New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News For MEDI;PFE;CELG;PRXL;ACOR;NPSP;ALKS;AZN;TEVA 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 | 6 | all recent news | >>
October 31, 2014
10:26 EDTACORAcorda Therapeutics management to meet with IS Group
Subscribe for More Information
07:31 EDTPRXLPAREXEL difficulties unlikely to be permanent, says Wells Fargo
Wells Fargo believes that the decline in PAREXEL's stock suggests that investors believe the company's strategic relationship are permanently impaired, while its book to bills will not recover to at least 1.1 in the near future. The firm does not know what is causing the reduction in the company's new business, but does not believe that the situation is permanent. Wells cut its valuation range on the name to $65-$68 from $70-$75 but says the weakness i nthe shares has created a buying opportunity.
October 30, 2014
11:58 EDTAZNSanofi looked to AstraZeneca head regarding Viehbacher, Bloomberg says
Subscribe for More Information
10:02 EDTPRXLOn The Fly: Analyst Downgrade Summary
Subscribe for More Information
09:11 EDTTEVATeva reported great Q3 results, says BMO Capital
Subscribe for More Information
09:06 EDTTEVATeva says assessing M&A opportunities of all sizes
08:49 EDTTEVATeva says may pursue generic businesses in emerging markets
Says not ruling out "transformational" transactions. Says open to specialty assets in U.S., Europe.
08:40 EDTTEVATeva says $5.00-$5.10 FY14 EPS guidance is for exclusive Copaxone scenario
Subscribe for More Information
08:14 EDTALKSAlkermes proprietary programs remain on track, says Leerink
Subscribe for More Information
08:09 EDTALKSAlkermes pipeline value set to come into focus, says FBR Capital
FBR Capital says investor sentiment toward Alkermes will "meaningfully shift" over the next 18 months as results from key trials become available. With an FDA action date of August 22, 2015, FBR believes the commercial potential of aripiprazole lauroxil may not be known until 2016. It thinks the 2016 results from the Phase III program of ALKS 5461, a potential treatment for major depressive disorder, may be more important. It sees the company's pipeline value coming into focus over the next six to 18 months and keeps a Market Perform rating on Alkermes following the company's Q3 results.
07:19 EDTAZNAstraZeneca says FDA approves once-daily XIGDUO XR
Subscribe for More Information
07:15 EDTPFEASCO / ASTRO / IASLC to hold symposium
Subscribe for More Information
07:06 EDTTEVATeva board authorizes increase in share repurchase program to $3B
The Company announced today that, as authorized by the Board of Directors, it will increase its share repurchase program by $1.7 billion to $3 billion. The program has no time limitations. The Company intends to begin purchasing shares promptly.
07:05 EDTTEVATeva raises FY14 EPS view to $5.00-$5.10 from $4.90-$5.10
Subscribe for More Information
07:05 EDTTEVATeva reports Q3 EPS $1.32, consensus $1.23
Subscribe for More Information
06:42 EDTACORAcorda Therapeutics: More than 60% of new AMPYRA patients enroll in First Step
Subscribe for More Information
06:42 EDTACORAcorda Therapeutics backs FY14 R&D expense $60M-$70M
Subscribe for More Information
06:41 EDTACORAcorda Therapeutics reports Q3 Ampyra revenue $96.4M
Subscribe for More Information
06:14 EDTACORAcorda Therapeutics reports Q3 non-GAAP EPS 65c, may not be comparable to 5c
Subscribe for More Information
06:04 EDTPRXLPAREXEL downgraded to Neutral from Outperform at RW Baird
Baird downgraded PAREXEL to Neutral following the Q1 report and disappointing guidance.
October 29, 2014
18:59 EDTPRXLOn The Fly: After Hours Movers
Subscribe for More Information
16:14 EDTPRXLPAREXEL sees FY15 EPS $2.56-$2.75, consensus $2.69
Subscribe for More Information
16:13 EDTPRXLPAREXEL sees Q2 EPS 56c-62c, consensus 66c
Sees Q2 revenue $495M-$508M, consensus $539.08M.
