FDA's do­mes­tic in­spec­tion hold will con­tin­ue un­til Feb­ru­ary

Amid a back­log of in­spec­tions, the FDA has an­nounced that it will ex­tend its pause of do­mes­tic in­spec­tions not con­sid­ered mis­sion-crit­i­cal due to the out­break of the Omi­cron vari­ant.

While the agency will con­tin­ue both for­eign and do­mes­tic in­spec­tions deemed mis­sion-crit­i­cal, oth­ers will be paused through at least Feb. 4, and restart as soon as pos­si­ble af­ter that.

Pre­vi­ous­ly planned for­eign in­spec­tions will car­ry on as long as they’re in a coun­try that has been cleared, and are with­in the CDC’s Lev­el 1 or Lev­el 2 Covid-19 trav­el rec­om­men­da­tion — oth­er­wise, they’ll be resched­uled. The FDA hopes to re­turn to a reg­u­lar ca­dence for for­eign in­spec­tions in April.

Qui­et­ly in the start of Jan­u­ary, the FDA an­nounced that it paused in­spec­tions not con­sid­ered mis­sion-crit­i­cal for “at least two weeks” to en­sure the safe­ty of FDA em­ploy­ees. Some­what nor­mal in­spec­tions had on­ly just re­sumed in Ju­ly. A No­vem­ber 2021 re­port not­ed that 52 new drug ap­pli­ca­tions were de­layed, in part due to the back­log.

“The agency will pro­ceed with pre­vi­ous­ly planned for­eign sur­veil­lance in­spec­tions that have re­ceived coun­try clear­ance and are with­in the CDC’s Lev­el 1 or Lev­el 2 Covid-19 trav­el rec­om­men­da­tion; oth­er­wise, the in­spec­tion will be resched­uled,” FDA spokesper­son Michael Fel­ber­baum said. “The FDA’s goal is to re­turn to a reg­u­lar ca­dence for for­eign sur­veil­lance in­spec­tions in April.”

If for­eign reg­u­la­tors have giv­en the site the OK, par­tic­u­lar­ly in Eu­rope, the FDA re­serves the right to make a de­ci­sion based on lo­cal in­for­ma­tion. A shift to re­mote as­sess­ments of the fa­cil­i­ties is the end goal, but much of the back­log is due to sur­veil­lance in­spec­tions, which must be done on-site.

The news comes days af­ter a bill that would re­quire the FDA to of­fer the same lead time to do­mes­tic com­pa­nies as it does to for­eign man­u­fac­tur­ers was in­tro­duced by two Re­pub­li­can sen­a­tors. Sens. Mike Braun (R-IN) and Joni Ernst (R-IA) have penned a bill called the Cre­at­ing Ef­fi­cien­cy in For­eign In­spec­tions Act, in hopes of lev­el­ing the play­ing field and bring­ing more man­u­fac­tur­ing to the coun­try.

“This bill will put Amer­i­can pro­duc­ers on a lev­el play­ing field with for­eign com­peti­tors, help bring man­u­fac­tur­ing back to the US, and re­duce our re­liance on com­mu­nist Chi­na,” Ernst said in a press re­lease.

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

Man­u­fac­tur­ing roundup: Phar­maron se­cures ac­qui­si­tion of a Rhode Is­land fa­cil­i­ty; GSK to open hub in South Amer­i­ca

A Chinese pharma company is growing its presence in the US with a newly acquired API manufacturing site.

Pharmaron has entered into a definitive agreement to acquire a Coventry, Rhode Island-based API manufacturing site from drug manufacturer Noramco, which was previously owned by Johnson & Johnson and now owned by the private equity firm SK Capital.

According to Pharmaron, the site has an established history of API manufacturing from pilot kilogram to commercial metric ton scales. However, according to The People’s Radio, an NPR station covering Rhode Island and parts of Massachusetts, the facility was formerly owned by a subsidiary of Purdue Pharmaceuticals called Rhodes Technologies and was known for making opioid products. According to that report, because of Purdue’s 2019 bankruptcy filing, the Coventry factory was sold to Noramco, another opioid ingredient manufacturer.

Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Nassim Usman, Catalyst Biosciences CEO

Af­ter $60M Ver­tex deal, group of Cat­a­lyst share­hold­ers claims biotech could’ve sold as­sets three years ago

Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.

In came Vertex, with $60 million to buy up the South San Francisco biotech’s preclinical complement drugs, which target the system that bridges the body’s innate and adaptive immune response and a class most known for Ultomiris and Soliris. The deal includes CB 2782-PEG, the dry AMD drug that Biogen no longer wanted in March.

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Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

Pharma brands are losing their shine with US consumers who are now thinking about the economy and inflation instead of Covid. (Credit: Shutterstock)

Phar­ma brands fade in an­nu­al Har­ris con­sumer vis­i­bil­i­ty poll: Mod­er­na drops off and Pfiz­er dips

As Covid-19 concerns are fading in the US, so is biopharma visibility. The annual Axios Harris Poll survey to determine and rank the 100 most top-of-mind brands in the US finds Moderna, which was No. 3 last year, not on the list at all for 2022, and Pfizer sinking 37 spots.

However, it’s not that Moderna or Pfizer did anything wrong, it’s just that Americans have moved on to other worries beyond Covid.

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