The top 10 pipeline blowups, setbacks and snafus for H1 2021

July 7, 2021 07:30 AM EDT

The top 10 pipeline blowups, setbacks and snafus for H1 2021

John Carroll

Editor & Founder

Once the pandemic hit, it was instantly clear that the industry was going to create an entire pipeline of vaccines and new drugs to fight back against Covid-19. In doing so, it also became instantly clear that we were going to get a crash course on just how bad things can go.

In the backdrop to some spectacular successes, we saw some of the biggest players in biopharma stumble, fall and in some cases never get back up again. You can find some of the most significant setbacks in the list below.

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Optimizing Cell and Gene Therapy Development and Production: How Technology Providers Like Corning Life Sciences are Spurring Innovation

Corning Life Sciences

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

David Baker working with a student on their protein design (Jason Mast)

May 16, 2022 09:28 AM EDT

People

Discovery

In Focus

Scientists are finally learning how to design proteins from scratch. Drug development may never be the same

Jason Mast

Editor

SEATTLE — It’s a cloudy Thursday afternoon in mid-July and David Baker is reclining into the futon in his corner office at the University of Washington, arms splayed out like a daytime talk show host as he coaches another one of his postdocs through the slings and arrows of scientific celebrity.

“Be jealous of your time,” he says, before plotting ways of sneaking her out of Zooms. “It’s this horrible cost to science that you’re tied up in some stupid meeting.”

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May 17, 2022 10:13 AM EDT

Bioregnum

Presenting a live Endpoints News event: Managing a biotech in turbulent times

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

ENDPOINTS CAREERS

Senior Finance Associate

Atlas Venture

Cambridge, MA, USA

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May 17, 2022 10:02 AM EDT

R&D

Manufacturing

Amidst R&D reshuffle, Vertex expands its presence in Boston, aiming to become number one

Tyler Patchen

News Reporter

Vertex Pharmaceuticals has been one of the buzzier names in the bustling Boston biotech scene, but now the company is looking to vault to number one status — at least in terms of physical footprint.

At a ribbon cutting on Tuesday for its new Jeffrey Leiden Center for Cell and Genetic Therapies at the Boston Seaport, Vertex announced it would embark on a new project: The company will build a 344,000 square foot facility in the seaport to accommodate the company’s growing R&D needs, especially in its cell and gene therapies program.

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Patty Murray, D-WA (Graeme Sloan/Sipa USA)(Sipa via AP Images)

May 17, 2022 02:46 PM EDT

Pharma

FDA+

Senate user fee reauthorization bill omits accelerated approval reforms, shows wide gaps with House version

Zachary Brennan

Senior Editor

The Senate health committee on Tuesday released its first version of the bill to reauthorize all the different FDA user fees. But unlike the House version, there are only a few controversial items in the Senate’s version, which does not address either accelerated approval reforms or clinical trial diversity (as the House did).

While it’s still relatively early in the process of finalizing this legislation (the ultimate statutory deadline is the end of September), the House and Senate, at least initially, appear to be starting off in different corners on what should be included.

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Warren Buffett, Berkshire Hathaway CEO

May 17, 2022 02:35 PM EDTUpdated 03:55 PM

Pharma

Berkshire Hathaway pulls out of AbbVie, Bristol Myers Squibb investments

Tyler Patchen

News Reporter

It looks like Warren Buffett is sticking to ice cream and railroads for the moment.

The billionaire CEO of Berkshire Hathaway backed out of two major holdings in the pharma industry, Forexlive first reported, including a $410 million investment in AbbVie and a $324.4 million stake in Bristol Myers Squibb.

The move comes after Berkshire abandoned its Teva shares just last quarter, Bloomberg reported.

Clay Siegall (Photo by Dimitrios Kambouris/Getty Images for Gabrielle's Angel Foundation)

May 16, 2022 06:48 AM EDTUpdated 11:48 AM

People

UPDATED: Clay Siegall resigns from Seagen amid investigation into domestic violence claims

Amber Tong

Senior Editor

A week after Seagen revealed that longtime CEO Clay Siegall was on leave due to an allegation of domestic violence, he has resigned.

Since that shocking revelation, more details about the claims have emerged into the public eye. As Endpoints News reported, Siegall was arrested on April 23. A police report about that night and a subsequent temporary restraining order described a pattern of abusive behavior against his wife and a physical altercation that left her with multiple bruises. Siegall denied the claims.

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Senior Research Scientist, Platform Biology

Siduma Therapeutics

New Haven, CT, USA

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May 17, 2022 02:14 PM EDT

Pharma

Manufacturing

Long-expected UK layoffs imminent for Novartis following sale

Josh Sullivan

Associate Editor

Nearly a year ago, more than 200 workers at Novartis’ Grimsby, UK, facility were able to hang on to their jobs after the pharma closed a Switzerland site as a part of its workforce restructuring plan. Now, it looks like those employees’ time is up, as the site has been sold, Grimsby Telegraph reported today.

The manufacturing site has been sold to Humber Industrials, a subsidiary of International Process Plants. None of the current staff members will be working with the new owners, however.

May 17, 2022 01:43 PM EDT

FDA+

FDA lobbies Congress over rare disease court ruling with wide implications

Zachary Brennan

Senior Editor

Usually reserved for making decisions on drug applications or enforcing what Congress stipulates, the FDA is now dipping its toe into the wild world of congressional politics as it attempts to fix a major court decision that could have a chilling effect on rare disease R&D.

The case in question from last October saw a US appeals court overturn a prior FDA court win, saying that the agency never should’ve approved a rare disease drug because a previously approved but more expensive drug with the same active ingredient has orphan drug exclusivity barring such an approval.