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Policy & Regulation

Inspection Delay Puts Back Hanmi/Spectrum’s Rolontis

US FDA defers action on Spectrum’s approval application for neutropenia candidate Rolontis due to pandemic-related difficulties inspecting partner Hanmi’s plant. The action date has been put back by around four months although the companies stress no CRL has been issued. 

South Korea United States Drug Review

Coronavirus Vaccines As A Public Good: How Reasonable Is Reasonable?

During a recent press briefing, health officials in China disclosed the country is poised to reach an annual production capacity of 610 million doses for coronavirus vaccines. But they said prices must be based on manufacturing costs and not driven by supply and demand.

Coronavirus COVID-19 Vaccines China

Policy

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Latest From Policy

AMR Action Fund Will Start Screening Antibiotic Candidates Early Next Year

The industry-backed investment fund to combat antimicrobial resistance hopes to be operational by end of year and begin assessing programs to invest in during the first quarter of 2021.

Policy Financing

Executive Privilege: How Giving Trump Special Access To Experimental COVID Treatment Could Backfire

Trump receives Regeneron’s experimental antibody under FDA’s expanded access program, Gilead’s remdesivir and dexamethasone. The president’s treatment choices could influence clinical trials of all COVID-19 medicines and even trial recruitment for other diseases, experts said.

Clinical Trials Elections

Amgen Shadow Pricing Of Enbrel Under Scrutiny At US House Hearing

Amgen CEO Bradway told Congress the biggest driver of list pricing for Enbrel has been the need to match the price of AbbVie's Humira to secure formulary access.

Pricing Debate Politics

US House Drug Pricing Hearings Start Slow As Pharma Execs Dodge Some Punches

Bristol Myers Squibb CEO Giovanni Caforio, former Celgene CEO Mark Alles and Teva CEO Kare Schultz fielded roughly four hours of questioning at an oversight hearing on pricing practices for Revlimid and Copaxone.

Pricing Debate Legislation

Teva Gambles Indictment Is Better Than Pleading Guilty To US Price-Fixing Claims

Teva’s market overhang and legal uncertainty intensifies with DOJ charges it conspired to fix generic drug prices. Five other companies have pled guilty and reached deferred prosecution agreements.

Generic Drugs Legal Issues

Countering Coupons: Large Employers Will Boost Copay Accumulator Programs In 2021

Annual large US employer health benefits survey also evaluates plans for managing the cost of cell and gene therapies in the coming years, anticipating growing use of outcomes-based contracts, but very limited uptake of payment-over-time models.

Gene Therapy Private Payers
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Regulation

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Latest From Regulation

US COVID-19 Vaccine Adcomm: First Take-Aways

From efficacy endpoints to patient warehousing, US FDA advisors weigh in on vaccine development and regulatory review.

Coronavirus COVID-19 Vaccines

Purdue's $8.3bn Settlement With DOJ Requires Reconstitution As Public Benefit Company

Purdue pleads guilty to three felony charges over marketing of OxyContin under settlement that requires Purdue to be dissolved and transformed into an entity that provides addiction and overdose medicines. Twenty-five state AGs oppose creation of a PBC, arguing Purdue should be sold to another company.

Legal Issues Drug Safety

Coronavirus Update: Human Vaccine Challenge Study Gains UK Backing

The UK backs the world's first COVID-19 human challenge studies to accelerate research – though the first results will not be ready until mid-2021.

Coronavirus COVID-19 Regulation

Approval Beckons For Orchard’s Gene Therapy Libmeldy

Orchard Therapeutics is on the cusp of the first approval for its ex vivo gene therapy, Libmeldy, for metachromatic leukodystrophy.

Companies Gene Therapy

Kite’s Tecartus PRIMEd For EU Market With CHMP Nod

Gilead/Kite’s second CAR-T product is given the go-ahead for approval by the CHMP for mantle cell lymphoma.

Approvals Companies

12 Approvals To Look Out For In Q4

The end of the year should see a flurry of new products reaching the market to break new commercial ground or shake up their respective therapeutic areas. Here, Scrip takes a look at 12 of the more interesting approvals expected in the coming months, with the help of analysts at Biomedtracker.

Approvals Commercial
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