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 Disposable bioreactor provides operational flexibility
EMD Millipore’s (Billerica, MA) Enhanced Mobius 3L CellReady single-use bioreactor includes additional features intended to enhance its operational flexibility. The unit’s headplate now incorporates a septum injection port for small-volume additions. The bioreactor also incorporates a subsurface fluid inlet–outlet port appropriate for operations such as perfusion, sampling, cell retention, and inoculation. In addition, the Enhanced CellReady bioreactor includes a sensing port for monitoring parameters such as carbon dioxide and viable cell density.
The CellReady 3L bioreactor exhibits cell-culture performance and physical-characterization properties (e.g., kLa values, heating profiles, and mixing times) similar to those of traditional glass bioreactors. EMD Millipore manufactures the device with lot-to-lot consistency to reduce the risks of improper assembly and help bring consistency to customers’ processes. The unit’s results can be scaled up to 15-L glass and 2000-L stainless-steel systems. The fully assembled, gamma-irradiated bioreactor has been designed to work with most existing benchtop bioreactor controllers. |
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Bayer HealthCare Pharmaceuticals (Leverkusen, Germany) and biopharmaceutical company EndoCeutics (Québec), formed a collaborative agreement for Phase III development and marketing of Dehydroepiandrosterone (DHEA), a treatment for vaginal atrophy and female sexual dysfunction. Bayer will pay up to CAD $330 million dollars ($325 million) in milestone payments and research costs, plus royalties on product sales.
Elan Drug Technologies (Athlone, Ireland), a business unit of Elan Corporation, launched its Manufacturing Services business. Services include drug-product optimization, scale-up, and commercial-scale manufacturing of solid oral dosage forms.
GlaxoSmithKline (GSK, London) took an 18% minority equity stake in Convergence Pharmaceuticals (Cambridge, UK), a new biotechnology company that will focus on the development of analgesic compounds. Under the terms of the agreement, Convergence Pharmaceuticals has acquired two clinical-stage assets from GSK that target voltage-gated ion channels. In return, Convergence Pharmaceuticals has issued shares to GSK to the value of $4.7 million. GSK will also be eligible to receive additional shares on completion of asset milestones. In addition, GSK has taken up an observer role on the board of Convergence Pharmaceuticals.
Human Genome Sciences (HGC, Rockville, MD) and Novartis (Basel) decided to halt development of 900-mcg Zalbin (albinterferon alfa-2b, known in Europe as Joulferon), dosed every two weeks for the treatment of chronic hepatitis C, after receiving a Complete Response Letter from the US Food and Drug Administration regarding the company’s biologics license application for the drug.
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Immunovaccine (Halifax, Canada), a vaccine developer, and biotechnology company IRX Therapeutics (New York) entered into a preclinical research collaboration to evaluate the combination of IRX's primary cell-derived biologic, IRX-2, and Immunovaccine’s DepoVax-based therapeutic cancer vaccines. The research aims to demonstrate that the combination of the two technologies generates a superior anti-tumor immune response, according to a company press release.
Biotechnology company Isogenica (Cambridge, UK) formed a pact with NovaBiotics (Aberdeen, UK), a clinical-stage biotechnology company, to fast-track the development of NovaBiotics’ platform peptide anti-infective technology. As part of the agreement, the companies will collaborate on two research projects, one concerning peptide selection and the other concerning peptide maturation with the aim of expanding Novabiotic’s product portfolio.
Medivir (Huddinge, Sweden), a speciality pharmaceutical company focused on infectious diseases, named healthcare company Luxembourg Pharmaceuticals (Caesarea, Israel), as the exclusive distributor for Xerclear (acyclovir and hydrocortisone cream), Medivir’s treatment for recurrent cold sores, in Israel and the Palestinian Authority. Under the terms of the agreement, Luxembourg Pharmaceuticals will be responsible for obtaining regulatory approval, marketing, sales, and distribution of the drug.
Novartis Pharmaceuticals Corporation, a US subsidiary of Novartis AG (Basel), reached a resolution with the US Attorney's Office for the Eastern District of Pennsylvania regarding the previously disclosed investigation into civil and criminal allegations of the off-label promotion of Trileptal (oxcarbazepine) as well as civil allegations relating to five other products: Diovan (valsartan), Exforge (amlodipine and valsartan), Sandostatin (octreotide acetate), Tekturna (Aliskiren), and Zelnorm (Tegaserod). Under the agreement, the company will pay a total of $422.5 million in criminal and civil claims. In addition, the company will enter into a Corporate Integrity Agreement with the Office of the Inspector General of the US Department of Health and Human Services as part of the settlement.
