Tag Archives: Pharmaceuticals

GenQual Announces Initial Closing Of Its First Preferred Equity Funding Round

Released on: November 22, 2011, 10:55 am
Author: Jonathan Mirich
Industry: Biotech

GenQual announces initial closing of its first preferred equity funding round

November 22, 2011– GenQual is pleased to announce initial closing of its first preferred equity round. Financial terms were not disclosed. This inaugural funding round allows GenQual to pursue proof-of-principle testing for its companion diagnostic approach for IL-6 mAb and other JAK/STAT inhibitors for autoimmune diseases and oncology indications. GenQual aims to prospectively identify responders for clinical-stage therapeutics to improve drug trial response rates and improve chances for drug approval. The round remains open for further funding.

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Global Health Progress Releases New Report that Features Innovative Solutions to Improve Access to Healthcare in India

Released on: July 24, 2010, 3:09 am
Author: Global Health Progress
Industry: Healthcare

Global Health Progress’ recently released report, Innovative Solutions to Improving Health in India, summarizes how the organization is committed to building sustainable, innovative solutions to secure access to healthcare for all Indian communities.

The report notes that access to healthcare remains problematic in parts of India, especially in rural areas. For instance, forty percent of the country’s primary healthcare centers are understaffed and fewer than one in five have a telephone connection. Nearly one million Indians die every year due to inadequate healthcare facilities and lack of access to healthcare. Without qualified health care professionals and fully equipped health facilities, programs to assist patients with medicines (both patented and unpatented) are of little use.

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NAICONS and NexThera Transfer Rights Of NAI-107, A New Anti-MRSA Antibiotic, To Sentinella Pharmaceuticals


Released on: January 19, 2010, 5:46 am
Author: NAICONS – NexThera
Industry: Pharmaceuticals

Milano, Italy, January 19th, 2010 – NAICONS (New Anti-Infectives CONSortium) and NexThera Biosciences, Italian companies focusing on the discovery and development of novel anti-infective drugs, today announced that they have entered into an agreement with Sentinella Pharmaceuticals, Inc., a US-based pharmaceutical company established by Care Capital LLC, a leading life sciences venture capital firm. Under the terms of the agreement, Sentinella has acquired all rights to NAICONS’ proprietary lantibiotic technology, including its lead product candidate NAI-107, in exchange for an upfront cash payment, future development and commercialization milestones, royalties on future product sales and an equity stake in Sentinella. Lantibiotics represent a new class of natural products with potent bactericidal activity against gram positive bacteria including the multi-drug resistant pathogens MRSA and VRE.

“This agreement represents an important recognition of NAICONS’s ability to discover and characterize innovative antibiotics with a novel mechanism of action”, stated Stefano Donadio, NAICONS’ Chief Scientific Officer. “Our technology is based on fermentation products and includes strong expertise in manipulating antibiotic-producing bacterial strains. This agreement further supports NAICONS’ mission of rebuilding the strong and successful Italian tradition in the antibiotic field.”

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Senior Director of Biotechnology at Catalent To Lead Immunogenicity Course

Released on: December 03, 2009, 01:28 pm
Author: Jennings and Co.
Industry: Pharmaceuticals

Ana T. Menendez, Ph.D., Senior Director of Biotechnology at Catalent Pharma Solutions, will lead a two-day international course on immunogenicity. The course will take place at the Regus Victoria in London on Wednesday, December 2 through Thursday, December 3, 2009.

The interactive course, titled “Introduction to Immunogenicity,” will enable attendees to better understand ways to detect, reduce and characterize unwanted immunogenicity. Additionally, Menendez will aid in interpreting the latest regulatory guidelines, and will assist attendees in formulating a winning strategy to implement in their business immediately.

The sessions will include a formal presentation by Menendez followed by facilitated breakout groups where delegates will be given the opportunity to apply the principles taught in the sections. Case studies, cut-point exercises and protocol workshops will increase the participants’ hands-on experience in developing and validating sensitive and rugged methods to detect and characterize unwanted immunogenicity.

