When it comes to vaccines and preparedness, platform delivery technologies can be both a boon and a barrier. On the one hand, an existing platform can speed development of a vaccine targeting an unexpected viral scare such as the recent Bundibugyo Ebola and Andes hantavirus outbreaks. On the other hand, the intellectual property (IP) protecting that platform adds to the economic hurdles facing smaller vaccine developers, Douglas Bucklin, a life sciences patent attorney with Volpe Koenig, told BioWorld.
With increasing competition from China and other countries, the U.S. Department of Health and Human Services is rolling out Operation Trailblazer, a department-wide strategy to once again make the U.S. the go-to destination for early stage drug development.
Although shot down last year by the U.S. Court of Appeals for the Ninth Circuit, a constitutional challenge to a state law requiring biopharma companies to disclose trade secrets could live to see another court battle.
In a little more than a month, 17 big biopharma companies will be subject to U.S. President Donald Trump’s long-promised section 232 global biopharma sector tariff. But instead of paying the 100% duty on imported patented drugs and their key ingredients, most of those companies, if not all, will pay much reduced rates or no tariff at all, based on where the imports are coming from, what type of drug is being imported, and whether the companies have signed onshoring and most-favored-nation pricing agreements with the administration.
The recent introduction of the bipartisan Biotech Investment National Security Act in the U.S. House has industry and venture capitalists urging lawmakers to take a breath, step back, and consider a less invasive approach than restricting U.S. biopharma deals with Chinese innovators.
Wuxi Apptec isn’t going down without a fight after the U.S. Department of Defense added it to the Section 1260H list June 8 as a designated “Chinese military company,” which makes it a “biotechnology company of concern” under the Biosecure Act. “Such designation is mistaken and baseless,” the global contract research, development and manufacturing organization said in an open letter to its life sciences partners. “We will pursue every available avenue to correct this mistake.” That includes appealing the designation.
The recent introduction of the bipartisan Biotech Investment National Security Act in the U.S. House has industry and venture capitalists urging lawmakers to take a breath, step back, and consider a less invasive approach than restricting U.S. biopharma deals with Chinese innovators.
The U.S. FDA’s year-old Commissioner’s National Priority Voucher (CNPV) pilot program played to mixed reviews at the agency’s June 4 listening session intended to get various stakeholders’ perspective on the ultra-accelerated review process being offered to qualifying drugs.
The U.S. Supreme Court handed Hikma Pharmaceuticals and the entire generic industry a big victory June 4 with its 9-0 opinion ensuring the future of skinny labels and correcting the Federal Circuit’s flawed understanding of infringed inducement.
Nearly a year after Health and Human Services Secretary Robert Kennedy announced the U.S. was cutting off funding for Gavi, a global vaccine alliance, Secretary of State Marco Rubio said his department is reengaging with the organization in light of the ongoing Ebola outbreak in central Africa. In testifying before a June 2 Senate Foreign Relations Committee hearing, Rubio said the State Department made the decision to reengage a few weeks earlier with Gavi. He provided no detail of what that engagement looks like.
