Perrigo predictor: Private label firm unveils its Easy Ovulation Predictor, equivalent to Inverness Medical Innovations' Clearblue Easy, at the Private Label Manufacturers Association trade show Nov. 16-18 in Chicago. The seven-test kit will ship in January. Perrigo also launched adult low-strength aspirin, a national brand equivalent (NBE) to McNeil Consumer & Specialty Pharmaceutical's St. Joseph's. The 81 mg coated tablets come in a 180-count bottle. Separately, the Allegan, Mich.-based firm received approval this month for a product comparable to Aleve Cold & Sinus...
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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ZIN, the Dutch health technology assessment body, estimates that the number of patients eligible for treatment with a PARP inhibitor will be halved following a reassessment of drugs in the class.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
Extended-release stimulants will add a new ‘Limitation of Use’ about weight loss in children under 6 years, reflecting concerns about overuse from the Make America Healthy Again commission, a concern multiple studies did not find valid.