Manufacturing News and Research

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

Ranier's Cadisc-L spinal disc replacement granted CE Mark Approval

Ranier Technology, the medical device development company focusing on the commercialisation of spinal implants, has announced that it has received CE Mark approval for its Cadisc™-L; an elasto-mimetic spinal disc replacement device for the lumbar spine. The CE Mark approval was received following a review of the company's multi-centre European clinical study and its extensive portfolio of biocompatibility and biomechanical testing.

13 Sep 2010

Santarus expands development pipeline, adds two novel biologic drug candidates

Santarus, Inc., a specialty biopharmaceutical company, has expanded its development pipeline with the addition of two novel biologic drug candidates focused on specialty markets.

13 Sep 2010

Advaxis publishes research article on Her2 antigen for Listeria vaccine

Scientists at Advaxis, Inc.,the live, attenuated Listeria monocytogenes (Listeria) immunotherapy company, recently had their research using ADXS31-164, a live Listeria vaccine that targets Her2, published in a leading peer reviewed journal (Shahabi, et al 2010 Cancer Gene Therapy epublished ahead of print).

13 Sep 2010

More men than women discontinue medications due to side effects

Men are more likely than women to discontinue a medication due to side effects. More and more men are diagnosed with age-related issues like enlarged prostate and men are being prescribed medications that have side effects. These side effects often cause men to say "NO." In the U.S. and Canada, Prostate prescriptions dominate the treatment of enlarged prostate.

10 Sep 2010

K-V successfully completes FDA inspection for resumption of manufacturing and shipment of products

K-V Pharmaceutical Company announced today that it has received notice from the U.S. Food and Drug Administration ("FDA") of the successful completion of an inspection of the Company's facilities and approval to return its first product to market. Under the Company's Consent Decree, successful FDA inspections of the Company's quality systems, processes and facilities are expected to be required before K-V is permitted to resume manufacturing and shipment of particular products.

10 Sep 2010

Bioniche reduces net loss per share from $0.15 in fiscal 2009 to $0.02 in fiscal 2010

Bioniche Life Sciences Inc., a research-based, technology-driven Canadian biopharmaceutical company, today announced financial results for its 2010 fiscal year ended June 30, 2010.

10 Sep 2010

Campaign for Tobacco-Free Kids applauds FDA for action against electronic cigarette distributors

We applaud the U.S. Food and Drug Administration for taking appropriate enforcement action today against five distributors of electronic cigarettes for various violations of the Federal Food, Drug and Cosmetic Act (FDCA), including unsubstantiated claims and poor manufacturing practices.

10 Sep 2010

FDA issues warning letters to five electronic cigarette distributors

The U.S. Food and Drug Administration today issued warning letters to five distributors for various violations of the Federal Food, Drug, and Cosmetic Act (FDCA) including unsubstantiated claims and poor manufacturing practices.

10 Sep 2010

Shire announces expansion of Human Genetic Therapies pipeline

Shire plc, the global specialty biopharmaceutical company, today announced the expansion of its Human Genetic Therapies pipeline through the exclusive license, in markets outside of North America, for the activin receptor type IIB class of molecules being developed by Acceleron Pharma Inc., a private biotechnology company based in Cambridge, Massachusetts.

10 Sep 2010

Edimer Pharmaceuticals, CMC Biologics execute manufacturing contract to develop EDI200 recombinant protein

Edimer Pharmaceuticals and CMC Biologics today announce the execution of a manufacturing contract to support the development of EDI200, a clinical-stage recombinant protein for the treatment of X-linked Hypohidrotic Ectodermal Dysplasia (XLHED), a rare genetic disease with orphan designation in the USA and Europe.

10 Sep 2010

NovaSterilis issued US patent

NovaSterilis Inc. has been issued US Patent # 7,771,652 B2 for “Combined Use of an Alkaline Earth Metal Compound and a Sterilizing Agent to Maintain Osteoinduction Properties of a Demineralized Bone Matrix”

9 Sep 2010

Patheon third-quarter total revenues decrease 0.7% to $163.3 million

Patheon Inc., a leading provider of contract development and manufacturing services to the global pharmaceutical industry, announced today its results for the third quarter and nine months ended July 31, 2010. Total revenues for the third quarter were $163.3 million or 0.7% lower than the same period last year. Excluding currency fluctuations, current year third quarter revenues would have increased by approximately 3.9% versus the same period last year.

