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.
The FDA has given Merit Medical Systems de novo clearance for its Embosphere Microspheres for treating symptomatic enlarged prostate through prostatic artery embolization procedures. The spheres are designed to be delivered through the femoral artery or the radial artery via a microcatheter.
The FDA has granted Summit Medical clearance to market its noninvasive jaw fracture recovery device, which evenly fixes the jaw in place using a system of sutures inserted between the teeth to support recovery.
The Cerene cryotherapy endometrial ablation device from Emeryville, Calif.-based Channel Medsystems has been granted CE mark approval by European regulators. The device is intended for the treatment of heavy menstrual bleeding brought about by benign causes.
An amicus curiae brief has been filed by AdvaMed with the Supreme Court to request review of a lower-court decision in a product liability case brought over Ethicon's TVT-O pelvic mesh. The decision, which prevented the Johnson & Johnson subsidiary from providing evidence that the product met 510(k) clearance requirements as it appealed a $3.3 million verdict, prevents juries "from hearing the full story ... [and] can result in FDA's assessment of a product's safety and effectiveness being supplanted by a court ruling," said Matthew Wetzel, assistant general counsel for AdvaMed.