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

MV vaccine prevents TB in people with HIV infection

Results from clinical trials conducted in Tanzania show that a new vaccine against tuberculosis, Mycobacterium vaccae (MV), is effective in preventing tuberculosis in people with HIV infection. Findings from the trials, which were conducted by investigators from Dartmouth Medical School in the United States, will be published in the next issue of AIDS, the leading journal in the field of HIV and AIDS research. The journal is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health, a leading provider of information and business intelligence for students, professionals, and institutions in medicine, nursing, allied health, and pharmacy.

3 Feb 2010

Lannett Company plans to submit NDA for Morphine Sulfate products to FDA

Lannett Company, Inc. today announced plans to submit its New Drug Application (NDA) for its Morphine Sulfate products to the U.S. Food and Drug Administration (FDA) at the end of the month.

2 Feb 2010

Long-term harmful effects of BPA exposure: Cereplast lauds FDA's demand for additional study

Cereplast, Inc., manufacturer of proprietary bio-based sustainable plastics, applauds the Food and Drug Administration (FDA) for demanding increased study of the long-term effects of Bisphenol A (BPA) exposure.

2 Feb 2010

FDA requests additional data on CMC section of NDA for taliglucerase alfa from Protalix BioTherapeutics

Protalix BioTherapeutics, Inc. announced today that, in connection with the New Drug Application (NDA) filed by the Company in December 2009 for taliglucerase alfa for the treatment of Gaucher disease, the U.S. Food and Drug Administration (FDA) has requested additional data regarding the Chemistry, Manufacturing and Controls (CMC) section of the NDA.

2 Feb 2010

Scientists and engineers conduct research on environmental health impacts of nanomaterials

As researchers around the world hasten to employ nanotechnology to improve production methods for applications that range from manufacturing materials to creating new pharmaceutical drugs, a separate but equally compelling challenge exists.

2 Feb 2010

Suzhou Erye Pharmaceutical receives Chinese SFDA approval for manufacturing penicillin at new facility

NeoStem, Inc., an international biopharmaceutical company with operations in the U.S. and China, announced that it recently was advised that its Suzhou Erye Pharmaceutical subsidiary ("Erye") received approval from the State Food and Drug Administration (SFDA) in China to manufacture solvent crystallization sterile penicillin and freeze dried raw sterile penicillin at their new facility which provides 50% and 100% greater manufacturing capacity, respectively, than its existing facility. Historically, these two lines have accounted for approximately 20% of Erye's sales.

2 Feb 2010

Kyowa Hakko Kirin enters into distribution agreement with Hisamitsu Pharmaceutical

Orexo AB announces today that its partner Kyowa Hakko Kirin Co., Ltd. has entered a joint distribution agreement for the cancer pain drug KW-2246 (Orexo’s sublingual fentanyl product) with the pharmaceutical company Hisamitsu Pharmaceutical Co., Inc.

2 Feb 2010

U.S. Marshals seize unapproved ozone generators from Applied Ozone Systems

At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized 79 ozone generators, models AOS-1M and AOS-1MD, from Applied Ozone Systems of Auburn, Calif. The seized goods, which are medical devices, are valued at $75,900.

30 Jan 2010

Salient Surgical Technologies, Exeter Hospital and Moffitt Cancer Center donate medical supplies to Haiti

Salient Surgical Technologies of Portsmouth, New Hampshire, has partnered with Exeter Hospital in Exeter, New Hampshire and Moffitt Cancer Center in Tampa, Florida, to donate equipment and supplies for a mission to aid victims of the January 12 earthquake in Haiti.

30 Jan 2010

New vaccine effective in preventing TB in HIV patients

Investigators from Dartmouth Medical School (DMS) have reported results of a clinical trial showing that a new vaccine against tuberculosis, Mycobacterium vaccae (MV), is effective in preventing tuberculosis in people with HIV infection.

30 Jan 2010

Pioneer Surgical Technology plans to open new office facility in Austin, Texas

Pioneer Surgical Technology, Inc., a leader in innovative medical devices, announced today the company's plan to open a new office facility in Austin, Texas, April 1, 2010. The new facility provides Pioneer greater recruiting access to industry professionals who will help further the growth and development of Pioneer's Spine Division.

30 Jan 2010

sigma-tau Group acquires Enzon’s specialty pharmaceutical business

Enzon Pharmaceuticals, Inc. ("Enzon") announced today that it has closed the sale of its specialty pharmaceutical business to the sigma-tau Group ("sigma-tau"). Enzon is a biopharmaceutical company dedicated to the discovery and development of important medicines for patients with cancer and other life-threatening conditions. Enzon's business now consists of its royalties, Peg SN38, LNA and PEG technology platforms.

