Articles by Suzanne Hodsden
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Hikma Opens Oncology API Manufacturing Plant
9/18/2014
Multinational company, Hikma Pharma, opened the doors to a new manufacturing plant in Jordan that specializes in active pharmaceutical ingredients (API) for oncology medicines. This move is expected to create thousands of jobs and strengthen Jordan’s growing foothold in a global pharmaceutical market.
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Alchem International Steps Up to Resolve Supply Gap In Tropane Alkaloid APIs
9/17/2014
With several European principal players exiting the market, Alchem International has committed to continue the manufacture of tropane alkaloid active pharmaceutical ingredients (APIs) crucial for the manufacture of numerable drugs and therapies.
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FDA Launches Purple Book Of Biosimilars
9/16/2014
The FDA has released a first edition of the “Purple book,” which lists biologic products currently licensed by the agency and their interchangeable biosimilars. The “Purple Book” is the biologic equivalent of the “Orange Book,” which was first published in 1980 and performs a similar function for chemical drugs.
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Almac, U.K. Universities and Industry Experts To Collaborate On Green Chemicals
9/10/2014
Almac, a contract development and manufacturing organization (CDMO), has partnered with Bangor University (Wales) and Hockley International to develop a synthetic biology project in the hopes of creating innovative and more environmentally sound approaches to chemical development.
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Clinical Trial Recruitment Education Becoming Increasingly Interactive
9/8/2014
As myths and misconceptions about participation in clinical trials continue to proliferate, researchers are continually on the hunt for new ways to educate potential patients — especially parents and children — about the importance of participating in clinical trials. A recent example of this is the launch of a new video game from The New England Research Institutes (NERI), which aims to educate children about clinical research trials and is available for free download from the National Heart, Lung, and Blood Institute (NHLBI).
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DPT Laboratories Expands New Jersey Location With Purchase of Meda Pharma Facilities
9/5/2014
Texas-Based DPT Laboratories announced the acquisition of Meda Pharmaceutical’s Lakewood, New Jersey facilities for an undisclosed amount, expanding DPT’s current Lakewood base by 90,000 square feet.
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India Considering Waiving Clinical Trials For Certain In-Demand Drugs
9/4/2014
Currently, the Central Drugs Standard Control Organization (CDSCO) requires all drugs marketed in India to first undergo a local phase IV clinical trial, even if regulatory agencies from other countries have already approved the medication. However, recently, the New Drug Advisory Committee (NDAC) has proposed a waiver for two cancer drugs, Aflibercept and Trastuzumab, on the grounds that no alternative treatment currently exists to meet the demand.
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ACRO Addresses India’s Proposed IT-Enabled Clinical Trials System
9/3/2014
In an effort to offer more function transparency, the Central Drugs Standard Control Organization (CDSCO) recently issued a proposal which outlined a new online system that would make clinical trials easier to monitor and faster to approve. Shortly after the release of this proposal, however, the Association of Clinical Research Organizations (ACRO) issued a statement which addressed questions the current proposal brought up and offered the organization’s expertise in streamlining and improving India’s proposed new system.
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Piramal Exits Early-Stage R&D In Mumbai
9/2/2014
Piramal announced plans to shut down its early-stage drug research in Mumbai, shifting willing personnel to other facilities and focusing the company’s research on late-stage drug development and moving some of their research abroad.
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Extended-Release Form Of Baxter’s Advate Succeeds In Clinical Study
8/28/2014
Baxter announced that Phase III studies of BAX 855, a full-length, longer-acting recombinant factor VIII developed to increase the half-life of ADVATE, led to a 95 percent reduction in annualized bleeding rate in patients with hemophilia A.