New User:

Forgot your password?

Stock Market & Financial Investment News

News Breaks
June 10, 2014
35th Annual Global Healthcare Conference to be held in Rancho Palos Verdes, California on June 10-12.
Sign up for a free trial to see the rest of the stories you've been missing.
1 | 2 | 3 | 4 >>
September 28, 2015
05:26 EDTTEVATeva announces approval of Copaxone in Japan
Teva announced the approval by the Japanese Ministry of Health, Labour and Welfare of once-daily COPAXONE 20mg injection for the prevention of relapse of multiple sclerosis . The product will be commercialized in Japan by Takeda Pharmaceutical Company Limited. In Japan, glatiramer acetate was developed as an Unapproved New Drug by Teva Pharmaceutical K.K., a wholly owned subsidiary of Teva, at the request of the MHLW. In March, 2013, Takeda and Teva signed an agreement in which Teva granted Takeda the right to commercialize COPAXONE in Japan. The Japanese approval for COPAXONE is based on the safety and efficacy results of an open-label, 52-week clinical trial conducted by Teva Pharmaceutical K.K. in patients with relapsing-remitting multiple sclerosis in Japan as well as the pivotal trial data sets used for approvals in other countries.
05:15 EDTRHHBYGenentech announces Phase III study of ocrelizumab met primary endpoint
Subscribe for More Information
September 27, 2015
17:02 EDTRHHBYNewLink Genetics reports early Phase 1a data on GDC-0919
Subscribe for More Information
16:53 EDTTEVATeva reports Phase 3 data on reslizumab for asthma exacerbations
Teva Pharmaceutical presented results from a post hoc analysis of two pivotal Phase 3 clinical trials showing that treatment with reslizumab reduced clinical asthma exacerbations by 75% versus placebo in a subgroup of patients with late onset asthma with elevated blood eosinophils, who were inadequately controlled on inhaled corticosteroids. Reslizumab is a humanized anti-interleukin-5 monoclonal antibody. Results were pooled from two Phase 3 clinical trials that investigated reslizumab IV 3mg/kg in patients who had at least one asthma exacerbation within the previous year. In the subgroup with late onset asthma, reslizumab showed a 75% reduction in asthma exacerbations and improvement in lung function as measured by forced expiratory volume in one second. In the overall pooled patient population, asthma exacerbations were reduced by 54%, and in the subgroup of subjects diagnosed with asthma at less than 40 years of age, exacerbations were reduced by 42%. Common adverse events in the reslizumab treatment group were comparable to placebo.
16:42 EDTRHHBYRoche present Phase 2 results on atezolizumab for urothelial cancer
Subscribe for More Information
16:40 EDTRHHBYRoche reports results from two Phase 2 studies on atezolizumab
Genentech, a member of the Roche Group, announced results from two Phase 2 studies that evaluated the investigational cancer immunotherapy atezolizumab -- or anti-PDL1; MPDL3280A -- in people with advanced non-small cell lung cancer. In the randomized Phase 2 study POPLAR, atezolizumab met its primary endpoint and showed a statistically significant survival benefit compared to chemotherapy in people with recurrent NSCLC whose tumors expressed medium and high levels of PD-L1, which corresponded with people living 7.7 months longer than people who received docetaxel chemotherapy. A separate, single-arm Phase 2 study, BIRCH, met its primary endpoint and showed that atezolizumab shrank tumors in up to 27% of people whose disease had progressed on prior medicines and also expressed the highest levels of PD-L1. Median survival had not yet been reached. In both studies of atezolizumab, adverse events were consistent with those observed in previous studies. "We plan to submit these results to global health authorities to bring this potential new option to people as soon as possible," said Chief Medical Officer Sandra Horning.
