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GSK Is First Big Pharma To Seek Gene Therapy Approval, Plans More

 
• By Sten Stovall

Britain’s biggest drug maker is seeking regulatory approval in Europe to use gene transfer technology in children born with ADA-SCID and has further programs using the approach in two other rare diseases - metachromatic leukodystrophy and Wiskott-Aldrich syndrome - with both currently in clinical trials.

GlaxoSmithKline PLC has become the first big pharma to file for marketing approval of a gene therapy by submitting GSK2696273 for ADA-severe combined immune deficiency in Europe. GSK’s five-year-old rare diseases unit plans follow-up indications using the same therapy aimed at fixing faulty genes, but a similar regulatory filing in the U.S. isn’t imminent, the company says.

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More from Italy

German, Dutch And Italian HTA Processes Not Supportive Of RWD, Say Companies

 
• By Eliza Slawther

Payers and health technology assessment bodies in the Netherlands, Germany and Italy are either unwilling to use real-world data in assessments or cannot due to their existing frameworks, say representatives from Gilead Sciences and Autolus Therapeutics.

Gene Editing Therapy Casgevy Now Funded In 8 Countries But French Access Withdrawn

 
• By Eliza Slawther

The world’s first CRISPR gene editing therapy, Casgevy, has been made available to patients with sickle cell disease in England, adding to access arrangements in the US, Austria, Bahrain, Germany, Luxembourg, Italy and Saudi Arabia.

Teva Fined Half A Billion Dollars Over European Copaxone Antitrust Breach

 
• By Dave Wallace

Teva has been fined €463m – just over half a billion US dollars – over a breach of EU antitrust rules, after the European Commission found that it abused its dominant position to delay competition to Copaxone, including by misusing the patent system and disparaging rivals. The firm has strongly disagreed with the decision – which is claims is “legally untested” and “not supported by the facts” – and says it will appeal.

Italy Sets Up Project To ‘Break Industry Monopoly’ On Drug Information

 
• By Ian Schofield

The COSIsiFA initiative includes a new independent website, regular newsletters, a six-monthly bulletin, and training courses to help promote the appropriate use of medicines.

More from Europe

Non-Submissions To UK HTA Body Could Increase Unless Commercial Environment Improves, Warns Industry

 
• By Leela Barham

Finding ways to lower the rebates paid by the pharmaceutical industry to the UK government and fostering partnerships to make the UK a more attractive launch market could help reduce the number of terminated technology appraisals conducted by NICE, the health technology appraisal institute, says the UK pharmaceutical industry.

Non-Submissions To England’s NICE Surge Across All Disease Areas

 
• By Leela Barham

Blood cancer therapies were most proportionately impacted by the failure of pharmaceutical companies to submit evidence on their cancer therapies to England’s health technology appraisal body, shows analysis by the Pink Sheet.

UK Mandates Unmodified Standardized Contracts To Speed Clinical Trial Set-Up

 
• By Vibha Sharma

The policy expectation that the model clinical trial agreements are used without modification is in line requests from industry and the NHS/HSC.