Nader Pourhassan, CytoDyn CEO (Jeff Kravitz/FilmMagic for CytoDyn’s Pro, via Getty Images)
May 17, 2021 04:31 PM EDTUpdated May 21, 03:13 PM
Bioregnum
FDA+

FDA to Cy­to­Dyn: Those 2 Covid tri­als you keep tout­ing both failed on all end­points and your sub­group analy­sis does­n't help. Are we clear now?

As a matter of official policy, the FDA doesn’t comment about unapproved drugs and the data gathered to back them.

As an unofficial policy, though, the agency can still be provoked by a seemingly unending stream of promotional releases to call a company out for a complete and utter failure.

So it was today with CytoDyn, a biotech company that has a habit of blasting statements out about their drug leronlimab, which has been touted as a potential treatment for Covid-19.

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SPONSORED
June 21, 2021 06:00 AM EDT

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

Brian Abrahams

Co-Head of Biotechnology Equity Research

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

Fred Upton and Diana DeGette
June 22, 2021 12:23 PM EDT
FDA+

New DARPA-like NIH agency preps for re­al­i­ty as E&C un­veils bi­par­ti­san Cures 2.0 draft bill

Zachary Brennan

Senior Editor

House Energy & Commerce leaders Fred Upton (R-MI) and Diana DeGette (D-CO) on Tuesday released new draft legislation with wide-ranging implications for public health, the FDA, NIH, and that would create a new, $6.5 billion federal advanced research agency under NIH, with an aim to cure cancer, Alzheimer’s and other difficult diseases.

Similar to DARPA, the new NIH division to be known as ARPA-H, would be run by a small group of program managers with more latitude to pursue high-risk, high-reward projects that other government agencies would likely shy away from.

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June 22, 2021 07:03 AM EDTUpdated 07:54 AM
Financing
In Focus

On the hunt for the next Mod­er­na, in­vestors have pumped 'plat­form plays' with cash. Can any­thing slow the run­away train?

Nicole DeFeudis

Editor

It didn’t take an expert to see that mRNA platforms could be huge.

Julie Sunderland partnered with both Moderna and BioNTech about a decade ago while she was running program-related investments for the Bill & Melinda Gates Foundation — and even then the potential for their platforms was obvious despite some well-founded concerns about whether the next-gen tech would ever cross the finish line.

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Sen. Ron Wyden (D-OR) with reporters in the Senate Subway (Graeme Sloan/Sipa via AP Images)
June 22, 2021 10:48 AM EDT
Pharma

Top Wyden pri­or­i­ty for drug price re­forms: Medicare ne­go­ti­a­tions

Zachary Brennan

Senior Editor

As the Biden administration tries to wrangle the details of its infrastructure bill, Senate Finance Committee Chair Ron Wyden (D-OR) took a concrete step forward on drug pricing reforms on Tuesday and unveiled five principles for such reforms, including providing Medicare with the ability to negotiate prices.

“Allowing the Secretary of HHS to negotiate the price Medicare will pay creates a much needed mechanism to achieve fairer prices when the market has failed to do so,” Wyden wrote.

June 21, 2021 10:53 AM EDT
Publisher's note

End­points News is now 5 years old. Here's how you can sup­port us for the next phase of growth

Arsalan Arif

Publisher & Founder

Endpoints News turned five years old over the weekend. I wanted to mark the happy occasion by extending our deepest gratitude to Endpoints’ premium subscribers while outlining several other ways to support us as we go broader and get bigger this year and beyond.

Same as any business, we’ve got to create value and get paid for delivering it. So if you depend on Endpoints to stay abreast on biopharma developments, we depend on you too.

Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)
June 21, 2021 07:43 AM EDTUpdated 07:57 AM
People
Pharma

Ac­tivist in­vestor El­liott in talks with oth­er Glax­o­SmithK­line in­vestors about re­plac­ing Em­ma Walm­s­ley, spin­ning off vac­cine busi­ness — re­port

Amber Tong

Senior Editor

As Emma Walmsley reveals details this Wednesday about the upcoming split of GlaxoSmithKline’s pharma and consumer units, some tough questions may be coming her way.

