Monthly Archives: June 2013

Activism Is A Bitter Pill More Healthcare Companies May Have To Swallow

by Barbara Ryan In the next three months it is likely that three healthcare companies will face crucial activist votes.  At Alere Inc., Coppersmith Capital Management, LLC wants the company to sell/divest assets which it believes could allow them to pay down over $3B in debt.  In response, Alere is mounting a Hess style defense, […]
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Strange Bedfellows No More: EMA Moves Closer to Payers

That strict red line between regulatory authorization and market reimbursement is blurring pink – at least in Europe.  At a Drug Information Association [DIA] session earlier this week, European Medicines Agency [EMA] Senior Medical Officer Hans-Georg Eichler confirmed that the agency was finally moving to test the feasibility of a new, “holistic” approach to obtaining […]
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Better Safe than Sorry: Assessing Suicide Risk in Clinical Trials

With the FDA striving to avoid post-market reactions to drugs with worrisome side-effect profiles, preventive measures that screen for obvious risks such as suicidal behavior and abuse potential are making their way into the lexicon of regulators and drug developers alike, in tandem with its mandate that stresses safety first and efficacy a close second. […]
Posted in compliance, FDA, R&D, Regulatory, Safety, Strategy | Tagged , , , , , , , , , | 2 Comments

FTC vs Actavis: Patent Settlements Become More Risky

Pharmaceutical companies can anticipate more costly, drawn-out patent litigation in the wake of the June 17 US Supreme Court decision, which creates great uncertainty about the grounds for negotiating settlements in patent cases. In ruling that “pay-for-delay” arrangements could violate the antitrust laws, and that the Federal Trade Commission (FTC) has the right to challenge […]
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EU Tense as Crunch-Time for Counterfeits Approaches

By Reflector, Pharm Exec’s Brussels correspondent. Tensions are rising in Europe’s pharmaceutical sector as crunch-time approaches for the legislation to combat counterfeits. By this time next year, the European Commission is due to have decided on the mechanisms required to put into effect the European Union’s hugely complex new rules to keep falsified medicines out […]
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