Ahead of US gene therapy explosion, big contract drug manufacturer Catalent makes $1.2 billion bet on Paragon Bioservices

April 15, 2019 06:06 AM EDTUpdated May 30, 11:44 AM

Natalie Grover

Ahead of US gene therapy explosion, big contract drug manufacturer Catalent makes $1.2 billion bet on Paragon Bioservices

As drug developers aggressively pursue gene therapies and their makers, the manufacturing end of the supply chain is also fortifying itself for the wave of therapies expected to hit the market in the coming years. Less than a month after Thermo Fisher unveiled a $1.7 billion deal to swallow Brammer Bio — a company that does contract viral vector manufacturing for cell and gene therapy developers — Catalent is planning to fork over $1.2 billion for private-equity backed Paragon Bioservices.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,500+ biopharma pros reading Endpoints daily — and it's free.

Paul Hudson, Getty Images

December 9, 2019 05:27 PM ESTUpdated December 10, 08:48 AM

John Carroll

R&D

UPDATED: Sanofi CEO Hudson lays out new R&D focus — chopping diabetes, cardio and slashing $2B-plus costs in surgical dissection

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

“To be out of cardiovascular and diabetes is not easy for a company like ours with an incredibly proud history,” Hudson said on a call with reporters, according to the Wall Street Journal. “As tough a choice as that is, we’re making that choice.”

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,500+ biopharma pros reading Endpoints daily — and it's free.

Psilocybin mushrooms (via The Denver Post)

December 12, 2019 07:22 AM ESTUpdated 08:09 AM

Natalie Grover

R&D

In a key step for psychedelic research, magic mushroom compound clears first clinical safety hurdle

Exasperated with the often-ineffective existing slate of antidepressants, COMPASS Pathways set up shop in London 2016 — and made a beeline for psilocybin, the psychoactive ingredient in magic mushrooms.

On Wednesday, the startup said its man-made version of the chemical — which is illegal across geographies in its natural fungi form — had been well-tolerated in an early-stage, placebo-controlled trial in 89 healthy volunteers.

December 12, 2019 07:08 AM EST

Amber Tong

China

IPOs

Alphamab Oncology rounds out HKEX's second biotech IPO year with $230M raise and high local interest

Alphamab Oncology has inspired a surge of local interest in what will likely be the Hong Kong Stock Exchange’s last biotech run of the year, pricing its IPO on the high end of the range and raising over $230 million (HK$1.83 billion).

After rejigging the offering structure and making up to 50% available for enthusiastic local investors, the biotech sold 179.4 million shares at $1.31 (HK$10.2) and saw its stock rise to $1.77 ($13.8) on the first day of trading.

ENDPOINTS CAREERS

Associate Director, Regulatory Affairs

Cold Genesys, Inc.

Irvine, CA

view job offer post your job now

December 12, 2019 07:02 AM ESTUpdated 07:15 AM

John Carroll

R&D

For sale: Long-acting PhIII GLP-1 diabetes drug that’s way behind rivals, now spurned by Sanofi

Almost exactly 4 years ago Sanofi came to the bargaining table with South Korea’s Hanmi bearing $434 million dollars in cash and offering about $4 billion in milestones to in-license their once-weekly GLP-1 injectable. The pact was intended to revive their ailing diabetes division. Instead, it turned into a very expensive grave to mark the end of Sanofi’s R&D ambitions in the field.

Sanofi CEO Paul Hudson used efpeglenatide’s demise — while committing to paying hundreds of millions of more dollars to push it through 5 late-stage studies — as a marker of the company’s determination to stay focused on first and best-in-class drugs.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,500+ biopharma pros reading Endpoints daily — and it's free.

December 12, 2019 06:00 AM ESTUpdated 06:15 AM

Jason Mast

Startups

Parkinson's transplants emerge as stem cell pioneer Jeanne Loring joins R&D race

Jeanne Loring hadn’t studied Parkinson’s in 22 years when she got an email from a local neurologist.

The neurologist, Melissa Houser, didn’t know Loring had ever published on the disease. She was just looking for a stem cell researcher who might hear her out.

“I think I was just picked out a hat,” Loring told Endpoints News.

At a meeting in Loring’s Scripps Research office, Houser and a Parkinson’s nurse practitioner, Sherrie Gould, asked her why there was so much research done in stem cell transplants for other neurodegenerative diseases but not Parkinson’s. They wanted to know if she would work on one.

December 11, 2019 10:23 AM ESTUpdated 3 hours ago

John Carroll

R&D

What does $6.9B buy these days in oncology R&D? AstraZeneca has a landmark answer

Given the way the FDA has been whisking through new drug approvals months ahead of their PDUFA date, AstraZeneca and their partners Daiichi Sankyo may not have to wait until Q2 of next year to get a green light on trastuzumab deruxtecan (DS-8201).

The pharma giant this morning played their ace in the hole, showing off why they were willing to commit to a $6.9 billion deal — with $1.35 billion in a cash upfront — to partner on the drug.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,500+ biopharma pros reading Endpoints daily — and it's free.

Paul Hudson, Sanofi

December 10, 2019 10:46 AM ESTUpdated 11:00 AM

John Carroll

R&D

Paul Hudson promises a bright new future at Sanofi, kicking loose me-too drugs and focusing on landmark advances. But can he deliver?

Paul Hudson was on a mission Tuesday morning as he stood up to address Sanofi’s new R&D and business strategy.

Still fresh into the job, the new CEO set out to convince his audience — including the legions of nervous staffers inevitably devoting much of their day to listening in — that the pharma giant is shedding the layers of bureaucracy that had held them back from making progress in the past, dropping the duds in the pipeline and reprioritizing a more narrow set of experimental drugs that were promised as first-in-class or best-in-class. The company, he added, is now positioned to “go after other opportunities” that could offer a transformational approach to treating its core diseases.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,500+ biopharma pros reading Endpoints daily — and it's free.

ENDPOINTS CAREERS

Associate Director / Director, Technology Transfer (US/China)

Cold Genesys, Inc.

view job offer post your job now

Large advertisements for the drug Vivitrol decorate the walls of Grand Central Station on June 15, 2017 in New York City. (Photo: Andrew Lichtenstein via Getty)

December 11, 2019 03:48 PM EST

Jason Mast

Regulatory

FDA slaps down Alkermes for misleading Vivitrol ads — don't forget vulnerability to opioid overdose

The ads piqued interest as soon as they started appearing in 2016: at Grand Central Station, on the Red Line in Cambridge, and on a billboard off the New Jersey Turnpike. All showed a young person, generally with his or her arms crossed, and the question, “what is Vivitrol?”

Vivitrol’s maker, Alkermes, was in the midst of a marketing and lobbying campaign to promote the anti-opioid addiction drug — a campaign that would face significant backlash for tarnishing competitors despite little evidence for Vivitrol’s superiority.

December 11, 2019 10:59 AM EST

Jason Mast

R&D

FDA in-house review spotlights an issue with one of Horizon's endpoints but notes efficacy for lead drug

The FDA in-house review highlights a disagreement of investigators’ use of a key endpoint by Horizon Pharma in the late-stage trial for the top drug in its pipeline, but largely agreed that the antibody was effective.

Horizon submitted a BLA for thyroid eye disease (TED) drug teprotumumab in March, less than two years after they bought the drug (and the rest of a division) from Narrow River for $145 million upfront. With breakthrough status, priority review, orphan designation and in-house sales projections of up to $750 million, the one-time Roche reject became the marquee pipeline asset for a company that’s developed some of the world’s most expensive drugs.