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Manufacturing Process Scale-Up for Phase III: Clear Sailing or Storms Ahead?
Download this whitepaper to learn how building scalability into formulation throughout drug development, as well as transferring the project to a knowledgeable CDMO in Phase III, can help mitigate some of the challenges that arise in Phase III.
WuXi AppTec Immunotherapy Report: Biotech Sector Will Drive Biggest Advancements in Decades on Cancer Treatments
WuXi AppTec – ­­the leading global pharmaceutical and biopharmaceutical open access capability platform – has published a new report on the prospects of immunotherapy treatments, and identified smaller, nimble biotechs, and early stage companies as the single biggest factor behind the next generation of approaches in development.
Biological Bypass Shows Promise in Coronary Artery Disease
A new gene therapy that targets the heart and requires only one treatment session has been found safe for patients with coronary artery disease, according to a successful trial carried out in Finland. Enhancing circulation in the oxygen-deficient heart muscle, the effects were visible even 1 year after the treatment.
UPM Pharmaceuticals Successfully Serializes Its First Pharmaceutical Product
UPM Pharmaceuticals successfully serialized their first product in May of this year. UPM anticipates having all of their clients' products serialized by November 2017. In accordance with the Drug Supply Chain Security Act which had mandated that pharmaceutical manufacturers serialize all pharmaceutical products starting in November 2017, UPM is excited to be ahead of schedule.
Pfizer Partners With Catalent for Exclusive Long-Term Supply Agreement
Catalent Pharma Solutions recently announced that following a successful 20-year collaboration on the development and manufacture of Advil® Liqui-Gels® (ibuprofen), it has entered into an exclusive long-term supply agreement to produce the next generation of Pfizer Inc.’s leading OTC)pain relief product.
Daiichi Sankyo, Max Planck Innovation and Lead Discovery Center Announce Cancer Research Collaboration
Daiichi Sankyo Co., Limited (hereafter, Daiichi Sankyo), Max Planck Innovation GmbH and the Lead Discovery Center GmbH have signed an agreement providing Daiichi Sankyo with the option to receive the exclusive rights to a new lead compound for the treatment of cancer to be discovered and developed at the Lead Discovery Center.
Lonza Completes Acquisition of Capsugel, Creating Leading Integrated Solutions Provider
Lonza announced that following the receipt of all required regulatory approvals, it has completed the acquisition of Capsugel S.A. from KKR for $5.5 billion in cash, including refinancing of existing Capsugel debt of approximately $2 billion.
Enable Injections Introduces First Multi-Vial/Multi-Syringe Biologics Delivery System
Enable Injections, Inc., the developer of advanced large-volume wearable injectors (LVWI) for subcutaneous delivery of biologics and high-volume drugs, recently announced a new single-, partial-, or multi-vial/syringe transfer system for filling its LVWIs.
Microneedles - A Novel Alternative in Selected Drug Delivery Areas
Microneedles are a novel drug delivery technology that can offer promising advantages as an alternative to classical needle injections and other routes of administration. Therefore Vetter, global provider of aseptic prefilled drug delivery systems and Microdermics, a medical device company developing a novel hollow, metal microneedle drug and vaccine delivery system, have entered into a strategic cooperation.
CordenPharma & GE Healthcare Offer Unique End-to-End Solution to Accelerate Oligonucleotide Drug Development
CordenPharma International and GE Healthcare’s Dharmacon business have entered a strategic collaboration to create an end-to-end solution for oligonucleotide-based drug discovery.
West Highlights Rigid Needle Shields for Prefilled Syringes
West Pharmaceutical Services, Inc., a global leader in innovative solutions for injectable drug administration, provided more information on its product offering, the Rigid Needle Shield (RNS), at the Parenteral Drug Association (PDA) Europe Annual Meeting.
Q BioMed Finalizes License Agreement for Novel Liver Cancer Treatment
Q BioMed Inc recently announce their entry into a final license agreement with The Oklahoma Medical Research Foundation (OMRF) and the Rajiv Gandhi Centre for Biotechnology (RGCB) for the global exclusive rights to develop and market a novel chemotherapeutic drug to treat liver cancer.
COPD Market Set to Hit $14.1 Billion by 2025
The chronic obstructive pulmonary disease (COPD) space across the eight major markets of the US, France, Germany, Italy, Spain, the UK, Japan, and Australia, is set to rise from $9.9 billion in 2015 to around $14.1 billion by 2025, representing a compound annual growth rate of 3.7%, according to research and consulting firm GlobalData.
IntelGenx Receives Patent for Topical Oral Film Technology
IntelGenx Corp. recently announced that the United States Patent and Trademark Office has issued US Patent 9,668,970 covering the design and manufacturing of topical oral films (TOF) for the local (topical) treatment of diseases of the oral mucosa using mucoadhesive particles.
Lubrizol Invests $60 Million to Expand Particle Sciences, Vesta & Other Facilities
The Lubrizol Corporation recently announced its LifeSciences business continues to invest in its key capabilities through a variety of planned expansions. During this latest phase, a $60-million investment will focus on new product solutions, capacity expansion, and additional cGMP manufacturing.
FAQs on What Happens If You Miss the Serialization Deadline
Serialization affects all stages of the supply chain and with many companies, small and large, unprepared for the scope of regulations and data support required it leads to the question: what happens if you miss the serialization deadline?
Acasti Pharma & CordenPharma Announce Large-Scale Production of CaPre With Continuous Manufacturing
Acasti Pharma Inc. recently announced the achievement of a major corporate milestone by manufacturing the first cGMP batches of CaPre®, Acasti’s omega-3 pharmaceutical product candidate, produced with a proprietary and innovative continuous manufacturing process developed in partnership with CordenPharma.
Vetter & Microdermics Enter Into Strategic Agreement to Develop Innovative Microneedle Drug Delivery Systems
Vetter, a leading and innovative provider of aseptic prefilled drug delivery systems and Microdermics Inc., a Vancouver-based medical device company developing a novel hollow, metal microneedle drug and vaccine delivery system, recently announced that they have entered into a strategic cooperation agreement.
Pion Inc. Acquires Sirius Analytical Instruments Ltd.
Pion Inc., an industry leader in analytical instrumentation for drug development for the pharmaceutical industry, recently announced the acquisition of Sirius Analytical Instruments Ltd., headquartered in East Sussex, United Kingdom.
Hovione Announces Start of Phase 1 Clinical Trial
Hovione will soon initiate recruitment for its Phase 1 clinical trial of HY02, a proprietary minocycline sterile ointment to treat a subset of ocular surface inflammation, generally manifesting on the inner edge of the eyelids, leading to eye irritation and sometimes more severe symptoms such as blurring of the vision and/or irritation of the cornea.

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