 |
PharmaBrand Summit 2011
June 27–June 29, 2011
Montreux, Switzerland
7th Annual Improving Solubility Summit
June 28–June 30, 2011
London, United Kingdom
Social Media in the Pharmaceutcial Industry
July 6–July 7, 2011
London, United Kingdom
Biostatistics for Non-Statisticians
July 11–July 13, 2011
Los Angeles, CA
CPhI Japan
July 13–July 15, 2011
Osaka, Japan
3rd Annual Effective Business Development Outsourcing Relationships Conference
July 19–July 21, 2011
Philadelphia, PA 
|
|
|
 |
 |
New FDA Strategy to Tackle Imports, Supply Chain
FDA released a new strategy on that is aimed at meeting the challenges posed by rapidly rising imports of FDA-regulated products and the growing complexity of the pharmaceutical supply chain.  J&J Issues Voluntary Recall of Risperdal
A subsidiary of Johnson & Johnson initiated a voluntary recall of its antipsychotic medication, Risperdal, due to an unusual odor.
FDA Study Finds Traditional Print Drug Ads Unclear
The traditional method of conveying information in the brief summary of a printed prescription-drug advertisement is neither the most comprehensible nor the most preferred by consumers, according to an FDA study.
Novartis Invests in Russia
Novartis has commenced construction of a new manufacturing plant in Russia that represents the company's most significant investment in the country to date.
|
 Instrument characterizes particles accurately
The PT-X powder-characteristics tester from Hosokawa uses Carr indices and Kawakita’s equation for compressibility to determine the flowability and floodability of dry powders. The unit provides automated vibration and includes an electronically controlled vibration sensor to ensure results’ repeatability. The PT-X instrument’s feeder was specially designed to maintain reliable sample feeding.
By reducing the amount of operator intervention required, the device helps ensure analytical accuracy and repeatability. Analysis is performed quickly through the machine’s user-friendly software, which has multilanguage functionality. Users can perform measurements by recording each test sieve’s serial number. The instrument is available with an integrated high-efficiency particulate air filter for dust protection. The instrument complies with FDA requirements and the US Pharmaceopeia recommendations for measuring tapped bulk density. In addition, compact design makes the machine 34% smaller than previous models.
Advertisement:
Seem like the only thing some contract labs are testing is your patience?
With Celsis, you get fast, accurate testing for a full spectrum of CGMP lab services performed accurately, on time and on budget. We offer compendial, non-compendial or custom methods. Raw material to container and finished product testing. We even have HPLC, LC-MS/MS, GC, IC, dissolution, AA and more. Get a quote now.  celsis.com/labs/quote |
|
|
|
 |
|
Array BioPharma, a biopharmaceutical company, is restructuring to focus on the development of its clinical programs. The company intends to advance ARRY-520, a KSP inhibitor for multiple myeloma, ARRY-614, a p38/Tie-2 inhibitor for myelodysplastic syndrome, and MEK162, an MEK inhibitor for cancer in codevelopment with Novartis. The restructuring will result in a reduction of Array's staff by approximately 20%, or 70 employees, which are primarily in discovery research and support positions.
Advertisement:
It’s all about Aptuit service. Our customers say they respect our commitment to resolving challenging issues. They will work with us again because of our ability to accomplish goals in aggressive timelines while staying on budget. They are voicing their positive response to our recent breakthrough systems, and providing even greater global service efficiencies.
Across the entire drug development continuum, it’s all about Aptuit service.
 www.aptuit.com/ItsAllAboutTheService/service.htm |
AstraZeneca plans to establish a Predictive Science Center in St. Petersburg, Russia, during the next year. The center will be staffed with 30 employees and focus on developing bioinformatics, data-analysis methods, software, and systems to help predict the safety and efficacy of potential new medicines. Earlier this year, the company began construction of a $150-million manufacturing facility in the Kaluga region to supply locally manufactured medicines in Russia.
