Manufacturing News and Research

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

Neoprobe Corporation presents information on Lymphoseek at TERACHEM Symposium

Neoprobe Corporation a diversified developer of innovative oncology surgical and diagnostic products, today announced that Senior Vice President of Pharmaceutical Research and Clinical Development, Dr. Frederick O. Cope, presented information on the Company's lead pipeline initiative, Lymphoseek, at the International Symposium on Technetium and Other Radiometals in Chemistry and Medicine (TERACHEM), held September 8-11, 2010 in Bressanone (Bolzano), Italy.

14 Sep 2010

IGI submits first ANDA to FDA

IGI Laboratories, Inc., a New Jersey based formulation and manufacturing company, today announced that it has submitted its first abbreviated new drug application (ANDA) to the US FDA. IGI President and CEO Charlie Moore commented "This is a significant step forward in validating IGI's commitment to pharmaceutical product development.

14 Sep 2010

Experts warn dip in antibiotic R&D could lead to treatment challenges

The 50th annual meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) kicked off in Boston on Sunday with experts warning that a "slowdown" in research on antibiotic development could result in treatment challenges.

14 Sep 2010

Acsis recognized as 2010 'Top Preferred Solution Provider' by LogiPharma

Acsis, Inc., a leader in supply chain visibility and traceability for manufacturing and distribution, today announced that it has been recognized as a 2010 "Top Preferred Solution Provider" by LogiPharma. The company was selected based on a survey by World Business Research (WBR) to more than 2,000 pharmaceutical executives who identified Acsis, Inc. as one of the top solution providers focused on advancing supply chain efficiencies.

13 Sep 2010

Merit Medical Systems acquires BioSphere Medical

Merit Medical Systems, Inc. today announced the completion of its acquisition of BioSphere Medical, Inc., a leading developer and marketer of embolotherapeutic products for the treatment of uterine fibroids, hypervascularized tumors, and arteriovenous malformations.

13 Sep 2010

Geron, UCS collaborate to develop hESC-derived chondrocytes for cartilage damage, joint disease treatment

Geron Corporation today announced that the company has entered into a collaboration with University Campus Suffolk (UCS) in the U.K. to develop human embryonic stem cell-derived chondrocytes for the treatment of cartilage damage and joint disease.

13 Sep 2010

Cell quality control mechanism research paves way for new understanding of neurodegenerative diseases

Scientists from The Scripps Research Institute have solved a long-standing mystery of how cells conduct "quality control" to eliminate the toxic effects of a certain kind of error in protein production. The findings may lead to a better understanding of a host of neurodegenerative diseases.

13 Sep 2010

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

Manufacturing News and Research

Further Reading

Neoprobe Corporation presents information on Lymphoseek at TERACHEM Symposium

IGI submits first ANDA to FDA

Experts warn dip in antibiotic R&D could lead to treatment challenges

Acsis recognized as 2010 'Top Preferred Solution Provider' by LogiPharma

Merit Medical Systems acquires BioSphere Medical

Geron, UCS collaborate to develop hESC-derived chondrocytes for cartilage damage, joint disease treatment

Cell quality control mechanism research paves way for new understanding of neurodegenerative diseases

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

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