The ousted spokesperson that Stephen Hahn removed? FDA says she’s still an appointee, but won’t say what she does

Inside FDA HQ (Endpoints file photo)

October 9, 2020 11:48 AM EDTUpdated October 12, 10:43 PM

The ousted spokesperson that Stephen Hahn removed? FDA says she’s still an appointee, but won’t say what she does

Jason Mast

Associate Editor

In late August, after FDA commissioner Stephen Hahn and president Donald Trump vastly overstated the benefits of convalescent plasma at a press conference authorizing the therapy, Hahn removed the agency’s top spokesperson: a conservative communications professional and former journalist for the far-right network One America News with little experience in medicine and public health, who had been appointed to the job just weeks prior.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

October 22, 2020 10:19 PM EDTUpdated 06:34 AM

Regulatory

Coronavirus

In historic Covid-19 adcomm, vaccine experts debate a sea of questions — but offer no clear answers

Jason Mast

Associate Editor

Nicole DeFeudis

Associate Editor

The most widely anticipated and perhaps most widely watched meeting in the FDA’s 113-year history ended late Thursday night with a score of questions and very few answers.

For nearly 9 hours, 18 different outside experts listened to public health agencies and foundations present how the United States’ Covid-19 vaccine program developed through October, and they debated where it should go from there: Were companies testing the right metrics in their massive trials? How long should they track patients before declaring a vaccine safe or effective? Should a vaccine, once authorized, be given to the volunteers in the placebo arm of a trial?

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

Charles Baum, Mirati CEO

October 25, 2020 10:45 AM EDT

R&D

Mirati plots a march to the FDA for its KRAS G12C drug, breathing down Amgen’s neck with better data

John Carroll

Editor & Founder

Mirati Therapeutics $MRTX took another closely-watched step toward a now clearly defined goal to file for an approval for its KRAS G12C cancer drug adagrasib (MRTX849), scoring a higher response rate than the last readout from the class-leading rival at Amgen but still leaving open a raft of important questions about its future.

Following a snapshot of the first handful of responses, where the drug scored a tumor response in 3 of 5 patients with non-small cell lung cancer, the response rate has now slid to 45% among a pooled group of 51 early-stage and Phase II patients, 43% — 6 of 14 — when looking solely at the Phase I/Ib. Those 14 patients had a median treatment duration of 8.2 months, with half still on therapy and 5 of 6 responders still in response.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

Stephen Hahn, FDA commissioner (AP Images)

October 20, 2020 10:21 AM EDTUpdated 10:48 AM

Regulatory

Coronavirus

As FDA sets the stage for the first Covid-19 vaccine EUAs, some big players are asking for a tweak of the guidelines

John Carroll

Editor & Founder

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

ENDPOINTS CAREERS

Clinical Operations Lead

Vigeo Therapeutics

Cambridge, MA

view job offer post your job now

Michel Vounatsos, Biogen CEO (via YouTube)

October 21, 2020 08:11 AM EDTUpdated 10:22 AM

R&D

Biogen spotlights a pair of painful pipeline setbacks as aducanumab showdown looms at the FDA

John Carroll

Editor & Founder

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

Pascal Soriot, AstraZeneca CEO (Zach Gibson/Bloomberg via Getty Images)

October 23, 2020 03:17 PM EDTUpdated 04:55 PM

Regulatory

Coronavirus

UPDATED: FDA gives AstraZeneca the thumbs-up to restart PhIII Covid-19 vaccine trials, and J&J is preparing to resume its study

Max Gelman

Associate Editor

Several countries had restarted their portions of AstraZeneca’s global Phase III Covid-19 vaccine trial after the study was paused worldwide in early September, but the US notably stayed on the sidelines — until now. Friday afternoon the pharma giant announced the all clear from US regulators. And on top of that, J&J announced Friday evening that it’s preparing to resume its own Phase III vaccine trial.

Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

October 22, 2020 05:09 PM EDTUpdated October 23, 09:02 AM

Pharma

Regulatory

Coronavirus

UPDATED: FDA anoints Gilead's remdesivir as the Covid-19 treatment winner, handing down full approval — despite some deep skepticism

Max Gelman

Associate Editor

Seven months into the Covid-19 pandemic, the race to develop a treatment for the disease that’s proved to be the biggest health crisis in a century has an officially designated winner: Gilead. And they’re picking up the prize — worth billions in peak sales — despite a major study that concluded the drug was no help in reducing the number of people who die from the virus.

The FDA handed down a thumbs-up for remdesivir, the company announced Thursday afternoon, as the drug becomes the first fully approved treatment for Covid-19 in the US. Remdesivir, to be marketed as Veklury, will come with a label for treatment in adults and children older than 12 in Covid-19 cases that require hospitalization.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

Stephen Hoge, Moderna president (Moderna)

October 22, 2020 10:47 AM EDT

Regulatory

Coronavirus

On morning of FDA Covid-19 adcomm, Moderna completes PhIII enrollment, putting them neck-and-neck with Pfizer

Jason Mast

Associate Editor

Weeks away from a potential EUA application, Moderna announced they have completed enrollment in their 30,000-person Phase III Covid-19 vaccine trial, with over a third of volunteers non-white and a quarter over the age of 65.

The announcement caps what has been the most closely-watched recruitment race in the history of drug development, as Pfizer and Moderna rushed to get enough volunteers to prove whether or not experimental vaccines could actually protect people from contracting Covid-19. Pfizer reached that mark on Sept. 15. Moderna said around the same time that they would slow down enrollment to ensure they enrolled enough participants from minority and at-risk groups.

ENDPOINTS CAREERS

Director of Regulatory Affairs

Recursion Pharmaceuticals

Salt Lake City, UT

view job offer post your job now

October 23, 2020 04:25 PM EDT

R&D

BiondVax stock implodes after a big PhIII gamble for its universal flu vaccine fails

Nicole DeFeudis

Associate Editor

After flying high on Wall Street for the last few months of a pandemic, BiondVax’s stock and dreams of getting approval for its universal flu vaccine hit the windshield.

The Jerusalem-based biotech announced on Friday that its only clinical candidate, M-001, failed both primary and secondary endpoints in a Phase III study. There was no statistically significant difference in reduction of flu illness and severity between the vaccine and placebo groups, according to the company. The vaccine did prove safe, if ineffective, BiondVax said.

October 23, 2020 11:19 AM EDTUpdated 12:53 PM

Deals

Cell/Gene Tx

Ultragenyx injects $40M to grab Solid's microdystrophin transgene — while sidestepping the AAV9 vector that stirred up safety fears

Amber Tong

Editor

Since before Ilan Ganot started Solid Bio to develop a gene therapy for kids like his son, who has Duchenne muscular dystrophy, Ultragenyx CEO Emil Kakkis has been watching and advising the former investment banker as he navigated the deep waters of drug development.

Just as Solid is getting back up on its feet after a yearlong clinical hold, Kakkis has decided to jump in for a formal alliance.

With a $40 million upfront, Ultragenyx is grabbing 14.45% of Solid’s shares $SLDB and the rights to its microdystrophin construct for use in combination with AAV8 vectors. Solid’s lead program, which utilizes AAV9, remains unaffected. The company also retains rights to other applications of its transgene.