We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended six drugs for approval following its recent meeting, including products to treat intolerance to sunlight, ovarian cancer, oestrogen deficiency and hemophilia B. Read More
Drugmakers may soon have to report to the FDA how they decide when to launch a corrective or preventive action (CAPA) investigation, if they have a performance index for their product’s critical quality attributes and the seniority level of the employee who signs off on the annual product review. Read More
Generics giant Mylan confirmed its intention to merge with Abbott Laboratories and reincorporate in the Netherlands early next year, a move that comes as other U.S. pharma companies have abandoned their plans to move overseas in the face of new U.S. tax rules. Read More
A federal judge has struck down Mylan’s Paragraph IV ANDA challenge against Pfizer’s blockbuster cancer drug Sutent, ruling that the therapy’s patents are not invalid. Read More
The UK’s cost-effectiveness watchdog has recommended coverage of Bayer’s blood thinner Xarelto for preventing blood clots in people who have had a heart attack based on evidence the drug can decrease the cardiovascular risk by up to 20 percent. Read More
Actavis’s birth control pill Lo Loestrin FE is safe from generic competition for the moment after a federal appeals court reaffirmed a lower court’s decision finding that ANDAs by generics makers Lupin and Amneal infringed the drug’s patent. Read More
European regulators say they are prepared to start a continual assessment of data on experimental Ebola treatments as soon as they receive each submission. Read More
Generic drug prices in Canada are up to seven times more expensive than those in comparable countries, according to a study that challenges a major price-setting deal between Canadian generics firms and provincial governments. Read More
To avert drug shortages, Health Canada has partially lifted an import ban on products from three Indian manufacturing facilities that were barred from doing business in the country due to quality violations. Read More
The UK healthcare cost watchdog gave the final green light for national coverage of GlaxoSmithKline’s skin cancer drug Tafinlar, a decision that was made in record time, according to the drug’s evaluators. Read More
The president-elect of the European Commission said yesterday that oversight of EU drug policy will remain under the health directorate, marking an about face on a decision last month that would have switched the responsibility to the industry department. Read More