Conceptual Entity

AnaptysBio Announces Strategic Business Split to Create Two Public Companies, Sharpening Asset Focus

3 weeks ago talkbio0Tagged AnaptysBio, asset, biopharmaceutical development, business split, Immunology, Imsidolimab, Jemperli, public companies, restructuring, royalty management

AnaptysBio; business split; royalty management; biopharmaceutical development; Jemperli; imsidolimab; public companies; immunology treatments; asset value; restructuring

AstraZeneca Plans Direct US Stock Listing While Maintaining UK Headquarters

4 weeks ago talkbio0Tagged American Depositary Receipts, AstraZeneca, Capital Markets, Drug Industry, headquarters, London, Nasdaq Stockholm, NYSE, shareholders, Stock exchange, U.S., UK

AstraZeneca; US stock listing; NYSE; London Stock Exchange; Nasdaq Stockholm; American Depositary Receipts; capital markets; pharmaceutical industry; shareholders; UK headquarters

FDA Issues Warning Letter to J&J Subsidiary Over Stopper Issues and Quality Reporting at Korean Plant

1 month ago talkbio0Tagged Cautionary Warning, Incheon, Janssen Vaccines, Johnson & Johnson, Korean language, pharmaceutical manufacturing, Plants, production, quality control violations, spotty complaint reporting, United States Food and Drug Administration, vial stopper defects

FDA warning letter; Johnson & Johnson subsidiary; Janssen Vaccines; Korean production plant; vial stopper defects; quality control violations; spotty complaint reporting; good manufacturing practices; Incheon; pharmaceutical manufacturing

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

1 month 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

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

Lundbeck Offloads Assets to Three Partners as It Exits 27 Markets, Leaving 602 Jobless

2 months ago talkbio0Tagged asset, Exit, Lundbeck, Market, neuro-rare diseases, neuro-specialty diseases, NewBridge Pharmaceuticals, offloading, partnerships, restructuring, Swixx Group, Zuellig Pharma

Lundbeck; market exit; asset offloading; partnerships; job cuts; Swixx Group; Zuellig Pharma; NewBridge Pharmaceuticals; restructuring; neuro-rare diseases; neuro-specialty diseases

FDA restricts bluebird bio’s Skysona to CALD patients without suitable stem cell donors after higher blood cancer risk emerges

3 months ago talkbio0Tagged boxed, CALD, Cautionary Warning, Cerebral Adrenoleukodystrophy, Donor person, Elivaldogene autotemcel, gene therapy, Hematologic Neoplasms, HLA Match, label update, Leukemia, Myelocytic, Acute, MYELODYSPLASTIC SYNDROME, Safety, Skysona, United States Food and Drug Administration

FDA; bluebird bio; Skysona; elivaldogene autotemcel; eli-cel; cerebral adrenoleukodystrophy; CALD; hematologic malignancies; myelodysplastic syndrome (MDS); acute myeloid leukemia (AML); boxed warning; label update; postmarketing safety; HLA-matched donor; gene therapy safety

FDA tightens Skysona label, restricting use to CALD patients without alternative options due to increased blood cancer risk

3 months ago talkbio0Tagged boxed, CALD, Cautionary Warning, Cerebral Adrenoleukodystrophy, Elivaldogene autotemcel, gene therapy, Hematologic Neoplasms, HLA‑matched donor, labeling changes, Leukemia, Myelocytic, Acute, MYELODYSPLASTIC SYNDROME, Safety, Skysona, United States Food and Drug Administration

FDA; bluebird bio; Skysona; elivaldogene autotemcel; labeling changes; boxed warning; hematologic malignancy; myelodysplastic syndrome; acute myeloid leukemia; cerebral adrenoleukodystrophy; CALD; HLA‑matched donor; gene therapy safety; post‑marketing reports

Amid MFN Talks, Lilly Chief Warns US Adoption of International Drug Prices Could Bring ‘Worst of Two Worlds’

3 months ago talkbio0Tagged Cautionary Warning, Chief, Does speak, Drug Industry, drug price, Eli Lilly, International Drug Prices, MFN, Policy, U.S.

Lilly chief; MFN talks; international drug prices; US drug pricing; pharmaceutical industry; policy warning