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BsUFA III Expands Biosimilar Supplement Review Goals To Speed Approvals

Six supplement categories based on submission content will be created with review goals between three and 10 months.

User Fees Biosimilars Regulation

Netherlands Gives Funding Nod To CGRP Inhibitors For Chronic Migraines

The Dutch health technology appraisal body, ZIN, said Novartis’ Aimovig should be reimbursed for the treatment of chronic migraine after initially advising against it.

Europe Netherlands Health Technology Assessment

Paying For Gene Therapy: Biggest Cost Challenges Two To Three Years Away?

Only about one-quarter of the 40 gene therapies projected to launch by the end of 2025 would have potential US patient populations of more than 50,000. But a handful of treatments could target millions of individuals.

Gene Therapy Reimbursement Government Payers

Spotlight On Coronavirus

Real-World Evidence Will Take Center Stage At US FDA Advisory Committee On COVID Boosters

If regulators agree with Pfizers conclusions – and briefing documents suggest thats a big if – about real-world studies showing Comirnatys effectiveness waning over time, thereby justifying the need for a booster dose, it could be part of a historical moment for FDA’s use of RWE.


Advisory Committees Coronavirus COVID-19

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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: Takeda’s Exkivity Clears US FDA; BeiGene’s Busy Summer

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

US FDA Performance Tracker Approvals Drug Review


Global Pharma Guidance Tracker – August 2021

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

Policy & Regulation Explore this Topic

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Latest From Regulation

Drug Rejection Hearings Are Having A Moment At US FDA

With Intarcia's request, the rarely used mechanism could now produce two hearing this year, but outcomes of the few other times the process has been undertaken should not generate a lot of confidence for sponsors that this a path that they want to go down.

Complete Response Letters Drug Review

Accelerated Approval: US FDA Wants Comprehensive Development Plan From Oncology Sponsors

Cancer drug developers should come to the agency early with a package of clinical trials to support accelerated approval and confirm clinical benefit rather than with plans to sequentially conduct such studies, Oncology Center of Excellence’s Richard Pazdur says; he also suggests closer scrutiny ahead of whether postmarketing trials are being conducted with ‘due diligence.’

Review Pathway Clinical Trials

Coronavirus Notebook: UK Rolls Out Ronapreve To Hospitalized Patients, Drug Safety Unit Reviews mRNA Vaccine Heart Inflammation Link

Pressure is growing on richer countries to share their excess vaccine doses, and the European Parliament has passed legislation intended to strengthen the EU’s health security framework and make joint vaccine procurement more transparent.

Europe International

Generic Drugs: ‘Competitive’ Exclusivity Benefited Few Sponsors But Is Increasingly Popular

The six months of additional exclusivity from US FDA’s CGT program appears to have kept some generic sponsors from the market, and didn’t even prompt others to enter quickly, but use of the competitive generic exclusivity program continues to grow.

Generic Drugs Intellectual Property

US FDA Works To Stay Ahead Of Benzodiazepine Misuse

FDA and NIH are looking to spark research on approaches to reduce use of benzodiazepines and to help mitigate issues with withdrawal associated with the widely prescribed therapies.

Drug Safety Post Market Regulation & Studies

CDC Vaccine Advisors Must Fill In Missing Holes On Pfizer’s COVID Booster Plan

ACIP will get a chance to further restrict and tailor the US booster plan for COVID vaccinations. Among other things, CDC's advisors may have to define what constitutes being at high risk of severe COVID-19 post-primary vaccination, occupations at high risk of COVID exposure, and whether people who didn’t receive Pfizer’s primary vaccine series could get the company’s mRNA booster shot.

Vaccines Advisory Committees

Latest From Policy

Korea Should Pursue Two-Pronged Strategy In Global Vaccine Hub Bid

South Korea is making a strategic push to strengthen its vaccine capabilities, with a focus on COVID-19 and future pandemics and the aim of becoming a global development hub. But one expert told a recent meeting that these goals should not overshadow the government’s original aim of becoming self-sufficient for the national immunization program.

