Geographic Area – Talk Bio

AbbVie Extends Rinvoq Exclusivity to 2037, Delaying Generics in U.S.

5 days ago talkbio0Tagged AbbVie, exclusivity extension, Generic competition, Market, Patent Settlement, pharmaceutical litigation, Rinvoq, U.S., upadacitinib

AbbVie; Rinvoq; patent settlement; generic competition; exclusivity extension; upadacitinib; US market; pharmaceutical litigation

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

6 days 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

7 days 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

Regeneron and Sandoz Settle Eylea Biosimilar Patent Dispute

1 week ago talkbio0Tagged Approved, Biosimilars, Enzeevu, Eylea, launch, Ophthalmology specialty, Patent Settlement, Regeneron, sandoz, United States, United States Food and Drug Administration

Regeneron; Sandoz; Eylea; Enzeevu; biosimilar; aflibercept; patent settlement; FDA approval; U.S. launch; ophthalmology

Junshi Biosciences Announces Phase 3 Win for IL-17A Drug JS005 in Psoriasis, Prepares China NDA Submission

1 week ago talkbio0Tagged Biosciences, China, clinical endpoints, Drug Approval, IL-17A monoclonal antibody, JS005, Junshi, Psoriasis

Junshi Biosciences; JS005; IL-17A monoclonal antibody; psoriasis; phase 3 trial; clinical endpoints; China drug approval

BioNTech and DualityBio Achieve Phase 3 Success with ADC Therapy for HER2-Positive Breast Cancer, Advancing Oncology Pipeline

1 week ago talkbio0Tagged Antibody-Drug Conjugates, BioNTech, DualityBio, HER2-positive carcinoma of breast, Market, Oncology Pipeline, pamirtecan, Phase 3 trial, Progression-Free Survival, trastuzumab

BioNTech; DualityBio; antibody-drug conjugate (ADC); HER2-positive breast cancer; trastuzumab pamirtecan; BNT323/DB-1303; phase 3 trial; progression-free survival; oncology pipeline; ADC market