Intellectual Product – Page 3

FDA’s Move to Update GSK’s Leucovorin for Autism Raises Questions on Dose, Supply, and Data

3 weeks ago talkbio0Tagged Autistic Disorder, Clinical Data, Dosage, drug relabeling, leucovorin, Neurodegeneration Due To Cerebral Folate Transport Deficiency, SmithKline Beecham, United States Food and Drug Administration, Wellcovorin

FDA; GSK; leucovorin; Wellcovorin; autism; cerebral folate deficiency; drug relabeling; dose; supply; clinical data

Celltrion Acquires Eli Lilly’s New Jersey Manufacturing Site for $330 Million

4 weeks ago talkbio0Tagged Acquisition, Biopharmaceutical manufacturing, Biosimilars, Celltrion, Contract agreement, eli lilly, Investments, Jersey site, supply chain, US tariffs

Celltrion; Eli Lilly; New Jersey site; acquisition; biopharmaceutical manufacturing; US tariffs; contract manufacturing; supply chain; biosimilars; investment

Ionis Heads to FDA as Antisense Therapy Aces Pivotal Study in Rare Neurological Disease

4 weeks ago talkbio0Tagged access program, Alexander Disease, Antisense Oligonucleotides, Fast Track, Identifier, Improvement, Infrequent, Ionis Pharmaceuticals, nervous system disorder, orphan drug designation, Phase I – III study, Speed, United States Food and Drug Administration, Zilganersen

Ionis Pharmaceuticals; zilganersen; antisense oligonucleotide; Alexander disease; pivotal Phase I–III study; FDA Fast Track designation; rare neurological disease; expanded access program; walk speed improvement; Orphan Drug designation

bluebird bio Rebrands as Genetix Biotherapeutics Following Private Equity Buyout

1 month ago talkbio0Tagged Anemia, Sickle Cell, Bluebird Bio, Capital Partners, Carlyle, Cerebral Adrenoleukodystrophy, commercial, David Meek, DKK1 gene, execution, FDA-approved therapies, gene therapy, Genetix Biotherapeutics, Investments, Manufacturing, Private Equity, rebranding, Thalassemia

bluebird bio; Genetix Biotherapeutics; private equity buyout; Carlyle; SK Capital Partners; gene therapy; rebranding; FDA-approved therapies; David Meek; sickle cell disease; β-thalassemia; cerebral adrenoleukodystrophy; commercial execution; manufacturing investment

A Concerning Pattern: Pharma Mulls UK Divestments as Government Action Lags in Life Sciences

1 month ago talkbio0Tagged AstraZeneca, Biological Science Disciplines, drug price, drug spending, eli lilly, Government, Investments, Merck, Nance-Horan syndrome, pharmaceutical divestment, Policy, R&D, sanofi, UK

UK life sciences; pharmaceutical divestment; Merck; AstraZeneca; Sanofi; Eli Lilly; R&D investment; drug pricing; government policy; NHS drug spending

FDA Crackdown on Pharma TV Ads Targets Pfizer, Novartis, BMS, Lilly & Others

1 month ago talkbio0Tagged Burning Mouth Syndrome, Cautionary Warning, Correspondence as Topic, Crackdown, Direct-to-Consumer, drug marketing compliance, Eli Lilly, Novartis, Pfizer, pharma TV ads, provision, Sufficient, United States Food and Drug Administration

FDA crackdown; pharma TV ads; Pfizer; Novartis; BMS; Lilly; warning letters; direct-to-consumer advertising; adequate provision rule; drug marketing compliance

Hikal Receives US FDA Warning Letter Over Metal Contamination at Jigani Facility

1 month ago talkbio0Tagged adulteration, alpha 1-antitrypsin, Cautionary Warning, GMP violations, Hikal, India, Jigani Facility, Letter [Publication Type], Manufacturer, Metals, pharmaceutical manufacturing, Regulatory Compliance, United States Food and Drug Administration

Hikal; FDA warning letter; metal contamination; API manufacturer; GMP violations; Jigani facility; India; pharmaceutical manufacturing; regulatory compliance

PMV Pharma’s p53 Drug Shows Effect in Ovarian Cancer, but Financial Challenges Loom

1 month ago talkbio0Tagged cash runway, Clinical Trials, Familial mitral valve prolapse, File (record), Frequency of Responses, Funding, ovarian neoplasm, TP53 gene, United States Food and Drug Administration

PMV Pharmaceuticals; rezatapopt; p53; ovarian cancer; clinical trial; response rate; FDA filing; funding; cash runway

Trump Administration Weighs Severe Restrictions on US Pharmas Licensing Chinese Medicines

1 month ago talkbio0Tagged AstraZeneca, chinese medicine, Drug Industry, drug manufacturing, executive order, licensing restrictions, lobbying, National Security, Pfizer, Transplant Registry Unified Management Program, United States Food and Drug Administration

Trump administration; Chinese medicines; executive order; pharmaceutical industry; licensing restrictions; national security; lobbying; Pfizer; AstraZeneca; biotech; drug manufacturing; FDA review

Second MAHA Report Emphasizes Chronic Disease, Tilts at Vaccine Reform

1 month ago talkbio0Tagged childhood health, childhood vaccine schedule, Chronic disease, Commission, federal directives, Food Policy, MAHA, Prescription Drug Overuse, public health medicine (field), Robert F. Kennedy Jr., Vaccine Reform

MAHA Commission; chronic disease; vaccine reform; Robert F. Kennedy Jr.; childhood health; food policy; medication overuse; public health; federal directives; childhood vaccine schedule