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.

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Hal Barron and Rick Klausner (GSK, Lyell)

October 8, 2019 07:00 AM EDTUpdated 07:53 AM

John Carroll

Cell/Gene Tx

Deals

Exclusive: GSK’s Hal Barron allies with Rick Klausner’s $600M cell therapy startup, looking to break new ground blitzing solid tumors

LONDON — Chances are, you’ve heard little or nothing about Rick Klausner’s startup Lyell. But that ends now.

Klausner, the former head of the National Cancer Institute, former executive director for global health at the Gates Foundation, co-founder at Juno and one of the leaders in the booming cell therapy field, has brought together one of the most prominent teams of scientists tackling cell therapy 2.0 — highlighted by a quest to bridge a daunting tech gap that separates some profound advances in blood cancers with solid tumors. And today he’s officially adding Hal Barron and GlaxoSmithKline as a major league collaborator which is pitching in a large portion of the $600 million he’s raised in the past year to make that vision a reality.

“We’ve being staying stealth,” Klausner tells me, then adding with a chuckle: “and going back to stealth after this.”

“Cell therapy has a lot of challenges,” notes Barron, the R&D chief at GSK, ticking off the resistance put up by solid tumors to cell therapies, the vein-to-vein time involved in taking immune cells out of patients, engineering them to attack cancer cells, and getting them back in, and more. “Over the years Rick and I talked about how it would be wonderful to take that on as a mission.”

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October 12, 2019 09:38 AM EDT

John Carroll

Pharma

R&D

First place finish: Eli Lilly just moved to franchise leader with their second migraine drug OK in 1 year

In a rare twist for Eli Lilly’s historically slow-moving R&D group, the pharma giant has seized bragging rights to a first-in-class new drug approval. And all signs point to an aggressive marketing followup as they look to outclass some major franchise rivals hobbled by internal dissension.

The FDA came through with an OK for lasmiditan on Friday evening, branding it as Reyvow and lining it up — once a substance classification comes through from the DEA — for a major market release. The oral drug binds to 5-HT1F receptors and is designed to stop an acute migraine after it starts. That makes it a complementary therapy to their CGRP drug Emgality, which has a statistically significant impact on preventing attacks.

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Allogene HQ Open House on September 17, 2019 in South San Francisco. (Jeff Rumans, Endpoints News)

The next 10 years: Where is biotech headed?

The last 10 years have seen a revolution in drug development. Timelines have shortened, particularly in oncology. Regulators have opened up. Investment has skyrocketed. China became a player. Biotechs have multiplied as gene and cell therapy has exploded — offering major new advances in the way diseases are treated, and sometimes cured.

So where are we headed from here? I journeyed out to San Francisco in September to discuss the answer to that question at Allogene’s open house. If the last 10 years have been an eye-opener, what does the next decade hold in store?

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Medical Director to Senior Director Clinical Development - Neuromuscular Disorders / Spinal Muscular Atrophy

Biogen

Cambridge, Massachusetts, USA

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Patrick Mahaffy, Getty Images

October 11, 2019 11:04 AM EDTUpdated 8 hours ago

John Carroll

R&D

Court green-lights Clovis case after detailing evidence the board ‘ignored red flags’ on false safety and efficacy data

Clovis investors have cleared a major hurdle in their long-running case against the board of directors, with a Delaware court making a rare finding that they had a strong enough case against the board to proceed with the action.

In a detailed ruling at the beginning of the month that’s been getting careful scrutiny at firms specializing in biotech and corporate governance, the Delaware Court of Chancery found that the attorneys for the investors had made a careful case that the board — a collection of experts that includes high-profile biotech entrepreneurs, a Harvard professor and well-known investigator as well as Clovis CEO Patrick Mahaffy — repeatedly ignored obvious warnings that Mahaffy’s executive crew was touting inflated, unconfirmed data for their big drug Roci. Serious safety issues were also reportedly overlooked while the company continued a fundraising campaign that brought in more than a half-billion dollars. And that leaves the board open to claims related to their role in the fiasco.

The bottom line:

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October 10, 2019 09:55 AM EDTUpdated 10:44 AM

Jason Mast

R&D

Bill Gates backs Ginkgo Bioworks' $350M raise to fuel the buzzy synthetic biology 'revolution'

If you want to understand Ginkgo Bioworks, the name should suffice: Bioworks, a spin off “ironworks,” that old industrial linchpin devoted to leveraging scale as a wellspring for vast new industries capable of remaking society. Ginkgo wants to be the ironworks for the revolution it’s heralded with as much fanfare as they can, playing off of one of the buzziest technologies in biotech.

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October 10, 2019 04:22 AM EDTUpdated 04:44 AM

John Carroll

Deals

UCB bags a rival to Soliris in $2.1B buyout deal — but will an increasingly vigilant FTC sign off?

UCB is buying out Ra Pharma $RARX, announcing an acquisition deal that rings up at $48 a share, or $2.1 billion net of cash, and puts them toe-to-toe with Alexion on a clinical showdown.

Ra shares closed at $22.70 on Wednesday.

There’s a small pipeline in play at Ra, but UCB is going for the lead drug — a C5 inhibitor called zilucoplan in Phase III for myasthenia gravis (MG) looking to play rival to Alexion’s Soliris. Soliris has the market advantage, though, with a much earlier approval in MG in late 2017 that UCB feels confident in challenging.

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October 9, 2019 08:53 AM EDT

John Carroll

R&D

A new player is taking the field in a push for a hemophilia A gene therapy, and it’s a big one

BioMarin, the execs at Spark (and buyer-to-be Roche) as well as the Sangamo/Pfizer team have a new rival striding onto the hemophilia block. And it’s a big one.

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