16:12 EDTPRXLPAREXEL reports Q1 adjusted EPS 65c, consensus 58c
Subscribe for More Information
14:46 EDTPFEPfizer confirms FDA acclerated approval for TRUMENBA
Pfizer announced that the U.S. FDA has granted accelerated approval of TRUMENBA for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. Approval of TRUMENBA is based on demonstration of immune response, as measured by serum bactericidal activity against four serogroup B strains representative of prevalent strains in the United States. The effectiveness of TRUMENBA against diverse serogroup B strains has not been confirmed. As part of the accelerated approval process, Pfizer will complete its ongoing studies to confirm the effectiveness of TRUMENBA against diverse serogroup B strains. TRUMENBA was reviewed and approved under the FDA’s Breakthrough Therapy designation and Priority Review programs.
14:03 EDTPFEFDA approves Trumenba vaccine for serogroup B Meningococcal disease
The FDA announced the approval of Trumenba, the first vaccine licensed in the United States to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. Trumenba was granted breakthrough therapy status, which is intended to expedite the development and review of medical products that address a serious or life-threatening condition. Trumenba is manufactured by Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer.
08:31 EDTPFEPfizer publishes PRISTIQ clinical study
Subscribe for More Information
07:13 EDTALKSAlkermes reports Q3 AMPYRA, FAMPYRA revenues $16.5M
Subscribe for More Information
07:11 EDTALKSAlkermes says entering Q4 with 'strong momentum'
Subscribe for More Information
07:09 EDTACOR, ALKSAlkermes sees FY14 free cash flow $20M
Subscribe for More Information
07:05 EDTALKSAlkermes sees FY14 EPS 19c-32c consensus 27c
Subscribe for More Information
07:04 EDTALKSAlkermes reports Q3 EPS 3c, consensus 2c
Subscribe for More Information
October 28, 2014
17:01 EDTAZN, PFEOn The Fly: Closing Wrap
Stocks on Wall Street opened in positive territory despite two disappointing economic data points and a mixed report from social media giant Twitter (TWTR). The market moved in a narrow range for the opening half hour of trading but gained upside momentum following a much better than expected consumer confidence reading. The market continued to tack on points throughout the afternoon and closed at its highs, led by the Nasdaq, which gained 1.75% for the session. ECONOMIC EVENTS: In the U.S., durable goods orders fell 1.3% in September, significantly undershooting expectations for them to have rise 0.7% in the month. The S&P Case-Shiller home price report showed prices were lower on a seasonally adjusted basis in the month of August compared to the prior month. A reading of consumer confidence surged to a seven-year high of 94.5 in October from a revised 89.0 final reading for September. The Richmond Fed's manufacturing index rose 6 points to 20 in October, beating expectations for it to have pulled back to 10. COMPANY NEWS: Twitter (TWTR) sunk $4.78, or 9.84%, to $43.78 after the social media company reported in-line profit and higher than expected Q3 revenue, but also reported a slowdown in user growth and provided weaker than expected Q4 guidance. Following last night's report, the stock was downgraded at RBC Capital, Nomura and Bank of America Merill Lynch to "Hold" or equivalent ratings, while Stifel lowered its rating on Twitter shares to Sell from Hold... Shares of Pfizer (PFE) edged up 6c, or 0.21%, to $29.09 after the pharmaceutical giant reported third quarter adjusted earnings per share and revenue that were a bit better than expected and narrowed its fiscal year profit outlook. Of note, Pfizer said during its earnings conference call that while proposed rule changes have made "inversions" more difficult, that meaningful value from inversion deals can still exists on a "case-by-case" basis. Shares of AstraZeneca (AZN), which was previously a target of Pfizer, gained 67c, or 0.95%, to $71.43 following Pfizer's comments. MAJOR MOVERS: Among the notable gainers following their earnings reports were Whirlpool (WHR), which advanced $10.66, or 6.77%, to $168.06, Cummins (CMI), which gained $9.22, or 6.81%, to $144.59, and Cliffs Natural (CLF), which jumped $2.05, or 22.19%, to $11.29. Among the noteworthy losers was Kohl’s (KSS), which dropped $3.89, or 6.64%, to $54.66 after the department store operator’s outlook for third quarter same store sales and fiscal 2014 profit missed expectations. Also lower were shares of Coach (COH), which fell $2.15, or 5.95%, to $34.00 after the luxury handbag and accessory maker reported sales declined 9% on a constant currency basis in its first quarter. INDEXES: The Dow rose 187.81, or 1.12%, to 17,005.75, the Nasdaq advanced 78.36, or 1.75%, to 4,564.29, and the S&P 500 gained 23.42, or 1.19%, to 1,985.05.
