Pharmaceutical outsourcing used to be a relatively simple affair: Do most of the R&D or scaleup work inhouse, then hand off some limited portion of the development or manufacturing work to a partner. As competitive pressures and consolidation continue to […]
Read MoreThe increasing concern for patient safety in addition to increased quality and regulatory requirements have contributed to the evolution of improved drug delivery. Choices for primary containment and delivery systems can impact time to market, and more importantly, patient outcomes. […]
Read MoreThe British government’s WWII rallying cry, “Keep Calm and Carry On” is worth keeping in mind as the US biopharma industry (pharma and biotech) goes through its current wave of mergers, acquisitions and realignments. There will be layoffs (layoffs have […]
Read MoreSpecialty pharmaceuticals, specialty distribution and specialty pharmacies are all the rage in the US biopharma industry today; the generally accepted notion is that specialties will represent half of industry revenue by the end of the decade, if not sooner. But […]
Read MoreThe merging of Patheon and the pharma assets of DSM International, first announced last fall, has been completed with the naming of the new entity: DPx, to be headquartered in Durham, NC, and headed by Jim Mullen, current president of […]
Read MoreOn a not-serious level, one can ask, ‘Why didn’t I think of that?’ But on another, much more serious level, there’s news from FDA and Kaléo (Richmond, VA) that could lead—very quickly—to saving lives and providing some good news in […]
Read MoreFig. 1. Extended-release formulation is rated as one of the most effective methods of extending the life cycle of a drug. Credit: Best Practices LLC The FDA clarified the regulatory thicket surrounding the 505(b)(2) approval pathway for drug formulations just […]
Read MoreFig. 1. Savsu’s PHD shipper for small volumes. Credit: Savsu Upholding cold-chain integrity and regulatory compliance standards are morphing into major issues, experts say, with the explosion of temperature-sensitive pharmaceutical products, new global and regional manufacturing mandates, and supply chains […]
Read MoreAn autoinjector pen went from concept lower right) to detailed design elements to finished product for one client. Source: NobleRx With the time and resources invested in developing and evaluating new drugs through clinical trials, the reality is much of […]
Read MorePackaging Coordinators Inc. (PCI; Philadelphia) has begun construction of a 93,000-sq.-ft. storage and distribution facility, following through on an earlier decision to expand in this area in 2011 with the construction of a clinical packaging plant. The combination will complement […]
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