Alzheimer's trial flops at Annovis

Today’s Big News

Apr 29, 2024

Japan's Ono pays $2.4B for Qinlock-maker Deciphera as biotech readies another approval run


FDA finalizes rule to bring lab-developed tests into the regulatory fold


Annovis' shares plummet 60% on another failure for lead Alzheimer's med


Pharma’s reputation falls for first time since 2018 as pandemic-era halo slips


FDA approves Abbott's dissolving stent for blocked arteries below the knee


AstraZeneca, Daiichi tout Enhertu trial win in earlier, broader HER2-low breast cancer


FDA wants to hear from you on future of advisory committee meetings

 

Featured

Japan's Ono pays $2.4B for Qinlock-maker Deciphera as biotech readies another approval run

Japan’s Ono Pharmaceutical is picking up Deciphera Pharmaceuticals for $2.4 billion, a price tag that brings both the approved cancer drug Qinlock and another candidate heading to the FDA’s desk in the coming months.
 

Top Stories

FDA finalizes rule to bring lab-developed tests into the regulatory fold

At its heart, the 528-page final rule looks to make clear that in vitro diagnostic tests are to be considered medical devices like any other.

Annovis' shares plummet 60% on another failure for lead Alzheimer's med

Annovis Bio heralded a “significantly higher rate of improvement” in patients with Alzheimer’s disease who received buntanetap, however digging a little deeper into the muddled readout suggests the trail was a failure.

Pharma’s reputation falls for first time since 2018 as pandemic-era halo slips

Pharma’s pandemic-era halo is slipping. After tracking a surge in the industry’s reputation, PatientView found patient groups soured on drugmakers somewhat last year to send pharma’s standing to its lowest level since 2020.

FDA approves Abbott's dissolving stent for blocked arteries below the knee

Abbott has returned to the field of bio-absorbable, dissolving stents, and in somewhat uncharted territory. The Esprit BTK implant aims to treat the most severe form of peripheral artery disease, a condition known as chronic limb-threatening ischemia.

AstraZeneca, Daiichi tout Enhertu trial win in earlier, broader HER2-low breast cancer

AstraZeneca and Daiichi Sankyo’s trailblazing Enhertu appears to have outdone itself. After spearheading the new HER2-low category in breast cancer treatment, Enhertu has shown it could be useful against tumors with even lower expression of the HER2 protein.

FDA wants to hear from you on future of advisory committee meetings

The U.S. FDA is planning to hold an advisory committee meeting on…well, advisory committee meetings.

Merck KGaA, Huma collab bears fruit with launch of bladder cancer patient support app

Just a few months after announcing their team-up, Merck KGaA and Huma Therapeutics have already checked off the first item on their joint to-do list.

On doorstep of approval, Merck compares V116 pneumococcal vaccine to 1983 warhorse Pneumovax 23

Five months ago, Merck revealed data that indicate its next-generation pneumococcal vaccine offers more protection for older adults than Pfizer’s market dominator Prevnar 20. Now, the company is comparing the investigational shot to its old warhorse, Pneumovax 23 (PPSV23).

Labcorp nets companion diagnostic approval for Pfizer’s hemophilia B gene therapy Beqvez

The FDA has bestowed a green light to a companion diagnostic for Pfizer’s recently approved hemophilia B gene therapy—because at a cost of $3.5 million per dose, you want to make sure it will work.

With sales still stagnant, BioMarin adds divestiture to list of options for gene therapy Roctavian

After last quarter presenting three factors necessary for a more successful launch of hemophilia A gene therapy Roctavian, BioMarin has now added a divestiture to the list of potential paths for the struggling medicine.

Regeneron, Sanofi 'Du More' Dupixent asthma ads, using humor to convey breathe better message

Regeneron and Sanofi are back with another push to show how Dupixent can help people with asthma “Du More.” The fourth generation of the campaign dials up the humor to try to connect with patients on the No. 1 driver of visits to the doctor: breathing.

Bristol Myers pays $65M to expand Repertoire of autoimmune assets

Bristol Myers Squibb is placing a $65 million bet on Repertoire Immune Medicines’ approach to resetting the immune system. The deal, which features up to $1.8 billion in future payments, gives BMS the right to collaborate with Repertoire on tolerizing vaccines for up to three autoimmune diseases.
 
Fierce podcasts

Don’t miss an episode

'The Top Line': A look at pharma revenue rankings

This week on "The Top Line," Fierce Pharma Senior Editor Eric Sagonowsky and Senior Writer Kevin Dunleavy are diving into our annual top pharma companies by revenue special report.
 

Resources

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Guidance for Biotechs Choosing Next-Gen Contract GMP/CMC Labs

Choosing the right contract lab can help drug developers accelerate their timelines and generate cost-efficiencies. For insights into what to look for when selecting a GMP/CMC lab partner read this white paper which delves into a range of factors that can support your needs in both the short-term and in planning for the future.
 

Industry Events

Drug Development Boot Camp® VIRTUAL | Spring 2024

April ‌10-11, ‌2024

On Helix

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

 

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