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.

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.

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.

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.

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

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. 

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.

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.

Higher dose or adjuvanted seasonal flu vaccines – Fluzone, Fluad and Flubok – provide benefit over other vaccines for older adults, advisory committee concludes. Merck’s PCV15 pneumococcal vaccine and GSK’s Priorix MMR vaccine are recommended for pediatric use by ACIP.

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.

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

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.

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.

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.

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.

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.

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.

The system likely will evolve as the post-pandemic world unfolds, but adds to the list of agency programs expecting to continue using virtual platforms once in-person activities are no longer restricted by COVID-19.