CPhI Worldwide is the world’s leading pharmaceutical networking event for Pharma Ingredients. Along with co-located events ICSE for Contract Services, InnoPack for Innovative Packaging and P-MEC Europe for Technology, Equipment and Machinery, this is a one-stop shop event that cannot be missed by anyone serving the (Bio)Pharmaceutical industry.

First launched in 1990, the events have grown to a scope of 2,200 exhibitors and 30,000+ attendees from over 140 countries. An ideal networking platform, CPhI and co-located events allow you to meet all your business partners under one roof!

CPhI and co-located events host zones for each area of Pharma. From APIs to Generics, from Fine Chemicals to Intermediates and Finished Dosage, Custom Manufacturing and Clinical Trials, Transportation, Lab Devices, Track and Trace and much more.

Where else in the world can you find this many companies, showcasing their innovations, looking to meet people just like you?

CPhI and co-located events host zones for each area of Pharma. From APIs to Generics, from Fine Chemicals to Intermediates and Finished Dosage, Custom Manufacturing and Clinical Trials, Transportation, Lab Devices, Track and Trace and much more.

Drop by from October 9–11, 2012 in Feria de Madrid, Spain. Admission is free of charge when you register online in advance, but a special VIP pass is also available against a small fee. With this VIP pass, gain access to the VIP lounge, which includes refreshments and free Wifi access, the exhibitor party and CPhI Pharma Awards ceremony and more. Please visit our website for more information about our packages and their advantages

Register online now. We look forward to seeing you there!

Eli Lilly will stop ongoing clinical studies investigating pomaglumetad methionil, also known as mGlu2/3, for treating schizophrenia. Lilly expects the decision to stop ongoing Phase III development of the drug will result in a third-quarter pretax charge of $25 million to $30 million. The decision was made after a recently conducted independent futility analysis concluded HBBN, the second of Lilly’s studies, was unlikely to be positive in its primary efficacy endpoint if enrolled to completion. The decision was not based on any safety signals. Additionally, the recently completed Phase II study, HBCO, which investigated pomaglumetad methionil as an adjunctive treatment with atypical antipsychotics, did not meet its primary endpoint. Read More

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Genmab has entered into a global license and development agreement for daratumumab (HuMax-CD38), a human CD38 monoclonal antibody with Janssen Biotech, a subsidiary of the Janssen Pharmaceutical Companies of Johnson & Johnson. Under the agreement, Genmab will grant Janssen an exclusive worldwide license to develop and commercialize daratumumab as well as a backup human CD38 antibody. Under the agreement, Genmab will receive an upfront license fee of $55 million and Johnson & Johnson Development Corporation will invest DKK 475 million, (approximately $80 million) to subscribe for 5.4 million new shares of Genmab at a price of DKK 88 per share (approximately $15 per share). Genmab could also be entitled to up to $1 billion in development, regulatory, and sales milestones, in addition to tiered double-digit royalties. Janssen will be fully responsible for all costs associated with developing and commercializing daratumumab going forward, including the costs of two ongoing Phase I/II studies. Read More

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Hospira has agreed to acquire an API manufacturing facility and an associated R&D facility from Orchid Chemicals & Pharmaceuticals, an Indian pharmaceuticals company, for approximately $200 million. The proposed acquisition follows Hospira’s 2010 purchase of Orchid’s generic injectable business and permits Hospira to be vertically integrated into certain beta-lactam antibiotic APIs. Read More

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Teva Pharmaceutical Industries has announced that FDA has granted approval for tbo-filgrastim (XM02 filgrastim), a granulocyte colony-stimulating factor (G-CSF). Tbo-filgrastim is a short-acting recombinant form of G-CSF, indicated to reduce the duration of severe neutropenia in patients with certain types of cancer (nonmyeloid malignancies) who are receiving chemotherapy that affects the bone marrow. Teva currently markets filgrastim in Europe under the trade name Tevagrastim, a biosimilar to Amgen’s Neupogen. Tbo-filgrastim was filed in the US as a biologics license application because a biosimilar approval pathway had not been established at the time of submission. Teva will market tbo-filgrastim as early as November 2013, in accordance with a previous settlement reached with Amgen. Read More

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A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers. Read More

The US Pharmacopeia Convention (USP) held its first Science and Standards Symposium in Sao Paulo, Brazil, on Aug. 23–24, 2012. The meeting focused on the importance of the Biopharmaceutics Classification System. Almost 300 regulators, academics, pharmaceutical manufacturers, and quality control experts from Latin American countries and the US attended the Symposium, which was cosponsored by the University of Sao Paulo.

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According to a press release, Roger Williams, MD, chief executive officer of USP, closed the meeting by asking the attendees to think about a “global system of interchangeable products.” Williams stated, “If you have a highly soluble drug substance that is rapidly dissolving, it should be optimally bioavailable. Then, if you have two different products with the same active ingredients that are both optimally bioavailable, they should be bioequivalent.” According to release, “drug product monographs in the new USP Medicines Compendium, coupled with labeling, might advance the general approach for the classification and regulation of biopharmaceuticals.”

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