Andrey Petrikovets
September 10, 2021 09:51 AM EDTUpdated 10:27 AM
FDA+

In a first, FDA warns a re­searcher for fail­ing to sub­mit da­ta 3 years af­ter tri­al com­ple­tion

Josh Sullivan

Associate Editor

For the first time ever, the FDA has threatened an individual clinical trial investigator with a fine after he failed to publish trial data on a government database. The warning is part of a wider attempt to hold researchers and companies accountable for submitting trial results after trials finish.

Andrey Petrikovets, a surgeon from Los Angeles, ran a study on pain drug regimens following vaginal pelvic floor reconstructive surgery, but failed to publish results on time, the FDA said in a warning letter posted this week.

Endpoints News

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SPONSORED
September 27, 2021 06:00 AM EDT

Why it Works: Man­u­fac­tur­ing a Vac­cine in a Mul­ti-Prod­uct Fa­cil­i­ty.

Grand River Aseptic Manufacturing

COVID-19 launched the pharmaceutical industry to the frontline in the battle against the fast-spreading global pandemic. The goal: distribute a safe, effective vaccine as quickly as possible. Major players in the vaccine market needed to partner with contract development and manufacturing organizations (CDMOs) to achieve the goal of mass vaccine quantities under expedited timelines. With CDMOs stepping up to play a critical role in the vaccine manufacturing process, multi-product CDMO facilities took the spotlight. Partnerships quickly formed as the race to save lives and fight a pandemic was on.

Habib Dable, Acceleron CEO
September 24, 2021 10:09 PM EDTUpdated September 27, 07:15 AM
Deals
R&D

Days of heat­ed ru­mors cul­mi­nate in a re­port that Ac­celeron is in ad­vanced buy­out talks

John Carroll

Editor & Founder

Days of frothy rumors about possible M&A discussions at Acceleron were capped late Friday with a Bloomberg report asserting that the biotech company is in advanced talks for an $11 billion buyout deal.

Bloomberg was unable to identify any bidders in the deal, but speculation has been running rampant that the surging value of Acceleron stock had to be the result of leaks around the auction of the company. As of early Monday morning, we’re still awaiting the final word.

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Merck CEO Rob Davis
September 27, 2021 06:04 PM EDTUpdated 14 hours ago
Deals
Pharma

Mer­ck emerges as lead bid­der in po­ten­tial Ac­celeron buy­out with deal pos­si­ble this week — re­port

Kyle Blankenship

Managing Editor

With rumors swirling about a potential buyout of biotech Acceleron and its lead PAH drug sotatercept, market watchers have been keeping close tabs on industry movers and shakers due up for an expensive bolt-on. According to a new report, it appears Merck may be the one.

Merck is in “advanced talks” on a deal to acquire Cambridge, MA-based Acceleron in what previous reports pegged as a potential $11 billion buyout, the Wall Street Journal reported Monday. A deal could come as early as this week, according to the Journal.

Alexander Lefterov/Endpoints News
September 27, 2021 07:12 AM EDTUpdated 09:08 AM
Coronavirus
In Focus

The coro­n­avirus vac­cine that the world for­got could still help save it

Jason Mast

Editor

Back at the beginning of the pandemic — back when we still called the virus “novel” and a single case in Washington state could make headlines — there emerged the story of the coronavirus vaccine that the world forgot.

It was an allegory for our pandemic ill-preparedness. At a time when the world had been caught so flat-footed, there were a pair of scientists who had seen the crisis coming, lab-coated Cassandras with an antidote if only the world had listened sooner.

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Peter Marks (Jim Lo Scalzo/Pool via AP Images)
September 28, 2021 06:51 AM EDTUpdated 08:12 AM
FDA+
Coronavirus

Tur­moil at CBER: Pe­ter Marks grabs con­trol of FDA's Of­fice of Vac­cines ahead of 2 key ca­reer leader de­par­tures

Zachary Brennan

Senior Editor

FDA’s top vaccine official Peter Marks is pulling the plug on a months-long transition for two top career vaccine officials who abruptly called it quits in late August.

Marion Gruber, director of the FDA’s Office of Vaccines Research & Review and 32-year veteran of the agency, her deputy director Phil Krause, announced their departures and then raised concerns with Covid-19 booster shots ahead of and during a recent Covid-19 booster vaccine advisory committee.