September 25, 2015
18:59 EDTNVONovo Nordisk confirms FDA approval of Tresiba
Subscribe for More Information
16:35 EDTGILDStocks end week lower as biotechs sink, Volkswagen crashes
Stocks ended the week lower after concerns about drug prices were reignited, sinking biotech stocks, an emissions scandal engulfed Volkswagen (VLKAY), dragging down shares of automakers and their suppliers, and Caterpillar (CAT) announced that it may eliminate as many as 10,000 jobs in the next three years as commodity prices continue to slump. MACRO NEWS: Following the Federal Reserve's decision last week to wait before raising rates, the central bank made a concerted effort to give the market more clarity this week. Over last weekend, three Federal Reserve officials - San Francisco Fed President John Williams, St. Louis Fed President James Bullard and Richmond Fed President Jeffrey Lacker - all argued that an interest-rate increase is still warranted this year. Then, on Thursday night, Fed Chair Janet Yellen said during a speech at UMass Amherst that the central bank remains inclined to hike rates this year. Yellen's remarks were incrementally hawkish, but welcomed by the market, since they helped clarify the message the Fed delivered a week ago... In the U.S., Markit's flash manufacturing purchasing manager's index was flat at 53.0 in September, which was slightly better than the expectation for it to dip to 52.8. Durable goods orders for August declined 2.0%, versus expectations for a drop of 2.3%. When transportation items were removed, the core reading was breakeven, versus expectations for a rise of 0.1%. The third estimate of second quarter GDP showed the economy grew 3.9% quarter-over-quarter, versus expectations for the GDP growth estimate to stay at 3.7%. Personal consumption in Q2 is now believed to have grown 3.6%, up from the prior estimate of 3.1%. The final University of Michigan consumer sentiment reading for September came in at 87.2, which was down from August's 91.9 but above the expected 86.2 reading... The Asian Development Bank cut its growth forecast for the region, citing a weaker outlook for China and India and a delayed recovery in the world's advanced economies. The bank now sees the Chinese economy growing 6.8% this year and 6.7% next year, down from its previous forecasts of 7.2% and 7%, respectively. Markit's flash manufacturing PMI for China fell to 47.0 in September from 47.3 last month. Meanwhile, Japanese Prime Minister Shinzo Abe unveiled new economic targets, including a goal for a 20% increase in the target size of the Japanese economy to 600T yen, though he gave no timeframe for achieving this aspiration... In Europe, Markit's composite PMI for the eurozone came in at 53.9 in the first look for September, down from 54.3 in August and below expectations for a reading of 54.1. COMPANY NEWS: Biotech stocks declined after privately-held Turing Pharmaceuticals made headlines by enacting a 5,000% price increase on its treatment for toxoplasmosis, reigniting a debate around drug prices that previously embroiled costly Hepatitis C drugs including AbbVie's (ABBV) Viekira Pak and Gilead's (GILD) Sovaldi and Harvoni. Presidential candidate Hillary Clinton sent the debate to center stage by criticizing the "outrageous" prices of specialty drugs and laying out a plan to tackle "price gouging" in the specialty drug market. The NASDAQ Biotechnology index fell roughly xxx% for the week amid the attention paid to Turing's drug and Clinton's response... Volkswagen (VLKAY) shares trading in New York fell sharply to begin the week and ended the week far from where they'd been last Friday before the EPA said it found manipulations that violate U.S. environmental standards while testing certain of the automaker's diesel cars. The EPA said Volkswagen may face civil penalties of $37,500 for each vehicle not in compliance with federal clean air rules, which could total as much as $18B, according to Reuters. In the wake of the scandal, Chief Executive Officer Martin Winterkorn resigned, with the company's supervisory board subsequently praising the decision and selecting Matthias Mueller, the former head of Porsche (POAHY), as Winterkorn's successor as the company's new CEO... Caterpillar (CAT) shares dropped after the heavy machinery maker announced plans for job cuts and lowered its revenue guidance for this year and next. Caterpillar said that it would lay off 4,000-5,000 of its employees between now and the end of 2016 and could lay off up to 10,000 employees by 2018. Caterpillar cut its fiscal year 2015 revenue forecast by $1B and said its sees its fiscal year 2016 revenue to be 5% below this year, adding that it expects revenue declines in all three large segments next year... Online and mobile deal provider Groupon (GRPN) said it plans to cut 1,100 jobs relating primarily to the company's international operations... Nike jumped after the athletic gear giant reported better than expected earnings and futures orders, prompting numerous price target hikes and at least one upgrade at Street research firms. Among other companies reporting earnings this week, BlackBerry (BBRY), ConAgra (CAG), Carnival (CCL), and CarMax (KMX) fell immediately following their quarterly reports... Apple (AAPL), which has previously been reported to be working on an electric car via its "Project Titan," is speeding up those efforts and setting 2019 as a target to ship its first vehicle, according to The Wall Street Journal... Against the backdrop of China's President Xi Jinping visiting the U.S., Boeing (BA) announced deals to sell 300 planes to three Chinese companies and set up an aircraft factory in in the Asian nation, while Cisco (CSCO) announced a partnership with Chinese server maker Inspur Group... Lloyd Blankfein, Goldman Sachs (GS) Chairman and CEO, disclosed that he was diagnosed with lymphoma. "Fortunately, my form of lymphoma is highly curable and my doctors' and my own expectation is that I will be cured," Blankfein stated in an open letter that was shared by the bank... GoPro (GPRO) finished the week about xxx% lower after Barron's contended in a feature article last weekend that the company's stock could plunge another 30% to $25 as Apple, Sony (SNE) and others pressure the company's "one-hit wonder" products... On the M&A front, Atmel (ATML) agreed to be acquired by German chipmaker Dialog Semiconductor in a deal valued at roughly $4.6B and Starwood Waypoint (SWAY) announced a stock-for-stock merger agreement with Colony American Homes. INDEXES: The Dow lost about 0.43% to close at 16,314.67, the S&P 500 fell about 1.35% to close at 1,931.34, and the Nasdaq declined about 2.89% to close at 4,686.50.
