Archive for June 2016
FDA Suggests 5-Point Scale to Measure Topical Patch Adhesion
Drugmakers submitting ANDAs for products using transdermal delivery systems are expected to demonstrate that they made “reasonable efforts” to optimize the adhesive characteristics of their patches, the FDA says. Source: Generic Line
Read MoreIndustry: Workforce Bill Would ‘Hinder’ Quality of Biosimilar Market
Industry groups are worried that a section of the proposed FDA and NIH Workforce Authorities Modernization Act would exempt biologics from adhering to U.S. Pharmacopeial standards for quality. Source: Generic Line
Read MoreEuropean Regulators Propose Fast Tracking Generic Drugs to Lower Prices
European regulators are proposing a series of indirect methods for driving down prescription drug costs without stepping outside the science-focused parameters of their roles. Source: Generic Line
Read MoreHigh Court Denies Merck’s Appeal on Cubicin Patents
The U.S. Supreme Court has paved the way for Pfizer’s Hospira to develop a generic version of a Merck unit’s skin infection therapy after denying an appeal to uphold several of its patents. Source: Generic Line
Read MoreIndustry Calls on FDA to Establish Working Groups
As the FDA makes plans for its GDUFA-mandated fiscal 2017 Regulatory Science Plan, industry trade groups are pushing the agency to spend more time communicating its intentions. Source: Generic Line
Read MoreAmgen Sues Sandoz Over Biosimilar Application for Neulasta
Amgen is suing generics maker Sandoz, claiming that Sandoz’s attempts to market a biosimilar for the blockbuster bone marrow drug Neulasta infringes on two of its patents for the drug. Source: Generic Line
Read MoreStudy: Generic Cancer Drugs Priciest in U.S., Least Affordable in India, China
While retail prices for generic cancer drugs may be the highest in the U.S., these medicines aren’t necessarily affordable in poorer countries such as India and China despite their lower prices, according to a study. Source: Generic Line
Read MoreGeneric Drug Complete Response Letters Finally Drop in May
Complete Response Letters for generic drug applications have finally taken a dip in 2016. Source: Generic Line
Read MoreBiocad Sues Roche Over Alleged Predatory Pricing Practices of Biosimilars
Biopharmaceutical firm Biocad has filed suit against Roche and its Genentech subsidiary over their alleged use of predatory pricing practices in Russia to decimate the sales of the Russian drugmaker’s biosimilars. Source: Generic Line
Read MoreStudy: Physicians Confused Over Biosimilar Product Differences
The majority of physicians in the U.S. are familiar with biologics and biosimilars, but many lack the technical knowledge of their structural and therapeutic differences. Source: Generic Line
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