October 13, 2021 12:09 PM EDTUpdated 02:19 PM
R&D

FDA+ roundup: Marks on Wood­cock­'s tenure as act­ing com­mis­sion­er; FDA lead­ers of­fer per­spec­tive on bar­ri­ers to di­ver­si­ty in re­search

Zachary Brennan

Senior Editor

CBER director Peter Marks praised Janet Woodcock’s work as acting FDA commissioner, and while noting that Biden needs to nominate someone to fill the role permanently by Nov. 16, he said he has “no idea” when that actually might occur.

“Dr. Woodcock has been at the agency for over three decades and she, during that time, has proven herself to be a remarkably capable manager,” Marks said at the Alliance for Regenerative Medicine’s meeting Tuesday. “And she’s been managing as if she’s commissioner, unlike some previous acting [commissioners] who are afraid to actually do things. She doesn’t appear to be afraid to do things. I have not felt any different now from when we had a commissioner in place,” he added.

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Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.
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May 29, 2023 06:00 AM EDT

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

The Janssen Pharmaceutical Companies of Johnson & Johnson

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

June 1, 2023 03:53 PM EDT
Pharma

Eu­ro­pean Par­lia­ment calls mem­ber states to ac­tion on an­timi­cro­bial re­sis­tance

Nicole DeFeudis

Editor

Members of the European Parliament have called on EU countries to develop national action plans against antimicrobial resistance (AMR), calling it a top-three priority health threat.

Parliament on Thursday announced recommendations for the fight against AMR, including national action plans that must be updated at least every two years, an EU-level database tracking AMR and antimicrobial use and increased partnership between the pharma industry, patient groups and academia.

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Andrey Zarur, GreenLight Biosciences CEO
June 1, 2023 12:28 PM EDT
R&D
Manufacturing

Green­Light Bio­sciences se­cures merg­er as it looks to go pri­vate

Tyler Patchen

News Reporter

GreenLight Bioscience, the developer and manufacturer of RNA vaccines and therapeutics, is set to be acquired.

The company announced earlier this week that it would be acquired by a group of buyers led by Fall Line Capital in a cash deal valuing GreenLight at around $45.5 million. According to a release, Fall Line and the group agreed to acquire all of the shares of the company for $0.30 per share. The deal is expected to close sometime in the third quarter of this year.

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June 1, 2023 11:19 AM EDTUpdated 03:26 PM
People

Bausch + Lomb to pro­mote three SVPs to ex­ec­u­tive team

Paul Schloesser

Associate Editor

Bausch + Lomb is making more executive change-ups, including the promotion of three of its senior VPs that will report directly to CEO Brent Saunders.

Earlier this year, Saunders returned to lead Bausch + Lomb and its roughly 12,000 employees after originally running the company from 2010 to 2013.

Bausch + Lomb said Thursday that Luc Bonnefoy, John Ferris and Yang Yang — the leaders of its surgical, consumer and vision care businesses, respectively — will join the executive management team and report directly to Saunders. It also said that Joseph Gordon, head of global consumer, surgical and vision care, is now a strategic advisor to Saunders.

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June 1, 2023 11:05 AM EDT
News Briefing

Bay­er buys li­cense to Cedil­la pre­clin­i­cal can­cer pro­gram; MEI Phar­ma says no to un­so­licit­ed of­fer

Lei Lei Wu

News Reporter

Paul Schloesser

Associate Editor

Bayer has acquired exclusive rights to Cedilla Therapeutics’ preclinical cancer drug candidates for an undisclosed amount.

Bayer announced Thursday morning that it is acquiring the license for Cedilla’s preclinical Cyclin E1/CDK2 complex inhibitors. Cyclin E1 activates CDK2, and the two drive cancer progression and are overexpressed in cancer cells.

Bayer did not disclose what indications it will be pursuing under this partnership. The deal is structured traditionally — Bayer will pay Cedilla an undisclosed amount upfront, and the latter is also eligible for potential development and commercial milestones and royalties. — Lei Lei Wu

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June 1, 2023 10:50 AM EDT
Manufacturing

Roche plans to di­vest from lega­cy Genen­tech man­u­fac­tur­ing fa­cil­i­ty in Cal­i­for­nia

Tyler Patchen

News Reporter

Roche is planning to make some changes to its subsidiary’s manufacturing network in California.

