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Stock Market & Financial Investment News

News For PFE;ACT;JNJ;NVS;TEVA;MYL;GNK;BMY;GSK From The Last 14 Days
Check below for free stories on PFE;ACT;JNJ;NVS;TEVA;MYL;GNK;BMY;GSK the last two weeks.
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September 22, 2014
19:03 EDTACTAllergan rejected buyout bid from Actavis, in advanced talks for Salix, WSJ says
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16:07 EDTNVSAnacor announces commercial launch of KERYDIN topical solution in U.S.
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10:15 EDTACTOn The Fly: Analyst Downgrade Summary
Today's noteworthy downgrades include: Actavis (ACT) downgraded to Equal Weight from Overweight at Barclays... Aetna (AET) downgraded to Neutral from Buy at BofA/Merrill... Auxilium (AUXL) downgraded to Hold from Buy at Stifel... CARBO Ceramics (CRR) downgraded to Neutral from Buy at Sterne Agee... Commerzbank (CRZBY) downgraded to Underperform from Neutral at Exane BNP Paribas... Concur (CNQR) downgraded to Neutral from Buy at Nomura... Dresser-Rand (DRC) downgraded to Neutral from Accumulate at Global Hunter... Finish Line (FINL) downgraded to Equal Weight from Overweight at Morgan Stanley... General Communications (GNCMA) downgraded to Hold from Buy at Drexel Hamilton... InvenSense (INVN) downgraded to Neutral from Outperform at RW Baird... Las Vegas Sands (LVS) downgraded to Market Perform from Outperform at Wells Fargo... Lindsay Corp. (LNN) downgraded at Sterne Agee... Melco Crown (MPEL) downgraded to Market Perform from Outperform at Wells Fargo... Outerwall (OUTR) downgraded to Sell from Neutral at B. Riley... PSEG (PEG) downgraded to Hold from Buy at Jefferies... Realogy (RLGY) downgraded to Underperform from Neutral at Credit Suisse... Regal-Beloit (RBC) downgraded to Accumulate from Buy at Global Hunter... SABMiller (SBMRY) downgraded to Market Perform from Outperform at Bernstein... Saba Software (SABA) downgraded to Neutral from Buy at B. Riley... Suburban Propane (SPH) downgraded to Market Perform from Outperform at Wells Fargo... Swiss Re (SSREY) downgraded to Underperform from Neutral at Exane BNP Paribas... Towers Watson (TW) downgraded to Buy from Conviction Buy at Goldman... Valmont (VMI) downgraded at Sterne Agee... Walgreen (WAG) downgraded to Equal Weight from Overweight at Barclays... Watts Water (WTS) downgraded to Neutral from Buy at Janney Capital... Wynn Resorts (WYNN) downgraded to Market Perform from Outperform at Wells Fargo... Yahoo (YHOO) downgraded to Neutral from Buy at BofA/Merrill.
10:15 EDTGSKOn The Fly: Analyst Upgrade Summary
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08:10 EDTACTActavis multiple expansion case 'compelling,' says JPMorgan
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07:50 EDTJNJDoctors continue to use morcellators despite FDA warning, J&J halt, WSJ says
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07:21 EDTBMY, GSKEBD Group to hold a conference
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07:07 EDTJNJSynageva appoints Robert Bazemore as COO
Synageva announced the appointment of Robert Bazemore as Chief Operating Officer. Bazemore will oversee the planned global commercial launch of the company's lead program, sebelipase alfa for LAL Deficiency, and will have responsibility for the company's global commercial, market access and medical affairs operations. Bazemore last served at Johnson & Johnson (JNJ) in varoius roles including Vice President, Ethicon New Growth Platforms and President of Janssen Biotech, a part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
05:52 EDTACTActavis downgraded to Equal Weight from Overweight at Barclays
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05:27 EDTGSKGlaxoSmithKline upgraded to Buy from Neutral at Goldman
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September 19, 2014
16:00 EDTPFEOptions Update; September 19, 2014
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14:18 EDTACTAkorn competition settlement over VersaPharm deal approved by FTC
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11:25 EDTMYLSenators bring bill requiring companies to settle before inverting
U.S. Senators Sherrod Brown and Dick Durbin announced new legislation requiring corporations to "Pay What You Owe Before You Go" – settling their U.S. tax bill before relocating to a foreign country. "Everyone knows that before you leave a restaurant you have to settle your tab," Brown said. "Corporations shouldn’t get to play by different rules. While it is critical that we reach a long-term solution that reforms our international corporate tax code by implementing a global minimum tax and reducing the statutory tax rate, this bill is an immediate, commonsense measure to ensure businesses settle up before leaving the U.S." Among the deals or possible transactions that involve inversion are Mylan's (MYL) acquisition of Abbott (ABT), Medtronic's (MDT) acquisition of Covidien (COV) and Valeant's (VRX) proposed takeover of Allergan (AGN).
