Despite being haunted by the progressive multifocal leukoencephalopathy (PML) specter raised by natalizumab, Takeda Pharmaceutical Co. Ltd.’s Entyvio got strong support Monday from two advisory committees that weren’t overly concerned by trials that missed some endpoints.
Closing the book on another quirky chapter in the life of Dendreon Corp.’s Provenge, two hedge fund analysts have each agreed to a six-month suspension and $25,000 civil penalty in a settlement with the SEC over statements made in 2010 regarding the cancer vaccine that the commission considered “materially misleading.”
Since China, Canada and Mexico are the U.S.’ biggest trade partners, it should come as no surprise that they have the most import alerts involving U.S. FDA-regulated products.
Drugmakers shouldn’t be forced into the waste disposal business. That’s the gist of a federal lawsuit filed by several industry trade associations in the hopes of throwing out a King County, Wash., regulation requiring drugmakers to set up and maintain secure take-back programs for unused prescription and over-the-counter drugs – at no cost to King County residents.
While patents continue to clog the U.S. biosimilar pipeline, other countries are benefiting from an increasing flow of the discounted copies of complex biologics.
With the FDA backpedaling on a decision it made three years ago to severely limit the use of Glaxosmithkline plc’s (GSK) Avandia and other diabetes drugs containing rosiglitazone, the damage resulting from that decision is calling into question the need for massive cardiovascular outcome trials (CVOTs) for diabetes drugs and the future regulatory role of meta-analysis.
Although Gilead Sciences Inc.’s sofosbuvir could make history as the first interferon-free treatment to be approved for hepatitis C, it may face generic competition in India soon after it hits the market because it isn’t innovative enough, according to some advocacy groups.
Lawmakers are leaving no stone unturned in their struggle to free FDA user fees from indiscriminate sequestration cuts. The latest effort was a letter, sent last week, asking congressional budget negotiators to clearly state in their final agreement Congress’ intent to spare all user fees from the sequester.
No one will benefit from a guardian angel that safeguards investors right out of the market, the SEC was told Thursday at a small business forum on capital formation.
