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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
European regulators are asking drugmakers to submit information on products that were part of bioequivalence trials conducted at contract research organization GVK Biosciences’ India facility, after an inspection raised serious concerns about good clinical practice compliance. Read More
Manufacturers of new drugs, biologics and biosimilars will pay slightly more in user fees this fall for their applications, facilities and products. Read More
The FDA expects to collect $312.2 million in generic drug user fees next fiscal year, with companies paying slightly less for each ANDA filing and facilities that produce active pharmaceutical ingredients (API) and finished generic products paying more. Read More
Difficulties finding the right patients for clinical trials and high active pharmaceutical ingredient costs are among the most pressing challenges in bringing new antibiotics for resistant infections to market. Read More
Injectables giant Hospira has initiated its second nationwide recall in as many months due to a glass supplier issue that resulted in the presence of particulates. Read More
A group of brand and generic drugmakers has asked a federal judge to toss out a multidistrict class action lawsuit accusing them of colluding to delay generic versions of the painkiller Lidoderm, arguing that a patent infringement settlement between the parties was anything but anticompetitive. Read More