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Following the news that the current supply of Genzyme's (Cambridge, MA) Fabrazyme (agalsidase beta) will not be sufficient to address the needs of the nearly 600 Fabry patients receiving the treatment in Europe, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the use of alternate Fabry treatments, such as Replagal, manufactured by Shire (Dublin, Ireland).

After 18 years, Human Genome Sciences (HGS, Rockville, MD) may soon have its first drug on the market. And thanks to a bold scale-up strategy, HGS?s manufacturing organization is ready.

Merck (Whitehouse Station, NJ) expects that emerging markets will account for more than 25% of its global pharmaceutical and vaccine revenue in 2013, based on the implementation of the company?s emerging markets strategy.

ATMI, Inc. (Danbury, CT), and Sartorius Stedim Biotech S.A. (Aubagne, France) have extended their marketing and distribution alliance by adding new technologies.

Intercell AG's (Vienna, Austria) investigational vaccine enhancement patch (VEP) system for avian H5N1 influenza has failed its Phase 2 clinical trial.

Crucell N.V. (Leiden, the Netherlands) has begun a discovery program for the development and commercialization of a universal respiratory syncytial virus (RSV) vaccine.

MorphoSys, AG (Munich, Germany) and biopharmaceutical company Xencor, Inc. (Monrovia, CA) have signed a worldwide exclusive license and collaboration agreement for an antibody in Phase 1 clinical development.

New Brunswick Scientific, an Eppendorf Company (Edison, NJ), and Pall Corporation (Port Washington, NY) have entered into a product development and marketing agreement to create and supply new disposable bioreactor systems.

The US Food and Drug Administration has issued a new draft guidance regarding the types of manufacturing changes that can be reported in annual reports.

Celgene to Acquire Abraxis

FDA approves Genentech's Lucentis

Vetter held a groundbreaking ceremony for its new facility in Ravensburg.

US Food and Drug Administration has granted fast track status to Cambridge, MA-based Genzyme Corporationhas been granted fast track status by the FDA for its alemtuzumab for multiple sclerosis (MS) development program.

BiondVax Awarded $1 Million Universal Flu Vaccine Grant from Israeli Office of the Chief Scientist

As part of a news series on the H1N1 influenza pandemic, BioPharm International interviewed Ben Machielse, Drs., executive vice president of operations at MedImmune, to ask about his company's experience manufacturing vaccines against H1N1.

CPL Biologicals, a joint venture of Cadila Pharmaceuticals Ltd. (Ahmendabad, India) and Novavax, Inc. (Rockville, MD), has completed construction of its vaccine facility in Dholka, India.

Baxter BioScience (Deerfield, IL) and the US Food and Drug Administration have notified healthcare professionals of a market withdrawal being conducted as a precautionary measure because of an increased number of adverse event reports of allergic reactions associated with two lots of GammaGard Liquid.

In February, we reported on Pfizer's plans for reconfiguring its global manufacturing network of 79 plants, following its recent acquisition of Wyeth. Now, we have the answer.

Abbott (Abbott Park, IL) will acquire full ownership of Piramal Healthcare Limited?s Healthcare Solutions business (Mumbai, India), a provider of Indian-branded generics, for an up front payment of $2.12 billion, plus $400 million annually for the next four years.

Shimadzu (Kyoto, Japan) and bioMérieux (Marcy l?Etoile, France) will commercialize a mass spectrometry system for bacterial identification in microbiology laboratories.

The US Food and Drug Administration has cleared the Simplexa Influenza A H1N1 (2009), a test for the 2009 H1N1 influenza virus in patients with signs and symptoms of respiratory infection.

Covidien (Dublin, Ireland), a provider of healthcare products, will sell its Specialty Chemicals business, known in the industry as two brand names, J.T.Baker and Mallinckrodt Laboratory Chemicals to an affiliate of New Mountain Capital, L.L.C. for $280 million.

Teva Pharmaceutical Industries (Tikva, Israel) is developing a generic version of Roche's (Basel, Switzerland) blockbuster antibody drug Rituxan, in what may possibly be the first US generic version of a monoclonal antibody.

A first-of-its-kind vaccine to prevent breast cancer has shown favorable results in animal models, according to a study by researchers at Cleveland Clinic?s Lerner Research Institute (Cleveland, OH).

The US Food and Drug Administration has approved Prolia (denosumab), manufactured by Amgen Inc. (Thousand Oaks, CA), for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.

Thomson Reuters' Mark Gordon looks at how real partnership opportunities are developing in a virtual pharma world.

Xcellerex, Inc. has begun construction of a state-of-the-art current good manufacturing practices-compliant FlexFactory biomanufacturing facility at its headquarters in Marlborough, MA.

The pharmaceutical and medical device industries can learn from Toyota's recalls to avoid their own "runaway" quality problems.

Now is not an easy time to lead a pharmaceutical company. The patent cliff is fast approaching, pipeline challenges remain, capital markets are tight, and the blockbuster model is fast on its way out. Meanwhile, regulations on sales and marketing continue to tighten.

Althea Technologies, Inc. (San Diego, CA), a provider of services for biopharmaceutical development and manufacturing will acquire the assets and IP portfolio of Altus Pharmaceuticals (Cambridge, MA).