FDA commissioner Stephen Hahn (AP Images)

Stephen Hahn con­firmed as new FDA chief

The Sen­ate has vot­ed 72-18 to con­firm Stephen Hahn as the na­tion’s 24th com­mis­sion­er of food and drugs, ush­er­ing in a long­time re­searcher and med­ical ex­ec­u­tive that faced lit­tle back­lash in the con­fir­ma­tion process but was wide­ly seen as a sec­ondary choice for those around the agency.

Four ex-FDA chiefs and dozens of high-pro­file groups had pub­licly en­dorsed for the job act­ing com­mis­sion­er Ned Sharp­less, who served from Scott Got­tlieb’s sur­prise de­par­ture through No­vem­ber 1, when Pres­i­dent Don­ald Trump of­fi­cial­ly nom­i­nat­ed Hahn. Got­tlieb al­so gave his sup­port to Sharp­less on Twit­ter.

Brett Giroir has act­ed as com­mis­sion­er since Sharp­less’s de­par­ture.

The MD An­der­son ex­ec, though, large­ly sailed through his con­fir­ma­tion hear­ings last month. Con­tin­u­al­ly ex­tolling the virtues of sci­ence, da­ta and trans­paren­cy, Hahn evad­ed firm an­swers on ques­tions about drug pric­ing, opi­oids and e-cig­a­rettes that have be­come is­sues of na­tion­al de­bate.

“I’m very much in fa­vor of trans­paren­cy,” he said in re­sponse to a ques­tion from Re­pub­li­can Sen­a­tor Su­san Collins on Ab­b­Vie’s con­tro­ver­sial strat­e­gy to keep its Hu­mi­ra patents through 2023.

The vague stance – not un­com­mon for any con­fir­ma­tion hear­ing – fell well short of cost­ing him the job but was a fac­tor in how some sen­a­tors vot­ed. De­mo­c­ra­t­ic Sen­a­tor Mag­gie Has­san cit­ed non-com­mit­tal an­swers Hahn gave on e-cig­a­rettes and the agency’s his­to­ry with opi­oids in her “no” vote.

“The Food and Drug Ad­min­is­tra­tion has an es­sen­tial mis­sion to pro­tect the health and safe­ty of all Amer­i­cans – and its lead­ers must make de­ci­sions based on sci­ence, not po­lit­i­cal in­flu­ence,” Has­san said in a state­ment.

Many groups long close with the agency, in­clud­ing the Amer­i­can As­so­ci­a­tion for Can­cer Re­search, sup­port­ed Hahn once he was nom­i­nat­ed and pub­licly wel­comed the con­fir­ma­tion.

“The AACR is look­ing for­ward to work­ing close­ly with him and his ex­tra­or­di­nary team at the FDA to help fa­cil­i­tate and ex­pe­dite the de­vel­op­ment and ap­proval of safe and ef­fec­tive treat­ments for can­cer pa­tients,” they said in a state­ment.

Hahn comes with ex­pe­ri­ence in on­col­o­gy’s most cut­ting edge ther­a­pies, but he’s found him­self in con­tro­ver­sy be­fore, most re­cent­ly when Chi­nese re­searchers were dis­missed from MD An­der­son, rais­ing ques­tions about racial pro­fil­ing.

He steps in­to an FDA that faces its own bevy of ques­tions, in­clud­ing as to whether the agency’s push to get drugs to pa­tients as fast as pos­si­ble has gone too far.

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.

Cy­to­ki­net­ics’ ALS drug fails PhI­II, leav­ing the biotech with a sin­gle late-stage prospect

Cytokinetics’ candidate for the muscle disease amyotrophic lateral sclerosis, or ALS, failed a Phase III trial, the Bay Area biotech announced Friday morning.

At a second interim analysis of the trial, an independent review committee recommended that Cytokinetics discontinue its COURAGE-ALS trial for reldesemtiv, as it “found no evidence of effect” compared to placebo on the primary or key secondary endpoints.

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CHMP gives thumbs-up for We­govy use in ado­les­cents, along with nine new drug rec­om­men­da­tions

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

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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Lu­pus drug de­vel­op­ment mar­ket heat­ing up, while FDA links with ad­vo­ca­cy group to fur­ther ac­cel­er­ate re­search

The long-underserved systemic lupus erythematosus (SLE) market is suddenly buzzing with treatment possibilities. Less than two years after AstraZeneca’s approval for Saphnelo — the first new SLE drug in a decade and joining just one other approved in GSK’s Benlysta – the pipeline of potential drugs numbers in the dozens.

Although most are very early stage — Spherix Global Insights estimates five in Phase II/III — the pharma R&D enthusiasm is catching on among doctors, patients and advocacy groups. On Wednesday, the Lupus Research Alliance and the FDA formed a novel private-public partnership called Lupus Accelerating Breakthroughs Consortium (Lupus ABC) to help advance lupus clinical trial success.

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Green­Light re­ceives buy­out of­fer; Apol­lomics com­pletes SPAC merg­er

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.

TScan Therapeutics' departing CEO David Southwell and CSO/COO Gavin MacBeath

TCR up­start an­nounces CEO ex­it, with CSO now act­ing re­place­ment

A public T cell biotech’s chief executive has decided to leave the company.

TScan Therapeutics said Friday morning that CEO David Southwell stepped down earlier this week, leaving both his chief executive and board member roles. Filling in is Gavin MacBeath, the company’s CSO and COO. He became the acting CEO on Tuesday, and will continue to remain CSO and COO, TScan’s announcement read.

Sar­to­rius to ac­quire French man­u­fac­tur­er for $2.6B+ in cell and gene ther­a­py play

The German life science group Sartorius will be picking up French contract manufacturer Polyplus for the price of €2.4 billion, or $2.6 billion.

On Friday, Sartorius announced the acquisition through its French subgroup, Sartorius Stedim Biotech, which will be acquiring Polyplus from private investors ARCHIMED and WP GG Holdings IV. Polyplus has 270 employees and produces materials and components that go into making viral vectors that are used in cell and gene therapies. This includes DNA/RNA reagents as well as plasmid DNA. Polyplus has locations in France, Belgium, China and the US.

Austin biotech Mol­e­c­u­lar Tem­plates lays off more than 100 staffers as pipeline nar­rows

Molecular Templates is ridding itself of a Phase I HER2 asset and fine-tuning its pipeline to focus on three programs and a preclinical Bristol Myers Squibb collaboration. With the narrowed scope on its so-called engineered toxin bodies, the Austin, TX biotech is laying off about half of its staff.

That’s a little more than 100 employees, per an SEC filing. Molecular’s layoffs, approved by its board Wednesday, add to the dozens of pullbacks in the industry in the first three months of 2023.

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