Con­gress moves bill re­quir­ing de­clas­si­fi­ca­tion of Covid-19 ori­gins in­fo to Biden's desk

A bill that re­quires the Di­rec­tor of Na­tion­al In­tel­li­gence to de­clas­si­fy new in­for­ma­tion on the ori­gins of Covid-19 passed the House unan­i­mous­ly on Fri­day. The bill sim­i­lar­ly cleared the Sen­ate last week, and now heads to Pres­i­dent Joe Biden’s desk.

The White House hasn’t of­fi­cial­ly re­leased a state­ment on whether Biden will sign the bill, but he al­so has not in­di­cat­ed that he would ve­to it. In 2021, Biden told the US in­tel­li­gence com­mu­ni­ty and gov­ern­ment labs to in­crease their ef­forts to reach a con­sen­sus over the two com­pet­ing the­o­ries on how Covid-19 start­ed.

The bill re­quires the DNI to de­clas­si­fy all of the in­for­ma­tion no longer than 90 days af­ter its ap­proval, in­clud­ing ac­tiv­i­ties re­lat­ed to the Wuhan In­sti­tute of Vi­rol­o­gy in Chi­na, and in­for­ma­tion re­gard­ing re­searchers at the lab who fell ill in the fall of 2019. The bill al­so asks for an un­clas­si­fied re­port to be sub­mit­ted to Con­gress with nec­es­sary redac­tions.

The in­tel­li­gence com­mu­ni­ty and fed­er­al gov­ern­ment have been di­vid­ed on the ori­gins. Some be­lieve the virus like­ly orig­i­nat­ed in an an­i­mal mar­ket in Chi­na and jumped to hu­mans, while oth­ers be­lieve it like­ly re­sult­ed from a lab ac­ci­dent in Chi­na.

The US En­er­gy De­part­ment re­cent­ly sent shock­waves through the ori­gins dis­cus­sion when it said the Covid pan­dem­ic most like­ly came from a lab leak in Chi­na, ac­cord­ing to re­port­ing in the Wall Street Jour­nal. And FBI Di­rec­tor Christo­pher Wray al­so made sim­i­lar com­ments on Fox News ear­li­er this month, say­ing the start of the pan­dem­ic “most like­ly” came from “a po­ten­tial lab in­ci­dent in Wuhan.”

An un­clas­si­fied re­port from the Of­fice of the DNI said that four in­tel­li­gence agen­cies “as­sess with low con­fi­dence that the ini­tial SARS-CoV-2 in­fec­tion was most like­ly caused by nat­ur­al ex­po­sure to an an­i­mal in­fect­ed with it or a close prog­en­i­tor virus.”

The re­port added that an­a­lysts at three in­tel­li­gence agen­cies were un­able to say ei­ther way, with­out more in­for­ma­tion.

Chi­nese of­fi­cials have de­nied that the Wuhan In­sti­tute of Vi­rol­o­gy had any­thing to do with the out­break and said they were shar­ing da­ta and re­search re­sults on virus trac­ing, the As­so­ci­at­ed Press re­port­ed, though the US De­part­ment of State has said that the Chi­nese gov­ern­ment has “sys­tem­at­i­cal­ly pre­vent­ed a trans­par­ent and thor­ough in­ves­ti­ga­tion of the COVID-19 pan­dem­ic’s ori­gin.”

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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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.

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.

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.”