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In Brief

Prestige Brands growth argues against Genomma bid; Abbott Nutrition refutes China research report; FDA expects annual doubling of supplement AERs; FTC settles with acai online marketers; Schiff Nutrition revises full-year sales growth guidance upward; more news In Brief.

Prestige Brands Holdings Inc.expects sales in its current quarter will grow 38% year-over-year to $96.4 million, an announcement that comes as the OTC firm fends off a hostile takeover bid by Genomma Lab Internacional SAB de CV. In its fiscal 2012 fourth quarter ending March 31, Prestige projects adjusted net income will increase 84% to $11.8 million, though with the costs of acquiring and integrating brands from GlaxoSmithKline Consumer Healthcare LP, Prestige expects to report a net loss of about $2.3 million. Irvington, N.Y.-based Prestige has accused Genomma of trying to acquire it at a low price, before the value of the GSK deal is fully accretive ([A#05120319001]).

[Abbott Nutrition] refutes allegations by Hong Kong financial analysis firm CER Research that a Similac infant formula product in China...

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• By Neena Brizmohun

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.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Nielsen Hobbs

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Nielsen Hobbs

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

A new pilot aims to take Brazil closer to ‘digital transformation.’

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Room For Improvement? EU Industry Prepares Feedback For SPC Manufacturing Waiver Review

 
• By Dave Wallace

As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.

Report Shows Extent Of AI Use In EU Medicines Regulation During 2024

 
• By Eliza Slawther

The AI observatory, created by the European medicines regulatory network to track the evolving use of artificial intelligence in medicines development and regulation, has issued its first annual report.

Prasad Cites Unproven Theory Defending His COVID-19 Vaccine Decisions

 
• By Sarah Karlin-Smith

In defending his decision to overrule agency staff on three recent COVID-19 vaccine applications, the CBER director questioned the original timing of Pfizer’s COVID-19 vaccine authorization, reviving a long-held, but unproven grievance of President Trump.