New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
March 26, 2013
06:32 EDTBMY, TEVA, ACT, GNK, NVS, PFE, GSK, MYL, JNJSome justices seem skeptical about payments to generic drug firms, NY Times says
Several Supreme Court justices seemed skeptical about the practice of brand name pharmaceutical companies paying generic companies to keep their cheaper drugs off the market for a longer time, according to The New York Times. Some of the justices appeared to be interested in issuing a narrow ruling in the case they are hearing regarding the issue that would not create a precedent, the newspaper added. Reference Link
News For PFE;ACT;JNJ;NVS;TEVA;MYL;GNK;BMY;GSK From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
1 | 2 | 3 | 4 | 5 | all recent news | >>
December 8, 2014
05:42 EDTNVSSandoz Phase III data shows filgrastim has similar safety, efficacy as NEUPOGEN
Sandoz, a Novartis (NVS) company, announced Phase III data that demonstrated similarity of its investigational biosimilar filgrastim compared to the US-licensed reference product, Amgen's (AMGN) NEUPOGEN in the prevention of severe neutropenia in patients with breast cancer receiving neoadjuvant myelosuppressive chemotherapy. The study also showed that repeated switching at each cycle between the investigational biosimilar and the originator filgrastim showed no impact on efficacy, safety or immunogenicity. The PIONEER study was a Phase III study designed to compare the efficacy and safety of the investigational biosimilar and the reference product with respect to mean duration of severe neutropenia following Cycle 1 chemotherapy. PIONEER was a randomized, double-blind, four-group, multi-center non-inferiority trial conducted at 27 centers. The trial randomized 218 breast cancer patients receiving neoadjuvant myelosuppressive chemotherapy.
December 7, 2014
14:54 EDTJNJIMBRUVICA data suggests promise in multiple myeloma
Subscribe for More Information
14:10 EDTBMYAmerican Society of Hematology to hold a meeting
Subscribe for More Information
13:06 EDTBMYBMY announces positive results in Phase 1b trial evaluating Opdivo
Subscribe for More Information
December 5, 2014
16:49 EDTACTAdvisory Committee recommends approval Of Actavis' ceftazidime-avibactam
Actavis announced that the Anti-Infective Drugs Advisory Committee convened by the U.S. Food and Drug Administration has voted to recommend approval of Actavis' New Drug Application for ceftazidime-avibactam, an investigational antibiotic being developed to treat hospitalized patients when limited or no treatment options are available for complicated intra-abdominal infections and complicated urinary tract infections caused by Gram-negative pathogens. The committee found the scientific and clinical evidence submitted by Cerexa, a wholly owned subsidiary of Actavis, adequately demonstrated the safety and efficacy of ceftazidime-avibactam in the treatment of the proposed cIAI and cUTI indications. The committee voted not to recommend approval of the combination for hospital-acquired bacterial pneumonia /ventilator-associated bacterial pneumonia and bacteremia.The Advisory Committee recommendation is not binding on the FDA, which makes the final decision regarding approval. Actavis expects FDA action on its NDA for ceftazidime-avibactam during the first quarter of 2015.
10:22 EDTPFE, BMYBristol-Myers call activity attributed to takeover speculation
Subscribe for More Information
10:05 EDTPFE, BMY, MYLBristol-Myers jumps 2% amid talk of potential Pfizer bid
Shares of Bristol-Myers (BMY) are up in early trading amid chatter of a potential takeover bid from Pfizer (PFE). The stock is up $1.26 to $60.15. Bristol's market capitalization stands around $99B, less than twice that of Pfizer's $200B. A Jefferies analyst last week called Mylan (MYL) the most likely takeover target for Pfizer. Pfizer is "highly motivated" to buy a foreign company using its overseas cash and Mylan looks like the most likely target, Jefferies analyst Jeffrey Holford wrote.
