Strategic solutions for cost, time and quality challenges in drug development – recent developments

drug development; cost reduction; timeline acceleration; quality management; integrated CDMO/CRO models; AI in pharma; CMC optimization; clinical development efficiency; supply chain risk; biotech strategy

Biogen, Stoke Boost Epilepsy Drug’s Blockbuster Potential With Early Seizure Reduction Data

Biogen; Stoke Therapeutics; zorevunersen; Dravet syndrome; epilepsy; antisense oligonucleotide; seizure reduction; blockbuster drug; EMPEROR Phase III trial; American Epilepsy Society 2025; Jefferies analysts; natural history controls; SCN1A

German Court Blocks Merck’s Subcutaneous Keytruda Over Patent Dispute with Halozyme

Merck; Keytruda SC; Halozyme; Germany; patent infringement; preliminary injunction; Munich Regional Court; subcutaneous formulation; cancer drug; MDASE patents

Rakovina Therapeutics Announces Q3 2025 Financial Results and Corporate Update

Rakovina Therapeutics; Q3 2025; financial results; net loss; research and development expenses; AI-powered drug discovery; ATR inhibitor; CNS penetration; corporate milestones; NanoPalm joint-venture; investment conference; DTC eligibility

Whitehawk Therapeutics Appoints Margaret Dugan as Chief Medical Officer

Whitehawk Therapeutics; Margaret Dugan; Chief Medical Officer; CMO; oncology; ADC; drug development; clinical trials; Novartis; Dracen Pharmaceuticals; Schrödinger

Tessera Therapeutics Advances Gene Writing Technology with Major Funding and Strategic Partnerships

Tessera Therapeutics; Gene Writing; in vivo CAR-T; ARPA-H grant; Regeneron partnership; TSRA-196; alpha-1 antitrypsin deficiency; Lipid Nanoparticles; in vivo genome engineering; clinical trials

Pharma Faces Supreme Court Deadline as IRA Price Negotiation Takes Effect

Inflation Reduction Act; SCOTUS; drug price negotiation; AstraZeneca; Medicare; pharmaceutical lawsuits; Fifth Amendment; supreme court petition; Farxiga; Centers for Medicare & Medicaid Services; price controls