Weeks before the US #FDA decision on MOV, numerous scientists identified issues with Merck’s statistical analyses, the risks posed to individual patients, and the risks for viral evolution.
Sally Otto and I explained the viral evolution risk here. 6/12 https://virological.org/t/mutagenic-antivirals-the-evolutionary-risk-of-low-doses/768
Lilly drug slows Alzheimer’s decline in large study —FDA encourages decentralized trials with new guidance — Masimo suit against Apple over smartwatch trade secrets ends in mistrial -- See more on our front page news http://bit.ly/w28kSd #alzheimers #fda #elililly #clinicaltrials #legal #apple #masimo #tradesecrets #smartwatch #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
#alzheimers #FdA #elililly #clinicaltrials #legal #apple #masimo #tradesecrets #smartwatch #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
Astellas to acquire eye drug developer Iveric Bio for $5.9B —With negative FDA panel vote, AstraZeneca's Lynparza looks set for narrow nod in prostate cancer—Otsuka, Lundbeck gain FDA nod for longer-acting version of schizophrenia drug Abilify -- See more on our front page news http://bit.ly/w28kSd #astellas #mergersandacquisitions #eyehealth #fda #prostatecancer #astrazeneca #abilify #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
#astellas #mergersandacquisitions #eyehealth #FdA #ProstateCancer #astrazeneca #abilify #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
Amgen cuts lupus programs for futility, hours after Lilly officially walks away from one too —FDA sent letter to HCPs warning of cybersecurity risk in Illumina sequencing software—GSK's RSV vaccine first to get EU regulator's nod -- See more on our front page news http://bit.ly/w28kSd #fda #amgen #lupus #elililly #hcps #cybersecurity #illumina #rsv #gsk #europe #vaccines #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
#FdA #amgen #lupus #elililly #HCPs #cybersecurity #illumina #RSV #gsk #europe #vaccines #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
FDA approves first oral microbiome therapy Vowst —EU publishes proposed drug laws overhaul, setting up tussle with industry—Lilly drug Mounjaro succeeds in second weight loss study -- See more on our front page news http://bit.ly/w28kSd #fda #microbiome #eu #europe #pharmaindustry #elililly #obesity #mounjaro #clinicaltrials #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
#FdA #microbiome #eu #europe #pharmaindustry #elililly #obesity #mounjaro #clinicaltrials #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
FDA rejects Teva’s high-potency biosimilar of Humira again — After a record run, fewer biotechs are going public— Sarepta shares drop as report says FDA almost rejected under-review gene therapy -- See more on our front page news http://bit.ly/w28kSd #tevapharma #fda #humira #abbvie #biosimilars #ipos #genetherapy #sarepta #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
#tevapharma #FdA #humira #abbvie #biosimilars #ipos #genetherapy #sarepta #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
Moderna announces new vaccine candidates against Lyme disease and norovirus — Merck KGaA's multiple sclerosis drug hit with partial FDA hold — Sanofi, AstraZeneca and Sobi simplify Beyfortus agreements ahead of US launch -- See more on our front page news http://bit.ly/w28kSd #moderna #vaccines #mrna #lymedisease #norovirus #ms #multiplesclerosis #merckkgaa #fda #sanofi #rsv #astrazeneca #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
#moderna #vaccines #mrna #lymedisease #norovirus #ms #multiplesclerosis #merckkgaa #FdA #Sanofi #RSV #astrazeneca #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
Sanofi's Provention buyout hit with FTC delay. Will Pfizer's Seagen deal go off as planned? — Biopharma rallies behind FDA after Texas abortion pill ruling — Moderna sees up to $15 bln in respiratory vaccine sales in 2027 -- See more on our front page news http://bit.ly/w28kSd #mergersandacquisitions #ftc #antitrust #sanofi #pfizer #fda #abortionpill #moderna #vaccines #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
#mergersandacquisitions #FTC #antitrust #Sanofi #pfizer #FdA #abortionpill #moderna #vaccines #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
“If courts can overturn drug approvals without regard for science or evidence,” the letter said, “or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone.” #FdA #AbortionRights #VoteBlue
#FdA #AbortionRights #VoteBlue
Q1 claimed the highest number of trial starts in 2022 — AbbVie knocks down earnings forecast due to IPR&D charge — FDA forces unproven premature birth drug Makena off market -- See more on our front page news http://bit.ly/w28kSd #abbvie #researchanddevelopment #fda #makena #pretermbirth #clinicaltrials #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
#abbvie #researchanddevelopment #FdA #makena #PretermBirth #clinicaltrials #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
FDA approves Keytruda/Padcev combo in advanced urothelial cancer — Record growth in U.S. life sciences real estate footprint — Diabesity drugs and their free ‘contract sales force’ -- See more on our front page news http://bit.ly/w28kSd #fda #merck #astellas #urothelialcancer #realestate #diabetes #obesity #novonordisk #elililly #keytruda #lifesciences #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
#FdA #merck #astellas #urothelialcancer #realestate #diabetes #obesity #novonordisk #elililly #keytruda #lifesciences #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
SUPER IMPORTANT FOR U.S. FOLKS:
The FDA has just announced that Narcan (naloxone) nasal spray is now approved for nonprescription over-the-counter (OTC) use.
