The Office of the US Trade Representative will attempt to resolve issues raised by US medtech companies about India's price controls on medical devices, as well as intellectual property disputes, Trade Representative Robert Lighthizer said at a Senate Finance Committee hearing on trade policy. Lighthizer added that enforcement actions will be taken if India's actions are proven to have violated World Trade Organization rules.
Epizyme's tazemetostat has gained orphan drug status from the FDA to treat soft tissue sarcoma. Tazemetostat was previously developed as a treatment for patients with non-Hodgkin lymphoma as well as certain genetically defined solid tumors.
Thirteen varieties of trail mix, cranberry mix and kumbaya mix distributed by United Natural Trading have been recalled because they contain dates from Hudson Valley Farms, which found Listeria monocytogenes at its facility. Included in the recall were Woodstock, Nature's Promise, Wholesome Pantry and Market Basket brands, which were shipped in limited quantities nationwide.
LivaNova's Vagus Nerve Stimulation Therapy device has been granted expanded MRI labeling by the FDA. The approval allows patients using the minimally invasive device to have an appointment at any MRI center in the US and have access to over 90% of routine scans performed on patients with epilepsy.
European regulators have given ImpediMed CE mark approval for its Sozo bioimpedance spectroscopy platform, which uses the company's L-Dex lateral lymphedema assessment system for noninvasive measurement and monitoring of body composition and fluid status. The platform is designed to be used by patients recovering from a coronary artery disease-related event or those with fluid management problems, heart failure or end-stage renal disease.
Glenmark Pharmaceuticals gained an exclusive license to APC Therapeutics' antigen-presenting, cell technology-based anticancer compound, which has the potential to be used either as monotherapy or in combination with approved drugs. Under the terms of the deal, Glenmark will handle all clinical development and regulatory and commercialization activities.
Panelists the BIO International Convention discussed assessing value when determining drug prices, including factors such as caregiver burden and productivity. "We have no idea what we should be paying for medicines. Maybe we should be paying more," said Joshua Ofman, Amgen's SVP of Global Value, Access and Policy. Another topic of interest among attendees is the effect of Brexit on UK biotechs, with many thinking the companies will follow the European Medicines Agency when its headquarters leaves London.
Rubius Therapeutics, which is developing a unique drug-discovery technique involving re-engineered red blood cells, has raised $120 million to advance the technology. The platform will serve as a basis to create new drugs for various diseases, particularly blood cancers.
Dragonfly Therapeutics and Celgene will partner to cultivate new therapies for the treatment of hematologic cancers such as multiple myeloma using Dragonfly's TriNKET immunotherapy platform. Celgene will gain exclusive rights for up to four treatments developed by Dragonfly, which will receive an upfront payment of $33 million for the development of the therapies.
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