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News Breaks
February 5, 2013
11:25 EDTACHN, ACHN, IDIX, IDIX, BMY, BMY, MRK, MRK, RHHBY, RHHBY, GILD, GILD, VRTX, VRTXLazard's biotech analyst research team holds an analyst/industry conference call
Biotech Analyst Research Team discusses the HCV treatment outlook on an Analyst/Industry conference call. Relevant companies BMY, MRK, RHHBY, GILD, VRTX, ACHN and IDIX may be discussed on the Analyst/Industry conference call to be held on February 5 at 12 pm.
News For BMY;MRK;RHHBY;GILD;VRTX;ACHN;IDIX From The Last 14 Days
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April 9, 2015
10:48 EDTVRTXDeutsche compares PTC Therapeutics to Vertex, boosts target by $40
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09:25 EDTMRKPiper Jaffray pharmaceuticals analysts hold an analyst/industry conference call
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07:27 EDTVRTXPTC Therapeutics price target raised to $115 from $75 at Deutsche Bank
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06:12 EDTGILDSovaldi prices causes Medicaid spending for hepatitis C drugs to soar, WSJ says
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April 8, 2015
15:19 EDTRHHBYRoche says receives European approval for Avastin plus chemotherapy
Roche announced that the European Commission approved Avastin -- bevacizumab -- in combination with standard chemotherapy for the treatment of adult patients with persistent, recurrent or metastatic carcinoma of the cervix. The EU approval was based on the significant survival benefit in the pivotal GOG-0240 study, which showed that women who received Avastin plus chemotherapy had a statistically significant 26% reduction in the risk of death, representing a median improvement in survival of nearly four months, compared to women who received chemotherapy alone.
08:08 EDTBMYuniQure price target raised to $50 from $28 at Leerink
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08:06 EDTBMYBristol-Myers completes acquisition of Flexus Biosciences
Bristol-Myers Squibb Company announced that it has completed the previously announced planned acquisition of Flexus Biosciences, Inc. The transaction includes full rights to F001287, Flexus’ lead preclinical, small-molecule IDO1-inhibitor targeted for IND filing in the second half of 2015 and an IDO/TDO discovery program that includes its IDO-selective, IDO/TDO dual and TDO-selective compound libraries. A newly formed entity established by the current shareholders of Flexus will retain, from and after the closing, all non-IDO/TDO assets of Flexus including those related to Flexus’ Phase 1 FLT3 and CDK4/6 inhibitor, its earlier stage small-molecule Treg cancer immunotherapy programs, and its current personnel and facilities.
07:33 EDTMRKAdvaxis, Merck begin enrollment in Phase 1/2 of ADJX-PSA with Keytruda
Advaxis (ADXS) and Merck (MRK) announced that enrollment has initiated in the Phase 1/2 clinical trial evaluating the combination of ADXS-PSA, an investigational Lm-LLO immunotherapy, and Keytruda, the first anti-PD-1 therapy approved in the United States, in patients with previously treated, metastatic castration-resistant prostate cancer, or mCRPC. The clinical trial, KEYNOTE-046, is the first-in-human study of Advaxis's lead Lm-LLO immunotherapy candidate for prostate cancer. It is the second study initiated to evaluate the use of KEYTRUDA in the treatment of advanced prostate cancer. ADXS-PSA and KEYTRUDA are members of a class of cancer treatments known as immuno-oncology therapies. Data from preclinical studies suggest that Advaxis Lm-LLO immunotherapies in combination with a PD-1 antibody may lead to an enhanced anti-tumor immune response. The results from KEYNOTE-046 will determine the future clinical development program for the combination.
07:04 EDTMRKMerck's investigational Hep C therapy granted breakthrough therapy designations
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April 7, 2015
17:58 EDTGILDGilead submits NDA for investigational combination for treatment of HIV-1
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16:00 EDTGILDOptions Update; April 7, 2015
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07:14 EDTRHHBY, MRK, BMYEyeforpharma to hold a summit
Philadelphia 2015 Commercial Pharma Summit is being held in Philadelphia on April 7-8.
April 6, 2015
16:17 EDTBMYOn The Fly: Closing Wrap
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12:44 EDTBMYOn The Fly: Midday Wrap
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12:13 EDTBMYuniQure price target raised to $40 from $35 at Piper Jaffray
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08:13 EDTBMYCelldex announces initiation of Phase 1/2 study of Varlilumab combination
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07:56 EDTACHNAchillion price target lowered to $20 from $25 at Deutsche Bank
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07:36 EDTGILDGilead Q1 HCV revenue poised to beat expectations, says RBC Capital
After analyzing weekly prescription data, RBC Capital believes that Gilead's weekly hepatitis C prescriptions are tracking towards $3.5B-$3.6B of revenue from hepatitis C drugs for Q1, versus the consensus outlook of about $2.6B. The firm keeps an Outperform rating on Gilead.
07:33 EDTBMYBristol-Myers announces strategic collaboration with uniQure
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April 5, 2015
14:43 EDTGILDActavis seeks FDA approval to market generic version of Gilead's Letairis
Actavis (ACT) on Friday, confirmed that it has filed an Abbreviated New Drug Application with the FDA seeking approval to market Ambrisentan Tablets, 5 mg and 10 mg. Actavis' ANDA product is a generic version of Gilead Science's (GILD) Letairis, which is a treatment for pulmonary arterial hypertension. Gilead Sciences and Royalty Pharma Collection Trust filed suit against Actavis on April 1, in the U.S. District Court for the District of Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of U.S. Patent number RE42,462. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis' ANDA for up to 30 months from the date the plaintiffs received notice of Actavis' ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities. Based on available information, Actavis believes it may be a "first applicant" to file an ANDA for the generic version of Letairis and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity. For the 12 months ending December 31, Letairis had global sales of approximately $595M, according to Gilead.
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