10:07 EDTPFEHigh option volume stocks
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05:58 EDTGSKGlaxoSmithKline to pay GBP 297M fine to Chinese government
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September 17, 2014
16:18 EDTACTDepomed says FDA recognizing 7 years orphan-drug exclusivity for Gralise in PHN
Depomed (DEPO) disclosed in a filing that on September 16 the company received a letter from the FDA informing the company that pursuant to the order issued on September 5 by a judge of the U.S. District Court for the District of Columbia, the FDA is recognizing seven years of orphan-drug exclusive approval for the company’s Gralise for the management of postherpetic neuralgia. The letter also confirms the FDA will not approve any abbreviated New Drug Application referencing Gralise during the period of orphan-drug exclusive approval, which began on January 28, 2011. The FDA has 60 days after issuance of the order in Depomed, Inc. v. HHS to file a notice appealing the order to the United States Court of Appeals for the Federal Circuit. The period of orphan drug exclusivity applicable to Gralise for PHN is separate from marketing exclusivity arising from the previously disclosed decision issued on August 19 in the company’s patent litigation lawsuit against Actavis (ACT) related to an ANDA filed by Actavis seeking to market generic versions of Gralise. The decision found that Actavis infringed all seven of the company’s patents asserted in the litigation, upheld the validity of the patents and enjoined FDA approval of the Actavis ANDA until February 26, 2024, the latest expiration date of the infringed patents. On September 15, Actavis filed a notice appealing the decision to the United States Court of Appeals for the Federal Circuit, Depomed stated. Previously disclosed settlement agreements between the Company and two other Gralise ANDA filers permit the sale of generic Gralise beginning on January 1, 2024.
14:57 EDTGSKProsensa announces commencement of re-dosing of drisapersen
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11:01 EDTMYL, TEVA, ACTActavis drops after NY AG seeks to block Alzheimer drug switch
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09:16 EDTACTActavis Namenda sales of $990M could be at risk, says BMO Capital
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09:06 EDTACTNew York AG files antitrust lawsuit against Actavis
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08:36 EDTJNJJanssen-Cilag announces results from post-hoc canagliflozin analysis
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08:12 EDTJNJJanssen-Cilag announces results from Phase 3 Invokana trial
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08:05 EDTTEVAEagle Pharm says Teva requests motion to dismiss Bendamustine lawsuit
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07:43 EDTBMY, PFEBofA/Merrill to hold a conference
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07:39 EDTGSKMorningstar to hold a conference
Management Behind the Moat Conference to be held in Chicago on September 17-18.
September 16, 2014
11:51 EDTPFE, ACT, MYLOECD looks to close tax loopholes with new proposals
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07:33 EDTMYL, GSKMylan initiates Phase III clinical trials for Advair Diskus and Lantus
Mylan (MYL) announced it is initiating Phase III clinical trials for its generic version of GlaxoSmithKline's (GKS) Advair Diskus and its insulin analog to Sanofi's (SNY) Lantus. In October Mylan will commence a Phase III clinical trial to evaluate the equivalence of its product to Advair Diskus when administered by inhalation in adult asthma patients.