30 Jan 2010

Thoratec reports revenues of $373.9M for fiscal 2009

Thoratec Corporation, a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, said today that a 30 percent growth in revenues from its Cardiovascular Division in fiscal 2009 led to a 19 percent increase in total 2009 revenues versus those in fiscal 2008.

29 Jan 2010

Regis Technologies' 4-Aminopyridine manufacturing facility receives FDA's EIR and PAI approval

Regis Technologies, Inc., a leading provider of cGMP and non-GMP synthesis and separations services for active pharmaceutical ingredients (APIs) and intermediates, announced it has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) stating that Regis passed the FDA’s pre-approval inspection (PAI) for its manufacture of 4-Aminopyridine the active ingredient in Ampyra™.

29 Jan 2010

Watson Pharmaceuticals acquires Eden Biopharm Group for approximately $15M

Watson Pharmaceuticals, Inc. today announced that it has completed the acquisition of Eden Biopharm Group Limited for approximately $15 million. Eden is a biopharmaceutical development and contract manufacturing company located in Liverpool, UK. As a result of the acquisition of the Arrow Group in December 2009, Watson had previously acquired approximately 36 percent of Eden.

29 Jan 2010

Kensey Nash announces financial results for second quarter of fiscal year 2010

Kensey Nash Corporation, a leading medical technology company that provides innovative solutions and technologies for a wide range of medical procedures, today reported the results for its three and six months ended December 31, 2009.

28 Jan 2010

Procter & Gamble reports increased net sales for October - December quarter

The Procter & Gamble Company delivered net sales growth of six percent for the October - December quarter to $21.0 billion. Organic sales grew five percent which was at the top of the Company's guidance range.

28 Jan 2010

Baxter International reports net income of $572M for the fourth-quarter of 2009

Baxter International Inc. today reported strong performance for the fourth quarter of 2009, and provided its financial outlook for the first quarter and full-year 2010.

From Baxter International Inc. 28 Jan 2010

Study highlights benefits of reducing dietary salt

"This study provides excellent ammunition both to convince patients about the benefits of reducing their individual salt intakes and also to persuade the EU of the urgent need to introduce legislation to restrict the salt content of processed foods," said ESC spokesman Professor Frank Ruschitzka, a cardiologist and hypertension specialist from the University of Zurich, Switzerland.

28 Jan 2010

Formatech donates $308K in aseptic liquid fill and finish manufacturing services

Formatech continues its pledge to give back and make a difference in the biotechnology and pharmaceutical community with its Fillanthropy Program. Since the program’s inception, Formatech has donated $308K in aseptic liquid fill and finish manufacturing services to companies developing new drug therapies.

28 Jan 2010

Manufacturing News and Research

Further Reading

MV vaccine prevents TB in people with HIV infection

Lannett Company plans to submit NDA for Morphine Sulfate products to FDA

Long-term harmful effects of BPA exposure: Cereplast lauds FDA's demand for additional study

FDA requests additional data on CMC section of NDA for taliglucerase alfa from Protalix BioTherapeutics

Scientists and engineers conduct research on environmental health impacts of nanomaterials

Suzhou Erye Pharmaceutical receives Chinese SFDA approval for manufacturing penicillin at new facility

Kyowa Hakko Kirin enters into distribution agreement with Hisamitsu Pharmaceutical

U.S. Marshals seize unapproved ozone generators from Applied Ozone Systems

Salient Surgical Technologies, Exeter Hospital and Moffitt Cancer Center donate medical supplies to Haiti

New vaccine effective in preventing TB in HIV patients

Pioneer Surgical Technology plans to open new office facility in Austin, Texas

sigma-tau Group acquires Enzon’s specialty pharmaceutical business

Thoratec reports revenues of $373.9M for fiscal 2009

Regis Technologies' 4-Aminopyridine manufacturing facility receives FDA's EIR and PAI approval

Watson Pharmaceuticals acquires Eden Biopharm Group for approximately $15M

Kensey Nash announces financial results for second quarter of fiscal year 2010

Procter & Gamble reports increased net sales for October - December quarter

Baxter International reports net income of $572M for the fourth-quarter of 2009

Study highlights benefits of reducing dietary salt

Formatech donates $308K in aseptic liquid fill and finish manufacturing services

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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