09:56 EDTBMY, PFERumor: Bristol-Myers strength attributed to takeover speculation
Subscribe for More Information
07:54 EDTTEVALannett names Michael Bogda as president, effective December 1
Subscribe for More Information
06:04 EDTGSKGSK won't pursue divestment of certain brands in established products portfolio
As announced at the company’s Q2 results in July, GSK started a process to consider the divestment of certain North American and European brands in its Established Products Portfolio.The company has evaluated all bids received and has concluded, consistent with its key criteria of maximizing shareholder value, not to pursue divestment of these products.
December 4, 2014
12:22 EDTNVSOn The Fly: Midday Wrap
Stocks on Wall Street began the session slightly lower despite relatively in-line jobless claims data, as European markets moved down following a rate decision and accompanying commentary from ECB President Mario Draghi. Adding to the modest pressure seen in morning trading may be the fact that oil prices continue to move lower. ECONOMIC EVENTS: In the U.S., initial jobless claims fell 17K to 297K in the week ended November 29, which was nearly in-line with the expectation for 295K first-time claims. Challenger reported announced layoffs fell 15.2K in November to 35.9K. In Europe, the European Central Bank kept its key rates unchanged, as expected. ECB President Mario Draghi said in his accompanying press conference that the latest euro area macroeconomic projections indicate lower inflation, accompanied by weaker real GDP growth and subdued monetary dynamics. Additionally, he stated that early next year the Governing Council will reassess the monetary stimulus achieved, the expansion of the balance sheet and the outlook for price developments. "Should it become necessary to further address risks of too prolonged a period of low inflation, the Governing Council remains unanimous in its commitment to using additional unconventional instruments within its mandate. This would imply altering early next year the size, pace and composition of our measures," Draghi said. COMPANY NEWS: Shares of Barnes and Noble (BKS) slid about 10% after the company reported lower than expected second quarter earnings and said it continues to expect both Retail comparable bookstore sales and Retail Core comparable bookstore sales to decline in the low-single digits this fiscal year. Additionally, Barnes & Noble and Microsoft (MSFT) agreed to terminate their commercial agreement and B&N agreed to acquire Microsoft's entire preferred interest in NOOK Media in exchange for $62.4M cash and 2.74M shares of its stock. MAJOR MOVERS: Among the notable gainers was Hawaiian Electric (HE), which jumped 16% after its board approved a plan to spin off ASB Hawaii, the parent company for American Savings Bank, and establish it as an independent publicly traded company and NextEra Energy (NEE) agreed to acquire the company, excluding the banking subsidiary. Array BioPharma (ARRY) rose 15% after announcing it has reached a definitive agreement with Novartis (NVS) to regain full worldwide rights to binimetinib, a MEK inhibitor in three Phase 3 trials, which Piper Jaffray called a "big win" for the company. Among the noteworthy losers was UTi Worldwide (UTIW), which fell 11.5% after confirming that exploratory conversations have taken place with DSV, but adding those discussions never progressed beyond a preliminary stage and that no talks are currently taking place. Also lower were shares of Express (EXPR), which declined over 9% after the apparel retailer reported lower than expected Q3 revenue and gave EPS guidance that fell short of estimates. INDEXES: Near midday, the Dow was down 53.56, or 0.3%, to 17,859.06, the Nasdaq was down 2.80, or 0.06%, to 4,771.67, and the S&P 500 was down 5.49, or 0.26%, to 2,068.84.
