DIA Biosimilars 2013

Drug Sponsors

Biovest completes restructuring, emerges from bankruptcy

Wednesday, July 17, 2013 12:15 PM

Biovest International, a developer of personalized cancer vaccines, has emerged from Chapter 11 reorganization, formally completing its restructuring and recapitalization strategy with its reorganization plan. It has promoted Carlos F. Santos, Ph.D., to chief executive officer. Santos will lead the company's transition from the clinical stage to the commercial stage.

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Cenduit: Now with Patient Reminders

FTC seeks information on proposed Actavis acquisition of Warner Chilcott

Monday, July 15, 2013 01:17 PM

Actavis, a globally integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products, and Warner Chilcott, a supplier of inhalation drug development, delivery and supply capabilities, have both received a request for additional information from the Federal Trade Commission (FTC) in connection with Actavis' pending acquisition of Warner Chilcott. The information request was issued under notification requirements of the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended ("HSR Act").

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CRF Health – eCOA Forum

Galen acquires Synera topical patch

Friday, July 12, 2013 02:09 PM

Galen, a Northern Ireland-based pharmaceutical company, has acquired Synera (lidocaine 70mg/tetracaine 70mg) topical patch from ZARS Pharma, a wholly-owned subsidiary of Nuvo Research. Synera is indicated for use on intact skin to provide local dermal analgesia for superficial venous access and superficial dermatological procedures such as excision, electrodessication and shave biopsy of skin lesions. Galen U.S., a wholly owned subsidiary of Galen, will market and sell Synera in the U.S.

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Former Millennium CEO Deborah Dunsire joins EnVivo as president and CEO

Friday, July 12, 2013 01:57 PM

EnVivo Pharmaceuticals, developing a range of novel therapies for central nervous system (CNS) diseases, has named Deborah Dunsire, M.D., president and chief executive officer. She also joins the company's board of directors. Dunsire brings more than 25 years of scientific, clinical, operational and commercial experience and biological and pharmaceutical industry leadership to EnVivo.

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MannaResearch acquires Kells Medical Research Group

Friday, July 12, 2013 09:46 AM

Montreal-based MannaResearch, a group of independent clinical research centers, has announced acquired Kells Medical Research Group, a Montreal-based clinical investigator site.

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Acorda Therapeutics acquires neuropathic pain assets

Thursday, July 11, 2013 12:30 PM

Acorda Therapeutics, a biotechnology company focused on developing therapies that restore function and improve the lives of people with MS, spinal cord injury and other neurological conditions, has acquired two neuropathic pain management assets from NeurogesX. Qutenza is approved by the FDA for the management of neuropathic pain associated with postherpetic neuralgia. The company also acquired NP-1998 (previously NGX-1998), a phase III ready, prescription strength capsaicin topical solution.

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Azaya Therapeutics launches Parexo Labs

Wednesday, July 10, 2013 12:14 PM

Azaya Therapeutics, an oncology company focused on developing cancer treatments through its nanotechnology platform, has launched a new division, Parexo Labs, a contract development and manufacturing organization (CDMO) providing chemical testing and liposomal manufacturing services to outside organizations.

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ZS Genetics expands with new Massachusetts facility

Wednesday, July 10, 2013 08:52 AM

ZS Genetics, a developer of a Third-Generation DNA sequencing platform, has opened a new office and laboratory facility in Wakefield, Mass., a milestone in the company’s transition from R&D to product commercialization.

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Evotec to close Indian chemistry operations

Monday, July 8, 2013 02:19 PM

Hamburg, Germany-based Evotec will close its chemistry operations in Thane, India. All chemistry work now will be performed at its Abingdon, U.K., facility, to address to an increasing requirement to operate closer to the principal R&D laboratories of major customers. All project work in Thane will be completed by the end of September, and Evotec (India) Private will then wind down.

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Capricor to merge with Nile Therapeutics

Monday, July 8, 2013 12:30 PM

Capricor, a privately held biotechnology company developing cardiac stem cell (CDC) therapeutics to repair damaged heart muscle, and biopharmaceutical company Nile Therapeutics have entered into a merger agreement under which Capricor will become a wholly owned subsidiary of Nile Therapeutics in an all-stock transaction.

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September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

CISCRP to launch traveling science museum exhibit to demystify clinical trial participation

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The CenterWatch Monthly

October

New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
From protocol to patient recruiting, data analytics can yield valuable insights

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The CenterWatch Monthly

September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

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