Pharmacologic Substance
Crinetics’ Paltusotine Demonstrates Success in Second Phase III Trial for Oral Acromegaly Treatment, Prepares for FDA Filing
Crinetics Pharmaceuticals, Paltusotine, Acromegaly, Phase III trials, FDA submission, Oral treatment, Symptom reduction
Takeda’s $5.2B Ariad Deal Yields Label Expansion for Iclusig in Rare Leukemia
Takeda, Ariad, $5.2B deal, Iclusig, Label expansion, Rare form of leukemia
Regeneron Antitrust Suit Against Novartis Gains Momentum with Appellate Ruling
Regeneron, Novartis, Antitrust lawsuit, Appeal court backing, Eye treatments (Eylea & Lucentis), Patent dispute
Bayer Prepares Menopause Drug Rival to Astellas’ Veozah for Regulatory Filings Following Successful Phase 3 Trials
Bayer, Menopause Drug, Elinzanetant, Phase 3 Hat Trick, Regulatory Approval, Competition with Astellas’ Veozah
Bayer’s Menopause Drug Elinzanetant Achieves Successful Long-Term Results in Phase III Trial, Rivalling Astellas’ Veozah
Bayer, Elinzanetant, Menopause drug, Phase III trial, Long-term results, Hot flashes, Vasomotor symptoms, Astellas, Veozah, Competition
AstraZeneca and GSK Join Boehringer Ingelheim in Capping Out-of-Pocket Inhaler Costs at $35 per Month
AstraZeneca/ GlaxoSmithKline/ Boehringer Ingelheim/ inhaler/ out-of-pocket costs/ cap/ $35/ asthma/ COPD/ price reduction/ drug pricing/ U.S./ congressional scrutiny/ patient affordability/ medication accessibility.
FDA Unexpectedly Postpones Approval Decision for Eli Lilly’s Donanemab, Schedules AdComm Review
Donanemab, Eli Lilly, FDA delay, Approval postponement, Peripheral and Central Nervous System Drugs Advisory Committee (PCNS), Safety and efficacy review, Clinical trial results, Brain swelling and bleeding side effects, Accelerated approval declined, Leqembi and Aduhelm precedent, Full approval anticipated, Accelerated approval rejected.
MacroGenics and AbbVie Discontinue Development of ADAM9 Antibody-Drug Conjugate (IMGC936)
MacroGenics, AbbVie, Partnered ADC, ADAM9, IMGC936, Early Data, Safety Concerns, Efficacy Issues
Brukinsa by BeiGene Secures FDA Approval for Follicular Lymphoma Amid Imbruvica Setbacks
Brukinsa (zanubrutinib), BeiGene, FDA approval, follicular lymphoma, accelerated approval, obinutuzumab (Gazyva) combination therapy, ROSEWOOD trial, overall response rate (ORR), disease progression or unacceptable toxicity, competition with CAR-T cell therapies/ bispecific antibodies
FDA Greenlights Opdivo Combination Therapy for First-Line Bladder Cancer Treatment
Overall Survival, Combined, cisplatin, Opdivo