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News For JNJ;VRTX;BMY From The Last 14 Days
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November 24, 2015
07:01 EDTBMYBristol-Myers announces EC approved reconciliation of indications for nivolumab
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06:58 EDTBMYBristol-Myers announces FDA approval of Opdivo injection
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November 23, 2015
19:29 EDTBMYBristol-Myers receives FDA approval for Opdivo
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15:00 EDTBMYFDA approves Bristol-Myers drug to treat form of kidney cancer
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08:34 EDTVRTXVertex names Michael J. Parini EVP, chief legal officer
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November 20, 2015
10:52 EDTJNJFDA approves new oral medication to treat multiple myeloma
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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 18, 2015
12:01 EDTBMYBristol-Myers Squibb says Opdivo data shows 'superior' overall survival
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08:11 EDTBMY, JNJIMS Health forecasts global drug spending to increase 30% by 2020 to $1.4T
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08:11 EDTJNJAduro Biotech receives milestone payment from Janssen
Aduro Biotech (ADRO) announced that it has received a milestone payment from Janssen Biotech (JNJ) for Aduro's submission of an Investigational New Drug, or IND, Application to the FDA for ADU-741, a LADD immunotherapy product candidate for the treatment of prostate cancer. The IND will enable Janssen, Aduro's license partner for ADU-741, to initiate a multi-center Phase 1 trial to evaluate the safety and immunogenicity of intravenous administration of ADU-741 in patients with metastatic castration-resistant prostate cancer.
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 EDTBMYBristol-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.
November 16, 2015
17:05 EDTBMYBristol-Myers announces FDA accepts for priority review sBLA for Opdivo
Bristol-Myers Squibb Company announced that the U.S. FDA has accepted for filing and priority review a supplemental Biologics License Application for Opdivo for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. The FDA previously granted Opdivo Breakthrough Therapy Designation for this indication, underscoring the critical need for new treatment options for patients with advanced RCC who have received prior therapy. The projected FDA action date is March 16, 2016.
14:38 EDTJNJGenmab confirms FDA approval of Darzalex
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13:09 EDTJNJFDA approves Darzalex to treat multiple myeloma
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07:16 EDTVRTXHayman Capital gives quarterly update on stakes
NEW STAKES: Impax (IPXL), CF Industries (CF), GW Pharmaceuticals (GWPH), ProNAi Therapeutics (DNAI). INCREASED STAKES: BioMarin (BMRN), NMI Holdings (NMIH), Vertex (VRTX), Endo (ENDP). DECREASED STAKES: Mylan (MYL). LIQUIDATED STAKES: Perrigo (PRGO), Oasis Petroleum (OAS), Whiting Petroleum (WLL), Newfield Exploration (NFX), SM Energy (SM).
07:00 EDTBMYBristol-Myers announces data from Phase 3 ALLY-3+ trial for Daklinza
Bristol-Myers announced late-breaking data from the Phase 3 ALLY-3+ trial investigating a regimen of Daklinza in combination with sofosbuvir and ribavirin in genotype 3 hepatitis C patients with advanced fibrosis or cirrhosis, for treatment durations of 12 and 16 weeks. This patient population is one of the most difficult to treat, among whom sustained virologic response rates, or cure, have proved harder to achieve. The results show that 100% of patients in the advanced fibrosis cohort achieved SVR12 in both the 12- and 16-week arms of the study. SVR12 rates were 83% and 89% in patients with cirrhosis in the 12- and 16-week arms, respectively.

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