[PRESS RELEASE] – The Lubrizol Corporation announces its LifeSciences Pharmaceutical business will organize the first annual “Complex Drug Delivery Seminar: Micro- and Nano- Particulate Drug Product Development and Manufacturing” in Amsterdam on Thursday, September 27, 2018. Lubrizol LifeSciences through its pharmaceutical CDMO, Particle Sciences, and Co-Sponsor, Corbion, a world leader in bioresorbable polymers, would like to invite […]
Clinical Study Requirements: Drugs vs. Devices
Whether developing a new drug or medical device, designing and running clinical trials can be daunting. How drugs and devices are developed differ dramatically. Study design and regulatory pathways differ; requirements for study sites, end users, training, endpoints and follow up are all variables. This paper examines the key differences and how those impact clinical […]
From Zero to Six Million – Using a Component Management Process to Scale Up Manufacturing of Drug Delivery Devices
Drug delivery devices constitute one of the most rapidly growing segments of the medical device manufacturing market. Makers focus substantial R&D efforts on designing delivery mechanisms for new and existing drug formulations. However, even good initial designs can’t guarantee that all the parts for these devices can be manufactured correctly and assembled consistently, with few […]
PsiOxus Therapeutics shuffles the deck
PsiOxus Therapeutics shuffles the deck PsiOxus said it named Dr. Charles Morris as its chief development officer and Karen LaRochelle as its chief business officer. Morris comes from ImmunoGen, where he was chief development officer, bringing its lead candidate to Phase III development. Most recently, LaRochelle was the executive director of global business development at […]
Mylan CEO to testify before House panel over EpiPen pricing
(Reuters) –Mylan (NSDQ:MYL) Chief Executive Officer Heather Bresch will appear at a Sept. 21 congressional hearing over price increases for its EpiPen emergency allergy treatment, the U.S. House of Representatives Oversight Committee said in a statement on Wednesday. Mylan has been widely criticized, including by U.S. Democratic presidential candidate Hillary Clinton, for sharply raising the price […]
Novocure touts data from Optune-paclitaxel combination study
By Sarah Faulkner NovoCure (NSDQ:NVCR) announced yesterday that its ‘tumor treating fields, combined with the drug paclitaxel, are effective against ovarian cancer, the 5th most-common cause of cancer death in women in the US. The St. Helier, N.J.-based company won FDA approval in July for the Optune device to treat a type of brain cancer called glioblastoma. TTFields […]
PharmaJet inks pact with World Health Organization for polio vaccine
By Sarah Faulkner PharmaJet said yesterday that it inked a multi-year partnership as part of the World Health Organization’s effort to eradicate polio, using the Colorado-based company’s needle-free technology. Their Tropis device administers medication through the skin, without the use of needles. Although polio has been eradicated from the Americas, Europe, South East Asia and the Western […]
MIT, Singapore Univ. dev 3-D-printed structures that “remember” their shapes
By Sarah Faulkner Engineers from MIT and Singapore University of Technology and Design are using light to create 3D structures that remember their shape when triggered by external stimuli like temperature. These structures, also known as shape-memory polymers, could be useful as delivery vessels for drugs in the human body. Get the full story at […]
Mylan cuts EpiPen price in half after criticism
By Sarah Faulkner Mylan (NSDQ:MYL) said today that it would reduce the out-of-pocket patient cost for its EpiPen product, after being widely criticized for raising the price nearly 500% since 2009. Although the list price for the epinephrine injector remains the same, Mylan said it would increase eligibility for its patient assistance program, which eliminates out-of-pocket costs for uninsured […]
FDA request delays timeline for Sanofi’s iGlarLixi drug-device combo for diabetes
By Sarah Faulkner The FDA’s request for more data on the iGlarLixi drug-device combination for treating Type II diabetes pushed the timeline for a decision back 3 months, Sanofi (NYSE:SNY) and Zealand Pharma (CPH:ZEAL) said last week. Sanofi said August 19 that it submitted a new data package for iGlarLixi, an injection pen designed to […]
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