Al­ta­sciences, true to its word, ex­pands its foot­print with ac­qui­si­tion of Penn­syl­va­nia CRO

Chris Perkin

A Cana­di­an CD­MO with roots in Seat­tle is com­ing to the east coast.

Al­ta­sciences an­nounced the ac­qui­si­tion of Calvert Lab­o­ra­to­ries Wednes­day, a pre­clin­i­cal CRO in Penn­syl­va­nia. The move will com­ple­ment Al­ta­sciences’ Seat­tle-area op­er­a­tions.

Head­quar­tered in Laval, Cana­da, Al­ta­sciences op­er­ates six fa­cil­i­ties that run the gamut on ear­ly drug de­vel­op­ment: pre­clin­i­cal safe­ty test­ing, clin­i­cal phar­ma­col­o­gy, bio­an­a­lyt­i­cal, CRO ser­vices, and even CD­MO ca­pac­i­ty. No­vo Hold­ings scooped them up in Feb­ru­ary with the goal of court­ing small and medi­um-sized bio­phar­ma clients. CEO Chris Perkin said back in Feb­ru­ary that the move would help the com­pa­ny fos­ter its am­bi­tious growth plan, and this ac­qui­si­tion and the pres­ence it brings to the east coast is ev­i­dence.

Steve Ma­son

“This ac­qui­si­tion will in­crease small mol­e­cule ex­per­tise as well as add ef­fi­ca­cy phar­ma­col­o­gy, oph­thal­mol­o­gy and car­cino­genic­i­ty study ca­pa­bil­i­ties to Al­ta­sciences’ cur­rent pre­clin­i­cal of­fer­ing,” co-COO Steve Ma­son said in a state­ment. “Fur­ther­more, it ex­pands Al­ta­sciences’ pres­ence on the East Coast, and the site is con­ve­nient­ly lo­cat­ed in close prox­im­i­ty to our CD­MO fa­cil­i­ty.”

Al­ta­sciences has a 30,000-square-foot CD­MO in Philadel­phia that fea­tures Grade C clean­rooms for liq­uid and pow­der-filled cap­sules, nano-milled sus­pen­sions, creams, gels, pow­ders, tablets, and ter­mi­nal­ly ster­il­ized in­jecta­bles. That fa­cil­i­ty han­dles high po­ten­cy ac­tive phar­ma­ceu­ti­cal in­gre­di­ents.

Michael Rec­ny

The Calvert lab in Penn­syl­va­nia came un­der fire in March 2020 when it was ac­cused of an­i­mal cru­el­ty by Stop An­i­mal Ex­ploita­tion Now, an an­i­mal rights group. CEO Michael Rec­ny called the al­le­ga­tions “to­tal­ly false and with­out mer­it.”

In 2019, the well-con­nect­ed Chi­na-based CRO WuXi joined forces with Al­ta­sciences, who pro­vide sup­port for WuXi AppTec’s In­ves­ti­ga­tion­al New Drug (WIND) plat­form. That deal helped WuXi ex­pe­dite its R&D process from pre-IND clin­i­cal stages and bring ther­a­pies to pa­tients faster.

The com­pa­ny al­so has lo­ca­tions in Que­bec City, Mon­tre­al, Kansas City, and now Los An­ge­les, which it opened up af­ter ac­quir­ing the CRO WC­CT Glob­al in Feb­ru­ary.

Chris Perkin, Al­ta­sciences via Youtube

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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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.

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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Growth hor­mone from No­vo Nordisk is in short­age over man­u­fac­tur­ing de­lays

Novo Nordisk’s growth hormone Norditropin is in shortage because of manufacturing delays, according to an FDA site that tracks drug shortages as well as the American Society of Health-System Pharmacists’ shortages list.

The FDA has shortages of the drug listed for its 5, 10, 15 and 30 mg doses, while the pharmacists’ group, also known as ASHP, reported shortages of the same doses, except for the 15 mg version.

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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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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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