Naturmade Essentials relaunch will be backed by TV ads in the fourth quarter, while print ads continue. The line is being rebranded to combine all Nature Made multivitamins and add four multi/herbal combos: gingko biloba, kava kava, ginseng and garlic & soy (1"The Tan Sheet" Jan. 24, p. 14). The company's new double-strength SAMe 400 mg is more effective than doubling the dose of its original SAMe 200 mg, Pharmavite says. The extension is sold in 12- and 30-count bottles and is priced the same as the 20- and 50-counts of the smaller dosage product. The 20-count 200 mg SAMe will be available with a 10-count trial size of Super B Complex or a special 24-count bottle for the same price. A $2.5 mil. print ad spend follows a $4 mil. TV campaign in March and April and complements a $900,000 PR spend and $2 mil. budgeted for detailing. Pharmavite has also relaunched CalBurst calcium chews with improved chocolate flavor and new vanilla
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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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A new pilot aims to take Brazil closer to ‘digital transformation.’
Mexico’s drugs regulator will be able to grant quicker drug approvals based on decisions issued by World Health Organization listed authorities and founding ICH members.
Biogen has U-turned on its original decision not to file Qalsody for marketing approval in the UK for treating certain patients with amyotrophic lateral sclerosis. The move appears to have been triggered by a change in the reimbursement pathway agreed for the product.
Just a week and a half into his tenure at the agency, the new CDER Director George Tidmarsh was also tapped to serve as acting head of CBER. Prasad’s swift ouster at CBER may point to a softening in cell and gene therapy regulation but could also portend even more scrutiny on vaccines.
