JD Supra8d
Patent Poetry: Federal Circuit Reverses Novartis Patent Decision
The Federal Circuit has issued a precedential decision reversing a lower court’s decision that certain claims of Novartis’s ...
Monthly Prescribing Reference2d
Nasal Spray Formulation of Bumetanide Under FDA Review
The NDA is supported by data from a clinical trial that compared the absorption and efficacy of the nasal treatment with oral and IV bumetanide in 68 healthy adults.
JD Supra9d
Federal Circuit Says Proper Orange Book-Listed Patent Must Claim Active Ingredient
In Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC, the Federal Circuit jumped on the bandwagon ...
Hosted on MSN2mon
APLT Stock Plunges 77% After FDA Issues CRL for Galactosemia Drug NDA
Applied Therapeutics APLT announced that the FDA has issued a Complete Response Letter (CRL) for the new drug application ... and cannot approve the NDA in its current form due to deficiencies ...
Hosted on MSN1mon
Chimerix Stock Draws Heavy Retail Chatter After Landing Price-Target Hike On FDA Submission Plan For Cancer Drug
The microcap biopharmaceutical company announced plans to submit a New Drug Application (NDA) to the U.S. Food and ... patients suffering from this lethal form of brain cancer who have extremely ...
The Bakersfield Californian9d
KalVista Announces Orphan Drug Designation and NDA Submission for Sebetralstat in Japan for Hereditary Angioedema
KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted sebetralstat Orphan Drug Designation. The Company has also ...