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Abbott Laboratories (Abbott Park, IL) and AstraZeneca (London) received a complete response letter (CRL) from the US Food and Drug Administration for their new drug application for Certriad (rosuvastatin/fenofibric acid delayed release) capsules. The companies are evaluating the CRL and said they would respond to the agency’s request for additional information.
Avid Bioservices (Tustin, CA), a provider of current good manufacturing practice (CGMP) manufacturing services for the biotechnology and biopharmaceutical industries, expanded its commercial-supply relationship with the biopharmaceutical company Halozyme Therapeutics (San Diego). Halozyme designated Avid a preferred supplier for future products requiring Avid's process-development and biomanufacturing capabilities and expertise. Avid has manufactured commercial products for Halozyme since 2005 in the company's CGMP facility. Financial terms were not disclosed.
Boehringer Ingelheim (Ingelheim, Germany) launched its corporate venture capital fund, the Boehringer Ingelheim Venture Fund (BIVF). The company said BIVF wll invest in biotech and startup companies that provide therapeutic approaches and technologies to help drive innovation in medical science.
The contract analytical services provider Celsis Analytical Services (Chicago, IL) expanded the analytical chemistry capabilities of its accredited current good manufacturing practice laboratories to include mass spectrometry and ion chromatography.
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The US District Court for the Southern District of Indiana upheld the validity of Eli Lilly’s (Indianapolis, IN) compound patent on Gemzar (gemcitabine HCl for injection), which maintains Lilly's US exclusivity for Gemzar through November 15, 2010. In a separate case, a second patent for Gemzar, related to its FDA-approved uses, has a 2013 expiration date and was ruled invalid by the US District Court for the Eastern District of Michigan. Lily is appealing that decision.
GlaxoSmithKline (London) and Isis Pharmaceuticals (Carlsbad, CA) formed a strategic alliance to apply Isis’ antisense drug-discovery platform to seek out and develop new therapeutics against targets for rare and serious disease, including infectious diseases and some conditions causing blindness. The alliance covers six programs and Isis will receive an upfront $35 million payment from GSK and is eligible to receive on average up to $20 million in milestones per program. Isis will be eligible to receive license fees and milestone payments, totaling nearly $1.5 billion, if all six program are successfully developed for one or more indications and commercialized through to pre-agreed sales targets.
Hospira (Lake Forest, IL), a specialty pharmaceutical company, completed its acquisition of Orchid Chemicals & Pharmaceuticals (Chennai, Tamil, Nadu, India) for $400 million. The newly appointed managing director of Hospira India, C.B. Rao, will oversee the 450 former Orchid employees and report to CEO Terry Kearney. The acquisition includes Orchid's beta-lactam antibiotic formulations manufacturing complex (comprising cephalosporin, penicillin, and carbapenem facilities) and pharmaceutical research and development (R&D) facility at Irungattukottai, Chennai, as well as its generic injectable dosage-form product portfolio and pipeline. In addition, the companies signed a long-term agreement for Orchid to supply active pharmaceutical ingredients for the acquired generic injectable pharmaceuticals business. The two companies also formed transitional services agreements for approximately 15 months to support various alliances and distribution arrangements of the acquired business.
The drug discovery and development company MDRNA (Bothell, WA) announced a study effort with Pfizer (New York). The study effort will focus on the evaluation of MDRNA's proprietary di-alkylated amino acids (DiLA2) platform and UsiRNA constructs for RNA interference. In other news, MDRNA signed a definitive agreement to acquire Cequent Pharmaceuticals (Cambridge, MA), a biopharmaceutical company, in an all stock transaction valued at approximately $46 million.
The biopharmaceutical company Medivation (San Francisco) announced plans to reduce its workforce and operating costs in order to focus on prioritized-dimebon trials and the continued development of MDV3100, a drug candidate for treating prostate cancer. The company will reduce the number of staff by 23, or approximately 20%. The reduction is effective March 29, 2010.
Merck & Co. (Whitehouse Station, NJ) announced that Zegerid OTC (omeprazole 20 mg/sodium bicarbonate 1100 mg capsules) for treating frequent heartburn will be available in drug stores, grocery stores, mass merchandisers, and club stores nationwide. The drug, a proton pump inhibitor, was approved by FDA for over-the-counter use in December 2009.
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The bioscience company Penn Pharma (Tredegar, UK)) started construction on a cold-storage facility at its good manufacturing practice warehouse in South Wales. The facility is scheduled to be completed by June 2010.
The contract research organization Ricerca Biosciences (Concord, OH) announced a business-development agreement with Life Science Partner (LSP, Tokyo). LSP was granted the ability to market the full spectrum of services offered by Ricerca to those companies represented by LSP.
