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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
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June 29, 2015
08:35 EDTNVSAnacor announces amendment to KERYDIN commercialization agreement
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05:15 EDTNVSNovartis acquires Spinifex Pharmaceuticals, terms not disclosed
Novartis announced that it has entered into an agreement to acquire Spinifex Pharmaceuticals. Spinifex Pharmaceuticals is a U.S. and Australian-based, privately held development stage company, focused on developing a peripheral approach to treat neuropathic pain such as EMA401, a novel angiotensin II Type 2 receptor, or AT2R, antagonist. Financial terms were not disclosed.
June 26, 2015
10:38 EDTGSK, TEVACourt revives lawsuit over GlaxoSmithKline Lamictal drug, Bloomberg reports
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08:31 EDTBMYAlexandria Real Estate announces lease with Bristol-Myers in Cambridge
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07:44 EDTNVSNovartis drug Farydak recommended by CHMP for EU approval
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June 25, 2015
14:02 EDTNVSNovartis initiated with a Buy at HSBC
Price target CHF 115.
14:01 EDTGSKGlaxoSmithKline initiated with a Buy at HSBC
Price target GBP 17.
13:59 EDTTEVATeva initiated with a Hold at HSBC
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12:52 EDTTEVA, MYLEU to decide by July 29 on Mylan's bid for Perrigo, Reuters reports
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09:34 EDTBMYBristol-Myers expects Waltham site to close in early 2018
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09:32 EDTBMYBristol-Myers opens research site in Cambridge, discontinues virology research
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08:05 EDTTEVATeva, Active Biotech say patient enrollment finalized for CONCERTO trial
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June 24, 2015
13:37 EDTGSKGSK says CDC committee votedfor meningococcal group B vaccines
GlaxoSmithKline (GSK) announced that the U.S. Centers for Disease Control Advisory Committee on Immunization Practices voted for a Category B recommendation for meningococcal group B vaccination, including Bexsero, in individuals aged 16 to 23. Bexsero was approved by the FDA in January for use in individuals aged 10 through 25 years and acquired by GSK in March following the closure of the three-part transaction with Novartis (NVS).
13:23 EDTPFEPfizer says CDC committee votes to recommend MenB vaccine
Pfizer announced that the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices voted to recommend that decisions to vaccinate adolescents and young adults 16 through 23 years of age against serogroup B meningococcal disease should be made at the individual level with healthcare providers. It added, "Specifically, the ACIP voted that a serogroup B meningococcal vaccine series may be administered to adolescents and young adults 16 through 23 years of age to provide short term protection against most strains of serogroup B meningococcal disease. The preferred age for MenB vaccination is 16 through 18 years of age." Pfizer's Trumenba is FDA-approved for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. The ACIP recommendation will be forwarded to the director of the CDC and the U.S. Department of Health and Human Services for review and approval, Pfizer said.
11:02 EDTPFEPfizer lung cancer treatment granted FDA orphan drug designation
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09:07 EDTPFECAR-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
08:04 EDTTEVATeva launches PainMatters.com to support ‘responsible pain management’
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07:29 EDTBMYFDAnews to hold a summit
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June 23, 2015
14:17 EDTPFEGlycoMimetics to receive $20M payment from Pfizer
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14:16 EDTMYL, TEVABMO Capital sees strong fundamentals in Perrigo regardless of Mylan deal
Shares of Perrigo (PRGO) are trading higher intraday after BMO Capital Markets initiated coverage of the stock with an Outperform rating. The research firm is bullish on the shares regardless of whether Mylan's bid for the company succeeds, saying Perrigo is well-positioned to ride momentum in reduced-price healthcare. WHAT'S NEW: BMO Capital Markets' David Maris initiated coverage of Perrigo with an Outperform rating and a $246 price target. Maris cited the company's 70%-plus market share in store- and private-label brands, as well as its roughly $1B annual sales in the generics space. The analyst believes Perrigo will see continued benefit from larger trends driving consumer-centric healthcare and the curtailing of medical costs. WHAT'S NOTABLE: BMO Capital Markets noted that two upcoming Tysabri-related events are not accounted for by the Street, giving rise to a "significant" undervaluing of the shares. Mylan (MYL) has submitted multiple unsolicited offers for Perrigo, and while the likelihood of the deal seems low given Perrigo's numerous rejections and Teva's (TEVA) 4.61% blocking stake in Mylan. BMO Capital remarked that a failed deal should see "limited downside" for Perrigo. There could certainly be near-term volatility if a Mylan agreement doesn't materialize, but the analyst was confident in the well-positioned company's ability to deliver on both earnings per share and cash flow. PRICE ACTION: Shares of Perrigo are up nearly 2% in afternoon trading. The company saw a nearly 25% leap following Mylan's initial offer on April 8, though it has since dipped from that high.
