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.
Thursday, November 18, 2021
Endo International plc announced that its Par Sterile Products business has begun shipping calcitonin salmon injection, USP, multi-dose vials (2 mL) ...
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Friday, November 19, 2021
New data from the AZD7442 COVID-19 PROVENT prevention and TACKLE outpatient treatment Phase III trials both showed robust efficacy from a one-time ...
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Friday, November 19, 2021
BioNTech SE announced that the FDA granted Fast Track Designation for BNT111, an investigational cancer immunotherapy for the potential treatment of ...
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Friday, November 19, 2021
Merck announced an update regarding the Phase 2 IMAGINE-DR clinical trial (MK-8507-13), which is evaluating the investigational combination of MK-8507...
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Wednesday, November 24, 2021
Seqirus, a business of CSL Limited, announced that the FDA has granted supplemental approval of a multi-dose vial (MDV) presentation of AUDENZ™ (...
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Monday, November 29, 2021
Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and the European Medicines...
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Wednesday, December 01, 2021
Merck and Ridgeback Biotherapeutics provided the following statement at the conclusion of the FDA Antimicrobial Drugs Advisory Committee (AMDAC) ...
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Wednesday, December 01, 2021
Merck announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review a supplemental Biologics License Application (sBLA) for ...
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Friday, December 03, 2021
Bristol Myers Squibb announced that the FDA has accepted for priority review the supplemental Biologics License Application (sBLA) for Reblozyl® (...
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Wednesday, December 08, 2021
Shanghai Pharmaceuticals and Syntegon have signed an agreement to build a laboratory for continuous manufacturing technology in China. The cooperation...
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Thursday, December 09, 2021
Octapharma USA announced the FDA has approved cutaquig® [Immune globulin, Subcutaneous (Human)-hipp, 16.5% Solution] for the treatment of pediatric ...
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Thursday, December 09, 2021
AstraZeneca's Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody (LAAB) combination, has received emergency use authorization ...
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Friday, December 10, 2021
Pfizer Inc. and BioNTech SE announced that the FDA has expanded the Emergency Use Authorization (EUA) of a booster dose of the Pfizer-BioNTech COVID-...
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Tuesday, December 14, 2021
Merck announced that the FDA has placed clinical holds on the investigational new drug applications (INDs) for the oral and implant formulations of ...
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Wednesday, December 15, 2021
ArisGlobal, a provider of life sciences software that automates core drug development with its end-to-end drug development technology platform ...
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