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Contract OTC manufacturer Gopers Int. doesn’t have a quality control unit, keep batch records or properly train its employees, according to an FDA Form 483 that features a litany of quality violations. Read More
Luitpold Pharmaceuticals was chided by the FDA for failing to properly investigate how severe roof leaks in 2013 and 2014 affected production. Read More
Three European industry groups are asking the European Commission to block an Italian law that encourages off-label drug use, saying it is driven entirely by economics at the expense of patient health. Read More
Bristol-Myers Squibb and Pfizer’s Eliquis won a positive nod in the UK, with the National Institute for Health and Care Excellence deeming it clinically effective and cost-effective in treating and preventing blood clots in the lungs, pelvis, legs or arms. Read More
Gilead Sciences has ratcheted up efforts to get the Supreme Court to hear a double patenting lawsuit, arguing the Federal Circuit’s ruling invalidating patent protection for its influenza drug Tamiflu effectively rewrites the obviousness-type double patenting doctrine. Read More
Particulate contamination and a labeling error prompted Hospira to recall single lots of two injectable drugs, 0.9 percent sodium chloride injection and magnesium sulfate injection in 5 percent dextrose. Read More
Clinical trial sites using software to obtain patients’ informed consent remotely should make sure that data is stored securely, the FDA says in Friday draft guidance on handling electronic informed consents. Read More
China is opening its market to biosimilars, issuing the country’s first-ever guideline on the technical review of the products and criteria for establishing biosimilarity. Read More
The FDA Friday gave a green light to the first U.S. biosimilar, finding Sandoz’s Zarxio clinically comparable to Amgen’s blockbuster chemotherapy product Neupogen. Read More