Health

Slow adoption of alternatives to animal testing in the current decentralized regulatory framework.

Requests for “enforcement actions are not within the scope of FDA’s citizen petition procedures,” CDER says, rejecting petition dosing device firm Parenteral Technologies submitted as it prepares for workshop on Pediatric Research Equity Act requirements for OTC NDA sponsors.

FDA grants de novo authorization to Healgen Rapid Check COVID-19/Flu A&B Antigen Test, making it the first OTC flu test to be cleared outside the emergency use pathway.

UK pharma also reaches agreement in principle, subject to DoJ approval, to pay $70m to resolve a whistleblower complaint filed by Valisure, the testing lab which in 2019 raised concerns about a potential link between the use of drugs containing ranitidine, a histamine-2 blocker, and cancer.

A round-up of the latest appointments in Europe's consumer health industry: Dr Reddy's hires UK head; Mayoly names CEE lead; NèreS adds director.

Requests for “enforcement actions are not within the scope of FDA’s citizen petition procedures,” CDER says, rejecting petition dosing device firm Parenteral Technologies submitted as it prepares for workshop on Pediatric Research Equity Act requirements for OTC NDA sponsors.

Control of Sanofi Consumer Healthcare – recently rebranded as Opella – may soon pass to US private-equity firm CD&R but the French firm looks set to retain a substantial stake in a business which has some big Rx-to-OTC switches in the pipeline.

Bayer adds dry eye treatment to its Bepanthen skin care range; Stada launches special edition Elotrans supplement for Eintracht Frankfurt fans; Hermes offers chewable magnesium supplement; and Klosterfrau introduces Oyono Night extension to help troubled sleepers maintain their immunity.

Bayer adds dry eye treatment to its Bepanthen skin care range; Stada launches special edition Elotrans supplement for Eintracht Frankfurt fans; Hermes offers chewable magnesium supplement; and Klosterfrau introduces Oyono Night extension to help troubled sleepers maintain their immunity.

UK consumer healthcare industry association PAGB is calling on the UK government to explore the Rx-to-OTC switch of at least 25 OTC products over five years, and work with the country's medicines agency to re-evaluate the restrictive criteria for reclassification. 

In addition to its recently established Precision Health division, Bayer Consumer Health is using artificial intelligence to save time on routine tasks and to manage supply and demand, the firm’s head of digital transformation and IT, Cristina Nitulescu, tells HBW Insight.

To coincide with Stoptober – an annual campaign that encourages smokers in the UK to quit smoking for the month of October – Kenvue has launched a digital “branded entertainment” series for smoking cessation brand Nicorette that follows smokers on their quitting journeys.

UK consumer healthcare industry association PAGB is calling on the UK government to explore the Rx-to-OTC switch of at least 25 OTC products over five years, and work with the country's medicines agency to re-evaluate the restrictive criteria for reclassification. 

In addition to commentary and information about the OTC drug, dietary supplement and cosmetic industries, speakers offered candid remarks on subjects well known across the consumer health industry or well recognized by consumers.

“It's really the elected officials who are making the final determination on what happens. They're really the owners of the teams, you guys in the industry are playing the game we’re refereeing,” FDA Commissioner Robert Califf says at Consumer Healthcare Products Association conference.

An end to litigation filed by institutional investors, insurance companies and pension funds comes four CEOs after Perrigo's chief exec during Mylan's tender in 2015, Joseph Papa, resigned to lead another firm in 2016. Plaintiff attorneys are asking for up to 20% of settlement in fees.