With Trump’s new FDA com­mish nom­i­nee loom­ing, in­dus­try ex­ecs are keep­ing their fin­gers crossed for Scott Got­tlieb

Scott Got­tlieb

Last week Pres­i­dent Trump said he was just days away from an­nounc­ing an ab­solute­ly “fan­tas­tic” new FDA com­mis­sion­er. One who would cut up to 80% of the reg­u­la­tions around drug de­vel­op­ment, blaz­ing a short­er path to an ap­proval. One who would get ex­per­i­men­tal meds to dy­ing pa­tients, over­haul­ing time­lines and slash­ing de­vel­op­ment bud­gets.

By and large, the mes­sage has spurred more than a lit­tle trep­i­da­tion in the in­dus­try that the pres­i­dent, who has earned a rep­u­ta­tion for shoot­ing first and ask­ing ques­tions lat­er, was go­ing to rad­i­cal­ly change the ap­proval process at the FDA. And that might in­di­cate that lib­er­tar­i­an “seast­ead­er” Jim O’Neill — who has fa­mous­ly said that drugs should be ap­proved on safe­ty alone — has the in­side track with the new pres­i­dent.

But he’s not the in­dus­try’s first choice. That dis­tinc­tion ap­pears to be re­served al­most en­tire­ly for Scott Got­tlieb, the for­mer deputy com­mis­sion­er at the FDA un­der George W. Bush with a rep­u­ta­tion as a staunch con­ser­v­a­tive with no known ap­petite for toss­ing grenades in­to the reg­u­la­to­ry un­der­brush.

Mizuho Se­cu­ri­ties USA ran a quick sur­vey of 53 drug com­pa­nies ask­ing them which of the four can­di­dates men­tioned so far in the me­dia — Got­tlieb, O’Neill, Bal­a­ji Srini­vasan and Joseph Gul­fo — would get their vote.

Sev­en­ty-two per­cent picked Got­tlieb. The rest were al­so rans. O’Neill got a hand­ful of votes at 8%, with Gul­fo at 9% and Srini­vasan at a mere 2%. (Gul­fo has pro­mot­ed his own can­di­da­cy with­out any in­de­pen­dent con­fir­ma­tion from the Trump ad­min­is­tra­tion that he’s ever been a se­ri­ous can­di­date or been with­in 100 feet of the new pres­i­dent.)

In his week­ly roundup on Fri­day, Baird’s Bri­an Sko­r­ney came to the same con­clu­sion with­out any polling. He wrote: “We be­lieve in­dus­try and in­vestor sup­port is over­whelm­ing­ly in fa­vor of Scott Got­tlieb.”

“He leans right, he’s got ex­pe­ri­ence in the agency, he’s got the M.D. cre­den­tial, and he’s out­spo­ken,” Michael Ga­ba, fed­er­al pol­i­cy leader of law firm Hol­land & Knight’s na­tion­al Health­care & Life Sci­ences Team, told Reuters re­cent­ly.

I asked Ga­ba to elab­o­rate on that. And he sent me this:

When it comes to the FDA, bio­phar­ma, and reg­u­lat­ed in­dus­try as a whole, puts a pre­mi­um on pre­dictabil­i­ty, speed to mar­ket, and the abil­i­ty to make dif­fer­en­ti­at­ing claims in the mar­ket­place about their prod­ucts’ ef­fec­tive­ness to treat and mit­i­gate dis­ease.  Safe­ty is the giv­en once a prod­uct makes it through the FDA, and by it­self doesn’t dis­tin­guish prod­ucts in the mar­ket­place.  Among the FDA com­mis­sion­er can­di­dates we’ve read about, Dr. Got­tlieb is well known to in­dus­try and has the req­ui­site ex­pe­ri­ence and tal­ent to re­form and stream­line the FDA ap­proval process.

The theme among the oth­er can­di­dates ap­pears to be to speed prod­ucts to mar­ket by lim­it­ing the agency’s role to eval­u­at­ing safe­ty on­ly.  Not on­ly would this dy­nam­ic be chal­leng­ing to in­dus­try, providers and pa­tients, it would re­quire a statu­to­ry change to the FD­CA – and we all know that the leg­isla­tive process it­self can be very messy and un­pre­dictable.

Got­tlieb’s nom­i­na­tion would con­tin­ue a long­stand­ing tra­di­tion of nam­ing a trained physi­cian for the top job at the FDA. As a res­i­dent fel­low at the Amer­i­can En­ter­prise In­sti­tute, he’s kept the heat on Oba­macare through a se­ries of op-eds in high pro­file pub­li­ca­tions like the Wall Street Jour­nal. As a ven­ture part­ner at New En­ter­prise As­so­ci­ates he’s a board mem­ber at Me­dA­vante, which mar­kets soft­ware for an­a­lyz­ing clin­i­cal tri­al da­ta. And he’s an ad­vi­sor to Glax­o­SmithK­line, which has shown no ap­petite for rad­i­cal change in the way de­vel­op­ers prove a drug works.

It’s the kind of re­sume that would in­di­cate a sym­pa­thy for con­tin­u­ing to evolve reg­u­la­tions to speed de­vel­op­ment, but with­out any ap­petite for play­ing rev­o­lu­tion­ary.

