Siddhartha Mukherjee, AP Images
June 17, 2021 08:04 AM EDTUpdated June 18, 05:09 AM
R&D
Manufacturing

Sid Mukher­jee's Vor adds clin­i­cal man­u­fac­tur­ing fa­cil­i­ty at ex­ist­ing Boston-area site, beef­ing up for a com­mer­cial push

Josh Sullivan

When Siddhartha Mukherjee founded Vor Biopharma in 2016, he had the goal of rewriting the book on stem cell transplants. To get there, Vor needed a leg up in clinical manufacturing — and now it has one.

Vor will build an in-house clinical manufacturing facility next to its Cambridge, MA headquarters, which is anticipated to be up and running in 2022, the company said Thursday. The outlay is all out of pocket, but Vor says the buildout won’t impact its cash runway, which is sufficient to early 2023.

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March 27, 2023 06:00 AM EDT

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Victoria Maharaj

M.S.,Technical Sales & Scientific Advisory, Forge Biologics

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

March 27, 2023 10:20 AM EDTUpdated 10:38 AM
R&D
Special

Who’s spend­ing and who’s cut­ting from Big Phar­ma’s $127B R&D bud­get? Here are the top 15 play­ers

John Carroll

Editor & Founder

A couple of the Big 15 biopharma companies in R&D hit the gas on research spending last year. Merck and Sanofi still have lots to prove in the pipeline, and they’re willing to gamble large sums to make a better future for themselves.

Doing nothing would be infinitely worse.

But collectively, the top players rang up a modest 2.4% increase in spending in 2022, which didn’t cover inflationary pressures. And that set the tone for an extraordinarily cautious year for the industry — even as it laid out about $127 billion to advance new drugs or up the ante on approved therapies.

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Jeff Bluestone (R), Sonoma Biotherapeutics CEO
March 28, 2023 07:30 AM EDT
Financing
Bioregnum

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO
March 28, 2023 04:11 PM EDT
R&D

Van­da wins court case against FDA over dis­clo­sure of CRL de­tails for sleep drug

Zachary Brennan

Senior Editor

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.

March 28, 2023 07:30 AM EDTUpdated 10:17 AM
R&D
Pharma

Gun­ning for 2023 ap­proval, GSK de­tails PhI­II da­ta for Jem­per­li in front­line en­dome­tri­al can­cer

Amber Tong

Senior Editor

GSK has a new slate of data to offer on its PD-1 inhibitor, Jemperli — data that the pharma giant hopes will cement one of the four drug approvals it’s expecting this year.

While Jemperli (dostarlimab) is already approved for a subset of patients with second-line endometrial cancer, GSK set out in the Phase III RUBY trial to test it as an earlier line of treatment while also enrolling a broader group of patients. In an interim analysis, Jemperli was shown to extend progression-free survival for both the subset and the overall trial population when added to chemotherapy.

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March 27, 2023 03:04 PM EDT
Pharma
Manufacturing

Eli Lil­ly to in­crease in­vest­ment to $1B in­to new Irish man­u­fac­tur­ing fa­cil­i­ty — re­port

Tyler Patchen

News Reporter

The US pharma giant Eli Lilly will be increasing its financial commitment to a manufacturing site in Ireland.

According to a release from Ireland’s Industrial Development Agency (IDA) on Monday, Lilly will be investing another $500 million in its manufacturing facility in Limerick, Ireland — bringing the total investment into the facility to approximately $1 billion.

In January of last year, Lilly announced it was placing a $446 million investment into the site to expand active pharmaceutical ingredient and monoclonal antibody production.

Doug Williams, departing Codiak BioSciences CEO
March 27, 2023 08:49 AM EDT
People
R&D

Co­di­ak files for Chap­ter 11 bank­rupt­cy as most ex­ec­u­tives head for the ex­it

Kyle LaHucik

Associate Editor

Codiak BioSciences has filed for Chapter 11 bankruptcy, spelling an end to the employment of most executives, including founder Doug Williams, as the biotech says it “expects to consummate a sale.”

The eight-year journey at Codiak is nearing an end with Williams; CFO Linda Bain; medical chief David Mauro; scientific head Sriram Sathyanarayanan; legal and compliance chief Yalonda Howze; and SVP of HR Nicole Barna all packing up their bags in the first few days of April. Chief technology officer Konstantin Konstantinov will stay.

Chaim Lebovits, BrainStorm Cell Therapeutics CEO
March 27, 2023 06:41 AM EDTUpdated 12:44 PM
R&D
FDA+

Brain­Storm gets FDA ad­comm for ALS drug af­ter failed tri­al and RTF

Katherine Lewin

News Reporter

BrainStorm Cell Therapeutics has had a rocky road trying to get its ALS treatment through to the FDA, including a particularly difficult setback after the FDA slapped the company with a refusal to file (RTF) letter in November after it submitted its original BLA in September last year.

But there’s a glimmer of hope for BrainStorm’s ALS treatment, NurOwn – the FDA will hold an advisory committee meeting to discuss the company’s BLA for the treatment, the company announced today.

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Robert Califf, FDA commissioner (Photo by Drew Angerer/Getty Images)
March 28, 2023 02:21 PM EDTUpdated 03:32 PM
Pharma
FDA+
Manufacturing

House com­mit­tee to in­ves­ti­gate FDA's re­sponse to on­go­ing drug short­ages

Tyler Patchen

News Reporter

Republican leaders of the House Committee on Energy & Commerce sent a five-page letter yesterday announcing an investigation into the ongoing drug shortages that have rankled the US during the pandemic and the FDA’s response to it.

The letter, signed by Chair Cathy McMorris Rodgers (R-WA), explains how shortages have become more common over the past decade, while pointing to a report from the National Academies of Science, Engineering and Medicine finding that drug shortages have been “on the rise” over the past several decades and are lasting longer, with new drug shortages in the US seeing a 30% increase from 2021 to 2022.

Sid Mukher­jee's Vor adds clin­i­cal man­u­fac­tur­ing fa­cil­i­ty at ex­ist­ing Boston-area site, beef­ing up for a com­mer­cial push

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Who’s spend­ing and who’s cut­ting from Big Phar­ma’s $127B R&D bud­get? Here are the top 15 play­ers

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

Van­da wins court case against FDA over dis­clo­sure of CRL de­tails for sleep drug

Gun­ning for 2023 ap­proval, GSK de­tails PhI­II da­ta for Jem­per­li in front­line en­dome­tri­al can­cer

Eli Lil­ly to in­crease in­vest­ment to $1B in­to new Irish man­u­fac­tur­ing fa­cil­i­ty — re­port

Co­di­ak files for Chap­ter 11 bank­rupt­cy as most ex­ec­u­tives head for the ex­it

Brain­Storm gets FDA ad­comm for ALS drug af­ter failed tri­al and RTF

House com­mit­tee to in­ves­ti­gate FDA's re­sponse to on­go­ing drug short­ages