Pharmaceuticals News and Research

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Vanda initiates Fanapt Phase I study in patients with schizophrenia

Vanda Pharmaceuticals Inc. announced today that Novartis Pharmaceuticals Corporation, an affiliate of Vanda's sublicensor Novartis Pharma AG, has initiated a clinical study to evaluate the long-acting injectable formulation of Fanapt.

11 Apr 2011

Auxilium to receive $30 million from Pfizer following XIAPEX sale in EU market

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced that the Company will receive a $30 million regulatory milestone payment from its EU partner, Pfizer Inc., following the first sale of XIAPEX in a major EU market.

11 Apr 2011

PAREXEL's QbD approaches can help pharma companies maximize product quality, safety

PAREXEL International Corporation, a leading global biopharmaceutical services provider, and the Parenteral Drug Association today announced the publication of Quality by Design: Putting Theory into Practice, written to help companies maximize product quality and safety. As increasing regulatory pressure is being placed on biopharmaceutical companies to be accountable for Quality Systems, the book serves as a definitive source on the interpretation and implementation of Quality by Design approaches.

From Parexel 11 Apr 2011

Endo Pharmaceuticals to acquire American Medical Systems

Endo Pharmaceuticals and American Medical Systems today that they have entered into a definitive agreement under which Endo will acquire AMS, a leading provider of world-class devices and therapies for male and female pelvic health, for $30 per share, or $2.9 billion in cash, which includes the assumption and repayment of $312 million of AMS debt.

11 Apr 2011

Scientists develop new approach to accelerate evolution of biomolecules in lab

Scientists at Harvard University have harnessed the prowess of fast-replicating bacterial viruses, also known as phages, to accelerate the evolution of biomolecules in the laboratory.

11 Apr 2011

Research on rare cancers

A cancer diagnosis can be a life-changing event. Many questions arise, with one of the first being, "Where should I be treated?" Patients diagnosed with rare cancers may have difficulty finding a physician knowledgeable in treating their type of cancer.

11 Apr 2011

Government shutdown would hurt America's spirit of innovation

It is important that the United States begin to live within its means and address the federal deficit. But APS believes that as a nation we need to be smart about how we do it. Cutting spending across the board without a clear understanding of what it means for America's future jeopardizes the very future we want to secure for our children.

11 Apr 2011

Cellix expands European distribution network with Tebu-bio

Cellix are pleased to announce the signing of a distribution agreement with tebu-bio SAS. tebu-bio has a well-established pan-European presence, recognised by the international scientific community with local offices in France, Germany, Belgium, the Netherlands, Italy, Denmark, Portugal, Spain and the UK.

11 Apr 2011

Pfizer to support immatics' IMA901 Phase III trial in advanced renal cell carcinoma

immatics biotechnologies GmbH, a clinical-stage biopharmaceutical company developing advanced therapeutic vaccines that are active against cancer, today announced that Pfizer has agreed to support its pivotal Phase III trial with IMA901, its therapeutic cancer vaccine for advanced renal cell carcinoma.

11 Apr 2011

Takeda, Heptares collaborate to develop new drugs against CNS disorders

Heptares Therapeutics and Takeda Pharmaceutical Company today announced the formation of a two-year drug discovery collaboration focused on a single G-protein coupled receptor that plays an important role in the pathology of central nervous system disorders.

11 Apr 2011

Annals of Neurology publishes Diamyd Medical´s NP2 Enkephalin Phase I results in cancer pain

Diamyd Medical´s Phase I clinical trial results evaluating the safety and efficacy of the candidate drug NP2 Enkephalin to treat intractable cancer pain has been published in the medical journal Annals of Neurology.

11 Apr 2011

Lonza, Roche sign agreement to commercialize MycoTOOL PCR-test

Roche and Lonza announced today that they have entered into a co-exclusive distribution agreement for the commercialization of Roche's MycoTOOL mycoplasma PCR assays.

11 Apr 2011

Gilenya can reduce risk of disability progression in patients with RRMS

A new analysis demonstrated that Gilenya reduced the risk of disability progression in patients with relapsing-remitting multiple sclerosis, regardless of treatment history. This analysis of the phase III two-year FREEDOMS study is one of 11 abstracts on Gilenya being presented at the 63rd annual meeting of the American Academy of Neurology.

11 Apr 2011

FDA grants tentative approval for Hi-Tech Pharmacal's generic Combigan ANDA

Hi-Tech Pharmacal Co., Inc., a specialty pharmaceuticals company, announced today that the US Food and Drug Administration, (FDA) granted tentative approval for the Company's Abbreviated New Drug Application, (ANDA) for brimonidine tartrate with timolol maleate ophthalmic solution, the generic for Allergan's Combigan® ophthalmic solution which had sales of $108 million for the 12 months ended December 2010 according to IMS sales data.

8 Apr 2011

Unity receives first order for new BD Italian Tablet press

Unity Management Group, Inc. is a Health Resource Company specializing in Physician, and Hospital Practice Management, Business Services, Billing Software and Technologies, along with Pharmacy Instrumentation, Calibration, Data Acquisition, and Equipment Distribution.

8 Apr 2011

Amgen acquires Bergamo, expands operations in Brazil

Amgen, the world's largest biotechnology company, announced today the expansion of its operations in Brazil, including the acquisition of Bergamo, a privately-held Brazilian pharmaceutical company.

8 Apr 2011

Watson confirms patent challenge by Alcon for generic Vigamox

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Moxifloxacin Hydrochloride Ophthalmic Solution USP, 0.5%. Watson's Moxifloxacin Hydrochloride Ophthalmic Solution USP, 0.5% is a generic version of Alcon, Inc.'s Vigamox®, an antibiotic solution that is indicated for the treatment of bacterial conjunctivitis.

8 Apr 2011

Impax, Banner Pharmacaps collaborate for commercialization of softgel capsule products

Impax Laboratories, Inc. today announced that it will collaborate with Banner Pharmacaps Inc. with respect to the supply and commercialization of two softgel capsule products.

8 Apr 2011

Idenix prices underwritten registered public offering of 18 million shares of common stock

Idenix Pharmaceuticals, Inc., a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced the pricing of an underwritten registered public offering of 18,310,000 shares of its common stock at a public offering price of $2.80 per share. All of the shares are being sold by Idenix.

8 Apr 2011

Marking World Health Day, WHO warns misuse of antibiotics undermining global fight against infectious diseases

U.N. officials on Thursday marked World Health Day with a warning that "the misuse and irrational use of antibiotics has undermined the global fight against tuberculosis and malaria, warning of a possible return to the days before the drugs were developed," and called for urgent action to control the spread of drug resistance, Reuters reports.

8 Apr 2011