Regulatory
The study notes that about half of recent drug approvals were built on a single pivotal clinical trial. Typically, two pivotal, Phase III trials were the norm.
The approval was based on two randomized open-label clinical trials that evaluated the combination of empagliflozin, linagliptin and metformin and their individual components in healthy adults.
Non-Sedative Orexin Receptor Antagonist Proven Effective for Both Sleep Onset and Sleep Maintenance With No Meaningful Differences Between Dayvigo and Placebo on Next-Day Postural Stability or Memory and Improvement of Daily Functioning
Dificid is a macrolide antibiotic that was previously approved for CDAD in adults.
Robert Bazemore, president and chief executive officer of Epizyme, called the accelerated approval of Tezverik “a landmark event” for people with epithelioid sarcoma, a soft-tissue cancer.
Eisai Co., Ltd. has obtained the approvals of supplementary new drug applications in Japan for its in-house developed antiepileptic drug Fycompa for an additional indication for monotherapy of partial-onset seizures and an additional indication for partial-onset seizures in pediatric patients aged 4 years and older, as well as a new fine granule formulation.
Coherus BioSciences, Inc. announced the Company has entered into a licensing agreement with Innovent Biologics, Co., Ltd.,, a leading biopharmaceutical company headquartered in China, to commercialize Innovent’s biosimilar candidate to Avastin® in the United States and Canada.
The CRL not only brings up the potential toxicities of the drug, but also raises questions about the drug’s efficacy.
Tuesday afternoon the U.S. Food and Drug Administration approved Tepezza (teprotumumab-trbw) as the first treatment for this condition.
Pharming Group N.V. announced it has received European Medicines Agency approval of a Type II Variation for a new production facility for the Company’s lead product, RUCONEST®.
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