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News Breaks
March 19, 2014
07:28 EDTARGS, NAVB, RHHBY, CELG, ACTM, ADXS, AZN, NVS, NVGN, CAH, PFE, RNNSachs Associates to hold a forum
2nd Annual Sachs Cancer Bio Partnering & Investment Forum is being held in New York on March 19.
News For CELG;RNN;NVS;RHHBY;PFE;AZN;NAVB;CAH;ADXS;ARGS;NVGN;ACTM From The Last 14 Days
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June 25, 2015
07:34 EDTADXSAdvaxis provides milestones outlook for 2015 and 2016
The company anticipates the following milestones through the remainder of 2015 and into 2016 for ADXS-HPV: Commence enrollment in the Phase 3, registration quality trial, AIM2CERV; Complete enrollment in Stage 2 of the ongoing GOG-0265 Phase 2 trial of ADXS-HPV in persistent or recurrent cervical cancer being conducted by the Gynecologic Oncology Group, anticipating up to 38 patients enrolled by June 30, 2016 with Final Stage 1 safety and efficacy data to be presented at an upcoming major medical meeting in 2015. Final study data to be available in the first half of 2017; Enroll the first patient this summer in a collaborative Phase 1/2 study of ADXS-HPV in combination with AstraZeneca/MedImmune's MEDI4736 in cervical cancer and HPV-associated head and neck cancer in second half of 2015 with data available in the first half of 2016; Complete enrollment in Part A of our Phase 1 study evaluating higher doses of ADXS-HPV immunotherapy and repeat cycles of treatment with data available from Part A in 2016. Complete enrollment of the Mount Sinai investigator-sponsored Phase 1/2 study of ADXS-HPV in patients with HPV-associated head and neck cancer. Data to be available in the first half of 2016; Commence enrollment in a Phase 2 study in patients with HPV-associated metastatic anal cancer by year's end with data available in the second half of 2016; Commence enrollment in the second half of 2015 on the Phase 1/2 combination study with Incyte Corporation's IDO-1 inhibitor. Expects to complete enrollment in Part A in the first half of 2016 in the Phase 1/2 study of ADXS-PSA as a monotherapy or in combination with Merck's anti-PD-1 therapy, Keytruda, in metastatic, castration-resistant prostate cancer. Data to be available in second half of 2016. Expects to enroll the first patient in a Phase 1 first-in-human trial of ADXS-HER2 in metastatic HER2 expressing solid tumors in the second half of 2015 with data to be available in the second half of 2016; Initiate a clinical study of ADXS-HER2 in pediatric osteosarcoma in partnership with the Children's Oncology Group in 2016; Secure conditional license for ADXS-HER2 for the treatment of canine osteosarcoma from the U.S. Department of Agriculture in 2016.
June 24, 2015
13:23 EDTPFEPfizer says CDC committee votes to recommend MenB vaccine
Pfizer announced that the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices voted to recommend that decisions to vaccinate adolescents and young adults 16 through 23 years of age against serogroup B meningococcal disease should be made at the individual level with healthcare providers. It added, "Specifically, the ACIP voted that a serogroup B meningococcal vaccine series may be administered to adolescents and young adults 16 through 23 years of age to provide short term protection against most strains of serogroup B meningococcal disease. The preferred age for MenB vaccination is 16 through 18 years of age." Pfizer's Trumenba is FDA-approved for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. The ACIP recommendation will be forwarded to the director of the CDC and the U.S. Department of Health and Human Services for review and approval, Pfizer said.
