Stephen Hahn at Senate confirmation hearing. AP Images

Sen­ate com­mit­tee backs Stephen Hahn as the next FDA com­mis­sion­er

A Sen­ate com­mit­tee hand­i­ly vot­ed in fa­vor of con­firm­ing MD An­der­son’s Stephen Hahn as the next of­fi­cial FDA com­mis­sion­er, suc­ceed­ing the inim­itable Scott Got­tlieb. And he was whisked through the 18-5 vote on the back of some tardy praise from a host of health­care groups — in­clud­ing quite a few that ini­tial­ly sup­port­ed act­ing com­mis­sion­er Ned Sharp­less for the job.

In the end, the out­come of the vote Tues­day morn­ing wasn’t re­al­ly in ques­tion, es­pe­cial­ly con­sid­er­ing the luke­warm op­po­si­tion he faced dur­ing his job in­ter­view dur­ing the Sen­ate hear­ing on the nom­i­na­tion.

Forty in­sti­tu­tions — in­clud­ing Friends of Can­cer Re­search, Na­tion­al Or­ga­ni­za­tion for Rare Dis­or­ders (NORD) and the Na­tion­al Pa­tient Ad­vo­cate Foun­da­tion — wrote to the HELP com­mit­tee back­ing Hahn’s nom­i­na­tion.

When Sharp­less was the fa­vorite, en­dorse­ments were not in short sup­ply. Got­tlieb made it abun­dant­ly clear on Twit­ter that the in­ter­im chief was his pick, while oth­er for­mer FDA lead­ers and pa­tient ad­vo­ca­cy non­prof­its — in­clud­ing Robert Califf and Mar­garet Ham­burg as well as Friends of Can­cer Re­search, the Na­tion­al Brain Tu­mor So­ci­ety and the Leukemia and Lym­phoma So­ci­ety — al­so de­clared their sup­port.

Hahn cur­rent­ly serves as the chief med­ical ex­ec­u­tive of MD An­der­son Can­cer Cen­ter. Un­der his tenure, the Uni­ver­si­ty of Texas re­search and treat­ment fa­cil­i­ty has un­der­gone a ma­jor re­struc­tur­ing to cope with the fi­nan­cial cri­sis of the last decade and Chi­nese staff sci­en­tists have been dis­missed, at a time when the Trump ad­min­is­tra­tion has made its aver­sion to the Asian coun­try ap­par­ent. The clin­i­cian, board-cer­ti­fied in ra­di­a­tion on­col­o­gy, med­ical on­col­o­gy, and in­ter­nal med­i­cine, has wad­ed in­to the realm of con­tro­ver­sy when the fu­ture of MD An­der­son has been in ques­tion — but at his more than two-hour au­di­tion at the Sen­ate last month, a mut­ed Hahn showed up.

He per­sis­tent­ly ex­tolled the virtue of “sci­ence and da­ta con­gru­ent with the law,” but steered clear of tak­ing a stand on the is­sues that are on top of the health care agen­da — from a po­ten­tial ban on fla­vored e-cig­a­rettes to im­port­ing drugs to ad­dress sky­rock­et­ing drug prices.

A New Fron­tier: The In­ner Ear

What happens when a successful biotech venture capitalist is unexpectedly diagnosed with a chronic, life-disrupting vertigo disorder? Innovation in neurotology.

That venture capitalist was Jay Lichter, Ph.D., and after learning there was no FDA-approved drug treatment for his condition, Ménière’s disease, he decided to create a company to bring drug development to neurotology. Otonomy was founded in 2008 and is dedicated to finding new drug treatments for the hugely underserved community living with balance and hearing disorders. Helping patients like Jay has been the driving force behind Otonomy, a company heading into a transformative 2020 with three clinical trial readouts: Phase 3 in Ménière’s disease, Phase 2 in tinnitus, and Phase 1/2 in hearing loss. These catalysts, together with others in the field, highlight the emerging opportunity in neurotology.
Otonomy is leading the way in neurotology
Neurotology, or the treatment of inner ear neurological disorders, is a large and untapped market for drug developers: one in eight individuals in the U.S. have moderate-to-severe hearing loss, tinnitus or vertigo disorders such as Ménière’s disease.1 With no FDA-approved drug treatments available for these conditions, the burden on patients—including social anxiety, lower quality of life, reduced work productivity, and higher rates of depression—can be significant.2, 3, 4

Patrik Jonsson, the president of Lilly Bio-Medicines

Who knew? Der­mi­ra’s board kept watch as its stock price tracked Eli Lil­ly’s se­cret bid­ding on a $1.1B buy­out

In just 8 days, from December 6 to December 14, the stock jumped from $7.88 to $12.70 — just under the initial $13 bid. There was no hard news about the company that would explain a rise like that tracking closely to the bid offer, raising the obvious question of whether insider info has leaked out to traders.