The Swiss pharma announced Wednesday that it plans to divest from Genentech’s manufacturing facility in Vacaville, CA, around 58 miles northeast of San Francisco. According to a statement from Roche, the move is part of a “broader strategy” to bring its manufacturing capabilities in line with its future pipeline. Roche is starting the process of finding a buyer for the site but has not named any candidates yet.

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June 1, 2023 10:19 AM EDTUpdated 04:00 PM
R&D
FDA+

FDA lifts hold on Mol­e­c­u­lar Tem­plates’ mul­ti­ple myelo­ma tri­al af­ter less than two months

Lei Lei Wu

News Reporter

The FDA has lifted a partial clinical hold on Molecular Templates’ early-stage trial for a multiple myeloma drug, the biotech company announced Thursday morning.

Regulators had put the trial on partial hold in early April, pausing patient enrollment, following two adverse heart-related events in patients who received the highest dose of Molecular Templates’ treatment MT-0169 last year. One patient had asymptomatic grade 2 myocarditis, or heart muscle inflammation, while the other had a grade 3 cardiomyopathy. Both recovered within two months.

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Roger Perlmutter, Eikon Therapeutics CEO
June 1, 2023 08:05 AM EDT
Financing
Deals

Roger Perl­mut­ter builds Eikon's pipeline with deal-mak­ing flur­ry, rais­ing $106M more

Andrew Dunn

Biopharma Correspondent

Eikon Therapeutics announced three business development deals on Thursday, effectively dropping in a pipeline of cancer drugs alongside more than $100 million in fresh funding.

The Hayward, CA-based company has become one of biotech’s richest startups since its 2019 founding, having raised nearly $775 million. It’s developing a massive, automated research approach built around Nobel Prize-winning microscope science to peer inside cells and watch proteins in action. After its Series B last year, PitchBook reported a $3.02 billion valuation. And while CEO Roger Perlmutter declined to comment on that figure, he said its first tranche of nearly $106 million in Series C funding is a “meaningful step-up to our Series B valuation.”

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June 1, 2023 07:38 AM EDT
People

Far­al­lon says it's won all de­sired board seats from Ex­elix­is af­ter share­hold­er vote

Paul Schloesser

Associate Editor

Less than two months after Farallon Capital Management launched a proxy fight to gain control of three seats on cancer biotech Exelixis’ board, it got what it wanted at the company’s annual shareholder meeting.

The hedge fund said Wednesday that preliminary results at Exelixis’ annual shareholder meeting elected all three of Farallon’s candidates to the board: Tom Heyman, Dave Johnson and Bob Oliver.

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FDA+ roundup: Marks on Wood­cock­'s tenure as act­ing com­mis­sion­er; FDA lead­ers of­fer per­spec­tive on bar­ri­ers to di­ver­si­ty in re­search

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

Eu­ro­pean Par­lia­ment calls mem­ber states to ac­tion on an­timi­cro­bial re­sis­tance

Green­Light Bio­sciences se­cures merg­er as it looks to go pri­vate

Bausch + Lomb to pro­mote three SVPs to ex­ec­u­tive team

Bay­er buys li­cense to Cedil­la pre­clin­i­cal can­cer pro­gram; MEI Phar­ma says no to un­so­licit­ed of­fer

Roche plans to di­vest from lega­cy Genen­tech man­u­fac­tur­ing fa­cil­i­ty in Cal­i­for­nia

FDA lifts hold on Mol­e­c­u­lar Tem­plates’ mul­ti­ple myelo­ma tri­al af­ter less than two months

Roger Perl­mut­ter builds Eikon's pipeline with deal-mak­ing flur­ry, rais­ing $106M more

Far­al­lon says it's won all de­sired board seats from Ex­elix­is af­ter share­hold­er vote

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