Mass. officials used confidentiality clauses in dozens of settlements despite supposed NDA ban, audit finds
State Auditor Diana DiZoglio on Tuesday charged that Massachusetts is relying on a “broken system” for both executing and ...
HR Dive1d
Nearly half of employees say they’re subject to an NDA
Restrictive covenants could limit workers’ ability to report discrimination and harassment, two Lift Our Voices studies ...
Vanda Pharmaceuticals Inc.: Vanda Pharmaceuticals Accepts FDA Opportunity for a Hearing on New Drug Application for Tradipitant in Gastroparesis
Highlights faulty FDA review WASHINGTON, Jan. 27, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today provides an update on the tradipitant ...
Le Lézard2d
Vanda Pharmaceuticals Accepts FDA Opportunity for a Hearing on New Drug Application for Tradipitant in Gastroparesis
Vanda Pharmaceuticals Inc. (Vanda) today provides an update on the tradipitant development program. Gastroparesis is a ...
Zacks.com on MSN5d
Vertex Down 13% in 6 Months: Buy, Sell or Hold the Stock?
The stock of Vertex Pharmaceuticals Incorporated VRTX has declined almost 13% in the past six months. A key reason for the stock price decline was unimpressive data from a phase II study on its key ...
Quoin Pharmaceuticals Announces Further Clinical Evidence of QRX003 Effectiveness in Netherton Syndrome
After Discontinuation of Treatment with QRX003 Complete Reversal of Positive Clinical Improvements Across all Measured Endpoints ...
Joplin Globe6d
Verastem Oncology Outlines 2025 Strategic Priorities and Milestones for Novel Pipeline Targeting RAS/MAPK Pathway-Driven Cancers
Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced its 2025 priorities and upcoming ...
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 ...
Disc Medicine Announces Successful Type C Meeting with FDA for Bitopertin in Erythropoietic Protoporphyria (EPP) and Shares Plans for NDA Submission
Pursuing accelerated approval for bitopertin in EPP with protoporphyrin IX (PPIX) reduction as the surrogate endpointPlanning to submit NDA under ...
Le Lézard8d
KalVista Announces Orphan Drug Designation and NDA Submission for Sebetralstat in Japan for Hereditary Angioedema
KalVista Pharmaceuticals, Inc. , today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has granted sebetralstat Orphan Drug Designation. The Company has also submitted a New Drug ...
JD Supra8d
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 ...
Stockhouse10d
Applied Therapeutics, Inc. Sued for Securities Law Violations - Investors Should Contact Levi & Korsinsky for More Information - APLT
the Company's lead drug candidate. The CRL indicated that the FDA completed its review of the application and determined that it was unable to approve the NDA in its current form citing deficiencies ...