BioCentury | Dec 4, 2020
Product Development

Dec. 3 Quick Takes: Moderna, NIH tout persisting neutralizing antibodies from COVID vaccine; plus Bayer, Galapagos, Braeburn, J&J and Equillium

...said FDA issued a complete response letter regarding its NDA seeking final approval of Brixadi buprenorphine...
...is a subcutaneous weekly and monthly extended release formulation of the opioid use disorder therapy buprenorphine...
BioCentury | Nov 17, 2020
Regulation

Alkermes expects quick resolution to FDA setback for antipsychotic

...in November 2018 against approval of that therapy, which combines samidorphan with partial MOR agonist buprenorphine.Alkermes...
BioCentury | Nov 5, 2020
Management Tracks

Rosén joins Horizon as CSO and R&D head; plus moves at Boehringer, Dr. Reddy’s, Mylan and more

...Wang as COO, Ajim Tamboli as CFO and Jullian Jones as SVP, head of business development.Relmada...
...Pappagallo as acting CMO. Manfredi was co-founder and scientific director of Medeor Inc., now merged into Relmada. Pappagallo...
...Golovin Boehringer Ingelheim Horizon Therapeutics plc GlaxoSmithKline plc Dr. Reddy's Laboratories Ltd. Mylan N.V. Rhythm Pharmaceuticals Inc. Silence Therapeutics plc Monte Rosa Therapeutics Inc. Relmada...
BioCentury | May 28, 2020
Management Tracks

Quick departure for Semerjian as Immunomedics CEO; plus Ziopharm, Kinnate, Applied Therapeutics, Relmada, AskBio and more

...BV-CYP01, a preclinical program for Huntington’s disease, via its acquisition of BrainVectis. CNS disorders company Relmada...
...Staff Asklepios BioPharmaceutical Inc. Seer Inc. Meridian Biopharmaceuticals Liquidia Technologies Inc. Amphista Therapeutics Ltd. Science 37 Inc. Amylyx Pharmaceutical Oligomerix Inc. Galecto Inc. Applied Therapeutics Inc. Relmada...
BioCentury | May 1, 2020
Product Development

April 30 Quick Takes: Pfizer to co-develop Valneva’s Lyme disease vaccine; plus Aravive-WuXi Biologics, Siga-BARDA, Pear, Capricor

...for substance use disorder; and reSET-O, which is for patients with opioid use disorder receiving buprenorphine...
BioCentury | Apr 4, 2020
Management Tracks

CureVac names Stéphenne chairman; plus Desmond-Hellmann to Pfizer’s board, Reagan-Udall, Kyowa Kirin, Assembly, BioCryst and more

...the RNA-targeting gene therapy company, he was CEO of Utility Therapeutics Ltd. CNS disorders company Relmada...
BioCentury | Mar 12, 2020
Management Tracks

Hoerr takes helm from Menichella at CureVac; plus Genmab hires Mancini as COO, Tricida, Akcea, Refuge, Adaptate, Thermo Fisher and more

...Ehlers, COO and president of clinical diagnostics, will step down in June. CNS disorders company Relmada...
BioCentury | Feb 11, 2020
Politics, Policy & Law

Senate bill introduced to close Orphan drug ‘loophole’

...its development and distribution costs. Controversy over Orphan exclusivity for opioid use disorder therapy Sublocade buprenorphine...
BioCentury | Jan 29, 2020
Politics & Policy

House bill seeks to tweak Orphan Drug Act, could pose threat to pathway

...recovery pathway, a recent controversy over Orphan exclusivity for an opioid use disorder therapy Sublocade buprenorphine...
BioCentury | Jan 11, 2020
Company News

Management Tracks: Wave CFO departs; plus Polaris, Turning Point, ADC, Relmada, Aravive, Affimed, Impel, Candel and more

...lymphoma (see “ADC’s Loncastuximab Data Could Clear Path for BLA, IPO Filing” ). Neurology company Relmada...
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