12:57 EDTAZN, PFEOn The Fly: Midday Wrap
Subscribe for More Information
10:48 EDTPFEPfizer says reviewing options around two businesses
Subscribe for More Information
10:23 EDTPFE, AZNPfizer says still looking at deals based on strategic fit
Pfizer (PFE) said during its earnings conference call that uncertainty around future tax actions remain a concern, but that the company is still looking for M&A opportunities. Pfizer says proposed rule changes have made "inversions" more difficult, but that meaningful value from inversion deals can still exists on a "case-by-case" basis. Shares of AstraZeneca (AZN), which was previously a target of Pfizer, are up 1.3% to $71.69 as Pfizer's earnings conference call continues.
09:34 EDTCELGCelgene management to meet with Leerink
Subscribe for More Information
07:50 EDTCELGCelgene added to US 1 List at BofA/Merrill
Subscribe for More Information
07:35 EDTPFEDURECT price target liowered to $1.50 from $2.50 at Stifel
Subscribe for More Information
07:24 EDTCELGCelgene added to US 1 List at BofA/Merrill
07:06 EDTPFEPfizer reports Q3 GEP sales down 6% operationally, GIP sales down 4%
Subscribe for More Information
07:05 EDTPFEPfizer narrows FY14 adjused EPS view to $2.23-$2.27 from $2.20-$2.30
Subscribe for More Information
07:01 EDTPFEPfizer reports Q3 adjusted EPS 57c, consensus 55c
Subscribe for More Information
October 27, 2014
20:54 EDTAZNLeerink's major pharma analyst holds an analyst/industry conference call
Subscribe for More Information
16:36 EDTPFEOn The Fly: Closing Wrap
Subscribe for More Information
15:36 EDTPFENotable companies reporting before tomorrow's open
Subscribe for More Information
15:18 EDTAZN, PFEEarnings Preview: Pfizer looks to new products to offset generic competition
Subscribe for More Information
12:46 EDTPFEPfizer October weekly volatility elevated into Q3 and outlook
Subscribe for More Information
12:44 EDTCELGStocks with call strike movement; CELG MYL
Celgene (CELG) April 115 call option implied volatility increased 4% to 30, Mylan (MYL) April 60 call option implied volatility increased 3% to 29 according to IVolatility.
08:15 EDTPFEPain Therapeutics to regain full rights to REMOXY
Subscribe for More Information
08:08 EDTPFEDURECT reports Pfizer to discontinue agreement with Pain Therapeutics
DURECT (DRRX) reported today that Pfizer (PFE) announced that it has notified Pain Therapeutics (PTIE) that Pfizer has decided to discontinue its agreement to develop and commercialize REMOXY Extended-Release Capsules CII, an investigational extended-release oral formulation of oxycodone. Pfizer will return all rights, including responsibility for regulatory activities, to Pain Therapeutics. As a result, Pain Therapeutics has the rights to develop and commercialize REMOXY on its own or with an alternative licensee. Pain Therapeutics had the rights to develop and commercialize this product candidate under a license from DURECT.
