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Set Alert for US

Paxlovid, Molnupiravir Access Threatened By ‘Dismal' Pharmacy Dispensing Fees, CMS Told

Pharmacy organization urges the Centers for Medicare and Medicaid Services to recommend a dispensing fee commensurate with the effort involved in filling scripts for the drugs.

Coronavirus COVID-19 Government Payers

Califf Confident Public Trust In US FDA Will Be Rebuilt

Commissioner nominee strikes an optimistic note as former FDA heads raise concerns about the decrease in agency credibility during the pandemic.

FDA Leadership

Avastin Withdrawal Showed Accelerated Approval Hearing Process No Easy Task For US FDA

Internal emails show the 2011 hearing on Genentech’s VEGF-inhibitor was taxing for FDA employees, who had to deal with a number of novel issues; the workload is likely to be similarly complex for staff involved in upcoming hearing on Covis’ preterm birth prevention drug Makena.

Pink Sheet Perspectives Review Pathway

US Accelerated Approval: As Makena Withdrawal Hearing Looms, A Look Back At The Avastin Experience

With the public hearing on Covis’ drug for preterm birth prevention expected in 2022, the Pink Sheet talked to several former FDA officials and advisory committee members about their experiences at the 2011 hearing on withdrawal of Avastin’s accelerated approval for breast cancer.

Pink Sheet Perspectives Review Pathway

Avastin Vs. Makena: A Comparative Timeline Of The Two Accelerated Approval Withdrawal Fights

The effort to remove Makena from the market has already lasted longer than the Avastin process from initial advisory committee vote favoring withdrawal until the final order, and the Makena appeal hearing hasn’t even been scheduled yet.

Pink Sheet Perspectives Review Pathway

GAO Examines How US Learned To Use Defense Production Act More Effectively Against COVID-19

Report says agencies took steps to use DPA more effectively, but HHS still working on a strategy for DPA use that will strengthen domestic supply chains and manufacturing.

Manufacturing Regulation

‘Dangling’ Cancer Indications In US: New Year Brings New Withdrawals Of Accelerated Approvals

Gilead pulls Zydelig’s third-line indications in follicular B-cell lymphoma and small lymphocytic lymphoma due to confirmatory trial enrollment challenges resulting from an evolving treatment landscape; 13 cancer indications now have been withdrawn since the FDA began cracking down on accelerated approvals that have not confirmed clinical benefit.

Clinical Trials Review Pathway

Accelerated Approval Makes Big Splash In 2021 Novel Agents, Despite Crackdown On ‘Dangling’ Cancer Claims

US FDA’s accelerated approvals hit a contemporary high in 2021, accounting for one-third of novel US approvals, but the big story was the agency’s crackdown on delinquent confirmatory trials for oncology AA indications.

United States Pink Sheet Perspectives

Merger Enforcement: FTC And Justice Department Casting Wide Net In Considering Changes

Agencies seek public comment on how they can modernize merger guidelines to enforce antitrust laws. List of questions, including what types of evidence show that a merger could reduce competition, indicate pharma and other mergers will face greater scrutiny.

M & A Enforcement

US Supply Chain In Brief: White House Aims To Deliver With Block Stowing And Industrial Base Expansion

Biden administration works to expedite medical supplies and expand medical countermeasures production, while US FDA's DSCSA anti-counterfeiting paperwork burden estimate surges.

Distribution Manufacturing

Culture Wars Reach Labeling For COVID-19 Treatments

Senators ask US FDA to change statements in COVID-19 monoclonal antibody fact sheets that factors like race or ethnicity may place a patient high-risk of serious illness, saying they promote racist decisions.

Diversity & Inclusion Coronavirus COVID-19

Lilly Resolves US FDA Concerns About Emgality TV Ads That Were Not Meant To Run Solo

With the Winter Games approaching, case offers lesson for companies with complex advertising packages. Lilly told the agency two commercials featuring Olympic and Paralympic athletes were intended to run sequentially with another ad including indication and risk information.

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