The latest news from the global pharmaceutical industry. Below you will find news and information to keep you up-to-date with what is happening in your industry. Coverage includes regulatory approvals, recall announcements, mergers and acquisitions, personnel news and appointments, new facility and facility expansion updates, collaborations and agreements, and financial updates.
Breckenridge announced the FDA has granted final approval of its ANDA for Asenapine Sublingual Tablets in 5mg strength.
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Apellis announced the company will not pursue additional development of APL-9, an investigational targeted C3 therapy designed for acute interventions...
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BioEclipse Therapeutics™ announced the administration of the first dose of CRX100 to a volunteer in the ongoing Phase 1 clinical trial in patients ...
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Immutep has decided to expand Part B of its TACTI-002 Phase II trial, under the study’s Simon’s two- stage clinical trial design.
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OncoSynergy announced the first patient was treated in the Company's First-in-Human Phase 1 clinical trial evaluating OS2966 for the treatment of ...
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Blueprint announced the EMA has validated the company's Type II variation marketing authorization application for AYVAKYT for the treatment of ...
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GeoVax Labs announced the filing of two additional patent applications important to the Company’s key focus on vaccines against SARS-CoV-2 and cancer ...
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Neurocrine Biosciences announced investigational drug luvadaxistat did not meet its primary endpoint in the Phase II INTERACT study in adults with ...
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NeuroSense has announced the successful completion of its first Phase IIa study.
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eXIthera announced the FDA has accepted its IND application to initiate a trial for EP-7041, a small-molecule inhibitor of coagulation Factor XIa.
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Chimerix, worldwide licensee of Cantex's DSTAT investigational product, has reported promising results of the first cohort of patients hospitalized ...
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Clearside Biomedical announced completion of dosing in the first cohort of OASIS, its ongoing Phase 1/2a clinical trial of CLS-AX in patients with AMD...
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Wednesday, March 03, 2021
GW announced the CHMP has adopted a positive opinion on the Company’s Type II variation application for EPIDYOLEX as an adjunctive treatment of ...
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Wednesday, March 03, 2021
Agios has submitted a sNDA to the FDA for TIBSOVO as a potential treatment for patients with previously treated isocitrate dehydrogenase 1 mutated ...
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The FDA issued an EUA for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19.
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