08:02 EDTPFEPfizer to discontinue agreement on REMOXY ER capsules CII
Pfizer Inc. (PFE) has notified Pain Therapeutics, Inc. (PTIE) that it has decided to discontinue its agreement to develop and commercialize REMOXY Extended-Release Capsules CII, an investigational extended-release oral formulation of oxycodone. Pfizer will return all rights, including responsibility for regulatory activities, to Pain Therapeutics, Inc. Pfizer has concluded an internal review of the top-line results of five recently completed clinical studies required to address the Complete Response Letter received in June 2011 from the U.S. Food and Drug Administration (FDA). Pfizer and Pain Therapeutics, Inc. will work together for an orderly transition of REMOXY to Pain Therapeutics, Inc. Pfizer will continue ongoing activities under the agreement for the next six months until the scheduled termination date. Pfizer supports the appropriate use of opioid pain medications, and believes that abuse-deterrent products are important to help address the growing public health problem of opioid abuse in the U.S.
07:29 EDTAZNWorldwide Business Research to hold a conference
ProcureCon Pharma 2014 is being held in Philadelphia on October 27-29.
07:22 EDTAZN, PFE, TEVAAmerican College of Chest Physicians to hold a conference
Subscribe for More Information
05:38 EDTPRXLICON plc downgraded to Equal Weight from Overweight at Barclays
Subscribe for More Information
October 24, 2014
10:29 EDTNPSPOptions with decreasing implied volatility
Subscribe for More Information
10:03 EDTNPSPOn The Fly: Analyst Downgrade Summary
Subscribe for More Information
09:18 EDTNPSPOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Microsoft (MSFT), up 4.3%... KLA-Tencor (KLAC), up 8.8%... Rubicon Project (RUBI), up 17.8%... Gigamon (GIMO), up 16%. ALSO HIGHER: Procter & Gamble (PG), up 2.7% after earning report, announcing plans to exit Duracell business by creating a stand-alone Duracell company... Vitae Pharmaceuticals (VTAE), up 40% following its report of top-line results from two Phase 1 clinical trials... Digital River (DRIV), up 47% after agreeing to be acquired by investor group for $26.00 per share. LOWER: Amazon (AMZN), down 9.3%, downgraded at Cowen and Janney Capital following the company's Q3 report... DryShips (DRYS), down 26% after filing an automatic common stock shelf... NPS Pharmaceuticals (NPSP), down 4.4% following PDUFA date for Natpara extended three months to January 24... Abercrombie & Fitch (ANF), down 4% after downgraded at Goldman and BMO Capital. DOWN AFTER EARNINGS: Pandora (P), down 7%... Synaptics (SYNA), down 9.9%... Flowserve (FLS), down 5%... New Oriental Education (EDU), down 4%.
09:09 EDTNPSPNPS Pharmaceuticals worst case scenario unlikely, says BofA/Merrill
Subscribe for More Information
08:41 EDTNPSPNPS Pharmaceuticals downgraded to Neutral from Buy at Goldman
Subscribe for More Information
07:19 EDTCELGCelgene pipeline could double market cap in 3-5 years, says Deutsche Bank
Deutsche Bank raised its price target for Celgene shares to $134 from $115 following the company's Q3 results saying its pipeline could potentially double the market capitalization over the next 3-5 years. Deutsche views Celgene's pipeline as "the most transformative in biotech" and keeps a Buy rating on the stock.
07:18 EDTCELGCelgene price target raised to $117 from $104 at JMP Securities
Subscribe for More Information
07:13 EDTCELGCelgene price target raised to $119 from $99.50 at Citigroup
Citigroup raised its price target for Celgene shares to $119 following the company's Q3 results on expectations Revlimid will continue to drive growth. It keeps a Buy rating on the stock.
