Topic:
Regulatory
Latest Headlines
Latest Headlines
Amgen's Xgeva gets new approval, just not one it wants most
Amgen has gotten an FDA approval for an expanded use of its drug Xgeva, just not the one it covets most. The drug was approved Thursday for treatment of the rare giant cell tumor of the bone (GCTB).
Myriad's Supreme Court loss is Quest Diagnostics' gain
Quest Diagnostics wasted no time after the U.S. Supreme Court ruled that human genes are a product of nature and cannot be patented. Hours after the historic decision, the company disclosed it will offer tests that spot two key breast cancer genetic mutations at the center of the judicial ruling.
In a blow to Myriad, SCOTUS rules human genes as unpatentable
Myriad Genetics faces a potential setback now that the U.S. Supreme Court has ruled unanimously that human genes are products of nature and can't be patented. But the court also came up with a compromise involving man-made gene variations that could benefit the industry.
UPDATED: In mixed decision, Supreme Court throws up a barrier around gene patents
In a mixed decision, the Supreme Court has ruled that companies can not obtain a patent on human genes. But companies like Myriad Genetics will be able to nail down patent protection on complementary gene work, or cDNA, which requires human tinkering.
FDA wants tighter cybersecurity for medical devices
As concerns about the hackability of medical devices mount around the world, the FDA is proposing tighter regulations for manufacturers, suggesting that companies include cybersecurity information along with clinical data when seeking approval.
Zydus recalls warfarin after oversized tablets discovered
The FDA says that Zydus Pharmaceuticals is voluntarily recalling one lot of warfarin 2 mg tablets, after receiving one complaint that four oversized tablets had been discovered.
FedEx vows not to settle with feds on online pharmacy shipments
In April, UPS agreed to pay $40 million to U.S. authorities and admitted doing business with illegal online pharmacies in a deal that kept it from being prosecuted. Competitor FedEx is also a target of the investigation but does not intend to roll over so easily.
FDA comes down on another Indian drugmaker
Just weeks after the FDA issued a ban on products from a Wockhardt plant, another Indian company, RPG Life Sciences, has been issued a warning that accuses it of backdating worksheets, selectively reporting test results and destroying some records of out-of-spec test findings.
FDA setback sends Dynavax shares tumbling again
Dynavax saw its share price tumble in November after FDA advisers suggested its hepatitis B vaccine needed more data to support approval. FDA rejection followed in February, sending shares down still further. Now the stock has dropped for a third time.
FDA clears Sanofi to compete for 4-in-1 flu vaccine market
The 2013-14 flu season is set to be the most closely watched in years. In February, FDA cleared the use of quadrivalent vaccines which protect against two A and two B strains. GlaxoSmithKline and AstraZeneca began gearing up, and Sanofi will now join them too.