Advertisement:
Pharmaceutical starches from Grain Processing Corporation (GPC) range from basic unmodified starches for tableting to very specialized, innovative starches for unique applications. Spress® Pregelatinized Corn Starches NF perform as binders, disintegrants and lubricants for granulations, direct-compression tablets, capsules, dry blends and roller compaction. PURE-COTE® film-forming starches are
designed for coating applications, oral thin films, capsules and any applications where clear, flexible films are required.
 http://www.grainprocessing.com |
Bioscale, a provider of protein-measurement technology, has opened a new 30,000-ft2 laboratory and manufacturing facility in Lexington, Massachusetts. The facility will house research and development, applications development, and instrument manufacturing of analytical tools used in protein research. The company also will manufacture its consumable MEMS sensor cartridges and reagents used in the analysis of proteins at the Lexington site.
Advertisement:
HPLC familiarity with UPLC performance.
For laboratories that perform routine analyses or develop methods, or simply prefer the flexibility of a multi-solvent delivery system, the only choice has been HPLC-until now.
The ACQUITY UPLC H-Class system can enable your laboratory to access the productivity and chromatographic performance of UPLC® in a system that combines the flexibility of ternary or quaternary solvent blending with the simplicity of flow-through needle injections.
 Learn More |
Bristol-Myers Squibb received FDA approval for Nulojix (belatacept), a biologic-based drug to treat organ rejection. Nulojix will be available as 250-mg lyophilized powder.
Advertisement:
Critical Path Decisions for the 4 C's in Life Sciences
Streamline production, increase cash flow, and minimize risk in your Order to Cash, Contracts, Chargebacks and Compliance processes.
Owens Minor Healthcare Logistics and CDC Software address the pains, the capabilities needed and results possible in these 4 "C" processes. Looking to upgrade your business solution? Get tips for making your buy, subscribe or outsourcing decision. Watch Now |
The contract development and manufacturing organization (CDMO) Catalent Pharma Solutions and Cevec Pharmaceuticals, a provider of human protein expression systems derived from amniocytes, are collaborating on a joint commercial cell-line development service. The service combines Cevec's human cell line, CAP-Technology, with Catalent's GPEx technology to generate high-expression, stable human cell lines.
Advertisement:
At Solvay Chemicals, we manufacture BICAR® Sodium Bicarbonate and Soda Ash IPH to meet the exacting specifications of the US and EP Pharmacopeias and National Formulary. Produced according to cGMP, these are the products of choice for API or excipient applications requiring effervescent or desiccant properties. Solvay Chemicals, Inc. is part of the Solvay Group, the leading global producer of sodium bicarbonate and soda ash.
 www.solvaychemicals.us/marketsapplications/marketshidden/0,,40615-2-0,00.htm |
Endo Pharmaceuticals, a specialty pharmaceutical company, has completed its $2.9-billion acquisition of American Medical Systems, a producer of medical devices and therapies for male and female pelvic health.
Advertisement:
TABLET PRESS REPLACEMENT PARTS SHIPPED SAME-DAY!
By stocking over 300,000 parts for nearly every press on the market, Natoli is able to provide quality parts at incredible prices, faster than anyone else in the industry. All Natoli parts are manufactured in the U.S.A. and are available for international delivery – and most items are available with same-day shipping! Browse online or request a FREE QUOTE now!
 www.natoli.com/parts |
GlaxoSmithKline has agreed to acquire the remaining 51% equity interest of Shenzhen Neptunus Interlong Bio-Technique (Neptunus), a Chinese vaccine company, in the companies' joint venture, Shenzhen GSK–Neptunus Biologicals (GSKNB), for £24 million ($39 million). After approval of this agreement by the Chinese authorities, GSK will become the sole owner of GSKNB.
Advertisement:
The latest in news and information from Bosch Packaging Technology
At our new Blog  http://boschpackagingpharmana.wordpress.com Currently on the blog 150 years of Packaging History, single-use
dosing technology updates, and a capsule filling system comparison.
|
The biopharmaceutical company Ligand Pharmaceuticals has formed a commercial supply agreement with Merck & Co. for clinical and commercial supplies of Captisol (cyclodextrin) for an undisclosed program. Pending regulatory approval, Ligand expects to deliver multiple metric tons of Captisol annually.