06:53 EDTCELGCelgene price target raised to $120 from $105 at Cantor
Subscribe for More Information
06:49 EDTAZN, PFEPfizer repurchase could squash AstraZeneca bid goal, Reuters says
Subscribe for More Information
05:54 EDTNPSPStocks with implied volatility movement; NPSP HLF
Subscribe for More Information
October 23, 2014
18:52 EDTPFE, NPSPOn The Fly: After Hours Movers
UP AFTER EARNINGS: Rubicon Project (RUBI), up 19.2%... KLA-Tencor (KLAC), up 15.8%... Gigamon (GIMO), up 13.5%... Maxwell (MXWL), up 11.3%... Qlik Technologies (QLIK), up 9.8%... NetSuite (N), up 5.5%... Microsoft (MSFT), up 3.3%... Juniper Networks (JNPR), reverses in after-hours trading and is up 1.4% after reporting third quarter results and announcing a $1.1B increase to the company's share repurchase authorization. ALSO HIGHER: Vitae Pharmaceuticals (VTAE), up 38.6% following positive top-line results from two Phase 1 clinical trials of BI1181181/VTP-37948... Pfizer (PFE), up 1.8% after announcing a new $11B share repurchase program. DOWN AFTER EARNINGS: Amazon.com (AMZN), down 10.7%... Synaptics(SYNA), down 12.7%... Pandora (P), down 6.8%... Lattice Semiconductor (LSCC), down 5.6%... Maxim Integrated (MXIM), down 5.8%. ALSO LOWER: DryShips (DRYS), down 16.5% after filing an automatic common stock shelf... NPS Pharmaceuticals (NPSP), down 7.9% following PDUFA date for Natpara extended three months to January 24... GoPro (GPRO), down 2.8% after being initiated with an Underperform at Oppenheimer.
18:18 EDTPFEGlenview Capital acquires stake in Actavis, Bloomberg reports
Subscribe for More Information
16:47 EDTNPSPNPS Pharmaceuticals PDUFA date for Natpara extended three months to January 24
NPS Pharmaceuticals reported that the FDA has extended the company’s Prescription Drug User Fee Act, or PDUFA, action date for its Natpara Biologics License Application by three months from October 24 to January 24, 2015. The FDA extended the action date to provide time for a full review of a major amendment; such extensions are provided for by regulation. In addition, the FDA requested that NPS Pharma submit a Risk Evaluation and Mitigation Strategy, or REMS, for Natpara and the company is working to finalize the REMS in advance of the revised PDUFA action date. To date, the FDA has not requested that additional clinical studies be completed prior to the approval of Natpara; however, the company expects a post-approval study commitment. Francois Nader CEO of NPS Pharma said, “We continue to advance our commercial readiness activities and are planning for the launch of Natpara in 2Q15.”
16:17 EDTPFEPfizer announces new $11B share repurchase program
The board of directors also authorized a new $11B share repurchase program to be utilized over time. This new program is in addition to the $1.3B of authorization remaining under the company’s current share repurchase program.
12:20 EDTCELGOn The Fly: Midday Wrap
Subscribe for More Information
10:54 EDTCELGAcceleron, Celgene to present sotatercept prelinical interim clinical data
Acceleron Pharma (XLRN) reported that its collaboration partner, Celgene (CELG), and investigators on the sotatercept program will present sotatercept preclinical and interim clinical data at the American Society of Nephrology Kidney Week 2014. The meeting will be held in Philadelphia on November 11-16. Preliminary data, including safety and effects on hemoglobin, bone density and vascular calcification from the ongoing phase 2a clinical trial of sotatercept will be presented on Thursday, November 13. Additionally, data from preclinical studies will be presented on Friday and Saturday, November 13 and 14.
08:15 EDTPFEPfizer wins SUTENT patent case In Delaware District Court
Pfizer (PFE) announced today that the U.S. District Court for the District of Delaware upheld its basic patent and the L-malate salt patent covering SUTENT capsules. This decision, which is subject to appeal, affirms Pfizer’s right to exclusively provide sunitinib malate as SUTENT to patients through the term of the patent, which expires in 2021. Pfizer filed suit in June 2010 after Mylan (MYL) applied to the U.S. Food and Drug Administration to market a generic version of SUTENT prior to the expiration of the patents covering sunitinib malate and its uses. After a four-day trial, the Court agreed that Mylan infringed the valid patents covering SUTENT.
