SAFC (St. Louis, MO), a member of the Sigma-Aldrich group, and Cherokee Pharmaceuticals (Riverside, PA), have formed an exclusive strategic partnership that encompasses the sourcing, analytical testing, warehousing, packaging, and distribution of large-scale raw materials for pharmaceutical manufacturing meeting cGMP quality standards.
SAFC Pharma (St. Louis, MO) has received certification by SafeBridge Consultants, Inc., for the safe handling of potent drug substances of its highly potent active pharmaceutical ingredient (HPAPI) conjugation suite, located in St. Louis, MO.
Nupotential, a small Louisiana biotechnology firm, believes it may have an answer to the ethical concerns and technological challenges involved in turning stem cells into medical therapies.
The US Food and Drug Administration has made "mixed progress" in information technology (IT) modernization, according to findings from the Government Accountability Office (GAO).
Laura Bush, editor in chief of BioPharm International, has joined the 2010 Interphex Conference Advisory Board.
Emerson Process Management (Austin, TX) has been selected by Lonza Group, Ltd. (Basel, Switzerland) to provide engineering and design services, and digital automation architecture and control technologies for a new Lonza biopharmaceutical plant in Singapore.
MedImmune (Gaithersburg, MD) has been awarded a US Department of Health and Human Services (HHS) contract to manufacture monovalent (single-strain) live attenuated influenza vaccine for Novel Influenza A (H1N1) to vaccinate priority populations identified by HHS in the National Strategy for Pandemic Influenza. An initial order of $90 million of vaccine has been placed, with the potential for additional orders.
The European Directorate for Quality of Medicines & HealthCare (EDQM) has established bilateral confidentiality agreements with the US Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA), respectively, to share non-public information regarding inspections of active pharmaceutical ingredients (API) and excipients manufacturers.
Emisphere Technologies, Inc. (Cedar Knolls, NJ), a biopharmaceutical company that focuses on delivery of therapeutic molecules using its Eligen Technology, and AAIPharma, Inc. (Wilmington, NC), have formed a strategic alliance intended to expand the application of Emisphere' s Eligen Technology and AAIPharma's drug development services.
Nupotential, a small Louisiana biotechnology firm, believes it may have an answer to the ethical concerns and technological challenges involved in turning stem cells into medical therapies.
On April 24, Senators Charles Grassley (R-IA) and Edward Kennedy (D-MA) introduced The Drug and Device Accountability Act of 2009, which would give the FDA more resources for conducting foreign drug plant inspections and the power to issue subpoenas.
ImmunoVaccine Technologies, Inc. (IVT, Halifax, Nova Scotia), a vaccine development company, has signed a three-year research agreement with Defence Research and Development Canada (DRDC).
An in-depth analysis of blood from patients recovering from the H5N1 avian influenza virus has provided important insights into how to combat the potentially lethal virus.
In its latest setback, Discovery Labs (Warrington, PA) has failed to receive FDA approval for the fourth time for Surfaxin (lucinactant).
Millipore Corporation (Billerica, MA) and Microbix Biosystems, Inc. (Toronto, Canada), have formed a collaboration to develop a novel purification process for influenza virus vaccine manufacturing.
Members of the pharmaceutical and biotech industries have formed a new industry coalition, called "Rx-360," with the goal of improving supply chain safety.
Merck & Co., Inc. (Whitehouse Station, NJ), Medarex, Inc. (Princeton, NJ), and Massachusetts Biologic Laboratories (MBL, Jamaica Plain, MA) of the University of Massachusetts Medical School (UMMS) have signed an exclusive worldwide license agreement for CDA-1 and CDB-1.
In response to requests from the US Centers for Disease Control and Prevention (CDC), the US Food and Drug Administration has authorized the use of the antiviral drugs Tamiflu and Relenza beyond their approved indications in response to the outbreak of swine flu.
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.
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.
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.
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.
Novavax, Inc. (Rockville, MD), has formed a joint venture with Cadila Pharmaceuticals, Ltd. (Ahmedabad, India), to develop, manufacture, and market vaccines, pharmaceuticals, and diagnostic products in India.
Roche (Basel, Switzerland) will acquire 100% of Innovatis, AG (Bielefeld, Germany).
Covance Inc. (Princeton, NJ) has completed an additional 8,000-sq. ft. to its biotechnology services facility in Harrogate, UK.
SAFC Biosciences (Lenexa, KS) has completed the conversion of its dry powder cell culture media continuous milling production site in Lenexa, KS to animal component free (ACF) status. This is the first of several similar conversions planned by SAFC Biosciences to support growing customer requirements for ACF manufacturing.
The US Food and Drug Administration has released a new draft guidance on somatic cell therapies that are designed to advance the treatment of heart disease through the regeneration of cardiac tissues.
ImClone Systems, Inc. (Branchburg, NJ), and Bristol-Myers Squibb (BMS, New York, NY) voluntarily recalled 13 lots of their cancer drug Erbitux (cetuximab) after a report from a doctor?s office about a leaking cap on a vial of the biologic.
Pall Corporation (East Hills, NY) has acquired an exclusive license to manufacture, market, and sell Single Pass TFF (SPTFF), an SPF Innovations, LLC (Watertown, MA) technology for biopharmaceutical applications.
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.