14:52 EDTNVONovo Nordisk gets FDA approval for diabetes mellitus treatments
The U.S. FDA announced that it approved Tresiba and Ryzodeg 70/30 to improve blood sugar control in adults with diabetes mellitus. Tresiba is a long-acting insulin analog indicated to improve glycemic control in adults with type 1 and 2 diabetes mellitus. Ryzodeg 70/30 is a mixture of insulin degludec, a long-acting insulin analog, and insulin aspart, a rapid-acting human insulin analog. It is indicated to improve glycemic control in adults with diabetes mellitus. Tresiba and Ryzodeg are manufactured by Novo Nordisk.
14:51 EDTNVONovo Nordisk gets FDA approval for diabetes mellitus treatments
Subscribe for More Information
09:02 EDTTEVATeva acquires Gecko Health Innovations, terms not disclosed
Subscribe for More Information
09:01 EDTMDCOThe Medicines Co. receives CHMP positive opinion for Ionsys
Subscribe for More Information
08:37 EDTTEVAAntares Pharma could benefit from drug pricing controversy, says Oppenheimer
Subscribe for More Information
07:42 EDTRHHBYExelixis: CHMP adopts positive opinion for cobimetinib, vemurafenib combination
Subscribe for More Information
07:34 EDTGILDGilead says CHMP adopts poistive opinion for single tablet regimen Genvoya
Gilead Sciences announced that the Committee for Medicinal Products for Human Use has adopted a positive opinion on the company's Marketing Authorization Application for the investigational, once-daily single tablet regimen Genvoya for the treatment of HIV-1 infection. The data submitted in the MAA support the use of the regimen among adult and adolescent treatment-naive individuals, virologically suppressed adults who switch regimens and adults with mild-to-moderate renal impairment. The CHMP's recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union. If authorized, Genvoya would be Gilead's first single tablet regimen to contain TAF. The MAA for Genvoya is supported by 48-week data from two pivotal Phase 3 studies in which the regimen met its primary objective of non-inferiority compared to Gilead's Stribild among treatment-naive adult patients. In the studies, Genvoya demonstrated improvement in surrogate laboratory markers of renal and bone safety as compared to Stribild. The MAA is also supported by data from additional Phase 3 studies evaluating the TAF-based regimen among adolescents, virologically suppressed adult patients who switched to Genvoya and adult patients with mild-to-moderate renal impairment.
07:22 EDTTEVA, RHHBYEuropean Society for Medical Oncology to hold a conference
Subscribe for More Information
06:23 EDTRHHBYRoche CEO: Will see growth regardless of setbacks, Reuters reports
Roche Holding's product lineup is so good that the company will see growth regardless of setbacks, Reuters reports, citing an interview with CEO Severn Schwan with Finanz und Wirtschaft. "Roche could have six new active pharmaceutical ingredients approved within two years. We never had this before," Schwan said. Reference Link
September 24, 2015
08:36 EDTBDXBecton Dickinson's Enteric Parasite Panel cleared by FDA
Subscribe for More Information
07:26 EDTTEVATeva stock performance can improve into year-end, says Deutsche Bank
Subscribe for More Information
07:12 EDTTEVATeva added to short-term buy list at Deutsche Bank
Subscribe for More Information
1 | 2 | 3 | 4 >>

Sign up for a free trial to see the rest of the stories you've been missing.
I agree to the disclaimer & terms of use