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CMC in Medical News

Vellore’s CMC Offers Hope for Bhutanese Patient

Thimphu: Sonam Choden, the mother of two-year-old Leki Dorji, never hoped to be happy again. But thanks to the Vellore-based Christian Medical College in India's Tamil// Nadu state, which treated the burn injuries of Dorji and made him "eat, walk and also talk". Choden, an uneducated 23-year...

Need For Social Churning Emphasized In CMC Meet On ‘Leadership In Healthcare

The Secretary of the National Commission on Macroeconomics and Health, K Sujatha Rao, emphasized the need for the Union Government to make mandatory a comprehensive Universal Health Insurance System for the people//. She advocates the utilization of 9 % of the GDP on health and adopt a cross-se...

Glivec - New Hope For CMC Patients

For those unlucky to be afflicted by the deadly chronic myeloid leukemia (CMC) and their near and dear ones, there's some good news. One of the deadliest forms of leukemia - commonly called 'blood cancer' - kills thousands across the globe. Chronic myeloid leukemia was one of the deadliest kil...

Bellicum Pharmaceuticals Announces Initiation of Phase I/II Clinical Trial of Novel Vaccine for Patients With Advanced Prostate Cancer

...in-licensed certain key technologies, and Chief Executive Officer Thomas J. Farrell has assembled a team of seasoned clinical, regulatory, quality and cmc consultants to advance product candidates into human clinical trials. For more information, visit http://www.bellicum.com ...

CMC Limited and FileVision LLC Announce Partnership to Provide Business Productivity Solutions to a Global Market

... ATLANTA, Aug. 4 /PRNewswire/ -- cmc Limited and FileVision LLC announced today their p...en FileVision's productivity software solution and cmc Ltd.'s world class consultancy services will help ...cer, "Our partnership with FileVision will provide cmc a strategic platform to expand our solution and se...

Savient Pharmaceuticals Receives Complete Response Letter from U.S. Food and Drug Administration for KRYSTEXXA(TM)

...cating to patients and physicians an understanding of the risks of KRYSTEXXA treatment. The complete response letter included additional cmc comments focused on tightening manufacturing parameters and narrowing analytical specifications associated with commercial production. The Company wa...

Covance Expands Analytical and Stability Service Capacity in North America

... "Covance is committed to providing world-class cmc analytical services for our clients to provide the...edicated program management team, we can now offer cmc analytical services as part of an entire molecule ...ustry, Covance offers a comprehensive portfolio of cmc analytical services, including analytical method d...

Asymchem Announces sFDA Certification for Drug Product Manufacturing

...rving the pharmaceutical industry. With a 14 year track record, Asymchem is committed to the highest level of quality and excellence in the integrated cmc services arena. For further information, please visit the Asymchem website at www.asymchem.com . ...

Asymchem Announces Opening of High Potency API and Drug Product Facility

...serving the pharmaceutical industry. With a 14-yr track record, Asymchem is committed to the highest level of quality and excellence in the integrated cmc services arena. For further information, please visit the Asymchem website at www.asymchem.com . ...

'Topical Dermatological Product Development in the USA' Workshop to Be Held on June 4, 2009 in East Brunswick, New Jersey, USA

... focused workshop." The morning session will cover formulation and screening of topical products for regulatory, clinical and commercial success, cmc issues and pitfalls, and the role of project management in successful development programs. The afternoon session will cover FDA safety concerns...
CMC in Medical Technology

CMC ICOS Biologics and Implicit Bioscience Ltd Announce IC14 Antibody Manufacturing Agreement and Patent License

... May 8 /PRNewswire/ -- Implicit Bioscience Ltd and cmc ICOS Biologics today announced the execution of a ...ar rationale for clinical development in ALI. cmc ICOS is a company dedicated to contract developmen... negotiated a non-exclusive license to utilize the cmc proprietary CHEF1(R) expression technology, a syst...

InteKrin Therapeutics Announces Enrollment Completion of 360 Patient, 24 week Phase 2b Study

...d CEO, Denny Lanfear. "We anticipate having results from INT131-007 in the second half of this year concurrent with completion of all nonclinical and cmc efforts, enabling initiation of the INT131 Phase 3 program in 1H2010." INT131 is a selective PPAR gamma modulator which has consistently demonstr...

