Manufacturing News and Research

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

FDA may seek criminal penalties against J & J for faulty recall of children's Tylenol, other medicines

The Wall Street Journal: "The Food and Drug Administration said it is weighing whether to seek criminal penalties against the Johnson & Johnson unit that made children's Tylenol and other over-the-counter kids' medicines recalled last month. Joshua Sharfstein, the FDA's principal deputy commissioner, told lawmakers at a hearing Thursday that J&J's McNeil Consumer Healthcare unit had a 'pattern of noncompliance' with good manufacturing practices.

29 May 2010

VaxGen signs definitive agreement to acquire diaDexus in stock-for-stock merger

VaxGen, Inc., a biopharmaceutical company, and diaDexus, Inc., a privately held diagnostics company focused on the development and commercialization of patent-protected in vitro diagnostic products addressing unmet needs in cardiovascular disease, announced today that they have entered into a definitive agreement under which VaxGen will acquire diaDexus in a stock-for-stock merger.

29 May 2010

US HIFU acquires Sonatherm 600 medical device from Misonix

USHIFU, LLC (US HIFU), a world leader in minimally invasive high intensity focused ultrasound (HIFU) technologies and manufacturer of the Sonablate® 500 (Sonablate) medical device, announces the acquisition of certain Misonix HIFU assets and European distribution rights. In addition, through its transaction with Misonix, US HIFU acquires the Sonatherm® 600 medical device, a laparoscopic HIFU system used to ablate certain soft tissues.

29 May 2010

Study measures effects of BPA on male reproductive system

Increasing Bisphenol-A levels in urine are associated with worsening male sexual function, according to a Kaiser Permanente study appearing online in the Journal of Andrology.

28 May 2010

Hamilton Thorne announces vendor partnership agreement with Leica Microsystems

Hamilton Thorne Ltd., a leading provider of advanced laser systems and instruments for the stem cell research and fertility clinic markets, today announces a vendor partnership agreement with Leica Microsystems GmbH of Wetzlar, Germany, a leading global designer and producer of innovative high-tech precision optics systems for the analysis of microstructures.

28 May 2010

Celsis International updates Drug Master Files with FDA

Celsis International, the global leader in rapid microbial detection, announced it has recently updated its Drug Master Files with the U.S. Food & Drug Administration (FDA) to include information on testing both non-sterile and sterile raw materials, in-process solutions and finished goods on the Celsis system.

28 May 2010

Flextronics to expand existing partnership with Citrix Systems

Flextronics today announced that it will expand its existing partnership with Citrix Systems, Inc. to include the joint design of Citrix's next generation hardware for WAN optimization and secure access appliances and primary outsourcing partner. Flextronics has provided manufacturing and logistics solutions to Citrix for more than five years.

28 May 2010

Welch Allyn climbs to #35 rank in "The Best Companies to Work For" in Mexico list

For the second consecutive year, The Gestion de Negocios named Welch Allyn, a leading global manufacturer of frontline medical products and solutions, to its list of "The Best Companies to Work For" in Mexico, the country's most comprehensive study of workplace culture. This year's ranking represented a leap of 42 spots, as the company moved from #77 in 2009 to #35 this year—a significant accomplishment for the Welch Allyn de Mexico factory that has only been in operation since 2006.

27 May 2010

Biomedical/Clinical Engineering practice improves healthcare: Health Association Nova Scotia

The week, May 23 to May 29, is National Biomedical/Clinical Engineering Appreciation Week and celebrations across the country are recognizing the importance of this field to improving healthcare and the contributions of its practitioners.

27 May 2010

Impax Laboratories, IGI Laboratories announce product development and supply agreement

Impax Laboratories, Inc. today announced that it has entered into a product development and supply agreement with IGI Laboratories, Inc., a formulation and manufacturing company. IGI will be responsible for developing two topical drug products, obtaining FDA marketing approvals, and manufacturing the commercial products.

27 May 2010

Jubilant Organosys announces repayment of FCCBs amounting to $50M and YTM of $19M

Jubilant Organosys Limited, an integrated pharmaceutical industry player and the largest Custom Research and Manufacturing Services Company out of India, today announced the repayment of FCCBs amounting to US$ 50 million along with the YTM of US$ 19 million. The FCCBs were due for redemption on May 24, 2010.

26 May 2010

ifp Institut für Produktqualität sells molecular biological, PCR-based food test product line to QIAGEN

The Berlin-based diagnostics company ifp Institut für Produktqualität has sold its molecular biological, PCR-based food test product line to QIAGEN at a price not revealed. QIAGEN has purchased all the required patents and licences and will immediately begin to market and distribute the newly acquired portfolio of 70 molecular biological tests. With the support of this powerful and experienced partner in food diagnostics ifp can now make available its expertise in food analytics globally.

