Manufacturing News and Research

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

SAFC expands fermentation capabilities in Israel facility

SAFC, a member of the Sigma-Aldrich® Group (Nasdaq: SIAL), today announced the completion of its state-of-the-art expansion of its Jerusalem, Israel facility. The additional capacity expands SAFC's contract manufacturing capabilities in large molecule recombinant proteins and small molecule Active Pharmaceutical Ingredients (APIs) through fermentation, including High Potent APIs (HPAPIs) and secondary metabolites.

6 Oct 2010

Liquidia commences dosing in LIQ-001 Phase 1 trial for seasonal influenza

Liquidia Technologies, a privately held nanotechnology company developing particle-based vaccines and therapeutics, today announced the initiation of human dosing of its lead vaccine product candidate, LIQ-001, in a Phase 1 clinical trial. LIQ-001, the first in a pipeline of PRINT® vaccines, is being developed as a seasonal influenza vaccine for enhanced protection in the elderly and represents the company's migration from proof of concept to the clinical application of PRINT technology.

5 Oct 2010

FDA grants Matrix tentative approval under PEPFAR for Atazanavir Sulfate Capsules ANDA

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its Abbreviated New Drug Application (ANDA) for Atazanavir Sulfate Capsules, 150 mg and 300 mg. This product will be eligible for purchase outside the U.S. in certain developing countries.

5 Oct 2010

Novo Nordisk announces $73M expansion of Clayton insulin delivery systems manufacturing facility

Novo Nordisk, a global healthcare company and leader in diabetes care, today announced a $73 million expansion of its Clayton, NC manufacturing facility to accommodate increased production capacity for the Company's insulin delivery devices.

5 Oct 2010

FDA announces dates for public hearing on Biologics Price Competition and Innovation Act of 2009

The U.S. Food and Drug Administration has scheduled a two-day public hearing on Nov. 2-3, 2010, on the implementation of the Biologics Price Competition and Innovation (BPCI) Act of 2009. The hearing will be held from 8:30 a.m. to 4:30 p.m. at the FDA's White Oak Campus, 10903 New Hampshire Ave., Building 31, room 1503, in Silver Spring, Md.

4 Oct 2010

VIVUS announces divestiture of MUSE to Meda

VIVUS, Inc. today announced that it has entered into an asset purchase agreement with Meda - an international specialty pharma company - for MUSE®, transurethral alprostadil, for the treatment of erectile dysfunction (ED). Under the agreement, Meda will acquire the MUSE assets including the United States and foreign MUSE patents, existing inventory and the manufacturing facility located in Lakewood, New Jersey.

4 Oct 2010

Emdeon acquires Chamberlin Edmonds

Emdeon Inc., a leading provider of healthcare revenue and payment cycle management solutions, today announced it has completed the acquisition of Chamberlin Edmonds & Associates, Inc., a leading provider of government program eligibility and enrollment services to over 200 acute care facilities in 31 states. Chamberlin Edmonds' technology-enabled services assist hospitals in lowering the incidence of uncompensated care, reducing bad-debt expense and increasing overall cash flow.

4 Oct 2010

FDA provides Celsion guidance for Thermodox NDA to treat primary liver cancer

Celsion Corporation, a leading oncology drug development company, announced that the Company has reached agreement with the U.S. Food and Drug Administration (FDA) that the requirements for non-clinical studies have been met for the New Drug Application (NDA) of ThermoDox.

4 Oct 2010

Pharmatek adds roller compaction to GMP manufacturing facilities

Pharmatek Laboratories, Inc., a premier contract development and manufacturing organization supporting the pharmaceutical industry, announced that it has added roller compaction to its solid oral dosage form manufacturing capabilities. The company has purchased two roller compactors, a pilot-scale Vector TFC-220 roller compactor with a rate of 20 kg/hour, and a Vector TFC-LAB Micro lab-scale roller compactor with a rate of 1 kg/hour. Both machines have been integrated into Pharmatek's GMP facility and are ready for GMP manufacturing.

4 Oct 2010

Sanofi-aventis commences tender offer for Genzyme acquisition

Sanofi-aventis announced today it has commenced a tender offer for all outstanding shares of common stock of Genzyme Corporation for $69 per share, net to the seller in cash, without interest and less any required withholding taxes. The transaction is valued at approximately $18.5 billion.

4 Oct 2010

Bionovo enters definitive agreement to raise $3.0 million in registered direct offering

Bionovo, Inc., a drug discovery and development company focused on unmet needs in women's health and oncology, today announced that it has entered into definitive agreements to raise approximately $3.0 million in gross proceeds in a registered direct offering through the sale of common stock and warrants.

