September 2025 – Page 11

AstraZeneca Pauses £200M Expansion in UK Amid Pharma Uncertainty

1 month ago talkbio0Tagged AstraZeneca, Cambridge, expansion, Investments, Pauses, Pharma, UK

AstraZeneca; UK Pharma; Investment; Cambridge; Expansion Pause

Eli Lilly Pauses UK Biotech Incubator Plans Amid Concerns Over NHS Drug Pricing

1 month ago talkbio0Tagged Biological Science Disciplines, biotech incubator, biotech industry, Eli, Eli Lilly, Gateway Labs, Government, Investments, Nance-Horan syndrome, Pauses, pharmaceutical innovation, UK

Eli Lilly; Gateway Labs; UK biotech incubator; pause; investment; NHS drug spending; life sciences; biotech industry; government funding; pharmaceutical innovation

Eli Lilly Loses Appeal to Overturn $183.7 Million Medicaid Rebate Judgment

1 month ago talkbio0Tagged appeal, Circuit, court, drug price, eli lilly, False Claims Act, Fraud, judgment, Medicaid, Positive

Eli Lilly; Medicaid; rebate; court ruling; False Claims Act; drug pricing; whistleblower; 7th Circuit Court of Appeals; fraud; $183.7 million judgment

FibroGen Settles with SEC for $1.25M Over Roxadustat Data Tampering Allegations

1 month ago talkbio0Tagged Anemia, cardiovascular safety, Clinical Trials, data manipulation, FibroGen, Kin-Hung Peony Yu, Phase 3, roxadustat, seconds, settlement, United States Food and Drug Administration

FibroGen; SEC; roxadustat; data manipulation; settlement; Kin-Hung Peony Yu; phase 3 clinical trial; anemia drug; cardiovascular safety; FDA

Capsida Suspends Gene Therapy Trial After First Patient Death

1 month ago talkbio0Tagged CAP-002, Capsida Biotherapeutics, Clinical Trial Suspension, Encephalopathies, gene therapy, Patient Death, STXBP1 gene, United States Food and Drug Administration

Capsida Biotherapeutics; gene therapy; CAP-002; clinical trial suspension; STXBP1 encephalopathy; patient death; FDA

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

1 month 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

LB Pharmaceuticals Upsizes IPO to $285M, Marks First Major Biotech Listing in Months

1 month ago talkbio0Tagged IPO, IPOs, LBRX, Nasdaq, Phase III, Pounds, public entity, Schizophrenia

LB Pharmaceuticals; IPO; biotech; $285 million; LBRX; schizophrenia; Phase III; public offering; Nasdaq; 2025 biotech IPOs

Intercept Withdraws Ocaliva from US Market After FDA Safety Concerns

1 month ago talkbio0Tagged Clinical Trials, concerns, Drug withdrawal syndrome, Injury of liver, Intercept Pharmaceuticals, Liver diseases, Ocaliva, Primary Biliary Cholangitis, regulatory setbacks, Safety, United States Food and Drug Administration

Intercept Pharmaceuticals; Ocaliva; liver disease; primary biliary cholangitis; FDA; drug withdrawal; safety concerns; liver injury; clinical trial hold; regulatory setbacks

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

FDA Begins Publishing Complete Response Letters for Ongoing Drug Applications in Real Time

1 month ago talkbio0Tagged Application procedure, drug applications, openFDA, public health medicine (field), radical transparency, real-time disclosure, regulatory transparency, Response Letters, United States Food and Drug Administration

FDA; complete response letters; real-time disclosure; drug applications; radical transparency; pending applications; regulatory transparency; public health; openFDA