07:33 EDTCELGCelgene raises FY14 adjusted EPS view to $3.65-$3.70 from $3.60-$3.65
Subscribe for More Information
07:32 EDTCELGCelgene reports Q3 REVLIMID sales $1.3B
Subscribe for More Information
07:32 EDTCELGCelgene reports Q3 adjusted EPS 97c, consensus 95c
Subscribe for More Information
06:51 EDTALKSAlkermes concerns removed with FDA acceptance, says Citigroup
Subscribe for More Information
October 22, 2014
15:37 EDTCELGNotable companies reporting before tomorrow's open
Notable companies reporting before tomorrow's market open, with earnings consensus, include Comcast (CMCSA), consensus 71c; Union Pacific (UNP), consensus $1.52; 3M (MMM), consensus $1.96; AbbVie (ABBV), consensus 77c; Celgene (CELG), consensus 95c; Eli Lilly (LLY), consensus 67c; Occidental Petroleum (OXY), consensus $1.57; Caterpillar (CAT), consensus $1.36; Alexion Pharmaceuticals (ALXN), consensus $1.16; Precision Castparts (PCP), consensus $3.32; Raytheon (RTN), consensus $1.60; American Electric Power (AEP), consensus $1.02; Southwest Airlines (LUV), consensus 53c; Lorillard (LO), consensus 90c; T. Rowe Price (TROW), consensus $1.15; Mead Johnson (MJN), consensus 91c; Zimmer Holdings (ZMH), consensus $1.30; Nucor (NUE), consensus 73c; Nielsen (NLSN), consensus 65c; Prologis (PLD), consensus 46c; Sigma-Aldrich (SIAL), consensus $1.06; Under Armour (UA), consensus 40c; EQT (EQT), consensus 56c; Dr Pepper Snapple (DPS), consensus 88c; Cameron International (CAM), consensus $1.10; Coca-Cola Enterprises (CCE), consensus 89c; Quest Diagnostics (DGX), consensus $1.08; CMS Energy (CMS), consensus 41c; Airgas (ARG), consensus $1.29; PulteGroup (PHM), consensus 36c; Diamond Offshore (DO), consensus 79c; Bemis (BMS), consensus 67c.
11:55 EDTCELGStocks with call strike movement; YHOO CELG
Yahoo (YHOO) January 48 call option implied volatility decreased 6% to 32, Celgene (CELG) April 110 call option implied volatility increased 2% to 32 according to IVolatility.
11:38 EDTCELGBiogen retreats after Tecfidera sales miss, patient death reported
Subscribe for More Information
11:01 EDTCELGBiogen trading lower on slower growth, PML case, says Deutsche Bank
Deutsche Bank attributes the pullback in shares of Biogen (BIIB) to slower sequential revenue growth and the one PML case with Tecfidera disclosed on today's earnings call. Deutsche believes investors are now favoring Celgene (CELG) over Biogen due to near term headline risks. The firm says it likes Celgene more as well due its pipeline, but keeps a Buy rating on Biogen.
