Whether converting positive sputum culture to negative will lead to an improvement in how a person feels, functions or survives is at the heart of agency’s review of Insmed’s amikacin liposome inhalation suspension for accelerated approval in mycobacterial lung disease.

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.

Of the 27 suits brought so far, four have resulted in patent settlements; restarting patent dance is new trend for ongoing litigation.

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.

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.

Max Cold & Flu All-In-One is the first Mucinex product providing an “all-in-one-and-done proposition" and is expected to offset the impact of private label products. Mucinex plus growth and expansion plans for infant formula spark increase in firm’s 2018 forecast.

FDA chastised Chinese API maker for inadequate cleaning validation, failing to ensure that products are manufactured in a state of control, and lax stability testing practices. The agency noted that the firm did not learn from observations the agency made of similar mistakes during previous inspections.

As Zhejiang Huahai works to rid its valsartan API manufacturing process of NDMA impurity, two competitors also have launched recalls after discovering the probable carcinogen in their valsartan API. Meanwhile, US FDA confronts Huahai over handling of impurities that visited chromatograms in the form of ghost peaks.

FDA guidance aims to establish uniform dissolution testing methods for highly soluble immediate-release solid oral dosage forms.

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.

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."