FDA Suggests Reintroduction of Bovine-Derviced Heparin

Heparin

During an advisory committee meeting with its Science Board in early June, the FDA suggested a reintroduction into the US market of bovine-derived heparin. Despite theoretical risks associated with bovine-derived products, heparin is a vital product for clinical use, FDA representatives argued, and single animal/country specific sourcing is risky. (more…)

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Navigating Clinical Trials in Russia: the Challenges, Solutions and Benefits

Clinical Trials in Russia

Slated to rise from 11th to 8th place in the global pharmaceutical rankings, Russia is steadily proving to be a lucrative market for investors. With increased healthcare expenditure and governmental support of innovation through the implementation of Strategy 2020, policymaking and industry reform are shaping Russia’s drug development landscape. Efforts to localize pharmaceutical manufacturing and increase domestic R&D have been successful. Most of large pharma has set up camp in the country and remains present despite a drop in clinical trials in 2013. (more…)

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How Changes to Strategic Portfolio Development are Affecting Generics & API Manufacturers

API Manufacturers

Medical treatments are becoming increasingly specialized, personalized, and targeted to specific therapies. The shift in drug portfolios has impacted not only the innovation landscape, but also the generic drug landscape and the active ingredient landscape. Understanding how these shifts will impact your business strategies, partnerships, and potential competition is critical for your company’s long term growth and success. (more…)

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Creating Strategic Value In The Changing Generics Market: CPhI Worldwide 6th Annual Pre-Connect Congress

API Sourcing

“The patent cliff is changing the patterns of generic competition.” – Kate Kuhrt, Senior Director, Generics, Thomson Reuters

 

The day before the official start of the CPhI Worldwide tradeshow in Paris, several hundred attendees gathered once again for a day of presentations, discussions, and debate on topics impacting the pharmaceutical industry. Participants in the program could choose between commercial and technical tracks. (more…)

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Anticancer Protein Kinase Inhibitors: Strengths, Weaknesses, Opportunities and Threats

Kinase

Signal transduction in cancer cells is a sophisticated process that involves receptor tyrosine kinases to trigger cellular signaling pathways in order to promote growth, pro-apoptotic signaling and angiogenesis, and ultimately cancer development. Molecularly targeted anticancer therapies using either small molecules or antibodies to these tyrosine kinases have been successfully introduced to treat various cancers, and the future of anticancer therapy may largely lay with agents such as these, particularly as more is learned about cancer cell biology. Thomson Reuters analysts have assessed the strengths, weaknesses, opportunities and threats for the therapeutic agents in this area; selected highlights are presented. (more…)

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Get More out of your Data by Extending Collaboration with Partners

big data

Most Big Data initiatives are inherently selfish. The vision is that all you need to do is build your data “lake” and then enlightenment will simply emerge from patterns in your own data. This article will address what Big Data means in a collaborative world. (more…)

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Video: Macrogenics Draws Takeda to Potential $500M Alliance

macrogenics

In a chat with BioWorld, Scott Koenig, president and CEO, Macrogenics Inc., reflects on how it enticed a fifth big pharma partner — Takeda Pharmaceutical Co. Ltd. to the table with a candidate from its DART platform in a deal worth around $469 million. (more…)

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How to Survive in the Post-Patent Cliff World?

patent cliff

Patent cliff is felt by many players in the industry: innovators, generics, and API manufacturers. Patent cliff refers to a large number of blockbusters losing patent protection in a narrow time frame. Certainly, we are continuing to see new molecules come to the market every year, and every year several of them are losing patent protection. But after 2015, the number of products going generic is lower than we’ve gotten accustomed to. And the dollar volumes exposed to generic competition will be quite a bit lower than in recent past. (more…)

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Biosimilars Set to Revolutionize Global Drug Development Industry

biosimilars

It is rare to see a new business segment emerge in any market, but this is what is happening within the biopharmaceutical development industry. There are currently 700 follow-on biologics therapies moving through pipelines with many already approved and 245 biopharma companies and institutes developing or already marketing follow-on biologics in markets throughout the world. Biosimilars are expected to account for approximately one quarter of the $100 billion worth of sales stemming from off-patent biologics by the end of the decade. (more…)

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‘Back to the Future:’ Bioimmunoadjuvants in Cancer Therapy

Bioimmunoadjuvants

A recent multi-centre report, published online in Science Translational Medicine, includes the Johns Hopkins Medical Institutes, the Ludwig Center and M.D. Anderson Cancer Center. The authors report that an intra-tumour injection of the spores of an attenuated strain of Clostridium novyi (Cl. novyi-NT) induced tumour lysis in two animal models. The first was a rat orthotopic brain tumour model. The second was a spontaneous tumour model in dogs. (more…)

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