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Aggressive staffing goals for FDA’s gene and cell therapy review group might not be fully achieved – but the head of CBER believes the new organization is on track to deliver on his high expectations going forward.
An explicit ban on patent linkage would ensure that competition to originator drugs is not delayed, according to off-patent industry group Medicines for Europe.
Biopharma veteran Ted Love assured industry that the sector remains fundamentally strong during remarks at the BIO CEO & Investor Conference.
Pink Sheet’s Drug Review Profile explores Amgen’s Wezlana, an interchangeable biosimilar to Janssen’s Stelara. FDA determined late in the review that switching studies generally would not be needed for interchangeable ustekinumab products, prompting Amgen to seek the designation.
Melanoma treatment Amtagvi is US FDA’s biologics center’s first novel approval of 2024.
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.
Stakeholders suggested a ‘Dear Healthcare Provider’ letter or speaking about the risks to professional societies to emphasize the psychiatric adverse events that prompted a boxed warning for the now-generic asthma drug montelukast. The NY Attorney General is adding more pressure.
Of three accelerated approval drugs that have been ordered withdrawn to date, Pepaxto marks the shortest interval between the FDA drugs center's withdrawal proposal and the agency’s final order, suggesting that FDORA’s expedited withdrawal procedures helped move things along more quickly.
Pink Sheet’s Drug Review Profile looks at the timeline behind the development and FDA review of Amgen’s Wezlana (ustekinumab-auub), an interchangeable biosimilar to Janssen’s Stelara.
Pipeline is concentrated around Phase II, but sponsors have a few chances to see how FDA handles its ‘foundational constructs’ for psychedelic drugs, led by Lykos’ pending NDA for PTSD and Compass Pathways’ Phase III synthetic psilocybin COMP360 for treatment-resistant depression.
While EU preparations are underway to introduce strict legal requirements for all AI systems, the UK has doubled down on its flexible, non-regulatory framework. In this second of a two-part article, a lawyer explains the pros and cons of each for pharma and medtech firms.
Flexible thinking and rigorous standards will both be needed to develop psychedelics as drug therapies in order to surmount the many complicating factors, from unique ‘set and setting’ aspects to functional unblinding, speakers at Reagan-Udall Foundation meeting agree.
While approaching the third year of its launch, the parallel advice program has seen a handful of applicants, but regulators on both sides of the Atlantic remain optimistic.
International interest in fast-track regulatory reliance and collaboration pathways such as Project Orbis and the ACCESS Consortium has grown in recent years, a trend that looks set to continue in 2024. But some policy experts have warned that faster approvals are not always better, with one academic claiming the bar for marketing authorizations has dropped “far too low.”
The latest developments in a US Congressional draft bill to curb Chinese biotech operations in the US is separating contract manufacturing and research from gene sequencing service providers, which may give China's major contract players reasons to breathe easy.
Bills to narrow the Medicare price negotiation program’s reach generated extensive discussion at the hearing.
The FDA commissioner also does not want the agency setting goals for rare disease treatment development.
Members of the European Parliament have ignored pleas from the EPP political group and the German Federal Council to drop a proposal allowing third parties to oppose the granting of a supplementary protection certificate.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add three new products, including Velsipity, Pfizer's treatment for moderately to severely active ulcerative colitis in patients 16 years of age and older.
An analysis spanning two decades found that 65% of health technology assessments in England were based on evidence of poor or unacceptable quality, raising concerns around the efficacy of drugs reaching patients.
Confidential pricing would give companies more flexibility to negotiate discounts and prevent withdrawals.
Despite Marks' relatively upbeat attitude, FDA experts warn that even absent government shutdowns or minimally impactful ones, the current cycle of continuing resolutions and the lingering threat of budget sequestration is harmful to the agency’s operation.
However, David Kaslow, director of the FDA’s vaccines office, says only a ‘may’ recommendation is supported and that giving an extra dose after June ‘may not be optimal’ if vaccines are reformulated for the fall.
Agency anticipated receiving more applications for the program, which aims to bring Operation Warp Speed-like response to investigational rare disease therapies, than it has so far, though a last-minute ‘flood’ is still expected. CBER and CDER are accepting requests through 1 March.
Expedited approval pathway had been a secondary option when traditional approval was not possible, but the CBER director wants surrogate endpoints increasingly considered from the beginning, especially with pediatric rare disease gene therapies.
Legislation intended to remove the fragmentation in the supplementary protection certificate system has been OKd by the European Parliament, which will try to reach agreement with the EU member states following the June parliamentary elections.
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