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.
Kaléo announced that the U.S. Food and Drug Administration (FDA) has approved its Naloxone Auto-injector 10 mg (NALOXONE HYDROCHLORIDE injection) ...
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Merck announced the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending ...
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Innovent Biologics, Inc. and Eli Lilly and Company announced that in light of both parties' shared commitment to continue bringing innovative ...
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The U.S. Food and Drug Administration announced it is requesting a total budget of $8.4 billion as part of the President's fiscal year (FY) 2023 ...
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Santhera Pharmaceuticals (and ReveraGen BioPharma, Inc announced the initiation of a rolling new drug application (NDA) submission to the FDA for ...
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Australian biotech company Noxopharm announced the FDA granted Orphan Drug Designation (ODD) to Veyonda®, its lead oncology drug candidate, for use in...
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Wednesday, March 30, 2022
Mapi Pharma Ltd. announced that the company has been granted U.S. Patent No. 11,167,003 entitled: “Methods for suppressing or alleviating primary or ...
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FDA is announcing the availability of a final guidance for industry entitled “Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment.”
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Novavax, Inc. and Serum Institute of India Pvt. announced that the Thailand Food and Drug Administration (Thai FDA) has granted emergency use ...
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The FDA has published Manual of Policies and Procedures (MAPP) 5240.10, “Classifying Approved New Drug Products and Drug-Device Combination Products ...
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Hansa Biopharma AB, “announced the acceptance by the U.S. FDA of Hansa’s Investigational New Drug (IND) application to proceed with a Phase 3 study of...
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Wednesday, April 20, 2022
Arcturus Therapeutics Holdings Inc. announced topline data from an ongoing Phase 1/2/3 trial evaluating ARCT-154, Arcturus’ self-amplifying mRNA ...
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The University of Tokyo and Astellas Pharma Inc. have entered the second phase of their collaboration for co-creating innovative new medicines and ...
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Merck announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending...
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Prothena Corporation plc announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for PRX012, a potential best-in...
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