07:31 EDTNVS, JNJ, GSKEuropean Association for Study of Diabetes to hold annual meeting
50th Annual Meeting of EASD to be held in Vienna, Austria on September 15-19.
07:19 EDTPFECompanies' share buybacks at fasttest clip since 2007, WSJ reports
Companies are buying back their own shares at its fastest pace since the financial crisis to fuel a stock rally, reports the Wall Street Journal. According to Birinyi Associates, companies have bought back $338.3B of stock in 1H14, the most since 2007. Citing an analysis by Barclays, companies with the largest buyback programs by dollar value have outperformed the broader market by 20% since 2008. Reference Link
06:06 EDTACTActavis, subsidiary sued by NY attorney general, Reuters says
New York attorney general Eric Schneiderman filed a lawsuit versus Actavis and its subsidiary, Forest Laboratories, to impede the firms from stopping its Alzheimer's medication production, claiming that they were aiming to illegally maintain a monopolistic stance, according to Reuters, citing comments from Schneiderman. Reference Link
06:00 EDTBMYBristol-Myers announces Health Canada approval of Yervoy
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September 15, 2014
16:10 EDTGSKFive Prime announces option exercise by GlaxoSmithKline to obtain license
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09:25 EDTPFEJPMorgan biotech analysts hold an analyst/industry conference call
Analysts assess Pfizer's M&A options on an Analyst/Industry conference call to be held on September 15 at 10 am.
07:27 EDTNVS, JNJ, GSK, PFEIBC Life Sciences to hold a conference
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07:27 EDTACT, PFEPfizer acquisition could drive shares higher, says JPMorgan
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07:21 EDTNVSHeart Failure Society of America to hold annual meeting
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06:34 EDTMYLMylan signs agreement with Gilead
Mylan (MYL) announced that its subsidiary Mylan Laboratories Limited has entered into an agreement with Gilead Sciences (GILD), under which Mylan has been licensed the non-exclusive rights to manufacture and distribute sofosbuvir and the investigational single tablet regimen of ledipasvir/sofosbuvir in 91 developing countries. Sofosbuvir is marketed by Gilead under the brand name Sovaldi. The countries within the agreement account for more than 100M people living with hepatitis C globally representing 54% of the total global infected population. Under the licensing agreement, Mylan will receive a technology transfer enabling the company to manufacture low-cost versions of the medicines for developing markets.
September 14, 2014
13:32 EDTPFEPfizer shares look cheap, Barron's says
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September 12, 2014
10:32 EDTACT, PFEPfizer CEO says company still open to inversion deal, FT says
Pfizer (PFE) CEO Ian Read said U.S. rhetoric against tax inversions has been "political theater" ahead of midterm elections and made clear that his company is still open to a potential tax-saving acquisition, according to Financial Times, which added Read's comment about not being “held hostage” over price would likely be read as a signal the company might look elsewhere after being rebuffed by AstraZeneca (AZN). The Fly notes that Bloomberg previously reported, citing people familiar with the matter, that Pfizer is looking at targets other than AstraZeneca, including Actavis (ACT). Shares of Actavis trading in New York are up 2% this morning. Reference Link
09:01 EDTTEVATeva to present Copaxone gene expression analysis
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08:06 EDTTEVATeva presents new clinical safety data in RRMS patients treated with Laquinimod
Teva (TEVA) and Active Biotech (ACTI) announced new follow-up data evaluating the clinical safety of laquinimod in patients with relapsing-remitting multiple sclerosis, or RRMS, who were treated with laquinimod in Phase II, Phase III and open-label extension studies for two or more years. The pooled safety analysis of the Phase II LAQ/5063 and the Phase III ALLEGRO and BRAVO extension studies supports findings observed in the core studies where currently identified risks were observed within the first months of laquinimod treatment. In the pooled safety analysis, rates of adverse events, or AEs, and serious AEs were lower in the open-label extensions than in the core studies and less than three percent of patients discontinued treatment due to AEs during these extensions. Additionally, shifts to potentially significant laboratory values were considerably lower in patients exposed to at least two years of laquinimod.