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Short at­tack­er Sahm Ad­ran­gi draws crosshairs over a fa­vorite of Sanofi’s new CEO — with PhII da­ta loom­ing

Sahm Adrang Kerrisdale

Kerrisdale chief Sahm Adrangi took a lengthy break from his series of biotech short attacks after his chief analyst in the field pulled up stakes and went solo. But he’s making a return to drug development this morning, drawing crosshairs over a company that’s one of new Sanofi CEO Paul Hudson’s favorite collaborators.

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Civi­ca and Blue Cross Blue Shield launch new ven­ture to low­er gener­ic prices

Five years after Martin Shkreli put a smug face to the volatile prices companies can charge even for generic drugs, payers and governments are coming up with outside-the-box solutions.

The latest fix is a new venture from the Blue Cross Blue Shield Association, 18 of its members and Civica, the generics company founded in 2018 by hospitals fed up with high prices for drugs that had long-since lost patent protection. While Civica focused on drugs that hospitals purchased, the new company will aim to lower prices on drugs that, like Shkreli’s Daraprim, are purchased by individuals.

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Merck Invests in State-Of-The-Art Biotech Development Facility in Switzerland

Mer­ck KGaA match­es lofty R&D goals with €250M in­vest­ment in­to a new clin­i­cal man­u­fac­tur­ing site in Switzer­land

As Merck KGaA strives to prove itself as a capable biopharma R&D player, it has begun construction on a €250 million facility dedicated to developing and manufacturing drugs for use in clinical trials.

The German drugmaker chose a location at Corsier-sur-Vevey, Switzerland, where it already has a commercial manufacturing site, in order to “bridge together research and manufacturing.”

“This investment in the Merck Biotech Development Center reflects our commitment to speed up the availability of new medicines for patients in need, and confirms the importance of Switzerland as our prime hub for the manufacturing of biotech medicines,” CEO Stefan Oschmann said at the groundbreaking ceremony, according to a statement.

Breast can­cer ap­proval in tow, As­traZeneca, Dai­ichi armed an­ti­body scores in key gas­tric can­cer study

AstraZeneca kicked off Monday with a flurry of good news. Apart from unveiling positive results on its stroke trial testing its clot-fighter Brilinta, and welcoming its experimental IL-23 inhibitor brazikumab back from Allergan — the British drugmaker also disclosed some upbeat gastric cancer data on its HER2-positive oncology therapy it is collaborating on with Daiichi Sankyo.

Buoyed by the performance of its oncology drugs, last March AstraZeneca chief Pascal Soriot bet big to partner with Daiichi on the cancer drug, with $1.35 billion upfront in a deal worth up to roughly $7 billion. Roughly 8 months later, as 2019 drew to a close, the FDA swiftly approved the drug — trastuzumab deruxtecan — for use in breast cancer, months ahead of the expected decision date.

Sor­ren­to shrugs off an anony­mous pri­vate eq­ui­ty group’s $1B of­fer to buy the com­pa­ny

San Diego-based Sorrento Therapeutics isn’t going the M&A route — at least not today.

The biotech caused quite a stir when it put out word a few weeks ago that an unidentified private equity group was bidding a billion dollars-plus for the company. The news drove a quick spike in the company’s share price as investors hooked up for the ride — that didn’t happen.

The update sparked a 5% drop in the share price $SRNE ahead of the bell. It’s now trading just above $4, without any evidence that the $7 price looked like it was firm.

UP­DAT­ED: Ab­b­Vie do­nates $1M+ of the HIV drug that Chi­na is now rec­om­mend­ing for coro­n­avirus treat­ment

AbbVie is donating more than $1 million worth of an HIV drug to help combat the fast-spreading coronavirus outbreak in China, the company announced on Friday.

China’s National Health Commission has suggested Aluvia, a pill containing lopinavir and ritonavir, as one of two possible treatments for the symptoms of the virus currently known as 2019-nCoV in the absence of effective antiviral medications. The other part is nebulized alpha-interferon.

UP­DAT­ED: Ab­b­Vie and Al­ler­gan di­vesti­tures are in, and an old As­traZeneca drug comes home

When AbbVie announced their $63-billion Allergan acquisition last year, executives acknowledged the two companies would have to divest some drugs to satisfy regulators. The two main assets in discussion have now been sold off – and one of them is coming home.

AstraZeneca will acquire brazikumab, Allergan’s late-stage IL-23 candidate for Crohn’s disease and ulcerative colitis. The drug was originally developed by AstraZeneca’s defunct subsidiary MedImmune, in collaboration with Amgen. Allergan licensed it for $250 million upfront and $1.27 billion in milestones.

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