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News Breaks
May 21, 2014
11:09 EDTBMY, ABBV, MRK, GILDGilead sees new pushback over price of hepatitis C drug
An insurance trade group harshly criticized Gilead (GILD) for charging too much for its hepatits C drug, while Florida has reportedly restricted the ability of Medicaid recipients to receive the drug. WHAT'S NEW: The price that Gilead is charging for its HCV treatment Sovaldi is "astronomical," America's Health Insurance Plans stated on its blog yesterday. The drug has shown "tremendous results" and is the "kind of medical innovation we need to sustain," but the price is not sustainable for consumers or society and is the result of Gilead taking "advantage of a lack of competition," according to the group, which represents the health insurance industry. Meanwhile, Florida has restricted the ability of Medicaid patients in the state to access Sovaldi, Bank of America Merrill Lynch reported in a note to investors earlier today. The firm wrote that Florida's decision supports its thesis that payers will increasingly limit access to expensive drugs. WHAT'S NOTABLE: In late March, shares of Gilead fell after three Democratic members of the House Committee on Energy and Commerce said they were concerned about the price the company is charging for Sovaldi. In a letter to Gilead's CEO, the House members stated that reports have indicated that Gilead plans to charge $84,000 per treatment for Sovaldi and that they were concerned that the drug would not be able to cure patients if it cannot be afforded. Sovaldi's costs are likely to be too high for many patients, including those with both public and private insurance, the lawmakers contended, adding that the FDA's decision to speed the approval of Sovaldi makes the high price of the drug even more problematic. They requested that the company provide more information about its methodology for determining Sovaldi's prices and they sought information about any discounts the company is providing to low income patients. Other companies that are developing HCV drugs include AbbVie (ABBV), Bristol-Myers Squibb (BMY), and Merck (MRK). PRICE ACTION: In mid-morning trading, Gilead rose 24c, or 0.3%, to $81.38. Over the last three months, Gilead shares are down about 1.5%.
News For GILD;ABBV;BMY;MRK From The Last 14 Days
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July 2, 2015
09:35 EDTGILDActive equity options trading on open
Active equity options trading on open: AAPL HP TSLA FB GRPN BP MEP GILD
July 1, 2015
16:33 EDTGILDGilead submits NDA to FDA for single tablet regimen for HIV containing R/F/TAF
Gilead Sciences (GILD) announced that it has submitted a New Drug Application, or NDA, to the FDA for an investigational, once-daily single tablet regimen that combines Gilead’s emtricitabine 200 mg and tenofovir alafenamide, or TAF, 25 mg with rilpivirine 25 mg, or R/F/TAF, from Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ), for the treatment of HIV-1 infection in adult and pediatric patients 12 years of age and older. The data submitted in the NDA support the use of R/F/TAF among patients who are HIV treatment-naïve or who are virologically suppressed and want to replace their current antiretroviral treatment regimen. A Priority Review voucher acquired from Knight Therapeutics in November 2014 was submitted to the FDA along with the R/F/TAF NDA. Under the Prescription Drug User Fee Act, or PDUFA, the anticipated target action date for the R/F/TAF NDA is six months after the FDA’s acceptance of the filing. TAF is a novel, investigational nucleotide reverse transcriptase inhibitor, or NRTI, that has demonstrated high antiviral efficacy at a dose less than one-tenth that of Gilead’s Viread, as well as improved renal and bone laboratory parameters as compared to TDF in clinical trials in combination with other antiretroviral agents. In addition to R/F/TAF, two other TAF-based HIV treatments are also under FDA review.
June 30, 2015
11:58 EDTGILDStocks with call strike movement; GILD YHOO
Gilead (GILD) November 130 call option implied volatility increased 2% to 28, Yahoo (YHOO) October 46 call option implied volatility decreased 2% to 29 according to IVolatility.
