Young Bride Chooses Molecular Profiling and Clinical Trial

Young Bride Chooses Molecular Profiling and Clinical Trial

Allison Lippman was 30 years old when she was diagnosed with acinar cell carcinoma, a rare type of pancreatic cancer. Before Allison Lippman of Dallas met her now-husband, she was not convinced she wanted to date anyone. “I was turning 30 and wanted to be single, focus on my career and travel.” But life doesn’t […]

1 Day Course: Drafting and Negotiating Clinical Trial Agreements (London, United Kingdom – November 13, 2018 …

1 Day Course: Drafting and Negotiating Clinical Trial Agreements (London, United Kingdom – November 13, 2018 …

Clinical trial agreements are one of the most important agreements in the pharma industry as no research can start without the right agreement in place between sponsor and host organisation. They provide a contract which manages the relationship and responsibilities of both parties, and provide for the allocation of risk, obligations, the protection of academia, […]

JHL Biotech Receives Positive CHMP Scientific Advice for Global Phase III Clinical Trial of Proposed Bevacizumab …

JHL Biotech Receives Positive CHMP Scientific Advice for Global Phase III Clinical Trial of Proposed Bevacizumab …

HSINCHU, Taiwan and WUHAN, China, Aug. 9, 2018 /PRNewswire/ — JHL Biotech has announced it received a positive Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) related to the EU approval pathway for its proposed bevacizumab biosimilar, JHL1149 to treat patients with non-small cell lung cancer […]

Local Crohn's patient sees vast improvement with clinical trial

Local Crohn's patient sees vast improvement with clinical trial

Patrick Sapinski suffered for more than a decade with symptoms of Crohn’s disease before discovering a new clinical trial that gave him a full year of relief from symptoms.  Qu Biologics, a Canadian biotech firm, has developed a treatment that’s showing signs of eliminating the inflammatory bowel disease, and it is moving into Phase 2 […]

Celltrion Begins Global Phase 3 Clinical Trial for Its Bevacizumab Biosimilar 'CT-P16'

Celltrion Begins Global Phase 3 Clinical Trial for Its Bevacizumab Biosimilar 'CT-P16'

INCHEON, South Korea–(BUSINESS WIRE)–Aug 10, 2018–Celltrion, Inc. (KRX:068270) is set to launch global Phase 3 clinical trial for its bevacizumab biosimilar ‘CT-P16’ for the treatment of cancer. Celltrion successfully completed Phase 1 clinical study on the safety and pharmacokinetic assessment of CT-P16 in June 2018. Further, it recently submitted its Clinical Trial Application for Phase […]

IMV Inc. Reaches Multiple Milestones in Advanced Ovarian Cancer Clinical Trial

IMV Inc. Reaches Multiple Milestones in Advanced Ovarian Cancer Clinical Trial

HALIFAX, Nova Scotia, Aug. 09, 2018 (GLOBE NEWSWIRE) — Enrollment Completed for Phase 1b Cohorts First Dosing Occurred in Phase 2 Portion of the Program IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology corporation, today announced that it has reached two important milestones in its ongoing clinical trial collaboration with Incyte Corporation. Investigators […]

Certara outlines the role of quantitative systems pharmacology in FIH trial design, EMA responds

Certara outlines the role of quantitative systems pharmacology in FIH trial design, EMA responds

The European Medicines Agency’s (EMA’s) recently responded to Certara’s “Letter to the Editor,” both of which were published in Clinical Pharmacology & Therapeutics​. The EMA said it “welcomed the initiative shown”​ in Certara’s letter, which describes the role that quantitative systems pharmacology (QSP) can play in defining dosing criteria for first-in-human (FIH) clinical trials. The […]

Pediatric Clinical Trials: The Need for Regulation

By Dr. Martine Dehlinger-Kremer, VP, Global Medical and Regulatory Affairs Despite the fact that some labeling for children did exist since 1979, more than 80 percent of listed medications’ labels lacked prescribing information for children because most of them were being used off label. Why? Because 50-90 percent of medicines being used for children were […]