European regulators approved Sanofi and Regeneron's Kevzara, or sarilumab, as a treatment for adults with moderately to severely active rheumatoid arthritis and who have intolerance or an inadequate response to one or more disease-modifying antirheumatic drugs. The decision was backed by seven late-stage studies in which Kevzara showed statistically significant, clinically meaningful improvements in patients.
Recent Supreme Court decisions dealing with patents have some experts concerned about a weakening of patent holders' rights. In TC Heartland v. Kraft Foods Group Brands, a venue case, the Supremes limited the ability of patent holders to sue in other states. And in Impression Products v. Lexmark International, the court ruled that a product can't be sold with fewer rights or a subset of ownership rights. In effect, the high court found, once an entity purchases an ink cartridge, they can do what they want with it. Read the story.
Takeda licensed its measles and pertussis vaccines to Biological E. to allow Biological E. to develop and market the vaccines in China, India and low- and middle-income countries. Biological E. will use Takeda's vaccine technology to develop a pertussis-containing combination vaccine and a combination measles and rubella vaccine.
AMAG Pharmaceuticals' supplemental new drug application for a subcutaneous auto-injector formulation of Makena, or hydroxyprogesterone caproate, has been accepted for review by the FDA with an expected action date of Feb. 14. Makena, a preterm birth medication, has already been approved as an intramuscular injection.
A $359 million merger deal between Repligen and Spectrum Laboratories is expected to strengthen the companies' position in the bioprocessing industry as the leading developer of monoclonal antibodies. The merged firms also plan to expand into the fields of vaccine manufacturing, and production of recombinant proteins and gene therapies.
Ring spot-resistant biotech papaya saved an $11 million industry in Hawaii. Scientist Dennis Gonsalves, a plant pathologist at Cornell University, and two other researchers inserted a gene from the ring spot virus into the papaya genome, making the fruit resistant to the virus.
Advanced Biofuels Canada released a study of biofuel use in the country in which emphasis is placed on biofuel types, biofuel blending rates and feedstocks utilized at the provincial level. "This report also aims to inform governments, as they assess the role our industry can play to reduce greenhouse gas emissions and drive clean innovation investments from new fuel regulations, such as the national clean fuel standard," said ABFC President Ian Thomson.
Although the lymphoma drug Adcetris, developed by Seattle Genetics and Takeda Pharmaceutical, met the primary goal of a late-stage study to measure progression-free survival in blood cancer patients, the difference between the drug and control arm results -- 82.1% percent for Adcetris vs. 77.2% in the control group -- was deemed not significant, and analysts said the modest gain could create cost issues among payers. Seattle Genetics still plans on filing for an expansion of the drug's label in the US soon.
Sandoz's Rixathon, a biosimilar to MabThera, or rituximab, has been launched in the UK as a treatment for patients with follicular lymphoma, diffuse large B-cell lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis or microscopic polyangiitis. The company also introduced Erelzi, a biosimilar to Enbrel, or etanercept, which is intended to treat inflammatory conditions such as axial spondyloarthritis, rheumatoid arthritis, plaque psoriasis, juvenile idiopathic arthritis, psoriatic arthritis and pediatric plaque psoriasis.
Several Yummy brand breaded chicken products were recalled by Maxi Canada because of the presence of milk not declared on the label. Included in the recall are Dino Buddies Chicken Breast Nuggets, Dinosaur-Shaped Chicken Breast Patty Fritters, Yummy! Yummy! Dino Wheels Chicken Breast Rings and 100% All Natural Chicken Breast Fries with Whole Grain Breading, all of which bear the establishment number of 348, were produced between June 1, 2016, and June 1, 2017, and were shipped nationwide in Canada.
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