Intellectual Product

American Academy of Pediatrics; AAP; COVID-19 vaccine; children; CDC; Robert F. Kennedy Jr.; pediatric immunizations; public health guidance; vaccine policy

Tariffs and MFN Policy Power a Broad, Confusing Pharma War

4 days ago talkbio0Tagged Drug Industry, drug manufacturing, Drug Prescriptions, Medicaid, MFN, Nation, onshoring, pharma innovation, Policy, Trump administration

tariffs; Most Favored Nation (MFN) policy; prescription drug pricing; pharmaceutical industry; Trump administration; drug manufacturing; onshoring; Medicaid; pharma innovation

Federal Appeals Court Overturns FDA Rejection of Vanda’s Hetlioz for Jet Lag Disorder

5 days ago talkbio0Tagged Clinical Trials, Evidence, Federal Appeals Court, Hetlioz, jet lag disorder, New Drug Application, regulatory law, sNDA, United States Food and Drug Administration, Vanda Pharmaceuticals

Vanda Pharmaceuticals; Hetlioz; FDA; jet lag disorder; Federal Appeals Court; supplemental New Drug Application (sNDA); regulatory law; clinical trial evidence

Reunion Psychedelic Therapy Advances to Pivotal Trials after Postpartum Depression Success

5 days ago talkbio0Tagged Clinical Trials, Depression, Postpartum, Montgomery-Åsberg Depression Rating Scale, Montgomery-Asberg Depression Rating Scale Questionnaire, Neuroscience discipline, Phase 2 Clinical Trials, Phase 3 Clinical Trials, psychedelic therapy, RE104, RECONNECT, remission rates, Reunion

Reunion Neuroscience; RE104; psychedelic therapy; postpartum depression (PPD); Phase II trial; Phase III trial; RECONNECT trial; clinical trial results; Montgomery-Åsberg Depression Rating Scale (MADRS); remission rates

Precigen Receives FDA Approval for First Immunotherapy for HPV-Related Recurrent Respiratory Papillomatosis

1 week ago talkbio0Tagged Adenovirus Vector, Approved, Episodic, gene therapy, human papillomavirus, Identifier, Immunotherapy, Papzimeos, Precigen, Recurrent respiratory papillomatosis, RRP, United States Food and Drug Administration, zopapogene imadenovec-drba

Precigen; FDA approval; Papzimeos; zopapogene imadenovec-drba; HPV; recurrent respiratory papillomatosis (RRP); immunotherapy; gene therapy; adenoviral vector; Breakthrough Therapy designation

US to Stockpile Critical Drug Ingredients Under Latest Trump Executive Order

1 week ago talkbio0Tagged ASPR, domestic manufacturing, drug ingredients, essential medicines, executive order, National Security, Pharmaceutical Ingredients Reserve, Pharmaceutical Supply Chain, strategic, Transplant Registry Unified Management Program

Trump; Executive Order; drug ingredients; pharmaceutical supply chain; Strategic Active Pharmaceutical Ingredients Reserve; ASPR; domestic manufacturing; national security; essential medicines

Eli Lilly Vows Vigorous Defense as Texas Sues Over Alleged Drug Kickbacks

2 weeks ago talkbio0Tagged Drug Prescriptions, eli lilly, Free Nurse Program ', Glucagon-Like Peptide 1, Ken Paxton, kickback scheme, Medicaid fraud, Mounjaro, pharmaceutical litigation, Support Services Program, Texas, Zepbound

Eli Lilly; Texas Attorney General; kickback scheme; drug prescriptions; Mounjaro; Zepbound; GLP-1 drugs; Medicaid fraud; Free Nurse Program; Support Services Program; Ken Paxton; pharmaceutical litigation