From QIAGEN Manchester Limited 26 May 2010

CEVEC, Pevion Biotech sign license option agreement for transient CAP-T cell expression technology

CEVEC Pharmaceuticals, the German developer of a novel human expression system derived from amniocytes, announced today the signing of an exclusive license option agreement with Pevion Biotech, the Swiss vaccine company. The agreement enables Pevion Biotech to exclusively use CEVEC's transient CAP-T™ cell expression technology to manufacture and commercialize a protein antigen for vaccination against a widespread human infectious disease.

26 May 2010

ReVision Optics receives $35 million in capital funding

ReVision Optics, Inc. (RVO), an ophthalmic surgical products company, recently received $35 million in capital funding. The Lake Forest, Calif.-based firm specializes in the research, development and manufacturing of custom products to correct and maintain near vision.

26 May 2010

Lumizyme receives FDA approval for patients with late-onset Pompe disease

The U.S. Food and Drug Administration approved Lumizyme (alglucosidase alfa) for patients ages 8 years and older with late-onset (non-infantile) Pompe disease, a rare genetic disorder.

26 May 2010

Genzyme's Lumizyme for Pompe disease receives FDA marketing approval

Genzyme Corporation announced today that the FDA has granted U.S. marketing approval for Lumizyme™ (alglucosidase alfa), produced at the 4000 liter (L) bioreactor scale at its manufacturing facility in Geel, Belgium. Lumizyme is the first treatment approved in the United States specifically to treat patients with late-onset Pompe disease.

25 May 2010

Exactech acquires Brighton Partners

Exactech, Inc., a developer and producer of bone and joint restoration products for hip, knee, shoulder, spine and biologic materials, announced today that the company has acquired Brighton Partners, Inc., the sole source supplier of the direct compression molded polyethylene bearings used exclusively in Exactech's flagship product, the Optetrak® knee replacement system.

25 May 2010

Genzyme signs consent decree of permanent injunction, agrees to disgorgement

Genzyme Corp. has signed a consent decree agreeing to correct manufacturing quality violations at its Allston, Mass., manufacturing facility and will turn over to the federal government $175 million in unlawful profits from the sale of products that were made at the plant, the U.S. Food and Drug Administration announced today.

25 May 2010

Genzyme finalizes terms for consent decree regarding Allston manufacturing plant

Genzyme Corporation announced today that the terms for the consent decree regarding the Allston manufacturing plant have been finalized. These terms are in line with the company's expectations announced last month. The consent decree is subject to approval by the United States District Court for the District of Massachusetts.

25 May 2010

Elite Pharmaceuticals acquires hydromorphone hydrochloride tablets from Mikah Pharma

Elite Pharmaceuticals, Inc. announced today the acquisition of a currently approved Abbreviated New Drug Application (ANDA) for hydromorphone hydrochloride 8 mg tablets from Mikah Pharma LLC. The hydromorphone hydrochloride tablets are the generic equivalent of Dilaudid® 8 mg.

25 May 2010

Manufacturing News and Research

Further Reading

FDA may seek criminal penalties against J & J for faulty recall of children's Tylenol, other medicines

VaxGen signs definitive agreement to acquire diaDexus in stock-for-stock merger

US HIFU acquires Sonatherm 600 medical device from Misonix

Study measures effects of BPA on male reproductive system

Hamilton Thorne announces vendor partnership agreement with Leica Microsystems

Celsis International updates Drug Master Files with FDA

Flextronics to expand existing partnership with Citrix Systems

Welch Allyn climbs to #35 rank in "The Best Companies to Work For" in Mexico list

Biomedical/Clinical Engineering practice improves healthcare: Health Association Nova Scotia

Impax Laboratories, IGI Laboratories announce product development and supply agreement

Jubilant Organosys announces repayment of FCCBs amounting to $50M and YTM of $19M

ifp Institut für Produktqualität sells molecular biological, PCR-based food test product line to QIAGEN

CEVEC, Pevion Biotech sign license option agreement for transient CAP-T cell expression technology

ReVision Optics receives $35 million in capital funding

Lumizyme receives FDA approval for patients with late-onset Pompe disease

Genzyme's Lumizyme for Pompe disease receives FDA marketing approval

Exactech acquires Brighton Partners

Genzyme signs consent decree of permanent injunction, agrees to disgorgement

Genzyme finalizes terms for consent decree regarding Allston manufacturing plant

Elite Pharmaceuticals acquires hydromorphone hydrochloride tablets from Mikah Pharma

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