Metagenomi axes ALS program after Biogen, Ionis setbacks

Today’s Big News

Aug 14, 2024

To approve Amgen's lung cancer med Imdelltra, FDA saw past 'large number' of missing adverse events


Gone are the days of Galera: Biotech says goodbye to staffers and initiates wind down


Metagenomi axes ALS program after seeing Biogen and Ionis flounder


With FDA approval of Livdelzi, Gilead launches an inflammatory drug for the first time


Flying solo, Grail will cut 30% of staff and narrow its R&D, commercial focus


Bluebird stock plummets 18% with slow uptake of sickle cell disease gene therapy Lyfgenia

 

Featured

To approve Amgen's lung cancer med Imdelltra, FDA saw past 'large number' of missing adverse events

In granting an accelerated approval to Amgen's first-in-class DLL3 bispecific Imdelltra, the FDA had to work through a “large number” of missing adverse events from a pivotal trial.
 

Top Stories

Gone are the days of Galera: Biotech says goodbye to staffers and initiates wind-down

Galera Therapeutics is shuttering, with the biotech’s board OK'ing a liquidation plan that whittles down the company’s workforce to just three people.

Metagenomi axes ALS program after seeing Biogen and Ionis flounder

Metagenomi is editing its pipeline, choosing to seek a partner for a program Moderna dropped and axing its amyotrophic lateral sclerosis activities in response to setbacks at a competitor.

With FDA approval of Livdelzi, Gilead launches an inflammatory drug for the first time

The FDA has approved Gilead's primary biliary cholangitis treatment Livdelzi. The drug, which was acquired in a $4.3 billion buyout of CymaBay Therapeutics six months ago, is the first inflammatory treatment launched by Gilead.

Flying solo, Grail will cut 30% of staff and narrow its R&D, commercial focus

The first cut is the deepest: On its inaugural earnings call as a publicly traded company, Grail said it would reduce staff as much as 30% to focus solely on obtaining regulatory and reimbursement green lights for its Galleri multi-cancer early detection test.

Bluebird stock plummets 18% with slow uptake of sickle cell disease gene therapy Lyfgenia

Bluebird Bio is making progress on the launch of its three approved gene therapies but appears to be trailing Vertex in competition to attract patients to their respective treatments for sickle cell disease.

Evotec eyes 400 layoffs, citing 'challenging market'

Evotec has set its sights on scrapping about 400 roles as the German company continues to battle tough market conditions.

Viracta lays off 23% of staff, pauses program to slim down for race to finish line in lymphoma

Viracta Therapeutics is going all-in on its lymphoma program. The biotech responded to phase 2 data by throwing its resources behind a plan to file for a blood cancer approval in 2026, hitting pause on its solid tumor program and putting 23% of its staff out of a job in the process.

J&J and Roche are the strongest companies in the biopharma industry, says S&P Global

Johnson & Johnson and Roche are at the top of S&P Global’s pharmaceutical industry power ratings, which assess the strength of the world’s top 17 drugmakers.

Denali reports new method to get antisense oligonucleotides across blood-brain barrier

Antisense oligonucleotides, which bind to RNA and prevent them from being translated into proteins, have gained popularity in recent years as a way to treat neurodegenerative diseases. However, getting these drugs into the brain has been challenging, requiring invasive infusion directly into the cerebrospinal fluid.

Acadia gets in on the 'Deadpool' hype with Parkinson’s campaign starring Ryan Reynolds

The “Merc With a Mouth” is using his voice for good. Amid a whirlwind global press tour for “Deadpool & Wolverine,” Ryan Reynolds has stepped out of the spandex suit to join forces with Acadia Pharmaceuticals to raise awareness about lesser-known symptoms of Parkinson’s disease.

Moderna unveils free Coursera curriculum on mRNA medicines to boost STEM skills

With analysts estimating that millions of jobs in the STEM fields are currently going unfilled in the U.S., Moderna is doing its part to strengthen the workforce and close that gap.

CDMOs must look to leadership diversity, retention and specialized skills to stay on top: report

Facing a unique set of challenges and staring down multiple new technologies and modalities, CDMOs must work to recalibrate their leadership requirements if they hope to stay on the cutting edge, executive search advisory firm WittKieffer said in a new report.
 
Fierce podcasts

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What the data says about the telehealth market

In this week's episode of "Podnosis," we’re discussing the challenges and opportunities for telehealth, given some notable setbacks for the industry in recent months.
 

Resources

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2024 Life Sciences Industry Outlook

The definitive report on the state of our industry.  Readers will gain an understanding of key indicators to monitor, future predictions, and guidance for investors and founders navigating the therapeutic enabling tools and services, healthtech and techbio sectors through 2024 and beyond.
 

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On Helix

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

 

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