J.R. Simplot's Russet Burbank biotech potato variety, which is resistant to late blight, generates less potentially cancer-causing chemicals and can be kept at colder temperatures for an extended period, has been cleared by the US Department of Agriculture. Approvals from the FDA and the Environmental Protection Agency are expected within a year. The firm intends to start commercial planting by 2017.
Exelixis' cobimetinib has received clearance from regulators in Switzerland for the treatment of advanced melanoma. Cobimetinib, which will be commercialized as Cotellic, is intended for use along with Roche Holding's Zelboraf, or vemurafenib. The approval was granted based on trial data showing the drug induced longer progression-free survival and higher objective response rates among previously untreated BRAF V600 mutation-positive advanced melanoma patients, compared with Zelboraf monotherapy.
The All Wales Medicines Strategy Group endorsed the use of Celgene's Imnovid, or pomalidomide, along with dexamethasone, as a treatment for previously treated patients with relapsed and refractory multiple myeloma. The decision was supported by data from a trial showing that the combination treatment yielded longer progression-free survival and overall survival, compared with dexamethasone alone. The UK's National Institute for Health and Care Excellence rejected Imnovid earlier this year, saying the benefits were not good enough to justify the cost, but is re-evaluating the decision.
The FDA has approved the abbreviated new drug application submitted by Aurobindo Pharma to market its Raloxifene hydrochloride tablet. The drug is a generic version of Eli Lilly & Co.'s Evista tablet for addressing and preventing osteoporosis in postmenopausal women.
The FDA granted approval to Sunovion Pharmaceuticals' Aptiom, or eslicarbazepine acetate, as a monotherapy for partial-onset seizures. The approval was backed by two studies demonstrating that Aptiom decreased patients' seizures. The treatment was previously intended only for those who failed to respond to one or two previous anticonvulsive therapies.
Telesta Therapeutics' intravesical immunotherapy MCNA has received priority-review status from the FDA for use in high-risk nonmuscle-invasive bladder cancer patients who have previously had bacillus Calmette-Guerin therapy. The designation was backed by late-stage trial data that showed 25% of MCNA-treated patients achieved one-year disease-free survival. The decision is expected by Feb. 27.
A recall involving 6,458 units of CareFusion's Alaris syringe pump has been categorized by the FDA as Class I. The recall was made over concerns about an error causing the pump to stop delivering fluids to the patient after an audible and visual alarm is triggered.
The BioMonitor 2, a device from Biotronik intended for remote monitoring of tachycardia, bradycardia, syncope and atrial fibrillation patients, has obtained CE mark approval from European regulators. The device, which uses the firm's home monitoring system to transmit as many as six electrocardiogram scans each day, can deliver ECG monitoring for more than an hour.
Draft guidance from the Health Resources and Services Administration calls for six conditions to be met for discounted prescriptions under the 340B Drug Pricing Program. The proposal includes limits on when people may be considered patients of a 340B-covered organization, as well as when patients may be considered outpatients whose prescriptions are eligible for the discounts.
Celgene has wrapped up its purchase of Receptos for $7.2 billion. The deal boosts Celgene's inflammation and immunology portfolio and gives it access to Receptos' Ozanimod, which has been evaluated as a potential treatment for several indications, such as ulcerative colitis and relapsing multiple sclerosis.
- Page 1