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Coppertone ‘Assurance Assessment’ Anticipates Criticism From Sunscreen Reviews

Bayer shares results from a consulting firm's assessment of its operations, procedures and testing at the root of Coppertone SPF claims and other labeling aspects. The firm could get in front of a conversation that tends to arise this time of year regarding sunscreen safety, effectiveness and truthfulness in marketing.

Commercial Business Strategies

Robert Califf Talks Verily, Hopes Gottlieb Can Push Back On Trump

Former US FDA Commissioner is joining the health-technology firm Verily, a Google spin off. In a podcast interview he discusses his new advisory role with the company and expresses his hope that new FDA Commissioner Scott Gottlieb would stand up to any 'whimsical directives' from President Trump.

FDA Legislation

Amgen's Repatha Contract With Harvard Pilgrim Includes A Full Refund

Harvard Pilgrim Chief Medical Officer Michael Sherman said the full warranty behind the agreement is the right kind of deal to balance access and cost.

Reimbursement Pricing Strategies

Neurocrine's US Label For Ingrezza Should Provide Edge Over Teva's Austedo In TD

A summertime battle is expected between Neurocrine and Teva once both companies get their tardive dyskinesia drugs on the US market, but Neurocrine's April 11 approval for Ingrezza without an FDA warning label is already giving the biotech an edge.

Approvals Business Strategies

Hawaii's Proposed Oxybenzone Sunscreen Ban Fails Science Test – CHPA

CHPA commits to fighting against onslaught of bills in Hawaii aiming to ban or limit the use of oxybenzone-containing sunscreens, says CEO and President Scott Melville during his address on 2017 priorities during the CHPA Annual Executive Conference in Amelia Island, Fla. March 21.

United States Consumer

Pain Therapeutics Confident It Has US Approval Pathway Set For Remoxy ER

Biotech says it can complete two FDA-mandated studies by year-end and re-file the NDA rejected three times previously by the US agency. Pain Therapeutics also says it will not attempt to commercialize the abuse-deterrent opioid product without a partner.

Drug Approval Standards Complete Response Letters
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