Pharma channel feed

Top bio­phar­ma ex­ecs of­fer scare tac­tics and mixed mes­sages on drug pric­ing bills mak­ing their way to Capi­tol Hill

Top biopharma execs from Merck, Eli Lilly, Takeda and industry lobbying group PhRMA tried their best to persuade the media Wednesday that drug price negotiation bills making their way through Congress this month will be catastrophic for the industry’s bottom line.

But the pitch fell almost completely flat, with Merck’s executive chair Ken Frazier contradicting Lilly CEO David Ricks on which large companies may take the largest hit, as the execs listed a garden variety of scare tactics on how R&D will be cut in half, how massive job cuts will follow and how patient access will be severely hampered.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 118,000+ biopharma pros reading Endpoints daily — and it's free.

Jim Wilson (WuXi Global Forum at JPM20)

Mod­er­na sur­faces as the first part­ner for Jim Wilson's rare dis­ease non­prof­it, do­nat­ing an mR­NA pro­gram at no cost

A week after Jim Wilson and Alex Karnal debuted their Tachi Yamada-inspired nonprofit aimed at treating ultra-rare diseases, the partner providing the Institute for Life Changing Medicines with its first pipeline program has emerged from the shadows.

Moderna jumped into the spotlight Tuesday, announcing it had donated an mRNA-based therapy for Crigler-Najjar syndrome free of charge. In a press release, CEO Stéphane Bancel said Moderna would have had to charge a fortune if the company had gone on to develop it for profit given the ultra-rare nature of the disease.

Boris Johnson (AP Photo/Matt Dunham)

UK unions lam­bast plan for ma­jor lay­offs at MHRA as Brex­it takes its toll

The UK’s MHRA may have to lay off about 300 of its 1,200 employees, thanks to a decline in income due to reduced medical product submissions following Brexit, spurring anger among unions across the island.

Five UK unions are now demanding action from Prime Minister Boris Johnson and his government, noting that the layoffs will likely either lead to longer timelines for new drug and device submissions or “the MHRA will be reduced to effectively ‘rubber stamping’ EU regulatory decisions.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 118,000+ biopharma pros reading Endpoints daily — and it's free.

Eric Lander [Yuri Gripas/Abaca/Sipa USA(Sipa via AP Images)]

White House seeks $65B to pre­pare for fu­ture pan­demics in 'Apol­lo'-like ef­fort

Eric Lander, the famed geneticist who now serves as the Biden administration’s top science advisor, unveiled a sweeping plan Friday to transform the US’ preparedness for future pandemics, drawing a parallel to the ambitious Apollo program that put the first humans on the moon.

The plan calls for $65 billion in spending over the next 7 to 10 years, including an immediate $15 billion ask in the current $3.5 trillion budget reconciliation efforts currently moving through Congress. Lander said the proposal would include funding for vaccine and drug development, as well as improving testing and pandemic detection systems.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 118,000+ biopharma pros reading Endpoints daily — and it's free.

David Ricks (AP Images)

Eli Lil­ly sued by for­mer em­ploy­ees al­leg­ing age dis­crim­i­na­tion, cit­ing hir­ing prac­tices fa­vor­ing in­terns

A class action lawsuit from two former sales representatives has been filed in US District Court, accusing Eli Lilly of age discrimination throughout its hiring process and going as far as to allege that the Big Pharma hired younger workers on the basis of physical attractiveness.

The two plaintiffs have applied to work for Lilly several times, never making it past the first interview stage, the lawsuit says. Jerad Grimes, 49, worked as a Lilly sales rep for several years before being laid off from his position in Florida, and Georgia Emily Edmondson, 55, had previously held roles in pharma, but alleges she lost out on job opportunities at Lilly to younger applicants.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 118,000+ biopharma pros reading Endpoints daily — and it's free.

David Sackler testifies via video to a House Oversight Committee hearing (House Television via AP)

Sack­lers win im­mu­ni­ty from opi­oid law­suits as Pur­due Phar­ma is dis­solved in bank­rupt­cy set­tle­ment

The long-running battle involving the Sackler family, owners of Purdue Pharma, and lawsuits over their role in the opioid epidemic drew to a close Wednesday, with the company dissolved and the Sacklers absolved from liability.

A bankruptcy court in southern New York approved the settlement deal, which came after much consternation from critics saying it didn’t go far enough in holding the Sacklers accountable. The family will pay about $4.5 billion over the next nine years in exchange for the protections, and Purdue Pharma will be transformed into a public benefits company aimed at fighting the opioid crisis that has led to more than 500,000 deaths in the US.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 118,000+ biopharma pros reading Endpoints daily — and it's free.

John Oyler, BeiGene CEO (Paul Yeung/Bloomberg via Getty Images)

FDA ap­proves BeiGene's Brukin­sa in rare blood can­cer amid com­pa­ny's US ex­pan­sion plans

BeiGene has been anything but shy about its US expansion plans centered around blood cancer drug Brukinsa. To see those plans through, BeiGene will have to go right at AbbVie and J&J’s Imbruvica, and Brukinsa now has one more arrow in its quiver as part of that battle.

The FDA on Wednesday approved BTK inhibitor Brukinsa to treat Waldenström’s macroglobulinemia, a rare form of lymphoma, after the drug aced a head-to-head showdown with Imbruvica, the only other drug approved for that disease, BeiGene said in a release.

Jim Wilson (L) and Tachi Yamada

Scoop: In­spired by the late Tachi Ya­ma­da, Jim Wil­son launch­es new non­prof­it tar­get­ing un­der­served ul­tra-rare dis­eases

A group of powerhouse biotech leaders is coming together to launch a new nonprofit, one aimed at delivering therapies to rare disease populations they believe pharma is leaving behind.

Jim Wilson, the famed gene therapy researcher, teamed up with the late Tachi Yamada and Braidwell’s Alex Karnal to launch the Institute for Life Changing Medicines. The institute, which officially debuts Thursday morning, will hit the ground running with a program for the ultra-rare Crigler-Najjar syndrome, planning to launch a first-in-human study later this year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 118,000+ biopharma pros reading Endpoints daily — and it's free.

Ab­b­Vie's stock and next megablock­buster take hits fol­low­ing new JAK warn­ings from FDA

While the FDA’s new warnings on JAK inhibitors are based on a review of a Pfizer trial, it’s AbbVie that may be hurt the most.

AbbVie’s stock fell by about 10% at one point Wednesday as its prized JAK inhibitor Rinvoq, once forecast to haul in $8 billion annually by 2025, was looped into new class-wide FDA warnings, which include risks of serious heart-related events, cancer, blood clots and death.

Paul Hudson (Photo by ERIC PIERMONT / AFP) (Photo by ERIC PIERMONT/AFP via Getty Images)

An FTC re­view of the Sanofi/Trans­late merg­er has a new dead­line af­ter agency calls for more time

The old saying goes, “good things come to those who wait”— but in Sanofi’s case, more waiting on US regulators to approve its Translate Bio buyout is likely far from a good thing.

On Aug. 27, Sanofi and Translate refiled their premerger notification with the FTC after the agency indicated in “informal discussions” that it needed more time to review the biotech and pharma giant’s tie-up, Translate said in an SEC filing.