|
 |
  |
 |
|
Cleveland BioLabs (Buffalo, NY) received a $45-million federal grant from the US Department of Defense (DoD) Chemical Biological and Medical Systems (CBMS) Medical Identification and Treatment Systems (MITS) to develop and stockpile its investigational drug CBLB502 as a medical radiation countermeasure. Under the terms of the contract, the CBMS-MITS will provide $14.8 million for Cleveland BioLabs' development of CBLB502 through US Food and Drug Administration approval, after which the grant allows for the purchase of $30,000,000 worth of troop-equivalent doses.
DSM BioSolutions (Delft, The Netherlands), DSM’s microbial fermentation contract manufacturing organization business unit, and PolyTherics (London), a company focused on engineering proteins, entered into an agreement for the process development and manufacture of PolyTherics’ lead biobetter product, HiPEG IFN α-2a. PolyTherics has applied its HiPEG site-specific PEGylation technology to interferon alpha to produce a product (HiPEG IFN α-2a) that has eight-fold higher activity than a marketed PEGylated interferon in vitro and a comparable half-life in a preclinical study. DSM has successfully started development, scale-up, and manufacture of the recombinant his-tagged IFN α-2a, and the companies will work toward producing sufficient material for preclinical and clinical development.
In other DSM news, DSM Pharma Chemicals (Parsippany, NJ), a business unit of DSM Pharmaceutical Products, launched its InnoSyn route-scouting services. The services can identify potential reductions of synthesis steps or redesigns of synthesis routes.
Advertisement:
Comply with ICH guidelines on impurities in new drug products!
The Agilent 2100 Bioanalyzer plus High Sensitivity Protein 250 kit automatically detects and quantifies protein impurities down to 0.05% - meeting ICH guideline Q3B(R2)!
 Request Agilent’s Protein QC Application CD! |
Elan (Dublin) held a meeting of its board of directors and members unanimously accepted a report prepared by the United States law firm of McKenna Long & Aldridge based upon a review it conducted, according to an Elan press release. McKenna Long, serving as independent counsel to the board, reviewed a number of matters brought to the board's attention by certain directors and found no legal breaches or other wrongdoing of any nature by Elan management, any member of its board, or its advisors. Directors Vaughn Bryson and Jack Schuler have expressed their satisfaction with the outcome of the McKenna process and plan to resign from the board. They will do so within 90 days, upon the election of a new chairman or otherwise at the request of the chairman, according to the press release.
Forest Pharmaceuticals (New York) has agreed to plead guilty to charges relating to obstruction of justice, the distribution of Levothroid, which at the time was an unapproved new drug, and the illegal promotion of Celexa for use in treating children and adolescents suffering from depression, according to a press release from the US Department of Justice. Forest also agreed to settle pending False Claims Act allegations that the company caused false claims to be submitted to federal healthcare programs for the drugs Levothroid, Celexa, and Lexapro. As a result, Forest has agreed to pay more than $313 million.
Advertisement:
Fogging is no substitute for cleaning.
A thorough cleaning and a Spring clean must be performed prior to any fogging actions. If there is gross contamination ñ e.g. dust or covered surfaces ñ then the efficacy of the fogging will be severely reduced. It should also be noted that certain bacteria can remain viable in dust for long periods. Hence, for fogging decontamination to work well, the rooms should be subject to a Super and Spring clean. It is not possible to over-emphasize the importance of thorough cleaning of the room prior to the fogging process.
 Click here for more information.
|
Galapagos (Mechelen, Belgium) will acquire GlaxoSmithKline’s (GSK, London) research center in Zagreb, Croatia. Galapagos will provide research and development services to GSK under a three-year fee-for-service contract for EUR 14 million ($18.6 million). The acquisition arrangement provides for ongoing employment of the 130 staff. Further terms were not disclosed.
Genmab (Copenhagen) and Seattle Genetics (Bothell, WA) formed an antibody-drug conjugate (ADC) research collaboration pact. Under the agreement, Genmab may use Seattle Genetics’ ADC technology with its HuMax-TF antibody targeting the Tissue Factor antigen, which is expressed on numerous types of solid tumors. Seattle Genetics received an undisclosed upfront payment and has the right to exercise a codevelopment option for any resulting ADC products at the end of Phase I clinical development.
GlaxoSmithKline (GSK, London) and Genmab (Copenhagen) will shift the formulation and drug-delivery strategy of ofatumumab in autoimmune indications. After review of the program, GSK will focus development efforts on the subcutaneous delivery of ofatumumab in autoimmune indications and will stop further development work on the intravenous route of administration in autoimmune disease.
Advertisement:
Shimadzu
Powerful, Easy-To-Use X-ray Diffractometers Shimadzu's X-ray Diffractometers (XRD) feature a polycapillary parallel-beam optics system, which allows highly sensitive and accurate measurements of samples with curved or irregular surfaces. In addition, with fast measurements, high stability, easy operation, and advanced control, analysis and reporting software, our XRDs enable routine identification and quantification of a number of samples - even for beginners.