South Korea Vaccines

Unlocking Orphan Pricing In France

Heath technology assessments in the competitive orphan space, such as pulmonary arterial hypertension, could get tougher in France.

Europe France

340B Hospitals Charging Private Insurers Nearly Four Times Acquisition Costs On Cancer Drugs – Study

New report makes a case for further scrutiny of the 340B program's contributions to high drug costs, although manufacturers remain the main target of legislative and regulatory reform proposals.

Pricing Strategies Reimbursement

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

Drug Rejection Hearings Are Having A Moment At US FDA

With Intarcia's request, the rarely used mechanism could now produce two hearing this year, but outcomes of the few other times the process has been undertaken should not generate a lot of confidence for sponsors that this a path that they want to go down.

Complete Response Letters Drug Review

Accelerated Approval: US FDA Wants Comprehensive Development Plan From Oncology Sponsors

Cancer drug developers should come to the agency early with a package of clinical trials to support accelerated approval and confirm clinical benefit rather than with plans to sequentially conduct such studies, Oncology Center of Excellence’s Richard Pazdur says; he also suggests closer scrutiny ahead of whether postmarketing trials are being conducted with ‘due diligence.’

Review Pathway Clinical Trials

Back to The Past: The Case for Improving Upon, Not Throwing Out Traditional Cancer Phase I Study Designs

US FDA has pushed sponsors away from the traditional dose-finding designs for cancer drugs in recent years. But academics continue to make a case for keeping the 3+3 design with some improvements.

Clinical Trials ImmunoOncology

Commercial Explore this Topic

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Latest From Commercial

COVID-19 Leads To Less Industry Spend On Docs, But Not Necessarily Less Influence

Drug and medical device company payments to doctors and hospitals for non-research related activities dropped for the first time in 2020 since CMS’s Open Payments database began collecting the information. 

Advertising, Marketing & Sales Coronavirus COVID-19

Pink Sheet Podcast: Gene Therapy In Europe, Lilly’s Olympic TV Ads, 'Most Favored Nation' Rule

Pink Sheet reporters and editors discuss Bluebird Bio’s decision to pull its gene therapy business from Europe, Eli Lilly potentially pushing regulatory boundaries with its Olympic TV spots, and the CMS decision to scrap the Trump aministration’s most favored nation reimbursement rule.

Commercial Strategies Gene Therapy

A Prior Auth Truce? Novartis Willing to Embrace ICER-Like Price Determinations For Increased Access

Novartis gets some praise for being willing to embrace cost-effective drug prices, but health policy analysts are skeptical the industry would truly adopt the idea for its best-selling drugs, particularly if the appropriate guardrails were put in place to ensure broader budget impact was controlled.  Holes were also poked in the way Novartis determined the total cost of drug utilization management on the US health system. 

Pricing Debate Cost Effectiveness

Manufacturing Explore this Topic

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Latest From Manufacturing

Missed Review Deadlines Are Reminder That On-Time Approvals Are A Goal, Not A Guarantee

After more than a decade of sky-high rates of on-time regulatory action by the US FDA, missed user fee goal dates are back in a pretty big way – and it’s not just JAK inhibitor and COVID-19 delays.

US FDA Performance Tracker Drug Review

A PDUFA First: Pre-Approval Inspection Notice Goal Will Be Created

Under new user fee agreement, sponsors will get at least 60-day notice when a pre-approval inspection is necessary; regulators and manufacturers hope increased communications will lead to more efficient reviews.

User Fees Manufacturing

Cuban COVID-19 Vaccines To Come Under WHO Scrutiny

The Cuban government has approved the country’s home grown COVID-19 vaccine for emergency use in children, while Mexico is poised to authorize another Cuban vaccine.

North America Cuba
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