FDA Grants First Approval for Orchard Therapeutics’ Gene Therapy Lenmeldy in Treating Rare Pediatric Neuron Disease
Orchard Therapeutics, Lenmeldy, FDA Approval, Metachromatic Leukodystrophy (MLD), Rare Pediatric Disease, Autologous Gene Therapy, Pre-Symptomatic Late Infantile/ Early Juvenile Patients
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 Joins Price Cap Movement for Inhalers Following Boehringer Investigation
Evaluation, Inhaler, AstraZeneca, SmithKline Beecham, Prices
“Continuum Biologics’ PIPE-791 Advances with Johnson & Johnson Partnership in Initial Public Offering (IPO)”
Continuum Biologics, PIPE-791, Johnson & Johnson partnership, Initial Public Offering (IPO), Multiple sclerosis, Demyelinating diseases, Neuroinflammation, LPAR1 antagonist, Lysophosphatidic acid receptor Edg-2 antagonist
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.
Pfizer Reduces Stake in Haleon, Raising Over $2 Billion in Share Selloff
Pfizer, Haleon, Consumer Health Spinoff, Share Selloff, Stake Reduction, GSK, Debt Management, Strategic Focus
Contineum Launches IPO Campaign to Accelerate Multiple Sclerosis Pipeline
Contineum Therapeutics, Initial Public Offering (IPO), Johnson & Johnson (J&J) Backed, Multiple Sclerosis (MS) Pipeline, Phase II Trial, PIPE-307
FDA Grants Accelerated Approval to Madrigal’s Rezdiffra for MASH Treatment
FDA approval, Madrigal Pharmaceuticals, Rezdiffra (resmetirom), Metabolic dysfunction-associated steatohepatitis (MASH), Accelerated clearance, Adult patients with non-cirrhotic MASH and moderate-to-advanced liver fibrosis
Boehringer Ingelheim and Sosei Sign Potential $732 Million Collaboration for Schizophrenia Treatment
Boehringer Ingelheim, Sosei, Schizophrenia Treatment, Partnership, $732 Million Deal, GPR52 Targeting Portfolio
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.