Search jobs U.S. FDA Accepts Merck’s Gefapixant New Drug Application for Review
Application for Orally Administered Selective P2X3 Receptor Antagonist Based on Findings from Two Phase 3 Trials in Patients with Refractory or Unexplained Chronic Cough
Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application (NDA) for gefapixant, an investigational, orally administered, selective P2X3 receptor antagonist, for the treatment of refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults. This application for gefapixant will be discussed at an upcoming advisory committee meeting. No date has been set yet. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action date, of Dec. 21, 2021.
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During 2019 and 2020, states enacted fewer laws requiring drug manufacturers to disclose pricing and related information. Initially, the slowdown may have been due to federal actions to rein in drug prices through the Trump administration’s multiple executive orders.[1] Thereafter, states were focused on responding to the pandemic and drug pricing was understandably placed on the back burner.
Circumstances have since changed. We now have a new president and administration, and the country is hopefully turning the corner on the COVID-19 pandemic. Inevitably, the federal government and states will again turn their focus to drug prices. While the Trump administration’s executive orders made for good public sound bites, they had little to no actual impact on drug prices. At the end of the day, most of the Trump administration’s initiatives never made it to the regulatory rulemaking phase and those that did were met with
Biohaven Reports Fourth Quarter and Full Year 2020 Financial Results and Recent Business Developments
- NURTEC® ODT (rimegepant) net product revenues for the fourth quarter of 2020 were $35.1 million, representing a 98% increase compared to the third quarter of 2020, and $63.6 million for calendar year 2020 following U.S. commercial launch in March of 2020
- Exceeded market expectations with robust growth of NURTEC ODT totaling over 337,000 prescriptions in 2020 and over 24,000 unique prescribers
- Regulatory filing for rimegepant in Europe submitted and accepted for review by European Medicines Agency for dual-acting (acute and prevention) indication for treatment of migraine
- Life-cycle management studies for CGRP-antagonist program underway, including initiation of Phase 4 study of NURTEC ODT in pediatric migraine
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Medexus Achieves Record Revenue of $31.5 Million for the Third Quarter Fiscal 2021
Medexus Pharmaceuticals IncMarch 1, 2021 GMT
TORONTO, CHICAGO and MONTREAL, March 01, 2021 (GLOBE NEWSWIRE) Medexus Pharmaceuticals Inc. (the “Company” or “Medexus”) (TSXV: MDP) (OTCQX: MEDXF) (Frankfurt: P731) today announced its financial and operating results for the three and nine months ended December 31, 2020. All dollar amounts below are in Canadian dollars unless specified otherwise.
Third Quarter Fiscal 2021 Financial Highlights: The Company achieved record revenue of $31.5 million for the three-month period ended December 31, 2020, versus $16.2 million for the same period last year. As previously reported, the revenue for the period included approximately $3 million in IXINITY® revenues, which were originally expected to be realized in September 2020, but were instead realized in