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Morning brief: Herzuma launched in Europe, rare disease status for Orchard candidate and more

A rapid round-up of pharma, biotech and healthcare news

Novo NordiskObesity drug Saxenda lifts Novo Nordisk

Rising sales of obesity treatment Saxenda have helped Novo Nordisk post solid Q1 revenues.

The Copenhagen-headquartered firm saw its group sales rise 5% and profits climb 6%.

Saxenda saw sales rise 43% in the first three months of the year to DKr800m ($128m), with the company predicting that the global obesity epidemic is likely to fuel growth for years to come.

Read more here.

Biosimilars: Herzuma launched in Europe, FDA rejects Sandoz rituximab

Mundipharm has launched Herzuma, its biosimilar version of Roche’s Herceptin trastuzumab in Europe.

This follows hot on the heels of MSD (working with Samsung Bioepsis) that launched the first Herceptin biosimilar, Ontruzant, in March.

Meanwhile in the US, the FDA has issued a complete response letter (CRL) regarding Sandoz’s proposed biosimilar rituximab. Sandoz hasn’t disclosed the reasons for the FDA rejection, but says its submission contains robust evidence, and is currently evaluating the regulators points.

gene therapyOrchard gains rare disease status for ex-GSK therapy

Orchard Therapeutics has been granted an FDA Rare Pediatric Disease Designation for its rare disease gene therapy candidate OTL-200, which it has just acquired from GSK.

The UK cell and gene therapy company acquired OTL-200 along with Strimvelis, the ‘bubble boy’ syndrome treatment from GSK last month, after the big pharma decided to sell off its rare disease portfolio.

OTL-200 gene therapy is for the treatment of patients with metachromatic leukodystrophy (MLD). A rare, fatal, neurodegenerative, inherited metabolic disease caused by mutations in the ARSA gene, most patients do not survive their first decade of life.

Orchard will now work closely with the Hospital San Raffaele and the Telethon Foundation, acting through their joint Telethon Institute for Gene Therapy, in Milan, the partners with whom GSK developed Strimvelis.

Mark Rothera, president and CEO of Orchard says it anticipates filing OTL-200 with regulators from 2019, and added that the FDA nod provided incentives to continue expanding its pipeline.

The company says trials have shown that early treatment with OTL-200 has demonstrated preservation of cognitive and motor development to levels comparable with healthy individuals.

BMSBMS expands real-world data partnership with Roche’s Flatiron

Bristol-Myers Squibb has expanded an existing partnership with Flatiron Health, a start-up focused on mining electronic health records and real-world data to support cancer drugs development.

BMS says it will use Flatiron’s real-world data to accelerate its R&D and improve its ability to generate real world evidence (RWE). The expanded collaboration will see the companies form a joint Scientific Advisory Board to advance the use of RWE for regulatory decision making.

Thomas Lynch, MD, executive vice president and chief scientific officer, BMS said: “We will work with Flatiron to contribute to RWE industry guidance and standards, and advance new regulatory-focused RWE use cases. Ultimately, this work will enable us to accelerate our ability to help patients.”

The news is eye-catching as it is the first after Roche completed its $1.9bn acquisition of Flatiron last month. Roche and Flatiron had stipulated that the buyout would not see Flatiron turning away new pharma partnerships.

UK news: missed breast screening shortened up to 270 lives

Health Secretary Jeremy Hunt apologies for failure to invite 450,000 women for routine checks. Read more – BBC.

Article by
Andrew McConaghie

3rd May 2018

From: Research, Sales, Regulatory, Healthcare



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