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US FDA Pursuing Two-Track Approach To Regulatory Convergence For Cell and Gene Therapies

Discussions through the WHO are aimed at educating low- and middle-income countries, while efforts with ‘the larger regulators’ aim to reduce the development burden for products targeting ultra-rare diseases, CBER director Peter Marks tell DIA.

Gene Therapy Regenerative Medicine International

BioMarin’s Hemophilia Gene Therapy Among Nine Products On Track For EU-Wide Approval

Four orphan drugs and a new COVID-19 vaccine are among the latest products that the European Medicines Agency says should be approved.

Europe Approvals Regulation

RSV Vaccine May Be On Market In 2023, CDC’s ACIP Anticipates

Panel expects to review five respiratory syncytial virus vaccines and vote on one or two of them in June 2023 and others four months later. Sanofi presents results of three clinical trials of its monoclonal antibody nirsevimab, which is on track to be the second RSV prophylaxis for infants.

Advisory Committees Vaccines Clinical Trials

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Performance Trackers

Keeping Track: Tumor-Agnostic Approval For Novartis; Submissions From Krystal, Menarini, And Astellas

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

Gene Therapy Approvals US FDA Performance Tracker


Global Pharma Guidance Tracker – May 2022

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

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Latest From Regulation

Drugs From Sponsors ‘Located in Russia,’ Would Be Barred From US FDA Review By House Funding Bill

Language of the amendment cleared by appropriators in response to the Russian war against Ukraine in FDA’s fiscal year funding bill is vague, making impact of the funding ban on industry unclear. Democrats supported the amendment but said they wanted to continue to work on language to avoid “unintended consequences.” FDA would get a 10% bump in non-user fee funds under the bill.

United States FDA

US FDA Would Allow Separation Alternatives In Manufacture Of Low-Risk Beta-Lactams

Proposed guidance revision adds nuance to manufacturing facility separation expectations for beta-lactam compounds that pose less risk of anaphylaxis than penicillin and related antibiotics.

Manufacturing Quality

US FDA’s ALS Science Strategy Includes Near-Term Rare Neurodegenerative Disease Task Force

Five-year plan includes multi-phased approach to ALS at the same time that Amylyx’s AMX0035 is pending review with a late September decision deadline; action plan’s mid-term priorities for FY 2023-2024 include a cell and gene therapies safety project.

Drug Approval Standards Rare Diseases

EMA Gives Oncopeptides’ Multiple Myeloma Drug The Thumbs Up; Keeps US FDA In Loop

With Pepaxti now on track for pan-EU marketing approval to treat patients with triple class refractory multiple myeloma, Oncopeptides is in talks with the Food and Drug Administration to achieve a clear path forward for the drug in the US where it has experienced difficulties despite being granted an accelerated approval. 

Approvals Cancer

Valneva Wins EU Nod For COVID-19 Vaccine

In contrast with the five COVID-19 vaccines that are approved in the EU under conditional marketing authorizations, the European Medicines Agency has recommended that Valneva’s vaccine receive a standard approval.

Coronavirus COVID-19 Europe

US FDA Likely To Embrace In-Person, Remote Combo For Facility Inspections Going Forward

 

Manufacturing Coronavirus COVID-19

Latest From Policy

Moderna’s Pediatric COVID Vaccine Packaging Spurs Confusion Concerns From CDC Panel

Discrete packaging for authorized dose in 6-11 year-olds is not yet available, so vaccination providers have to use product from a vial labeled for ‘booster doses only’ in adults. ACIP members unanimously endorse use of the mRNA vaccine in individuals ages 6-17 years but urge manufacturers to move away from relying on color to differentiate formulations.

Coronavirus COVID-19 Vaccines

England Rejects Funding For Kimmtrak, Onureg & Minjuvi But Says Yes To Idefirix, Evrenzo & Verzenios

Immunocore’s advanced uveal melanoma drug, Kimmtrak, and Hansa’s Idefirix for increasing the chances of a successful kidney transplant are among the latest treatments that NICE has appraised regarding their cost-effectiveness.

United Kingdom Cost Effectiveness

Smaller EU Countries Call for More Comparative Trials

More should be done to incentivize comparative clinical trials so as to allow better decisions on drug pricing to be taken, said Austria’s representative at a recent meeting of EU health ministers.

Europe Belgium

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Latest From Research & Development

Califf: More Expedited Approvals Mean US Clearance Only The Beginning Of Learning About Medical Products

The US FDA commissioner said increased use of expedited approval pathways will help spur clinical research system reform.

Clinical Trials Research & Development

China Tweaks On-Site Inspection Priorities As Registration Filings Soar

China’s Center for Drug Evaluation has introduced a risk-based process to initiate on-site inspections related to drug registrations. It is hoped the novel system will suit the current capacity of auditor teams against a backdrop of an ongoing spike in product approval applications in the country since 2019.

China Clinical Trials

Continuous Pharmaceutical Manufacturing Bill Hitches A Ride With US FDA User Fee Legislation

US legislation could advance new manufacturing platforms for drugs and biologics with academic R&D and workforce development and in turn spur domestic growth.

Platform Technologies Research & Development

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BIO 2022 Notebook: Future Directions For R&D

News and views from day four of the BIO annual meeting include a fireside chat with FDA commissioner Robert Califf, gene therapy insights, and pharma efforts to provide cancer medicines in lower income countries.

Business Strategies Diversity & Inclusion

BIO 2022 Notebook: Deal Values In The Eyes Of The Beholders

News and views from day 3 of the BIO annual meeting include business development insights, such as Sanofi's global head of BD Alban De La Sabliere's promise that big pharma has no hidden agenda and an AbbVie BD exec's observations that lower company valuations have not led to lower asking prices. Also, BIO chairman and Nkarta CEO Paul Hastings' optimism that biotech will rebound and Venus Williams' Sjogren's disease story draws a crowd.

Business Strategies Deals

Prior Bad Conduct By Pharma Companies Could Be ‘Plus Factor’ In Merger Review

Experts suggest US FTC and DOJ retrospectively assess whether a merger gives companies increased leverage with PBMs and consider how it will impact vulnerable communities. Rutger’s Michael Carrier says there should be a presumption against mergers between two large firms.

M & A Enforcement

Manufacturing Explore this Topic

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Latest From Manufacturing

US FDA Would Allow Separation Alternatives In Manufacture Of Low-Risk Beta-Lactams

Proposed guidance revision adds nuance to manufacturing facility separation expectations for beta-lactam compounds that pose less risk of anaphylaxis than penicillin and related antibiotics.

Manufacturing Quality

AMR Industry Alliance Publishes Manufacturing Standard

The AMR Industry Alliance has formalized its years-old Common Antibiotic Manufacturing Framework by publishing an antibiotic manufacturing standard, in what it terms a “groundbreaking step” in the drive for responsible manufacturing.

Manufacturing Safety

US FDA Likely To Embrace In-Person, Remote Combo For Facility Inspections Going Forward

 

Manufacturing Coronavirus COVID-19
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