Exclusive: FDA probing death of Aduhelm patient as Biogen’s Alzheimer’s drug continues to stir controversy

Michel Vounatsos (Biogen via YouTube)

November 18, 2021 01:31 PM ESTUpdated November 19, 11:06 AM

FDA+

Exclusive: FDA probing death of Aduhelm patient as Biogen's Alzheimer's drug continues to stir controversy

John Carroll

Editor & Founder

Zachary Brennan

Senior Editor

The FDA tells Endpoints News today that it’s aware of the death of a patient taking Biogen’s controversial Alzheimer’s drug Aduhelm (aducanumab) and is “actively investigating” the case.

Their statement follows the latest comments from RBC analyst Brian Abrahams, who is back with an update on the death, and this time he says that there are solid reasons to believe that the event was likely drug related and may have been preventable.

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May 24, 2022 08:49 AM EDTUpdated 03:54 PM

R&D

In Focus

A new era of treatment: How biomarkers are changing the way we think about cancer

Nicole DeFeudis

Editor

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Katrine Bosley (AP Photo/Mark Lennihan)

May 26, 2022 07:53 AM EDT

People

Former Editas CEO Katrine Bosley goes the VC route, joining early-stage investor

Amber Tong

Senior Editor

More than three years after abruptly exiting Editas Medicine, Katrine Bosley is leaping to the venture capital side of things.

London-based early-stage investor Advent Life Sciences announced Thursday that Bosley is joining the firm as venture partner. It’s also adding two general partners to the team: Dominic Schmidt, formerly of Syncona, will be in the UK; and Satish Jindal, most recently the CEO of investment fund BioMotiv, will be based in Boston, just like Bosley.

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Serhat Gumrukçu, Enochian BioSciences co-founder (Seraph Research Institute)

May 26, 2022 07:23 AM EDT

People

LA biotech founder arrested, charged in murder-for-hire scheme behind 2018 death

Amber Tong

Senior Editor

A biotech founder has been arrested and charged for his role in a murder-for-hire scheme that resulted in the death of a man in Vermont back in 2018.

Serhat Gumrukçu, the co-founder of Enochian BioSciences, was arrested in Los Angeles, where the company is based, according to the Department of Justice. He was charged alongside Berk Eratay of Las Vegas, and a third person, Jerry Banks of Colorado, was previously arrested for kidnapping and allegedly murdering the victim, Gregory Davis.

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ENDPOINTS CAREERS

Associate Director, Information Scientist, Library & Information Services

Gilead Sciences

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Adam Russell, ARPA-H's incoming acting deputy director

May 26, 2022 07:16 AM EDTUpdated 07:54 AM

R&D

NIH's new, independent breakthrough drug accelerator ARPA-H gets its first employee

Zachary Brennan

Senior Editor

Despite the controversy of housing it in NIH, HHS Secretary Xavier Becerra on Wednesday afternoon formally announced the establishment of the Advanced Research Project Agency for Health (ARPA-H) as an independent entity within the NIH, as HHS had previously stipulated that “NIH may not subject ARPA-H to NIH policies.”

Becerra also announced the appointment of ARPA-H’s inaugural employee, Adam Russell, who will serve as acting deputy director.

May 25, 2022 12:46 PM EDT

Pharma

FDA+

FDA spells out the rules and restrictions for states seeking to import drugs from Canada

Zachary Brennan

Senior Editor

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

ProFound Therapeutics founding team

May 26, 2022 06:00 AM EDT

Financing

Startups

Flagship's latest biotech could turn some of the thousands of new proteins it discovered into therapies — and it has $75M to start

Kyle LaHucik

Associate Editor

Flagship Pioneering, the incubator of Moderna and dozens of other biotechs, says it has landed upon tens of thousands of previously undiscovered human proteins. The VC shop wants to potentially turn them into therapeutics.

Like other drug developers that have turned proteins into therapeutics (think insulin for diabetes), Flagship’s latest creation, ProFound Therapeutics, wants to tap into this new trove of proteins as part of its mission to treat indications ranging from rare diseases to cancer to immunological diseases.

Richard Silverman, Akava Therapeutics founder and Northwestern professor

May 26, 2022 05:19 AM EDTUpdated 06:31 AM

Startups

This time around, Lyrica's inventor is developing his Northwestern discoveries at his own biotech

Kyle LaHucik

Associate Editor

Richard Silverman was left in the dark for the last five years of clinical development of the drug he discovered. The Northwestern University professor found out about the first approval of Lyrica, in the last few days of 2004, like most other people: in the newspaper.

What became one of Pfizer’s top-selling meds, at $5 billion in 2017 global sales before losing patent protection in 2019, started slipping out of his hands when Northwestern licensed it out to Parke-Davis, one of two biotechs that showed interest in developing the drug in the pre-email days, when the university’s two-person tech transfer team had to ship out letters to garner industry appetite.

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Senior Finance Associate

Atlas Venture

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

May 24, 2022 02:29 PM EDT

FDA+

Pharma company continues its FDA lawsuit spree, this time after agency denies fast-track designation

Zachary Brennan

Senior Editor

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

May 25, 2022 02:21 PM EDTUpdated 03:08 PM

Pharma

Manufacturing

Eli Lilly set to invest $2.1B in home state manufacturing boost

Tyler Patchen

News Reporter

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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