Why data exclusivity is the new patent protection

Journal of Commercial Biotechnology
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Why data exclusivity is the new patent protection

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The Journal of Commercial Biotechnology is a unique forum for all those involved in biotechnology commercialization to present, share, and explore new ideas, latest thinking and best practices, making it an indispensable guide for those developing projects and careers within this fast moving field.

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Drug Patent Expirations for Oct 8, 2015

DrugPatentWatch provides competitive intelligence on small-molecule drugs and the 90,000 global patents covering them Click the patents below for more details, or visit DrugPatentWatch.com for more options. PRILOSEC OTC (omeprazole magnesium) Astrazeneca Pharms Patent number: 5,817,338 Expiration Date: Oct 6, 2015 LETAIRIS (ambrisentan) Gilead Patent number: 7,601,730 Expiration Date: Oct 7, 2015 LETAIRIS (ambrisentan) Gilead […]

Drug Patent Expirations for Oct 1, 2015

DrugPatentWatch provides competitive intelligence on small-molecule drugs and the 90,000 global patents covering them Click the patents below for more details, or visit DrugPatentWatch.com for more options. VALCYTE (valganciclovir hydrochloride) Hoffmann La Roche Patent number: 6,083,953 Expiration Date: Sep 29, 2015 MYCAMINE (micafungin sodium) Astellas Patent number: 6,265,536 Expiration Date: Sep 29, 2015 DEXFERRUM (iron […]

Biosimilars in Brazil: developments in 2015 and business perspectives

Brazil is looking into foreign technology to foster innovation in the country’s industrial health complex. Biological plants are being built and partnerships with multinationals have been established with the goal to in license technology, manufacture and supply the population with biosimilars made in Brazil. This article brings up-to-date information on the biosimilar market in the country, with information on the public-private partnerships and regulatory approvals. With two biosimilars approved in 2015 and the ongoing development regarding the local pharmaceutical companies, there is a good window of opportunity to create new businesses in the soon to be 4th pharmaceutical spender in the world. 

Investment in Life Sciences in Scotland: Challenges and Opportunities

As the global life sciences industry changes, the most successful regions in attracting inward investment will be those that evolve and adapt to provide the most attractive offer. In Scotland, the government is developing an environment to “push” its life sciences sector to complement the strong “pull” that these changes in the global life sciences industry and in investor sentiment have created.

The Scottish Government and the life sciences industry have developed a strategy that aims to anchor in Scotland those businesses that provide vital skills and market access; increase the number of more resilient companies and comprehensive supply chains; and attract new inward investment and talent that will build on Scotland’s existing capabilities.

The Scottish Government is improving on the country’s existing strengths and aims to capitalise on prior investment in Scotland’s research excellence, particularly in areas such as stem cells and regenerative medicine and ”precision medicine”, where there are significant current and emerging commercial opportunities.

EmergingCo: A Virtual “South-South” Biotech Model

The article proposes a “virtual” biotech model for the emerging markets – termed EmergingCo – and develops a comparative financial model to argue that such a virtual biotech can deliver drug candidates from discovery through proof-of-concept (Phase II) more cost effectively than the traditional drug development paradigm. Data from published studies on drug development costs have been compared with a cost structure model for EmergingCo using a framework where all R&D can be accomplished through a virtual network of partnerships within emerging markets. A couple of case studies from China and India are used to lend support to the cost structure model. Such a model, either as a venture backed company or a virtual unit of big pharma, could provide an alternate vehicle for delivering mid-to late stage clinical candidates, similar to Lilly’s Chorus model.

Undermining Patient Values: The ASCO Value in Cancer Care Task Force Framework

As stated in a recent article in the Journal of Clinical Oncology, ASCO established a Value in Cancer Care Task Force, with the goal of “developing a framework for comparing the relative clinical benefit, toxicity, and cost of treatment in the medical oncology setting. “  In developing this framework or tool, the Task Force runs roughshod over basic facts to create a metric that – while established to promote patient centered care – strives mightily to achieve the exact opposite outcome.

Flavonoids – World Healthiest Gift for the Benefit of Human Health

Flavonoids are one of the major nutrient families recognized to scientists, and comprise over 6,000 already recognized family members. A number of the best – recognized flavonoids include quercetin, kaempferol, catechins, and anthocyanidins. It is well…

Crowdfunding: A New Untapped Opportunity for Biotechnology Start-ups?

Crowdfunding is an evolving popular Internet-based process used to raise funding that has been employed by a few start-ups in the biotechnology industry. To solicit crowdfunding, companies profile their case on a specialized web platform (generally called a “crowdfunding portal”) to site members (i.e., the “crowd”) who choose which projects they would like to fund, in exchange for financial and nonfinancial inducements. We examine the evolving commercial and regulatory crowdfunding landscape and also identifies case studies of biotechnology industry use. We have found that a variety of crowdfunding mechanisms have been used and this alternative financing strategy may represent a viable option for biotechnology start-ups during early stage research or early stage clinical trials. A successful crowdfunding campaign may pave the way for the enterprise’s future capital formation phases by attracting angel investors or venture capital because it shows that the business or project is viable. Crowdfunding, like all other forms of capital formation, requires careful planning and execution before, during, and after a campaign. Strategies that appropriately tap into this innovative and disruptive use of technology and social networks may prove to be a unique capital formation niche for biotechnology start-ups; one that has yet to be fully leveraged.