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Policy & Regulation

New Designations Set To Speed Hemlibra, CAR-T In China

China is set to grant priority reviews to major biologics from Roche, the first CAR-T therapy from Wuxi Juno, and breakthrough therapy designation to a pediatric respiratory antiviral from ArkBio.

China Rare Diseases Cancer

No EUA For COVID-19 Vaccines Prior To Trials Completion, Says India

The Indian regulator says it is not considering emergency use authorization for COVID-19 vaccines before completion of clinical trials, a stand validated by AstraZeneca halting trials of its vaccine candidate due to an adverse event in UK. Meanwhile, India has signed up for Phase III trials of Russia’s vaccine candidate

Policy & Regulation Research and Development Strategies Coronavirus COVID-19

Policy

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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

Q&A: BIO CEO Michelle McMurry-Heath Outlines Diversity Goals

Expanding on difficult conversations during the recent BIO Digital meeting, the group aims to take actions that will increase diversity and inclusion in health care, science and industry.

Clinical Trials Human Capital

IQVIA: US Out-Of-Pocket Drug Costs Stable, But Overall Spending Is Higher

New report shows average out-of-pocket cost per prescription of $10.67 in 2019 was unchanged from 2018. But while the number of dispensed drugs barely increased, sales jumped more than 5%.

Pricing Debate Pricing Strategies

Sanofi/GSK Working With The US To Increase COVID-19 Vaccine Capacity

The $2.1bn investment under the US’ Operation Warp Speed will fund development, scale-up of US manufacturing and the first 100 million doses. 

Coronavirus COVID-19 Vaccines

Coronavirus Update: Warp Speed Companies Grilled On Vaccine Safety, Price And Timelines

House committee seeks reassurances on a range of issues, including the security of a US vaccines supply chain against a background of rising tensions with China.

Coronavirus COVID-19 Policy
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Regulation

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Stockwatch: The Fall, Rise And Challenges Of Seres' Microbiome Therapy

The public biotech’s first foray into the microbiome started well, but a clinical trial failure followed by a success has now left Seres with both regulatory and commercial issues.

Companies Regulation

Bristol/Agios AML Drug Idhifa Fails In Phase III

Idhifa is approved in the US for relapsed or refractory AML patients with IDH2 mutations based on Phase I/II complete responses but did not meet the overall survival endpoint in the Phase III IDHENTIFY.

Clinical Trials Personalized Medicine

Coronavirus Update: After Trump Pressure, US FDA Issues Emergency Use Authorization For Blood Plasma Therapy

US FDA Commissioner Stephen Hahn cites 35% improvement in study, but critics are dismayed by fudging of science and political pressure.

Coronavirus COVID-19 Approvals

Not Such A Sure Thing: FDA Knocks Back BioMarin’s Roctavian

BioMarin’s confidence that its first-ever hemophilia gene therapy would be cleared by the US FDA was shaken by a complete response letter that the company claims changed the requirements for approval.

Complete Response Letters Gene Therapy

Mylan Presses On With US Tecfidera Launch ‘At Risk’

Facing an appeal on a favorable US district court decision, Mylan has opted to launch the first generic Tecfidera in the US “at risk,” after obtaining FDA approval and seeing Biogen’s bid for injunctive relief shot down earlier this month.

Approvals Generic Drugs

Gilead’s RA Hopeful Filgotinib Hit By Complete Response Letter

Complete Response Letter is a major setback for Gilead and its partner Galapagos.

Commercial Companies
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