Manufacturing News and Research

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Manufacturing is the production of products across all industries, on a large-scale, using machinery.

U.S. District Court rules in favor of Teva in COPAXONE patent infringement case

Teva Pharmaceutical Industries Ltd. announced today the U.S. District Court for the Southern District of New York has found in favor of Teva in the Company's patent infringement lawsuit against Momenta Pharmaceuticals, Inc./Sandoz Inc. and Mylan Laboratories Inc./Natco Pharmaceuticals regarding Teva's relapsing-remitting multiple sclerosis (RRMS) product, COPAXONE.

23 Jun 2012

FDA issues CRL to Repligen's RG1068 NDA for treatment of pancreatitis

Repligen Corporation today announced that it has received a Complete Response Letter (CRL) from the U.S. Food & Drug Administration (FDA) regarding the Company's New Drug Application (NDA) for RG1068.

23 Jun 2012

Alexza resubmits ADASUVE NDA to U.S. FDA

Alexza Pharmaceuticals, Inc. announced today that it has resubmitted its ADASUVE New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in response to a Complete Response Letter (CRL) received in May 2012.

22 Jun 2012

Southern Implants, Keystone announce merger agreement

Keystone Dental, Inc., a leading oral healthcare company dedicated to the delivery of breakthrough implant technology, and Southern Implants, Inc., a producer of unique and innovative dental implant technologies aimed to simplify clinical challenges for implant surgeons and restorative dentists, today announced the companies have merged.

From Danaher 22 Jun 2012

Nouveau Life launches Azul Instant supplement for erectile dysfunction

Nouveau Life Pharmaceuticals Inc., a provider of quality all-natural dietary supplements, announced today the release of its Azul Instant supplement.

21 Jun 2012

DSM XD high cell density process technology granted patents in several countries

DSM Pharmaceutical Products, the custom manufacturing and technology business of Royal DSM N.V., announced today that several countries have granted patents or have given statements of patent allowance to its proprietary XD® high cell density process technology.

19 Jun 2012

Vetter prepares new filling line for syringes at Ravensburg location

The demand for prefilled syringes is on the rise and Vetter is prepared. The company, a leading contract development and manufacturing organization is building a state-of-the-art, high-performance filling line for syringes at its Ravensburg Vetter South location.

19 Jun 2012

FDA grants Cook Pharmica first commercial manufacturing approval

In a decision that paves the way for greater pharmaceutical industry use of the company's contract manufacturing services, Cook Pharmica LLC has received its first approval from the U.S. Food and Drug Administration (FDA) to manufacture commercial product.

18 Jun 2012

Mallinckrodt, Horizon enter co-promotion agreement for DUEXIS

Mallinckrodt, the Pharmaceuticals business of Covidien, today announced that it has entered into a co-promotion agreement with Horizon Pharma, Inc. to promote DUEXIS (ibuprofen and famotidine).

18 Jun 2012

Wellcome Trust awards University of Maryland $4M to accelerate development of conjugate NTS vaccine

The University of Maryland School of Medicine's Center for Vaccine Development (CVD) has received a $4 million Strategic Translation Award from the prestigious Wellcome Trust to support a collaboration with Bharat Biotech for clinical development of a new conjugate vaccine to prevent the potentially lethal infectious disease caused by invasive non-typhoidal Salmonella.

18 Jun 2012

CMC Biologics' Bothell manufacturing and testing facilities receive cGMP compliance

CMC Biologics, a leading contract manufacturing organization (CMO) known for its technical excellence in process development and cGMP manufacture, has received a Certificate of Good Manufacturing Practice (GMP) Compliance for commercial manufacturing issued by the Medicines and Healthcare products Regulatory Agency (MHRA).

18 Jun 2012

FDA completes review of compounded hydroxyprogesterone caproate products and APIs

FDA (or the Agency) approved Makena (hydroxyprogesterone caproate) in February 2011 for the reduction of the risk of certain preterm births in women who have had at least one prior preterm birth. Beginning many years before Makena was approved, a version of the active ingredient of Makena has been available to patients whose physicians requested the drug from a pharmacist who compounded the drug.

18 Jun 2012

iPS Academia Japan, Life Technologies partner for induced pluripotent stem cell patent portfolio

Life Technologies Corporation today announced that it has deepened its commitment to stem cell research and its customers by signing a non-exclusive agreement with iPS Academia Japan for its induced pluripotent stem (iPS) cell patent portfolio.

16 Jun 2012

Invuity closes $25M Series D round of financing

Invuity, a leading developer of state-of-the-art surgical visualization and illumination technology, has raised a $25 million Series D round of financing to expand the development, manufacturing and commercialization of the company's advanced medical devices.

14 Jun 2012

ABL to perform process development and cGMP manufacturing of recombinant scuPA

Advanced BioScience Laboratories, Inc. (ABL) will perform process development and cGMP manufacturing of recombinant scuPA, an enzyme therapy candidate for patients with pleural loculation or scarring surrounding the lung.

14 Jun 2012

IBBR, Sanaria to receive Phase II SBIR grant from NIAID for malaria vaccine

Sanaria Inc., a privately held company in Rockville, Maryland, and the Institute for Bioscience and Biotechnology Research (IBBR) of the University of Maryland College Park announce the receipt of a multi-year Phase II Small Business Innovation Research (SBIR) Grant from the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH).

14 Jun 2012

Viewpoints: Praise for insurers' move to keep consumer protections; Supreme Court's reputation falters

UnitedHealthcare, one of the nation's largest health insurers, announced this week that it would keep some of the popular benefits and consumer protections required by the federal health care law even if the Supreme Court strikes down all or part of it. ... But such voluntary actions are not a substitute for the broader mandatory reforms that will take effect after 2014 under the law.

13 Jun 2012

Cardinal Health to open three new cyclotrons across the US

At the Society of Nuclear Medicine's 59th Annual Meeting in Miami Beach, Fla., June 9-12, Cardinal Health today announced that it plans to open three new cyclotrons across the United States, further expanding its nationwide capability to manufacture molecular imaging drugs that aid in the early diagnosis, monitoring and treatment of cancer, neurological disorders and heart disease.

11 Jun 2012

Cambridge facility to become worldwide hub for SAFC's chiral service

Sigma-Aldrich Corporation today announced that its custom manufacturing and services business unit, SAFC, will consolidate its global chiral chromatography screening and small scale purification operations and locate them at its Pharmorphix Solid State Research Laboratories in Cambridge, UK, to support its new integrated chiral chemistry offer.

11 Jun 2012

BCSI launches 5 new cyclotrons for isotope research and production

Best Cyclotron Systems is unveiling five new cyclotrons for isotope research and production at the Society of Nuclear Medicine (SNM) Annual Meeting on June 9-12 in Miami Beach, Florida.

11 Jun 2012