Don­ald Trump is start­ing to win over bio­phar­ma

It would ap­pear that Don­ald Trump is start­ing to win over the minds — though per­haps not the hearts — of the bio­phar­ma in­dus­try.

Af­ter we ran two ear­li­er polls re­flect­ing a deep dis­taste for the Re­pub­li­can, Trump’s up­set vic­to­ry fol­lowed by a surge in in­dus­try stocks was fol­lowed by a re­spectable show of sup­port in our lat­est poll of biotech and phar­ma­ceu­ti­cal in­dus­try read­ers.

With 165 votes in, close to half (46%) felt that bio­phar­ma would be bet­ter off un­der Trump a year from now. That com­pares to 28% who felt it will be worse and 26% who felt that it will be no dif­fer­ent on the an­niver­sary of his win.

 

“I re­spond­ed to an ear­li­er sur­vey you held by vot­ing that Hi­lary would be bet­ter for bio­phar­ma than Trump, but my rea­son­ing for that re­sponse was that Trump was just go­ing to be a thin-skinned dis­as­ter as a pres­i­dent and that he would get us in­to a war or ma­jor cri­sis that would hurt the econ­o­my se­vere­ly,” not­ed one read­er. “Look­ing at Trump more close­ly, I think he’ll be more of a pos­i­tive, at least short term.”

An­oth­er thumbs up, fol­lowed by a thumbs down: ”Less reg­u­la­tion and price con­trols. So, bet­ter be­cause the in­dus­try will make more mon­ey and more re­search & ad­vance­ments will hap­pen. Worse, be­cause when a few bad ac­tors take ad­van­tage of this, there will be even big­ger rep­u­ta­tion hits for the in­dus­try. Think Shkre­li with a big­ger biotech.”

And don’t un­der­es­ti­mate the un­der­ly­ing dis­taste many of our read­ers have for Trump.

Vot­ing worse, a read­er notes: “The stock mar­ket will go down once he’s in of­fice. We will be in a pe­ri­od of in­sta­bil­i­ty. If his tax cuts go for­ward we will have an­oth­er re­ces­sion which will im­pact the abil­i­ty to raise mon­ey.”

One rea­son for the change of pos­i­tive sen­ti­ment can be seen in vot­ers thoughts on the like­ly shift ahead in M&A. A clear ma­jor­i­ty of re­spon­ders felt that Trump’s eco­nom­ic and tax poli­cies would help spur greater M&A in the in­dus­try, which can help over­all stock val­ues.

Here are some com­ments fa­vor­ing in­creased M&A, in which a num­ber of read­ers high­light­ed the like­li­hood of tax re­form:

“Par­tic­u­lar­ly if the tax code changes to en­cour­age com­pa­nies with cash trapped out­side the US to bring it back.”

“I as­sume he will ne­go­ti­ate a fa­vor­able phar­ma/biotech repa­tri­a­tion pol­i­cy (hel­lo Re­pub­li­can con­gress and sen­ate!) for ex-US dol­lars which will fu­el M&A.”

Here’s a note of cau­tion:

“We don’t quite know what are his eco­nom­ic poli­cies.”

The pres­i­dent-elect has clear­ly in­di­cat­ed that he wants to speed up the FDA and new drug ap­provals, but most read­ers aren’t ex­pect­ing any kind of dra­mat­ic change soon. Two-thirds said they don’t ex­pect a change in the next year. But 28% did be­lieve the FDA will be prod­ded in­to act­ing more quick­ly.

The same pro­por­tion of peo­ple be­lieve that the stock ral­ly will in­evitably flat­ten out, with the same num­ber look­ing for a con­tin­u­ing bull mar­ket.

“There will be lots of rhetoric but over­all no change, es­pe­cial­ly if the com­mis­sion­er stays in place.”

“I ex­pect some type of re­form, and some di­vi­sions sure need to speed up, but oth­ers (on­col­o­gy) al­ready are mov­ing at warp speed.”

“Sub­ject to the se­lec­tion of a trans­for­ma­tion­al leader whom I can­not iden­ti­fy, the agency will chug along al­most with­out re­gard to ad­min­is­tra­tion change. Four years is ac­tu­al­ly a pret­ty short time in FDA terms. Once the pub­lic learns that even “The Don­ald” can’t de­liv­er (no Wall, no pmt from Mex­i­co, lit­tle re­form, few jobs), he may be turfed out with the same en­thu­si­asm with which he was elect­ed. “

Fi­nal­ly, a sig­nif­i­cant mi­nor­i­ty of 43% said they ex­pect for­eign-born sci­en­tists will start leav­ing the US af­ter Trump takes of­fice. Slight­ly more than half said they ex­pect things will stay the same on that score. And you could hear a com­mon theme among many of the com­ments we re­ceived. Trump, many be­lieve, can’t be as bad as he made him­self out to be.

