LONDON – Brexit finally becomes a reality at midnight central European time on Jan. 31, but for the life sciences industry uncertainty continues, as the U.K. enters an 11-month transition phase during which the terms of its future relationship with the EU must be negotiated.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) looked with favor on a bucketload of would-be drugs, issuing positive opinions for the European Commission to consider across a range of indications.
Combination products with digital interfaces. Antibody-drug conjugates. Complex drugs. Synthetic biologics. They’re all examples of how technology is expanding the ambit of what’s considered a drug beyond the current U.S. binary regulatory system of small molecules and biologics.
BOGOTA, Colombia – A two-year-old shortage of measles, mumps and rubella (MMR) vaccine in Mexico has become more serious, with 2020 starting out with renewed complaints of even lower availability of the vaccine all over the country.
Whether large or small, or based in the U.S. or abroad, life sciences companies are an increasingly attractive target for shareholder suits. The number of securities fraud class action suits filed in the U.S. in 2019 across all industries totaled 404, just one more than the 403 cases filed in 2018 and down from the peak of 412 in 2017, according to a new Dechert LLP report.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is seeking input from industry stakeholders on a proposal to increase its fees to cover projected deficits this year. The proposal outlines three options.
Time will tell whether what the Trump administration is calling a “historic” and “landmark” trade agreement with China will better enable drug and device companies to more fairly compete in the Chinese market without having to sacrifice their intellectual property (IP) and technology.
In the final debate before the Iowa caucuses, the six leading contenders to be the Democratic presidential candidate had an opportunity to lay out how they would deal with U.S. prescription drug prices.
As a word to the wise in a week filled with FDA advisory committee meetings on potential new opioid drugs, the state of Oklahoma filed a lawsuit Monday against three distributors, reminding everyone in the U.S. opioid prescription supply chain of the risk of litigation and hefty penalties.
SAN FRANCISCO – Atop the stage where, just a year ago, he'd detailed the then-new $74 billion acquisition of Celgene Corp, Bristol-Myers Squibb Co. CEO Giovanni Caforio told attendees of this year's J.P. Morgan Healthcare Conference he intends to plunge ahead with "the agility and speed of a biotech company."
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