Mylan has once again run afoul of the FDA over its lack of upkeep at manufacturing plants.

For the second time in the last 12 months, the agency has sent a warning letter to the generic drugmaker calling out its failure to maintain industry-standard cleaning procedures that prevent contamination. In the letter, sent on Aug. 20 and published Tuesday, regulators also allege Mylan $MYL did not test incoming API for impurities, have mechanisms in place to detect such impurities from entering products, or keep cleaning records for bulk storage tanks.

Bristol Myers Squibb has gotten another approval from the old Celgene pipeline yesterday, this time for a once low-profile compound.

The FDA green-lighted Onureg, an oral drug previously known as CC-486. It’s chemically known as azacitidine — the same compound that in its IV form, branded as Vidaza, has long been used to treat acute myeloid leukemia and myelodysplastic syndromes. For Bristol Myers, it marks the second major approval since the Celgene merger was completed, after the multiple sclerosis drug Zeposia was OK’d earlier this year.

A new independent report on the FDA’s review practices for combination products under the Prescription Drug User Fee Act (PDUFA VI) gives the agency generally positive marks but finds room for refinements in communication and technology to improve the pre-submission and review process.

The report, commissioned by FDA as part of its PDUFA VI commitments, was conducted by Eastern Research Group and looked at FDA staff and sponsor experiences with combination products reviews during the pre-request for designation (pre-RFD), RFD, inter-center consult request (ICCR) and application submission stages.

As the FDA continues its review of the former-The Medicines Company, now-Novartis candidate inclisiran ahead of an expected PDUFA before the year is out, the Swiss pharma released pooled data that it hopes bolsters the case for approval.

A post-hoc analysis of two Phase III inclisiran trials showed consistency in efficacy and safety among patients with both hyperlipidemia and atherosclerotic cardiovascular disease despite statin therapy, with 99% of patients showing greater than 30% placebo-adjusted reduction in LDL-C levels. The average reduction was 54.1% from baseline in the 2,300 individuals between the two studies.

The FDA on Wednesday issued draft guidance providing recommendations to drugmakers on evaluating cancer drugs in patients with central nervous system (CNS) metastases. FDA says the guidance is meant to inform clinical trial designs to support product labeling that describes antitumor activity of drugs or biologics in patients with CNS metastases from solid tumors originating in other parts of the body.

A small Swiss-listed biotech spinout secured FDA approval for their first drug, setting them up to compete in a crowded market for acne.

Cassiopea received an okay for Winlevi, the drug that has been at the top of the company’s pipeline since the company spun out from the Swiss pharma Cosmo in 2015. It will take a little bit longer to market, though, likely because the company has little commercial infrastructure so far.  The biotech said they plan to start early 2021. A price will be announced in Q4, Reuters reported.