With backing from an FDA advisory committee and results from a positive phase 3 trial, respectively, Alnylam and BridgeBio are each on track to enter the blockbuster transthyretin amyloidosis cardiomyopathy (ATTR-CM) market. But doctors say they’ll mostly stick with Pfizer’s first-to-market franchise, according to two analyst groups.
Pfizer Inc. and the Scripps Research Institute allege in a new lawsuit that a copy of Vyndamax proposed by Dexcel Pharma Technologies Ltd. infringes three patents for the blockbuster heart drug, an increasingly important source of Pfizer’s revenue.
FDA Confirms Paragraph IV Patent Litigation for Tafamidis Capsules
Two months after taking a loss in a U.S. Supreme Court appeal, which prevents Pfizer from implementing a cost-sharing assistance program for its heart disease drugs Vyndaqel and Vyndamax, the company has gotten a win in a parallel case in a different court in Washington, D.C.
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) announced today the publication of a post-hoc, interim analysis showing that treatment with VYNDAQEL® (tafamidis meglumine) / VYNDAMAX® (tafamidis) provided a clinically significant survival benefit at five years for patients with transthyretin amyloid cardiomyopathy (ATTR-CM).
NICE has rejected regular NHS funding for Pfizer’s Vyndaqel (tafamidis) for a rare heart condition, although it has left the door open for negotiations if the pharma decides to drop its price.
Welcome to the FiercePharma political roundup, where each Monday we’ll highlight developments in Washington, D.C., and elsewhere that could affect drug pricing and how drugmakers operate.
WEST PALM BEACH, Fla -- October 9, 2020 -- Patients who received long-term tafamidis for treatment of transthyretin amyloid cardiomyopathy appear to benefit from the treatment even when therapy is delayed, according to a study presented at the 2020 Virtual Meeting of the Heart Failure Society of America (HFSA).
The Ministry of Food and Drug Safety has approved Pfizer's Vyndamax (ingredient: tafamidis), a treatment for wild-type or hereditary transthyretin amyloid cardiomyopathy (ATTR-CM), for reduced cardiovascular mortality and associated hospitalization in adult patients.
Add another name to the list of pharmas reporting sales declines amid the pandemic. But this company, Pfizer, is still dialing up its full-year revenue expectations—not that it’s counting any contribution from a closely watched COVID-19 vaccine candidate it’s hoping to launch this year.