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Senior Director of Biotechnology at Catalent To Present Course on Bioassays

Released on: November 11, 2009, 12:57 am
Author: Jennings and Co.
Industry: Pharmaceuticals

Ana T. Menendez, Ph.D., Senior Director of Biotechnology at Catalent Pharma Solutions, will be leading a course in Bioassay Method Development and Validation. The course is being offered through IBC Life Science on November 12-13, 2009 in Boston, MA.

Menendez will present a lecture outlining sensible approaches to developing reproducible bioassays using live systems and/or biologically derived reagents. Additionally, Menendez will conduct a workshop on writing validation protocols, and will give participants hands-on experience and case studies, which will add relevance to lecture material as well as create a point of discussion. Targeted audiences are bio-analytical scientists, validation specialists, project management leaders and bioassay scientists involved in bioassay execution. Upon completion of the course, participants will receive a certificate of attendance.

Bioassays are necessary components of the biopharmaceutical development process as functional potency assays during release, stability and formulation studies. The course expands on the importance of the appropriate use of non-analytical techniques that are critical during PK/PD evaluation and measurement of systematic responses to drugs, such as immunogenicity. Also included are immunological and enzymatic methods that are widely used in the detection of biological impurities due to their increased sensitivity and specificity over analytical methods.

As part of Catalent’s Development and Clinical Services segment, Dr. Menendez is responsible for the release tests required to verify the functionality and purity of biotechnology products and the complex processes involved in their manufacture. Menendez implemented biotesting at Catalent and currently leads the following laboratories at the North Carolina Research Triangle Park facility: Cellular Technologies, Molecular Technologies, Virology and Analytical Biosafety. The expertise of the department ranges from proteins (i.e., monoclonal antibodies, enzymes, growth factors) to therapeutic viruses, bacterial vaccines and aptamers. Menendez is an international instructor on bioassay development and validation and a frequent speaker at biopharmaceutical conferences.

For more information on Catalent’s broad range of drug and biologic development services, go to www.catalent.com/development.

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Catalent Expands Capabilities In Testing For Melamine In Food And Medicinal Products

Released on: November 5, 2009, 7:51 am
Author: Jennings and Co.
Industry: Pharmaceuticals

Research Triangle Park, NC, November 5, 2009 – At a time when melamine-contamination has received global attention, Catalent Pharma Solutions continues its legacy of innovation by rapidly developing new FDA guidance-compliant tests for trace amounts of key contaminants in food and medicine. Incidents of melamine contamination in milk products, baby formula, dairy and non-dairy products manufactured in China have been widely reported, leading to product recalls and increased inspections by the FDA.

The current good manufacturing practice (CGMP) regulations require that all components (i.e. ingredients or raw materials) be tested before they are released for use in the manufacture or preparation of drug products (21 CFR 211.84). It is critical that all manufacturers determine whether they are using an at risk component for melamine contamination to manufacture or prepare a drug product.

In response to the FDA’s new guidance titled “Pharmaceutical Components at Risk for Melamine Contamination,” Catalent has successfully qualified a method for determining if suspect excipients are contamination-free to within 2.5 parts per million. The method is based on that provided by the FDA (Laboratory Information Bulletin No. 4423 “GC-MS Screen for the Presence of Melamine, Ammeline, Ammelide, and Cyanuric Acid”).

Catalent is now able to provide its customers successfully qualified and validated limits tests for trace levels of melamine, ammeline, ammelide, and cyanuric acid in lactose.

Melamine is a compound made of carbon, nitrogen and hydrogen and is typically combined with formaldehyde to produce a durable and moldable plastic that is fire and heat resistant. Trace amounts of melamine have recently been discovered to be toxic to dogs, cats, pigs, and chickens by veterinary scientists after kidney or renal failure occurred due to their food being contaminated with the chemical.

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Catalent To Present Webinar On Stabilities Studies In Pharmaceutical Development

Released on: October 30, 2009, 4:25 am
Author: Jennings and Co.
Industry: Pharmaceuticals

Catalent Pharma Solutions will host a free Webinar featuring Senior Manager, Wei Pan, Ph.D. RAC and Kathy Waddle, Director, Stability QC Biology. The one-hour Webinar will cover stability studies as a critical part of the drug development process and the vital role they play for drug product marketing approval. The Webinar, titled “Stability Studies in Pharmaceutical Development,” will be held on Friday, November 20, 2009 at 2 p.m. (EST). To register for the Webinar please visit: https://www2.gotomeeting.com/register/280747146.

