Manufacturing News and Research

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

Onset Therapeutics expands its sales force to create nationwide presence

Onset Therapeutics LLC, a specialty pharmaceutical company focused in dermatology, today announced that the Company’s recent growth and future opportunities have facilitated an expansion of its field sales organization to cover more than twenty-five additional major metropolitan areas.

28 Jan 2010

Particle Sciences to share responsibilities in developing anti-HIV microbicides

Particle Sciences, a leading drug development CRO, will share formulation, analytic and production responsibilities in an effort to develop a vaginally administered microbicide, a product specifically designed to prevent the sexual transmission of HIV.

28 Jan 2010

Over 8% of medical devices in circulation are counterfeit: WHO

Counterfeit medical products are becoming an international epidemic. According to the World Health Organization (WHO), more than 8% of the medical devices in circulation are counterfeit. The offending products may be assembled from inferior quality components, or worse yet, from fake parts that could contain toxic materials. In either case the dangers are the same. Counterfeit medical devices pose a significant liability to the manufacturers and a health risk to both the patients and healthcare providers that could result in injury, permanent disability, or even death.

28 Jan 2010

Warner Chilcott receives complete response letter from FDA for low dose oral contraceptive

Warner Chilcott plc announced today that it has received a complete response letter from the U.S. Food and Drug Administration (FDA) to its New Drug Application submitted in March 2009 for its "low dose" oral contraceptive (also referred to as WC 3016).

27 Jan 2010

FDA recalls Huber infusion set needles

The U.S. Food and Drug Administration today announced a Class I recall of Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets and Exel/Exelint "Securetouch+" Safety Huber Infusion Sets, manufactured by Nipro Medical Corporation for Exelint International Corporation.finf

27 Jan 2010

Sinobiopharma's solid dosage Perindopril production facility receives Chinese SFDA approval

Sinobiopharma, Inc. is pleased to announce that its production facility for solid dosage Perindopril has passed the required Chinese State Food and Drug Administration (SFDA) inspection and is now approved for production and marketing.

27 Jan 2010

Waytronx, Ingenion Design announce development agreement for GasPT2 device

Waytronx, Inc., a platform company dedicated to the acquisition, development, and commercialization of new, innovative technologies, today announced that it has reached an agreement with British-based Ingenion Design Ltd. ("Ingenion") to develop and build its second generation Gas Quality Inferential Measurement Device (GasPT2).

27 Jan 2010

Symmetry Medical signs supply agreement with Indiana-based bio-science company

Symmetry Medical Inc., a leading independent provider of products to the global orthopedic device industry and other medical markets, announced today it has entered into an exclusive five-year supply agreement with OrthoPediatrics Corp., a Warsaw, Indiana-based bio-science company that develops, designs and distributes anatomically appropriate orthopedic implants and solutions for pediatric and small stature patients.

27 Jan 2010

Sagefrog Marketing Group awarded a contract for Agency of Record

Penn Pharma Americas announced today that Sagefrog Marketing Group, LLC, a full service marketing, interactive and public relations company, has been awarded a contract for Agency of Record for both marketing and public relations.

25 Jan 2010

IntelGenx and LTS announce strategic alliance

IntelGenx Corp. ("IntelGenx") today announced a strategic alliance with LTS Lohmann Therapie-Systeme AG ("LTS") for the exclusive manufacturing of products developed by IntelGenx using its VersaFilm drug delivery technology.

25 Jan 2010

Macada Holding announces company's plans and developments

Macada Holding, Inc. announced the GCNV deal has been canceled due to the structure of the company, and most important it is not right for the shareholders. And the future structure of what management is looking for to complete its plans and vision.

23 Jan 2010

Patheon constructs new pharmaceutical development center in Bourgoin-Jallieu

Patheon a global provider of drug development and manufacturing services to the international pharmaceutical industry announced today it has begun construction of a new pharmaceutical development center at its existing manufacturing facility in Bourgoin-Jallieu, France.

22 Jan 2010

CytRx announces its plans to advance multiple oncology development programs in 2010

CytRx Corporation, a biopharmaceutical company specializing in oncology, today announced its plans for 2010 aimed at advancing the clinical development of its high-value drug development pipeline and enhancing shareholder value.

22 Jan 2010

CMO to manufacture Gaia BioPharma's GAI-122 Mitochondria-targeted neuroprotective agent

AlphaRx Inc. announced today that its licensee, Gaia BioPharma Limited, has signed an agreement with a contract manufacturing organization (CMO), to manufacture GAI-122 for use in the planned Phase I and II clinical trials of that product candidate. GAI-122 is being developed as I.V. administered formulation of an intracellular neuroprotectant that employs AlphaRx's proprietary nano-emulsion formulation technology.

22 Jan 2010

New sensor could help diagnose and treat a variety of diseases

A tiny new sensor could provide fresh, inexpensive diagnosis and treatment methods for people suffering from a variety of diseases.

22 Jan 2010

FDA accepts ACT Biotech's ACTB1003 IND

ACT Biotech Inc., a privately held biotechnology company developing a portfolio of oral kinase inhibitors as anti-cancer drugs, today announced the acceptance of the Investigational New Drug (IND) application for ACTB1003 by the US Food and Drug Administration (FDA). The company has now assembled a complete preclinical package, including manufacturing and toxicology studies, allowing ACTB1003 to enter a clinical trial.

22 Jan 2010

Genzyme receives PDUFA date from FDA for its Biologics License Application for Lumizyme

Genzyme Corporation announced today that it has received a June 17, 2010 PDUFA date from the FDA for its Biologics License Application for Lumizyme™ (alglucosidase alfa) seeking approval for the therapy produced at the 4000 L scale.

21 Jan 2010

Pharmasset commences PSI-7977 Phase 2a trial for HCV

Pharmasset, Inc. today announces the initiation of a 28-day Phase 2a study with PSI-7977, a chirally pure isomer form of PSI-7851, a nucleotide analog polymerase inhibitor in development for the treatment of chronic hepatitis C (HCV). The trial will evaluate various doses of PSI-7977 in combination with Pegasys (peginterferon alfa 2a) and Copegus (ribavirin) in patients with HCV genotype 1 who have not been treated previously.

21 Jan 2010

Abaxis' new CRP assay receives FDA marketing clearance

Abaxis, Inc., a medical products company manufacturing point-of-care blood analysis systems, today announced that the U.S. Food and Drug Administration (FDA) has granted 510K marketing clearance of the new C-Reactive Protein (CRP) assay when used by healthcare professionals in conjunction with the Piccolo Xpress™ point-of-care analyzer.

21 Jan 2010

BioLife Solutions announces biologic packaging products pre-filled with GMP biopreservation media

BioLife Solutions, Inc., a leading developer, manufacturer, and marketer of biopreservation tools for cells, tissues, and organs, and OriGen Biomedical, a leading provider of biologic packaging products for research and clinical blood and cell-based therapies, today announced that the companies will introduce sterile standard and custom biologic packaging products pre-filled with BioLife's serum-free, protein-free HypoThermosol® cell and tissue storage/transport media and CryoStor™ cryopreservation media.

21 Jan 2010