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.
Pfizer will allow Teva to launch a generic of Viagra in the U.S. in 2017 — more than two years before the final patent on the drug expires — under a deal that settles a long-running patent flap. Read More
PhRMA is pushing back against the centerpiece of the FDA’s draft guidance on antibacterial drug development, saying superiority trials for antibacterials that treat drug-resistant infections are “neither routinely possible nor consistently ethical.” Read More
The European Medicines Agency (EMA) has indefinitely postponed a controversial plan to begin releasing to the public detailed information from clinical study reports contained in new drug applications, the central element to its clinical trial transparency initiative. Read More
HHS stands by its final rule expanding the discounts for orphan drugs that hospitals and healthcare providers can apply when used to treat non-rare diseases, the agency said in a court filing opposing PhRMA’s attempts to invalidate the rule. Read More
To satisfy new Australian guidance on supplier qualification for raw materials, drugmakers need to stop using one-size-fits-all questionnaires and adopt screening methods that are specific to the products they are making. Read More
The FDA does not intend to prevent compounders from making preterm birth drug Makena (hydroxyprogesterone caproate), the agency stated in a legal filing last week that outlines how it intends to approach one contentious issue involving compounders. Read More
A citizen watchdog group is again raising concerns about conflicts of interest on FDA advisory committees, charging that the agency should not have allowed a panel member to vote on a drug that a family member was taking. Read More
Looking to add to its growing skin care product portfolio, Valeant Pharmaceuticals said Monday it will acquire medical devicemaker Solta Medical for $250 million. Read More
While breakthrough therapy designation for new drug products has taken off dramatically at CDER, the FDA’s CBER has not moved quickly to approve applications for the new designation. Read More
The FDA plans to mandate that manufacturers of antibacterial soaps and body washes submit clinical outcome study data that address safety and efficacy of their products, regulating them as they would other OTC medications. Read More