FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of an­oth­er drug as a re­sult of the new coro­n­avirus vari­ants. On Thurs­day, the agency an­nounced that As­traZeneca’s an­ti­body com­bo Evusheld, which was an im­por­tant pre­ven­tion op­tion for many im­muno­com­pro­mised peo­ple and oth­ers, is no longer au­tho­rized.

The FDA said it made its de­ci­sion based on the fact that Evusheld works on few­er than 10% of cir­cu­lat­ing vari­ants.

Evusheld was ini­tial­ly giv­en emer­gency au­tho­riza­tion at the end of 2021. How­ev­er, as Omi­cron emerged, so did stud­ies that showed Evusheld might not work against the dom­i­nant Omi­cron strain. In Oc­to­ber, the FDA warned health­care providers that Evusheld was use­less against the Omi­cron sub­vari­ant BA.4.6. It fol­lowed that up with an­oth­er an­nounce­ment ear­li­er this month that it did not think Evusheld would work against the lat­est Omi­cron sub­vari­ant XBB.1.5.

As­traZeneca said in a news re­lease that it will con­tin­ue to work with the FDA and oth­er health au­thor­i­ties on da­ta aroundE­vusheld and Covid-19 vari­ants.Evusheld is still au­tho­rized in oth­er coun­tries where it is ap­proved for COVID-19 pre-ex­po­sure pro­phy­lax­is and treat­ment, in­clud­ing the EU and Japan.

As­traZeneca not­ed it is al­so work­ing on a suc­ces­sor to Evusheld that tar­gets new­er vari­ants. It said the new an­ti­body treat­ment could be avail­able as ear­ly as the sec­ond half of the year, de­pend­ing on tri­al re­sults and reg­u­la­to­ry re­view time.

As the virus has evolved, a num­ber of drugs have seen their emer­gency au­tho­riza­tions re­strict­ed as they fail against new vari­ants. Last year, the FDA cut off use on an­ti­bod­ies de­vel­oped by Eli Lil­ly, Re­gen­eron, and GSK/Vir. The FDA not­ed in its press re­lease that Pfiz­er’s Paxlovid, Gilead’s Vek­lury, and Mer­ck’s Lagevrio are still ex­pect­ed to work against cur­rent vari­ants. How­ev­er, un­like Evusheld, these treat­ment op­tions aren’t for pre­ven­tion.

Note that un­like with Eli Lil­ly’s bam­lanivimab, for which the FDA re­voked its au­tho­riza­tion in 2021, the agency has been re­vis­ing its au­tho­riza­tions in these in­stances, in case the treat­ments work on emerg­ing new vari­ants. The FDA rec­om­mend­ed that health­care providers hold on­to their Evusheld stock in the event that such vari­ants do ap­pear.

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.

Stéphane Bancel, Moderna CEO (AP Photo/Markus Schreiber)

Mod­er­na so­lid­i­fies deal with Kenya to build mR­NA man­u­fac­tur­ing fa­cil­i­ty

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

Ribbon cutting ceremony for Thermo Fisher's new cell therapy manufacturing site in San Francisco

Ther­mo Fish­er moves on cam­pus with new cell man­u­fac­tur­ing site in San Fran­cis­co

Thermo Fisher Scientific is putting down more roots in the Bay Area.

The manufacturer opened the doors to a new cell therapy manufacturing facility next to the University of California-San Francisco Medical Center’s Mission Bay campus and on the university’s campus.

UCSF and Thermo Fisher have had a partnership since 2021, with the new site focusing on manufacturing cell therapeutics for certain cancers, including glioblastoma and multiple myeloma. The new site plans to use Thermo Fisher’s expertise in manufacturing services to help UCSF accelerate the development of cell therapies and eventually get them into the clinic, said Dan Herring, the general manager of cell therapy services at Thermo Fisher, in an interview with Endpoints News.

Ivana Magovčević-Liebisch, Vigil Neuroscience CEO

FDA lifts par­tial clin­i­cal hold on Vig­il Neu­ro­science's TREM2 an­ti­body, re­mov­ing dos­ing cap

When Vigil Neuroscience filed its IPO papers in late 2021, the biotech revealed that the FDA had just cleared its Phase I trial — but with a partial clinical hold that limited dosing to under a certain level.

More than a year later, the FDA has lifted the hold.

Vigil is now free to dose VGL101, an antibody targeting TREM2, at levels higher than 20 mg/kg in its ongoing and future clinical trials in patients with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP), an inherited condition that affects the brain and spinal cord.

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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Man­u­fac­tur­ing roundup: Catal­ent to pro­duce low-cost ver­sion of nalox­one; CSL opens R&D site

Catalent will be manufacturing a low-cost version of the opioid overdose treatment naloxone as part of a contract with Harm Reduction Therapeutics.

Catalent plans to manufacture the treatment at its facility in Morrisville, NC. No financial details on the deal were disclosed.

Harm Reduction was granted priority review status for the NDA on its spray last year. The company has been working on a naloxone product since 2017. It is anticipating approval in July of this year and a US launch in early 2024.

As­pen looks to re­bound in pro­duc­tion and rev­enue af­ter Covid-19

Last year, South African-based vaccine manufacturer Aspen Pharmacare was facing reports that it had not received a single order for its manufactured Covid-19 shots and that manufacturing lines were sitting idle. But now the vaccine producer is looking to turn things around.

Aspen’s disclosure of its financial results in March unveiled that manufacturing revenue had decreased by 12% to R 603 million ($33.8 million), which Lorraine Hill, Aspen Group’s COO, said is attributable to lower Covid vaccine sales.

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.