Analyzing the Commercial Biosimilar Landscape

biosimilar

The 15th annual Business of Biosimilars conference was a continuation of many of the market discussions that have previously surrounded the biologics and biosimilars landscape. Topics presented during the 2-day event included: assessing the commercial realities once biosimilars are approved in the US; emerging market assessment; naming conventions such as the recently proposed biological qualifier (BQ) system by the WHO and biosimilar policies and their respective adoptions in the US and the European Union (EU). (more…)

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New FDA Guidance Clarifies the Transfer of Clinical Research Projects to a New Institutional Review Board (IRB)

IRB

Code of Federal Regulations (CFR) Title 45 – Part 46: Protection of Human Subjects provides a regulatory basis for policies that protect individuals in investigative clinical trials. Several government agencies provide resources on ethical considerations in biomedical research in the United States (US): (more…)

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Current Trends in the Pharmaceutical Industry: Emerging Markets

emerging markets

One of the largest pharmaceutical trade shows, CPhI Worldwide, recently concluded in Paris. The event brought together companies from an expanse of geographical regions and played host to countless meetings where industry professionals worked to identify potential suppliers, partners and opportunities for growth. Much of the discussion and presentations during the event focused on the increasingly globalized industry, and new markets presenting interesting opportunities. As the industry evolves in the wake of the patent cliff, and small molecule opportunities in mature markets wane, more companies are scouting emerging markets for prospects. Business models for both innovators and generics are changing; strategic partnering and outsourcing for specific capabilities are becoming integral decisions as firms strive to gain or maintain a competitive edge. (more…)

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How Patents, Availability, Regulations, and Market Conditions Affect your Future API Manufacturing Strategy

API

The “patent cliff” and ever tightening regulations together with payer pricing pressures have forever changed innovator and generics companies’ outlook on active pharmaceutical ingredient (API) sourcing. In order to succeed in this new world, how you select and develop new opportunities will have to change—while anticipating your current and future customers’ needs, possibly years before they do. Companies who adapt quickly to this new and challenging environment give themselves a major advantage over their competitors. (more…)

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Video: Wuxi’s Mission Critical – Fostering Innovation by Servicing Biopharma

Wuxi

It might act like a biopharmaceutical firm, but Wuxi Apptec’s Richard M. Soll, senior VP, International Discovery Service Unit, told BioWorld it’s still a CRO. He also discussed Wuxi’s role in helping to obtain the first U.S. FDA approval of a biologic product made by a Chinese company. (more…)

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Japan and China: Challenging Strategies in the Global Device Market

medical devices

Medical devices play an increasingly vital role in health care delivery. In Asia, 2 major players in the medical device industry—Japan and China—share strategic importance to the global market.

  • Japan: world’s second largest market after the US, estimated at $30 billion USD*
  • China: world’s fourth largest market, soon the third, estimated at $14 billion USD*, and with high growth rate, the potential is huge

(more…)

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New Drugs for Obesity and Diabetes

Contrave

In the last few weeks, a number of new agents have taken strides toward launch onto the diabetes and obesity markets, which both represent large and commercially lucrative market sectors. Diabetes affects approximately 350 million people worldwide, including a staggering 9.3% of the US population. It is the leading cause of blindness, amputation and kidney failure, and is predicted by the WHO to be the seventh leading cause of death by 2030. (more…)

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A Dendritic Cell ‘Vaccine’ is a First for ‘Promising Innovative Medicine’ (PIM) Status in the U.K.

Promising Innovative Medicine

‘Promising Innovative Medicine’ (PIM) status has been given in the U.K. for the first time, for a vaccine to treat cerebral glioblastoma multiforme (GBM). Northwest Biotherapeutics (NWBT), Bethesda, Maryland, U.S.A. developed the DCVax®-L vaccine which may now, under PIM status, be used as an adjunct to treat these aggressive brain tumours in patients in the U.K. (more…)

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FDA Suggests Reintroduction of Bovine-Derived 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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