Manufacturing News and Research

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

Cellerant Therapeutics signs contract with BARDA to develop CLT-008 therapy for ARS

Cellerant Therapeutics Inc., a biotechnology company developing novel hematopoietic stem cell-based cellular and antibody therapies for blood disorders and cancer, announced today that it has signed a contract valued at up to $153 million over five years with the Biomedical Advanced Research and Development Authority (BARDA) in the Office of the Assistant Secretary for Preparedness and Response of the Department of Health and Human Services, to develop CLT-008, a cellular therapy for the treatment of Acute Radiation Syndrome (ARS).

2 Sep 2010

Promega to provide FuGENE HD Transfection Reagent throughout life science market

Promega Corporation announces it will provide FuGENE HD Transfection Reagent throughout the life science market. The comprehensive, direct use offering from Promega means any life scientist can utilize FuGENE technology with no licensing requirements. FuGENE HD enables the transfection of DNA into many cell types with high efficiency and little-to-no toxicity.

2 Sep 2010

Nabi Biopharmaceuticals, Diosynth sign long-term commercial manufacturing agreement

Nabi Biopharmaceuticals announced today that it has entered into a long-term commercial manufacturing agreement with Diosynth RTP, Inc. for the manufacture of Drug Substance integral to the production of NicVAX, Nabi's innovative and proprietary investigational vaccine for the treatment of nicotine addiction and prevention of smoking relapse.

2 Sep 2010

LifeCell, Novadaq Technologies sign exclusive sales, marketing agreement

LifeCell Corporation, a business unit of Kinetic Concepts, Inc., and Novadaq Technologies Inc. announced today the signing of an exclusive sales and marketing agreement for distribution of Novadaq's SPY Imaging System in North American surgical markets. LifeCell will drive adoption for the SPY System in breast reconstructive, head and neck, and colorectal surgical specialties, with more than half a million procedures projected annually.

2 Sep 2010

Unitract Tuberculin syringe clears FDA 510k market clearance

Unilife Corporation, today announced that its Unitract Tuberculin (TB) Syringe has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA).

2 Sep 2010

ScinoPharm announces investment with Tanvex Biologics

ScinoPharm, a leading active pharmaceutical ingredient (API) developer and manufacturer headquartered in Taiwan, today announced an investment into Tanvex Biologics, Inc., a United States company registered in the State of Delaware. ScinoPharm's investment was in the form of tangible assets, intellectual properties, as well as cash.

2 Sep 2010

Martek Biosciences 2010 third quarter revenue increases 51% to $117.2 million

Martek Biosciences Corporation today announced its financial results for the third quarter of fiscal 2010.

2 Sep 2010

Irving Place Capital signs agreement to acquire Alpha Packaging

Irving Place Capital, a middle-market private equity firm, announced today that it has signed a purchase agreement to acquire Alpha Packaging, a leading blow molder of plastic bottles and jars for the nutraceutical, pharmaceutical and personal care markets. IPC is investing in partnership with Alpha's current management team, led by President and Chief Executive Officer Dave Spence and Chief Operating Officer Dan Creston. The transaction is expected to close in September of 2010.

31 Aug 2010

Ranaz second-quarter net earnings increase 11.5% to $410,443

Ranaz Corporation, a company specializing in the manufacturing and marketing of protein and dietary supplements, reported its results today for the second quarter ended June 30, 2010.

31 Aug 2010

Medicago included in President's report that examines drugs to prevent spread of infectious diseases

Medicago Inc., a clinical-stage biotechnology company focused on developing highly effective and affordable vaccines based on proprietary manufacturing technologies and Virus-Like Particles, today announced that it was included in a report of President Obama's Council of Advisors on Science and Technology entitled "Report to the President on Reengineering the Influenza Vaccine Production Enterprise to Meet the Challenges of Pandemic Influenza", which was released earlier this month. U.S. Health and Human Services Secretary Kathleen Sebelius and other public health officials held a briefing to discuss this report and the $2 billion plan to accelerate the development of drugs and vaccines to prevent the spread of infectious diseases.

31 Aug 2010

Halozyme identifies strategy to reintroduce HYLENEX

Halozyme Therapeutics, Inc. today announced the completion of its root cause investigation regarding HYLENEX manufacturing and has identified a corrective action plan and regulatory strategy to reintroduce HYLENEX to the market. Halozyme and Baxter are finalizing the materials for a meeting with the U.S. Food and Drug Administration to seek concurrence with the reintroduction strategy.

