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COVID-19 Vaccine ‘Booster’ Or Simply A Third Dose? US FDA’s Marks Starts To Reframe The Issue

It’s a classic example of an internal dispute between an FDA review team and agency leadership playing out at an advisory committee forum, except with the highest possible stakes.

Coronavirus COVID-19 Vaccines Regulation

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 Policy

Roche Among EU Fast-Track Hopefuls With Lymphoma Bispecific Mosunetuzumab

Two companies are set to learn whether the European Medicines Agency will agree that their planned EU marketing applications merit an accelerated assessment.

Europe Review Pathway Drug Review

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: New Formulations Dominate In CNS; Immunocore Brings First TCR Therapy To US FDA

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

Improper Dose In Phase II Trials Can ‘Make Or Break’ Drug Program, FDA’s Stein Says

Director of the US FDA’s Office of New Drugs says there will be a greater focus on identifying the optimal dose before a drug candidate advances into Phase III trials, but the problem is not limited to oncology, the target of Project Optimus.

Clinical Trials FDA

Adcomm Member Survey Shows Continued Support For Virtual Meetings After Pandemic

Despite acknowledging that fully in-person meetings overall are better, survey respondents said they still want the flexibility that virtual attendance offers.

Advisory Committees Drug Review

Pfizer Comes Close To Meeting FDA’s Guidance Standard For COVID Booster Dose, But It May Not Be Enough

Study data met two key endpoints laid out in agency guidance, but Pfizer may not have enough evidence of the booster’s impact on current circulating virus variants, particularly Delta. It is also unclear Pfizer has made the case to FDA that a booster dose is need at this time or that they provided enough safety data.

Advisory Committees Coronavirus COVID-19

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

One In, One Out: Mirum Seeks New EU Indication For Maralixibat, Withdraws Another

Sponsors of three drugs have withdrawn their EU marketing authorization applications in the middle of the assessment process, including one for a bladder cancer therapy that was recently turned down in the US.

Review Pathway Drug Review

Coronavirus Notebook: Nobel Laureates Press Germany To Back Vaccine IP Waiver

The EU vaunts its vaccine donations and starts building resilience against future health threats, and the UK MHRA says Moderna can be used as a booster dose. Aviptadil has received scientific advice from the MHRA for its potential use as a treatment for COVID-19 patients.

Europe International

Latest From Policy

Scottish Funding No For Two Orphans As SMC Tries To Catch Up After COVID-19 Backlog

Two orphan drugs, Chiesi’s Proscybi and Insmed’s Arikayce, were rejected for funding on the Scottish National Health Service.

Europe United Kingdom

IVI Warns Of Dire Consequences From COVID-19 Vaccine Inequity

The International Vaccine Institute’s director general warns about COVID-19 vaccine distribution inequalities and its serious consequences, arguing the case for increased global coordination and responsibility for action to improve the situation.

Coronavirus COVID-19 Vaccines

Some US FDA Advisory Committee Meetings Likely To Remain Virtual Post-Pandemic

Peter Stein says FDA will set criteria for holding a virtual meeting and will be seeking stakeholder feedback.

Advisory Committees FDA

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Latest From Research & Development

Coronavirus Notebook: Nobel Laureates Press Germany To Back Vaccine IP Waiver

The EU vaunts its vaccine donations and starts building resilience against future health threats, and the UK MHRA says Moderna can be used as a booster dose. Aviptadil has received scientific advice from the MHRA for its potential use as a treatment for COVID-19 patients.

Europe International

Pharma On Its Back Foot As US Drug Price Reform Advances

Big pharma leaders warn of steep cuts to R&D and US jobs if US drug pricing reform legislation paves the way for direct government price negotiations.

Pricing Debate Medicare

Publisher’s Spotlight: Shortlist Revealed For The 2021 Citeline Awards

From a record more than 100 entries, the finalists have been selected for 12 awards, representing the best and brightest of biopharmaceutical research. 

Clinical Trials Artificial Intelligence

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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

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Latest From 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

GMP Deficiencies Lead Brazil To Target Sinovac’s Chinese COVID-19 Vaccine Plant

Having decided to suspend 12 million doses of Sinovac’s coronavirus vaccine, Brazil’s regulatory agency says it will need to make its own on-site assessment of conditions at the Chinese facility that makes the product.

China Brazil

WHO Director General ‘Appalled’ At Industry Approach To COVID-19 Vaccines

World Health Organization director general says poorer countries should not have to be satisfied with richer country “left overs.”

Coronavirus COVID-19 Manufacturing
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