Agios Pharmaceuticals has been granted exclusive global rights to Aurigene Discovery Technologies' portfolio of small molecules targeting an undisclosed cancer metabolism. Under the terms of the deal, Aurigene gets $3 million upfront and is entitled to milestone payments of $17 million per licensed product, plus royalties, while Agios will fund development, regulatory and marketing activities.
BioMarin Pharmaceutical has received FDA approval for its Brineura, or cerliponase alfa, as a treatment for symptomatic pediatric patients with late infantile neuronal ceroid lipofuscinosis type 2, a type of Batten disease that is also called tripeptidyl peptidase 1 deficiency. The drug is expected to gain marketing approval for Europe in June.
The FDA has approved Silvergate's Xatmep, or methotrexate, oral solution indicated for treatment of acute lymphoblastic leukemia as part of multiphase combination chemotherapy maintenance in pediatric patients. Xatmep is also approved for the management of polyarticular juvenile idiopathic arthritis in patients who cannot use first-line therapies because they did not respond adequately to or cannot tolerate the treatment.
The FDA has accepted for review Regeneron Pharmaceuticals and Sanofi's resubmitted biologics license application for Kevzara, or sarilumab, with an action date of May 22. A final decision on an EU marketing authorization application for the drug is expected from the European Commission in the coming months.
Flex Pharma's investigational new drug application for FLX-787 has received FDA approval for a midstage trial involving patients with amyotrophic lateral sclerosis. The company is also exploring use of the drug for treatment of the Charcot-Marie-Tooth group of neuropathies.
The European Medicines Agency has granted priority medicines designation to uniQure's AMT-060, an investigational gene therapy for patients with hemophilia B. The designation was based on early-stage trial data showing patients with severe disease were nearly cured of spontaneous bleeding episodes with up to a year of follow-up, and they experienced significantly increased levels of Factor IX and substantially reduced need for Factor IX replacement.
The Bill & Melinda Gates Foundation, GV (formerly Google Ventures) and Alexandria Venture Investments led a Series D financing round that raised $45.5 million for Arsanis, which is moving an experimental treatment for Staphylococcus aureus pneumonia into Phase II testing. The drug, ASN100, combines two monoclonal antibodies, and the company said it will use the fresh funds to study other monoclonal antibodies for multi-drug resistant Escherichia coli and Klebsiella pneumoniae, Streptococcus pneumoniae and respiratory syncytial virus.
Clovis Oncology will partner with Myriad Genetics on a companion diagnostic test for germline BRCA mutations to fulfill a postapproval requirement for Rubraca, or rucaparib, with the FDA. The deal calls for Myriad to submit a supplementary premarket approval to the FDA under the existing PMA for BRACAnalysis CDx to add Rubraca.
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Biotech crops reduce the use of chemicals that permeate the soil and harm lungs, with a study in PLOS ONE showing the adoption of agricultural biotechnology cut pesticide use worldwide by 37% and led to a 22% rise in crop yields, writes former USDA Secretary Tom Vilsack. Eliminating the use of biotech crops, on the other hand, would reduce corn, soybean and cotton yields by 11.2%, 5.2% and 18.6%, respectively, according to a Purdue University study.
A proposal by CVR Energy's Carl Icahn to shift the blending point of obligation from refiners to fuel terminals is partly responsible for a sharp drop in the cost of compliance credits required under the Renewable Fuel Standard. CVR Energy said biofuels compliance expenses for its refining unit were negative during the first quarter of 2017.
BIO is hosting its BIO Talent Connect, presented by BioSpace (formerly the BIO Career Fair) on June 22 at the San Diego Convention Center, a FREE opportunity for those seeking career-advancement opportunities, professional-development resources, and access to hiring managers at the hottest global biopharma companies. There is no better venue for networking with 16,000 global biotech leaders. BIO Talent Connect registrants receive an Exhibition registration badge to access the BIO International Convention Exhibitions and company presentations all day June 20-22. Register now.
Humor has a tremendous place in this sordid world. ... If you can see things out of whack, then you can see how things can be in whack.
Theodor Seuss Geisel, writer and illustrator
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