Michael McCaughan
Big Pharma has learned some expensive lessons about compliance with health care fraud laws in the past five years. One...
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The Perils of Part D
The Medicare drug benefit means more federal spending on pharmaceuticals-and more oversight of the industry. Two prominent prosecutors are experienced and ready. The first place they will look: contracting between manufacturers and plans and its influence on the formulary selection process.
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In its latest attempt to curtail generic versions of Hetlioz, Vanda Pharmaceuticals asked FDA Commissioner Martin Makary to reverse a previous agency decision upholding two ANDA approvals, claiming an “unacceptable culture of bias toward approving generic drugs” at the agency.
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Complaint names LillyDirect in action targeting the company’s free nurse and reimbursement support programs for health care providers.
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Aurobindo is confident its planned Lannett acquisition will meet US FTC standards after an attempt to acquire Sandoz assets was nixed in 2020. The deal also could widen Aurobindo’s US manufacturing presence.
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Novartis failed to stop MSN from launching a generic Entresto and saw an earlier temporary ban lifted, potentially opening the market to competition before a final decision on a US patent dispute.
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The inclusion of investigational drugs in the Critical Medicines Act and new provisions on stockpiling are among the raft of amendments the European Parliament has made to the draft legislation.
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A meeting between the European Commission and industry stakeholders has revealed several areas of importance and lessons learned in relation to the EU Health Technology Assessment Regulation, which began to apply to certain medicinal products this year.
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The US FDA’s unprecedented publication of 89 recent CRLs for unapproved products comes with a promise to release future letters more promptly.