Bob Kramer, Emergent BioSolutions CEO

It looks like the fi­nal round of Emer­gen­t's As­traZeneca Covid-19 dos­es have been re­leased

Four more batch­es of As­traZeneca’s Covid-19 vac­cine that were made at Emer­gent BioSo­lu­tions’ Bal­ti­more plant have been cleared for ship­ment out­side the US by the FDA, but it seems like this will be the last round of up­dates the agency is pro­vid­ing in con­nec­tion to the quar­an­tined dos­es from the CD­MO, wrap­ping up a near­ly one-year saga that led to the toss­ing of mil­lions of Covid-19 dos­es.

The FDA dis­closed the news in its roundup on Fri­day, but did not make Emer­gent aware of the news, a spokesper­son told End­points News in an email Tues­day. In the roundup, the agency said:

The As­traZeneca vac­cine is not au­tho­rized for use in the U.S., but the FDA un­der­stands that these As­traZeneca lots, or vac­cine made from these lots, may now be ex­port­ed for use. The agency con­duct­ed a thor­ough re­view of fa­cil­i­ty records and the re­sults of qual­i­ty test­ing per­formed by the man­u­fac­tur­er and reached its de­ci­sion based on this re­view, tak­ing in­to con­sid­er­a­tion the cur­rent world­wide COVID-19 pub­lic health emer­gency.

“At this time, the agency does not an­tic­i­pate mak­ing any more de­ter­mi­na­tions on ad­di­tion­al As­traZeneca lots man­u­fac­tured at the Emer­gent fa­cil­i­ty,” it said.

The prob­lem orig­i­nat­ed at the com­pa­ny’s Bayview fa­cil­i­ty, which gen­er­al­ly had been tout­ed for its ca­pac­i­ty to rapid­ly scale man­u­fac­tur­ing. CEO Bob Kramer has re­peat­ed­ly stat­ed that his com­pa­ny was one of a few that stepped up to the plate when the com­pa­ny des­per­ate­ly need­ed man­u­fac­tur­ing ca­pac­i­ty. But as a re­sult, drug sub­stance from J&J’s batch was con­t­a­m­i­nat­ed dur­ing a mix-up with As­traZeneca’s vi­ral vec­tors. That led to 15 mil­lion dos­es of J&J’s shot be­ing ru­ined, and 60 mil­lion dos­es to­tal get­ting tossed, as the FDA quar­an­tined and test­ed even more dos­es. Be­fore Fri­day’s an­nounce­ment, at least nine batch­es of J&J’s shot and three batch­es of As­traZeneca’s — good for about 100 mil­lion dos­es — had been re­leased from that hold.

Mean­while, an in­ves­ti­ga­tion of the Bal­ti­more site re­vealed em­bar­rass­ing de­tails about the clean­li­ness of the site. A Form 483 re­vealed that the plant was filthy, with paint chip­ping on the walls, mold and oth­er un­known black and brown sub­stances grow­ing and a fail­ure to de­con­t­a­m­i­nate bags of waste be­fore trans­port­ing it through­out the ware­house.

Shares of the CD­MO’s stock plum­met­ed, drop­ping from $133.42 per share all the way down to $33.11 in No­vem­ber. Last month, founder and the orig­i­nal CEO Fuad El-Hi­b­ri an­nounced he would re­tire in April.

In Ju­ly, the FDA gave the go-ahead to re­sume pro­duc­tion. last month, Emer­gent land­ed an­oth­er big-mon­ey con­tract from BAR­DA to man­u­fac­ture an an­thrax vac­cine for the na­tion­al stock­pile.

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

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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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.

Boehringer re­ports ro­bust sales led by type 2 di­a­betes and pul­monary drugs, promis­es more to come high­light­ing obe­si­ty

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

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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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.

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.

J&J bows out of RSV vac­cine race, end­ing PhI­II study and ced­ing to Pfiz­er, GSK

Johnson & Johnson announced Wednesday morning it is ending development of its adult RSV vaccine that was in the middle of a 27,200-patient trial, giving up a big slice of what’s expected to be the next multibillion-dollar pharma market.

The decision came down to the shifting RSV “competitive landscape,” a company spokesperson tells Endpoints News, adding the “breadth of options” was much different than when J&J first started its pivotal study. The spokesperson declined to comment on the Phase III data, saying only the shot is undergoing an “ongoing assessment.”

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