Author Archive

Drug Shortages Still in Focus

Patricia Van Arnum PharmTech editor Drug shortages, particularly those for sterile injectable drugs, took center stage last year. In response, industry and the federal government, including FDA, took steps to address the problem. Progress has been made, and Congress is further evaluating if additional steps need to be taken. Read more »

From Interphex 2012: Modern Pharmaceutical Manufacturing

Patricia Van Arnum PharmTech editor In attending the exhibitions and conference sessions at Interphex 2012 this week in New York, we gain a pulse on the current and future state of pharmaceutical manufacturing. So, a fundamental question arises: what is modern pharmaceutical manufacturing? Read more »

An Important Addition to the National Bioeconomy Blueprint

Patricia Van Arnum PharmTech editor The Obama Administration released last week the National Bioeconomy Blueprint. The report outlines steps that federal agencies will take to drive the bioeconomy—economic activity powered by research and innovation in the biosciences—and details  ongoing efforts across the federal government to realize this goal. Given the importance of biotechnology to the pharmaceutical industry, does the plan do enough? Read more »

GlaxoSmithKline: A Rebuffed Suitor for the Moment

Patricia Van Arnum PharmTech editor Last week Human Genome Sciences (HGS) rejected GlaxoSmithKline’s (GSK) unsolicited $2.59 billion bid for HGS or $13 per share.  Although rejecting GSK’s initial bid, HGS kept the door open for other suitors, including again GSK. Read more »

Nanofactories: The next frontier in protein synthesis?

Patricia Van Arnum PharmTech editor Researchers at the Massachusetts Institute of Technology (MIT) recently developed nanoparticles that can be controllably triggered to synthesize proteins. The hope is that particles could be used to deliver small proteins that kill cancer cells and eventually larger proteins such as antibodies that trigger the immune system to destroy tumors. Read more »

Risk Management in Sterile Manufacturing

Patricia Van Arnum PharmTech editor Sterility assurance is a critical component in the planning and manufacturing of pharmaceutical products. Good risk management consists of identifying and assessing risks prior to the manufacturing process as well as taking measures during the production process to control, mitigate, or eliminate risks. An upcoming educational webcast by Pharmaceutical Technology, Risk Management in Sterile Manufacturing, will examine best practices for risk management in sterile manufacturing. Read more »

Steps Forward in Continuous Manufacturing

Patricia Van Arnum PharmTech editor Historically, the pharmaceutical industry had the luxury of accepting lower manufacturing utilization rates compared to other manufacturing industries given the higher margins for their products. But as the industry faces increased generic-drug incursion, reduced R&D productivity, and resulting greater profit pressure, containment of manufacturing and supply-chain costs has become evermore important. This need is moving the wheels of  innovation for a new model for pharmaceutical manufacturing, one that offers greater flexibility in aligning product demand with supply. Is continuous manufacturing the solution? Read more »

Is the US Facing a Pharmaceutical Manufacturing Gap?

Patricia Van Arnum PharmTech editor Last week, FDA Commissioner Margaret A. Hamburg testified before the House Committee on Energy and Commerce, Subcommittee on Health to outline the agency’s case for supporting the fifth authorization of the Prescription Drug User Fee Act (PDUFA), also known as PDUFA V. In addition to offering her support for PDUFA V, Hamburg also discussed renewal of legislation for promoting pediatric drug testing, the need of FDA to invest in science and innovation, and the agency’s efforts in confronting the continual challenges of globalization. In tackling globalization, a basic question arises: does the United States face a pharmaceutical manufacturing disconnect? Read more »

Roche Makes Bid to Advance Position in Personalized Medicine

Patricia Van Arnum PharmTech editor Personalized medicine, which targets individualized treatment and care based on personal and genetic variations, holds much promise for the pharmaceutical industry. Several pharmaceutical majors continue to invest in this emerging field as evident by Roche’s $5.7-billion bid last week for Illumina, a provider of gene-sequencing tools and related analytics. Read more »

Generic Drug and Biosimilar User Fees Gain Traction

Patricia Van Arnum PharmTech editor FDA issued last week its recommendations for three user-fee programs: the fifth authorization of the Prescription Drug User Fee Act (PDUFA) and new user-fee programs for human generic drugs and biosimilar biological products. The recommendations were transmitted to Congress, which will evaluate the recommendations. Read more »

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