Savient Provides Update on Pegloticase BLA

...development of pegloticase and developing other product candidates; our stock price and market conditions; varying interpretations of our clinical and cmc data by the FDA; delay achieving or failure to achieve FDA approval of pegloticase; inability to manufacture commercial quantities of our products; in...

Savient Announces FDA's Advisory Panel to Review Pegloticase for Treatment-Failure Gout Patients

...development of pegloticase and developing other product candidates; our stock price and market conditions; varying interpretations of our clinical and cmc data by the FDA; delay achieving or failure to achieve FDA approval of pegloticase; inability to manufacture commercial quantities of our products; in...

Bionovo Announces Development Plans for Menopausal Hot Flash Drug Candidate, Menerba (MF101), Following FDA Meetings

...ce on how Bionovo can move forward with the development of Menerba (formerly named MF101) for menopausal hot flashes. "We have concluded three cmc discussions with the FDA, and are moving to address the Agency's recommendations for further development of Menerba. The recommendations with respect ...

IDM Pharma Provides Update on Mifamurtide (L-MTP-PE) Regulatory Status Following September Meeting of European Committee for Medicinal Products for Human Use (CHMP)

...HMP requested that the Company provide additional data analyses from the Phase 3 L-MTP-PE trial (INT-0133), in addition to responding to the remaining cmc questions. The Company provided this information in accordance with the timeline for preliminary consideration by the CHMP at its plenary meeting in S...

IDM Pharma Provides Update on Mifamurtide (L-MTP-PE) Regulatory Status Following June Meeting of European Committee for Medicinal Products for Human Use (CHMP)

...HMP requested that the Company provide additional data analyses from the Phase 3 L-MTP-PE trial (INT-0133), in addition to responding to the remaining cmc questions. The Company believes that the additional data analyses requested will further confirm the overall survival benefit of L-MTP-PE seen in the ...

HUYA Bioscience Int'l Announces Pre-IND Outcome for HBI-3000 - Promising Anti-Arrhythmia Compound Sourced From China

...) for HBI-3000 (Sulcardine sulphate), a promising anti-arrhythmic compound sourced from China. The Agency reviewed and agreed with HUYA's IND-enabling cmc and toxicology plans and high level Phase I plans pending review of non-clinical and clinical data to be submitted as part of the complete IND package...

IDM Pharma Announces Updated Data From Mifamurtide (L-MTP-PE) Compassionate Access Program

...not limited to, whether the Company will be able to respond to the remaining issues with regard to the MAA, including verification of data quality and cmc items, to the satisfaction of the CHMP, whether the CHMP will ask the Company for further information at or following the June 2008 meeting to address...

Albemarle Optimizes Smallpox Drug Candidate for SIGA

... ST-246, according to Dr. Dennis E. Hruby, SIGA's Chief Scientific Officer. "Under the leadership of Dr. Shanthakumar Tyavanagimatt, SIGA's Director cmc operations & Formulations, Albemarle's R&D group have helped us flesh out a robust crystallization step that consistently delivers the most desired po...
CMC in Medical Products

Freedom® CMC ThumbFit™

Description: Freedom® CMC ThumbFit™ reduces joint instability without disturbing hand function. This low-profile splint is remarkably comfortable and easy for users to apply and adjust. Pamela Kirby, OTR/L, CHT and Robert V. Sypher Jr., MD, FAAOS, developed the splint together in response to patients...
Company:AliMed, Inc.

ThumSaver™ CMC Long

Description: When experiencing symptoms of tendinitis of the thumb, known as deQuervain's tenosynovitis, or arthritis of the CMC joint, the ThumSaver CMC Long provides wrist and thumb stability while still allowing function. The thumb is positioned for pinch without straining to hold a pen, utensil or to button...
Company:3-Point Products

ThumSaver™ CMC Short

Description: Ultra-thin, light weight and strong, the ThumSaver CMC Short lessens symptoms of arthritis, tendinitis or ligament injury at the CMC and/or MP joints of the thumb. The ThumSaver CMC Short allows partial wrist motion and full IP joint motion for function. Includes felt padding for cushioning. Ideal ...
Company:3-Point Products

Blue Line™ ThumStay

Description:...ol at the wrist and thumb and can easily be contoured for proper positioning and fit. Ideal for use those with deQuervain's tenosynovitis, tendinitis, cmc joint arthritis, and following cast removal. Machine washable. Available for right and left hands in sizes x-small through x-large....
Company:3-Point Products

