Articles by Laura Bush - BioPharm International

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Articles by Laura Bush

Small Vaccine Company Ready to Play its Part in Response to H1N1 Influenza

May 4, 2009

The current outbreak of the H1N1 influenza strain is exactly the kind of situation the vaccine company Novavax (Rockville, MD) has been preparing for over the last three years.

Novozymes' Recombinant Human Albumins Comply with New USP-NF Monograph

May 1, 2009

A new excipient monograph standard for recombinant human albumin (HSA) became official in the United States Pharmacopeia-National Formulary (USP-NF) today, and Novozymes Biopharma (Nottingham, UK) says that its "Recombumin" and "Albucult" products are the first to comply with the new standard.

The Least of Four Evils

Avoiding healthcare reform is not the best option for the pharmaceutical industry.
May 1, 2009

Avoiding healthcare reform is not the best option for the pharmaceutical industry.

FDA Authorizes Emergency Use of Tamiflu, Relenza to Treat Swine Flu

Apr 28, 2009

In response to requests from the US Centers for Disease Control and Prevention (CDC), the US Food and Drug Administration yesterday authorized the use of the antiviral drugs Tamiflu and Relenza beyond their approved indications in response to the outbreak of swine flu.

J&J's Once-Monthly Simponi Approved for Three Rheumatic Indications

Apr 27, 2009

Centocor Ortho Biotech (Horsham, PA), a subsidiary of Johnson & Johnson, received approval from the US Food and Drug Administration on April 24 for Simponi (golimumbad), a monthly treatment for moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis.

QbD Case Study Will Push Limits

Apr 10, 2009

When the final version of the Quality by Design (QbD) case study is made public this summer, it will be an aspirational document, says Ken Seamon, PhD, one of the project?s facilitators. "If the regulatory authorities read our final document and said 'yes, this is all fine,' we will have failed," he said.

Process Validation Guidance—Redux

The 45 comments submitted raised concerns about legacy products and ongoing process monitoring.
Apr 1, 2009

The 45 comments submitted raised concerns about legacy products and ongoing process monitoring.

Legacy Products and Process Monitoring Raise Concern in Revised Process Validation Guidance

Mar 13, 2009

In the Food and Drug Administration?s draft revision of the 1987 Process Validation Guidance, the lack of clarity about how the revised guideline applies to legacy products and the potential burden of new requirements for ongoing process monitoring are common concerns raised in many of the comments submitted by industry to the agency. To date, more than 45 companies or organizations have submitted comments on the draft revision, issued in November 2008.

Where We'll Be in 10 Years

At some point, will heavy investments in large, stainless-steel based facilities become a burden to US companies?
Mar 1, 2009

At some point, will heavy investments in large, stainless-steel based facilities become a burden to US companies?

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