FTC de­mands more in­fo from Bris­tol-My­ers, Cel­gene on pso­ri­a­sis drugs, sig­nal­ing a po­ten­tial hitch for $74B deal

Bris­tol-My­ers Squibb is sig­nal­ing a po­ten­tial hitch in its con­tro­ver­sial $74 bil­lion Cel­gene buy­out — but it’s not the kind that would ap­pear to threat­en the deal it­self.

In an SEC fil­ing the com­pa­ny re­port­ed that the FTC wants to get some ex­tra in­fo on “mar­ket­ed and pipeline prod­ucts for the treat­ment of pso­ri­a­sis,” as it does its an­ti-trust re­view. That will ex­tend their wait­ing pe­ri­od un­til 30 days af­ter they have com­plied with the ex­tra re­quest. 

But Bris­tol-My­ers was al­so quick to as­sure in­vestors that the com­pa­ny still ex­pects to close the deal in Q3.

“Sec­ond re­quests are com­mon in trans­ac­tions of this size,” not­ed a Bris­tol-My­ers spokesper­son.

The move, though, could sig­nal a prob­lem for Bris­tol-My­ers if reg­u­la­tors see an over­lap that might con­cern them on the an­ti-in­flam­ma­to­ry front.

Cel­gene has its ris­ing star Ote­zla on the mar­ket, with a ri­val oral TYK2 pso­ri­a­sis drug in the clin­ic at Bris­tol-My­ers Squibb dubbed BMS-986165. Now in Phase III, re­searchers post­ed promis­ing mid-stage da­ta last fall as BMS looked to ri­val a slate of new drugs that have hit the mar­ket re­cent­ly. 

Bris­tol-My­ers would like­ly want to keep Ote­zla if forced to choose. The drug earned $1.6 bil­lion world­wide in 2018, up sub­stan­tial­ly from the $1.28 bil­lion it grabbed in 2017.

Take­da ran in­to a sim­i­lar is­sue when they bought out Shire last year. Eu­ro­pean reg­u­la­tors forced Take­da to agree to sell the ex­per­i­men­tal SHP647 from Shire so it could re­tain its block­buster drug En­tyvio. That was some­thing they im­me­di­ate­ly agreed to.

In these deals, one in the hand is worth more than 2 in the bush. And no one is walk­ing away from this deal over the fate of 1 pro­gram in the hands of a com­pa­ny as big as Bris­tol-My­ers. That could cre­ate an op­por­tu­ni­ty for some­one in the mar­ket for a pso­ri­a­sis drug with sol­id hu­man da­ta to back it up.

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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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.

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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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.

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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