September 28, 2021 10:49 AM EDT
R&D
Cell/Gene Tx

Safe­ty fears force Pfiz­er to change piv­otal DMD gene ther­a­py tri­al pro­to­col

Kyle Blankenship

Managing Editor

As one of the biggest players in an increasingly packed gene therapy space, Pfizer has taken an early lead over specialists like Sarepta in taking a Duchenne muscular dystrophy (DMD) candidate into late-stage testing. But new safety fears have led Pfizer to scale back that trial, cutting out patients with certain genetic mutations.

Pfizer has amended its enrollment protocol for a Phase III test for gene therapy fordadistrogene movaparvovec in DMD after investigators flagged severe side effects tied to specific mutations, according to a letter the drugmaker sent to Parent Project Muscular Dystrophy, a patient advocacy group.

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Albert Bourla, Pfizer CEO (John Thys, Pool via AP Images)
September 28, 2021 10:17 AM EDTUpdated 10:39 AM
Coronavirus

Covid-19 roundup: Pfiz­er/BioN­Tech sub­mit vac­cine da­ta to FDA for younger chil­dren; Doc­tors kept pre­scrib­ing hy­drox­y­chloro­quine

Zachary Brennan

Senior Editor

Pfizer and BioNTech said Tuesday they submitted to FDA positive data from a Phase II/III trial of their Covid-19 vaccine in children aged 5 to less than 12 years old.

A formal EUA submission for the vaccine in these children is expected to follow “in the coming weeks,” the companies said in a statement.

The trial of 2,268 healthy participants aged 5 to less than 12 years old showed the vaccine was safe and elicited robust neutralizing antibody responses using a two-dose regimen of 10 μg doses, which is one-third the dose that’s administered to adults.

Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Ciaran McCrickard)
September 27, 2021 07:31 PM EDT
FDA+

Seiz­ing Aduhelm prece­dent, Bio­gen, Ei­sai get the ball rolling on an­oth­er ac­cel­er­at­ed Alzheimer's ap­proval

Amber Tong

Senior Editor

Biogen — together with partners at Eisai — will be the first to breeze down that Alzheimer’s trail it blazed with the FDA’s historic and controversial accelerated approval of Aduhelm.

Eisai disclosed it’s initiated a rolling BLA submission for lecanemab, or BAN2401, the anti-amyloid beta antibody that Biogen has long touted as a follow-on to Aduhelm (then aducanumab). Following the precedent that the agency has now set, the two companies are gunning for an OK based on data suggesting that the drug could lower amyloid beta plaques.

Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Ciaran McCrickard)
September 24, 2021 11:02 AM EDTUpdated 01:35 PM
FDA+

New ARIA cas­es dog Bio­gen's Aduhelm launch in an­oth­er po­ten­tial blow to block­buster hopes — an­a­lyst

Kyle Blankenship

Managing Editor

Perhaps anticipating a walkover with an FDA approval in hand, Biogen has instead faced a wall of pushback over its controversial Alzheimer’s med Aduhelm. With payers and clinics largely staying away, Biogen’s drug is posting some troubling safety signals that could derail the launch even further.

In a note to clients Friday, analysts from Baird revealed new safety data from the FDA’s Adverse Event Reporting System (FAERS) showing a troubling recurrence of ARIA in a crop of patients who have been dosed with Aduhelm.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 118,600+ biopharma pros reading Endpoints daily — and it's free.

In a first, FDA warns a re­searcher for fail­ing to sub­mit da­ta 3 years af­ter tri­al com­ple­tion

Why it Works: Man­u­fac­tur­ing a Vac­cine in a Mul­ti-Prod­uct Fa­cil­i­ty.

Days of heat­ed ru­mors cul­mi­nate in a re­port that Ac­celeron is in ad­vanced buy­out talks

Mer­ck emerges as lead bid­der in po­ten­tial Ac­celeron buy­out with deal pos­si­ble this week — re­port

The coro­n­avirus vac­cine that the world for­got could still help save it

Tur­moil at CBER: Pe­ter Marks grabs con­trol of FDA's Of­fice of Vac­cines ahead of 2 key ca­reer leader de­par­tures

Safe­ty fears force Pfiz­er to change piv­otal DMD gene ther­a­py tri­al pro­to­col

Covid-19 roundup: Pfiz­er/BioN­Tech sub­mit vac­cine da­ta to FDA for younger chil­dren; Doc­tors kept pre­scrib­ing hy­drox­y­chloro­quine

Seiz­ing Aduhelm prece­dent, Bio­gen, Ei­sai get the ball rolling on an­oth­er ac­cel­er­at­ed Alzheimer's ap­proval

New ARIA cas­es dog Bio­gen's Aduhelm launch in an­oth­er po­ten­tial blow to block­buster hopes — an­a­lyst