14:01 EDTPFEPfizer announces enrollment of first patient in RESET study
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09:53 EDTPFEPfizer management to meet with FBN Securities
Meeting to be held in New York on June 25 hosted by FBN Securities.
08:49 EDTTEVA, MYLMylan CFO to meet with Tel Aviv bourse head Wednesday, Reuters says
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07:25 EDTGSK, PFEPiper Jaffray to hold a summit
2015 Piper Jaffray Heartland Summit is being held in Minneapolis on June 23-24.
06:01 EDTMYLPerrigo initiated with an Outperform at BMO Capital
BMO Capital analyst David Maris started Perrigo (PRGO) with an Outperform rating and $246 price target. Maris calls shares "significantly undervalued" on a fundamental basis and sees limited downside risk should Mylan (MYL) remove its unsolicited bid for the company.
June 22, 2015
08:52 EDTBMY, PFEPortola, Bristol-Myers, and Pfizer announce results from Phase 3 ANNEXA study
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07:01 EDTGSK, PFEPfizer to acquire Nimenrix, Mencevax from GlaxoSmithKline for $130M
Pfizer (PFE) announced that it has entered into an agreement with GlaxoSmithKline (GSK) to acquire its quadrivalent meningitis ACWY vaccines, Nimenrix and Mencevax, for a total consideration of approximately $130M. This transaction will add two high-quality and complementary vaccines to Pfizer’s portfolio, allowing the company to reach a broader global population. Nimenrix is a single dose meningococcal ACWY-TT conjugated vaccine designed to protect against Neisseria meningitidis, an uncommon but highly contagious disease that can lead to disability and death. Mencevax is a single-dose meningococcal ACWY unconjugated polysaccharide vaccine used to control outbreaks of meningococcal infection and for travelers to countries where the disease is endemic or highly epidemic. Pfizer does not expect this transaction to have any significant impact on its 2015 financial performance. The transaction is subject to customary closing conditions as well as regulatory approvals in several markets, and is expected to occur in the second half of 2015. Pfizer’s legal advisors for the transaction were Ropes & Gray and Clifford Chance.
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
19:53 EDTTEVA, MYLMylan CEO says Teva's 4.61% stake may be 'illegal,' Bloomberg reports
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June 19, 2015
11:39 EDTBMYBristol-Myers announces European Commission approval of Opdivo
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08:30 EDTMYL, TEVATeva completes purchase of 4.61% interest in Mylan
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07:23 EDTTEVATeva data quite strong, says Bernstein
After Teva (TEVA) announced data for its TEV-48125 drug in episodic migraine, Bernstein notes that the drug met its primary and secondary endpoints. The firm says that the reduction in migraine days of Teva's drug appears to be higher than what Amgen (AMGN) and Lilly (LLY) have shown. The firm continues to see the migraine treatments from Teva and Alder as better than those from Lilly and Amgen.
05:47 EDTMYLStocks with implied volatility movement; MYLCMG
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June 18, 2015
17:05 EDTNVS, TEVANovartis announces U.S. launch of Glatopa
Sandoz, a Novartis (NVS) company, announced the U.S. launch of Glatopa, the first generic version of Teva's (TEVA) Copaxone 20 mg/ml one-time-daily multiple sclerosis therapy.
15:41 EDTMYL, TEVATeva tender offer for Mylan likely imminent, says Citi
Citi said Teva (TEVA) is likely to build up a 4.6% stake in Mylan (MYL) by today and that a formal tender offer is likely coming soon. An official bid could come with a provision requiring board changes and a tender will likely trigger a "poison pill" by Mylan, the firm added. Citi has a Buy rating and $70 price target on Teva shares.
13:08 EDTGSKGlaxoSmithKline management to meet with Piper Jaffray
Meeting to be held in Minneapolis on June 23 hosted by Piper Jaffray.
