ViaCyte to acquire Janssen BetaLogics | Bill aims to expedite development of Zika virus vaccine | New dosage of Merck's CINV drug receives FDA approval
 

February 5, 2016
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ViaCyte to acquire Janssen BetaLogics
ViaCyte will acquire Johnson & Johnson unit Janssen BetaLogics, including its assets, patents and knowledge in metabolic diseases, to boost the development of an embryonic stem cell-based insulin therapy for type 1 diabetes. The treatment is under Phase I development. Financial terms of the deal were not disclosed. The Washington Times/The Associated Press (2/4), Xconomy (2/4)
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Health Care & Policy
Bill aims to expedite development of Zika virus vaccine
A bill that would include Zika virus in the FDA's priority review voucher program has been introduced by Reps. G.K. Butterfield, D-N.C., and Susan Brooks, R-Ind. "We urgently need a solution, and the PRV program encourages the rapid development of safe and effective treatments and cures," Butterfield said. The bill is currently before the House Energy and Commerce Committee. Bloomberg BNA (free content) (2/3)
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New dosage of Merck's CINV drug receives FDA approval
Merck's supplemental new drug application for the single-dose administration of injectable Emend, or fosaprepitant dimeglumine, along with other antiemetic medications, has been approved by the FDA as a preventive therapy for delayed chemotherapy-induced nausea and vomiting in patients treated with moderately emetogenic chemotherapy. The approval was granted based on late-stage trial data. OncLive (2/4), Seeking Alpha (free registration) (2/4)
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Asterias' spinal cord injury therapy gains FDA orphan status
The FDA has granted orphan-drug status to Asterias Biotherapeutics' AST-OPC1, a human embryonic stem cell-derived oligodendrocyte progenitor population, for use in patients with acute spinal cord injury. Results from an early-stage trial showed four out of five patients who received the drug experienced spinal cord cavitation reduction. A trial using a cohort of patients with complete cervical spinal cord injuries is underway. European Pharmaceutical Review (U.K.) (2/4)
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Dry-eye-disease treatment from Shire accepted for FDA review
A new-drug application refiled by Shire for its dry-eye-disease drug lifitegrast has been accepted for review by the FDA. A final decision from the agency is expected by July 22. Seeking Alpha (free registration) (2/4)
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Brintellix gets FDA panel's support for boosting cognition of MDD patients
Takeda Pharmaceutical's and Lundbeck's antidepressant Brintellix, or vortioxetine, has been recommended for approval by the FDA's Psychopharmacologic Drugs Advisory Committee to be used to treat cognitive dysfunction in patients with major depressive disorder. The committee's decision was based on clinical trial data provided by Takeda that showed the medication provided a small improvement in patient cognition. MedPage Today (free registration) (2/3)
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Company & Financial News
Funding round brings in $24M for hepatitis B drug developer
A Series A funding round has pulled in $24 million for ENYO Pharma. Proceeds will be used to support the advancement of its hepatitis B drug candidate EYP001 into early-stage trials. FierceBiotech (2/3)
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Cesca Therapeutics obtains $15M investment
The Boyalife Group provided a $15 million investment to Rancho Cordova, Calif.-based Cesca Therapeutics. The stem-cell-medicine firm intends to use the money to expand its product pipeline and improve its international operations. The Sacramento Bee (Calif.) (tiered subscription model) (2/3), Seeking Alpha (free registration) (2/3)
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Food & Agriculture
Congress urged to act quickly on national biotech food labeling policy
The food industry is urging Congress to create a national labeling policy to prevent the enforcement of a mandatory biotech food labeling standard set to go into effect in Vermont in July. Critics and supporters of mandatory biotech food labeling have failed to come to an agreement after two rounds of talks organized by Agriculture Secretary Tom Vilsack. Congress wants a bipartisan compromise to be reached before summer. The Washington Post (tiered subscription model)/The Associated Press (2/4)
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Industrial & Environmental
Ethanol is beneficial to US
Regardless of media coverage of presidential candidates who are in favor of or against the Renewable Fuel Standard and misconceptions about subsidizing and mandated use of ethanol, the fact is that ethanol is beneficial for the country, writes Windsor, Colo., resident Kurt Felker in a letter to the editor of The Coloradoan in Fort Collins. Ethanol use lowers foreign oil dependence and gas emissions, and consumers have a choice of whether to buy it, writes Felker. The Coloradoan (Fort Collins, Colo.) (tiered subscription model) (2/4)
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