9 Sep 2010

Acceleron Pharma and Shire announce joint development of ACE-031 for DMD

Acceleron Pharma, Inc., a biopharmaceutical company developing novel therapeutics that modulate the growth of cells and tissues including muscle, bone, fat, red blood cells and the vasculature, and Shire plc, the global specialty biopharmaceutical company, today announced a joint development and commercialization agreement for ACE-031 and other novel molecules targeting the activin receptor type IIB (ActRIIB) pathway. This pathway plays critical roles in regulating the growth of skeletal muscle.

9 Sep 2010

NEXUS Biosystems acquires REMP from Tecan Group

NEXUS Biosystems, Inc., a leading innovator and worldwide provider of automated sample management systems, today announced the completion of the acquisition of REMP AG of Switzerland, a wholly-owned subsidiary of the Tecan Group.

From Tecan 8 Sep 2010

Zyngenia completes $15M Series A financing extension from NEA

Zyngenia, Inc., a privately held biotherapeutics company focused on next-generation antibody drug development, announced today the completion of a $15 million Series A financing extension from New Enterprise Associates (NEA), one of the world's leading venture capital firms. The capital will be used to continue to rapidly progress Zyngenia's pipeline of Zybodies™, which are novel, multi-specific, antibody-based molecules that address two or more biological targets with a single protein drug.

8 Sep 2010

Vela Laboratories renews GMP certificate for analytical and Quality Control laboratories

Vela Laboratories, a provider of analytical services to the global biopharmaceutical industry, today announced the renewal of the GMP certificate for its analytical and Quality Control laboratories until 2013.

8 Sep 2010

Liberator Medical Holdings' subsidiary receives 2010 Governor's Business Diversification Award

Liberator Medical Holdings, Inc. today announced its wholly owned subsidiary, Liberator Medical Supply, has received the 2010 Governor's Business Diversification Award in the Business Expansion category.

8 Sep 2010

Reports on smoking rates among Americans reveal dramatic progress in fight against tobacco

Two new reports released today by the Centers for Disease Control and Prevention show that while the United States has made dramatic progress in the fight against tobacco, too many Americans still smoke and too many non-smokers including more than half of all young children are still exposed to secondhand smoke.

8 Sep 2010

'Compliant concept' wins CTI Medtech Award 2010

"And the winner is- 'compliant concept' - Michael Sauter and his team receive the CTI Medtech Award 2010" was the announcement heard in the Casino in Bern on August 31st. The Medtech Event organized by the CTI, the Swiss Innovation Promotion Agency, is the meeting place for all the main players in the medical technology branch in the country.

8 Sep 2010

BioAlliance Pharma receives European patent for acyclovir Lauriad tablets for recurrent herpes labialis

BioAlliance Pharma SA, a company dedicated to the supportive care and treatment of cancer patients, today announced the grant of a European patent protecting its product acyclovir Lauriad.

8 Sep 2010

Manufacturing News and Research

Further Reading

Ranier's Cadisc-L spinal disc replacement granted CE Mark Approval

Santarus expands development pipeline, adds two novel biologic drug candidates

Advaxis publishes research article on Her2 antigen for Listeria vaccine

More men than women discontinue medications due to side effects

K-V successfully completes FDA inspection for resumption of manufacturing and shipment of products

Bioniche reduces net loss per share from $0.15 in fiscal 2009 to $0.02 in fiscal 2010

Campaign for Tobacco-Free Kids applauds FDA for action against electronic cigarette distributors

FDA issues warning letters to five electronic cigarette distributors

Shire announces expansion of Human Genetic Therapies pipeline

Edimer Pharmaceuticals, CMC Biologics execute manufacturing contract to develop EDI200 recombinant protein

NovaSterilis issued US patent

Patheon third-quarter total revenues decrease 0.7% to $163.3 million

Acceleron Pharma and Shire announce joint development of ACE-031 for DMD

NEXUS Biosystems acquires REMP from Tecan Group

Zyngenia completes $15M Series A financing extension from NEA

Vela Laboratories renews GMP certificate for analytical and Quality Control laboratories

Liberator Medical Holdings' subsidiary receives 2010 Governor's Business Diversification Award

Reports on smoking rates among Americans reveal dramatic progress in fight against tobacco

'Compliant concept' wins CTI Medtech Award 2010

BioAlliance Pharma receives European patent for acyclovir Lauriad tablets for recurrent herpes labialis

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