09:35 EDTGILDActive equity options trading on open
Active equity options trading on open: AAPL FB GILD BABA BAC MU WYNN MSFT NFLX
07:32 EDTGILD, ABBVJuno pact leaves Celgene set for growth past Revlimid, says Deutsche Bank
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June 29, 2015
16:30 EDTGILDFDA sued by advocacy groups for Gilead Hep-C drug trial data, Reuters says
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08:39 EDTMRKMerck says Phase 3 Emend data shows it provides 'greater protection' from nausea
Merck announced results from a Phase 3 study investigating the safety and efficacy of single-dose Emend for Injection, Merck’s substance P/neurokinin receptor antagonist, in combination with other anti-vomiting medicines, for the prevention of chemotherapy-induced nausea and vomiting, or CINV, in adult cancer patients receiving moderately emetogenic chemotherapy, or MEC. In the study, the first to evaluate an intravenous NK-1 receptor antagonist for the prevention of CINV associated with MEC, the single-dose Emend for Injection regimen provided greater protection from nausea and vomiting following administration of chemotherapy versus an active control of placebo with other anti-vomiting medicines. These data were presented in an oral session at the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology Annual Meeting on “Supportive Care in Cancer” in Copenhagen.
June 26, 2015
12:02 EDTABBVEMA adopts positive opinion on AbbVie's Humira for acne inversa
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08:31 EDTBMYAlexandria Real Estate announces lease with Bristol-Myers in Cambridge
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June 25, 2015
09:34 EDTBMYBristol-Myers expects Waltham site to close in early 2018
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09:34 EDTGILDActive equity options trading on open
Active equity options trading on open: AAPL FB NFLX AMZN BAC CVX TWTR INTC GILD BBBY
09:32 EDTBMYBristol-Myers opens research site in Cambridge, discontinues virology research
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June 24, 2015
09:07 EDTMRKCAR-T cancer drug researchers seen as M&A targets, Bloomberg says
Juno Therapeutics (JUNO), Kite Pharma (KITE) and Bluebird Bio (BLUE) are trading well above their IPO levels as takeovers predictions have spurred interest and share increases for the developers of CAR-T gene therapies, said Bloomberg's "Real M&A" column, quoting Dimo Dimov, a professor at the University of Bath’s School of Management, as having said that companies such as Pfizer (PFE), Merck (MRK), Roche (RHHBY) and AstraZeneca (AZN) are "closely watching" the firms. Cellectis (CLLS), which is working with Pfizer on its own approach to CAR-T therapy, has said it wants to bring its therapy to market and doesn’t anticipate a sale, the report noted. Reference Link
07:29 EDTBMYFDAnews to hold a summit
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06:12 EDTABBVAbbVie announces new TURQUOISE-III study results
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June 23, 2015
14:10 EDTGILDGilead price target raised to $150 from $130 at Argus
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June 22, 2015
09:40 EDTGILDActive equity options trading on open
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08:52 EDTBMYPortola, Bristol-Myers, and Pfizer announce results from Phase 3 ANNEXA study
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05:35 EDTBMYAllied-Bristol Life Sciences licenses IP from Harvard University
Allied-Bristol Life Sciences, a biopharmaceutical enterprise jointly owned by Allied Minds and Bristol-Myers Squibb, announced that it has entered into a licensing agreement with Harvard University based on research and intellectual property developed in Professor Malcolm Whitman’s lab at the Harvard School of Dental Medicine. Building on previous studies conducted with Mark Sundrud, PhD, and Anjana Rao, PhD, at Boston Children’s Hospital, Professor Whitman’s lab, in collaboration with Professor Ralph Mazitschek, PhD, at the Center for Systems Biology at Massachusetts General Hospital, has shown that HF works through inhibition of Prolyl-tRNA synthetase, which leads to activation of an amino acid restriction response pathway. Based on this novel and differentiated mechanism, several lead molecules have been identified by the groups at HMS and MGH that have the potential to lead to effective therapy for several conditions including fibrotic and autoimmune diseases. The licensing agreement with Harvard’s Office of Technology Development is among the first in a series of discovery and development projects that Allied-Bristol Life Sciences intends to pursue. The license to the technology from Professor Whitman’s lab will be held by a new ABLS subsidiary specifically formed to pursue further research and pre-clinical development of the technology and associated molecules.
June 21, 2015
13:14 EDTMRKMerck shares could return 25%, Barron's says
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