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To List or Not to List; That is the Question – The FTC Signals the Potential for Greater Scrutiny of Patent Information Submissions to FDA

The FDA Law Blog

Karst — Listing patent information in the Orange Book is a matter of judgment, but that judgment call is about to get a bit more scrutiny. Last week, the FTC held a Listening Session about the listing of patents in the Orange Book, which concluded with a unanimous vote to issue a Policy Statement.

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Aduhelm approval controversy dials up as FDA seeks probe

pharmaphorum

In another twist to the Aduhelm approval tale, FDA’s Janet Woodcock has called for an independent investigation into the relationship between agency staffers and Biogen executives. In the letter, she writes: “FDA’s decisions are far ranging and it is inevitable that some of those decisions will lead to controversy.”

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Amplifying the patient voice for better engagement, recruitment and retention

pharmaphorum

I wrote an Amazon-bestselling book called ‘Patient Recruitment for Clinical Trials using Facebook Ads’ that provides the foundations for how you can reach patients on Facebook. Prime Global are experts in medical communications, market access, patient insights, engagement, and recruitment. About Prime Global.

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6 common patient questions about insulin biosimilars

The Checkup by Singlecare

Yes, as of March 2020 , insulin is considered a biologic product by the FDA. Regulatory bodies such as the FDA conduct thorough tests to confirm that they meet safety, purity, and potency standards. The FDA Purple Book database can be a good resource to determine whether a biologic drug is interchangeable.

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Exforge antitrust settlement caps Novartis’ year of legal disputes

Pharmaceutical Technology

Last year, Novartis began with a win in January, as the US Court of Appeals affirmed the validity of Gilenya’s patent, allowing the company to sue a competitor generics company for filing for FDA approval for its Gilenya generic. Gilenya is an oral medication for multiple sclerosis. Fighting Entresto generics.

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How a new investment is powering a revolution in clinical trial operations

pharmaphorum

Clinical trials are the engine for pharmaceutical innovation, but their means of capturing and communicating data are stuck in the past. In most cases, the EHRs and EDCs don’t communicate, so in order to share that data with trial organisers, staff members at medical centres must manually copy data between the EHR and an EDC.

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How competitors are collaborating to shape biopharma best practices and regulations of the future

Pharmaceutical Technology

A regulatory success story from the SA25 user group came when one participating company achieved an industry first — the FDA approved commercial production of their biologic drug without requiring routine viable EM, but rather requiring viable EM only during process simulations.