31 Aug 2010

Bionovo receives positive guidance for Menerba drug candidate

Bionovo, Inc. announced today that it has received positive guidance from the U.S. Food and Drug Administration (FDA) regarding the Company's Chemistry, Manufacturing and Controls (CMC) plan for its lead drug candidate Menerba.

31 Aug 2010

Amsterdam Molecular first half 2010 net loss in line with last year

Amsterdam Molecular Therapeutics, a leader in the field of human gene therapy, today reported its results for the first half year of 2010.

31 Aug 2010

Achaogen receives contract from BARDA for developing ACHN-490 antibiotic treatment

Achaogen, a biopharmaceutical company discovering and developing innovative antibiotics to treat life-threatening, multi-drug resistant (MDR) bacterial infections, today announced the award of a contract with The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.

31 Aug 2010

Intendis granted rights to KYTHERA's ATX-101 candidate for minimally-invasive fat reduction outside US, Canada

KYTHERA Biopharmaceuticals, Inc. and Intendis, Bayer HealthCare's dermatology business, today announced that they have entered into a licensing agreement granting Intendis rights to KYTHERA's lead product candidate, ATX-101, outside of the US and Canada. ATX-101, a first-in-class investigational drug, is currently in clinical development for the reduction of localized fat under the chin (submental fat).

31 Aug 2010

Unilife Corporation 2010 fourth quarter revenue increases to $2.7 million

Unilife Corporation today announced preliminary financial results for the fourth quarter and fiscal year ended June 30, 2010.

31 Aug 2010

Biomagnetics to acquire Lanzhou New Sunshine Plastics Industry

Biomagnetics Diagnostics Corp., a developer of revolutionary diagnostic systems and technology for HIV, hepatitis, tuberculosis and malaria detection, and other innovative technologies, today announced the signing of a Letter of Intent (LOI) with Lanzhou New Sunshine Plastics Industry LTD. This expected acquisition is the fourth planned acquisition targeted at a share price of US $1.50 for Biomagnetics Diagnostics' common shares.

30 Aug 2010

Eisai receives new action date for FDA priority review of eribulin mesylate NDA for metastatic breast cancer

Eisai Inc. announced today that it has received notification from the U.S. Food and Drug Administration (FDA) that the agency expects to complete priority review of the eribulin mesylate New Drug Application (NDA) for locally advanced or metastatic breast cancer on or before December 30, 2010, which is a three month extension from the original Prescription Drug User Fee Act (PDUFA) action date of September 30, 2010.

30 Aug 2010

Meda signs agreement to acquire Alaven

Meda has signed an agreement to acquire the US specialty pharmaceutical company Alaven. The acquisition will significantly enhance Meda's marketing capabilities in the US and expand the therapeutic focus to include both gastroenterology and women's health; areas that Meda already operates in outside of the US.

30 Aug 2010

Bend Research granted patent for making solid amorphous dispersions of drugs with SDD technology

Bend Research Inc., a leading independent drug-formulation development and manufacturing company, announced today that it has received a new U.S. patent covering a process for making spray-dried solid amorphous dispersions of drugs using pressure nozzles.

30 Aug 2010

Manufacturing News and Research

Further Reading

Cellerant Therapeutics signs contract with BARDA to develop CLT-008 therapy for ARS

Promega to provide FuGENE HD Transfection Reagent throughout life science market

Nabi Biopharmaceuticals, Diosynth sign long-term commercial manufacturing agreement

LifeCell, Novadaq Technologies sign exclusive sales, marketing agreement

Unitract Tuberculin syringe clears FDA 510k market clearance

ScinoPharm announces investment with Tanvex Biologics

Martek Biosciences 2010 third quarter revenue increases 51% to $117.2 million

Irving Place Capital signs agreement to acquire Alpha Packaging

Ranaz second-quarter net earnings increase 11.5% to $410,443

Medicago included in President's report that examines drugs to prevent spread of infectious diseases

Halozyme identifies strategy to reintroduce HYLENEX

Bionovo receives positive guidance for Menerba drug candidate

Amsterdam Molecular first half 2010 net loss in line with last year

Achaogen receives contract from BARDA for developing ACHN-490 antibiotic treatment

Intendis granted rights to KYTHERA's ATX-101 candidate for minimally-invasive fat reduction outside US, Canada

Unilife Corporation 2010 fourth quarter revenue increases to $2.7 million

Biomagnetics to acquire Lanzhou New Sunshine Plastics Industry

Eisai receives new action date for FDA priority review of eribulin mesylate NDA for metastatic breast cancer

Meda signs agreement to acquire Alaven

Bend Research granted patent for making solid amorphous dispersions of drugs with SDD technology

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