08:03 EDTTEVATeva, Active Biotech present laquinimod follow-up data
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05:18 EDTNVSNovartis announces new data confirms high efficacy of Gilenya in achieving NEDA
Novartis announced new analyses presented at the Joint ACTRIMS-ECTRIMS Meeting in Boston, USA, which confirmed the high efficacy of Gilenya in achieving 'no evidence of disease activity', or NEDA, in people with relapsing-remitting multiple sclerosis, or RRMS, across four key disease measures - relapses, MRI lesions, brain shrinkage and disability progression. Specifically, patients taking Gilenya had a more than four-times greater likelihood of achieving NEDA across these four key measures. NEDA is currently defined as having no relapses, MRI lesions and disability progression. These new analyses from the phase III FREEDOMS and FREEDOMS II trials reinforce the value of including brain shrinkage to the definition of NEDA. The inclusion of brain shrinkage into the NEDA definition would allow physicians to obtain a more complete assessment of a patient's disease, including the underlying damage in MS.
September 11, 2014
09:31 EDTTEVATeva announces new data from Phase IIIb GLACIER study
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07:11 EDTJNJMedivation price target raised to $112 from $89 at Stifel
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03:27 EDTTEVATeva Canada announces launch of generic version of Cipralex
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September 10, 2014
14:25 EDTTEVATeva Canada announces launch of generic version of Cipralex
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10:14 EDTJNJJohnson & Johnson says off to 'very good start' this year
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09:58 EDTGSKGlaxoSmithKline has a conference call hosted by JPMorgan
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09:02 EDTACTActavis won't see serious long-term impact from rejection, says Sterne Agee
After the FDA's Cardiovascular and Renal Drugs Advisory Committee voted to recommend against approval of Actavis' New Drug Application for the fixed-dose combination of nebivolol and valsartan for the treatment of hypertension, Sterne Agee does not thinks the vote is very meaningful to the company's longer-term growth and earnings potential. The firm says that removing the product from its revenue outlook causes its 2018 EPS estimate for the company to drop by less than 1%. The firm still thinks the company can easily reach its 2017 EPS target of about $20. Sterne Agee keeps a $272 price target and Buy rating on the shares.
08:56 EDTACTFDA advisors recommend against approval of Actavis' nebivolol/valsartan combo
Actavis last night confirmed that the FDA's Cardiovascular and Renal Drugs Advisory Committee has voted to recommend against approval of Actavis' New Drug Application for the fixed-dose combination of nebivolol and valsartan for the treatment of hypertension. The committee vote was six to four recommending against approval. The committee recommendation is not binding on the FDA, which makes the final decision regarding approval. Actavis expects FDA action on its NDA for the fixed-dose combination of nebivolol and valsartan by the fourth quarter of 2014. Actavis' Senior VP, Global Brands Research and Development, David Nicholson, said, "Although we are disappointed in the Committee's recommendation regarding the fixed-dose combination of nebivolol and valsartan, we remain fully committed to supporting the NDA for this important potential new treatment option for patients with hypertension. We remain confident in the safety and efficacy of the combination of these two widely used and well-tolerated treatments, and we look forward to working with the FDA as it completes its review." Shares of Actavis are down more than 2% in pre-market trading following yesterday's committee recommendation.
07:02 EDTMYLMylan to acquire U.S. rights to Arixtra injection from Aspen
Mylan's subsidiary Mylan Ireland Limited has entered into an agreement to acquire the U.S. commercialization, marketing and intellectual property rights relating to Arixtra Injection and the authorized generic of Arixtra from Aspen Global Incorporated. Arixtra is indicated for the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism in patients undergoing hip fracture surgery. Mylan already is selling Arixtra in the U.S. through an interim distribution arrangement with Aspen and Apotex is currently selling the AG of Arixtra, which will be transitioning to Mylan Institutional by year end.