Elliott Management, the activist investor that’s previously threatened an attack on GSK (but eventually backed off), is floating more radical changes like replacing the CEO, further breaking up the company and spinning out the vaccine unit, or reviewing the focus on cancer drugs, the Financial Times reported.

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June 22, 2021 11:26 AM EDT
News Briefing

Roche's Alzheimer's drug spurred bio­mark­er changes but no cog­ni­tive im­pact — pa­per; vTv out-li­cens­es for­mer lead pro­gram

Max Gelman

Editor

Amber Tong

Senior Editor

Josh Sullivan

Associate Editor

More than a year ago, Roche and Eli Lilly were forced to contend with a Phase II/III failure of their respective Alzheimer’s drugs. But while Eli Lilly essentially threw in the towels, Roche wasn’t ready to give up yet.

The Swiss drugmaker now has some biomarker data to spotlight as investigators continue monitoring patients in an open-label extension study.

Dubbed DIAN-TU, the study had been designed to see whether Roche’s gantenerumab and Lilly’s solanezumab could spur a cognitive benefit for a group of patients who had a rare, inherited form of Alzheimer’s that’d tied to early-onset. In short, they didn’t: Both failed the primary endpoint.

Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)
June 22, 2021 10:00 AM EDT
R&D
Pharma

Mer­ck­'s Keytru­da blazes a path in first-line cer­vi­cal can­cer, mak­ing good on drug­mak­er's push for ear­li­er pa­tients

Kyle Blankenship

Managing Editor

In the years since I/O wonder drug Keytruda’s initial approval, Merck has struck an aggressive clinical trial program, which is now firmly focused on earlier lines of therapy. The drugmaker has scored some success there so far, and now it’s earned one of its biggest wins yet.

Keytruda plus chemotherapy with or without background Avastin significantly extended patients’ lives over those dosed with a placebo control in first-line patients with persistent, recurrent or metastatic cervical cancer, according to top-line data from the Phase III KEYNOTE-826 study revealed Tuesday.

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Kimberly Smith, ViiV via Youtube
June 22, 2021 07:16 AM EDTUpdated 07:26 AM
Deals

They went from dai­ly to once every two months. But how much longer act­ing can HIV meds be? Vi­iV en­lists Halozyme's tech to find out

Amber Tong

Senior Editor

It wasn’t easy navigating the manufacturing and controls issues that had led the FDA to reject ViiV Healthcare’s first pitch for the once-monthly HIV regimen cabotegravir and rilpivirine. But even as Kimberly Smith was knee-deep in sorting out those problems and putting together a new package that finally won the regulators over this January, her business development team kept looking for things that would take them to the next level.

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FDA to Cy­to­Dyn: Those 2 Covid tri­als you keep tout­ing both failed on all end­points and your sub­group analy­sis does­n't help. Are we clear now?

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

New DARPA-like NIH agency preps for re­al­i­ty as E&C un­veils bi­par­ti­san Cures 2.0 draft bill

On the hunt for the next Mod­er­na, in­vestors have pumped 'plat­form plays' with cash. Can any­thing slow the run­away train?

Top Wyden pri­or­i­ty for drug price re­forms: Medicare ne­go­ti­a­tions

End­points News is now 5 years old. Here's how you can sup­port us for the next phase of growth

Ac­tivist in­vestor El­liott in talks with oth­er Glax­o­SmithK­line in­vestors about re­plac­ing Em­ma Walm­s­ley, spin­ning off vac­cine busi­ness — re­port

Roche's Alzheimer's drug spurred bio­mark­er changes but no cog­ni­tive im­pact — pa­per; vTv out-li­cens­es for­mer lead pro­gram

Mer­ck­'s Keytru­da blazes a path in first-line cer­vi­cal can­cer, mak­ing good on drug­mak­er's push for ear­li­er pa­tients

They went from dai­ly to once every two months. But how much longer act­ing can HIV meds be? Vi­iV en­lists Halozyme's tech to find out