ThumSaver™ MP

Description:... The ThumSaver MP stabilizes the MP joint and the cmc joint of the thumb and has been shown to reduce subluxation of both of the thumb joints. An excellent choice for active persons who want control to el...
Company:3-Point Products

ACTION™ ThumSling™

Description:... The cmc joint is the most common site for arthritis in the hand. The ACTION ThumSling supports the cmc joint without restricting the wrist or other joint...s who need to control or reduce subluxation of the cmc joint of the thumb to perform work and leisure act...
Company:3-Point Products

REFRESH LIQUIGEL®

Description:...bricant Eye Drops combines the strength of a gel with the convenience of a liquid eye drop for long-lasting relief plus protection. Its extra-strength cmc formula provides lubrication on the eye for prolonged comfort. And with the PURITE® preservative, youll avoid the harsher preservatives found in m...
Company:Allergan, Inc.

Premier Thumb Spica

Features:... Indicated when immobilization of the MP and cmc joints is desired Indicated for deQuervain's syndrome and rheumatoid arthritis Maximum contouring at the palmar crease allows for full finger func...
Company:Bird & Cronin Inc.

Superior Thumb Spica

Features:... Supports and limits the motion of the MP and cmc joints Offers gentle thumb support Indicated for deQuervain's syndrome and rheumatoid arthritis ...
Company:Bird & Cronin Inc.

FREEDOM® Memory Thumb Spica

Features:... Immobilizes cmc and MP thumb joints Protects like a cast ...
Company:AliMed, Inc.
CMC in Biological News

Asthma gene clusters identified

...ic data analyses. This, in turn, will lead to customized care based on a patient's personal needs," according to Bruce Aronow, PhD, co-director of the cmc and co-author of the study. "Our ultimate goal is to provide physicians the data they need to prescribe the most effective medications, discover ne...
CMC in Biological Technology

Spherix Announces Full-Scale Production of Pharmaceutical Tagatose

.... One metric ton of drug was received from the manufacturer, Inalco S.p.A., of Italy. Spherix will use the tagatose in the process of satisfying the cmc (Chemistry, Manufacturing and Control) requirements of its NDA (New Drug Application) to the U.S. FDA. This batch, as well as subsequent batches, wil...

FDA Appointed Arthritis Advisory Committee Recommends U.S. Food and Drug Administration Approval for KRYSTEXXA(TM) for Refractory Chronic Gout

...endation of the Advisory Committee; any delay or failure by us in completing the development of KRYSTEXXA; varying interpretations of our clinical and cmc data by the FDA; difficulties in obtaining financing; potential development of alternative or more effective products by competitors; reliance on thir...

Bionovo Appoints Dr. Klaus Kohl as Chief Technical Officer

...ganization to meet with partnering and commercialization standards." Dr. Kohl's most recent position was as Vice President of Program Management, cmc and Regulatory Affairs at Novo Nordisk Delivery Technologies, where he was responsible for the development of an inhaled insulin drug/device combinati...

Dr. Chris Huber Joins Asymchem Laboratories Inc. as Director of Chemical Development

... serving the pharmaceutical industry. With a 14yr track record, Asymchem is committed to the highest level of quality and excellence in the integrated cmc services arena. For further information, please visit the Asymchem website at www.asymchem.com . ...

Savient Announces New Date for FDA Arthritis Advisory Panel Review of KRYSTEXXA(TM) for Treatment Failure Gout

...g development of KRYSTEXXA and developing other product candidates; our stock price and market conditions; varying interpretations of our clinical and cmc data by the FDA; delay achieving or failure to achieve FDA approval of KRYSTEXXA; inability to manufacture commercial quantities of our products; inab...

Savient Pharmaceuticals Reports First Quarter 2009 Financial Results

...g development of KRYSTEXXA and developing other product candidates; our stock price and market conditions; varying interpretations of our clinical and cmc data by the FDA; delay achieving or failure to achieve FDA approval of KRYSTEXXA; inability to manufacture commercial quantities of our products; inab...

World Micromachine Summit highlights technologies impacting energy and the environment

...new energy sources or the means to propel molecules of medicine to targeted disease sites," says Dan Gale, Chair of the Micromachine Summit and CTO of cmc Microsystems. Micromachining techniques at the 1 - millionth of a meter scale are used to manufacture a range of mechanical devices that can become ...

