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).
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.
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.
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.
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.
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.
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.
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.
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.
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.