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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.
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November 23, 2015
15:00 EDTBMYFDA approves Bristol-Myers drug to treat form of kidney cancer
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09:39 EDTGILDActive equity options trading on open
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08:34 EDTVRTXVertex names Michael J. Parini EVP, chief legal officer
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06:41 EDTGILDGilead granted marketing authorization in EU for Genvoya
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November 22, 2015
15:14 EDTRHHBYExelixis confirms Phase 3 data on Cotellic with Zelboraf for melanoma
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15:09 EDTRHHBYGenentech reports data on Cotellic with Zelboraf for treatment of melanoma
Genentech, a member of the Roche Group, announced data from the pivotal coBRIM study, showing that Cotellic, or cobimetinib, in combination with Zelboraf, or vemurafenib, helped people with BRAF V600E and V600K mutation-positive unresectable or metastatic melanoma live "significantly longer" than with Zelboraf alone, according to the company. Cotellic plus Zelboraf reduced the risk of death by 30% compared to Zelboraf alone and helped people live a median of nearly two years, with 74.5% of BRAF V600 patients alive at one year and 48.3% alive at two years. Ongoing study monitoring did not identify any new safety signals. The company noted that an approval decision on Cotellic from the European Commission is expected before year end.
15:03 EDTMRKMerck reports multiple data sets from Keytruda combination studies
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November 20, 2015
10:34 EDTVRTXVertex approval in Europe to bring gradual uptake, says Piper Jaffray
Piper Jaffray analyst Edward Tenthoff says Vertex Pharmaceuticals must now gain reimbursement in each individual country after the European Union approved Orkambi as expected. The approval will ultimately add around 12,000 homozygous F508del cystic fibrosis patients appropriate for the drug, but uptake will be gradual and dependent on the pace of reimbursement. He reiterates an Overweight rating on Vertex with a $180 price target.
05:36 EDTVRTXVertex receives EU approval for Orkambi
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November 19, 2015
06:34 EDTMRKEli Lilly, Merck expand immuno-oncology collaboration
Eli Lilly (LLY) and Merck (MRK) announced the extension of an existing collaboration to evaluate the safety and efficacy of the combination of Lilly's Alimta and Merck's Keytruda in a pivotal Phase III study in first-line nonsquamous non-small cell lung cancer, or NSCLC. The study will be sponsored by Merck and will be open to patients with NSCLC in the first-line setting, regardless of PD-L1 status. Financial details of the collaboration were not disclosed. The expansion of this oncology clinical trial collaboration comes following the release of encouraging data from a Phase I study, presented earlier this year at the 16th World Congress on Lung Cancer, which evaluated pemetrexed, carboplatin and pembrolizumab in first-line nonsquamous NSCLC.
November 18, 2015
12:01 EDTBMYBristol-Myers Squibb says Opdivo data shows 'superior' overall survival
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09:34 EDTGILDActive equity options trading on open
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08:28 EDTRHHBYLeerink to hold a bus tour
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08:11 EDTBMY, MRK, RHHBYIMS Health forecasts global drug spending to increase 30% by 2020 to $1.4T
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07:01 EDTMRKThreshold enters into definitive co-promotion agreement with Merck
Threshold Pharmaceuticals (THLD) announced that it finalized a definitive Co-Promotion Agreement for evofosfamide with Merck (MRK) pursuant to the companies' License and Co-Development Agreement entered into on February 2, 2012. Under the terms of the License and Co-Development Agreement, Threshold may co-promote evofosfamide in the U.S. subject to FDA approval of evofosfamide. Evofosfamide is Threshold's investigational hypoxia-activated prodrug, which is currently the subject of two fully enrolled Phase 3 clinical trials in advanced soft tissue sarcoma and advanced pancreatic cancer for which Threshold expects to announce top-line data around the end of 2015. Under the commercial leadership of Merck KGaA, Darmstadt, Germany, the terms of the License and Co-Development Agreement give Threshold the right, at its own cost, to field and be responsible for its own sales force in collaboration with Merck KGaA, Darmstadt, Germany's sales force in the U.S. pursuant to the terms of the new Co-promotion Agreement. Merck KGaA, Darmstadt, Germany remains responsible for all other commercial and medical affairs functions associated with the launch and promotion of evofosfamide. The development milestone payment and royalty payment portions of the License and Co-Commercialization Agreement remain the same. To date Threshold has received upfront and milestone payments of $110 million and can earn additional potential milestone payments of up to $440M.
05:41 EDTVRTXVertex receives 2 EU approvals for Kalydeco
Vertex Pharmaceuticals announced that the European Commission has approved expansion of the indication for Kalydeco to include children ages 2 to 5 with cystic fibrosis, or CF, who have one of nine gating mutations in the cystic fibrosis transmembrane conductance regulator, or CFTR, gene and to include people with CF ages 18 and older who have an R117H mutation. Ivacaftor was previously approved in the European Union, or EU, for use in people with CF ages 6 and older who have one of nine gating mutations. In Europe, approximately 125 children with CF ages 2 to 5 have one of the nine gating mutations included in today's approval and approximately 350 adults with CF have an R117H mutation. Vertex will now begin the country-by-country reimbursement approval processes for each new indication.
November 17, 2015
10:47 EDTBMY, GILDBristol-Myers strength attributed to sale chatter
The move higher in shares of Bristol-Myers (BMY) is being attributed by traders to chatter of a sale. The stock is up 2%, or $1.06, to $66.08 in morning trading. The unconfirmed talk has the company possibly approaching Gilead (GILD) about buyout interest. Bristol's market capitalization is just above $110B while Gilead's is just above $150B. Shares of Gilead are up 74c to $104.55.
08:04 EDTMRKMerck to present new KEYTRUDA findings at upcoming congresses
Merck announced that data investigating the use of KEYTRUDA, the company's anti-PD-1 therapy, in advanced non-small cell lung cancer, melanoma, classical Hodgkin lymphoma, multiple myeloma, and ER-positive/HER2-negative breast cancer will be presented at four medical congresses through the end of this year. In total, data from more than 30 abstracts will be presented at the Society for Melanoma Research 2015 Congress in San Francisco, Nov. 18 - 21; the 57th American Society of Hematology Annual Meeting in Orlando, Florida, Dec. 5 - 8; the San Antonio Breast Cancer Symposium, Dec. 8 - 12; and the European Society for Medical Oncology Asia 2015 Congress in Singapore, Dec. 18 - 21. By the end of 2015, data on the anti-tumor activity of KEYTRUDA will have been presented across more than 20 tumor types. "The field of immuno-oncology holds great potential across a broad spectrum of cancers," said Dr. Roy Baynes, senior vice president and head of global clinical development, Merck Research Laboratories. "Data for KEYTRUDA being presented at these scientific meetings include a first-time comparison to chemotherapy in advanced non-small cell lung cancer, novel combination data in advanced melanoma as well as first-time data in two additional tumor types, namely multiple myeloma and hormone receptor positive breast cancer, further demonstrating our deep commitment to advancing cancer treatment."
07:34 EDTRHHBYOphthotech to hold a conference call
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06:08 EDTRHHBYRoche subsidiary to participate in Ophthotech and Novartis agreement
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