Sanofi has entered into a two-year research collaboration with Audion Therapeutics, a biopharmaceutical company, to develop potential treatments for hearing loss through the optimization of small molecules by using a regenerative medicine approach. This pact will use technology developed at the Massachusetts Eye and Ear Infirmary in the Eaton–Peabody Laboratory. Under the terms of the agreement, Sanofi has an option to license technology rights from Audion related to research conducted under the collaboration.
The biopharmaceutical company Synageva BioPharma and the biopharmaceutical company Trimeris have agreed to merge in an all-stock transaction. Upon closing, the combined company will be named Synageva BioPharma Corp., and will operate under the Synageva management team, with Sanj K. Patel serving as the president and CEO. In addition, the company's board of directors will have representatives from both the existing Synageva and Trimeris boards.
The biopharmaceutical company Vertex Pharmaceuticals has formed a licensing agreement with Alios BioPharma, a biotechnology company, for ALS-2200 and ALS-2158, two oral drugs to treat hepatitis C, and which are expected to enter clinical development later this year. As part of the agreement, Alios will receive a $60 million up-front payment from Vertex for the worldwide rights to ALS-2200 and ALS-2158. Vertex is responsible for development costs related to ALS-2200 and ALS-2158 and will also provide research funding to Alios. In addition, Alios would be eligible to receive research and development milestone payments up to $715 million if both compounds are approved. Vertex expects to pay approximately $35 million in development milestones in 2011. Alios is also eligible to receive up to $750 million in sales milestones on sales of all approved medicines under the collaboration. The agreement also includes tiered royalties on product sales.
Vetter Pharma, a CDMO, has installed three additional lyophilizers at the company's Ravensburg Vetter South facility in Ravensburg, Germany, doubling its number of freeze-dryers. The site is expected to produce up to 24 million lyophilized units annually, and the new equipment increases the number of lyophilizers across all Vetter facilities by 30%.
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to ptpress@advanstar.com |
|
|
|
|
|
 |
|
|
The International Conference on Harmonization (ICH) steering committee and working groups met in Cincinnati, Ohio, June 11-16, 2011. As anticipated, the Q11 draft guideline on the development and manufacture of drug substances moved to Step 2 (six-party consensus) of the harmonization process based on its concept paper. The Quality Implementation Working Group, which focuses on the Q8, Q9, and Q10 guidelines, completed documents for publication on Criticality of Quality Attributes and Process Parameters, Control Strategy, and Level of Documentation in Enhanced (QbD) Regulatory Submissions. These documents will serve to provide supplementary information to the previously completed Q&A's and training materials, according to the ICH release. With regard to global cooperation, non-ICH regulators from China, Chinese Taipei, Korea, and Singapore were nominated during the meeting to serve as expert representatives on some of the organization's expert working groups. In addition, the East African Community, which includes Kenya, Uganda, Tanzania, Rwanda, and Burundi, joined in the Global Cooperation Group's (GCC) membership. GCC is the body of ICH that works with non-ICH members to coordinate and harmonize standards. In other scientific news, a group of global regulators working in the area of cell therapy updated the ICH Steering Committee on their activities and "reported that they are exploring potential areas for future harmonization or other approaches to regulatory convergence," according to the press release on the meeting. The next ICH meeting will be held in Sevilla, Spain, Nov. 5–10, 2011. Look for a full summary from ICH representatives in the August issue of PharmTech.
FDA issued Dr. Reddy's Laboratories in Hyderabad, India, a Warning Letter earlier this month based on a November 2010 inspection of its API manufacturing plant in Morelos, Mexico. The Warning Letter, noted that the inspector found significant cGMP deviations that, under the Federal Food, Drug, and Cosmetic Act, are considered to be product adulteration, and that Dr. Reddy's Dec. 1, 2010, response letter did not adequately address the corrective actions required. Deviations included validation of analytical methods used to test APIs, incomplete cleaning validation of nondedicated manufacturing equipment, a lack of full investigations for out-of-specification data, and irresponsibility in ensuring cGMP compliance with API manufacture. Dr. Reddy's was given 15 working days to reply to FDA about the steps it has taken to correct in full these deviations.
|
 |
|
|
| |
|
|
|
|
Strategies for Emerging Markets
Do you believe that a single strategy is sufficient to meet the needs of the fragmented emerging markets?
|
View the poll archive. |
|
|
|
