Two-and-a-half years after receiving a complete response letter, Teva's ANDA clears FDA; agency issued three guidances for development of generic epinephrine auto-injectors.

Trial protocols, annual reports, and adverse event reports on gene therapies now only go to US FDA, a signal that the products can be regulated like other drugs and biologics.

Amid aftermath of latest vaccine scandal, top officials including China’s drug reform flagbearer are forced to resign, sending shock waves across the industry.

HHS meeting with stakeholders may lead to adjustments to plan for implementing step therapy in Medicare Advantage for Part B drugs.

Proposed list of topics for review in 2019 by the Institute for Clinical and Economic Review includes a total of 15 drugs but that could change as the year goes on.

"Tipping point" occurred when Phigenix changed theory that Genentech's Kadcyla infringed its patent; CEO may be on hook for attorneys' fees.

What is claimed to be the first therapy targeting the underlying cause of Huntington’s disease and a gene therapy for Lorenzo’s Oil disease have become the latest investigational products to make it onto the European Medicines Agency’s priority medicines scheme.

Private start-up's acebilustat failed to improve lung function in Phase II, but the anti-inflammatory showed large numerical reductions in pulmonary exacerbations, which can be fatal.

Vertex says it will not file data on its cystic fibrosis drug Symkevi (tezacaftor/ivacaftor) until the UK's NICE changes the way it assesses drugs.

Submitting an OTC switch of Nasonex would be a first for Perrigo, as would marketing a national brand OTC if the switch is approved. In tandem with announcing divesture of Perrigo's Rx business, CEO Uwe Rohrhoff says marketing national brands in some OTC categories fits in the company's "value-creation road map."

Beginning in 2019, Medicare Advantage plans may use step therapy in Part B, potentially including “cross management” with Part D drugs, under new guidance from the Centers for Medicare and Medicaid Services.

Amid aftermath of latest vaccine scandal, top officials including China’s drug reform flagbearer are forced to resign, sending shock waves across the industry.

FDA is seeking input from an advisory committee on the use of a more data-driven model the agency is exploring to standardize quality assessment in generic drug reviews. Agency officials explain that model could help expedite the review of generic drugs to meet review goals under GDUFA II. 

Or perhaps it's been a week of intriguing international events in global drug quality, as an international group works to ratchet up global standards, regulators aim to ease the coming UK/EU divorce and the US and China play their hands in a tariff poker match. Meanwhile, US FDA looks to avert labeler code crisis, Quebec API firm comes clean about missing identity testing, and US firm recalls drug product based on FDA’s API supplier inspection findings.

While FDA does not identify specific product types on the agenda for its public workshop on approaches in skin toxicity testing for topical drug products, advocacy and trade groups anticipate sunscreen ingredient testing could be among the discussion topics. Product expansions have been stifled by regulatory concerns, drawing particular attention from the public health community.

Recalls include one lot of CVS Health Sinus Relief manufactured by Product Quest Manufacturing, Walmart's Equate laxative made by Lupin's US office and 12 cough and cold products marketed under Preferred Plus Pharmacy and other private label brands and made by RIJ Pharmaceutical Corp. Chart provides update on recent US OTC recalls.

"We're investing more to drive growth as we allocate capital to support the launches of new products in the segment like Lumify, for DTC advertising that continue to drive sales growth of other US consumer products like our eye vitamins," says CEO Joseph Papa.