12:51 EDTTEVATeva guidance assumed launch of Copaxone generic, says BMO Capital
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11:57 EDTTEVA, MYLMylan comments on ruling by appeals court on Copaxone patent
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11:54 EDTNVS, TEVA, MYLAppeals court invalidates Teva patent claim related to Copaxone
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10:41 EDTTEVAMomenta reports CAFC decision to invalidated remanded Teva patent
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10:01 EDTMYLOn The Fly: Analyst Initiation Summary
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09:35 EDTPFEActive equity options trading on open
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09:11 EDTTEVAAlexza Pharmaceuticals amends Adasuve commercial partnership agreements
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08:34 EDTTEVATeva to present new data from Phase 2b migraine prevention studies at AHS
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08:02 EDTTEVATeva, Microchips Biotech announce partnership agreement
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07:46 EDTMYLMylan initiated with a Buy at BTIG
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07:36 EDTTEVAReceptos remains an attractive takeover candidate, says Leerink
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06:57 EDTNVSMallinckrodt says Questcor facing multi-state antitrust probe
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06:09 EDTTEVA, MYLTeva raises stake in Mylan to 4.3%, Globes reports
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June 17, 2015
10:00 EDTPFE, BMYOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: AbbVie (ABBV) initiated with an Overweight at Piper Jaffray... Arista Networks (ANET) initiated with a Buy at Sterne Agee CRT... Astec (ASTE) initiated with a Buy at Maxim... Bristol-Myers (BMY) initiated with an Underweight at Piper Jaffray... Community Healthcare (CHCT) initiated with an Outperform at Oppenheimer... Eli Lilly (LLY) initiated with an Overweight at Piper Jaffray... Fitbit (FIT) initiated with a Buy ahead of IPO at Dougherty... Hortonworks (HDP) initiated with a Buy at Mizuho... II-VI (IIVI) initiated with a Buy at Benchmark Co.... J Sainsbury (JSAIY) initiated with an Underperform at Credit Suisse... McDermott (MDR) initiated with an Outperform at Cowen... Merck (MRK) initiated with a Neutral at Piper Jaffray... Molina Healthcare (MOH) initiated with a Buy at UBS... Pacific DataVision (PDVW) initiated with a Buy at Canaccord... Pfizer (PFE) initiated with an Overweight at Piper Jaffray... Quest Resource (QRHC) initiated with a Buy at Roth Capital... Regional Management (RM) initiated with a Buy at Janney Capital... Rofin-Sinar (RSTI) initiated with a Buy at Benchmark Co.... Salesforce (CRM) initiated with a Neutral at Exane BNP Paribas... Sprouts Farmers Markets (SFM) initiated with a Neutral at Cleveland Research... Tesco (TSCDY) initiated with an Underperform at Credit Suisse... WM Morrison (MRWSY) initiated with a Neutral at Credit Suisse... WWE (WWE) initiated with a Buy at BTIG... World Acceptance (WRLD) initiated with a Buy at Janney Capital... Zafgen (ZFGN) initiated with a Buy at SunTrust.
07:25 EDTBMY, PFEPiper calls Bristol 'modestly overvalued,' starts shares with sell
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07:21 EDTJNJGeneric ADHD drugs still sold despite FDA non-equivalance finding, NYT reports
The FDA announced last November that two generic versions of Johnson & Johnson's (JNJ) Concerta ADHD drug, one made by Mallinckrodt (MNK) and the other by UCB, could no longer be considered the equivalent of the branded drug after tests and analyses suggested that their effectiveness began to wear off much more quickly, but the drugs are still being sold despite an FDA mandated deadline having passed for the companies to either prove the drugs were equivalent or remove them from the market, said The New York Times. The report noted a third generic product, sold by Actavis (AGN), was found to be equivalent to the branded Concerta. Reference Link
07:12 EDTTEVANeurocrine price target raised to $87 from $63 at Piper Jaffray
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05:31 EDTPFEPfizer initiated with an Overweight at Piper Jaffray
Target $45.
05:31 EDTBMYBristol-Myers initiated with an Underweight at Piper Jaffray
Target $60.