J&J bows out of RSV vaccine race after scrapping trial — FDA lifts partial hold on Blueprint's CDK2 inhibitor — Pressure is building on pharma and biotech companies to take climate action -- See more on our front page news http://bit.ly/w28kSd #jnj #rsv #vaccines #clinicaltrials #fda #climatechange #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
#jnj #RSV #vaccines #clinicaltrials #FdA #climatechange #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
Novartis' Kisqali cuts recurrence risk in early-stage breast cancer — BioNTech's COVID-19 vaccine revenue forecasts lower than expected— BrainStorm secures FDA adcomm for ALS therapy NurOwn -- See more on our front page news http://bit.ly/w28kSd #novartis #breastcancer #biontech #vaccines #earnings #als #fda #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
#novartis #breastcancer #biontech #vaccines #earnings #ALS #FdA #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
AbbVie clinches back-to-back clinical wins in ulcerative colitis, lupus — Biotech startups face ‘Series A cliff’ as venture capital stays cautious— Incyte hit by CRL on extended-release JAK tablets -- See more on our front page news http://bit.ly/w28kSd #abbvie #ulcerativecolitis #lupus #startups #funding #venturecapital #seriesa #seriesb #fda #completeresponseletter #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
#abbvie #ulcerativecolitis #lupus #Startups #funding #VentureCapital #seriesa #SeriesB #FdA #completeresponseletter #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
FDA Works to Further Improve #Nutrition, Reduce Diet-Related Chronic Disease with Dietary Guidance Statements on Food Labels
https://content.govdelivery.com/accounts/USFDA/bulletins/350bb0a
Corporate food manufacturers are going to fight this with all the lobbyist money they can muster
#nutrition #food #foodpolitics #FdA
FDA's Peter Marks backs accelerated approval for gene therapies — Return of the megaround: is biotech back from the brink?— The rise, fall and future of Novavax -- See more on our front page news http://bit.ly/w28kSd #fda #acceleratedapprovals #venturecapital #funding #novavax #vaccines #covid19 #genetherapy #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
#FdA #acceleratedapprovals #VentureCapital #funding #Novavax #vaccines #covid19 #genetherapy #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
Will Sanofi and Regeneron's Dupixent be a game-changer for COPD? — Amazon closes blockbuster deal with One Medical— FDA's Robert Califf calls on insurers to help providers participate in critical clinical drug trials -- See more on our front page news http://bit.ly/w28kSd #sanofi #regeneron #copd #amazon #fda #clinicaltrials #robert califf #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
#Sanofi #regeneron #copd #amazon #FdA #clinicaltrials #Robert #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
Alzheimer's Association campaigns for broader Leqembi coverage — FDA reverses course; will hold adcomm for Sarepta’s DMD gene therapy— Pfizer and Astellas report positive data from prostate cancer therapy trial -- See more on our front page news http://bit.ly/w28kSd #alzheimers #eisai #biogen #fda #dmd #duchenne #pfizer #astellas #clinicaltrials #prostatecancer #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
#alzheimers #eisai #biogen #FdA #dmd #Duchenne #pfizer #astellas #clinicaltrials #ProstateCancer #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
Duchenne muscular dystrophy: major trials and events to watch in 2023 — Biogen gets EU court ruling in favor of blocking Tecfidera generic entry— FDA offers radio silence on question of spring Covid boosters -- See more on our front page news http://bit.ly/w28kSd #dmd #duchenne #fda #clinicaltrials #europe #generics #biogen #multiplesclerosis #ms #covid #covid19 #vaccines #boosters #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
#dmd #Duchenne #FdA #clinicaltrials #europe #generics #biogen #multiplesclerosis #ms #covid #covid19 #vaccines #boosters #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma