Top Stories
Pfizer transfers CAR-T assets to Allogene Therapeutics under a new alliance to further develop immuno-oncology therapeutics.
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The agency has release a report providing an overview of steps taken to enhance benefit-risk assessment in the review of drugs.
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INTERPHEX 2018 Keynote Series
Aseptic, Sterile, and Biologics Drug Manufacturing
Industry experts will discuss lyophilization best practices and continuous manufacturing for biopharmaceuticals.
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Industry News
A new scientific publication examines analytical processes for the emerging legal cannabis industry.
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Congress passed a $1.3-trillion omnibus budget bill March 22, 2018 that increases federal support for biomedical research and health programs for fiscal year 2018.
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Supplier News
MedPharm has received a multi-million dollar investment by Ampersand Capital Partners to diversify its service offering and regional coverage.
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The company has developed an intelligent laminate for supply chain security and traceability in addition to a new business unit that develops intelligent hyperspectral imaging solutions.
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Bio/Pharma News
Takeda is considering approaching Shire with a possible offer.
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Novartis’ Sandoz is seeking approval of its biosimilar referencing Johnson & Johnson’s Remicade (infliximab) for all of Remicade’s indications across gastroenterology, rheumatology, and dermatology.
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Regulatory News
The agency has accepted AstraZeneca's biologics license application for an investigational leukemia drug candidate and granted it priority review.
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EMA has recommended approval of the biosimilar for the same indications as Roche’s Herceptin (trastuzumab).
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QC/QA
A previously published article presented difficulties with the revised European guidelines on sterile manufacturing. The authors included a brief summary of the comments developed on the draft document. This article expands upon that summary, outlines the authors' rationale, and highlights the most difficult aspects of the revision draft.
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DRUG DEVELOPMENT
Formulation expertise can smooth the transition of a prospective therapy from medicinal chemistry to drug dosage form.
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STANDARDS & REGULATIONS
Certificates of analysis can be used to monitor the reliability of products and their suppliers, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
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Events
April 17–19, 2018
April 24–26, 2018
June 4–7, 2018
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eBOOKS
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Vaccines—from childhood and influenza immunizations, to epidemic prevention, to cancer and therapeutic treatments—present unique development challenges. In this Vaccine and Manufacturing eBook, the editors explore development and manufacturing options to make vaccines more accessible. |
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