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Policy & Regulation

New National Security Checks Could Hinder Investment, Warns UK Biotech Sector

Life science SMEs and their investors need to comply with new UK government checks on their dealmaking.

Companies Commercial Regulation

Novo Nordisk On The Pluses And Minuses Of The UK Post-Brexit R&D Environment

Post-Brexit Britain offers a fertile R&D ecosystem, but it needs to improve uptake in novel medicines there and strike a lasting deal with the EU over batch testing, Novo Nordisk’s UK general manager Pinder Sahota tells Scrip.

Brexit Clinical Trials Companies

Policy

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Latest From Policy

Closed-Loop Inspections? Strict COVID Zero Policy Delays FDA's China Field Trips

Chinese biotechs are bracing for lengthy delays as the nation’s unwaveringly stringent restrictions continue to cause barriers to on-site inspections from the US FDA. Hard-hit domestic firms are proposing a "quarantine bubble" like that used during the Beijing Winter Olympics to put back on track the field checks necessary for obtaining biologics approvals.

China Manufacturing

Shanghai Pharma Manufacturing Halves In April

China's main pharma hub of Shanghai reported sector output has plunged by more than half due in large part to the prolonged lockdown, while 58% of surveyed foreign companies in China across all industries project declining revenue.

China Coronavirus COVID-19

Curious Case Of LHQW: Behind The TCM Central To China’s COVID Zero Policies

The role of a traditional Chinese medicine provided to the general public in China to fend off COVID-19 is controversial given limited evidence and even misleading, some say.

China Coronavirus COVID-19

A Year's Struggle: How Japan Is Recovering Damaged Generic Supplies After Quality Violations

Japan struggles to recover its ever-expanding supply chain for generic drugs after several key players had their production stopped because of a series of GMP violations. As the share of generics grows under government policy, some in the industry argue the problems are deeply rooted in a decades-old pricing system.

Japan Generic Drugs

Trade Group Calls For mRNA Vaccines As Guangzhou Starts Lock Downs

Following Shanghai, China’s third-largest city Guangzhou is now on high alert as Omicron cases spread, while pharma and biotech face severe production and supply chain disruptions.

China Vaccines

Biogen’s Aduhelm Competitors Boosted By Final CMS Coverage Decision

The Center for Medicare and Medicaid Services’ final decision on Medicare coverage favors anti-amyloid antibodies approved for Alzheimer’s disease based on efficacy rather than biomarker data.

Market Access Medicare
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Regulation

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Latest From Regulation

Sanofi Closes In On A Pair Of Approval Firsts

The French major has secured a fourth approval, in eosinophilic esophagitis, for Dupixent, while the EMA is set to make Sanofi's enzyme replacement therapy, Xenpozyme, the first drug approved in Europe for acid sphingomyelinase deficiency.

Approvals Rare Diseases

Stada Poised To Launch As Calliditas Finally Wins EU Nod For Kinpeygo

The Swedish biotech’s patience paid off as it received a positive EU CHMP opinion on its rare nephrology drug Kinpeygo, known elsewhere as Tarpeyo, following delays related to manufacturing questions.

Approvals Renal

PTC Confident About Commercial Prospects For Gene Therapy Upstaza

PTC CEO Stuart Peltz tells Scrip that cost watchdogs are likely to look favorably on the firm’s transformational gene therapy for a distressing rare brain disorder in children who could not even lift their heads before treatment.

Gene Therapy Drug Review

FDA Leader: We Need To Remove Surprises From Gene Therapy Development

Embattled gene therapy companies will take comfort from desire of FDA and EMA help smooth the process of bringing the novel treatments to market.

Commercial Companies

UCB Rocked By US FDA Rejection Of Blockbuster-In-Waiting Bimzelx

The Belgian group’s US launch of Bimzelx could be delayed by up to a year after the FDA hit UCB with a complete response letter which states that "certain pre-approval inspection observations must be resolved” before the drug can get the green light for psoriasis.

Complete Response Letters Immune Disorders

Lecanemab Filing Complicates Biogen's Hunt For New CEO

Lecanemab is now filed for accelerated approval with the US FDA, but the wait for a Phase III readout could impact the hunt for Biogen’s next CEO.

Neurology Commercial
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