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News Breaks
June 12, 2014
13:29 EDTAZN, NKTRNektar Naloxegol can still be approved around end of year, says Piper Jaffray
After most members of an FDA panel voted against requiring a cardiovascular outcomes trial for Nektar's (NKTR) and AstraZeneca's (AZN) naloxegol and other similar drugs drugs, Piper Jaffray thinks the vote seems to be positive for Nektar. However, the firm thinks the drug's precise path to market remains uncertain, given what it sees as "FDA dysfunction." Piper continues to believe that the most likely outcome is that the drug will be approved around the end of 2014 and be launched in the first quarter of 2015. It reiterates an Overweight rating on Nektar.
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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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