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The U.S. biotechnology industry has endorsed a recent World Health Organization proposal to give biosimilar products a unique name qualifier that distinguishes them from the reference products’ nonproprietary name, a proposal that may run counter to naming protocols in the generic drug industry. Read More
The FDA delivered its fifth warning letter to a compounding pharmacy in roughly two weeks, admonishing a Texas compounder for poor aseptic processing of sterile drugs. Read More
A Chinese active pharmaceutical ingredient (API) maker was slammed by the FDA for falsifying batch record signoffs and product labeling, the latest international drugmaker to be caught in the agency’s crackdown on poor data integrity. Read More
Actavis initiated a consumer-level recall of its amoxicillin powder for oral suspension in New Zealand after pharmacists found glass particles in two bottles of the liquid antibiotic. Read More
The FDA asked healthcare professionals to watch out for drugs compounded by a Dallas-based pharmacy after a recent inspection revealed 22 lots of sterile drugs failed quality tests. Read More
Ventlab has received an FDA warning letter for its handling of complaints and a corrective and preventive action related to nonconforming manual resuscitation bag components. Read More
German manufacturer Fresenius Kabi’s U.S. subsidiary is recalling nearly 3 million vials of an injectable anti-seizure medication due to glass flakes in sample vials. Read More
Developers of influenza vaccines in Europe will have to conduct additional postmarket effectiveness studies and expand their criteria for evaluating immune responses of products in the clinical testing phase, according to the European Medicines Agency. Read More
Boehringer Ingelheim has sued Amneal Pharmaceuticals over its bid to make a generic version of the brand manufacturer’s anti-stroke drug Aggrenox. Read More
Boehringer Ingelheim’s inhalation spray Striverdi Respimat has received FDA clearance for patients with chronic obstructive pulmonary disease, including those with airflow obstruction due to chronic bronchitis or emphysema. Read More