FDA puts Solid Bio’s lead gene therapy program on hold — again — after another patient is hurt by SGT-001

November 12, 2019 07:15 AM ESTUpdated 07:35 AM

FDA puts Solid Bio’s lead gene therapy program on hold — again — after another patient is hurt by SGT-001

John Carroll

Editor & Founder

Solid Biosciences continues to be plagued by safety issues.

Close to 18 months after the gene therapy biotech was able to quickly shed an FDA hold on their lead Duchenne muscular dystrophy program for SGT-001, regulators have stepped back in to force another halt after another patient was hit hard by a set of serious adverse events remarkably similar to the first set.

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Janet Woodcock (Greg Nash/Pool via AP Images)

May 23, 2022 09:05 AM EDT

FDA+

'I really don’t look back': Janet Woodcock on her transition away from drugs

Zachary Brennan

Senior Editor

Janet Woodcock may have one of the most historically long and drug-intense tenures in FDA history, but her new role is outside of all things pharma and the once-acting FDA commissioner isn’t looking back.

“No I really don’t look back,” Woodcock told Endpoints News via email on Monday morning. “Yes I will be transitioning. Longer discussion on infrastructure needed.”

An NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

May 23, 2022 11:01 AM EDTUpdated 11:45 AM

R&D

'Xenotransplantation is coming': New NEJM paper gives detailed look into 2 pig-to-human kidney transplant cases

Lei Lei Wu

News Reporter

The thymokidney is a curious organ, if you could call it that. It’s a sort of Frankensteinian creation — a system of pig thymus embedded underneath the outer layer of a pig’s kidney, made for human transplantation.

In the first case of pig-to-human xenotransplantation of a kidney into a brain-dead patient, the thymokidney quietly featured front and center.

In that experiment, which took place in September of last year, NYU researchers led by Robert Montgomery sutured a pig thymokidney onto the leg of a brain-dead 66-year-old woman. That case was widely reported on by a horde of major media outlets, including the New York Times, the BBC, and an in-depth feature by USA Today.

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Vlad Coric, Biohaven CEO

May 23, 2022 08:50 AM EDTUpdated 12:42 PM

R&D

UPDATED: Fresh off $11.6B sale to Pfizer, New Biohaven hits Phase III setback just weeks after Vlad Coric chalked up promise

Kyle LaHucik

Associate Editor

When Pfizer bought up Biohaven’s migraine portfolio in the largest M&A deal of the year earlier this month, Biohaven CEO Vlad Coric promised the rest of the pipeline, which will live on under the umbrella of New Biohaven, still has a lot to offer. But that vision took a dent Monday as the drugmaker revealed it’s once again flopped on troriluzole.

The glutamate regulator failed to meet the primary endpoint on a Phase III study in patients with spinocerebellar ataxia, an inherited disorder that impairs a person’s ability to walk, speak and swallow. SCA can also lead to premature death.

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ENDPOINTS CAREERS

Associate Director, Information Scientist, Library & Information Services

Gilead Sciences

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May 19, 2022 05:07 PM EDTUpdated May 20, 07:24 AM

Deals

R&D

Bayer sounds retreat from a $670 million CAR-T pact in the wake of a patient death

John Carroll

Editor & Founder

Two months after Atara Biotherapeutics hit the hold button on its lead CAR-T 2.0 therapy following a patient death, putting the company under the watchful eye of the FDA, its Big Pharma partners at Bayer are bowing out of a $670 million global alliance. And the move is forcing a revamp of Atara’s pipeline plans, even as research execs vow to continue work on the two drugs allied with Bayer 18 months ago, which delivered a $60 million cash upfront.

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May 23, 2022 02:23 PM EDT

Pharma

Copay coupons gone wrong, again: Pfizer pays almost $300K to settle complaints in four states

Zachary Brennan

Senior Editor

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

May 23, 2022 02:22 PM EDTUpdated 02:36 PM

Pharma

Law

Delaware court rules against Gilead and Astellas in years-long patent case

Tyler Patchen

News Reporter

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

Taye Diggs (courtesy Idorsia)

May 23, 2022 02:01 PM EDT

Pharma

Marketing

Idorsia inks another celebrity endorser deal with actor and dad Taye Diggs as Quviviq insomnia ambassador

Beth Snyder Bulik

Senior Editor

Idorsia’s latest Quviviq insomnia campaign details the relatable dad story of a well-known celebrity — actor and Broadway star Taye Diggs.

Diggs stopped sleeping well after the birth of his son, now more than 10 years ago. Switching mom-and-dad nightly shifts to take care of a baby interrupted his sleep patterns and led to insomnia.

“When you’re lucky enough to be living out your dream and doing what you want, but because of something as simple as a lack of sleep, you’re unable to do that, it felt absolutely — it was treacherous,” he says in an interview-style video on the Quviviq website.

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Senior Finance Associate

Atlas Venture

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Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)

May 23, 2022 01:10 PM EDT

Pharma

Manufacturing

Merck KGaA pumps €440M into expanding and constructing Irish manufacturing facilities

Tyler Patchen

News Reporter

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.

Rep. Katie Porter (D-CA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

May 23, 2022 01:10 PM EDT

Pharma

House Dems to Senate leadership: Quickly move a reconciliation bill with drug price negotiation reforms

Zachary Brennan

Senior Editor

Twenty House Democrats, including Reps. Katie Porter of California and Susan Wild of Pennsylvania, are calling on Senate leaders to move quickly with a reconciliation bill (meaning they only need a simple majority for passage) with prescription drug pricing reforms, and to include adding new authority for Medicare to negotiate drug prices.

They also called on the Senate to specifically follow suit with the House passage of a $35 per month insulin cap (as Senate Majority Leader Chuck Schumer’s deadline for a vote on that provision has come and gone), and to cap Medicare Part D costs at $2,000 per year for seniors.