Gene or Genome
Gilead Wins Groundbreaking FDA Approval for Twice-Yearly HIV Prevention Shot
Gilead; FDA approval; lenacapavir; Yeztugo; HIV prevention; twice-yearly injection; PrEP; long-acting injectable; WHO guidelines
FDA Approves Gilead’s Twice-Yearly HIV Prevention Shot
FDA approval; Gilead Sciences; Lenacapavir; Yeztugo; HIV prevention; twice-yearly injection; PrEP; public health
Regeneron Leads $66M Series B for Actio Biosciences’ Rare Disease Therapeutics
Regeneron; Actio Biosciences; rare diseases; Series B financing; KCNT1 inhibitor; TRPV4 inhibitor; ABS-1230; ABS-0871; Charcot-Marie-Tooth disease; epilepsy; orphan drug; clinical trials
FDA Approves CSL’s Andembry, Directly Competing With Takeda’s Takhzyro in HAE
Andembry; garadacimab-gxii; FDA approval; hereditary angioedema; HAE; CSL; Takhzyro; Takeda; factor XIIa inhibitor; once-monthly dosing; subcutaneous injection
NextCure Partners with Simcere for Novel ADC in $745M Deal
NextCure; Simcere; Antibody-Drug Conjugate; ADC; SIM0505; CDH6 Targeting
AstraZeneca and CSPC Enter $5.3B AI-Driven Drug Discovery Pact in China
AstraZeneca; CSPC Pharmaceutical; AI research; drug discovery; chronic diseases; China; $5.3 billion; oral therapies; partnership; R&D investment
AstraZeneca Signs $110M AI-Driven R&D Deal with CSPC Pharmaceutical for Chronic Disease Drugs
AstraZeneca; CSPC Pharmaceutical; AI drug discovery; chronic diseases; immunological diseases; oral therapies; R&D collaboration; China pharma; milestone payments; pharmaceutical industry
Insmed’s ‘Unprecedented’ Phase 2 PAH Results Propel Stock and Next-Phase Plans
Insmed; PAH; TPIP; Phase 2b; clinical trial; treprostinil palmitil inhalation powder; stock surge; pulmonary arterial hypertension; Phase 3 trial; biotech
Insmed’s TPIP PAH Therapy Advances to Phase III Following Positive Phase 2b Results
Insmed; TPIP; treprostinil palmitil inhalation powder; pulmonary arterial hypertension; PAH; Phase 2b trial; Phase III trial; clinical trial results; FDA engagement
J&J’s Akeega Advances PARP Inhibition in Prostate Cancer, but FDA Pathway in Broader Patient Subsets Remains Unclear
Akeega; J&J; prostate cancer; PARP inhibitor; FDA approval; BRCA mutations; HRR gene alterations; AMPLITUDE study; metastatic castration-sensitive prostate cancer (mCSPC); metastatic castration-resistant prostate cancer (mCRPC)