Pfizer braces for Hurricane Milton

Today’s Big News

Oct 8, 2024

City Therapeutics breaks ground with $135M and blueprints from RNAi expert John Maraganore


Pfizer, bracing for Hurricane Milton, pledges aid to emergency services and health support


Compounders sue FDA for removing Eli Lilly's tirzepatide from shortage list


FDA clears at-home COVID/flu combo test with eye on fall season


J&J stops phase 3 trial of $5B bladder cancer prospect after interim review flop


Merck & Co. signs $1.9B deal with Mestag to explore fibroblast therapies for inflammation


GSK touts 3-year data on RSV shot Arexvy after CDC's narrower usage recommendation


Sage scraps Alzheimer's program as dalzanemdor goes 0 for 2, leaving hopes resting on Huntington's

 

Featured

City Therapeutics breaks ground with $135M and blueprints from RNAi expert John Maraganore

A new RNAi biotech is breaking ground with $135 million and John Maraganore, Ph.D., holding the key to the city.
 

Top Stories

Pfizer, bracing for Hurricane Milton, pledges aid to emergency services and health support

Pfizer—which opened a global hub in Tampa, Florida, in 2021—is setting out to bolster emergency services, pool donations and ease medical supply needs as Hurricane Milton touches down this week.

Compounders sue FDA for removing Eli Lilly's tirzepatide from shortage list

A compounding industry group has sued the FDA, claiming its action to remove Eli Lilly’s Mounjaro and Zepbound from its drug shortage list is a “reckless and arbitrary decision—lacking any semblance of lawful process.” In declaring the end of the shortage, the FDA has halted the ability of compounding pharmacies to manufacture the in-demand products.

FDA clears at-home COVID/flu combo test with eye on fall season

Previous over-the-counter tests had been granted emergency authorizations. The Rapid Check screener from Healgen received a de novo clearance.

J&J stops phase 3 trial of $5B bladder cancer prospect after interim review flop

The sun has set on Johnson & Johnson’s SunRISe-2 study. J&J called a halt to the phase 3 bladder cancer trial after an interim look at the data showed the TAR-200 candidate was no better than chemoradiation.

Merck & Co. signs $1.9B deal with Mestag to explore fibroblast therapies for inflammation

Mestag has been working to change how fibroblasts are activated and how they expand. Now, Merck & Co. wants in—penning a $1.9 billion biobucks deal to collaborate on new therapies for inflammatory diseases.

GSK touts 3-year data on RSV shot Arexvy after CDC's narrower usage recommendation

GSK on Tuesday unveiled fresh data from the late-stage AReSVi-006 study of Arexvy in RSV-triggered lower respiratory tract disease in older adults over the span of three full RSV seasons. The positive readout comes several months after the CDC voted to narrow vaccine recommendations for the virus.

Sage scraps Alzheimer's program as dalzanemdor goes 0 for 2, leaving hopes resting on Huntington's

Sage Therapeutics has seen another clinical trial go up in smoke. The biotech called time on its plans to develop dalzanemdor in Alzheimer’s disease after seeing midphase data, adding to an earlier Parkinson’s flop and leaving the team looking to an upcoming readout in Huntington’s to rescue the prospect.

Merck's Keytruda stages comeback in head and neck cancer with trial win in earlier-stage disease

Merck & Co. hopes a new positive readout can return Keytruda to glory in head and neck cancer about two years after a prior failure.

GEMMABio secures $100M partnership with health ministry to bring rare disease gene therapies to Brazil

GEMMABio, one of two new companies spun out of the now-folded Gene Therapy Program at the University of Pennsylvania, has announced its first major step in improving global access to rare disease gene therapies.

FDA amplifies Medtronic recall of MiniMed insulin pumps over shortened battery life

Medtronic has been notifying users of its MiniMed insulin pumps to be aware of potentially shortened battery lives, and to heed the devices’ low-power warnings and alerts.

Roche survey finds major gap in awareness of HPV-cancer link

A new survey commissioned by Big Pharma Roche has found that half of those polled “have either limited or no awareness” of the connection between a common infection and cervical cancer.

Bausch + Lomb taps broadcaster Erin Andrews to push fast-growing dry eye disease drug

Bausch + Lomb has teamed up with American sportscaster Erin Andrews to promote its dry eye disease treatment, launching the “Miebo ohh yeah” campaign to spread the word about the condition and drug.

Eversana sets up shop in Germany with newest pharma commercialization services outpost

Eversana is increasing its reach across the global pharmaceutical industry. With the opening of its first office in Germany, the provider of commercialization services now has a presence in four of the world’s five biggest pharma markets.
 
Fierce podcasts

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Breaking down BIOSECURE—Industry implications, what comes next

This week on "The Top Line," Fierce Pharma’s Fraiser Kansteiner and Arnold & Porter’s Dan Kracov break down the BIOSECURE Act's potential impact on the life sciences industry and what comes next after the House of Representatives' recent vote.

 

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