11:23 EDTJNJAppeals court reverses patent ruling in favor of J&J unit over Covidien
Ethicon Endo-Surgery, a Johnson & Johnson (JNJ) company, appealed a district court judgment regarding certain asserted patent claims of Tyco Healthcare. The appeals court affirmed-in-part, reversed-in-part, and vacated-in-part the prior judgment, because the lower court’s 102(g) findings were correct, but its 103 determination was improper, "including its decision to exclude the 102(g) prior art from the obviousness analysis," the court stated. In 2007, Tyco Healthcare changed its name to Covidien (COV). Reference Link
10:32 EDTTEVATeva receives positive outcomes in Europe for three-times-a-week COPAXONE
Teva Pharmaceutical Industries announced that it has received a positive outcome in the decentralized procedure for its new, three-times-a-week COPAXONE 40 mg/ml formulation for the treatment of adults with relapsing forms of multiple sclerosis RMS. The outcome follows a Positive Assessment Report from the United Kingdom, the Reference Member State’s Medicines and Healthcare Products Regulatory Agency, and all Concerned Member States in Europe who were involved in the procedure. Granting of national authorizations will happen in the near future. The three-times-a-week COPAXONE 40 mg/ml formulation will allow for an improved, less-frequent, subcutaneous dosing regimen for adults with RMS. The new formulation reduces the total number of injections by almost 60%, while maintaining the known benefits of once daily COPAXONE 20 mg/ml. “We welcome the opportunity to make COPAXONE 40 mg/ml available to patients with RMS in Europe,” said Rob Koremans, MD, President and CEO of Global Specialty Medicines at Teva. “Three-times-a-week COPAXONE 40 mg/ml will be available in Europe as early as the first quarter of 2015 with expected launches in Germany, Netherlands and Denmark. Launches in other EU countries are expected throughout 2015.”
10:03 EDTMYLMylan receives tentative FDA approval for abacavir/lamivudine NDAs
Mylan announced that its subsidiary Mylan Laboratories has received tentative approval from the FDA for its New Drug Applications for two dosages of abacavir/lamivudine tablets for oral suspension for the treatment of HIV-1 infection in pediatric patients. This is the first version of abacavir/lamivudine with scoring to allow for dose adjustment and is also flavored, Mylan said. The FDA's tentative approval through the President's Emergency Plan for AIDS Relief program means the formulations meet all of the agency's quality, safety and efficacy standards, it stated. The tentative approval follows a 2012 agreement between Mylan, Clinton Health Access Initiative and ViiV Healthcare to transfer the necessary technology and resources to facilitate regulatory authority submission, production and distribution of the new formulation to a total of 115 resource limited countries including all low-middle income, least developed countries and sub-Saharan Africa. Mylan's products are expected to be eligible for purchase in early 2015.
09:15 EDTNVSArray BioPharma to host conference call
Subscribe for More Information
09:01 EDTJNJVA negotiated $594 per dose price for Gilead HCV treatment
A Veterans Health Administration official told a Senate committee yesterday that Veterans' Affairs has "moved rapidly to deploy new, more effective, less toxic HCV treatments and has been able to negotiate significant discounts for these newer therapies." The agency negotiated a price of $594 per dose for Gilead's (GILD) Hepatitis C virus drug Sofosbuvir, below the commercial price of $1,000 per dose, VHA Chief Consultant for Pharmacy Benefits Management Michael Valentino told the Senate's Committee on Veterans' Affairs. The agency also received a $413 per dose price for Johnson & Johnson's (JNJ) Simeprevir, below the commerical price of $790. The VA has approximately 174,000 veterans in care with HCV, making it the largest single HCV provider in the U.S., Valentino pointed out. He added, "Like the rest of the country, VA has treated only a portion of Veterans for HCV because treatment and cures have been difficult to achieve due to low efficacy and high toxicity of standard drug therapies." Reference Link
08:45 EDTNVS, PFEAbbVie price target raised to $80 from $72 at Jefferies
Jefferies raised its price target for AbbVie shares to $80 while calling the company one of its top five global pharma picks for 2015. The firm's top U.S. pick is Pfizer (PFE) and its top Europe pick is Novartis (NVS). Bayer (BAYRY) and AstraZeneca (AZN) round out the top five. Jefferies thinks AbbVie's "strong momentum" will continue into the first half of 2015 and keeps a Buy rating on the name.
07:56 EDTACTActavis price target raised to $315 from $266 at Morgan Stanley
Subscribe for More Information
05:54 EDTNVSArray BioPharma regaining binimetinib a 'big win,' says Piper Jaffray
Subscribe for More Information
05:30 EDTTEVACTI BioPharma receives $15M payment from Teva for TRISENOX
Subscribe for More Information
1 | 2 | 3 | 4 | 5 | all recent news | >>

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use