Aldeyra receives inevitable FDA rejection

Today’s Big News

Nov 28, 2023

Acelyrin points to CRO error that could explain shocking phase 3 failure


Merck strides onto Pfizer’s turf, posting pivotal vaccine data and heading to regulators


With FDA’s inevitable rejection in hand for eye drug, Aldeyra plans speedy new trial


BMS, Avidity add another link to cardiovascular partnership with $100M expansion


Boehringer plugs in IBM-trained AI model to boost antibody drug discovery efforts


CAR-Ts targeting a 'special' solid tumor antigen work well in some mouse models, but challenges remain


Candel’s flame dims as cash crunch spurs layoffs to half of the company


Lilly to build new pearly Gate(way) in sunny San Diego as third accelerator site selected

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Featured

UPDATE: Acelyrin points to CRO error that could explain shocking phase 3 failure

Acelyrin sent a chill rippling through the IPO market in September when its phase 3 clinical trial unexpectedly failed. But now the company says some errors by the contract research organization running the study may have been to blame.
 

Top Stories

Merck strides onto Pfizer’s turf, posting pivotal vaccine data and heading to regulators

Merck & Co. has revealed data from a phase 3 trial designed to knock Pfizer’s pneumococcal vaccine off its perch. The vaccine candidate matched Prevnar 20 for shared serotypes and performed better for 10 of its 11 unique serotypes, positioning Merck to file for approvals around the world.

With FDA’s inevitable rejection in hand for eye drug, Aldeyra plans speedy new trial

Aldeyra Therapeutics had prepared for the worst and now it's here. The FDA has rejected the dry eye drug reproxalap.

Ethical, Regulatory, and Operational Considerations for Cell and Gene Therapy Research in Children

Pediatric CGT trials have the potential to cure diseases and prolong lives. Discover steps to protect safety and enhance operations in your CGT trials.

BMS, Avidity add another link to cardiovascular partnership with $100M expansion

Bristol Myers Squibb seems to have found a friend in Avidity Biosciences, as the two add a second link to a heart-focused research partnership for $100 million upfront.

Boehringer plugs in IBM-trained AI model to boost antibody drug discovery efforts

Boehringer Ingelheim will harness an artificial intelligence model trained in the computer labs of IBM as the German drugmaker becomes the latest Big Pharma to apply machine learning tools to its drug discovery efforts.

CAR-Ts targeting a 'special' solid tumor antigen work well in some mouse models, but challenges remain

A new study in mice has found that CAR-Ts targeting a common solid tumor antigen, GRP78, work well in some cases, but an unusual resistance pattern must be overcome for broader efficacy.

Candel’s flame dims as cash crunch spurs layoffs to half of the company

Candel Therapeutics is taking difficult measures to keep its clinical flame burning, laying off 50% of its team as part of a wide scale restructuring meant to save cash for a couple of core programs. 

Lilly to build new pearly Gate(way) in sunny San Diego as third accelerator site selected

Eli Lilly is set to open its third Gateway Labs location, this time in San Diego. The accelerator-like space with allow local biotechs and researchers to tap into Lilly's expertise and burgeoning pocketbook.

Pharma's Q3 growth rankings: GLP-1 drugs from Eli Lilly, Novo Nordisk were once again the big story

It was the second straight quarter where the overwhelming success of blood sugar regulating treatments were the dominant story in the biopharma industry. Eli Lilly and Novo Nordisk delivered the highest revenue gains, at 38% and 29%, respectively.

Imaging AI hogs the spotlight at RSNA, with debuts from GE, Siemens, Philips

Companies such as GE HealthCare, Siemens Healthineers, Philips and Hologic aim to keep the momentum in AI going at the annual radiology and digital imaging meeting.

Ardent Health Services hit with ransomware attack, forcing hospitals in multiple states to divert ambulances

Hospitals in multiple states have been forced to divert ambulances and reschedule some elective procedures after U.S. hospital owner Ardent Health Services was hit with a ransomware attack.

FDA approves Pfizer spinout SpringWorks' Ogsiveo as first treatment for disfiguring rare tumor type

Patients with ultra-rare desmoid tumors now have an FDA-approved treatment, thanks to a drug made by SpringWorks Therapeutics, which spun out of Pfizer in 2017 with a portfolio of rare disease candidates.
 
Fierce podcasts

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Alzheimer’s breakthroughs, Leqembi's potential and what's next

This episode of "The Top Line" is dedicated to Alzheimer’s disease, spotlighting the latest treatments and what lies ahead. Fierce Pharma's Fraiser Kansteiner discusses Leqembi's full approval with Eisai's Alexander Scott. Annalee Armstrong from Fierce Biotech interviews Alzheimer's expert Howard Fillit, M.D., exploring groundbreaking research. Fierce Pharma’s Eric Sagonowsky speaks with Reisa Sperling, M.D., about Leqembi's potential in preventing Alzheimer’s progression before symptoms emerge.

 

Resources

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Accelerate drug discovery with high-performance computing (HPC) powered by the cloud

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Effective Technology Transfers for Mammalian-Derived Biologics

As a leader of technology transfer activities in the industry, Lonza understands the challenges associated with this critical step. Download this White Paper today to learn more. 

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An Introduction to Organ-on-a-Chip Technology

Emulate in vivo biology with next-generation in vitro technology.
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Overcome Challenges and Secure Successful Technology Transfers of Complex Biological Products in Sterile Manufacturing

A critical area to consider in selecting a CDMO is their ability to successfully complete technology transfers, which involves an intricate set of activities and disciplines that, if done incorrectly, could result in delays and failures that impact the overall success of your end product. Recognizing what it takes to complete this process effectively and efficiently is crucial to selecting the best partner for your project and product needs. This white paper delivers an analysis of critical success factors for effective technology transfer.
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Enhance the cost-effectiveness of your GMP chemical supply chain

Learn how to develop a high-performing supply chain for cGMP chemicals used throughout your bioprocessing workflows.
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Plasmid DNA Design Considerations for Cell and Gene Therapy

Download our whitepaper to learn about plasmid DNA design considerations for cell and gene therapy applications.
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Artificial Intelligence in Healthcare & Medical Affairs

This paper explores AI’s potential impact on healthcare and on Medical Affairs (MA) more specifically. It also outlines what MA teams can do now to proactively leverage AI to improve service to their stakeholders.
 

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