Alkermes $ALKS is going to have to wait some more before launching its anti-psychotic combo drug ALKS-3831. The FDA has handed the biotech a CRL, rejecting the application in the company’s latest setback in R&D.

After getting a majority of the outside experts that reviewed the drug for the FDA to provide a thumbs up on approval, the biotech reported today that their manufacturing operations didn’t pass muster during their remote inspection of records — an alternative to a formal survey the agency adopted last summer as a result of the pandemic.

The FDA has once again shut the door on micro cap biotech Adamis Pharmaceuticals’ high dose naloxone injection.

Regulators handed down the program’s second CRL in nearly 12 months, Adamis announced Monday, sending the penny stock spiraling. The new rejection came as a result of new chemistry, manufacturing and controls issues, though Adamis noted that none of the problems stemmed from the “extractables and leachables testing” problems that caused the first thumbs down.

Apellis $APLS is one step closer to catching its rival for the rare blood disorder PNH.

The Waltham, MA-based biotech announced that the FDA has begun priority review for its experimental medicine pegcetacoplan after the drug beat Alexion’s blockbuster Soliris in a head-to-head Phase III. Regulators have set a PDUFA date for May 14, 2021, and Apellis noted that no adcomm is currently expected.

Investors seemed largely indifferent at the news, with Apellis down by about 0.8% at the end of day Monday. Alexion $ALXN shares, meanwhile, were flat.

A snap review didn’t lead to a quick OK for Sanofi’s sutimlimab. A day after the FDA’s supposed decision date on the orphan drug, the French pharma giant said it was handed a rejection.

The complete response letter cites “certain deficiencies identified by the agency during a pre-license inspection of a third-party facility responsible for manufacturing,” Sanofi wrote. Regulators apparently didn’t take any issue with the clinical data or safety.

Another day, another win for Merck’s blockbuster Keytruda.

The FDA has granted accelerated approval for the cash cow combined with chemotherapy in triple negative breast cancer, giving the drug the green light in its 18th different cancer. Monday’s new indication comes for patients with PD-L1-expressing tumors with a Combined Positive Score of at least 10.

Merck noted that due to the nature of the accelerated approval, the thumbs up is contingent upon confirmatory trials.

When pharmaceutical companies, health care leaders and regulators finally get a chance to debrief and pull lessons learned from the coronavirus pandemic, a chief takeaway may revolve around the many missed research opportunities. However, learnings from Covid-19 may one day lead to novel trial design and increased cooperation among these players promise a better path forward when speed and safety need equal consideration. This message was among many shared by a leading regulator in a 9 November audio interview with editors at the New England Journal of Medicine (NEJM).

A probe into Sanofi’s epilepsy drug Depakine has now entangled France’s National Medicines and Health Products Agency (ANSM), which was indicted on Wednesday for “injuries and manslaughter by negligence” related to birth defects and stillborn births caused by the drug.

Sanofi found itself at the center of a manslaughter investigation in August, several months after it was formally charged. The drug, sodium valproate, has been on the market since 1967 for epilepsy and bipolar disorder. It’s on the WHO’s list of “essential medicines,” and is prescribed in over 100 countries. But according to Reuters, France’s social affairs inspection agency estimates 425 to 450 babies exposed to the drug suffered congenital birth defects or were stillborn from 2006 to 2014.

In a wide-ranging Nov. 6 discussion with the president and CEO of the Friends of Cancer Research, Jeff Allen, CBER director Marks spoke to tempering public expectation, sustaining CBER staff despite a crushing workload during the coronavirus pandemic, and the possibility of more changes in 2021.

Under a new administration, said Marks, speaking at a virtual session of BioPharma Congress 2020, much could change. “So my hope is that we’ve already started the foundation for what needs to happen here.