Dan Polster, AP Images

US judge paves way for brand­ed and gener­ic opi­oid mak­ers to face land­mark Oc­to­ber tri­al

A US judge has thwart­ed ef­forts by ma­jor drug man­u­fac­tur­ers, dis­trib­u­tors and phar­ma­cies to re­ject claims that they played a piv­otal role be­hind the opi­oid cri­sis that has rav­aged the Unit­ed States.

In do­ing so, dis­trict judge Dan Pol­ster has cleared the path for a sched­uled land­mark tri­al, even as he push­es for a na­tion­wide set­tle­ment, not­ed a Reuters re­port on Tues­day. Pol­ster is pre­sid­ing over more than 2,000 opi­oid law­suits filed by states, coun­ties and cities. Opi­oid-re­lat­ed over­dos­es have claimed al­most 400,000 lives from 1999 to 2017, the CDC es­ti­mates.

In his rul­ing on Tues­day — one of sev­en de­ci­sions ahead of a sched­uled Oc­to­ber 21 tri­al by two Ohio coun­ties against Oxy­Con­tin mak­er Pur­due Phar­ma and sev­er­al oth­er de­fen­dants — Pol­ster found that the plain­tiffs have pre­sent­ed am­ple ev­i­dence to try to prove that de­cep­tive mar­ket­ing prac­tices by the de­fen­dants caused a sharp, harm­ful in­crease in opi­oid sup­ply and failed to re­strict di­ver­sion.

“A factfind­er could rea­son­ably in­fer that these fail­ures were a sub­stan­tial fac­tor in pro­duc­ing the al­leged harm suf­fered by Plain­tiffs,” the judge wrote.

Apart from Pur­due, oth­er de­fen­dants in­clude drug­mak­ers En­do and J&J; dis­trib­u­tors Amerisource­Ber­gen, Car­di­nal Health and McKesson; phar­ma­cy op­er­a­tors CVS Health, Rite Aid, Wal­greens Boots Al­liance and Wal­mart.

Gener­ic drug mak­ers — in­clud­ing Al­ler­gan, Te­va and Mallinck­rodt —  as­sert­ed that they did not pro­mote un­brand­ed opi­oids to pre­scribers, but the Cleve­land-based judge al­so ar­gued in fa­vor of the plain­tiffs that the al­le­ga­tions against man­u­fac­tur­ers en­gag­ing in fraud­u­lent mar­ket­ing prac­tices helped the en­tire opi­oid class (re­gard­less of brand­ed or gener­ic).

In re­cent weeks, Pur­due has of­fered $10-$12 bil­lion to wash its hands off the moun­tain of law­suits it is fac­ing. J&J was hit with a $572 mil­lion fine by an Ok­la­homa court, but the drug­mak­er is look­ing to ap­peal that rul­ing.

Tillman Gerngross, Adagio Therapeutics CEO

An­ti­body leg­end Till­man Gern­gross is el­bow­ing his way in­to the Covid-19 R&D cru­sade: 'I don’t see this end­ing any­time soon'

One of the most influential — and outspoken — scientists at work in the field of antibody discovery is jumping into the frenzied race to create new therapeutics to treat and prevent Covid-19. And he’s operating with the conviction that the current outbreak now once again spreading like wildfire will create plenty of demand for what he has in mind.

Dartmouth professor and Adimab CEO Tillman Gerngross tells me he’s raised $50 million from a group of close VCs to spin out a new company — Adagio Therapeutics — with a full C-suite team assembled to hire up a staff and keep rolling toward the clinic.

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Tal Zaks, Moderna CMO (Moderna via YouTube)

UP­DAT­ED: NI­AID and Mod­er­na spell out a 'ro­bust' im­mune re­sponse in PhI coro­n­avirus vac­cine test — but big ques­tions re­main to be an­swered

The NIAID and Moderna have spelled out positive Phase I safety and efficacy data for their Covid-19 vaccine mRNA-1273 — highlighting the first full, clear sketch of evidence that back-to-back jabs at the dose selected for Phase III routinely produced a swarm of antibodies to the virus that exceeded levels seen in convalescent patients — typically in multiples indicating a protective response.

Moderna execs say plainly that this first stage of research produced exactly the kind of efficacy they hoped to see in humans, with a manageable safety profile.