11:19 EDTADXSAdvaxis management to meet with Jefferies
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11:02 EDTPFEPfizer lung cancer treatment granted FDA orphan drug designation
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09:07 EDTRHHBY, AZN, PFECAR-T cancer drug researchers seen as M&A targets, Bloomberg says
Juno Therapeutics (JUNO), Kite Pharma (KITE) and Bluebird Bio (BLUE) are trading well above their IPO levels as takeovers predictions have spurred interest and share increases for the developers of CAR-T gene therapies, said Bloomberg's "Real M&A" column, quoting Dimo Dimov, a professor at the University of Bath’s School of Management, as having said that companies such as Pfizer (PFE), Merck (MRK), Roche (RHHBY) and AstraZeneca (AZN) are "closely watching" the firms. Cellectis (CLLS), which is working with Pfizer on its own approach to CAR-T therapy, has said it wants to bring its therapy to market and doesn’t anticipate a sale, the report noted. Reference Link
07:03 EDTNVGNNovogen announces Anisini on track to enter clinic in 2016
Novogen announced that its candidate cytotoxic chemotherapy drug, Anisina, has proved an effective anti-cancer agent in animals, the result of which it now has been fast-tracked by the Company to come into the clinic. Anisina targets the cytoskeleton of cancer cells. This is the same target of the most widely used chemotherapy drugs in cancer, the taxanes and vinca alkaloids. Beyond these approved uses, they are widely used off-label across most forms of cancers following failure of standard of care drugs. There remains a significant clinical need to improve on both the efficacy and safety of these commonly used drugs. Novogen believes that Anisina has the features to meet that need across a range of cancer types.
06:50 EDTAZNAstraZeneca loses top executive Ward-Lilley to Vectura, Reuters reports
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June 23, 2015
14:17 EDTPFEGlycoMimetics to receive $20M payment from Pfizer
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14:01 EDTPFEPfizer announces enrollment of first patient in RESET study
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09:53 EDTPFEPfizer management to meet with FBN Securities
Meeting to be held in New York on June 25 hosted by FBN Securities.
07:31 EDTAZNBIND Therapeutics announces FDA authorization of clinical trial with AZD2811
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07:25 EDTCAH, PFEPiper Jaffray to hold a summit
2015 Piper Jaffray Heartland Summit is being held in Minneapolis on June 23-24.
June 22, 2015
08:52 EDTPFEPortola, Bristol-Myers, and Pfizer announce results from Phase 3 ANNEXA study
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07:01 EDTPFEPfizer to acquire Nimenrix, Mencevax from GlaxoSmithKline for $130M
Pfizer (PFE) announced that it has entered into an agreement with GlaxoSmithKline (GSK) to acquire its quadrivalent meningitis ACWY vaccines, Nimenrix and Mencevax, for a total consideration of approximately $130M. This transaction will add two high-quality and complementary vaccines to Pfizer’s portfolio, allowing the company to reach a broader global population. Nimenrix is a single dose meningococcal ACWY-TT conjugated vaccine designed to protect against Neisseria meningitidis, an uncommon but highly contagious disease that can lead to disability and death. Mencevax is a single-dose meningococcal ACWY unconjugated polysaccharide vaccine used to control outbreaks of meningococcal infection and for travelers to countries where the disease is endemic or highly epidemic. Pfizer does not expect this transaction to have any significant impact on its 2015 financial performance. The transaction is subject to customary closing conditions as well as regulatory approvals in several markets, and is expected to occur in the second half of 2015. Pfizer’s legal advisors for the transaction were Ropes & Gray and Clifford Chance.
June 19, 2015
10:42 EDTADXSAdvaxis to host business news update conference call
Conference call to be held on June 25 at 8:30 am. Webcast Link
June 18, 2015
17:05 EDTNVSNovartis announces U.S. launch of Glatopa
Sandoz, a Novartis (NVS) company, announced the U.S. launch of Glatopa, the first generic version of Teva's (TEVA) Copaxone 20 mg/ml one-time-daily multiple sclerosis therapy.
11:54 EDTNVSAppeals court invalidates Teva patent claim related to Copaxone
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09:35 EDTPFEActive equity options trading on open
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07:36 EDTAZNReceptos remains an attractive takeover candidate, says Leerink
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06:57 EDTNVSMallinckrodt says Questcor facing multi-state antitrust probe
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