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New COVID Treatments Face FDA, Commercial Barriers Despite Ongoing Need

Sponsors want more endpoint clarity as current state of government pandemic response, along with scientific and regulatory hurdles, is constraining efforts to refill a shrinking COVID medicine cabinet and could create vulnerabilities for future pandemics.

Drug Approval Standards Coronavirus COVID-19

Insulin Prices, Cancer Treatment Innovation Pushed In State Of The Union As Biden Faces Divided Congress

Expanded federal research efforts around cancer treatment was one of a handful of bipartisan goals that President Biden highlighted in his State of the Union address.

Medicare Pricing Debate

Chinese Balloon Affair To Blow Up US Health Collaboration?

The latest surveillance balloon downing could torpedo improving bilateral health collaboration between China and the US at a time when warming ties are crucial to solving a flurry of gridlocks.

China United States

GSK’s Clinical Development Plan For Jemperli In Rectal Cancer Draws US FDA Concerns

Oncologic Drugs Advisory Committee asked to weigh in on adequacy of GSK’s proposal for two single-arm trials to support accelerated approval in a curative setting, as well as the potential novel use of clinical complete response as an approval endpoint.

Advisory Committees Clinical Trials

What The FDA Looks For When Inspecting Sites Soon After Approving Drugs

Quietly issued internal Compliance Program guidance on post-approval inspections suggests official action could be indicated when it turns out some “established conditions” are missing from applications. Whether the rate of these inspections will need to increase in the wake of the pandemic, particularly as applications for complex dosage forms and new manufacturing modalities multiply, remains to be seen.

Quality Drug Approval Standards

Aduhelm Shows Need For More FDA Transparency On Approval Decisions, Surrogate Endpoints, Critics Say

But Center for Drug Evaluation and Research leaders stand their ground at a National Academies meeting, asserting the Phase III data for a different Alzheimer’s drug, Leqembi, are likely to confirm their views on utility of amyloid as a surrogate endpoint.

Review Pathway Drug Review

Pricing Disclosure Demands During Medicare Negotiation Process May Be Fodder For Lawsuits

Regulatory attorneys suggest different issues that might form the basis of manufacturer-sponsored litigation against the Centers for Medicare and Medicaid Services.

Reimbursement Policy

Unjustifiable Delays In Generic Competition? Biopharma Contends There Is No Problem

As Congress prepares to again debate patent reforms, brand industry says allegations of ‘patent thickets’ and extended market exclusivity are based on inaccurate or misleading data. They assert there is no need for PTO and FDA to institute systemic policy changes.

FDA Biosimilars

External Controls: FDA Guidance Provides Clarity But Does Little To Remove Hurdles

Agency discourages use of externally controlled trials in all but a very limited number of situations truly ripe for such an approach; new draft guidance discusses at length the various confounding factors that can introduce bias into a comparison between an investigational treatment and an external control using either real-world data or data from another clinical trial.

Drug Approval Standards Real-World Evidence

Absence Of Braille In Generic Hetlioz Label Merits Its Withdrawal, Vanda Lawsuit Argues

Vanda complaint against US FDA says generic label is not the same as Hetlioz and omission of braille lettering will increase medication errors. Company seeks recall of Teva’s product.

Generic Drugs Legal Issues

‘Decentralized Clinical Trials 2.0’ On The Horizon

The remarkable shift towards decentralized clinical trials in the last three years is a testament to how this patient-centric approach of doing research has the potential to solve multiple issues such as time, cost and low participation rates. In this first segment of a two-part article, Pink Sheet looks at how innovation in this sector has just begun and we can expect more action ahead. 

Pink Sheet Perspectives Clinical Trials

Teva Quits PhRMA As Financial, Policy Challenges Loom For The Brand/Generic Hybrid Giant

With a leadership position in the US generics association and a new CEO focused on how to reallocate resources, Teva leaves the brand trade association after a review of the ‘effectiveness and value of engagements.’

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