SAFC, part of the life-sciences chemical company Sigma-Aldrich (St. Louis), announced the opening of a $30-million expansion to its manufacturing facility in Verona, Wisconsin. The expansion is designed to significantly increase SAFC’s capacity to produce commercial-scale high potency active pharmaceutical ingredients.
sanofi-aventis (Paris) settled US patent-infringement lawsuits related to generic versions of Eloxatin (oxaliplatin) with certain defendants involved in the litigation. Sanofi and Debiopharm (Lausanne, Switzerland), licensor of the involved patent rights, signed settlement agreements with generics makers Teva Pharmaceuticals (Jerusalem), Fresenius Kabi (Bad Homburg Germany), and Sandoz (Holzkirchen, Germany). Under terms of the settlement, the generic manufacturers will cease selling their generic oxaliplatin products on June 30, 2010, and will resume selling generic oxaliplatin products on August 9, 2012, under a license to re-enter the market.
Simcere Pharmaceutical Group (Nanjing, China), which specializes in the development, manufacturing, and marketing of branded-generic and proprietary pharmaceuticals, reported that China's State Food and Drug Administration (SFDA) issued a statement on its investigation into the human-use rabies vaccine manufactured by Jiangsu Yanshen Biological Technology Stock Co., of which Simcere has an interest. SFDA found that the four batches of human-use rabies vaccine manufactured by Jiangsu Yanshen and released had an insufficient amount of the active compound. The responsible employees of Jiangsu Yanshen are under criminal investigation.
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to ptpress@advanstar.com |
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| The US Food and Drug Administration will begin requiring device manufacturers to provide information in certain premarket applications regarding “pediatric patients who suffer from the disease or condition that the device is intended to treat, diagnose, or cure, even if the device is intended for adult use.” The new rule stems from the 2007 FDA Amendments Act. “Very few devices are developed or assessed specifically for use in pediatric patients, those 21 or younger at the time of treatment or diagnosis. This effort will provide a better understanding of which devices developed for use in adults should be assessed or modified for use in pediatric populations,” according to an FDA press release on the rule, which will also help the agency track approved devices that could benefit pediatric patients. See FDA’s Center for Devices and Radiological Health—Pediatric Medical Devices for more information.
FDA has published two new guidances for industry based on the Step-4 version of the International Conference on Harmonization’s (ICH) Q4B Annexes 7 and 9. The Q4B guideline covers the Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions. Annex 7 addresses dissolution testing and Annex 9 addresses tablet friability. The ICH steering committee adopted the two annexes last October. The FDA guidances allow industry to use the US Pharmacopeia, European Pharmacopeia, and Japanese Pharmacopeia interchangeably for these tests, although FDA can require exceptions at any point. For example, the FDA guidance for Annex 7 does not allow dissolution tests that involve enzymes; delayed-release, gastroresistant, or enteric-coated dosage forms; or large vessels to be interchangeable with the other pharmacopeial requirements. In October 2009, ICH also adopted Annex 10 on polyacrylamide gel electrophoresi, which FDA is expected to publish soon. It is the responsibility of each regulatory ICH member (FDA, EU, and MHLW) to publish approved ICH guidelines for its own region in an effort to harmonize standards.
FDA approved a new formulation for OxyContin that is designed to discourage misuse and abuse of the drug. “Because of its controlled-release properties, each OxyContin tablet contains a large quantity of oxycodone, which allows patients to take their drug less often. However, people intent on abusing the previous formulation have been able to release high levels of oxycodone all at once, which can result in a fatal overdose and contributes to high rates of OxyContin abuse,” according to an FDA press release. “The reformulated OxyContin is intended to prevent the opioid medication from being cut, broken, chewed, crushed or dissolved to release more medication.” Purdue Pharma (Stamford, CT), the manufacturer, will have to conduct a postmarket study on the new formulation and its effect on abuse and misuse. FDA published a list of recently approved Risk Evaluation and Mitigation Strategy (REMS) plans. Manufacturers provide the information in compliance with as part of the 2007 FDA Amendments Act.
Acting at the request of FDA, US Marshals seized several consumer products from Beehive Botanicals (Haywood, WI) last week for misbranding violations of the Federal Food, Drug, and Cosmetic Act. Products included creams, capsules, tablets, gum, throat spray, and shampoos. The company’s website made claims about the products' ability to diagnose, cure, and prevent diseases such as asthma, dermatitis, and ulcers, or about the products' antibiotic or antiviral properties, according to a Mar. 3, 2010 FDA press release. FDA issued a Warning Letter to the manufacturer in March 2007 regarding its marketing and promotional materials. |
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The biotechnology company Genzyme (Cambridge, MA) created the position of chief operating officer and appointed executive vice-president David Meeker to the position.
Ranbaxy Laboratories (New Delhi) plans to hire approximately 1500 marketing
executives. The move will expand the company's sales team by at least 50%,
according to various industry sources.
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Healthcare Reform and Pharma
How do you think the recently passed healthcare reform law will affect the pharma and biotech industries?
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Robotic inhaler tester increases productivity
