News brief­ing: Catal­ent, Mer­ck KGaA make big in­vest­ments in man­u­fac­tur­ing ops; J&J teams with Data­vant on da­ta shar­ing projects

We’re con­tin­u­ing to see big in­vest­ments in the glob­al bio­phar­ma man­u­fac­tur­ing in­fra­struc­ture.

Wednes­day morn­ing Catal­ent put out the word that it is in­vest­ing $130 mil­lion in its late-stage ops at its gene ther­a­py fa­cil­i­ty in Har­mans, MD. The con­tract man­u­fac­tur­er has been sink­ing a sig­nif­i­cant amount of mon­ey in­to gene ther­a­py as that field con­tin­ues to boom.

Mer­ck KGaA pre­ced­ed that an­nounce­ment with the news that the Ger­man bio­phar­ma play­er is trig­ger­ing a €59 mil­lion ex­pan­sion of its HPA­PI and ADC man­u­fac­tur­ing ca­pa­bil­i­ties and ca­pac­i­ty at its fa­cil­i­ty near Madi­son, WI. That move will add 50 new jobs as they ramp up work on the on­col­o­gy pipeline with new tech that al­lows con­tin­u­ous man­u­fac­tur­ing of AD­Cs.

“AD­Cs have post­ed in­cred­i­ble growth over the last decade, and reg­u­la­to­ry agen­cies’ ap­provals in re­cent years demon­strate their promise as a tar­get­ed ther­a­py,” said An­drew Bulpin, head of process so­lu­tions at the com­pa­ny’s life sci­ence busi­ness sec­tor.

Jazz hands over $10M to launch a new can­cer dis­cov­ery pact, with $210M up for grabs

Redx is pick­ing up $10 mil­lion in cash af­ter ink­ing a new dis­cov­ery and de­vel­op­ment pact with Jazz Phar­ma­ceu­ti­cals.

The UK biotech will be re­spon­si­ble for ex­plor­ing two can­cer tar­gets on the Ras/Raf/MAP ki­nase (MAPK) path­way. And there’s an­oth­er $10 mil­lion up for grabs if Jazz wants to push ahead in­to year 2, with $200 mil­lion in mile­stones at stake.

This new al­liance comes just a month af­ter As­traZeneca pro­vid­ed a $17 mil­lion life­line to Redx, which has been in and out of hot wa­ter over the years. Right now, things are look­ing up.

J&J signs up for a 2-way col­lab­o­ra­tion with Vivek Ra­maswamy’s Data­vant

Vivek Ra­maswamy’s Data­vant and J&J have linked up on some da­ta shar­ing ini­tia­tives.

Travis May

In this new pact, the phar­ma gi­ant is pick­ing up rights to use Data­vant’s tech to “in­te­grate dis­parate da­ta sets to cre­ate rich, lon­gi­tu­di­nal re­al-world and clin­i­cal datasets to bet­ter un­der­stand the holis­tic pa­tient jour­ney, there­by en­hanc­ing the de­sign and ex­e­cu­tion of Janssen’s clin­i­cal de­vel­op­ment pro­grams for pa­tients.”

In re­turn, J&J is of­fer­ing feed­back to Data­vant on the prod­ucts and ser­vices it’s pro­vid­ing the in­dus­try.

Travis May, Data­vant CEO, not­ed: “The abil­i­ty to safe­ly con­nect da­ta from across the health­care ecosys­tem to un­der­stand the safe­ty and ef­fi­ca­cy of, and ac­cess to drugs cre­ates the op­por­tu­ni­ty to great­ly im­prove pa­tient out­comes, and we look for­ward to build­ing our col­lab­o­ra­tion.”

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.

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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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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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.

FTC says patent bat­tle over Parkin­son's drug could have 'sig­nif­i­cant im­pli­ca­tion­s' for pa­tients

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.

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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