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.

A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

Jason Kelly. Mike Blake/Reuters via Adobe

Eye­ing big ther­a­peu­tic push, Gink­go bags $290M to build a cell pro­gram­ming em­pire

Ginkgo Bioworks is on a roll. Days after publicizing a plan to nurture new startups via partnerships with accelerators Y Combinator and Petri, the Boston biotech says it has raised another $290 million for its cell programming platform to reach further and wider.

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UP­DAT­ED: Speak­er Nan­cy Pelosi to un­veil bill for fed­er­al­ly ne­go­ti­at­ed drug prices

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.

David Grainger [file photo]

'Dis­con­nect the bas­tard­s' — one biotech's plan to break can­cer cell­s' uni­fied de­fens­es

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

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Jeff Kindler's Cen­trex­ion re­news bid to make pub­lic de­but

Jeffrey Kindler’s plan to take his biotech — which is developing a slate of non-opioid painkillers — public, is back on.

The Boston based company, led by former Pfizer $PFE chief Kindler, originally contemplated a $70 million to $80 million IPO last year— but eventually postponed that strategy. On Wednesday, the company revived its bid to make a public debut in a filing with the SEC — although no pricing details were disclosed.

Zachary Hornby. Boundless

'A fourth rev­o­lu­tion in can­cer ther­a­pies': ARCH-backed Bound­less Bio flash­es big check, makes big­ger promis­es in de­but

It was the cellular equivalent of opening your car door and finding an active, roaring engine in the driver seat.

Scientists learned strands of DNA could occasionally appear outside of its traditional home in the nucleus in the 1970s, when they appeared as little, innocuous circles on microscopes; inexplicable but apparently innate. But not until UC San Diego’s Paul Mischel published his first study in Science in 2014 did researchers realize these circles were not only active but potentially overactive and driving some cancer tumors’ superhuman growth.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Mer­ck helps bankroll new part­ner Themis' game plan to fin­ish the chikun­gun­ya race and be­gin on­colyt­ic virus quest

As Themis gears up for a Phase III trial of its chikungunya vaccine, the Vienna-based biotech has closed out €40 million ($44 million) to foot the clinical and manufacturing bills.

Its heavyweight partners at Merck — which signed a pact around a mysterious “blockbuster indication” last month — jumped into the Series D, led by new investors Farallon Capital and Hadean Ventures. Adjuvant Capital also joined, as did current investors Global Health Investment Fund, aws Gruenderfonds, Omnes Capital, Ventech and Wellington Partners Life Sciences.