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Featured Stories

Bluebird, Vertex Gene Therapies May Answer $1m Question: Can Competition Reduce Rx Prices?

Medicaid is expected to be the primary payer for the sickle cell treatments. Bluebird bio maintains an outcomes-based arrangement is a key part of its access strategy and will overcome what appears to be a significant competitive disadvantage on price compared to the Vertex product.

Reimbursement Gene Therapy Pricing Debate

Gene Therapy: US FDA Labeling For Vertex’s Casgevy, Bluebird’s Lyfgenia Reflect Different Risks

Agency grants same-day approval to the first two gene therapies for sickle cell disease; bluebird’s lentiviral-based lovo-cel carries a boxed label warning on hematologic malignancies, while Vertex’s CRISPR-Cas9 exa-cel carries a warning and precaution about potential off-target effects. Only the Vertex product qualified for a rare pediatric disease priority review voucher.

Approvals Gene Therapy Rare Diseases

Departing Teva Exec Issues Warnings On Popular Shortage Solutions

Before leaving her role as US generics COO, Christine Baeder discussed paying for quality, generic confidence, redundancy and predicting shortages in a Pink Sheet interview.

Supply Chain United States Generic Drugs

FDA Advertising Oversight

FDA Is ‘Getting More Aggressive’ In Going After Drug Efficacy Claims Outside Label

Regulatory experts note there has been an uptick in enforcement letters objecting to efficacy presentations in Rx drug promotions that are not consistent with FDA-required labeling. Panelists at FDLI meeting also discuss the use of real-world evidence in prescription drug promotion.

Advertising, Marketing & Sales Real-World Evidence

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Pink Sheet Podcast

Keep up with latest biopharma regulatory and policy developments with Pink Sheet podcasts.

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Performance Trackers

Keeping Track: US FDA Drugs Center Passes 50 Novel Agent Approvals In 2023

AstraZeneca’s Truqap and Evive’s Ryzneuta bring FDA center for drugs’ 2023 novel agent total to 51, while biologics center already sits on a record-breaking 14 novel approvals.

US FDA Performance Tracker Approvals Drug Review

Global Pharma Guidance Tracker – October 2023

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Guidance Documents Regulation International


Patient-Focused Listening Sessions For Medicare-Negotiated Drugs: Key Takeaways From Round One

Pink Sheet infographic breaks down the mix of patient advocacy groups, individual patients and clinicians offering input to CMS on the first 10 drugs facing Medicare price negotiation.

Reimbursement Medicare

Clinical Trial Diversity Plans: Early Oncology Experience Shows More Work Needed, US FDA Says

Few plans submitted to FDA’s oncology review divisions in the wake of the April 2022 draft guidance were deemed acceptable, with enrollment goals being the most common topic of agency feedback. However, representatives from FDA and industry say the regulatory demand for such plans is pushing sponsors to build diversity into clinical trial programs from the start.

Clinical Trials Diversity & Inclusion

Generics Review Data From US FDA Reveals Positives, Negatives For Industry

While a decline in complete response letters in FY 2023 is good, the continued drop in ANDA submissions could be a bad sign for the industry’s long-term health, a former FDA official worries.

Generic Drugs Review Pathway

Vanda Launches Barrage Of Suits Against FDA Seeking To Retain Hetlioz Market

In 17 suits against FDA in the last two years, firm seeks to block generics of its sleep-wake disorder drug and gain a jet lag indication. CEO Mihael Polymeropoulos tells the Pink Sheet that FDA has retaliated against Vanda for its first suit challenging a partial clinical hold on another drug.

FDA Drug Approval Standards
Regional Comparisons

Project Orbis 2023: FDA Approves Six New Cancer Drugs, But Partner Nations Lag Behind

Sixteen cancer therapies have been granted marketing authorizations or label variations in the US this year via the Project Orbis scheme. However, the majority of these are still under review by Orbis partners, which have also been outpaced by the non-Orbis EU.

