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Big Drug, Small Panel: US FDA Adcomm For Eisai/Biogen’s Leqembi Includes Only Six Voting Members

Six is the fewest number of voting experts for a drug or biologic advisory committee dating back to at least 2015, according to the Pink Sheet Performance Tracker. Agency issued two conflict-of-interest waivers for the meeting, one of which was to a site principal investigator on lecanemab and aducanumab studies but who is no longer participating in the Leqembi review.

Advisory Committees Review Pathway Drug Review

US FDA Balances Urgent Need For Platinum Chemotherapies Against Intas Plant’s Quality Failures

As politicians demand help for cancer-ridden constituents, the agency allows Indian plant that flunked inspection to resume exporting batches of cisplatin and carboplatin to the US, but only after passing independent 45-day batch certification reviews.

Manufacturing Quality Compliance

BIO Notebook: Waiting On Data, Adjusting To The IRA, And Focusing On All Patients

GSK, BridgeBio, and the US FDA’s patient-focused drug development director discuss contingency planning as the BIO International Convention concludes in Boston.

Clinical Trials Deals Financing

Vaccine Policy: Progress and Pitfalls

GSK Makes New Adult Immunization Push, Seeks Reimbursement Changes Following RSV Approvals

From ACIP to Part D to data transparency, GSK has several policy asks as it prepares to launch its new RSV vaccine for older adults. The Pink Sheet spoke with GSK’s vaccine policy lead about the firm’s new data platform and the worrisome US vaccination trends following the Covid pandemic.

Vaccines Policy

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Performance Trackers

US FDA’s June User Fee Calendar Starts Out Steady, But A Crescendo Of Decisions Will Start Mid-Month

Two gene therapies and two novel inhibitors of JAK kinases are among the upcoming goal dates from the Pink Sheet’s US FDA Performance Tracker.

US FDA Performance Tracker Drug Approval Standards Drug Review


Global Pharma Guidance Tracker – April 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

Policy & Regulation Explore this Topic

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Latest From Regulation

Eisai/Biogen’s Leqembi Breezes Through Adcomm; Labeling Discussions With US FDA May Be Knottier

To get regular approval, the Alzheimer’s treatment could see tightened labeling on the need to test for ApoE ε4 status given advisory committee recommendations. Some panelists also raised concerns around use with anticoagulants and in patients with cerebral amyloid angiopathy.

Advisory Committees Drug Review

US FDA’s PDUFA VIII Ideas Could Include Creating Regulatory Science Research Program

With regulatory science research already funded for generic drugs and biosimilars, CDER Director Patrizia Cavazzoni wants a program for prescription drugs considered for the next user fee renewal.

User Fees Research & Development

Global Pharma Guidance Tracker – May 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

COVID-19 Has ‘Permanently Changed’ How The EMA Works

Coronavirus COVID-19 Europe

AstraZeneca/Sanofi’s Nirsevimab Nears US FDA Approval After Overwhelmingly Positive Adcomm

When patients should receive the RSV prevention treatment was the subject of much debate even as the Antimicrobial Drugs Advisory Committee voted nearly unanimously that it should be approved for infants and neonates.

Advisory Committees Infectious Diseases

FDA’s Office Of Generic Drugs Gets New Permanent Director And Oversight Designee

Iilun Murphy, a 15-year agency veteran, takes helm of OGD. Jacqueline Corrigan-Curay to assume oversight of the office and report to CDER director.

FDA Generic Drugs

Latest From Policy

Medicare Part B Inflation Rebate List Doubles For Third Quarter, Adds Several Amgen Drugs

Amgen's Prolia appears to be the biggest drug on the list of products incurring price inflation penalties in Part B; many of the others have relatively low sales to Medicare.

Medicare Reimbursement

Canadian HTA Ups Industry Fees To Fund Review Process Improvements

Canada’s health technology appraisal body is to increase its industry fees well beyond inflation for conducting reviews and scientific advice. It says it will also improve its drug reimbursement review process.

North America Canada

Saudi Regulator Becomes First Arab Member Of PIC/S

Saudi Arabia’s medicines agency says its membership of the international Pharmaceutical Inspection Co-operation Scheme will contribute to developing and raising inspectors' efficiency.

Middle East and Africa Saudi Arabia

Clinical / R&D Explore this Topic

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Latest From Research & Development

US FDA’s PDUFA VIII Ideas Could Include Creating Regulatory Science Research Program

With regulatory science research already funded for generic drugs and biosimilars, CDER Director Patrizia Cavazzoni wants a program for prescription drugs considered for the next user fee renewal.

User Fees Research & Development

Danon Disease Gene Therapy & TGCT Treatment Win EMA PRIME Designations

Promising early clinical trial results from Rocket and Abbisko respectively helped the companies secure their places on the European Medicines Agency’s priority medicines scheme, which aims to help speed up the development and regulatory review of treatments for unmet medical needs.

Review Pathway Europe

UK Industry ‘Struggling’ With Skill Gaps In AI, Robotics & Data Analytics

A new report says that pharma firms are finding it difficult to recruit staff with experience in emerging scientific technologies, particularly in areas such as regulatory and quality assurance. COVID-19, Brexit and competition for talent with other countries and industry sectors are cited as key factors.

Europe United Kingdom

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Latest From Commercial

BIO Notebook Day 3: Venture Capital Musical Chairs, Pfizer’s Financing Strategy, And Boehringer on Being The Early Bird

Plus, Roche talks about why it wants to partner with firms that have machine learning expertise as the BIO International Convention continues in Boston.

Business Strategies Deals

BIO Notebook: GSK’s Walmsley On M&A; Merck On How Falling Valuations Are Affecting Deals

On the first day of the BIO International Convention, our reporters hear from industry leaders about tough financing, when to go public, and why ‘there shouldn't be 700 listed biotechs in the US.’

M & A Leadership

GSK Makes New Adult Immunization Push, Seeks Reimbursement Changes Following RSV Approvals

From ACIP to Part D to data transparency, GSK has several policy asks as it prepares to launch its new RSV vaccine for older adults. The Pink Sheet spoke with GSK’s vaccine policy lead about the firm’s new data platform and the worrisome US vaccination trends following the Covid pandemic.

Vaccines Policy

Manufacturing Explore this Topic

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Latest From Manufacturing

AMR Alliance Follows Up Global Industry Standard With Responsible Manufacturing Certification

A new voluntary certification from the AMR Industry Alliance and the British Standards Institution will assess pharmaceutical firms’ responsibility and sustainability when it comes to manufacturing antibiotic drugs, in an attempt to control the spread of antimicrobial resistance.

Generic Drugs Drug Safety

Saudi Regulator Becomes First Arab Member Of PIC/S

Saudi Arabia’s medicines agency says its membership of the international Pharmaceutical Inspection Co-operation Scheme will contribute to developing and raising inspectors' efficiency.

Middle East and Africa Saudi Arabia

Why Generic Drug Manufacturing Is Faltering And Ways To Bolster It

Academic expert provides insight into the economic and quality challenges behind generic drug shortages, and what to do about it.

Generic Drugs Supply Chain
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