Idea or Concept – Page 2

FDA Delays Decision on KalVista’s HAE Drug Sebetralstat, Citing Heavy Workload

1 month ago talkbio0Tagged Angioedemas, Hereditary, constraints, Deferred, Drug Approval, KalVista, on-demand, Oral cavity, PDUFA, Resources, Sebetralstat, United States Food and Drug Administration

KalVista Pharmaceuticals; sebetralstat; FDA delay; hereditary angioedema; resource constraints; PDUFA date; drug approval; oral on-demand treatment

Insmed’s ‘Unprecedented’ Phase 2 PAH Results Propel Stock and Next-Phase Plans

1 month ago talkbio0Tagged Clinical Trials, Insmed, PAH, Phase 3 trial, Pulmonary arterial hypertension, surge, TPTE2 gene, treprostinil palmitil inhalation powder

Insmed; PAH; TPIP; Phase 2b; clinical trial; treprostinil palmitil inhalation powder; stock surge; pulmonary arterial hypertension; Phase 3 trial; biotech

23andMe to Restart Auction After Former CEO Anne Wojcicki Outbids Regeneron

2 months ago talkbio0Tagged Anne Wojcicki, asset, auction, Bankruptcy, Regeneron, Sales - occupational activity, Science of genetics, TTAM

23andMe; auction; Anne Wojcicki; Regeneron; TTAM Research Institute; bankruptcy; asset sale; genetics

Ex-HHS Workers Accuse Trump Administration of Using Flawed Data to Justify Mass Firings

2 months ago talkbio0Tagged Agencies, CHARGE Syndrome, disability services, firings, Medicare, Project, public servants, Trump administration

HHS firings; Trump administration; federal workforce; flawed data; Project 2025; agency cuts; disability services; Medicare; public servants

RFK Jr. Ends CDC Covid Vaccine Recommendations for Healthy Children and Pregnant Women

2 months ago talkbio0Tagged Centers for Disease Control and Prevention (U.S.), CHARGE Syndrome, Child, COVID19 (disease), Pregnant Women, public health policy, Recommendation, RFK Jr., Secretary, Vaccines

RFK Jr.; COVID-19 vaccine; recommendations; children; pregnant women; CDC; HHS Secretary; public health policy

Uncertainty Surrounds Moderna’s Next-Generation COVID Shot Amid Policy Changes

2 months ago talkbio0Tagged COVID19 (disease), flu/COVID-19, Moderna, Policy, Recommendation, Regulatory Setback, United States Food and Drug Administration, vaccine access, Vaccines

Moderna; COVID-19 vaccine; FDA policy; combination flu/COVID-19 shot; vaccine access; mRNA-1083; vaccine recommendations; regulatory setback

Vinay Prasad’s First Major Policy: Challenging Covid Vaccine ‘Dogma’ at FDA

2 months ago talkbio0Tagged Clinical Trials, COVID19 (disease), Policy, Prasad, public health medicine (field), Recommendation, Regulatory Framework, United States Food and Drug Administration, Vaccines, Vinay

Vinay Prasad; FDA; Covid-19 vaccines; policy change; clinical trials; vaccine recommendations; public health; regulatory framework

‘Go ahead and do it’: Top RFK Jr. Deputy Dares Drugmakers Over Threats to Pull Manufacturing Amid Price Pressure

2 months ago talkbio0Tagged Big Pharma, Calley Means, CHARGE Syndrome, Drug Industry, drug price, executive order, HHS, Manufacturing, Prices, RFK Jr., Roche (company), threat

RFK Jr.; drug pricing; Calley Means; HHS; pharmaceutical industry; manufacturing threats; Roche; executive order; price limits; Big Pharma

Regeneron to Acquire 23andMe Out of Bankruptcy for $256 Million

2 months ago talkbio0Tagged Acquisition, Bankruptcy, data privacy, Genetic testing for cancer risk, Genome, personal genome service, Purchased Services, Clinical and Biomedical, Research, Regeneron, total health

Regeneron; 23andMe; acquisition; bankruptcy; genetic testing; genome; personal genome service; total health; research services; data privacy

Novo Nordisk CEO Departs Amid Weight-Loss Drug Market Pressures; Flagship Biotech Appoints CEO from Scholar Rock

2 months ago talkbio0Tagged Appointments, biotech, CEO, Challenge, departure - ActRelationshipType, Eli Lilly competition, Flagship, Lars Fruergaard Jørgensen, Market, Nordisk, Obesity, Scholar Rock

Novo Nordisk; CEO departure; Lars Fruergaard Jørgensen; obesity drugs; weight-loss market; Eli Lilly competition; market challenges; Flagship Biotech; CEO appointment; Scholar Rock