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President's Budget Allocates More Funding to FDA

EMA Releases New Guidance on Stem Cell Products

Follow-on Biologics Grow in India

The US Food and Drug Administration has approved the vaccine Gardasil, manufactured by Merck and Co. Inc. (Whitehouse Station, NJ), for the prevention of anal cancer and associated precancerous lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18 in people ages 9 through 26, according to an FDA press release.

At a press conference in Edina, Minnesota, on Dec. 30, 2010, US Senator Amy Klobuchar (D-MN) urged the US Food and Drug Administration and the pharmaceutical industry to address what she called an ?unprecedented? shortage of prescription drugs, especially for chemotherapy. ?Physicians, pharmacists, and patients are currently among the last to know when an essential drug will no longer be available. That?s not right. There needs to be better coordination between the pharmaceutical industry, the FDA, and healthcare providers so patients don?t lose access to the medications they depend on,? said Klobuchar in a press release.

London-based drugmaker GlaxoSmithKline (GSK) and Immutep S.A. (Orsay, France) have signed a license agreement granting GSK exclusive worldwide rights to ImmuTune IMP731 and any other antibodies that deplete LAG-3 positive cells. IMP731 has demonstrated potency at low doses in preclinical models of T-cell mediated inflammation and could represent a new therapeutic approach to the treatment of autoimmune diseases.

US researchers say they have developed a vaccine that may someday help cocaine addicts kick their habits. The vaccine combines a segment of the common cold virus with a molecule similar to cocaine, according to a study published in the online edition of Molecular Therapy.

Amgen (Thousand Oaks, CA) and Xencor, Inc. (Monrovia, CA) will collaborate to develop XmAb5871, an Fc-engineered monoclonal antibody dually targeting CD19 and CD32b. XmAb5871 is currently in late-stage preclinical development for the treatment of autoimmune diseases.

Avila Therapeutics, Inc. (Waltham, MA) and France-based sanofi-aventis have signed a global alliance to discover targeted covalent drugs for the treatment of cancers. Under the alliance agreement, sanofi-aventis obtains a worldwide exclusive license to develop and commercialize the compounds resulting from the discovery collaboration.

Novavax, Inc. (Rockville, MD) has begun patient enrollment in a Phase 1 clinical trial to assess the safety, immunogenicity, and tolerability of a vaccine candidate against respiratory syncytial virus (RSV). In this blinded, placebo-controlled, escalating-dose study of healthy adults 18 to 49 years old, a total of 100 subjects will be allocated to four cohorts and randomized to receive vaccine treatment or saline placebo in a 4:1 ratio. It is expected that interim data from the trial will be available in the third quarter of 2011.

California-based biopharmceutical company Spectrum Pharmaceuticals will develop a biosimilar version of Swiss pharmaceutical giant Roche Holding AG's monoclonal antibody drug rituximab. Spectrum aims to achieve this through a partnership with Viropro Inc (Irvine, CA).

GlaxoSmithKline (GSK) issued a statement on Jan. 2, 2011, to respond to a 60 Minutes segment that aired on Jan 2 that focused on quality-control problems at a former GSK manufacturing facility in Cidra, Puerto Rico. The segment focused on an interview with former GSK employee Cheryl Eckard, who detailed the problems at the facility and which eventually resulted in a $750-million settlement between GSK and federal and state governments that was announced in October 2010.

Merrion Pharmaceuticals, Plc (Dublin, Ireland), a product development company, has signed an oral drug delivery feasibility and option agreement with Rebel Pharmaceuticals, LLC (Thousand Oaks, CA) for two undisclosed compounds. Rebel will evaluate the ability of Merrion?s GIPET technology to enhance the compounds? clinical profiles and provide an improved product.

The US Food and Drug Administration posted on its website the minutes of the latest meetings between the agency and industry, and among stakeholders, regarding the reauthorization of the Prescription Drug User Fee Act V. The meetings were held Nov 17-18.

Baxter International Inc. (Deerfield, IL) and Takeda Pharmaceutical Company Limited (Osaka, Japan) have completed a development, license, and technology transfer agreement. Under the terms of the agreement, Takeda and Baxter will expand on their previously announced collaboration to bring Vero cell culture-based influenza vaccines to the Japanese market. Baxter will license its proprietary Vero cell-based influenza vaccine technology exclusively to Takeda for the Japanese market.

