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Top Stories
Catalent’s acquisition of Paragon Bioservices will provide expertise in expanding gene therapy market.
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Shareholders have approved the issuance of Bristol-Myers Squibb common stock for the pending $74-billion merger with Celgene.
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Industry News
Brexit has the potential to rumble on until Oct. 31, 2019 as the UK is granted a further six-month extension by European Union leaders.
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EDCTP has granted EUR 10 million to a collaboration of African and European antimalarial drug researchers to support late-stage clinical trials of a novel antimalarial combination.
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Supplier News
The companies will merge to offer a broader range of analytical data packages and regulatory support for biopharmaceuticals.
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Hovione Technology has acquired global rights to a dry powder inhaler for pulmonary drug delivery, the Papillon DPI, invented by Dr. Klaus-Dieter Beller.
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Bio/Pharma News
The UK’s Centre for Process Innovation is collaborating with GSK and AstraZeneca to establish a continuous wet granulation manufacturing facility for small-scale development of oral solid-dosage pharmaceuticals.
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Novartis has announced that FDA has accepted its biologics license application (BLA) for brolucizumab (RTH258) for the treatment of wet age-related macular degeneration (AMD).
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Regulatory News
EMA is evaluating the safety of Lemtrada (alemtuzumab) after new side effects were reported.
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FDA sent a warning letter to RIJ Pharmaceutical LLC after an inspection of the company’s Middletown, NY facility found CGMP violations.
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The pharma industry – defined.
Experience the long-standing expertise of CPhI with the convergence of pharma's most motivated buyers, experienced sellers, in addition to an array of networking opportunities at CPhI North America – happening April 30 – May 2, 2019 in Chicago, Illinois. Register now to walk our strategically zoned Expo Hall for free!
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FORMULATION
Easier access to information, targeting smaller patient populations, and increased regulatory focus on patient outcomes are driving patient centric drug development.
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ANALYTICS
Laboratory test methods evaluate cleaning agents and cleaning process design for removing resin residues from the surfaces of non-dedicated chromatography columns systems.
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DRUG DELIVERY
Intracellular strategies offer an effective alternative approach to deliver a range of therapeutic proteins.
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REGULATORY/GMP COMPLIANCE
At INTERPHEX 2019, CEO Richard Johnson highlighted the importance of PDA’s new Asian business unit and outlined the organization’s plans. Data integrity guidance for manufacturing and quality systems will be published by the end of the year, as efforts move into big data and artificial intelligence.
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UPCOMING WEBCASTs
Requirements for Fully-Integrated Service Offerings in a HPAPI and Cytotoxic Environment
Two Live Events: Tuesday, May 28, 2019, at 10am JST | 9pm EDT | 6pm PDT
Tuesday, May 28, 2019, at 5pm JST | 10am CEST
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Geographic Advantage: Accelerating Clinical Supply in China and Global Trials
Thursday, May 9 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Beating the Clock: Case Studies in Expediting Biologic Development
Tuesday, May 7, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Sustainable Sourcing & Supply Chain Engagement in Pharma
Tuesday, May 7, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Approaches to Analyze and Understand 1–100 µm Particles/Aggregates in Biotherapeutics
Tuesday, April 23, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Events
April 23–24, 2019
April 30–May 2, 2019
May 1–2, 2019
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eBOOKS
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The editors explore new tools for bio/pharma lab studies—such as robotics, augmented reality, and advanced instrumentation—as well as best practices for method development, multiple attribute monitoring, lab mixers, and raw material testing. |
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