FDAnews Drug Daily Bulletin

Sponsors of new drugs seeking approval with a companion in vitro diagnostic (IVD) need to work with trial sites to ensure they are not prescreening patients by local test methods — a process that can prove fatal for regulatory approval, an expert says.

To meet the dual challenges of drug discovery — developing new compounds faster and at less cost — drugmakers should consider forming more integrated partnerships where company staff and academic scientists work side-by-side, one expert suggests.

The Generic Pharmaceutical Association’s (GPhA) plan to help the FDA deal with drug shortages should launch in the coming weeks, after the FTC found it will not be anticompetitive as sensitive information will be protected.

PhaseBio Pharmaceuticals has commenced patient dosing in a multicenter Phase IIb trial designed to evaluate the efficacy and safety of three doses of once weekly Glymera compared to matched placebo as well as an active comparator for the treatment of uncontrolled Type 2 diabetes.

A former Abbott Laboratories saleswoman has filed a federal lawsuit against the company, accusing it of illegally promoting its cholesterol drug TriCor for uses not approved by regulators, including the prevention of cardiac health risks in patients with diabetes.

Wockhardt has received tentative FDA approval for marketing a generic version of 20-mg, 40-mg, 60-mg and 80-mg capsules containing Ziprasidone hydrochloride, which is used in the treatment of bipolar disorders and schizophrenia.

Although nearly 250 companies are working in the breast cancer treatment space, growth in the market will be driven by the uptake of three new drugs over the next 10 years and will plateau by 2018, according to a new market analysis from Decision Resources.

Biologic drug sponsors may have a powerful weapon to block competition from cheaper biosimilars, experts say, if they can successfully argue that the generic drug law’s safe harbor from patent infringement expires the moment a drug wins regulatory approval.

Alexza Pharmaceuticals announced the company has received its EU Certificate of GMP Compliance of a Manufacturer.