June 16, 2015
14:23 EDTTEVAReceptos price target raised to $348 at Wedbush on M&A potential
Wedbush analysts Liana Moussatos and Kelechi Chikere said they'd interpreted Receptos (RCPT) comments with its earnings report in May about its ability to commercialize ozanimod on its own as a message to potential buyers that their bids were too low. Following a recent report from Proactive Investors, which claimed that Receptos had turned down bids of $200 per share from AstraZeneca (AZN) and $280 per share from Teva (TEVA) and Gilead (GILD), the analysts said they have reconsidered their valuation assumptions, as they believe these bid values could be accurate. Wedbush raised its fair value estimate on Receptos to $348 from $211, citing a belief in increased industry interest in ozanimod and the rest of Receptos’ pipeline, and maintains an Outperform rating on the stock.
14:12 EDTMYL, TEVAAbbott backing marginally ups chances of Mylan-Perrigo deal, says BMO Capital
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13:16 EDTGSKFDA appoves labeling changes for GSK anti-seizure drug
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11:06 EDTMYL, TEVATeva says 'fully committed' to bid for Mylan, Bloomberg reports
After Abbott (ABT) announced earlier that it intends to vote its 14.5% stake in Mylan (MYL) in favor of Mylan's proposed acquisition of Perrigo (PRGO), a Teva (TEVA) spokesperson told Bloomberg in an email that the company remains "fully committed" to is offer to acquire Mylan, which Teva said is better than Mylan's suggested deal for Perrigo.
10:29 EDTTEVA, NVS, MYLGeneric drugs may be targets of congressional price probe, Bloomberg says
In addition to branded drugs that were cited for "staggering" price increases in a congressional probe on drug prices being led by U.S. Senator Bernie Saunders, generic drug makers may also be targeted, stated Bloomberg Intelligence. Data show some generics, including clomipramine hydrochloride and tetracycline, have seen "aggressive" quarterly price increases, the report noted. Generic drug makers that could be caught up in the probe include Mallinckrodt (MNK), Teva (TEVA), Novartis' (NVS) Sandoz unit, Mylan (MYL), Taro Pharmaceutical (TARO) and Teva (TEVA). Mallinckrodt shares are down about 4% in early trading.
09:21 EDTMYLMylan issues statement regarding Abbott's support for Perrigo transaction
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09:10 EDTMYLAbbott confirms support for Mylan's proposed acquisition of Perrigo
Abbott (BT) confirmed its continued support for Mylan (MYL) N.V's growth strategy by stating its intent to vote its 14.5% stake in Mylan in favor of Mylan's proposed acquisition of Perrigo (PRGO). "We chose Mylan to acquire our developed markets branded generics pharmaceuticals because its scale and breadth across critical distribution channels, broad and diverse portfolio, and commitment to patients and product quality strongly positions it for success in the years to come," said Abbott. "As both Mylan's largest shareholder and its partner through our continued manufacturing relationships, Abbott has considered the entire situation and we believe Mylan's standalone strategy and acquisition of Perrigo will further enhance its platform, is strategically compelling, value enhancing for shareholders, and offers a clear path to completion. In light of these factors, we will be voting in favor of the Perrigo transaction."
08:54 EDTMYLPulmatrix enter into development agreement with Mylan for PUR0200
Pulmatrix (PULM) announced that it has entered into an ex-U.S. development agreement with Mylan (MYL). The agreement is for PUR0200, a clinical stage bronchodilator therapy being studied for chronic obstructive pulmonary disease, or COPD, and the first small molecule formulation from the company's novel iSPERSE inhaled dry powder technology. PUR0200 is under development as a once-daily therapy in a capsule-based dry powder inhaler, or DP. Under the terms of the agreement, Pulmatrix will lead the development work and pharmacokinetic clinical study with collaborative support from Mylan. Mylan has retained an option for PUR0200 ex-U.S. based on successful completion of the clinical study. Financial terms of the agreement are confidential.
08:05 EDTTEVATeva reports ARM-TD study meets primary endpoint
Teva Pharmaceutical (TEVA) announced positive top-line results from the pivotal clinical study Aim to Reduce Movements in Tardive Dyskinesia, or ARM-TD, designed to evaluate the efficacy of SD-809 in the treatment of moderate to severe tardive dyskinesia. Top-line data showed that the study met its primary endpoint and demonstrated a positive trend in all secondary endpoints. The primary endpoint of ARM-TD was the change in the Abnormal Involuntary Movement Scale, or AIMS, from baseline to end of therapy, assessed by blinded centralized video rating. The study results show patients taking SD-809 achieved an improvement of 3.0 points on the AIMS score from baseline to end of therapy compared to 1.6 points in placebo for a clinically meaningful effect. Study results also demonstrated a favorable safety and tolerability profile of SD-809. Fewer patients taking SD-809 than placebo experienced serious adverse events. Three patients discontinued from the study for adverse events. For all other side effects reported in the study, rates in the SD-809 group were similar or lower than the placebo group. Further analysis of the additional data from the study is ongoing and details will be shared at future medical meetings and through peer-reviewed publication, the company said. SD-809 became part of Teva’s central nervous system product portfolio with the acquisition of Auspex Pharmaceuticals in May.
