ParaPRO grants RedHill rights to sell GERD drug | Pfizer's Besponsa for ALL gets FDA nod | AstraZeneca, Merck get expanded approval for Lynparza
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August 18, 2017
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ParaPRO grants RedHill rights to sell GERD drug
ParaPRO granted RedHill Biopharma exclusive rights to market gastroesophageal reflux disease drug Esomeprazole Strontium Delayed-Release capsules to gastroenterologists in some US territories for at least three years. Under the terms of the deal, RedHill will not need to make upfront or milestone payments but will share revenues with ParaPRO.
Seeking Alpha (free registration) (8/17) 
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Health Care & Policy
Pfizer's Besponsa for ALL gets FDA nod
Pfizer's Besponsa, or inotuzumab ozogamicin, was approved by the FDA as a treatment for adult patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia.
Seeking Alpha (free registration) (8/17) 
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AstraZeneca, Merck get expanded approval for Lynparza
AstraZeneca and Merck received approval from the FDA to expand the indication for Lynparza, or olaparib, to cover use as a maintenance therapy in patients with recurrent ovarian cancer that is responsive to platinum-based chemotherapy. The drug was previously approved as a treatment for women with advanced ovarian cancer who had at least three prior treatments with chemotherapy and were no longer responding to it.
Reuters (8/17) 
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CAR T-cell therapy shows potential in treating chronic lymphocytic leukemia
Patients with chronic lymphocytic leukemia previously treated with ibrutinib had an overall response rate of 71% to CD19-specific chimeric antigen receptor T-cell therapy, according to a study in the Journal of Clinical Oncology. In 17 of 21 patients whose bone marrow was tested with high-resolution flow cytometry, no marrow disease was detected.
Healio (free registration) (8/15) 
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FDA commissioner vows action to boost generic-drug development
Makers of brand-name drugs "game the system and game the rules" of a patient safety program to prevent generic-drug makers from obtaining adequate samples for equivalence studies, says FDA Commissioner Scott Gottlieb, who has vowed action to curb the practice.
USA Today (8/15) 
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Alexion adds patents to Soliris
Alexion has gained three new patents for its expensive biologic drug Soliris, or eculizumab, for paroxysmal nocturnal hemoglobinuria. Amgen has a potential eculizumab biosimilar in its pipeline.
FiercePharma (8/16) 
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Company & Financial News
Mylan agrees to pay $465M to settle EpiPen misclassification claims
Mylan agrees to pay $465M to settle EpiPen misclassification claims
(Joe Raedle/Getty Images)
EpiPen maker Mylan agreed to pay $465 million as part of a final settlement deal with the Justice Department, resolving claims that the firm overcharged the US government by misclassifying the epinephrine auto-injector as a generic product under Medicaid's Drug Rebate Program while it was being marketed and priced as a branded treatment. The settlement, which requires Mylan to reclassify EpiPen and pay rebates applicable to its new classification effective April 1, was criticized by several lawmakers who believe the settlement is too low.
Reuters (8/17),  The Hill (8/17) 
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J&J, India's IMTECH collaborate on tuberculosis treatment R&D
Johnson & Johnson and India's Institute of Microbial Technology, part of the Council of Scientific and Industrial Research, will collaborate on the research and development of new drug compounds for tuberculosis. The partnership will take advantage of J&J's research capabilities and CSIR-IMTECH's microbial technology competence.
Genetic Engineering & Biotechnology News (8/17) 
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Chinese drugmakers bid for Atlanta-based specialty pharma company
Specialty drugmaker Arbor Pharmaceuticals attracted bids from Shanghai Pharmaceuticals and Fosun Pharmaceutical's Hong Kong unit. Arbor, based in Atlanta, develops treatments for the hospital, pediatric and cardiovascular markets.
Reuters (8/14) 
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The Latest From BIO ...
Registration is open for the 2017 BIO Investor Forum
The BIO Investor Forum, Oct. 17-18 in San Francisco, is an international biotech investor conference focused on investment trends and opportunities in life sciences, with unbiased emphasis on venture-stage growth and emerging public companies. The BIO Investor Forum is attended by private equity and public investors, research analysts and industry executives focused on investment and business development opportunities in the life sciences. Network with executives and investors focused exclusively on life sciences during BIO One-on-One Partnering™ meetings, and take advantage of a rich program that consists of corporate presentations and panels on the sweet spots and growth challenges facing the industry. Register today!
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Food & Agriculture
ToolGen's CRISPR technology licensed to Monsanto
Monsanto secured intellectual property rights to ToolGen's CRISPR technology platform for the development of agricultural products. The agreement could help Monsanto further expand its portfolio of gene-editing tools to develop and improve sustainable crops.
Brownfield (8/17) 
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Industrial & Environmental
Renewable fuel standard boosts US economy
The renewable fuel standard has helped the US economy through the reduction of both fuel prices and oil imports along with increases in tax revenues and GDP, writes Bob Dinneen, president and CEO of the Renewable Fuels Association, citing a study featured in an upcoming issue of the American Journal of Agricultural Economics. "The results that we have presented confirm that the current RFS program considerably benefits the agriculture sector," the authors of the study say.
The Hill (8/18) 
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News From BIO
Secure document sharing services optimized for life science
ShareVault, a leading provider of highly secure and controlled document sharing solutions and virtual data rooms (VDR), has partnered with BIO to provide member companies with significantly discounted pricing and value-added features. ShareVault's VDR platform is optimized for life science companies of all sizes and flexibly priced so that even small biotech companies can afford and benefit from its technology. The ShareVault solution is intended for due diligence and other applications that require secure sharing of documents with third parties. Learn more and sign up for a free trial.
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The news summaries appearing in BIO SmartBrief are based on original information from news organizations and are produced by SmartBrief, Inc., an independent e-mail newsletter publisher. The information is not compiled or summarized by BIO. Questions and comments should be directed to SmartBrief at bio@smartbrief.com.
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