Disability and Poor Quality of Life Associated With Treatment Failure Gout Patients

...g development of KRYSTEXXA and developing other product candidates; our stock price and market conditions; varying interpretations of our clinical and cmc data by the FDA; delay achieving or failure to achieve FDA approval of KRYSTEXXA; inability to manufacture commercial quantities of our products; inab...

China Breaks Ground on Largest Comprehensive Stem Cell Storage and Processing Facility

... and occupying more than 20 square kilometers, the cmc district enjoys investment privileges as well as f...m the local, provincial and national governments. cmc is quickly becoming a world center for biotechnolo...and support in one location. Businesses located in cmc carry out a range of manufacturing and support ser...

ChemDiv Group Acquires Prudentas Through ChemRar High Tech Center

...versity Research Institute subsidiary, and our other discovery services holdings such as Drugs Technology Ltd., which provides GLP/GMP formulation and cmc services. We believe Prudentas will help us bring unique levels of clinical development productivity to pharma and biotech partners through risk mitig...
CMC in Biological Products

Big CHAP, Deoxy from Calbiochem

Description:... in anion exchange chromatography on DEAE-cellulose. Aggregation number: 8-16. Purity: ≥95% by HPLC. Soluble in H 2 O. Aggregation number 8 - 16, cmc 1.1 - 1.4 mM. CAS 86303-23-3, M.W. 862.1. ...
Company:Calbiochem

DDMAB from Calbiochem

Description:...e arm. More efficient for the extraction of mycoplasma membrane antigens under mild conditions than DDMAU. Purity: ≥98% by TLC. Soluble in H 2 O. cmc 4.3 mM. M.W. 299.5. References:Brenner, C., et al. 1995. Anal. Biochem. 224, 515; Chevalier, Y., et al. 1991. Langmuir 7, 848....
Company:Calbiochem

MEGA-9, ULTROL® Grade from Calbiochem

Description:...roperties. Can be readily removed by dialysis. Useful reagent for membrane research. Purity: ≥98% by HPLC. Absorbance (10%, H 2 O, 260 nm): 2 O. cmc 19 - 25 mM. CAS 85261-19-4, M.W. 335.5. ...
Company:Calbiochem
CMC in Biological Definition

Lipid

...the second critical micelle concentration (CMC-II) into elongated pipes, and at the lamellar point (LM or CMC-III) into stacked lamellae of pipes. The cmc depends on the chemical composition, mainly on the ratio of the head area and the tail length. Lipid bilayers form the foundation of all biological...
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(Date:12/22/2014)... 2014 Xarelto Lawsuit News : ... judges has granted a request to centralize pending and ... Court, Eastern District of Louisiana. The U.S. Judicial Panel ... 12 to transfer over 50 Xarelto cases–21 lawsuits and ... Louisiana court for consolidation under U.S. District Judge Eldon ...
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(Date:12/10/2014)...  Valencell, a leader in performance biometric data sensor ... from its licensees for highly accurate, clinically validated biometric ... coming from fitness and health sectors, but first responders/military ... is only as useful as the biometric data it ... in long-term mass consumer adoption of wearable products," said ...
(Date:12/10/2014)... December 9, 2014   ... Platform   Jifflenow, ... scheduling solutions for business-to-business (B2B) events, today announced ... in mobile near-field communication (NFC), Bluetooth low energy ... (Logo: http://photos.prnewswire.com/prnh/20140612/691055) , Jifflenow will integrate ...
(Date:12/3/2014)...   Marvin Test Solutions , a trusted ... military, aerospace, and manufacturing organizations, today announced the ... TS-900 PXI semiconductor test platform . The TS-960 ... to customers at a fraction of the footprint ... "Our semiconductor customers asked for ...
Breaking Biology News(10 mins):Wearable Technology Products Demand Highly Accurate Biometric Technology 2Jifflenow And ITN International Bring Cutting-Edge Badge Scanning Technology To B2B Events 2Jifflenow And ITN International Bring Cutting-Edge Badge Scanning Technology To B2B Events 3Marvin Test Solutions Brings New Capabilities to PXI-Based Semiconductor Test with TS-960 2Marvin Test Solutions Brings New Capabilities to PXI-Based Semiconductor Test with TS-960 3
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