FDA in­spec­tion un­cov­ers cher­ry-col­ored an­tibi­ot­ic residue on equip­ment at Teva's New Jer­sey site

An FDA in­spec­tion re­port on Te­va’s man­u­fac­tur­ing site in New Jer­sey has re­vealed is­sues with both equip­ment clean­ing and qual­i­ty.

The three-page re­port, which was ob­tained by End­points News via a FOIA re­quest from the FDA, showed sev­er­al ob­ser­va­tions from its in­spec­tion, which took place be­tween Nov. 1 and Nov. 10 of last year, at Te­va’s site in Fair­field, NJ.

In­spec­tors not­ed a buildup of “un­known residue” with­in two pro­duc­tion rooms that had been doc­u­ment­ed as cleaned. Specif­i­cal­ly, a pink- or red-col­ored residue was found on equip­ment in the mix­ing room that had most re­cent­ly been used to man­u­fac­ture Ce­fadrox­il tablets. Ce­fadrox­il, which is used to treat bac­te­r­i­al in­fec­tions in var­i­ous parts of the body, does not use any dyes or fla­vor­ings.

Pre­vi­ous­ly, the same equip­ment al­so pro­duced sev­er­al batch­es of Cephalex­in, an­oth­er an­tibi­ot­ic which does in­clude a cher­ry fla­vor­ing and a red dye, FDA said. Cephalex­in is used to treat pneu­mo­nia, res­pi­ra­to­ry in­fec­tions and oth­ers.

The re­port al­so in­di­cates that sev­er­al oth­er ar­eas of the mix­ing room con­tained un­known residue, in­clud­ing a work­sta­tion and sev­er­al blenders, one of which had pre­vi­ous­ly been used to make Cephalex­in cap­sules.

The in­spec­tion re­port al­so said that some Cephalex­in tablets had two com­plaints at­tached, which was part of a larg­er in­ves­ti­ga­tion in­to “de­fec­tive coat­ing.” As part of the in­ves­ti­ga­tion, the batch was sub­ject­ed to oth­er tests, but was al­so run through screen­ing equip­ment that was not doc­u­ment­ed as “qual­i­fied with tablet prod­ucts.” The re­port and the stan­dard op­er­at­ing prac­tices don’t give de­tails on the screen­ing of tablets. While over 34,000 tablets were re­ject­ed, the re­main­ing tablets that were scanned were re­leased for dis­tri­b­u­tion in the US in 2018.

Te­va al­so re­ceived 30 com­plaints re­lat­ed to de­fec­tive coat­ings on Cephalex­in be­tween Nov. 2018 and March 2021. Coat­ing en­hance­ments were rec­om­mend­ed, while the im­ple­men­ta­tion of these en­hance­ments is still pend­ing, ac­cord­ing to the re­port.

End­points reached out to Te­va for a state­ment on this re­port but did not re­ceive a re­sponse by press time.

Te­va’s man­u­fac­tur­ing sites have been un­der the FDAs mi­cro­scope in the past.

In 2021, in­ves­ti­ga­tors un­veiled sev­er­al prob­lems at a Te­va Phar­ma­ceu­ti­cals plant in Irvine, CA, in­clud­ing mold stem­ming from wa­ter leaks. Te­va halt­ed pro­duc­tion at that site, which even­tu­al­ly led to the re­call of 2.5 mil­lion vials of drugs, ac­cord­ing to a Bloomberg re­port.

That site was shut­tered in Au­gust of 2022, with 305 peo­ple be­ing laid off.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

Editor’s note: This is a live story and will be updated.

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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See­los Ther­a­peu­tics 'tem­porar­i­ly' stops study in rare neu­ro dis­or­der for busi­ness rea­sons

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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FDA ap­proves Nar­can opi­oid over­dose re­ver­sal spray for over-the-counter sale

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.

Alec­tor cuts 11% of work­force as it dou­bles down on late-stage neu­ro pro­grams part­nered with GSK, Ab­b­Vie

A month after revealing plans to concentrate on its late-stage immuno-neurology pipeline, Alector is trimming its headcount by 11%.

The layoffs will impact around 30 employees across the organization, the company disclosed in an SEC filing, adding that the plan will “better align the company’s resources” with the new strategy. With $712.9 million in cash, cash equivalents and investments as of the end of 2022, Alector believes the reserves will now get it through 2025.

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Hugo Peris, Spiral Therapeutics CEO

Hear­ing-fo­cused biotech grabs trio of pro­grams from Oton­o­my's fire sale

Otonomy may be shutting down, but the lessons learned there will live on at another biotech working on new treatments for hearing loss.

San Francisco-based Spiral Therapeutics has bought certain assets related to three of Otonomy’s programs, ranging from data, patent rights, and know-how to inventory. That includes data around Otonomy’s twice-failed lead program, OTO-104 (Otividex), a sustained-exposure formulation of dexamethasone.

CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.