The presentation will address the principles and practices of stability studies in the drug development process. Pan and Waddle will discuss the framework of the FDA cGMP guidelines as expressed in 21CFR211. Additionally, the Webinar will provide a comprehensive review of ICH and WHO stability guidelines by discussing the strategy used in stability protocols designed to support global registration.

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Catalent Develops New Decorin Molecule Form, Strikes Deal With Euclid

Released on: October 23, 2009, 7:46 am
Author: Jennings and Co.
Industry: Pharmaceuticals

SOMERSET, NJ -Catalent Pharma Solutions, a leading provider of advanced technologies and outsourced development and clinical services to the global pharmaceutical andbiotechnology industry, has announced the development of the Galacorin™ molecule, a proprietary form of the decorin molecule.

Catalent combined its proprietary GPEx® gene expression technology, Triplet-FixTM codon optimization technology and advanced scientific capabilities to greatly improve production and secretion of the GalacorinTM molecule in CHO cells. In addition, Catalent has developed a full cGMP production process for the GalacorinTM molecule.

Catalent has reached an agreement to provide the GalacorinTM molecule to Euclid Systems of Herndon, Virginia for an ophthalmic clinical trial. Financial terms of the agreement have not been disclosed. Additionally, Catalent is in the process of seeking partners for other indications.

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Senior Director of Biotechnology at Catalent To Present Industry Conferences

Released on: October 22, 2009, 3:43 am
Author: Jennings and Co.
Industry: Healthcare

RESEARCH TRIANGLE PARK, N.C.– Ana T. Menendez, Ph.D., Senior Director of Biotechnology at Catalent Pharma Solutions, will be delivering workshops this October at two industry conferences.

The first will be a pre-conference workshop at Cambridge Health Institute’s Immunogenicity Summit. The event will take place in Philadelphia on Monday, October 26, 2009. The interactive workshop, titled “Technical Advice on Assay Development,” will begin at 8:30 a.m. and will enable attendees to develop an immunogenicity pre-clinical and clinical testing protocol for a therapeutic protein.

The second presentation by Menendez will be a seminar at San Francisco’s Biologicals to Devices (B2G) conference on October 27. The workshop will be called “Effective transfer of Complex Biological Methods in the GMP Environment.”

As part of Catalent’s Development and Clinical Services Segment, Dr. Menendez is responsible for the release tests required to verify the functionality and purity of biotechnology products and the complex processes involved in their manufacture. Menendez implemented biotesting at Catalent and currently leads the following laboratories at the North Carolina Research Triangle Park facility: Cellular Technologies, Molecular Technologies, Virology and Analytical Biosafety. The expertise of the department ranges from proteins (i.e., monoclonal antibodies, enzymes, growth factors) to therapeutic viruses, bacterial vaccines and aptamers. Menenedez is an international instructor on bioassay development and validation and a frequent speaker at biopharmaceutical conferences.

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Lloydspharmacy Online Doctor Launches Online Sexual Partners Calculator

Released on: September 30, 2009, 7:30 am
Author: Lloydspharmacy
Industry: Healthcare

According to new research released by Lloydspharmacy, the typical British adult has slept indirectly with 2,811,024 people.

The leading community pharmacy chain has developed an online calculator which allows people to work out the number of indirect sexual partners they have had.

The sexual partners calculator has been developed to help people understand the risks of unprotected sex. According to the Health Protection Agency, cases of sexually transmitted infections rose last year by 0.5%, to 399,738 and cases of Chlamydia increased by eight per cent between 2006 and 2008.

The average British man claims to have had nine sexual partners while the average women claims 6.3 partners, giving an overall average of 7.65. However, as the new calculator demonstrates, they are potentially exposed to the sexually transmitted diseases of hundreds of thousands of others.

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