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 FDA says developers of next-generation heart drugs, known as PCSK9 inhibitors, will need to present data showing only their effectiveness at lowering cholesterol, blood pressure and inflammation, not reducing heart attack or stroke. Read More
The European Medicines Agency (EMA) has concluded a review of adverse event reporting deficiencies at Roche, concluding the company’s failure last year to report adverse events for 19 drugs did not cause any additional risks to consumers. Read More
Tamper-evident packaging and registered product trademarks are two features Johnson & Johnson (J&J) employs to minimize a product’s risk of being counterfeited or diverted. Read More
Twenty-five drugmakers have agreed to pay the state of Louisiana more than $88 million to settle Medicaid and Medicare fraud charges lodged against them as part of the state’s continuing crusade to recover funds paid out to drug companies improperly. Read More
The FDA has granted “regular” approval for Pfizer’s lung cancer drug Xalkori after conditionally approving it in August 2011 under the agency’s accelerated approval program. Read More
GlaxoSmithKline said Nov. 6 that several new chemical entities identified through its novel drug discovery program, Discovery Partnerships with Academia, are close to being ready for clinical studies. Read More
Today’s regulatory culture is too risk-averse when it comes to drug approvals and risks keeping promising treatments off the market, senior officials at the European Medicines Agency say. Read More
In a new “sunshine” bid, Britain’s brand drugmakers will begin disclosing payments made to physicians in connection with the development or sale of medicines, beginning in 2016. Read More
The European Medicines Agency will accept premarket applications with limited data for antibiotics that target unmet needs, according to an amended guideline on developing antibacterial drugs for multidrug-resistant infections. Read More
An effort to foster better communication between the FDA’s drug and device centers is starting to pay off, with fewer requests for duplicate data on companion diagnostic submissions. Read More