Of course, that’s one rea­son why he may not get the job. Trump has glee­ful­ly named new cab­i­net mem­bers based on their hos­til­i­ty to the agen­cies they’ll be run­ning and the reg­u­la­tions they’ve been in­volved in cre­at­ing. And his ex­ec­u­tive or­der de­mand­ing the elim­i­na­tion of two rules for every new one un­der­scores his com­mit­ment to elim­i­nat­ing hun­dreds of pages of regs for every one that sur­vives.

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Up­dat­ed: Amid mas­sive re­struc­tur­ing, Bio­gen looks to re­duce phys­i­cal pres­ence in Boston

Biogen is putting a sizable chunk of office and research space in Kendall Square and Weston, MA up for sublease, marking another big change as the biotech grapples with the aftershock of a disastrous and controversial rollout for its Alzheimer’s drug.

The subbleases are “part of Biogen’s overall implementation of the ‘Future of Work,’ which is allowing us to optimize our footprint and reduce the amount of space we occupy, taking into consideration new elements such as the hybrid work model,” Biogen spokesperson Ashleigh Koss wrote in a statement to Endpoints News, adding that the company has had subleases across several buildings for years.

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Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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Who are the women blaz­ing trails in bio­phar­ma R&D? Nom­i­nate them for End­points' 2022 spe­cial re­port

Over the past three years, Endpoints News has spotlighted 60 women who have blazed trails and supercharged R&D across the biopharma world. And judging from the response we’ve received, to both our special reports and live events, telling their stories — including any obstacles they may have had to overcome — has inspired our readers in many different ways.

But change takes time, and the fact remains that women are still underrepresented at the upper ranks of the drug-making world.

Pfiz­er launch­es re­bate pro­gram for rare dis­ease pa­tients who have to stop tak­ing Panzy­ga

Pfizer is launching its second-ever rebate program, this time for Panzyga, its treatment for a rare neurological disease of the peripheral nerves.

The program began last month, according to STAT which first reported the news, and offers a refund of out-of-pocket costs for patients who must discontinue their course before the fifth treatment for “clinical reasons.”

Panzyga was approved back in 2018 to treat primary immunodeficiency (PI) in patients two years and older and chronic immune thrombocytopenia (cITP) in adults. It has since picked up an indication in chronic inflammatory demyelinating polyneuropathy (CIDP), a condition that’s characterized by weakness of the arms or legs, tingling or numbness, and a loss of deep tendon reflexes, according to the NIH.

Horizon's back-to-school campaign for children with cystinosis includes an all about me poster as part of a care package box.

Hori­zon read­ies kids and fam­i­lies for back to school with week­long ac­tiv­i­ties around rare dis­ease cysti­nosis

Going back to school is usually a bumpy readjustment from summer freedom for all kids, but especially for kids with chronic health conditions. Horizon Therapeutics is hoping to help smooth the way for some who have the rare disease cystinosis. Cystinosis is a genetic disease that causes the amino acid cystine to build up in different tissues and organs.

The “Gear Up” for school campaign is running all week with different online and at-home events and activities for families and children with cystinosis. Each family who signed up receives a care package mailed to their home including an activity coloring book “Michael’s Show-and-Tell.” The book tells Michael’s story about living with cystinosis while offering kids matching, coloring and finding object games along with information.

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Phar­mas spend mil­lions on di­a­betes ad­ver­tis­ing, but few pa­tients can re­call brand names — sur­vey

While many Big Pharma diabetes brands spend millions of dollars on TV ads every year, most people with type 2 diabetes don’t recognize specific drug brand names, according to a new study.

No brand garnered more than 30% recognition in Phreesia Life Science’s latest in-office patient survey of more than 4,000 adults with type 2 diabetes. Eli Lilly’s Trulicity topped the list as the most recognized brand with 29% of those surveyed recalling it, followed by Boehringer Ingelheim and Lilly’s Jardiance at 27% and Merck’s Januvia and Novo Nordisk tying for the third spot with 24%. Meanwhile, 76% of the patients surveyed were familiar with the generic treatment metformin.

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Faced with thou­sands of opi­oid law­suits, En­do says it will like­ly file for bank­rupt­cy 'im­mi­nent­ly'

Endo International will likely be the next pharma company to file for bankruptcy under a mountain of opioid lawsuits.

The Dublin, Ireland-based company revealed in its Q2 results on Tuesday that it’s in talks with first lien creditors, and that “these negotiations will likely result in a pre-arranged filing under Chapter 11 of the U.S. Bankruptcy Code by Endo International plc and substantially all of its subsidiaries, which could occur imminently.”

Feud be­tween two biotechs left near­ly 12M dos­es of mon­key­pox an­tivi­ral on the ta­ble

As the US embarks on a new delivery strategy to stretch out its thinning supply of monkeypox vaccines, the need for treatments could pick up as cases of the virus rise. And the amount of courses of one potential antiviral, soon to be clinically tested for efficacy in humans, was almost 12 million more than it is today, according to SEC filings.

While not greenlit for treating monkeypox, SIGA’s FDA-approved smallpox antiviral, Tpoxx, can be requested by physicians under an expanded use program. As of Monday, HHS tells Endpoints News it had tapped into more than 15,000 of the 1.7 million courses of Tpoxx that have been stockpiled, but with cases climbing over the past few weeks, demand will likely not peter out in the near future, especially if the vaccine supply runs dry.

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