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Andy Jassy, Amazon CEO (Isaac Brekken/AP Images for NFL, File)

Up­dat­ed: FDA slaps Ama­zon with a warn­ing let­ter for sell­ing OTC mole re­moval prod­ucts

The FDA’s Center for Drug Evaluation and Research on Tuesday released a warning letter sent last week to Amazon CEO Andy Jassy in Seattle for selling mole removal products over-the-counter, or, as the FDA explains, “introducing, delivering, or causing the introduction or delivery into interstate commerce of products that are unapproved new drugs.”

“There are no over-the-counter (OTC) drugs that can be legally sold for mole or skin tag removal, and FDA has safety concerns about drugs marketed OTC directly to consumers for these uses,” the agency said in its Aug. 4 warning.

Warren Huff, Reata Pharmaceuticals CEO

Rea­ta’s ‘reg­u­la­to­ry con­cerns’ turn in­to three-month de­lay on FDA de­ci­sion for Friedre­ich’s atax­ia drug

In its Q2 report Monday, Reata Pharmaceuticals said that the FDA continues to have concerns about its Friedreich’s ataxia drug.

On Tuesday, those concerns manifested in a three-month delay on an FDA approval decision. Reata’s new FDA decision deadline for its Friedreich’s ataxia drug, omaveloxolone, is the end of February 2023, it announced this morning.

In the Q2 report, Reata noted that the FDA was concerned about the efficacy of omaveloxolone. The Plano, TX-based biotech said that in response to those concerns, it submitted additional data from its clinical trial. But in order to review that new data, the FDA needs more time, hence the three-month delay, Reata said Tuesday morning.

Joe Todisco, CorMedix CEO

CorMedix hit with sec­ond CRL for an­ti­fun­gal treat­ment, cit­ing man­u­fac­tur­ing and API is­sues

Following a C-suite shuffle, a shuttering of its European operations and a CRL for its treatment to prevent bloodstream infections in patients undergoing chronic hemodialysis, CorMedix is still not impressing the FDA.

The biotech has now been given a second rejection letter, as the NDA surrounding its antifungal solution, DefenCath, cannot be approved until issues surrounding its contract manufacturing organization and the supplier of the API heparin during inspections are resolved, CorMedix said Monday afternoon.

FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

With drug pric­ing al­most done, Con­gress looks to wrap up FDA user fee leg­is­la­tion

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

FDA's vac­cine ad­comm to re­view first fe­cal trans­plant to treat C. dif­fi­cile in­fec­tions

Back in 2018, Swiss drugmaker Ferring Pharmaceuticals made a big bet on Minnesota-based Rebiotix, buying up the company for its experimental poop-based drug implant to treat an infection caused by C. difficile, a potentially dangerous bacteria, in a new way.

Four years later, Ferring’s fecal microbiota transplant, dubbed RBX2660 or Rebyota, will face the FDA’s adcomm of outside vaccine experts on Sept. 22, debating whether the agency should license the transplant as a treatment for adults following antibiotic treatment for recurrent C. difficile infection.

Dave Marek, Myovant CEO

Pfiz­er and My­ovant’s en­dometrio­sis pain drug Myfem­bree gets an­oth­er FDA nod

After months of delay in its decision, the FDA has given a green light to Pfizer and Myovant’s drug Myfembree for pain related endometriosis, a gynecological condition associated with moderate to severe pain, making it the drug’s second indication approval.

The FDA had earlier delayed its decision to review additional data it had requested from the companies regarding bone mineral density. The regulators had “identified deficiencies that preclude discussion of labeling and/or post-marketing requirements and commitment at this time,” the companies had said.

Sen. Kyrsten Sinema (D-AZ) (Tom Williams/CQ Roll Call via AP Images)

De­moc­rats se­cure sup­port from key sen­a­tor ahead of po­ten­tial drug pric­ing vote

Senate Democrats may have all the votes they need to pass major drug pricing reform, after Sen. Kyrsten Sinema (D-AZ) reportedly pledged her support on Thursday — but will they fit it in before recess?

Sinema said she has agreed to “move forward” with the reconciliation bill with some stipulations, including the removal of a carried tax provision, according to recent reports. The bill is still expected to reduce the deficit by $300 billion, and Sen. Chuck Schumer (D-NY) said that he now anticipates “support from the entire Senate Democratic conference,” the Washington Post reported. 

Steve Davis, Acadia Pharmaceuticals CEO

Aca­dia hits an­oth­er Nu­plazid road­block as the FDA doles out CRL and rec­om­mends an­oth­er tri­al

Despite winning an approval back in 2016, Acadia’s Nuplazid has not had the easiest of paths in its journey to expand into new areas. And late Thursday night, the company put out a press release saying it received more bad news from the FDA.

Regulators rejected Acadia’s application to expand Nuplazid coverage into Alzheimer’s-related psychosis, the biotech said, turning away its supplemental NDA with a CRL. The rejection letter indicated the FDA also recommended that Acadia conduct an additional trial in ADP, Acadia said.

FDA is­sues new guid­ance for changes to dis­pos­able man­u­fac­tur­ing ma­te­ri­als

While the FDA is stepping up inspections of manufacturing sites after Covid-19 caused delays, the regulator has issued new guidance to the industry surrounding changes regarding disposable materials.

The guidance states that any changes to disposable materials used primarily in drug and biological product manufacturing, including at contract manufacturing sites, must “be available upon request during an FDA inspection.”