Intellectual Product – Page 6

Trump Administration Teases MFN Drug Pricing Rule as Commitment Deadline Looms for Companies

3 months ago talkbio0Tagged Commitment Deadline, direct-to-consumer sales, drug price, executive order, international reference price, Medicaid, MFN, Most-Favored-Nation, Parity, pharmaceutical manufacturers, Prices, Pricing, tariffs, Transplant Registry Unified Management Program

Trump administration; Most-Favored-Nation (MFN) pricing; drug pricing; executive order; pharmaceutical manufacturers; Medicaid; direct-to-consumer sales; price parity; commitment deadline; tariffs; international reference price

Trump Administration Launches Tariff Probe into Medtech and Pharmaceutical Industries

3 months ago talkbio0Tagged Evaluation, Manufacturing, Medical Devices, medtech industry, National Security, pharmaceutical imports, Sectioning technique, semiconductor tariffs, supply chain, tariffs, Transplant Registry Unified Management Program

Trump administration; tariffs; medtech industry; pharmaceutical imports; Section 232 investigation; semiconductor tariffs; national security; supply chain; manufacturing; medical devices

Sanofi Injects $625M Into Biotech Investment Arm to Accelerate Innovation

3 months ago talkbio0Tagged Cash, cell/gene therapy, digital health, expansion, Immunology, Infrequent, Infusion procedures, Investments, Neurology speciality, portfolio, sanofi, Sanofi Ventures, venture capital

Sanofi; Sanofi Ventures; biotech investment; $625M cash infusion; digital health; immunology; rare diseases; neurology; venture capital; cell/gene therapy; portfolio expansion

Biogen Plans Resubmission After FDA Declines High-Dose Spinraza for SMA, Requests More Production Information

3 months ago talkbio0Tagged Biogen, Candidiasis, Chronic Mucocutaneous, Complete, controls, High dose, Manufacturing, New Drug Application, nusinersen, regulatory, Response Letter, resubmission, Science of Chemistry, Spinal Muscular Atrophy, Spinraza, United States Food and Drug Administration

Biogen; Spinraza; nusinersen; high dose; FDA; Complete Response Letter; spinal muscular atrophy; SMA; supplemental New Drug Application; Chemistry Manufacturing and Controls; CMC; regulatory; resubmission

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

3 months 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

3 months 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

3 months 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

3 months 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

3 months 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

3 months 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