WASHINGTON (MedPage Today) — The FDA upgraded a recall of aortic balloon catheters to class I — the agency’s most serious — due to the device potentially becoming jammed in its sheath.
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Filed under: General Health News
(MedPage Today) — The manufacturer of a sodium bicarbonate injection recalled the product due to particles that may form in vials prior to the drug’s expiration.
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Filed under: Pharmacy News
WASHINGTON (MedPage Today) — The FDA upgraded a recall of aortic balloon catheters to class I — the agency’s most serious — due to the device potentially becoming jammed in its sheath.
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Filed under: Pharmacy News
Immune Network Ltd., advises that Immunitor has published data from the first half of the 120-patient imm01 clinical trial of its V5 immunomodulator product against tuberculosis, including difficult-to-treat forms of the disease.
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Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, and Topotarget A/S announced today that the first patient has been dosed in an Investigator Initiated Trial of belinostat in combination with Tarceva® for patients with Non-Small Cell Lung Cancer (NSCLC).
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ZIOPHARM Oncology, Inc., announced today that the first patient has been dosed in a Phase I, single arm, dose escalation study at the Indiana University Cancer Center of intravenous (IV) palifosfamide (ZIO-201) in combination with etoposide (VP-16) and cisplatin/carboplatin (platinum) in the treatment of small cell lung cancer (SCLC) and other cancers.
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Omeros Corporation, a biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation and disorders of the central nervous system, today announced results from the Phase 1/2 clinical trial of OMS201, the Company’s urological PharmacoSurgery™ product candidate.
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Filed under: Pharmacy News
CEL-SCI Corporation announced today that it has commenced its Phase III clinical trial for Multikine®, the Company’s flagship immunotherapy. CEL-SCI has now completed all of the manufacturing and regulatory requirements to begin enrollment of the study.
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Pharma IQ has conducted an interview with Chrissie Fletcher, Director and Head of International Biostatistics at Amgen, about Health Technology Assessment. Fletcher said: “The Health Technology Assessment dossier is really the single opportunity that people have to convince payers of the value of a new product coming through…
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Akorn, Inc., a niche generic pharmaceutical company, today reported that its Akorn-Strides LLC joint venture has entered into a purchase agreement with Pfizer Inc. to sell 16 Abbreviated New Drug Approvals (ANDAs) and 6 filed ANDAs. For its portion, Akorn, Inc. will receive $35 million in cash. Akorn-Strides LLC will continue to manufacture and distribute [...]
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Filed under: Pharmacy News
