BMS' sBLA for 3rd-line SCLC drug granted FDA priority review status | FDA fast-tracks Calithera's advanced kidney cancer candidate | Amgen, Novartis' Aimovig benefits patients with treatment-resistant migraine
Bristol-Myers Squibb's supplemental biologics license application for Opdivo, or nivolumab, as a treatment for patients with small cell lung cancer with disease progression after two or more previous lines of therapy was accepted under FDA priority review status with an Aug. 16 PDUFA date. The application was backed by data from the Phase I/II CheckMate-032 study, in which single-agent Opdivo yielded an overall response rate of 10%, a median overall survival of 4.4 months and a one-year OS rate of 33% in 98 previously treated SCLC patients.
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Calithera Biosciences' CB-839, in combination with Exelixis' Cabometyx, or cabozantinib, which is being developed as a treatment for patients with metastatic renal cell carcinoma who have failed up to two previous treatments, including at least one vascular endothelial growth factor tyrosine kinase inhibitor or a combination of Bristol-Myers Squibb's Yervoy, or ipilimumab, and BMS' Opdivo, or nivolumab, was given fast-track review status by the FDA.
A Phase IIIb LIBERTY trial showed that Amgen and Novartis' Aimovig, or erenumab, had a significant treatment effect in patients with episodic migraine who had failed two to four previous treatments. In the trial, 30.3% of patients who received Aimovig experienced at least a 50% reduction in migraine days versus 13.7% for placebo.
AstraZeneca and Daiichi Sankyo introduced in Japan its proton pump inhibitor Nexium, or esomeprazole magnesium hydrate, in 10- and 20-mg granules for suspension, sachet, which is a new formulation of Nexium 10- and 20-mg capsules. The new therapy is indicated for the treatment of gastric, duodenal and anastomotic ulcers; reflux esophagitis; nonerosive reflux disease; Zollinger-Ellison syndrome; inhibition of recurrence of gastric or duodenal ulcer during low-dose aspirin administration; inhibition of recurrence of gastric or duodenal ulcer during nonsteroidal anti-inflammatory drug administration; and support of Helicobacter pylori eradication.
Danish drug manufacturer Novo Nordisk is teaming up with the Red Cross to improve the treatment of chronic disease in conflict zones such as Syria and Yemen. Novo Nordisk has pledged a $3.58 million contribution and said it will supply the Red Cross with low-cost insulin, start projects aimed at combating diabetes and hypertension, and adapt production and ordering methods to further assist humanitarian organizations.
A follow-on funding pulled in $208 million for MorphoSys, which has plans of filing a rolling biologics license application to the FDA for relapsed or refractory diffuse large B cell lymphoma therapy MOR208 in the second half of 2019.
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The Max Planck Institute of Molecular Physiology agreed to work with AiCuris to discover and develop antibacterial drugs for the treatment of viral and bacterial infections. Under the collaboration, the institute's proprietary collection of natural product-based compounds will be used by AiCuris, and the two will jointly study compounds that have the potential to become anti-infective drugs.
The amended Farm Bill, which was recently approved by the House Agriculture Committee, would create a Biotechnology and Agricultural Trade Program to challenge foreign trade barriers that restrict the use of biotech commodities. The bill would also set up a national science-based education campaign to inform the public about the technologies used in food and agricultural production, and would require the Department of Agriculture to report to Congress its plans for improving the regulations on biotech products.
Japan's government approved a policy that will allow imports of ethyl tert-butyl ether made from US corn ethanol. Under the policy, corn-based ethanol can comprise up to 44% of the country's 217 million-gallon ethanol demand for the production of ETBE, which is used in gasoline as an oxygenate.
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The sea does not reward those who are too anxious, too greedy or too impatient. ... One should lie empty, open, choiceless as a beach -- waiting for a gift from the sea.
Anne Morrow Lindbergh, author and aviator
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