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Trans­port Sim­u­la­tion Test­ing for Your Ther­a­py is the Best Way to As­sure FDA Ex­pe­dit­ed Pro­gram Ap­proval

Modality Solutions is an ISO:9001-registered biopharmaceutical cold chain engineering firm with unique transport simulation capabilities that support accelerated regulatory approval for biologics and advanced therapeutic medicinal products (ATMP). Our expertise combines traditional validation engineering approaches with regulatory knowledge into a methodology tailored for the life sciences industry. We provide insight and execution for the challenges faced in your cold chain logistics network.

The $1B Mer­ck-Bay­er drug that di­vid­ed car­di­ol­o­gists in March gets pri­or­i­ty re­view

Three months after Merck published in the New England Journal of Medicine data that left doctors and investors divided 0ver just how well its experimental heart drug worked, the FDA has handed that drug priority review. A decision is now due by January 20, 2021.

Merck first announced the drug, known as vericiguat, as a Phase III success last November. In 2016, Merck had paid $1 billion upfront for US rights to the Bayer-developed drug. Early projections foresaw a few hundred million a year in sales, but the unspecified late-stage success raised the possibility for far more. After all, Novartis’s flagship heart drug, Entresto, was earning $1.7 billion per year and was expected to reach up to $4 billion in annual sales.

GSK’s Shin­grix leader Guil­laume Pfe­fer has jumped on board Flag­ship to helm a biotech hy­brid as Afeyan’s lat­est CEO-part­ner

After spending 4 years in a senior post with GlaxoSmithKline’s star team positioning Shingrix for a blockbuster approval, Guillaume Pfefer is headed back to the biotech world — in style.

Pfefer has signed on to join Noubar Afeyan’s busy group of partners at Flagship, and he’s taking the helm of an upstart — which today is being merged with another Flagship startup — with some grand plans of its own. The announcement this morning notes that Pfefer will run Kintai Therapeutics, one of the grads of the Flagship labs.

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Who are the women blaz­ing trails in bio­phar­ma R&D and lead­ing the fight against Covid-19? Nom­i­nate them for End­points' spe­cial re­port

One of the many inequalities the pandemic has laid bare is the gender imbalance in biomedical research. A paper examining Covid-19 research authorship wondered out loud: Where are the women?

It’s a question that echoes beyond our current times. In the biopharma world, not only are women under-represented in R&D roles (particularly at higher levels), their achievements and talents could also be undermined by stereotypes and norms of leadership styles. The problem is even more dire for women of color.

Donald Trump and Anthony Fauci (AP Images)

Covid-19 roundup: Fau­ci fires back at White House cam­paign to un­der­mine him

Anthony Fauci has called the White House campaign to discredit him “a bit bizarre” and said he stands by his previous statements, even if he has since changed his views.

The NIAID chief — who has received an outpouring of support following reports that the Trump administration has sent a document akin to opposition research to multiple news outlets — spoke with his usual candor in interviews with The Atlantic.

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De­spite safe­ty, ef­fi­ca­cy con­cerns, FDA Ad­Com nar­row­ly rec­om­mends Mallinck­rodt drug

A day after the FDA detailed significant concerns about just how effective or safe an experimental Mallinckrodt liver drug was, an advisory committee decided by a single vote to recommend it for approval.

“I voted yes to approve, but I also wrote in, ‘but barely,’” Paul Ridker, a cardiologist at Brigham and Women’s Hospital and one of the panelists, said at the meeting, according to FierceBiotech. The vote was 8-7.

John Furey, Imvax CEO

A neu­ro­sur­geon spent the past 30 years de­vel­op­ing a neoanti­gen tu­mor vac­cine. Now he has $112M for a piv­otal test

As a neurosurgeon, David Andrews knew there wasn’t much he could do for his glioma patients after resecting — rarely fully — their tumor. Even with the best treatment and care available, median overall survival is just somewhere between 14 and 16 months.

Then in the 1990s, his mentor at Thomas Jefferson University introduced him to Renato Baserga, a pathologist who had been studying the effect of using antisense oligonucleotide to knock out the insulin-like growth factor type 1 receptor in cancers. As IGF-R1 drives tumor growth and metastasis, the preclinical reasoning went, implanting a molecule targeting the receptor together with the tumor material near lymph nodes can slow down the spread of the cancer.

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