05:17 EDTNVSNovartis Gilenya data confirms reducing brain shrinkage matter for MS patients
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September 9, 2014
17:06 EDTACTFDA panel votes against Actavis blood pressure pill, Bloomberg says
FDA advisers said that Actavis's experimental pill that combines two existing drugs to lower high blood pressure doesn’t provide a clinically meaningful benefit over the two drugs alone, says Bloomberg. The advisory panel voted 6 to 4 against recommending the treatment, added Bloomberg. Shares of Actavis are trading down almost 1% in after-hours trading. Reference Link
10:18 EDTACTDollar General listed among 5 largest long positions by Jana Partners
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07:55 EDTNVSOphthotech earlier than expected Novartis payment positive, says Oppenheimer
After Ophthotech (OPHT) received a $50M Phase 3 enrollment payment from Novartis (NVS) earlier than expected, Oppenheimer thinks the payment highlights an underappreciated stock driver for Opthotech, and demonstrates that recent suggestions of Phase 3 enrollment timelines possibly slipping are unwarranted. The firm believes the company is executing well on the Fovista Phase 3 program and keeps an Outperform rating on the stock.
06:42 EDTMYLLew expects to make decision on combating inversion deals soon, NY Times reports
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06:25 EDTGSKDocuments show DOJ probed GSK China unit in 2012, Reuters says
Internal documents revealed that a U.S. anti-bribery investigation into GlaxoSmithKline (GSK) touched on the firm's Chinese consumer healthcare division two years ago, which infers that the company's compliance issues in the country could be broader than initially discovered, according to Reuters, citing the documents. Reference Link
September 8, 2014
12:40 EDTTEVAFTC sues AbbVie over blocking of AndroGel generics
The Federal Trade Commission has filed a complaint in federal district court charging several pharmaceutical companies with "illegally blocking American consumers’ access to lower-cost versions of the blockbuster drug AndroGel." The FTC's complaint alleges that AbbVie (ABBV) and its partner Besins Healthcare filed baseless patent infringement lawsuits against potential generic competitors to delay the introduction of lower-priced versions of the testosterone replacement drug AndroGel. While the lawsuits were pending, AbbVie then entered into an anticompetitive pay-for-delay settlement agreement with Teva Pharmaceuticals (TEVA) to further delay generic drug competition, the FTC claims. Reference Link
11:05 EDTMYLOptions with increasing implied volatility
Options with increasing implied volatility: NPSP GILD VNET AVNR GTAT YHOO RHT VRTX SDRL COV MYL
10:04 EDTMYLMylan calls active on activist investor speculation
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09:57 EDTMYLRumor: Mylan moves up on activist investor speculation
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09:27 EDTTEVA, NVS, MYLLeerink biotech analyst holds a luncheon meeting with a conference call
Biotech Analyst Schwartz provides an update on key trends and controversies for marketed MS therapies and discusses new data presented at ACTRIMS-ECTRIMS at a Luncheon Meeting with an Analyst/Industry conference call to be held in Boston on September 11 at 12:15 pm.
08:48 EDTGSKGilead announces AMBITION study results in collaboration with Glaxo
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08:38 EDTNVSMerus Labs acquires Sintrom from Novartis
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08:02 EDTTEVATeva completes Reslizumab Phase III program
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07:33 EDTNVSOphthotech achieves $50M milestone under ex-agreement with Novartis for Fovista
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07:15 EDTPFEIBC Life Sciences to hold a conference
10th Annual Cell Line Development & Engineering Conference to be held in Berkeley, California on September 8-10.
07:03 EDTMYLMylan annoucnes court grants summary judgment in favor of company
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