BioNTech partners with Genmab on cancer immunotherapies | Company challenges British clinical trial transparency reform | Gene therapy developer could secure $115M in IPO
May 21, 2015
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BioNTech partners with Genmab on cancer immunotherapies
BioNTech and Genmab agreed to collaborate on the research, development and marketing of cancer immunotherapies in a deal worth up to $15 million. Under the agreement, BioNTech will provide its expertise in immunomodulatory antibodies and onco-immunotherapy and will receive $10 million upfront and up to $5 million in potential additional payments, while Genmab will allow the use of its DuoBody platform. The firms will equally share ownership of the product and development and marketing costs. Genetic Engineering & Biotechnology News (5/19)
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In 2014, 66% of Approved Drugs Earned Clearance Through Accelerated Approvals
Understand the FDA factors needed to qualify for accelerated approvals: fast track designation, breakthrough designation, accelerated approval and priority review. Click here to read the article: FDA Expedited Pathways.
Company challenges British clinical trial transparency reform
Richmond Pharmacology, a company that runs human drug trials for major pharmaceutical firms, has brought a judicial review to challenge a reform proposed by Britain's Health Research Authority that would require registration of all such studies, including those with poor results. The effort toward greater transparency has been a major push of the AllTrials campaign, launched in 2013 by scientists from medical journals and the Cochrane Collaboration. The Guardian (London) (5/18)
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Gene therapy developer could secure $115M in IPO
Celyad is preparing an initial public offering of stock that could raise up to $115 million. The Belgium-based firm specializes in the development of gene therapies for cancer and cardiovascular disease. Capital (5/18)
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Anti-inflammatory drug from Pharmaxis acquired by Boehringer
Boehringer Ingelheim agreed to pay up to about $600 million to acquire Pharmaxis' investigational drug PXS4728A and develop it as a treatment for nonalcoholic steatohepatitis. Under the terms of the agreement, Pharmaxis will get about $31 million as an upfront fee and additional payments contingent on further development and marketing of the drug. BioSpectrum Asia (5/18), PharmaTimes (U.K.) (5/18)
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EMA confirms conflict-of-interest policy
A new conflict-of-interest policy by the European Medicines Foundation prohibits employees from participating in drug reviews if they plan to work in the pharmaceutical industry. (5/18)
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Other News
FEATURED ARTICLE: 10 Small-Business Predictions for 2015
Things are looking up for small businesses in 2015. We count down the 10 ways you can get ahead in the New Year. Read the article.

Asia Pacific
India unveils program to report, monitor medical device adverse events
The Materiovigilance Programme of India will be launched by the country's health ministry within three months to ensure that medical devices are safe for use. The program, which will begin with the establishment of sites in 10 medical schools, is being developed by a national committee appointed by the health ministry and will systematically report and track medical device-associated adverse events in India. (India) (5/18)
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Malaysia's medical device filing deadline is June 30
Medical device companies must file with Malaysia's Medical Device Authority by June 30 to continue sales in that country, which is using a new risk-based system that will eventually require conformity assessment reports. Companies that submit technical files by the deadline will receive provisional approval for five years. Clinica (5/19)
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North America
FDA supports LOINC code use in pharmaceutical, biological submissions
The FDA is asking that biological and pharmaceutical submissions use the Logical Observation Identifiers Names and Codes standard to ensure that clinical research data standards are in line with U.S. health IT programs. The agency supports LOINC code adoption because clinical laboratories are using it and it will make data easier to be filed, understood and analyzed by clinicians. It is also recommending the codes because the Study Data Tabulation Model, which is the standard used for sharing laboratory test results in studies, supports LOINC code exchange. Regulatory Focus (5/18)
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Providers can consult FDA website to avoid unauthorized drug distributors
The FDA Verify Wholesale Drug Distributor Licenses website can help health care providers comply with the Drug Supply Chain Security Act, which requires those who dispense or administer prescription drugs to purchase them only from federally or state-authorized trading partners. (5/18)
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Editor's Note
DIA Global SmartBrief will not publish May 26
DIA Global SmartBrief will publish on Thursday and Friday of next week, May 28 and 29, instead of the normal Tuesday/Thursday publishing schedule, in observance of Memorial Day in the U.S.
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