Mari Serebrov

Nine more biopharma companies have signed most-favored-nation (MFN) pricing agreements with the Trump administration. Together with the 17 big biopharma companies that had signed MFN deals earlier this year, the agreements cover 89% of the U.S. drug market, according to the White House.

The U.S. Federal Circuit handed Exelixis Inc. a win by affirming the validity of three patents protecting its blockbuster cancer drug, Cabometyx (cabozantinib). In a bid to clear the way for its generic, MSN Pharmaceuticals Inc. defended itself against Exelixis' infringement claims by contesting the patents as invalid due to what it argued was an insufficient written description. The Fed Circuit's Aug. 31 precedential ruling is expected to secure Cabometyx against generic competition for at least three more years, the company said.

As its first act of business after returning from its August recess, the U.S. House of Representatives passed the Senate's version of a continuing resolution (CR) that will keep the government running at current levels through Dec. 11. The Sept. 1 bipartisan House vote was 370-48.

Although the supply of U.S. FDA-approved estradiol transdermal patches nearly doubled over the past year, the brand and generic manufacturers of the patches are struggling to keep up with an increased demand spurred by the FDA's rethink of the benefits of hormone replacement therapies for menopause.

Accessing a medical device's copyrighted software programs for the purpose of repairing or servicing the device is not the same as selling tickets to a pirated copy of a film, the U.S. Court of Appeals for the District of Columbia Circuit said in upholding the fair use copyright exemption for such work.

To get a better handle on the state of botanical drug development in the U.S., the FDA issued a request for information on the challenges sponsors are facing and potential solutions. It's all part of the agency's effort to facilitate additional research, “with the goal of accelerating drug product development and review of clinical treatments in this space,” according to a notice published in the Sept. 4

The breadth and depth of the recent cyberattacks on medical device companies continue to expand as more companies disclose that they, too, were hit, and others more fully assess the impact an attack had on them.

The U.S. Court of Appeals for the District of Columbia Circuit recently clipped the Department of Health and Human Services' (HHS) regulatory wings even as it agreed with an HHS advisory opinion that Vertex Pharmaceuticals Inc.'s program providing assistance for fertility preservation to Casgevy patients would run afoul of the anti-kickback statute if it were offered to individuals covered by Medicaid.

“Acting” has been dropped from the titles of the interim directors of the U.S. FDA's drug and biologics centers, with Michael Davis and Karim Mikhail officially appointed late Sept. 8 as the directors of CDER and CBER, respectively.

An earth-shaking environment of regulatory and pricing pressures is fundamentally reshaping the biopharma commercialization landscape. And it's not just in the U.S. It's global. Instead of country-by-country pricing decisions, companies are developing global strategies that affect not only drug prices, but launch decisions, clinical trials and even which indications are pursued in various markets, Michael Abrams, managing partner at Numerof & Associates, told