FDA sounds the alarm on Pfizer’s blockbuster Xeljanz after a high dose was linked to a higher death rate, blood clots

February 25, 2019 04:59 PM EST

FDA sounds the alarm on Pfizer’s blockbuster Xeljanz after a high dose was linked to a higher death rate, blood clots

John Carroll

Editor & Founder

The FDA is sounding a formal warning about the potential safety hazard posed by a high dose of Pfizer’s blockbuster Xeljanz, taking a move that could put a serious crimp in its blockbuster sales revenue.

Their statement today includes:

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Cell and Gene Contract Manufacturers Must Embrace Digitization

Rachit Jain

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

August 11, 2020 09:29 AM EDTUpdated 2 hours ago

Coronavirus

Endpoints News ranks all 28 players in the Covid-19 vaccine race. Here's how it stacks up today

Nicole DeFeudis

Associate Editor

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

Endpoints News writer Nicole DeFeudis has posted a snapshot of all the companies, universities and hospital-based groups now racing through the clinic, ranking them according to their place in the pipeline as well as the latest remarks available on timelines. And we’ll keep this lineup updated right through the end of the year, as the checkered flags start to fall, possibly as early as October.

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August 10, 2020 07:15 AM EDTUpdated 09:52 AM

R&D

Phase III readouts spell disaster for Genentech’s lead IBD drug

Jason Mast

Associate Editor

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

ENDPOINTS CAREERS

Director of Regulatory Affairs

Recursion Pharmaceuticals

Salt Lake City, UT

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Bayer's Marianne De Backer with Endpoints founder John Carroll, Endpoints@JPM20 (Jeff Rumans for Endpoints News)

August 11, 2020 05:33 AM EDTUpdated 10:30 AM

Deals

UPDATED: Hunting a blockbuster, Bayer forges an $875M-plus M&A deal to acquire women’s health biotech

Amber Tong

Editor

Bayer has dropped $425 million in cash on its latest women’s health bet, bringing a UK biotech and its non-hormonal menopause treatment into the fold.

KaNDy Therapeutics had its roots in GlaxoSmithKline, which spun out several neuroscience drugs into NeRRe Therapeutics back in 2012. Five years later the team created a new biotech to focus solely on NT-814 — which they considered “one of the few true innovations in women’s health in more than two decades.”

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Eisai moves to 200 Metro Blvd. by late 2021 (ON3)

August 11, 2020 10:19 AM EDTUpdated 10:32 AM

Pharma

Eisai is creating a new US corporate, R&D HQ in Roche’s old Nutley, NJ campus

John Carroll

Editor & Founder

Eight years after Roche pulled up stakes from Nutley, NJ in a major R&D reorganization, Japan’s Eisai is moving its US corporate and research hub into their old campus.

Now the ON3 property, Eisai — a longtime Biogen partner focused on neurodegenerative disorders like Alzheimer’s — will bring together a staff of up to 1,200 employees. And execs are pitching the move to the New Jersey campus as a cultural game-changer.

DFC CEO Adam Boehler and Kodak CEO Jim Continenza (Kodak)

August 10, 2020 06:50 AM EDTUpdated 10:01 AM

Outsourcing

Pharma

Coronavirus

Covid-19 roundup: CureVac beefs up its unicorn IPO dreams as billionaire owner takes this Covid-19 mRNA player on a forced march to Nasdaq; Kodak's $765M deal is put on hold

Amber Tong

Editor

John Carroll

Editor & Founder

When CureVac initially jotted down $100 million for its IPO raise a couple of weeks ago, it seemed small. The German mRNA player, after all, had jumped into a Covid-19 race that swelled the sails of Moderna and BioNTech by tens of billions. And after raising $640 million in a slate of deals, $100 million in a hot market like this seemed like a pittance in the bigger scheme of things.

Today, we got a look at a figure that probably comes closer to the game-changing number the top execs probably have in mind. Selling 15.3 million shares at the high end of their $14 to $16 range would net a $243 million bounty. Majority owner Dietmar Hopp is putting in another €100 million, bringing the total to around $350 million. And what are the chances they want to do even better than that?

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Eric Shaff (Seres)

August 10, 2020 06:29 AM EDTUpdated 03:47 PM

R&D

UPDATED: After a 4-year sojourn, struggling microbiome pioneer Seres claims a breakout PhIII comeback. And shares respond in frenzied spike

John Carroll

Editor & Founder

Almost exactly 4 years ago, Seres Therapeutics $MCRB experienced one of those soul-crunching failures that can raise big questions about a biotech’s future. Out front in their pursuit of a gut punch to C. difficile infection (CDI), the Phase II test was a flat failure, and investors wiped out a billion dollars of equity value that never returned in the years that followed.

Seres, though, pressed ahead, changing out CEOs a year ago — bidding Merck vet Roger Pomerantz farewell from the C suite — and pushing through a Phase III, hoping that amping up the dosage would make the key difference. And this morning, they unveiled a claim that they had aced the Phase III and positioned themselves for a run at a landmark FDA OK.

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ENDPOINTS CAREERS

Director of Clinical Operations

Recursion Pharmaceuticals

Salt Lake City, UT

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Michel Vounatsos, Biogen CEO (via YouTube)

August 7, 2020 07:47 AM EDTUpdated 10:38 AM

R&D

Biogen scores a priority review for its Alzheimer's drug aducanumab, moving one giant leap forward in its controversial quest

John Carroll

Editor & Founder

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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Robert Gould, Fulcrum Therapeutics CEO

August 11, 2020 10:37 AM EDTUpdated 03:45 PM

R&D

Fulcrum stumbles in PhII of old GSK drug, sending shares tumbling

Jason Mast

Associate Editor

Investors are selling off shares of Fulcrum Therapeutics $FULC after their lead drug failed in a Phase II trial.

The company, founded three years ago on new research techniques such as CRISPR screening, isolated a gene called DUX4 they believed to have a central role in facioscapulohumeral muscular dystrophy, where patients’ muscle dies and is replaced by fat. And to target it, they licensed a GlaxoSmithKline drug that had failed as a cardio drug.

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