4 Oct 2010

Medicago announces official groundbreaking ceremony for U.S. plant-based commercial grade vaccine facility

Medicago U.S.A. Inc., a wholly owned subsidiary of Medicago Inc., a biotechnology company focused on developing highly effective and affordable vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today announced that company executives, along with U.S. Senator Kay Hagan (D-NC) and U.S. Congressman David Price (D-NC), are holding an official groundbreaking ceremony this morning for its U.S. plant-based commercial grade vaccine facility in Research Triangle Park, North Carolina.

1 Oct 2010

FDA takes action against unapproved single-ingredient oral colchicine

The U.S. Food and Drug Administration took action against companies that manufacture, distribute, and/or market unapproved single-ingredient oral colchicine, a medication commonly used for the daily prevention of gout, to treat acute gout flare-ups, and for the treatment of Familial Mediterranean Fever (FMF).

1 Oct 2010

Covance, sanofi-aventis enter definitive agreement for R&D partnership

Covance Inc. today announced the signing of definitive agreements with sanofi-aventis for Covance to become sanofi-aventis' R&D partner. Over the next ten years, Covance expects to provide drug development services to sanofi-aventis, with estimated payments ranging from approximately $1.2 billion to $2.2 billion.

30 Sep 2010

Genotoxic impurities in prescription drugs

Drug manufacturers have been adjusting to strict new government standards that limit the amount of potentially harmful impurities in medicine, according to the cover story of the current issue of Chemical & Engineering News (C&EN), ACS' weekly newsmagazine. The impurities are "genotoxic," capable of damaging the DNA in genes.

30 Sep 2010

New form of immunotherapy increases survival in children with neuroblastoma

Administering a new form of immunotherapy to children with neuroblastoma, a nervous system cancer, increased the percentage of those who were alive and free of disease progression after two years, according to researchers at the University of California, San Diego School of Medicine and fellow institutions. The percentage rose from 46 percent for children receiving a standard therapy to 66 percent for children receiving immunotherapy plus standard therapy, according to the study published in the Sept. 30, 2010 issue of the New England Journal of Medicine.

30 Sep 2010

ThromboGenics enters 10-year supply agreement with MSD Biologics for microplasmin

ThromboGenics NV, a biopharmaceutical company focused on the discovery and development of innovative treatments for eye disease, cardiovascular disease and cancer, announces that it has signed a 10-year supply agreement with MSD Biologics (UK) Ltd, part of the Merck BioManufacturing Network, for the production of microplasmin. ThromboGenics anticipates that this deal will meet its long-term commercial needs for bulk drug substance of this novel therapeutic agent.

30 Sep 2010

UC Berkeley Extension offers new options for career development in biotechnology

Biotechnology professionals in the Bay Area have three new options for career development from UC Berkeley Extension. The professional programs in Regulatory Affairs, Biopharmaceutical Product and Process Development, and Bioscience Manufacturing and Supply Chain join the education leader's lineup of programs and certificates designed to meet the biotechnology industry's demand for trained professionals.

30 Sep 2010

New immunotherapy regimen improves survival rate in children with neuroblastoma: Research

30 Sep 2010

Crocker Ventures announces acquisition of TMJ Implants

Crocker Ventures today announced that it has acquired TMJ Implants of Golden, Colo., the leading manufacturer of implants for the treatment of temporomandibular joint (TMJ) disorder.

29 Sep 2010

Manufacturing News and Research

Further Reading

SAFC expands fermentation capabilities in Israel facility

Liquidia commences dosing in LIQ-001 Phase 1 trial for seasonal influenza

FDA grants Matrix tentative approval under PEPFAR for Atazanavir Sulfate Capsules ANDA

Novo Nordisk announces $73M expansion of Clayton insulin delivery systems manufacturing facility

FDA announces dates for public hearing on Biologics Price Competition and Innovation Act of 2009

VIVUS announces divestiture of MUSE to Meda

Emdeon acquires Chamberlin Edmonds

FDA provides Celsion guidance for Thermodox NDA to treat primary liver cancer

Pharmatek adds roller compaction to GMP manufacturing facilities

Sanofi-aventis commences tender offer for Genzyme acquisition

Bionovo enters definitive agreement to raise $3.0 million in registered direct offering

Medicago announces official groundbreaking ceremony for U.S. plant-based commercial grade vaccine facility

FDA takes action against unapproved single-ingredient oral colchicine

Covance, sanofi-aventis enter definitive agreement for R&D partnership

Genotoxic impurities in prescription drugs

New form of immunotherapy increases survival in children with neuroblastoma

ThromboGenics enters 10-year supply agreement with MSD Biologics for microplasmin

UC Berkeley Extension offers new options for career development in biotechnology

New immunotherapy regimen improves survival rate in children with neuroblastoma: Research

Crocker Ventures announces acquisition of TMJ Implants

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