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Gene Therapy Reimbursement: Is Blindness A Bad First Test?

The first gene therapy approval could be coming soon – followed shortly by the first ever gene therapy coverage decision. An Express Scripts executive argues that the tone may be affected by the initial indication.

Pricing Debate Reimbursement Cost Effectiveness

Point-Of-Sale Rebates In Part D: Study Highlights Trade-Offs For Medicare

Analysis funded by Pharmaceutical Care Management Association concludes that using drug rebates to lower beneficiary cost sharing at the point-of-sale would raise premiums and increase government spending.

Pricing Debate Pharmacy Benefit Management Medicare

FDA's Budget Flat In House Bill, But Path For 'Cures' Funding Cleared

US agency's budget authority would remain at current level under FY 2018 appropriations bill reported out by a House subcommittee; measure includes language enabling FDA's Oncology Center of Excellence to receive 21st Century Cures funding transferred from National institutes of Health.

Legislation FDA Regulation

Best Of Biosimilar Agreement: FDA, Industry Tout Written Response, Pre-Submission Meeting

FDA's Leah Christl and Amgen and Sandoz representatives discuss key achievements of BsUFA II at DIA meeting; Christl expects to see interchangeable biosimilars come to market within the next two years.

BioPharmaceutical Regulation Biosimilars

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

BeNeLuxA Medicine Access Collaboration Plans Joint Horizon Scanning

Belgium, the Netherlands, Luxemburg and Austria are continuing their collaboration on improving access to medicines and are finalizing a proposal on a joint horizon scanning initiative.

Drug Review Health Technology Assessment Market Access

Latest From Regulation

Two New Italian €500m Funds for Innovative Drugs for Cancer, Hep C

New medicines for hepatitis C and cancer are among innovative therapies benefiting from two special funds set up by the Italian government.

Reimbursement Italy

Australian Industry Rejects Planned Tendering System For Off-Patent Drugs

Plans to introduce a tendering system for off-patent medicines have been sharply criticized by originator and generic industry bodies in Australia, but proposals for a fully operational electronic prescribing and health record system have met with a warmer reception.

Generic Drugs Government Payers

Generic Industry Gets 267 Reasons From FDA To Pursue ANDA Development

US agency’s list of off-patent, off-exclusivity drugs that lack generic versions is aimed at improving transparency and encouraging competition, but almost half the 267 listed products involve complex issues that would require further decision-making by FDA ahead of ANDA submission.

Generic Drugs Drug Approval Standards

Latest From Policy

Insider Trading: Ex-Ariad Staffers Charged With Using FDA Info On Iclusig

Former directors of pharmacovigilance and risk management agree to pay disgorgements and civil penalties in SEC complaints charging them with trading in Ariad stock in advance of FDA announcements about the leukemia drug Iclusig.

Legal Issues FDA

Chief Scientist At US FDA Is Hinton As Borio Moves To White House

Luciana Borio is detailed to National Security Council; FDA promotes Denise Hinton to acting chief scientist.

FDA Policy

FDA Getting Reg Slashing Directive In Trump Executive Order

Draft order wants "comprehensive review" to find regulations that that "unnecessarily increases expenses" for patients, researchers, and manufacturers.

Pricing Debate Generic Drugs

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

Big REVEAL: Merck's Anacetrapib Surprises With Success, But What Next?

The positive top-line results for Merck & Co's cardiovascular outcomes trial for its CETP inhibitor anacetrapib may not be enough to de-risk the class, and questions remain about the level of clinical benefit and the regulatory options.

Cardiovascular Clinical Trials

Esperion Expects Speedy Regulatory Path For Bempedoic Acid/Zetia Combo

Company plans to file the fixed-dose combination through FDA's 505(b)2 pathway, alongside a filing for bempedoic acid itself.

Review Pathway Cardiovascular

US FDA Updates Clinical Trial e-Reporting, e-Signature Guidance To Keep Up With Tech

In a draft guidance on electronic signature and record requirements for clinical trials used to submit applications across FDA product centers, the agency responds to technological advances since it last issued guidelines almost 15 years ago, while keeping its narrow enforcement of the "Part 11" rules in place.

Clinical Trials Research & Development

Commercial Explore this Topic

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Latest From Commercial

Best Of BIO: Policy & Regulatory Updates From BIO 2017

Antibiotic incentives, vaccine strategies, drug pricing, patent updates and more hot topics from the Biotechnology Innovation Organization's recent annual conference.

ImmunoOncology Market Access

Prestige Brands Updates PediaCare NDC Information A Year After Sale

The OTC drugs and personal care products company will correct Structured Product Labeling information in the US NDC Directory for PediaCare Children’s Plus Multi-Symptom Cold and Children’s Plus Flu to include one of the products' active ingredient, phenylephrine.

Commercial Regulatory

Value & Pricing Perspectives From ASCO, In Brief

Round-up of commentary on oncology drug value and costs during the American Society for Clinical Oncology annual meeting, including value frameworks, ways to lower drug costs and payer data.

Pricing Debate Health Technology Assessment

Manufacturing Explore this Topic

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Latest From Manufacturing

EU To Defer US GMP Inspections Ahead Of Mutual Recognition Agreement Becoming Operational In November

EU inspectorates are putting off their plans to undertake any good manufacturing practice inspections in the US wherever possible, in anticipation of the EU-US mutual agreement coming into force in November.

Manufacturing Regulation

FDA Offers To Expedite 'Priority' ANDA Reviews By Previewing Facility Information

An FDA guidance lists the criteria for reviewing “pre-submission facility correspondence” that permits expedited approval of priority generic drugs by allowing facility information to be reviewed prior to the submission of an ANDA. This mechanism was established by GDUFA II.

Manufacturing Quality

White House Mulls Proposal To Pause FDA's Quality Metrics Initiative

Trump administration briefing materials show that the pharmaceutical industry's complaints about FDA's quality metrics initiative are getting high-level attention.

Quality Manufacturing

Consumer / OTC Drugs Explore this Topic

Set Alert for Consumer OTC Drugs

Latest From Consumer

Safecor Recalls Acetaminophen, Calcium Vitamin Following GMP Citations

Safecor Health's recalls, recently categorized as class II by FDA, began in July 2016, a month after FDA's Office of Regulatory Affairs cited GMP problems at the firm's Columbus, Ohio, facility.

Consumer Recalls

Perrigo Predicts Upturn On OTC Private Label Breadth, Depth And Bandwidth

Perrigo counts on its OTC private label dominance to thwart new store brand entries and give it a leg-up in e-commerce sales, which are growing at 50% year-to-year. Private label is "a distinctly different business than the national brand space," says consumer health executive Jeffrey Needham.

Consumer Prescription To Otc Switch

Oral Contraceptive Switch Advocates Reject User Age As Approval Factor

FDA could soon receive an NDA from non-profit research group Ibis Reproductive Health and HRA Pharma, for an oral contraceptive switch in the US.

Prescription To Otc Switch Consumer