Perrigo Co. PLC's branded consumer health product business needs the firm's private label business "standards" and the help of the company president after tripping over unexpected costs, ill-timed advertising and other problems in late 2015.
Perrigo OTC Brand Journey Detours Into Management, Operating Problems
The firm's report of problems in its European branded product business during its earnings briefing prompted a sharp dip in its share price, closing down more than 10% at $130.40, and left analysts looking for its private label OTC business to continue as its growth driver.
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A German ordinance implementing the EU Health Technology Assessment Regulation offers little clarity on how far joint clinical assessment reports should be considered by national authorities.
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Payers and health technology assessment bodies in the Netherlands, Germany and Italy are either unwilling to use real-world data in assessments or cannot due to their existing frameworks, say representatives from Gilead Sciences and Autolus Therapeutics.
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An ordinance came into effect on 8 March to ensure that joint clinical assessments can be incorporated into the German pricing and reimbursement system.
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Trial sponsors in Germany should start preparing negotiation strategies to tackle difficult discussions with trial sites over standardized clauses.
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In a historic move for Africa, five products have been backed for approval via a pilot that tested a continental listing process.
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Pharmaceutical companies are being encouraged to reach out to NICE in relation to its HTA Innovation Lab, which provides a sandbox environment in which the health technology assessment body can test new methods of evaluating “innovative and disruptive” therapies.
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The weight management drug, Mysimba, continues to demonstrate a positive benefit-risk balance but the data available are not sufficient to fully determine the cardiovascular safety beyond 12 months. Meanwhile, Currax this month announced the publication of a peer-reviewed study of Mysimba that followed patients for over 4.7 years and found no evidence of excess cardiovascular risk.