Another hold for Novo's Hemlibra rival

Today's Big News

May 4, 2023

Next round of KRAS drugs stretch for their 4-minute mile in the footsteps of Amgen and Mirati


Lilly's Alzheimer's win looks like a runaway, but data is more comparable to Leqembi on a deeper dive, analysts say


Novo Nordisk’s Hemlibra rival faces another approval setback as FDA raises dosing, manufacturing questions


Roche creates organoid research institute to shake up drug discovery and development


Pfizer, Valneva push back Lyme disease vaccine filing to 2026 after cutting half of participants


Ionis' midphase misses send rare disease prospects to the abyss


'Mighty mice' take flight to find bone, muscle loss treatments for humans back on Earth

 

Featured

Next round of KRAS drugs stretch for their 4-minute mile in the footsteps of Amgen and Mirati

The KRAS inhibitor scene has always been a bit braggadocious with Amgen and Mirati Therapeutics battling it out for the first-to-market advantage. But now a new crop of scrappy KRAS upstarts has arrived on the medical conference circuit, trying to needle away at the leaders.
 

Top Stories

Lilly's Alzheimer's win looks like a runaway, but data are more comparable to Leqembi on a deeper dive, analysts say

The headline number from Eli Lilly’s Alzheimer’s data showing a 36% slowing of cognitive decline may have grabbed eyes, but analysts see a more even comparison with Biogen and Eisai’s Leqembi when you dig a little deeper.

Novo Nordisk's Hemlibra rival faces another approval setback as FDA raises dosing, manufacturing questions

Three years after the FDA forced Novo Nordisk to pause a trial of its potential Hemlibra rival over reports of blood clots, the U.S. regulator has placed a further barrier in front of the drug—even as it secures approval in other territories.

Roche creates organoid research institute to shake up drug discovery and development

Roche is betting preclinical drug development is on the cusp of a major change. After tracking advances in fields including engineering and computational science, the Swiss drugmaker has set up the Institute of Human Biology (IHB) and asked its staff to collaborate with external partners to create better models.

Pfizer, Valneva push back Lyme disease vaccine filing to 2026 after cutting half of participants

Pfizer and Valneva are pushing back a regulatory filing for their Lyme disease vaccine by a year after the companies were forced to pull half of the participants from a phase 3 study in February.

Ionis' midphase misses send rare disease prospects to the abyss

Lackluster midphase efficacy data have pushed Ionis Pharmaceuticals to trim its pipeline. The antisense specialist tossed out acromegaly prospect cimdelirsen and abandoned hopes of developing sapablursen in beta thalassemia.

'Mighty mice' take flight to find bone, muscle loss treatments for humans back on Earth

After sending mice into space, researchers have discovered that blocking or removing certain proteins can prevent muscle and bone loss—findings that could potentially translate into new therapies for humans with various conditions back here on Earth. 

Beating its rivals, GSK nabs world-first approval for adult RSV vaccine Arexvy

GSK is basking in "the golden age" of vaccine development with its newest shot, an exec said. Its next step will be to turn the recent approval into actual vaccinations, Leonard Friedland, M.D., vice president and director of scientific affairs and public health at GSK vaccines, said in an interview.

Akili's therapeutic video game improves ADHD symptoms in 83% of adults: study

Though it’s currently cleared by the FDA to lessen ADHD symptoms only in children between the ages of 8 and 12, Akili Interactive’s EndeavorRx digital therapeutic may actually be even more effective among older users.

Hospital margins inch up in March as volume, revenue growth outpace expenses

Kaufman Hall reports healthier hospital operations in March but warned that underlying labor and acuity trends are still worth keeping an eye on.

ValGenesis, Mepharma partner on services for Middle East, North Africa CROs

ValGenesis, which manages digital validation and approval processes for CROs, is teaming up with Dubai-based Mepharma to provide a wider service offering for drug development and clinical trial sites in the Middle East and North Africa.

Syneos taps Michael Bonello as CFO as talk of a sale swirls

Syneos Health, a North Carolina-based CRO, has tapped Michael Bonello as its next chief financial officer, effective July 1.
 
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