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4/28/2017

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.

4/28/2017

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.

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BioCentury
4/28/2017

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.

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Reuters
4/28/2017

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.

4/28/2017

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.

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The Hill
4/28/2017

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.

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Reuters
4/28/2017

The labeling for Novo Nordisk's Saxenda, or liraglutide, 3-mg injection has been updated to include safety and efficacy data from a three-year trial. The company said Saxenda is the only weight-loss and weight-management drug in pen form that is backed by long-term data on safety and efficacy.

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Reuters
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Novo Nordisk, Saxenda
4/28/2017

Bayer HealthCare Pharmaceuticals has received approval from the FDA to expand the indication for Stivarga, or regorafinib, to cover use in patients with hepatocellular carcinoma who had previous treatment with Nexavar. A trial found that median overall survival, progression-free survival and response rates were better in Stivarga-treated patients, compared with placebo.

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Pharmacy Times online
4/28/2017

Agile Therapeutics will resubmit its new-drug application for Twirla to the FDA by the end of second quarter, the company said.

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Reuters
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Agile Therapeutics, FDA
4/28/2017

China-based Innovent Biologics is evaluating its PD-1 monoclonal antibody-based drug in clinical trials for cancer patients. The company aims to develop an effective treatment at a fairly low price point for Chinese patients, who often cannot afford treatment.

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Innovent Biologics, cancer