Covid-19 man­u­fac­tur­ing roundup: Scot­tish gov­ern­ment in­vests $27M in Val­neva's Covid-19 man­u­fac­tur­ing; Mod­er­na part­ners with Latin Amer­i­can phar­ma

Val­ne­va’s Scot­tish unit has re­ceived a $27 mil­lion grant to fund the R&D of man­u­fac­tur­ing its Covid-19 vac­cine VLA2001.

The in­vest­ment comes from the coun­try’s eco­nom­ic de­vel­op­ment agency. Two grants will dis­trib­ute the mon­ey over the next three years, and ben­e­fit the man­u­fac­tur­ing site in Liv­ingston.

One grant, worth $16.65 mil­lion, will sup­port R&D con­nect­ed to man­u­fac­tur­ing VLA2001. A sec­ond, worth $9.9 mil­lion, will sup­port R&D for the man­u­fac­tur­ing of oth­er dis­eases. Among those oth­er vac­cines is VLA1553, a sin­gle-shot vac­cine against the mos­qui­to-borne vi­ral in­fec­tion chikun­gun­ya. That is al­so man­u­fac­tured in Liv­ingston.

“From the on­ly in­ac­ti­vat­ed, whole virus Covid-19 vac­cine can­di­date in clin­i­cal de­vel­op­ment in Eu­rope to the most clin­i­cal­ly ad­vanced vac­cine can­di­date against chikun­gun­ya in the world, Scot­tish En­ter­prise’s in­vest­ment will sup­port progress across Val­ne­va’s re­search and de­vel­op­ment port­fo­lio – as well as jobs and growth in Scot­land,” CEO Thomas Lin­gel­bach said in a state­ment.

Mod­er­na part­ners with Latin Amer­i­can Phar­ma

In a move to ad­vance the com­mer­cial­iza­tion of Mod­er­na’s Covid-19 shot in Latin Amer­i­ca, the biotech has inked a deal with a phar­ma na­tive to the con­ti­nent to help make and dis­trib­ute its shot.

Adi­um Phar­ma will com­mer­cial­ize Spike­vax across 18 coun­tries in Latin Amer­i­ca. That list in­cludes Brazil, Mex­i­co, Colom­bia and Ar­genti­na. The com­pa­ny will look to add up to 100 peo­ple to its team as well.

Stéphane Ban­cel

“Our new part­ner­ship with Adi­um will help en­sure broad ac­cess and de­liv­ery of our Mod­er­na Covid-19 vac­cine to peo­ple across Latin Amer­i­ca,” said CEO Stéphane Ban­cel. “A pres­ence in Latin Amer­i­ca is a key part of our glob­al com­mer­cial strat­e­gy. These part­ner­ships and the ex­pan­sion of our glob­al com­mer­cial foot­print po­si­tion Mod­er­na to play an im­por­tant role in pro­vid­ing health­care se­cu­ri­ty against Covid-19 and fu­ture vac­cine-pre­ventable dis­eases.”

Mod­er­na has on­ly got­ten emer­gency au­tho­riza­tion in five of those coun­tries so far, but Mod­er­na’s Ro­man Saglio told Bloomberg that the deal, which will lead to a sig­nif­i­cant ramp up of man­u­fac­tur­ing by Mod­er­na, will help the com­pa­ny be a lead­ing vac­cine provider for the re­gion.

How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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Laurence Reid, Decibel CEO

Still in pre­clin­i­cal test­ing for ear gene ther­a­pies, Deci­bel touts small snap­shot of chemo-in­duced hear­ing loss drug

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.

Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Members of the G7 from left to right: Prime Minister of Italy Mario Draghi, European Commission President Ursula von der Leyen, President Joe Biden, German Chancellor Olaf Scholz, British Prime Minister Boris Johnson, Canadian Prime Minister Justin Trudeau, Prime Minister of Japan Fumio Kishida, French President Emmanuel Macron and European Council President Charles Michel (AP Photo/Susan Walsh)

Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

Ben Zimmer, Priovant CEO

Roivant un­veils lat­est spin­out as Pfiz­er en­trusts JAK1/TYK2 to Pri­o­vant

In November, Pfizer disclosed it’s spun out the Phase II dual JAK1/TYK2 inhibitor to a startup formed in collaboration with an unnamed, experienced partner.

We now know who the partner is. And as Pfizer and Roivant officially take the wraps off Priovant Therapeutics, the companies reveal that they have started two registrational trials of the drug, brepocitinib, as part of a broader plan to develop a big, first-in-class franchise spanning multiple orphan and specialty autoimmune diseases.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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