FDA approves Mesoblast's GVHD cell therapy

Today’s Big News

Dec 19, 2024

Merck's HIV combo treatment meets the bar for viral suppression in pair of phase 3 studies


Novartis to shutter 2 MorphoSys sites, lay off 330 staffers in post-buyout consolidation


After two rejections, FDA approves Mesoblast's first-of-its-kind cell therapy


Vertex's pain trial hits endpoint but sinks stock as placebo comparison spooks investors


Labcorp launches bird flu test amid first severe case in the US


2025 forecast: The government crackdown on pharmas' direct-to-consumer outreach marches on

 

Featured

Merck's HIV combo treatment meets the bar for viral suppression in pair of phase 3 studies

However, the combination of Merck's approved doravirine and investigational islatravir didn't prove superiority over Gilead's top-selling Biktarvy in one of the studies.
 

Top Stories

Novartis to shutter 2 MorphoSys sites, lay off 330 staffers in post-buyout consolidation

Novartis confirmed Thursday that it’s closing down MorphoSys sites in Munich and Boston in a move that’s expected to result in around 330 layoffs. The company made the decision in November as it looks to “integrate all portfolio activities into Novartis."

After two rejections, FDA approves Mesoblast's first-of-its-kind cell therapy

An FDA advisory panel vote of 9-1 to recommend the approval of Mesoblast Limited’s graft versus host disease (GVHD) cell therapy was a cruel tease for the Australian company. More than four years later—and after two rejections from the agency—Mesoblast has finally gained an endorsement from the U.S. regulator for its first approved drug.

Vertex's pain trial hits endpoint but sinks stock as placebo comparison spooks investors

Vertex has reported a phase 2 win that dented confidence in its pain prospect suzetrigine. The trial linked the near-approval molecule to a significant improvement from baseline, but placebo performed similarly, triggering a 12% drop in Vertex’s share price in premarket trading.

Labcorp launches bird flu test amid first severe case in the US

According to the clinical testing giant, its H5N1 test can be used to help check potential human exposure, as the virus has begun to spread through outbreaks at poultry farms and dairy herds across the country.

2025 forecast: The government crackdown on pharmas' direct-to-consumer outreach marches on

The ways in which pharmaceutical companies market their drugs directly to consumers in the U.S. could face quite the evolution in 2025—at least, if legislators and other government powers have anything to say about it.

Pharma's reputation is stable-ish. Will that survive Trump 2.0?

Pharma’s reputation was 45% positive for the past two years. The latest survey put positive sentiment at 43%. After the whiplash changes of the COVID-19 era, things have settled down. Enter Donald Trump, a president-elect who fans and detractors alike agree has a propensity to try to shake things up.

Playing catch-up with Pfizer and Roche, China-made ALK drug clears FDA in lung cancer

Following in the footsteps of Pfizer, Roche and Takeda, another ALK inhibitor has made its belated entry into the U.S. The FDA nod comes four years after its initial approval in China.

BMS pays Leqembi originator $100M for next-gen preclinical Alzheimer's prospects

Bristol Myers Squibb has turned to the source of Leqembi to further its push into Alzheimer’s disease, paying BioArctic $100 million upfront for global rights to two preclinical antibodies.

Analysts tip BMS’ Cobenfy to be top dog in growing schizophrenia market

Launches from companies including Boehringer Ingelheim and Bristol Myers Squibb could drive sales of schizophrenia drugs up to $17 billion by 2031 despite generic erosion of incumbent products, according to GlobalData.

FDA elevates Boston Scientific cryoablation correction effort following four deaths

No hardware is being removed from use—instead, the company’s effort focuses on updating the instructions for the POLARx system, following higher-than-anticipated reports of damage to the esophagus, including seven injuries and four deaths.

Klick Health goes on a hiring spree to close out the year, adding 22 new leaders

Christmas seems to have come early for Klick Health, with a slew of new leaders arriving under the life sciences marketing agency’s metaphorical tree.
 
Fierce podcasts

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Integrating social-emotional learning in child education

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Resources

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Building a “Best Practice” R&D Organization in Biopharma

We interviewed 14 R&D biopharma leaders on the critical success factors for building a Best Practice R&D organization. This report shares what we learned.
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Single Cell RNA Profiling FFPE Tissue

Explore the robust cross-platform agreement between scRNA-seq and bulk RNA-seq, ensuring consistent and reproducible data on immune cell presence.
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Straight to Market in an Autoinjector

The use of prefilled syringes to administer biotherapeutics is beginning to gain traction because they offer a range of stability, efficacy, and patient safety benefits. Download this white paper to learn how Lonza has developed a novel workflow to ensure confidence regarding functionality in PFS and autoinjectors.
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Planning for success in cell-based manufacturing

Learn how to evaluate quality documentation to help you select the right raw materials at early decision points for your cell-based manufacturing processes.
 

Industry Events

On Helix

Date: ‌4 ‌July ‌2024 ‌- ‌Location: ‌Babraham ‌Research ‌Campus, ‌Cambridge ‌UK

 

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