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News Breaks
June 12, 2014
16:20 EDTNKTR, AZNNektar: U.S. AADPAC recommends no cardiovascular trial for pamora class
Nektar Therapeutics (NKTR) reported that partner AstraZeneca (AZN) announced that the majority of US FDA Anesthetic and Analgesic Drug Products Advisory Committee members voted that the FDA should not require cardiovascular outcomes trials for the peripherally-acting mu-opioid receptor antagonist class of drugs, which includes MOVANTIKTM, an investigational treatment for opioid-induced constipation for patients with chronic non-cancer pain. Following a clarification of the vote, the majority of the Committee suggested continued post-approval data collection for cardiovascular safety. The FDA convened a meeting of the AADPAC to review the class of peripherally acting opioid receptor antagonists on June 11-12. The meeting assessed the necessity, timing, design and size of cardiovascular outcomes trials to support approval of products in the class, for the proposed indication of OIC in patients taking opioids for chronic non-cancer pain. The FDA is not bound by the Advisory Committee's recommendation, but takes its advice into consideration when reviewing applications for investigational medicines. The Prescription Drug User Fee Act date set by the FDA for MOVANTIK is September 16.
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July 22, 2014
05:25 EDTAZNAdams Express, MedImmune announce clinical trial partnership
Advaxis (ADXS) has entered into a clinical trial collaboration with MedImmune, the global biologics research and development arm of AstraZeneca (AZN). The Phase I/II immunotherapy study will evaluate the safety and efficacy of MedImmune's investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with Advaxis' lead cancer immunotherapy vaccine, ADXS-HPV, as a treatment for patients with advanced, recurrent or refractory human papillomavirus, or HPV,-associated cervical cancer and HPV-associated head and neck cancer. Both MEDI4736 and ADXS-HPV are cancer immunotherapies, a new class of treatments that use the body's own immune system to help fight cancer. Under the terms of the agreement, MedImmune and Advaxis will evaluate the combination as a treatment for HPV-associated cervical cancer and squamous cell carcinoma of the head and neck. The Phase I part of the trial is expected to establish a recommended dose regimen of MEDI4736 with ADXS-HPV, and the Phase II portion will assess the safety and efficacy of the combination. The study will be funded and conducted by Advaxis. Results from the study will be used to determine whether further clinical development of this combination is warranted. Under the terms of the deal, MedImmune has a non-exclusive relationship with respect to HPV-driven tumour types. MedImmune has first right of negotiation for future development of combinations involving MEDI4736 and ADXS-HPV.
July 16, 2014
10:36 EDTAZNTreasury calls on Congress to halt inversion deals
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08:01 EDTAZNAlexion names former AstraZeneca CEO David Brennan to board
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07:59 EDTAZNTreasury Secretary urges Congress to take action on tax inversions
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July 15, 2014
11:38 EDTNKTRNektar management to meet with Jefferies
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