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News Breaks
May 13, 2014
14:25 EDTARIA, ARIA, ARIA, RXDX, RXDX, RXDX, RHHBY, RHHBY, RHHBY, PFE, PFE, PFE, PBYI, PBYI, PBYI, NVS, NVS, NVS, MRTX, MRTX, MRTX, MRK, MRK, MRK, INCY, INCY, INCY, EXEL, EXEL, EXEL, CLVS, CLVS, CLVS, BMY, BMY, BMY, AZN, AZN, AZN, TSRO, TSRO, TSROLeerink pharma and biotech analysts hold an analyst/industry conference call
Biotech and Pharmaceuticals Analysts provide updates on lung cancer, in conjunction with the upcoming ASCO Annual Meeting, on an Analyst/Industry conference call to be held on May 20 at 3 pm.
News For ARIA;AZN;BMY;CLVS;EXEL;INCY;MRK;MRTX;NVS;PBYI;PFE;RHHBY;RXDX;TSRO From The Last 14 Days
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October 21, 2014
06:10 EDTAZNInovio, MedImmune, UPENN awarded $12.2M collaborative study by DARPA
Inovio Pharmaceuticals (INO) announced the Defense Advanced Research Projects Agency, or DARPA, has awarded $12.2M for a collaborative study that will be conducted by scientists from the Perelman School of Medicine at the University of Pennsylvania; Inovio Pharmaceuticals; and MedImmune, the global biologics research and development arm of AstraZeneca (AZN). The group will develop DNA-based monoclonal antibodies, or mAbs, for infectious disease treatment. DARPA is an agency of the US Department of Defense that creates and supports novel technologies important for national security. Together, the three organizations will develop and assess the DNA mAbs in preclinical studies using technology developed by Penn and licensed by Inovio. The collaboration will focus on three disease areas – influenza virus, Pseudomonas aeruginosa and Staphylococcus aureus.
October 20, 2014
15:09 EDTNVSNovartis reports FDA advisory committee recommends approval of secukinumab
Novartis announced the Dermatologic and Ophthalmic Drugs Advisory Committee to the FDA voted unanimously to support the approval of AIN457, or secukinumab, a selective interleukin-17A inhibitor, for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. A Biologics License Application for secukinumab is currently under FDA review with an anticipated action date in early 2015.
12:37 EDTRHHBYOn The Fly: Midday Wrap
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08:06 EDTMRKMerck, Sanofi unit announce pediatric hexavalent vaccine BLA
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07:47 EDTPFE, AZNPfizer less likely to renew Astra pursuit after Shire deal breakdown, FT says
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07:34 EDTMRKAdvaxis names Mauro Chief Medical Officer
Advaxis (ADXS) announced that it has appointed David Mauro, as executive vice president, Chief Medical Officer Mauro most recently served as executive director, section head oncology clinical development at Merck (MRK). In connection with his appointment, Mauro received a one-time inducement award of 165K restricted shares, of which 55K are fully vested and as of the grant date. The remaining shares vest annually over a two-year period.
07:26 EDTNVSFDA Dermatologic & Ophthalmic Drugs Advisory Committee to hold a meeting
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07:19 EDTBMY, RHHBY, MRK, AZNIBC Life Sciences to hold a conference
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07:15 EDTPFEAmerican Academy of Child & Adolescent Psychiatry to hold annual meeting
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07:14 EDTAZNEuropean College of Neuropsychopharmacology to hold a conference
27th ECNP Congress is being held in Berlin, Germany on October 18-21.
07:12 EDTPFECongress of Neurological Surgeons to hold annual meeting
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07:11 EDTPFE, RHHBY, MRKAmerican Society for Reproductive Medicine to hold annual meeting
2014 Annual Meeting of ASRM is being held in Honolulu on October 18-22.
07:10 EDTRHHBY, PFEAmerican Society of Human Genetics to hold annual meeting
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07:06 EDTRHHBYNewLink announces worldwide license agreement for NLG919 development
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07:04 EDTRHHBY, TSRORoche approval would be positive for TESARO, says Jefferies
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October 17, 2014
16:41 EDTPFEPfizer confirms FDA labeling approval for EMBEDA capsules
Pfizer announced that the FDA has approved an updated label for EMBEDA extended-release capsules, for oral use to include abuse-deterrence studies. The updated label states that EMBEDA has properties that are expected to reduce abuse via the oral and intranasal routes when crushed. However, abuse of EMBEDA by these routes is still possible. The updated label also includes data from a human abuse potential study of intravenous, or IV, morphine and naltrexone to simulate crushed EMBEDA. However, it is unknown whether the results with simulated crushed EMBEDA predict a reduction in abuse by the IV route until additional postmarketing data are available. EMBEDA is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Pfizer expects EMBEDA will be available in the U.S. in early 2015.
16:30 EDTPFEFDA approves new labeling from Embeda extended-release capsules
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14:50 EDTNVSBARDA asks labs to ramp up Zmapp production, Reuters says
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08:01 EDTINCYIncyte names Gryska CFO to succeed Hastings
Incyte announced the appointment of David Gryska as Executive Vice President and CFO, effective October 31. Gryska will succeed David Hastings, who has served as Incyte’s Executive Vice President and CFO since October 2003. Hastings, who is leaving the company to pursue other opportunities, will remain with Incyte through the end of November and will work closely with Gryska to ensure a seamless transition.
07:58 EDTMRKDeutsche Bank specialty pharma analyst holds analyst/industry conference call
Specialty Pharmaceuticals Analyst Gilbert provides of preview of The Improved Reduction of Outcomes: Vytorin Efficacy Internal Study (IMPROVE-IT) on an Analyst/Industry conference call to be held on October 17 at 10 am.
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