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Amgen is recalling nine lots of its anemia drug Aranesp after a small number of syringes were found to potentially contain cellulose and/or polyester particles. Read More
The National Institutes of Health is asking pharmaceutical manufacturers, wholesalers and repackagers to submit samples of their pills as part of an ongoing push to better identify drug products. Read More
Two FDA advisory panels last week overwhelmingly recommended the agency not approve Clarus Therapeutics’ Rextoro testosterone replacement therapy. Read More
House lawmakers are making a new push to pass stalled legislation that would enable the FDA to accept less clinical data to approve antibiotics, the latest effort from the federal government to combat the spread of drug-resistant infections. Read More
The FDA is moving to ease industry fears that ANDAs filed after September of this year will receive priority over earlier applications simply because they were filed before the law required the agency to assign review deadlines to new applications. Read More
A new bipartisan House bill would stop brandmakers from relying on a drug-control program to deny generics firms the batch samples they need to put together an ANDA. Read More
GlaxoSmithKline must pay a fine of roughly $490 million and change its business practices in China after a Chinese court found the company guilty in a year-old bribery case. Read More
The FDA approved Eli Lilly’s diabetes drug Trulicity as a once-weekly subcutaneous injection to improve blood sugar levels, along with diet and exercise, in adults with the type 2 form of the disease. Read More
A federal effort to spur the development of new drugs to treat antibiotic-resistant infections comes as the industry warns the antibiotics pipeline is running dangerously low and more financial incentives will be required to encourage development in this area. Read More
The UK’s health-cost watchdog has recommended coverage of GlaxoSmithKline’s melanoma drug Tafinlar, but is requiring GSK to provide a discount on the product. Read More