07:31 EDTTEVAEagle Pharmaceuticals price target raised to $95 from $65 at Cantor
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05:45 EDTNVSNovartis to host two day investor event
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05:40 EDTNVSNovartis division Alcon receives CE Mark for AcrySof IQ PanOptix trifocal IOL
Alcon, a division of Novartis, has received European CE Mark for its AcrySof IQ PanOptix trifocal intraocular lens, or IOL, for patients undergoing cataract surgery who elect to address their near, intermediate, and distance vision needs with a single lens. The AcrySof IQ PanOptix trifocal IOL is an important addition to Alcon's broad portfolio of intraocular lenses for cataract patients.
June 15, 2015
11:40 EDTBMYNCCN update on NSCLC important for Bristol-Myers, says Morgan Stanley
Morgan Stanley noted that the National Comprehensive Cancer Network, or NCCN, just updated its guidelines for the treatment of NSCLC to include Bristol-Myers' Opdivo in second-line non-squamous and squamous non-small cell lung cancer without PD-L1 testing, which the firm said is important news since the company hasn't filed for non-squamous approval with the FDA yet. Morgan Stanley maintained its Opdivo projections and keeps its Overweight rating on the stock.
11:26 EDTBMYBristol-Myers mentioned positively at Morgan Stanley
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11:15 EDTJNJIdera advances after JPMorgan starts coverage with $6 target
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09:53 EDTACTActavis adopts Allergan as global name, now trading with ticker 'AGN'
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09:19 EDTACT, JNJBiotech Industry Organization to hold a conference
BIO 2015 is being held in Philadelphia on June 15-18.
09:16 EDTTEVAInternational Parkinson & Movement Disorder Society to hold a conference
9th International Congress of Parkinson's Disease and Movement Disorders is being held in San Diego, CA on June 14-18.
08:02 EDTTEVATeva announces FDA acceptance of BLA for Reslizumab
Teva Pharmaceutical Industries announced that the FDA has accepted for review the Biologics License Application for reslizumab, the company’s investigational humanized monoclonal antibody which targets interleukin-5, for the treatment of inadequately controlled asthma in adult and adolescent patients with elevated blood eosinophils, despite an inhaled corticosteroid based regimen. The BLA for reslizumab includes data from Teva’s Phase III BREATH clinical trial program. The program consisted of four separate placebo-controlled Phase III trials involving more than 1,700 adult and adolescent asthma patients with elevated blood eosinophils, whose symptoms were inadequately controlled with inhaled corticosteroid-based therapies. Results from these studies demonstrated that reslizumab, in comparison to placebo, reduced asthma exacerbation rates by at least half and provided significant improvement in lung function and other secondary measures of asthma control when added to an existing ICS-based therapy. Common adverse events in the reslizumab treatment group were comparable to placebo and included worsening of asthma, nasopharyngitis, upper respiratory infections, sinusitis, influenza and headache. Two anaphylactic reactions were reported and resolved following medical treatment at the study site.
08:01 EDTPFEPfizer Consumer Healthcare to expand Caltrate, Centrum production in China
Pfizer Inc announced that it broke ground for a $95M consumer products production facility in Suzhou, China. The new site is near the company’s existing Suzhou site and will help increase production capacity to meet growing demand for Pfizer Consumer Healthcare’s brands in China and the Asia-Pacific region. The new facility will primarily produce Caltrate dietary supplements and Centrum multivitamins, and in the future will support production of additional products. There are also plans to eventually house a research and development facility on the site to help support innovation in the region.
07:19 EDTJNJGeron discloses orphan designation for its imetelstat for myelofibrosis
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07:01 EDTPFEVentana receives FDA approval for IHC companion diagnostic for Xalkori
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06:02 EDTTEVA, MYLTeva raises stake in Mylan to almost 3.5%, Globes reports
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