Getting the Ensuring Pathways to Innovative Cures (EPIC) Act through the U.S. Congress to do away with the “pill penalty” in the Medicare drug price negotiations could require an epic effort, given the current politically fueled atmosphere on the Hill. With the Inflation Reduction Act (IRA), which created the negotiations, considered a signature achievement of the Biden administration, the negotiations have become, for many lawmakers, almost a sacred cow that can’t be touched. If anything, some of them want to expand the negotiations to more drugs and to the commercial market.
Novartis AG lost its bid, at least for now, to delay generic competition to its blockbuster heart drug, Entresto (sacubitril, valsartan), on the basis of patent infringement.
Astrazeneca Korea Co. Ltd. will pull its blockbuster diabetes drug, Forxiga (dapagliflozin), from the South Korean market, a company official confirmed to BioWorld, citing “multiple factors” like increasing local competition and continuing price cuts after patent expiry in 2023.
Astrazeneca Korea Co. Ltd. will pull its blockbuster diabetes drug, Forxiga (dapagliflozin), from the South Korean market, a company official confirmed to BioWorld, citing “multiple factors” like increasing local competition and continuing price cuts after patent expiry in 2023.
As South Korea awaits potential changes to drug pricing policies for generics and novel ultra-expensive therapies like Novartis AG’s Kymriah (tisagenclecleucel), the domestic pharmaceutical industry is proactively voicing concerns about some policies that could do more harm than good.
The U.S. FDA is in the midst of a shake-up of several major offices, including the Office of Regulatory Affairs, but its commissioner, Robert Califf, believes there are even greater issues faced by the agency. Califf said during an Aug. 22 public forum that prices for generic drugs are too low to encourage manufacturers to continue to produce these products, adding that the issue is sufficiently severe to constitute a national security risk.
The U.S. FDA approved the temporary importation of the unapproved chemotherapy drug cisplatin from Qilu Pharmaceutical Co. Ltd. to help address a shortage of drugs used in cancer treatments in the U.S. The decision opened the possibility of more Chinese drugs making their way to the U.S. market, but some warned that this decision would be likely be a one-off.
Citing significant implications for patients with advanced Parkinson’s disease, as well as the broader public interest that’s at stake, the U.S. FTC filed an amicus brief in Sage Chemical Inc.’s district court challenge of Supernus Pharmaceuticals Inc.’s strategies to block generic competition of its injectable Parkinson’s drug, Apokyn (apomorphine).
It pays to read the details of patent specifications. By keeping the pH range of its generic vasopressin injection at least 0.01 below that specified for Vasostrict, Eagle Pharmaceuticals Inc. cleared itself from claims that it had infringed two key patents protecting the brand drug.
As a last-ditch effort to preserve skinny labeling for generics, Teva Pharmaceuticals USA Inc. is asking the U.S. Supreme Court to review a Federal Circuit split opinion in Glaxosmithkline plc v. Teva Pharmaceuticals that upset the status quo of the generic marketplace.
