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Worries About 180-Day Exclusivity Reforms Persist As User Fee Bill Advances

FDA-crafted legislative text emerges that generic industry says could weaken the incentive, but so far no changes are in the draft House and Senate bills.

Generic Drugs Legislation

Copay Assistance Can Be Excluded From Medicaid ‘Best Price’ Without Strings Attached – US Court

Decision is a win for the Pharmaceutical Research and Manufacturers of America in lawsuit against the US Health and Human Services Department.

Medicaid Legal Issues

PK Evaluation In Pregnancy: Can HIV Show A Way Forward?

US FDA workshop on efforts to advance pharmacokinetic data collection in pregnant women highlights the (slow-moving) antiretroviral experience, but COVID therapies show that regulatory receptiveness is a poor match for recruitment and liability concerns.

Regulation Research & Development

At Solicitor General’s Urging, Supreme Court May Take Up Patent Eligibility Dispute Riling Biopharma

Federal Circuit’s rulings on subject matter patent eligibility have fractured the court, the US government says in advising the high court to review American Axle v. Neapco to provide clarity. BIO, former PTO director Kappos and Sen. Tillis also urge Supreme Court to hear the case.

Intellectual Property Legal Issues

FTC And PBMs: Support For Investigation Building But Outcome May Ultimately Disappoint Critics

Federal Trade Commission’s ‘pro-competitive’ perspective could support conclusion that pharmacy benefit managers serve useful role in lowering drug costs, health policy expert suggests. FTC will get an earful about PBM practices, but ‘those complaints could be an indication that competition is working.’

Reimbursement Market Access

Inter-Agency User Fees? US FDA/ARPA-H Relationship Could Get Interesting

The Biden Administration’s signature health research agency ARPA-H is still in the formative stages. Authorizing legislation moving through Congress could set up a very interesting dynamic when it comes to working with the US FDA.

FDA Research & Development

Surprise US FDA Facility Inspections Resume In India

Unannounced facility visits also were to start again in China, but FDA Commissioner Robert Califf said they have been delayed by the COVID-19 outbreak in the country.

Manufacturing India

House GOP Targets US FDA Applications With China-Only Data, Cites General Oversight Concerns

While industry concern with FDA’s policy shift on clinical data from China has focused on the disruption in business plans, Republican lawmakers appear to feel that the agency has not gone far enough and are seeking a GAO review of FDA’s entire bioresearch monitoring program.

Clinical Trials China

US FDA To Explore New Regulatory Pathways For Some Cellular Products

Agency re-evaluating criteria for certain human cells, tissues and cellular and tissue-based products (HCT/Ps) that are not ideally regulated as BLAs; industry suggests a 2014 guidance which created an alternative pathway for cord blood products could serve as potential template.

Regenerative Medicine Biologics

US FDA Supply Chain Guidance Includes More Stakeholders, More Risks Than CARES Act

Draft guidance on redundancy risk management plans layers risk-based expectations over new statutory requirements to plan more resilient supply chains for critical drugs.

Supply Chain Quality

Senate Commerce Leaders Want An FTC Study Into PBM Business Practices – And More

Committee Chair Maria Cantwell (D-Wash.) solicits advice from witnesses for additional authorities to conduct oversight of PBMs and pushes for a GAO study.

Pricing Debate Policy

Inhaler Changes For Environmental Reasons Worry Generic Sponsors, Prompt Call For FDA Research

ANDA sponsors say eliminating the HFC propellant, while important to help address climate change, could upend the generic market without guidance from the US FDA.

Generic Drugs Combination Products
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