Clinical Trials – Page 10

Apnimed Advances FDA Filing after Second Pivotal Win for Oral Sleep Apnoea Drug

3 months ago talkbio0Tagged AD109, Apnimed, aroxybutynin, atomoxetine, Clinical Trials, LunAIRo, oral drug, Sleep Apnea, Obstructive, Submission, SynAIRgy, United States Food and Drug Administration

Apnimed; AD109; obstructive sleep apnea; OSA; oral drug; phase 3 trial; LunAIRo; SynAIRgy; FDA submission; clinical trial; aroxybutynin; atomoxetine

Scancell’s Cancer Vaccine Supercharges Melanoma Immunotherapy in Recent Trials

3 months ago talkbio0Tagged Cancer Vaccines, checkpoint inhibitors, Clinical Trials, Immunotherapy, iSCIB1 +, melanoma, Melanoma TRP2 CTL Epitope Vaccine SCIB1, Scancell, SCOPE trial

Scancell; SCIB1; iSCIB1+; melanoma; cancer vaccine; immunotherapy; checkpoint inhibitors; clinical trial; SCOPE trial

Avalyn Pharma Raises $100M to Advance Inhaled Lung Disease Drugs

3 months ago talkbio0Tagged AP01, AP02, aspects of adverse effects, Avalyn, Clinical Trials, drug safety, Holdings, inhaled lung disease, nintedanib, Pharma, pirfenidone, Pulmonary Fibrosis, Series D, SNCG gene, Suvretta Capital Management

Avalyn Pharma; $100 million Series D; inhaled lung disease medications; pulmonary fibrosis; AP01; AP02; pirfenidone; nintedanib; clinical trials; drug safety; side effects; Suvretta Capital Management; SR One; Novo Holdings

Sarepta Stands Behind Elevidys After FDA Requests Withdrawal Amid Safety Concerns

3 months ago talkbio0Tagged Cessation of life, Clinical Trials, concerns, ELEVIDYS, gene therapy, Market, Muscular Dystrophy, Duchenne, Safety, United States Food and Drug Administration, Withdraw (activity)

Sarepta; Elevidys; FDA; gene therapy; market withdrawal; safety concerns; Duchenne muscular dystrophy; deaths; clinical trial hold

FDA Advisory Committee Rejects Lundbeck and Otsuka’s PTSD Bid for Rexulti

3 months ago talkbio0Tagged Advisory Committees, brexpiprazole, Clinical Trials, drug efficacy, Lundbeck, Otsuka, Post-Traumatic Stress Disorder, Rexulti, sertraline, United States Food and Drug Administration

Lundbeck; Otsuka; Rexulti; FDA advisory committee; PTSD; brexpiprazole; sertraline; clinical trials; drug efficacy; setback

Kowa Secures Expanded Rights to Nicox’s Glaucoma Drug NCX 470 in Major Global Deal

3 months ago talkbio0Tagged Clinical Trials, Denali, Glaucoma, Kowa, licensing agreement, milestone payments, naproxen-n-butyl nitrate, Ophthalmology specialty, royalties, TLX2 gene

Kowa; Nicox; NCX 470; glaucoma; exclusive rights; licensing agreement; Denali clinical trial; ophthalmology; royalties; milestone payments

FDA Advisory Committee Votes Against GSK’s Blenrep in Multiple Myeloma

3 months ago talkbio0Tagged Advisory Committees, Clinical Trials, drug safety, Eye, Multiple Myeloma, ODAC, SmithKline Beecham, Toxicity aspects, United States Food and Drug Administration, vote

FDA Advisory Committee; Blenrep; GSK; multiple myeloma; ODAC vote; drug safety; ocular toxicity; clinical trials

Takeda’s Oveporexton Succeeds in Two Phase III Trials, Paving Way for Narcolepsy Drug Filings

4 months ago talkbio0Tagged Clinical Trials, File (record), Narcolepsy, Narcolepsy type 1, orexin agonist, oveporexton, Phase 3 Clinical Trials, Takeda, United States Food and Drug Administration

Takeda; Oveporexton; narcolepsy; Phase III trials; orexin agonist; FDA filing; Narcolepsy Type 1; clinical trial results

AstraZeneca’s Baxdrostat Achieves Pivotal Phase 3 Success for Hypertension, Validating $1.3B CinCor Acquisition

4 months ago talkbio0Tagged Acquisition, AstraZeneca, baxdrostat, CinCor Pharma, Clinical Trials, Hypertensive disease, treatment-resistant hypertension, Uncontrolled

AstraZeneca; baxdrostat; CinCor Pharma; hypertension; high blood pressure; phase 3 trial; aldosterone synthase inhibitor; $1.3 billion acquisition; clinical trial win; uncontrolled hypertension; treatment-resistant hypertension

AbbVie Acquires Rights to Ichnos Glenmark’s Lead Myeloma Antibody (ISB 2001) in $1.93 Billion Deal

4 months ago talkbio0Tagged AbbVie, bis(3-bis(4-chlorophenyl)methyl-4-dimethylaminophenyl)amine, CD3 Antigens, CD38 Antigen, Clinical Trials, Global Licensing, Ichnos Glenmark, ISB, Multiple Myeloma, Neoplasms, Phase 1 (qualifier value), Trispecific Antibody

AbbVie; Ichnos Glenmark; ISB 2001; trispecific antibody; multiple myeloma; biotech deal; CD3; BCMA; CD38; Phase 1 clinical trial; global licensing; oncology