Learn more at  www.ssi.shimadzu.com/MT |
Biotechnology company Gentronix (Manchester, UK) partnered with Charles River Laboratories (Wilmington, MA), a preclinical contract research organization, to offer BlueScreen HC Screening services for the early detection of genotoxicity. The services are designed to offer accurate, low-compound use and rapid results generation to identify genotoxic problem compounds earlier in discovery and preclinical development.
L.B. Bohle (Warminster, PA) opened its US service center in Warminster, Pennsylvania. The center provides demonstration and training on operation of tablet-coating equipment, containment applications, process development and optimization, blending, milling, and more. The center will also accommodate workshops and seminars.
RTS Life Science (Manchester, UK), a supplier of automated sample management and pharmaceutical testing systems, formed a new Pharmaceutical Testing Group. The group will focus on products for inhaler and tablet testing as well as dissolution and content-uniformity testing.
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to ptpress@advanstar.com |
|
|
 |
|
AAIPharma Services (Wilmington, NC), a provider of pharmaceutical product-development services, appointed Philippe M. Maitre executive vice-president and chief financial officer. Maitre was previously chief financial officer at Oscient Pharmaceuticals (Waltham, MA), a commercial-stage pharmaceutical company.
Agios Pharmaceuticals (Cambridge, MA), a biopharmaceutical company, appointed Scott Biller as its chief scientific officer. Biller joins Agios from Novartis Pharmaceuticals (Basel), where he was vice-president and head of global discovery chemistry at the Novartis Institutes for BioMedical Research.
Jeffrey A. Winton was named vice-president of communications at Eli Lilly (Indianapolis), effective Oct. 11, 2010. Winton will report to Bart Peterson, senior vice-president of corporate affairs and communications.
Kite Pharma (Los Angeles), a biopharmaceutical company focused on developing immunotherapies for cancer, named Aya Jakobovits its president and CEO.
Advertisement:
CBI Supplier Audits
IVT's Life Sciences Forum on Supplier Audits - November 15-17, La Jolla, CA Ensure GxP Compliance for Supplier Quality and Management. Attend this event and have an opportunity to hear case studies, identify best practices and openly discuss industry standards that ensure appropriate supplier quality oversight.
Register today at
 www.ivtevents.com/supplieraudits
and save $300 with promo code DSG382! |
Mallinckrodt Baker (Phillipsburg, NJ) appointed Robert Harrer executive vice-president, chief financial officer, and chief administrative officer. Harrer will oversee the company’s financial operations as well as its information technology, human resources, legal department, and global shared services.
Contract research organization Velesco Pharmaceutical Services (Plymouth, MI) appointed Shirley Smith director of quality and Yuan Chen senior pharmaceutical scientist.
|
|
The US Pharmacopeial Convention (USP) is transitioning the Pharmacopeial Forum (PF) to a free, online resource as of January 2011. The forum includes proposals for new and revised standards for the official United States Pharmacopeia–National Formulary (USP–NF). The new PF will include only proposals for which USP is seeking public comment, making it easier for users to identify and respond to these proposals, according to a USP press release on the subject. For example, the new version will include articles about standards development, how to use PF, in–process revision, proposed interim revision announcements (IRAs), Pharmacopeial Discussion Group harmonization proposals (Stage 4), and Stimuli articles.
Some items that are currently published in PF will not appear in the new free online version. However, they will be made publicly available on USP’s website. These include policies and announcements, final IRAs, IRA reference standard information, Errata, previous PF proposals still pending, and canceled proposals. The new PF will provide a list of links noting where to find these relocated items.
PDA and ISPE are hosting a Washington, DC-based ICH workshop Oct. 6–8, 2010, covering implementation of the quality trio, Q8 Pharmaceutical Development, Q9 Pharmaceutical Risk Management, and Q10 Pharmaceutical Quality System. The workshop will feature members of the ICH Quality Implementation Working Group, including representatives from FDA and EMA, and include breakout sessions on design space, control strategy, quality system, and risk management. Industry is encouraged to attend.
The International Pharmaceutical Supply-Chain Consortium, Rx-360, received good news last week when the Federal Trade Commission said it would not recommend challenging industry’s plans to implement joint supplier and audit programs. Rx-360 has been working for the past 18 months to encourage the sharing of information about supplier audits throughout the global pharmaceutical manufacturing industry. |
|
|
|
|
 |
| Statistical Solutions: Visual Inspection Goes Viral |
|
Lynn D. Torbeck
To properly inspect based on measurement, a reference standard is crucial for comparison.
Coming Soon: A supplement to Pharmaceutical Technology’s October issue focuses on analytical technology. |
|
|
|
|
|
|
Pharma Packaging
What is the most important feature of pharma secondary packaging?
|
View the poll archive. |
|
|
|
Reporting software offers analytical capabilities
