Cafepharma Today

May 9 2025 - FDA chief Martin Makary sets June deadline for genAI rollout

FDA chief Martin Makary sets June deadline for genAI rollout
FDA misses another approval decision target date, this time for GSK's Nucala in COPD
4 more biotechs cut staff amid market tumult
AZ plots wider Imfinzi use in bladder cancer after trial win
*please scroll down for all the latest news *

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FDA chief Martin Makary sets June deadline for genAI rollout
Clinical Trials Arena
Friday, May 9, 2025 - 9:41am
tags:
FDA, Marty Makary, artificial intelligence, genAI
FDA layoffs could slow safety communications, experts warn
BioPharma Dive
Friday, May 9, 2025 - 9:39am
tags:
FDA, regulatory, drug safety, layoffs, recalls
FDA misses another approval decision target date, this time for GSK's Nucala in COPD
Fierce Pharma
Friday, May 9, 2025 - 9:36am
tags:
FDA, HHS, GSK, COPD, Nucala, regulatory, drug approvals
4 more biotechs cut staff amid market tumult
BioPharma Dive
Friday, May 9, 2025 - 9:35am
tags:
Vor Bio, Korro Bio, Insitro, Rallybio, biotech, layoffs
Qilu Pharmaceutical pays $38M upfront for greater China rights to Minghui's ADC
Fierce Biotech
Friday, May 9, 2025 - 9:32am
tags:
Qilu Pharmaceutical, China, Minguhui Pharmaceutical
Moderna’s flu-COVID vaccine beats standard shots
Beckers Hospital Review
Friday, May 9, 2025 - 9:30am
tags:
Moderna Therapeutics, MRNA, vaccines, flu-COVID combo vaccines, COVID-19, clinical trials
Leo tames eczema in phase 2b, reporting primary endpoint hit for ex-argenx asset
Fierce Biotech
Friday, May 9, 2025 - 9:26am
tags:
LEO Pharma, eczema, temtokibart, clinical trials
Johnson & Johnson (JNJ) reports Icotrokinra results show significant skin clearance in patients with difficult-to-treat scalp and genital psoriasis
Marketscreener
Friday, May 9, 2025 - 8:59am
tags:
JNJ, clinical trials, icotrokinra, psoriasis
US, UK reach deal on tariffs, market access
Medtech Dive
Friday, May 9, 2025 - 8:37am
tags:
tariffs, Donald Trump, UK
AZ plots wider Imfinzi use in bladder cancer after trial win
Pharmaphorum
Friday, May 9, 2025 - 8:30am
tags:
AstraZeneca, Imfinzi, bladder cancer, clinical trials
Sanofi axes IGM pact, sparking 80% layoffs at the biotech and facility closures
Fierce Biotech
Friday, May 9, 2025 - 8:28am
tags:
Sanofi, IGM Biosciences, layoffs
In first oncology expert meeting under Makary, FDA spotlights cancer drugs from J&J, Pfizer, Roche and UroGen
Fierce Pharma
Thursday, May 8, 2025 - 10:56pm
tags:
FDA, Richard Pazdur, Marty Makary, cancer, oncology, JNJ, Pfizer, Roche, Urogen
Accelerated FDA Approval Makes Verastem Drug the First Therapy for Rare Type of Ovarian Cancer
MedCity News
Thursday, May 8, 2025 - 10:54pm
tags:
Verastem Oncology, ovarian cancer, KRAS mutation, FDA
Illumina outlines $4.18B to $4.26B guidance for 2025 amid China headwinds and strategic cost reductions
MSN/Seeking Alpha
Thursday, May 8, 2025 - 10:51pm
tags:
Illumina, Medtech, earnings, China
Sanofi exec tells biotechs not to scrimp on clinical trial design
Clinical Trials Arena
Thursday, May 8, 2025 - 10:47pm
tags:
Sanofi, biotech, clinical trials, clinical trial design
$1.8 billion in NIH grant cuts hit minority health research the hardest
Science News
Thursday, May 8, 2025 - 10:45pm
tags:
NIH, federal grant, R&D, Donald Trump
Viatris’ new form of old pain drug scores in large trials
BioPharma Dive
Thursday, May 8, 2025 - 10:42pm
tags:
Viatris, post surgical pain, meloxicam, clinical trials
J&J survey finds pace of oncology innovation is overwhelming physicians
Fierce Pharma
Thursday, May 8, 2025 - 11:17am
tags:
JNJ, oncology, oncologists, physicians, innovation
Novavax sales jump 600% YoY as COVID-19 vaccine still in limbo at FDA
BioSpace
Thursday, May 8, 2025 - 11:14am
tags:
Novavax, earnings, vaccines, COVID-19
Biotech is guessing how Vinay Prasad might change the FDA. His research, writing offer clues.
BioPharma Dive
Thursday, May 8, 2025 - 11:11am
tags:
FDA, CBER, Vinay Prasad

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