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.
SAN FRANCISCO – Guardant Health Inc. has set the standard for liquid biopsy. That success has catapulted the Redwood City, Calif.-based company from an IPO in the fall of 2018 to a current valuation in excess of $7 billion. It has made its name – and much of its revenue – with its Guardant360 test, a molecular diagnostic test that assesses 74 cancer-related genes from the circulating tumor DNA to aid in designing the best treatment for advanced cancer patients with solid tumors.
More than a decade after one of its early splashes in therapeutic development caused ripples in the U.S. patent tide pool, the Wisconsin Alumni Research Foundation, better known as WARF, is taking a more seasoned approach to drug discovery and development.
One sentence buried more than 1,500 pages into a fiscal 2020 spending bill the U.S. Senate passed Thursday could open the door to a broader range of insulin biosimilars. The provision, requested by the FDA, expands the definition of a “biological product” to include chemically synthesized polypeptides. The provision, requested by the FDA, expands the definition of a “biological product” to include chemically synthesized polypeptides.
A mere 26 months after the first patient was enrolled in its pivotal phase II study and about three months ahead of its PDUFA date, the FDA granted accelerated approval for Padcev (enfortumab vedotin-ejfv) to treat adults with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery or in a locally advanced or metastatic setting.
The FDA took concrete steps Wednesday in mapping out import routes for prescription drugs by issuing a notice of proposed rulemaking and a draft guidance. If finalized, the proposed rule, for the first time, would implement a 20-year-old provision of the Federal Food, Drug and Cosmetics Act that gives the Health and Human Services (HHS) secretary the authority to authorize the import of certain small molecule drugs from Canada. However, the proposal is getting pushback from Canada.
The FDA’s proposed rule would, for the first time, implement Section 804 of the Federal Food, Drug and Cosmetics Act (FDCA), which allows certain small-molecule drugs approved in Canada to enter the U.S. market – if the Health and Human Services secretary certifies that the drugs would pose no additional risk to public health and safety and that they would result in a significant reduction in cost.