Pfizer (New York) discontinued its Phase III trial evaluating Sutent (sunitinib malate) in combination with prednisone for men with advanced castration-resistant prostate cancer that had progressed despite treatment with a docetaxel-based chemotherapy regimen. During a scheduled interim analysis, an independent Data Monitoring Committee found that the combination of sunitinib with prednisone was unlikely to improve overall survival when compared to prednisone alone.
Speciality European Pharma (SEP, London), a specialty pharmaceutical company focused on urology, acquired the cancer drug Mitem, a powdered form of mitomycin currently sold in Germany, from Curasan (Kleinostheim, Germany). SEP will obtain German distribution rights and plans to introduce the product into other European markets after obtaining regulatory approval.
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to [email protected] |
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3-V Biosciences (Menlo Park, CA) appointed Merdad V. Parsey as its CEO. Parsey previously held positions of increasing responsibility at Genentech, a member of the Roche Group (Basel), most recently as senior group medical director in the company's research and early development sector.
Accera (Broomfield, CO), a biotechnology company, appointed Thomas Werner president and CEO. Werner was elected to Accera's board of directors in March 2009.
Philip Pratten joined Elan (Dublin) as vice-president of its newly launched manufacturing-services operations.
Hospira (Lake Forest, IL), a global specialty pharmaceutical company, named Svend Andersen corporate vice-president and president of the company’s European, Middle East, African business. Andersen will report to Ron Squarer, senior vice-president and chief commercial officer, effective Nov. 1, 2010.
NGM Biopharmaceuticals (South San Francisco, CA), a biotechnology company focused on treatments for Type 2 diabetes and other metabolic diseases, named William J. Rieflin as its CEO and appointed him to the company’s board of directors.
NormOxys (Wellesley, MA), a biotechnology company, appointed Gerard (Rod) Riedel vice-president of regulatory affairs and program management. Riedel will work to advance the company’s lead drug candidate, OXY111A, an allosteric modulator of affinity of oxygen to hemoglobin, which is currently being evaluated in clinical studies as a treatment for cardiovascular diseases and cancers.
Jacques Banchereau joined Roche (Basel) as senior vice-president and head of the inflammation and virology discovery and translational areas. Banchereau will relocate to the Roche research and development site in Nutley, New Jersey. He also will serve as Roche Nutley's chief scientific officer. |
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FDA will hold a two-day public hearing Nov. 2–3, 2010, in Silver Spring, Maryland, on the implementation of the Biologics Price Competition and Innovation Act of 2009, part of the healthcare reform legislation signed by President Obama last year. The Act “would establish an abbreviated approval pathway for biological products that are demonstrated to be highly similar (biosimilar) to, or interchangeable with, an FDA-licensed biological product,” according to an FDA news release about the meeting. The hearing is meant to obtain feedback on the Act’s implementation, especially regarding any potential scientific and technical challenges associated with the larger molecular structure and manufacturing of biological products, says the notice.
FDA also has announced nearly $3 million in grants for tuberculosis (TB) research as part of its Critical Path initiatives. The grants are supporting six research projects aimed at the diagnosis, treatment, and prevention of TB, which “remains a major public health challenge with an increasing prevalence worldwide,” according to the agency's announcement. Two recent articles published by FDA’s Office of Critical Path Programs note that “advances are urgently needed in TB drug development to shorten therapy and to treat drug-resistant disease.” The grantees are listed on the FDA website.
Rx-360, the international pharmaceutical supply-chain consortium, has elected a new board of directors. The new leadership will begin their terms on Jan. 1, 2011. Taking over the chairmanship, which has been held by Martin Van Trieste of Amgen, will be Lynne Byers of GlaxoSmithKline. Vice-chair will be Al Kentrup of Pfizer. A full list of board members and their representative bio/pharmaceutical companies are listed on the Rx-360 website.
This week, in Bethesda, Maryland, ISPE and PDA will co-host a workshop on the implementation of pharmaceutical development, risk management, and quality systems as part of the ICH quality-trio workshop series. 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 and PharmTech will be blogging from the event at blog.PharmTech.com. |
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Small-Molecule Outsourcing
Did your company increase its level of outsourcing for small-molecule (i.e., chemical) development and manufacturing in 2010 compared with 2009?
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