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Top Stories
Merger cites combined strengths in oncology, immunology and inflammation, and cardiovascular disease.
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The $8-billion acquisition will broaden Lilly's oncology portfolio in precision medicines and treatments that target cancers caused by specific gene abnormalities.
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Industry News
Drug pricing and reimbursement concerns will continue to hinder industry growth in 2019, according to data and analytics company GlobalData.
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The company is recalling 5 lots of Ceftriaxone for Injection, USP, 250mg; 10 lots of Ceftriaxone for Injection, USP, 500mg; 24 lots of Ceftriaxone for Injection, USP, 1g; and 3 lots of Ceftriaxone for Injection, USP 2g because of the presence of particulate matter in reconstituted vials.
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Supplier News
The $252-million acquisition is expected to strengthen Cambrex’s position as a small-molecule CDMO across the drug lifecycle.
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Tornado Spectral Systems, winner of the 2018 CPhI Excellence in Pharma Award for Analysis, Testing, and Quality Control, discusses real-time process measurement for biopharmaceutical and small-molecule drug manufacturing.
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Bio/Pharma News
AbbVie and immunotherapy company Tizona Therapeutics will join forces to develop and commercialize CD39-targeted therapeutics to treat cancer.
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The companies will work together to discover and develop new treatments for neurological conditions such as Alzheimer’s and Parkinson’s disease.
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Regulatory News
In 2018, the agency authorized 42 drugs with new active substances, three advanced therapies, and 21 orphan drugs.
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FDA sent a warning letter to Skylark CMC Pvt. Ltd. after employees refused to let agency inspectors enter the company’s Ahmedabad, Gujarat, India facility.
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The future of pharmaceutical chemical imaging
Renishaw's RA802 Pharmaceutical Analyser offers scientists a step change in vibrational spectroscopy-based imaging techniques. Three of the most common complaints about conventional Raman microscopy and infrared microscopy (IR microscopy) systems are sample focus, speed of analysis and ease-of-use. The RA802 Pharmaceutical Analyser combines Renishaw's proprietary LiveTrack™ and StreamLine™ technologies to generate chemical images up to 150 times faster than conventional methods.
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REGULATORY/GMP COMPLIANCE
A required time frame should not be the driving force behind root cause investigations, says Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates.
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DRUG DELIVERY
Transdermal patch design, materials, and manufacturing variables, as well as drug formulation and interactions between the API and the adhesive, can affect adhesion and drug delivery.
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You drive development. We'll offer directions. Eurofins Lancaster Laboratories PSS Insourcing Solutions is a program that places our exclusively managed laboratory services team to execute a scope of work or project directly at the client's site, using the client's laboratories and quality systems. We collaborate with clients as a strategic partner to understand their distinct body of work.
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OUTSOURCING
CMOs and CDMOs made investments in new and expanded facilities and services in the last quarter of 2018.
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Exclusive Interview from AAPS
Developing New Technologies in Controlled Release
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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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