BioPharmaceutical Market Access

Watching The Clock Stop: US/EU Regulatory Review Time Parity In Sight, Study Suggests

European Union reform proposals could reduce ‘clock stop’ time in drug reviews, which a new study identified as the primary driver of longer review times at the EMA compared with the US FDA.

Regional Comparisons Drug Review

International Regulators Say Collaboration Is Key To Tackling Pharma Globalization Challenges

Regulators from Canada, the UK and Australia discuss their experiences of working together under both the ACCESS Consortium, an international regulatory worksharing coalition, and Project Orbis, a parallel review process designed to speed up access to oncology medicines.

Europe United Kingdom

Project Orbis: More Cancer Drugs Available In Scotland Than England

The UK joined Project Orbis in 2021 with the aim of speeding up the regulatory process for promising cancer drugs, but fewer than half of the drugs licensed under this pathway are available on the NHS in England.

BioPharmaceutical Cancer
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Recent Stories

US Generics Industry Group Gets New Board Chair, Begins Search For New CEO In Earnest

Christine Baeder’s departure from Teva means transition at the Association for Accessible Medicines’ board of directors as well; Sandoz’s Keren Haruvi becomes chair. The group also started looking for a new permanent CEO to replace Dan Leonard, who left AAM in December 2022.

Generic Drugs Leadership

Medicare Incentives For Quality Drugs Should Not Wait For US FDA Ratings, Experts Tell Congress

Medicare payment for higher quality drugs would help abate shortages, experts with the Brookings Institution, Civica Rx and University of California say. Brookings’ Wosińska explains how hospitals could identify quality generic injectable drug manufacturers without waiting for FDA quality ratings.

Supply Chain Quality

New EU Filings

Beremagene geperpavec, Krystal Biotech’s topical, redosable gene therapy for treating dystrophic epidermolysis bullosa, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Drug Review Europe

‘Historic’ New Funding Mechanism To Boost African Vaccine Production

Up to $1bn in incentive and milestone payments is to be offered to manufacturers over a 10-year period, focusing on priority antigens and diseases.

Middle East and Africa Manufacturing

Patent ‘March-In’ Policy Shift Will Likely Drive Uncertainty More Than Price Drops

Biden administration’s new framework will consider whether a product’s price is reasonable in deciding whether to exercise march-in rights. Numerous other factors could limit provision’s impact, but industry is concerned it will discourage firms from licensing government-funded inventions.

Intellectual Property Market Access

Lack Of Competition Equals Higher Drug Prices: HHS Analysis Is Slogan In Search Of Solutions

Findings could provide a basis for future policy interventions, the department says. Speeding generics and biosimilars would seem a natural outshoot of the conclusions, but the report does not contain any recommendations.

Pricing Debate Biosimilars

US FDA, NCI Collaboration Deepens To Include Clinical Trial Innovation ‘Think Tank’

Former NCI Director Monica Bertagnolli, who now is head of the NIH, said FDA, NCI and National Clinical Trials Network officials are working on potential clinical trial system innovations.

Oncology Clinical Trials

All Biosimilars Interchangeable? FDA Backs Switching With Spotlight On Science

In meta-analyses of biosimilar switching studies, FDA researchers found ‘zero difference in the risk of death, serious adverse events, and treatment discontinuations between participants who switched between biosimilars and reference products and participants who did not switch.’

Biosimilars Regulation
Europe Denmark

EU Biosimilar Filings, Opinions And Approvals

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

Europe Approvals

EMA To Address Challenges Of Using Organ-On-Chip Models In Drug Development

Microphysiological systems such as organ-on-chip models could not only improve the translational success of drug candidates into the clinic, but also impact the 3Rs in non-clinical safety testing, according to the European Medicines Agency.

Research & Development Europe

Biden's Latest Rx Pricing Moves Are At Once Bold And Incremental

As the president’s reelection campaign themes take shape, the administration is preparing to leverage NIH patents in ways it had previously eschewed. As with the merger oversight effort, though, the germs of the plans began earlier in Biden’s tenure.

Pricing Debate Intellectual Property