FDA has organized its quality initiative around review, inspection, surveillance, policy and research Two trends stand out in the rapidly changing landscape of pharma and biotech manufacturing today: the whirlwind of mergers, acquisitions and buyouts will not let up anytime […]
Read MoreSpringtime, the annual BIO meeting, and the general upswing in both commercial and investor activity in biotech (see p. 8) has brought a raft of new announcements of manufacturing capacity. Interestingly, most of the new announcements involve non-US companies expanding […]
Read MoreThe annual report from Evaluate Pharma, World Preview 2015, Outlook to 2020, compiles a variety of data on research, drug pipelines, and current and projected sales. By its count, the No. 1 biopharma company in the world both in 2014 […]
Read MoreFig. 1 AstraZeneca’s Seroquel (top), the 2014 HCPC winner; Lilly’s Strattera (middle); Novartis’ Exforge (bottom) Pharma manufacturers (and their contract packaging providers) who are considering compliance (unit-dose) packaging have three trends to take advantage of: More of the overall healthcare […]
Read More*Excerpted from PDA Technical Report 68, available at no charge, at http://www.pda.org/scientific-and-regulatory-affairs/ regulatory-resources/drug-shortage. Published with permission of PDA. Copyright © Parenteral Drug Association. Fig. 1. A risk triage model of patient impact. Unfortunately, drug shortages have become more frequent […]
Read MoreReasons for Drug Shortages: 2013 source: FDA Over the past decade, drug shortages have been on the rise, creating a significant public health issue. The healthcare industry has seen shortages of essential drugs such as chemotherapy agents, anesthesia drugs for […]
Read MorePharmaceutical 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 […]
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