The FDA will hustle up an expedited review for AstraZeneca’s next shot at a blockbuster cancer drug franchise

October 17, 2019 07:29 AM EDTUpdated 07:48 AM

The FDA will hustle up an expedited review for AstraZeneca’s next shot at a blockbuster cancer drug franchise

John Carroll

Editor & Founder

AstraZeneca paid a hefty price to partner with Daiichi Sankyo on their experimental antibody drug conjugate for HER2 positive breast cancer. And they’ve been rewarded with a fast ride through the FDA, with a straight shot at creating another blockbuster oncology franchise.

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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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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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ENDPOINTS CAREERS

Senior Analyst, Oncology

Brass Tacks Health

Remote

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Merck CEO Rob Davis

September 27, 2021 06:04 PM EDTUpdated 15 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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Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

September 28, 2021 07:23 AM EDT

R&D

Coronavirus

Sanofi calls it quits on mRNA Covid-19 shots, scrapping vaccine from $3.2B Translate Bio buyout

Max Gelman

Editor

Sanofi is throwing in the towel on mRNA-based Covid-19 vaccines.

The French drugmaker will halt development on its unmodified mRNA Covid-19 shot despite what it said were positive Phase I/II results, a spokesperson told Endpoints News on Tuesday morning. Sanofi said the reason it’s stopping the Covid-19 mRNA program, developed in partnership with its new $3.2 billion acquisition Translate Bio, is because the market is too crowded.

Brian Hubbard, Anji Pharmacetuticals CEO

September 28, 2021 06:30 AM EDTUpdated 09:50 AM

Financing

R&D

Looking to rewrite the rules of drug licensing, startup Anji is on the hunt for 'dynamic equity' joint ventures

Kyle Blankenship

Managing Editor

Licensing is one of the most common ways big drugmakers leverage biotech innovation to drive gains across their pipelines — and the structure of those deals is pretty well established. But one biotech with home bases in China and the US thinks it may have a better way.

On Tuesday, Cambridge-based biotech Anji Pharma closed a $70 million Series B with two late-stage molecules in the fold and a mission to rewrite the rules of drug licensing through what it calls “dynamic equity” deals and a joint venture-heavy game plan. The round was funded in whole by Chinese hedge fund CR Capital.

ENDPOINTS CAREERS

Senior Scientific Research Analyst

American Association for Cancer Research

Philadelphia, PA, USA

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September 28, 2021 10:57 AM EDTUpdated 03:06 PM

R&D

In Focus

Contract research is having a moment right now. Will M&A splashes drive the industry to even greater heights?

Nicole DeFeudis

Editor

Contract research organizations are a fairly mysterious bunch. They’re typically considered the skilled laborers behind big drug development — the stage crews who run the trials behind some of the most (and least) successful data reveals in biopharma history.

But all that is changing.

This year, a couple of huge, out-of-the-blue M&A deals sounded the alarm on just how much money is flying around in this corner of the industry.

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Biohaven CEO Vlad Coric

September 27, 2021 10:27 AM EDT

R&D

Biohaven turns out a dud in fatal neurodegenerative disease, casting doubt on drug's chances in ALS

Kyle Blankenship

Managing Editor

With one migraine drug on the market, Biohaven has gone big with its next phase of growth, targeting major neurodegenerative diseases in Alzheimer’s and ALS. The former effort has already gone up in smoke, and a new failure elsewhere in the pipeline could now bode poorly for the latter.

Biohaven’s verdiperstat failed to outperform placebo in reducing the symptoms of patients with multiple system atrophy (MSA), a rare and fatal neurodegenerative disorder, according to a “focused analysis” of the drug’s Phase III trial in that disease toplined Monday.

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