Law professors call for FDA to disclose all safety and efficacy data for drugs

April 21, 2021 01:23 PM EDTUpdated 01:44 PM

Law professors call for FDA to disclose all safety and efficacy data for drugs

Zachary Brennan

Senior Editor

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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July 27, 2021 07:03 AM EDT

R&D

In Focus

How one startup foretold the neuroscience renaissance after '50 years of shitshow'

Max Gelman

Editor

In the past couple of years, something curious has happened: Pharma and VC dollars started gushing into neuroscience research.

Biogen’s controversial new Alzheimer’s drug Aduhelm has been approved on the basis of removing amyloid plaque from the brain, but the new neuro-focused pharma and biotechs have much loftier aims. Significantly curbing or even curing the most notorious disorders would prove the Holy Grail for a complex system that has tied the world’s best drug developers in knots for decades.

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Ryan Watts, Denali CEO

July 26, 2021 07:36 AM EDTUpdated 08:11 AM

R&D

Denali slips as a snapshot of early data raises some troubling questions on its pioneering blood-brain barrier neuro work

Max Gelman

Editor

Denali Therapeutics had drummed up considerable hype for their blood-brain barrier technology since launching over six years ago, hype that’s only intensified in the last 14 months following the publications of a pair of papers last spring and proof of concept data earlier this year. On Sunday, the South San Francisco-based biotech gave the biopharma world the next look at in-human data for its lead candidate in Hunter syndrome.

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Why is Oncology Drug Development Research Late to the Digital Biomarkers Game?

Tyler Guthrie

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

ENDPOINTS CAREERS

Director-Regulatory

Icosavax, Inc.

Seattle, WA, USA

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July 27, 2021 07:21 AM EDT

FDA+

Coronavirus

Businesses and schools can mandate the use of Covid-19 vaccines under EUAs, DOJ says

Zachary Brennan

Senior Editor

As public and private companies stare down the reality of the Delta variant, many are now requiring that their employees or students be vaccinated against Covid-19 prior to attending school or to returning or starting a new job. Claims that such mandates are illegal or cannot be used for vaccines under emergency use authorizations have now been dismissed.

Setting the record straight, the Department of Justice on Monday called the mandates legal in a new memo, even when used for people with vaccines that remain subject to EUAs.

Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)

July 27, 2021 04:47 PM EDTUpdated 05:04 PM

Deals

Amgen bellies back up to the M&A table for another biotech buyout, this time with a $2.5B deal for an antibody player focused on PSMA

John Carroll

Editor & Founder

Five months after Amgen CEO Bob Bradway stepped up to the M&A table and acquired Five Prime for $1.9 billion, following up with the smaller Rodeo acquisition, he’s gone back in for another biotech buyout.

This time around, Amgen is paying $900 million cash while committing up to $1.6 billion in milestones to bag the privately held Teneobio, an antibody drug developer that has expertise in developing new bispecifics and multispecifics. In addition, Amgen cited Teneobio’s “T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform.”

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July 27, 2021 10:08 AM EDTUpdated 01:20 PM

R&D

Pharma

FDA+

UPDATED: Panel of neuroscience experts lays out the complications with using Biogen's new Alzheimer's drug

Zachary Brennan

Senior Editor

Treatment of early Alzheimer’s patients with Biogen’s new drug Aduhelm should closely resemble how the drug was studied in its pivotal clinical trials, according to new recommendations from a panel of neuroscience experts led by UNLV’s Jeffrey Cummings.

“Those considering aducanumab therapy should understand that the expected benefit is slowing of cognitive and functional decline; improvement of the current clinical state is not anticipated,” they wrote Tuesday in The Journal of Prevention of Alzheimer’s Disease, noting that some of their recommendations are more specific or more restrictive than the information provided in the FDA’s prescribing information.

Frank Pallone (Kevin Dietsch/Pool via AP Images)

July 26, 2021 03:34 PM EDT

FDA+

House committee seeks more from FDA on inspection backlog, when to restart work on foreign sites

Zachary Brennan

Senior Editor

House Energy & Commerce committee leaders are raising fresh questions about the FDA’s ability to conduct foreign manufacturing site inspections and bring down its growing backlog.

“While we understand that the emergence of COVID-19 required the agency to suspend in-person inspection activities temporarily, we remain concerned that more than one year into the pandemic, the strategy for resuming all inspections and addressing the backlog of delayed inspections remains unclear,” E&C chair Frank Pallone (D-NJ) and a group of five other bipartisan leaders of the committee wrote to FDA acting commissioner Janet Woodcock.

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Director, High-Throughput Screening (HTS) Drug Discovery Group

Pliant Therapeutics

South San Francisco, CA, USA

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July 26, 2021 07:17 AM EDT

Pharma

J&J’s Remicade — the poster child for how to block biosimilars — finally settles Pfizer suit

Zachary Brennan

Senior Editor

Biosimilars have proven time and again (although mostly in Europe) that competition works to bring down the cost of a once-pricey biologic, and can even expand its use.

J&J’s Remicade, however, has always proven to be an outlier.

Back in 2016, Pfizer won FDA approval for its infliximab biosimilar, known as Inflectra, but when the launch foundered, the company sued J&J, claiming that the company’s plan to block biosimilar competition worked incredibly well. Pfizer even went on to win FDA approval for a second infliximab biosimilar in 2017, known as Ixifi, but decided to never launch it.

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Art Levinson (Calico)

July 27, 2021 10:58 AM EDTUpdated 11:14 AM

Deals

R&D

Google-backed Calico doubles down on anti-aging R&D pact with AbbVie as partners ante up $1B, start to detail drug targets

John Carroll

Editor & Founder

Seven years after striking up a major R&D alliance, AbbVie and Google-backed anti-aging specialist Calico are doubling down on their work with a joint, $1 billion commitment to continuing their work together. And they’re also beginning to offer some details on where this project is taking them in the clinic.

According to their statement, each of the two players is putting up $500 million more to keep the labs humming.

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