“As long as Trump is not a com­plete id­iot – I sus­pect he does not re­al­ly in­tend to do a lot of the things he said dur­ing the cam­paign.”

George Scangos (L) and Marianne De Backer

Pi­o­neer­ing biotech icon George Scan­gos hands in his re­tire­ment pa­pers — and this time it’s for re­al

George Scangos, one of the all-time great biotech CEOs, says the time has come to turn over the reins one last time.

The 74-year-old biotech legend spent close to three decades in a CEO post. The first was at Exelixis — which is still heavily focused on a drug Scangos advanced in the clinic. The second “retirement” was at Biogen, where he and his team were credited with a big turnaround with the now fading MS blockbuster Tecfidera. And the third comes at Vir, where he traded in his Big Biotech credentials for a marquee founder’s role back on the West Coast, hammering out a Covid-19 alliance with Hal Barron — then R&D chief at GSK — and breaking new ground on infectious diseases with some high-powered venture players.

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Jeanne Loring, director of the Center for Regenerative Medicine (Credit: Jamie Scott Lytle)

A stem cell pi­o­neer sent an ex­per­i­ment in­to space. Pa­tients are the next fron­tier

Last July, Jeanne Loring stood on a dirt road surrounded by Florida swampland and watched as a nearby SpaceX rocket blasted into the sky. The payload included a very personal belonging: cell clusters mimicking parts of her brain.

For more than two decades, Loring has been at the forefront of a stem cell field that always seems on the brink of becoming the next thing in medicine, but has been slow to lift off.

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FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

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.

In­vestor 'misalign­men­t' leads to tR­NA biotech's shut­ter­ing

A small biotech looking to carve a lane in the tRNA field has folded, an investor and a co-founder confirmed to Endpoints News.

Similar to Flagship’s Alltrna and other upstarts like Takeda-backed hC Bioscience, the now-shuttered Theonys was attempting to go after transfer RNA, seen as a potential Swiss Army knife in the broader RNA therapeutics space. The idea is that one tRNA drug could be used across a galaxy of disorders and diseases.

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In a win for Re­gen­eron, No­var­tis' sy­ringe for AMD drug de­clared 'un­patentable'

Regeneron has won a patent case against Swiss pharma giant Novartis over the delivery system for its eye drug Eylea.

The US Patent Trial and Appeal Board ruled that Novartis’ pre-filled syringe for injecting its eye medication Lucentis was “unpatentable” and handed the victory to Regeneron and its AMD drug Eylea.

In the initial complaint in 2020, Novartis alleged to the US International Trade Commission that certain pre-filled syringes for the intravitreal injection, and ultimately Regeneron’s delivery system for Eylea, were infringing on Novartis’ patent. Regeneron filed a petition to review Novartis’ claims in 2021.

'Tis the sea­son: GSK ad­dress­es win­ter virus surges with celebri­ty and in­flu­encer vac­cine aware­ness cam­paigns

GSK is rounding up the usual suspects this winter — flu, respiratory syncytial and even shingles viruses — for multiple marketing efforts all aimed at encouraging vaccinations.

Mom influencers take center stage in its “Flu is a Family Affair” campaign to reach family decision-makers or “chief health officers.” GSK is asking them in the digital campaign to take care of themselves, and take the family along, when they go to the pharmacy or doctor’s office for a flu vaccine.

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Bris­tol My­ers claims win with CAR-T ther­a­py Breyanzi in leukemia

Bristol Myers Squibb is looking to expand Breyanzi into more indications — and the pharma’s newest data readout makes progress on that front.

The Big Pharma put out word Thursday that the CAR-T cell therapy met the primary endpoint of complete response rate compared to historical control in a subset of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) that were refractory to a BTK inhibitor and pretreated with a BCL-2 inhibitor.

FDA takes next step in Tor­rent Phar­ma­ceu­ti­cal­s' trou­bled In­dia plant saga, is­sues OAI

The FDA has handed Torrent Pharmaceuticals an official action indicated (OAI) status for a previously inspected manufacturing facility in India.

Torrent Pharma sent a letter to the National Stock Exchange of India earlier this week with word that the manufacturer has received a “communication from the FDA determining the inspection classification as ‘Official Action Indicated’ (OAI)” for one of its sites. An OAI classification from the FDA comes after the agency has completed an inspection and determines if the facility complies with the applicable laws and regulations. Being given an OAI classification means that regulatory or administrative actions will be recommended to Torrent. However, the details on the recommended actions have not been given.