Mer­ck hands Sutro $60M to start on im­munomod­u­la­to­ry drug dis­cov­ery; Eli Lil­ly spin­ning out an­i­mal health group

→ Drugs that can tune the hu­man im­mune sys­tem are all the rage these days, es­pe­cial­ly at Big Phar­ma R&D groups like Mer­ck’s. And to­day the phar­ma gi­ant is spot­light­ing a deal to de­vel­op more of these drugs with the help of Sutro Bio­Phar­ma in South San Fran­cis­co. 

Mer­ck is pay­ing Sutro $60 mil­lion up­front to get start­ed on the dis­cov­ery deal, look­ing for im­munomod­u­la­to­ry drugs that can work on can­cer or au­toim­mune dis­eases — ei­ther tap­ping the gas or the brakes on an im­mune re­sponse. The deal in­cludes a hefty $1.6 bil­lion in mile­stones to keep things go­ing.

Sutro gets to han­dle the pre­clin­i­cal work in the deal, with the gi­ant Mer­ck tak­ing the best drugs in­to the clin­ic with world­wide rights.

Eli Lil­ly will spin out its an­i­mal health unit Elan­co, sell­ing a mi­nor­i­ty in­ter­est in an IPO and then di­vest­ing the rest in what it calls a “tax-ef­fi­cient trans­ac­tion.”

→ The FDA has hand­ed Apel­lis Phar­ma­ceu­ti­cals $APLS a fast track des­ig­na­tion for its ad­vanced dry AMD drug called APL-2. The med is a nov­el in­hibitor of com­ple­ment fac­tor C3 meant to treat pa­tients with ge­o­graph­ic at­ro­phy, an ad­vanced form of age-re­lat­ed mac­u­lar de­gen­er­a­tion, as a monother­a­py. Apel­lis plans to start a Phase III tri­al of the drug lat­er this year, it said in a state­ment.

→ Chi­na’s Vi­va Biotech Hold­ings has ap­plied for an IPO in Hong Kong to both fund their pur­suit of promis­ing up­starts and boost their man­u­fac­tur­ing ca­pa­bil­i­ties. The Shang­hai-based com­pa­ny is half in­cu­ba­tor and half drug dis­cov­ery busi­ness, of­fer­ing both “eq­ui­ty for ser­vice” and “cash for ser­vice” mod­els to bio­phar­mas look­ing for out­sourc­ing ser­vices. Its port­fo­lio cur­rent­ly in­cludes 21 biotech star­tups.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Andy Plump, Takeda R&D chief (Jeff Rumans for Endpoints News)

What kind of PhI­Ib da­ta is worth $4B cash? Take­da’s Andy Plump has some thoughts on that

A few months back, when Takeda caused jaws to drop with its eye-watering $4 billion cash upfront for a mid-stage TYK2 drug from Nimbus, it had already taken a deep dive on the solid Phase IIb data Nimbus had assembled from its dose-ranging study in psoriasis.

Now, it’s rolling that data out, eager to demonstrate what inspired the global biopharma to go long in a neighboring, but new, disease arena for the pipeline. And the most avid students of the numbers will likely be at Bristol Myers Squibb, who will have a multi-year head start on pioneering the TYK2 space with Sotyktu (deucravacitinib) as Takeda makes its lunge for best-in-class status.

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No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

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FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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FDA warns Proc­ter & Gam­ble over NyQuil la­bel's in­gre­di­ent list­ings

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

Mar­ket­ingRx roundup: What could a US Tik­Tok ban mean for phar­ma? Pfiz­er, Lil­ly lead phar­ma March Mad­ness ad­ver­tis­ers

Just as pharma marketers finally make moves into TikTok, the threat of a US ban on the social media channel is now looming. Already banned on federal employee phones by an initial Congressional act, more bills and maybe bans are on the way. With rare bipartisan agreement, lawmakers have introduced legislation that would give the US president the power to ban TikTok (although not mentioned by name) and other foreign-owned technology platforms that represent a security threat to the US.

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Chat­G­PT with phar­ma da­ta de­buts for med­ical meet­ings, be­gin­ning with AACR

What do you get when you combine ChatGPT generative AI technology with specific pharma and clinical datasets? A time-saving tool that can answer questions about medical conference abstracts and clinical findings in seconds in one new application from ZoomRx called FermaGPT.

ZoomRx is debuting a public version of its generative AI product specifically for medical conferences beginning this week for the upcoming American Association for Cancer Research (AACR) annual meeting that runs April 14-19.

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Vipin Garg, Altimmune CEO

Al­tim­mune’s shares halved af­ter in­ter­im look at PhII weight loss drug da­ta

Altimmune’s attempt to catch up to Novo Nordisk and Eli Lilly’s GLP-1 drugs hit an investor snag Tuesday after the biotech shared interim Phase II weight loss data.

The Maryland biotech’s pemvidutide is a GLP-1/glucagon dual receptor agonist meant to activate GLP-1 receptors to squash appetite and glucagon to ramp up energy use. The 2.4 mg dose showed a placebo-adjusted weight loss of 9.7% at week 24 of 48, which Jefferies analysts said would be comparable to Novo Nordisk’s semaglutide (Wegovy) and Eli Lilly’s tirzepatide (Mounjaro).

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Who are the women break­ing bar­ri­ers in drug de­vel­op­ment? Nom­i­nate them for End­points' an­nu­al re­port

Today, we’re opening nominations for our fifth annual Women in Biopharma R&D special report.

Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. We’re looking for big thinkers, scientists, executives and other enterprising women who are breaking barriers in drug development and inspiring the next generation of leaders.