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Top Stories
Novartis plans to acquire Endocyte, a biopharmaceutical company, to accelerate the development of innovative radioligand technology for treating cancer.
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To achieve a more dynamic marketplace, FDA is issuing guidance documents and targeted advisories to support R&D on complex generics and combination products.
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Industry News
The US Department of Health and Human Services has published its proposed rule on the disclosure of drug prices, just in time for the November mid-term elections.
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Dr. C. Frank Bennett, has been announced as a recipient of the Breakthrough Prize in Life Sciences in recognition of his contribution to the discovery and development of the first drug approved for the treatment of spinal muscular atrophy.
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Supplier News
Cambrex will create a new center of excellence for API process development and clinical supply at its High Point, NC facility and expand its API manufacturing facility in Italy.
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An advanced combination polymer for enteric coatings has been launched by Evonik and will be showcased during AAPS PharmSci 360 in Washington DC.
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Bio/Pharma News
The companies will work together to develop Ionis-FB-LRx for the treatment of complement-mediated diseases, including Geographic Atrophy (GA), the advanced stage of dry age-related macular degeneration (AMD), in a deal worth $760 million.
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The companies will work together to advance a number of Morphic's oral integrin therapeutics for fibrosis-related indications in a deal with $100 million.
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Regulatory News
The recommended drugs include one biosimilar, two orphan medicines, and three extensions of therapeutic indications.
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The agency, in partnership with international regulatory and law enforcement agencies, cracked down on 465 websites marketing illegal opioids and other drugs claiming to treat conditions such as cancer and HIV.
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ANALYTICS
Experts weigh in on up-to-date analytical procedures for the lot release testing of small-molecule pharmaceuticals.
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FORMULATION
Lipid-based formulations offer a means of addressing the physicochemical and biological challenges of poorly soluble APIs.
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QUALITY SYSTEMS
This article explores major aspects for United States biotech companies to consider when creating a compliant post-Brexit strategy.
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Events
November 1–2, 2018
November 4–7, 2018
November 28–29, 2018
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AAPS PharmSci 360 Exhibitor Preview
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CordenPharma is your full-service partner in the contract development & manufacturing (CDMO) of APIs, drug products, and packaging services.
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Distek engineers highly innovative, technically modern and user-friendly instruments that provide many innovative features to customers, worldwide.
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Eurofins Lancaster Laboratories supports all functional areas of bio/pharmaceutical manufacturing.
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Lonza Pharma & Biotech provides global contract development and manufacturing services that enable pharma and biotech companies to bring medical innovations to patients in need.
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LSNE is a privately held company with five cGMP facilities; four located in New England and one in Madison, WI.
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eBOOKS
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This ebook covers novel technologies for the formulation, manufacture, purification, and delivery of sterile small- and large-molecule drugs, including single-use systems, facilities and equipment, contamination issues, and process analytics. |
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