Latest news on Covid vaccine delay for kids; Door slammed shut for China-only data; Eric Lander is out; Looking back at the boom; and more

February 12, 2022 06:00 AM EST

Latest news on Covid vaccine delay for kids; Door slammed shut for China-only data; Eric Lander is out; Looking back at the boom; and more

Amber Tong

Senior Editor

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

We’ve been getting emails from readers asking about one of our most popular annual features — the Endpoints 20 under 40 — and when they can start nominating people. Well, the answer is now. Tell us about the fresh-faced academics or executives you believe are behind the next big idea here. The deadline is February 18.

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Lina Gugucheva, NewAmsterdam Pharma CBO

June 28, 2022 08:00 AM EDT

Deals

Pharma group bets up to $1B-plus on the PhIII resurrection of a once dead-and-buried LDL drug

John Carroll

Editor & Founder

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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June 28, 2022 07:17 AM EDT

Pharma

In Focus

How prepared is biopharma for the cyber doomsday?

Amber Tong

Senior Editor

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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June 27, 2022 07:00 AM EDT

R&D

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

Kyle LaHucik

Associate Editor

John Carroll

Editor & Founder

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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ENDPOINTS CAREERS

Director of Quality Assurance

ImmunityBio

Dunkirk, NY, USA

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June 28, 2022 08:37 AM EDTUpdated 08:56 AM

R&D

Pharma

Scoop: Roche scraps one of two schizophrenia PhII trials after failing the primary endpoint

Kyle LaHucik

Associate Editor

Roche has terminated one of two Phase II trials testing its drug ralmitaront in patients with schizophrenia, the Big Pharma confirmed to Endpoints News.

The study was terminated last month, according to a June 22 update to the registry on clinicaltrials.gov. Begun in September 2020, the trial was looking at ralmitaront in patients with acute schizophrenia. The trial enrolled 286 patients out of an originally planned 308.

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Merdad Parsey, Gilead CMO

June 28, 2022 09:12 AM EDT

R&D

Pharma

Four months after CRL due to contaminant worries, Gilead returns to FDA for next-gen HIV drug

Paul Schloesser

Associate Editor

Just shy of four months ago, Gilead’s next-gen HIV drug candidate lenacapavir got hit with a CRL over CMC issues involving the type of vials planned for use. Now, the pharma is headed back to the FDA for round two.

Gilead announced Monday afternoon that it had refiled its NDA submission filled with new CMC data after the FDA essentially balked at borosilicate glass vials, originally used for the non-oral form of lenacapavir. The drug candidate, which recently won a positive opinion from Europe’s CHMP, is being developed for HIV-1 infection “in heavily treatment-experienced (HTE) people with multi-drug resistant (MDR) HIV-1 infection.”

June 28, 2022 08:52 AM EDT

Deals

Years after linking arms with Bristol Myers and both Mercks, Sutro finds its latest partner in Tokyo

Kyle LaHucik

Associate Editor

Astellas and Sutro Biopharma are linking arms on a new field of antibody-drug conjugates that they hope will improve upon existing cancer immunotherapies.

The Tokyo pharma will dole out $90 million in cash for the collaboration, the companies said Monday afternoon. That upfront payment will extend the South San Francisco biotech’s runway from late 2023 into the first half of 2024, Cowen analysts noted.

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

June 28, 2022 07:00 AM EDT

People

Startups

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

Tyler Patchen

News Reporter

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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ENDPOINTS CAREERS

Product Sales Manager

ImmunityBio

Remote

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Matt Gline, Roivant CEO (John Sciulli/Getty Images for GLG)

June 28, 2022 07:47 AM EDT

R&D

Roivant chops sickle cell gene therapy, dermatology drugs to focus on 'higher value projects'

Amber Tong

Senior Editor

Roivant is sweeping a suite of drugs, including a gene therapy for sickle cell disease already in the clinic, out of its pipeline.

Six programs from four of its “vants” are being wound down as part of “a company-wide cost optimization and pipeline reprioritization initiative to reduce our expected operating expenses and prioritize our capital resources.”

When reached by Endpoints News, a spokesperson said, “We don’t anticipate a material reduction in headcount but we will likely reassign some folks to higher value projects as part of winding down specific programs.”

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June 25, 2022 06:00 AM EDT

Weekly

15 LGBTQ leaders in biopharma; Paul Stoffels’ Galapagos revamp; AstraZeneca catches up in ATTR; and more

Amber Tong

Senior Editor

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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