Drugs

Biopharm Companies Need New Engagement Plans: Analysis

APCO Worldwide says that while the biopharmaceutical industry’s reputation remained stable since last year, there is little reason to believe it will continue in a positive direction without a shift in engagement strategies. The firm’s Return our Reputation study says the central industry vulnerability is a doubt about its purpose. “To keep balance in favor of strengths (what the industry does) and not tip to the criticisms (how it behaves), there must be certainty that the industry is at the service of public health,” writes APCO Insight director Chrystine Zacherau. “In this context, maintaining a positive direction is unlikely, and is seen as the reputation of specific companies are declining during the same period of time.”

Zacherau says that in the past year the industry had to confront a uniquely hostile social and political environment. “Now is the time for engagement,” she concludes. “The combination of unprecedented levels of civic activism with growing concern about companies’ conduct will keep the spotlight shining on the pharmaceutical sector. Scientific discovery must be connected to everyday value, not investment portfolios. And, the doors of companies must open to reveal researchers, doctors, nurses, and public health experts, not sales teams.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome