With Covid-19 locking down travel across the world, not even drug safety regulators have been spared from costly delays. For the FDA, whose inspection schedule keeps the trains on time for new marketing approvals, those delays are continuing to prove costly.

The FDA has pushed review of Mallinckrodt’s allogeneic skin graft for burns, dubbed StrataGraft, after the agency admitted it wasn’t able to conduct a plant inspection in the needed timeframe for a decision, the drugmaker said last week.

The FDA has long taken a collaborative approach to working with drugmakers on approval applications, all in the interest, it says, of bringing the best molecules to market. But when the drug is a lemon, the cozy relationship between regulators and industry courts easy blame.

Could a “firewall” between regulators and drugmakers prevent lousy drugs from getting the agency’s backing? Acting commissioner Janet Woodcock says no way.

Amgen is looking to go where no other drugmaker has gone before with the KRAS inhibitor sotorasib, which posted big Phase II lung cancer response data in late January. The FDA has been listening, and now it’s ready to give Amgen its ear.

The FDA will speedily review sotorasib’s application to treat second-line patients with locally advanced or metastatic non-small cell lung cancer in what would be the first successful bid to inhibit KRAS, Amgen said in a release.

Hard-and-fast rules in drug development are hard to come by, but one has long been the standard for market approvals — you have to hit your primary endpoints in pivotal studies. But for Novartis’ heart failure med Entresto, what’s a Phase III miss between friends?

The FDA on Tuesday approved Entresto, a combination of neprilysin inhibitor sacubitril and angiotensin receptor II blocker valsartan, to treat heart failure patients with a preserved ejection fraction (HFpEF), making it the first drug on the market for that population.

After years spent in the penny stock range, Sesen Bio has nabbed a long-awaited FDA review for its antibody-drug conjugate bladder cancer program.

The FDA will give an accelerated audit to Sesen and its bladder cancer candidate Vicineum, an antibody-drug conjugate acquired in the company’s buyout of Toronto-based Viventia back in 2016. Sesen is penciled in for an Aug 18 PDUFA, and there is no adcomm on the docket right now, the company said.

The FDA has thrown a minor wrench in Cortexyme’s unorthodox plan to treat Alzheimer’s.

On Monday, the Bay Area biotech announced that the agency had put one of the studies in their pivotal program on hold after the company reported that patients experienced liver problems while taking their lead drug. The issues were reversible and had no known long-term effects, the company said.

The hold will not affect the Phase II/III, blinded, randomized controlled study they hope to read out towards the end of this year. Instead, the agency has decided to end, for the time being, an open-label extension study that had been measuring their molecule’s long-term effects on patients who already completed the initial 48-week study. No new patients will be enrolled and patients currently in the trial will be discontinued.

Astellas and Seagen made a big splash with their Nectin-4 targeting therapy Padcev in late 2019, scoring a conditional FDA approval to target urothelial cancer. Now, the results are in for the confirmatory study for that indication, and it looks like a resounding win for Padcev.

Astellas and Seagen’s Padcev extended patients’ lives to an average 12.9 months compared with nine months for a chemo control, according to full data from the Phase III EV-301 study presented Friday at the virtual ASCO GU meeting.

Inadequate responses to findings of potency discrepancies, blending issues and out-of-specification samples during a May 2020 inspection recently landed tablet manufacturer Allay Pharmaceuticals with a scorching FDA warning letter.

In a heavily-redacted version of the Jan 27 letter that was made available this week, the FDA chided the Hialeah, Florida manufacturer for vague and insufficient responses across the board to three major observations discovered during the May 5 to 15, 2020 site inspection. Those observations were communicated through a Form 483 letter, and Allay’s responses to the FDA on June 6 clearly irked the agency.