral sclerosis.

Back in 1995 riluzole became the first FDA-approved therapy for ALS, which remains incurable. Its exact mechanism of action is unknown but it’s been proposed that the drug blocks the release of glutamate from nerve cells, thereby alleviating glutamate-induced deterioration. As a result, the original drug was shown to delay symptoms and even death.

The FDA on Thursday released product-specific guidance documents for 81 active pharmaceutical ingredients to aid generic drug development, including 28 new draft guidances and 53 revised draft guidances.

The guidances, when finalized, are intended to promote generic competition by clarifying the FDA’s expectations for the studies required to demonstrate that a generic drug is equivalent to a reference listed drug. So far, the FDA has issued nearly 1,800 product-specific guidances.

While speculation that Sanofi is considering options for its consumer healthcare unit erupts ahead of a planned strategic update next month, it looks like the French drugmaker is losing a senior executive in charge of strategy.

Muzammil Mansuri, executive vice president of strategy, and business development — and member of Sanofi’s executive committee — is set to leave the company by the end of November, Reuters reported on Friday, citing an internal memo.

Another executive is migrating from the echelons of Big Pharma to the corridors of small biotech.

In April 2018, Badrul Chowdhury took his more than two decades of experience at the FDA to AstraZeneca, where he took on the role of senior vice president and chief physician-scientist for respiratory, inflammation and autoimmunity late-stage development in biopharmaceuticals R&D.

After about a year and a half in this role, Chowdhury is moving to a small Texas biotech called Savara, where he will serve as chief medical officer.