Aushon BioSystems, Inc. (Billerica, MA), a provider of multiplex immunoassay products and services for biomarker discovery, development, and analysis, will partner with LightArray Biotech Company, Ltd. (Shanghai, China) to provide Aushon?s suite of multiplex biomarker products and services to pharmaceutical, biotechnical, and academic research institutions located in mainland China.

GE Healthcare (Uppsala, Sweden) and G-Con Manufacturing LLC (College Station, TX) will develop a modular portable bioprocess manufacturing solution for vaccines and therapeutics. This collaboration combines GE Healthcare?s global presence and expertise in biopharmaceutical manufacturing technology with G-Con?s modular portable cleanroom technology.

China and India will become the world leaders in innovation during the next decade, according to an international survey released by AstraZeneca.

Tolerx, Inc. (Cambridge, MA), a biopharmaceutical company developing novel therapies by modulating T cell activity, and the Cancer Vaccine Acceleration Fund (CVAF, New York, NY)?a nonprofit program of the Cancer Research Institute established in partnership with the Ludwig Institute for Cancer Research?have signed a research agreement to support the development of Tolerx?s drug candidate, TRX518. TRX518 is a monoclonal antibody designed to enhance the immune system by enabling T cells to more effectively attack cancer cells. It is the first anti-glucocorticoid-induced tumor necrosis factor receptor (GITR) drug candidate to enter human clinical trials.

Approvals, politics, and user fees are among the issues that make for an uneasy relationship between the US Food and Drug Administration and the life sciences industry, according to findings from a recent PricewaterhouseCoopers (PwC) survey of the industry. This survey, ?Improving America?s Health V,? the fifth such survey performed since 1995, found that although relations between the FDA and the life sciences industry have improved over time, there is still much progress to be made.

Wassim Nashabeh, PhD, the global head of technical regulatory policy and strategy at Genentech, has joined the Editorial Advisory Board of BioPharm International.

ZRG Partners (Westborough, MA) has released its analysis of overall life sciences hiring trends for Q3 2010 and if you live outside of the Americas, hiring trends are generally up.

Boehringer Ingelheim (Ingelheim, Germany) and MacroGenics (Rockville, MD) have entered into a global alliance to discover, develop, and commercialize antibody-based therapeutics that may span multiple therapeutic areas, including immunology, oncology, respiratory, cardiometabolic, and infectious diseases. These developmental drug candidates will be based on MacroGenics?s dual-affinity re-targeting (DART) platform and will be directed against up to 10 combinations of molecular targets.

Medicago Inc. (Quebec City, Canada) a biotechnology company focused on developing vaccines based on proprietary manufacturing technologies and virus-like particles (VLPs), has received clearance from Health Canada to commence a Phase 2 human clinical trial for its H5N1 avian influenza vaccine. Enrolment of volunteers is now underway.

FDA has to address multiple technical and legal issues to bring similar versions of biotech therapies to market.

LigoCyte Pharmaceuticals, Inc. (Bozeman, MN) has announced positive results from a Phase 1?2 challenge study of its norovirus virus-like particle (VLP) vaccine candidate. Baylor College of Medicine?s Robert Atmar, MD, the study's principal investigator, shared data from the trial via an oral presentation at the Infectious Diseases Society of America (IDSA) 2010 Annual Meeting on October 23 in Vancouver, British Columbia.

The US Food and Drug Administration's Puerto Rico district office "may be having difficulty exercising oversight on the numerous pharmaceutical manufacturing facilities on the island," according to Rep. Edolphus Towns (D-NY), chair of the US House of Representatives Committee on Oversight and Government Reform.

Paragon Bioservices, a Baltimore-based CMO focused on the contract research, process development, and manufacturing of biologics, has been awarded a $4.99 million contract to assist the US Army Medical Research Institute for Infectious Diseases (USAMRIID) in its vaccine development efforts.

Laureate Pharma, Inc. (Princeton, NJ) has entered into a development and manufacturing agreement to produce AV-203, AVEO Pharmaceutical?s (Cambridge, MA) monoclonal antibody targeted against ErbB3. Laureate?s services will include process development, protein production, purification, and aseptic filling of AP-203 for AVEO. Laureate expects to supply AVEO with clinical product in the second quarter of 2011. Terms of the manufacturing agreement were not disclosed.

Sanofi-Aventis has told Genzyme to stand aside and let the shareholders decide on whether an acquisition should take place.