Most Clicked BIO SmartBrief Stories


1. Ambrx to be purchased by WuXi, other firms

BIO SmartBrief | May 26, 2015

San Diego-based Ambrx will be acquired by a consortium that includes Wuxi PharmaTech. The acquisition, which is expected to be completed sometime in the next several weeks, will give WuXi access to Ambrx's antibody-drug conjugate technology and its biologics development expertise. BioPharmaReporter.com (05/22)


2. Janssen licenses Novo Nordisk's autoimmune therapy

BIO SmartBrief | May 21, 2015

Janssen Biotech secured the exclusive worldwide rights to develop and market an autoimmune diseases program from Novo Nordisk. Financial terms of the agreement were not disclosed. PharmaTimes (U.K.) (05/20) Nasdaq.com (05/20)


3. Biosimilars may not repeat success of generic drugs

BIO SmartBrief | May 21, 2015

Generic versions of biologic drugs may not duplicate the success of generic drugs in the 1980s because biosimilars can be as complex to manufacture as their reference products. In Europe, biosimilars cost 15% to 25% below the prices of their biologic counterparts, compared with an average 75% savings for generics of chemical medications. Seeking Alpha (free registration) (05/19)


4. Completed Pfizer-Hospira merger expected by year's end

BIO SmartBrief | May 20, 2015

Pfizer's $17 billion acquisition of Hospira is expected to close by the end of 2015, bringing such products as biosimilars and sterile injectables to Pfizer's pipeline. BioSpectrum Asia (05/19)


5. BioNTech partners with Genmab on cancer immunotherapies

BIO SmartBrief | May 20, 2015

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 (05/19)


6. European agency releases draft guidelines for gene therapies

BIO SmartBrief | May 26, 2015

The European Medicines Agency has released guidelines on the authorization of gene therapies. The recommendations include consideration of biological vectors, potential in vivo effects on nucleic acid sequences and the design of nonclinical trials. Regulatory Focus (05/21)


7. Pfenex is developing Lucentis biosimilar

BIO SmartBrief | May 21, 2015

Pfenex is developing a biosimilar form of Lucentis, which it expects could compete with the off-label use of Avastin for the treatment of wet age-related macular degeneration. BioPharmaReporter.com (05/19)


8. J&J to seek regulatory approval for 10 drugs in next 4 years

BIO SmartBrief | May 22, 2015

Johnson & Johnson will submit at least 10 new drugs for review by 2019 and seek more than 40 expanded approvals for existing treatments. Each of the 10 potential new drugs could earn at least $1 billion annually, according to the company, and they include investigational treatments for psoriasis, multiple myeloma and rheumatoid arthritis. Many were developed with partners or licensed from other drugmakers. The Wichita Eagle (Kan.) (05/20) The Wall Street Journal (tiered subscription model) (05/20)


9. EU recommends approval of Merck's Keytruda for melanoma

BIO SmartBrief | May 26, 2015

The European Medicines Agency endorsed Merck's Keytruda, or pembrolizumab, for the treatment of advanced melanoma as a first-line therapy and in patients who received prior treatment. The drug has been approved in the U.S. Reuters (05/22)


10. House panel OKs 21st Century Cures measure

BIO SmartBrief | May 22, 2015

The 21st Century Cures bill passed the House Energy and Commerce Committee in a 51-0 vote Thursday. The bill would speed up drug approval by requiring the FDA to improve its drug review process, look at more flexible forms of clinical studies and include patient experience in the decision-making process. The full House is expected to vote on the measure in June. The Hill (05/21) Reuters (05/21)




Sign up for BIO SmartBrief



Designed specifically for biotechnology industry professionals like you, BIO SmartBrief is a FREE daily e-mail newsletter. It provides the latest news and information you need to stay informed about important biotech issues. Learn more