Uptake of biosimilars has been slow in the US, according to a session at the American College of Rheumatology annual meeting, where physician Roy Fleischmann noted, "There is no benefit in cost to patients and no improvement in access to biologic therapy to patients." Europe has had more success with the drugs, where a biosimilar for Remicade, or infliximab, costs 69% less in Norway than the reference biologic.
7 keys: Put real-world evidence into action Life sciences organizations need to know how their therapies work in the real world once clinical trials end. And these seven key components to standardizing real-world data and analytics platforms are how they get started. Read the paper, Institutionalizing Real World Evidence.
A late-stage trial of Novartis' breast cancer drug Kisqali in combination with hormonal therapies in premenopausal women was able to stop the progression of hormone-receptor positive, human epidermal growth factor receptor-2 negative advanced breast cancer longer than hormonal therapy alone, according to the company.
GlaxoSmithKline submitted a supplemental new drug application to the US FDA for Nucala, or mepolizumab, as an add-on to maintenance therapy for eosinophilic chronic obstructive pulmonary disease. The interleukin-5 antagonist was approved in 2015 to treat asthma caused by eosinophilic inflammation.
Merck & Co. and Pfizer announced the availability in the UK of Bavencio, or avelumab, which is indicated for the treatment of metastatic Merkel cell carcinoma. Until now, the sole option for treatment of this rare, aggressive skin cancer has been chemotherapy, the companies said.
China is stepping up its monitoring of the internet to halt illegal drug and medical device sales. Local China FDA officials are expected to use social media sites to share information with the public.
The FDA sent a combined warning letter to Lupin citing violations in good manufacturing practices at its facilities in Goa and Indore, India. The company said the product supply from the facilities will not be interrupted despite the warnings, although new product approvals from the plants will likely be delayed.
A dengue fever vaccine developed by Takeda shows sustained antibody responses against all four strains of the virus, according to 18-month data published in the journal Lancet Infectious Diseases. Takeda is testing a two-dose regimen of the vaccine in a late-stage trial to achieve a faster rate of response.
A group of Senate Democrats asked Allergan CEO Brent Saunders to disclose the terms of the drugmaker's deal to transfer patents on dry-eye drug Restasis to a Native American tribe, shielding the patents from Patent Trial and Appeal Board review, and asked whether the Allergan plans similar deals.
A recall was initiated by Boston Scientific involving its 180- and 200-mm Innova self-expanding stent system and 150-mm Eluvia drug-eluting vascular stent. The recall was issued because of the number of complaints associated with partial stent deployment, which may cause prolongation of the implant procedure or vessel trauma and could require major surgery.
The needle destruction device, currently named the "sharps needle destruction device," would be reclassified from a Class III device to a Class II device with special controls under a proposed order issued by the FDA. The order was put forward as part of the 2014-2015 strategic priority of the agency's Center for Devices and Radiological Health to review Class III devices for possible reclassification.
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