07:35 EDTAZNCardiometabolic Health Congress to hold annual meeting
Subscribe for More Information
07:02 EDTALKSAlkermes aripiprazole lauroxil NDA accepted for filing by FDA
Subscribe for More Information
October 21, 2014
09:48 EDTNPSPShire could target BioMarin, TheStreet's Feuerstein says
Subscribe for More Information
09:23 EDTCELGCelgene GED-0301 said to have 67% 12-week remission at high dose in trial
Subscribe for More Information
07:54 EDTALKSLeerink a buyer of Alkermes, ImmunoGen, Incyte
Subscribe for More Information
07:15 EDTPFE, AZNFDA to hold workshop on breast cancer drug development
Subscribe for More Information
07:06 EDTPFEFierce Biotech to hold a breakfast meeting
Subscribe for More Information
06:10 EDTAZNInovio, MedImmune, UPENN awarded $12.2M collaborative study by DARPA
Inovio Pharmaceuticals (INO) announced the Defense Advanced Research Projects Agency, or DARPA, has awarded $12.2M for a collaborative study that will be conducted by scientists from the Perelman School of Medicine at the University of Pennsylvania; Inovio Pharmaceuticals; and MedImmune, the global biologics research and development arm of AstraZeneca (AZN). The group will develop DNA-based monoclonal antibodies, or mAbs, for infectious disease treatment. DARPA is an agency of the US Department of Defense that creates and supports novel technologies important for national security. Together, the three organizations will develop and assess the DNA mAbs in preclinical studies using technology developed by Penn and licensed by Inovio. The collaboration will focus on three disease areas – influenza virus, Pseudomonas aeruginosa and Staphylococcus aureus.
October 20, 2014
13:26 EDTCELGCelgene I&I franchise boosted by Crohn’s trial data, says William Blair
William Blair said it views the preliminary Phase II efficacy and safety data from mongersen in Crohn’s disease reported by Celgene as encouraging. The firm noted that the 10 mg arm did not achieve significance, but the three data points collectively formed a robust dose-response that William Blair said lends support for the drug's proposed mechanism of action. William Blair believes mongersen complements Celgene’s Inflammation & Immunology portfolio and the firm maintains its Outperform rating on the stock, which is up 4% to $91.65 in afternoon trading.
13:21 EDTCELGCelgene reports Phase II data in Crohn’s Disease to be presented at UEG
Subscribe for More Information
09:22 EDTNPSPOn The Fly: Pre-market Movers
Subscribe for More Information
07:47 EDTPFE, AZNPfizer less likely to renew Astra pursuit after Shire deal breakdown, FT says
Subscribe for More Information
07:19 EDTAZNIBC Life Sciences to hold a conference
Subscribe for More Information
07:15 EDTPFEAmerican Academy of Child & Adolescent Psychiatry to hold annual meeting
Subscribe for More Information
07:14 EDTAZNEuropean College of Neuropsychopharmacology to hold a conference
27th ECNP Congress is being held in Berlin, Germany on October 18-21.
07:12 EDTPFECongress of Neurological Surgeons to hold annual meeting
Subscribe for More Information
07:11 EDTPFEAmerican Society for Reproductive Medicine to hold annual meeting
2014 Annual Meeting of ASRM is being held in Honolulu on October 18-22.
07:10 EDTPFEAmerican Society of Human Genetics to hold annual meeting
Subscribe for More Information
06:56 EDTNPSPShire reopens acquistion talks with NPS Pharmaceuticals, Cubist, Telegraph says
Subscribe for More Information
06:28 EDTTEVAAllergan price target raised to $210 from $190 at Citigroup
Subscribe for More Information
October 17, 2014
16:41 EDTPFEPfizer confirms FDA labeling approval for EMBEDA capsules
Pfizer announced that the FDA has approved an updated label for EMBEDA extended-release capsules, for oral use to include abuse-deterrence studies. The updated label states that EMBEDA has properties that are expected to reduce abuse via the oral and intranasal routes when crushed. However, abuse of EMBEDA by these routes is still possible. The updated label also includes data from a human abuse potential study of intravenous, or IV, morphine and naltrexone to simulate crushed EMBEDA. However, it is unknown whether the results with simulated crushed EMBEDA predict a reduction in abuse by the IV route until additional postmarketing data are available. EMBEDA is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Pfizer expects EMBEDA will be available in the U.S. in early 2015.
16:30 EDTPFEFDA approves new labeling from Embeda extended-release capsules
Subscribe for More Information
13:18 EDTCELGLeerink's biotech analyst holds an analyst/industry conference call
Subscribe for More Information
<< 1 | 2 | 3 | 4 | 5 | 6 | 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