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Profectus BioSciences, Inc. (Baltimore, MD), a clinical stage biopharmaceutical company focused on the development of novel vaccine candidates for serious chronic infections, has signed a research collaboration agreement with the PATH Malaria Vaccine Initiative (Bethesda, MD) to conduct proof-of-concept studies with its proprietary, recombinant vesicular stomatitis virus (rVSV) vector technology as a preventative malaria vaccine.

Shire plc (Cambridge, MA) has completed its submission of a new drug application (NDA) for velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Type 1 Gaucher disease, with the US Food and Drug Administration.

Novavax (Rockville, MD) recently achieved positive Phase 2a results for its trivalent virus-like particle (VLP) vaccine against seasonal influenza, and positive preclinical results for a VLP vaccine against H1NI (swine) flu.

Pharmaceutical giant Pfizer, Inc., (New York, NY) has opened a new 64,600-square-foot biotech plant in Strangnas, Sweden.

GlaxoSmithKline has partnered with Brazil?s Oswaldo Cruz Foundation (Fiocruz) to develop and manufacture vaccines for pressing public health problems in Brazil.

Protalix BioTherapeutics received "fast track" designation from the US FDA yesterday for prGCD, a development drug for Gaucher's disease.

London-based GlaxoSmithKline?s Hiberix, a haemophilus influenzae Type b (Hib) vaccine, was approved by the US Food and Drug Administration.

A new vaccine for norovirus has been produced in tobacco plants, a scientist reported on August 18 at the national meeting of the American Chemical Society in Washington DC.

Protalix BioTherapeutics received approval from the US FDA on August 17 to proceed with its treatment protocol for prGCD, a development drug for Gaucher's disease.

SAFC Biosciences (St. Louis, MO) has developed a chemically defined cell culture supplement based on the characterization of hydrolysate components proven to provide cell growth and protein production capabilities equivalent to traditional undefined hydrolysate raw materials.

Amgen (Thousand Oaks, CA) and GlaxoSmithKline (GSK, London, UK) will share commercialization of Amgen's monoclonal antibody denosumab for postmenopausal osteoporosis (PMO) in Europe, Australia, New Zealand, and Mexico once the product is approved in these countries.

FDA Acting Commissioner Margaret Hamburg outlined six steps to improve FDA enforcement in a speech given on August 6, eight weeks into her tenure.

Baxter International, Inc. has completed production of its first commercial batches of Celvapan A/H1N1 pandemic vaccine in late July and is discussing plans for distribution with national health authorities, subject to obtaining appropriate authorizations.

The prospect of conducting risk assessments, as part of the quality risk management strategy promoted by the International Conference on Harmonization (ICH) Q9 guideline, tends to evoke blank stares and confusion. It also prompts many questions: Which of the many tools-PHA, HACCP, FMEA, etc.-should we use?

Millipore Corporation (Billerica, MA) has filed a lawsuit in the US District Court for the District of Massachusetts against W.L. Gore & Associates for infringement of Millipore's patent rights under US Patent No. 7,293,477, "Disposable, Pre-Sterilized Fluid Receptacle Sampling Device."

Preliminary evidence has shown that ImmuneRegen BioSciences' selective Neurokinin 1-receptor agonist Homspera is active on oral administration and provides therapeutic effects against the current pandemic H1N1 virus infection.

ImmunoVaccine Technologies, Inc. (IVT) has formed a research agreement with Scancell, Ltd. to explore the potential of using IVT's DepoVax delivery system for Scancell's ImmunoBody DNA vaccines.

Debiopharm Group (Lausanne, Switzerland) and MSM Protein Technologies (MSM, Boston, MA) have entered into an exclusive agreement for the development and commercialization of Debio 0929, an antibody targeting a G protein-coupled receptor (GPCR), to be developed into a new oncology therapeutic drug.

Sartorius Stedim Biotech (Goettingen, Germany) and SAFC Biosciences (St. Louis, MO), a division of SAFC, have entered into a partnership to share expertise, support each other in developing custom solutions for customers, and generate data on the performance of equipment in different applications.

The US FDA has approved Genentech's Avastin (bevacizumab) plus interferon-alfa for people with metastatic renal cell carcinoma, the most common type of kidney cancer.

The House Energy and Commerce Committee approved a legislative amendment that would give 12-years data exclusivity to innovator biologics. The amendment was introduced by Reps. Anna Eshoo (D-CA) and Jay Inslee (D-DC).

Single-use technologies can be configured and installed fairly quickly, but are they ready to handle the urgency and scale of a pandemic?

French drug manufacturer Sanofi Aventis will purchase the Indian vaccine company Shantha Biotechnics for $784 million.

In an effort to boost its biologics pipeline, Bristol-Myers Squibb (BMS, New York, NY) will acquire Medarex (Princeton, NJ) for approximately $2.4 billion.

Wyeth has voluntarily recalled one lot of single-dose prefilled syringes of Prevnar, the company?s pneumococcal 7-valent conjugate vaccine.

The Senate?s Health, Education, Labor, and Pensions Committee yesterday passed The Affordable Health Choices Act, the committee?s healthcare reform legislation that gives 12 years of data exclusivity to innovator biologics. The committee had adopted the 12-year data protection amendment to the healthcare legislation on Monday.

When Roche bought Genentech in March, layoffs were expected, and now the company has begun downsizing at Genentech?s South San Francisco headquarters.

Prolor Biotech, Inc. (Nes-Ziona, Israel), formerly Modigene, Inc., has been issued two new patents from the US Patent and Trademark Office for the company's long-acting CTP-enhanced human growth hormone (hGH-CTP) and human erythropoietin (EPO-CTP). The patents cover the composition of Prolor's proprietary pharmaceutical compounds and certain associated methods.

Netherlands-based biopharmaceutical company OctoPlus N.V. has started pharmaceutical production in its new manufacturing facility in Leiden. The facility has received a license from the Dutch authorities to manufacture pharmaceutical products according to international good manufacturing practice (GMP) guidelines.

Vetter Pharma International (Ravensburg, Germany), a provider of aseptically pre-filled injection systems, has completed the installation of six automatic packaging lines at Vetter Secondary Packaging (VSP), the company's new packaging services facility.