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News For MRK;PFE;GSK;JNJ;BMY;NVS;SHPG;ABT;CELG;SNY From The Last 14 Days
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April 17, 2014
16:31 EDTJNJFDA alert on laparoscopic morcellation mixed for Hologic, says Piper Jaffray
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15:55 EDTGSKGlaxoSmithKline, Genmab get FDA approval for Arzerra use
GlaxoSmithKline (GSK) and Genmab (GNMSF) announced that the U.S. FDA has approved a Supplemental Biologic License Application for the use of Arzerra, a CD20-directed monoclonal antibody, in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukemia for whom fludarabine-based therapy is considered inappropriate. The FDA approval of the first-line indication is based on results from a Phase III study which demonstrated statistically significant improvement in median progression-free survival in patients who received the combination of ofatumumab and chlorambucil compared to patients who received chlorambucil alone.
15:03 EDTGSKFDA grants wider approval for Glaxo's Arzerra in treatment of CLL
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13:50 EDTMRKFDA approves Ragwitek for short ragweed pollen allergies
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11:43 EDTGSKGlaxoSmithKline announces Canadian approval for Incruse Ellipta
GlaxoSmithKline announced that Incruse Ellipta has received market authorization in Canada for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, or COPD, including chronic bronchitis and emphysema. This is the first market authorization granted for this product anywhere in the world, the company noted.
08:38 EDTPFETeva settles patent ligitigation with Pfizer on Celebrex
Teva (TEVA) announced that its subsidiary Teva Pharmaceuticals USA, Inc. has entered into a settlement with Pfizer (PFE) related to Tevaís generic version of Celebrex 50, 100, 200 and 400 mg capsules in the United States. Under the terms of the settlement, Teva may launch its generic versions in December 2014 or earlier under certain circumstances. Teva has received tentative approval from the U.S. Food and Drug Administration for all strengths and believes that it is first-to-file on at least the 100, 200 and 400 mg capsules. Sales of Celebrex were $2.2B in the U.S. according to IMS data as of December, 2013.
08:15 EDTJNJJohnson & Johnson price target raised to $116 from $104 at Argus
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07:20 EDTGSKGlaxoSmithKline opens internal probe of bribery allegations, WSJ says
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April 16, 2014
13:54 EDTABTDanone slips after fresh dairy volume shrinks
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13:51 EDTNVSAlnylam COO critical of big pharma, FierceDrugDelivery reports
After Novartis (NVS) decided to end its RNAi research, Alnylam COO Barry Greene told FierceDrugDelivery that big pharma has "never been able to innovate." Greene attributes the recent sell-off in Alnylam shares to "generally bearish sentiment on Wall Street regarding biotech stocks in particular." Reference Link
11:19 EDTNVSNovartis launches new eye care products facility in Singapore, Nikkei says
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09:35 EDTABTAbbott: We have plenty of cash for M&A activity, not constrained on borrowing
09:15 EDTSNYImpax launches generic Renvela for kidney disease licensed from Sanofi
Impax Laboratories (IPXL) is commencing shipment of authorized generic Renvela 800 mg tablets, through Global Pharmaceuticals, Impax's generics division. Renvela is indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis. Under the terms of a settlement agreement, Sanofi (SNY) company Genzyme agreed to grant Impax a license to sell an allotment of a specified number of bottles of an authorized generic version of Renvela tablets commencing on April 16. Impax continues to pursue approval of its pending Abbreviated New Drug Application for generic Renvela with the FDA.
09:15 EDTABTAbbott sees pace of EPS growth and sales to accelerate throughout FY14
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09:14 EDTABTAbbott sees Q2 EPS 50c-52c, consensus 51c
Sees Q2 sales growth in low to mid single digits, consensus $5.54B.
09:13 EDTABTAbbott sees accelerating sales growth in 2H14
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08:34 EDTCELGPiper Jaffray tech and biopharma analysts hold analyst/industry conference call
Technical Analyst Johnson, along with BioPharma Analysts, discuss the recent downturn in the biotech and specialty pharmaceuticals industries on an Analyst/Industry conference call to be held on April 17 at 10 am.
07:49 EDTABTAbbott expects to increase global capacity to meet demand in 2014
Expects three new manufacturing facilities scheduled to come on line in China, India and the U.S. in Q2. Adult Nutrition remains on track to achieve an operating margin ratio of more than 20 percent of sales by 2015.
07:47 EDTABTAbbott completes enrollment in U.S., China, Japan in Absorb regulatory trials
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07:46 EDTABTAbbott backs FY14 adjusted EPS $2.16-$2.26, consensus $2.20
07:46 EDTABTAbbott reports Q1 adjusted EPS 41c, consensus 36c
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07:38 EDTJNJJohnson & Johnson reported very strong Q1 results, says Bernstein
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April 15, 2014
17:38 EDTJNJJohnson & Johnson stock looks attractive, Barron's says
Johnson & Johnson stock looks attractive and there's still time to buy in, Barron's contends in its "Barron's Take" column. The company can still deliver strong returns, the paper adds. Reference Link
16:22 EDTJNJOn The Fly: Closing Wrap
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15:19 EDTABTNotable companies reporting before tomorrow's open
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14:29 EDTGSKGlaxoSmithKline confirms FDA approval for Tanzeum
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14:14 EDTABTEarnings Preview: Abbott's established pharmaceuticals sales in focus
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12:58 EDTJNJOn The Fly: Midday Wrap
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10:23 EDTJNJOptions with decreasing implied volatility: FDO JNJ FAST EPB
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10:14 EDTGSKFDA approves Tanzeum to treat type 2 diabetes
The Food and Drug Administration approved Tanzeum subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes. Tanzeum has a Boxed Warning to warn that tumors of the thyroid gland have been observed in rodent studies with some GLP-1 receptor agonists, but that it is unknown whether Tanzeum causes thyroid C-cell tumors, including a type of thyroid cancer called medullary thyroid carcinoma, in humans. Tanzeum should not be used in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2. The FDA approved Tanzeum with a Risk Evaluation and Mitigation Strategy, which consists of a communication plan to inform health care providers about the serious risks associated with Tanzeum. Tanzeum is manufactured by GlaxoSmithKline.
09:16 EDTJNJOn The Fly: Pre-market Movers
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09:11 EDTJNJJohnson & Johnson says has implemented some cost reductions in MD&D sector
Says has implemented some cost reductions, combined some businesses in the Medical Devices & Diagnostics sector to better compete in the current marketplace.
08:56 EDTJNJJohnson & Johnson sees FY net interest expense $400M-$500M
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08:23 EDTGSK, MRK, BMYLeerink's pharma and biotech analysts hold an analyst/industry conference call
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08:19 EDTBMY, MRKLeerink's pharma and biotech analysts hold an analyst/industry conference call
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08:19 EDTJNJJohnson & Johnson sees deal to sell K-Y brand to Reckitt closing mid-year
Sees sees deal to sell K-Y brand to Reckitt Benckiser (RBGPF) closing mid-year. Says offer from Carlyle Group (CG) to acquire Ortho-Clinical Diagnostics expected to close mid-year. Comments from slides that will be presented on the Q1 earnings conference call.
08:06 EDTGSKProsonix, Mylan enter licensing deal for generic version of Flixotide, Flovent
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08:04 EDTPFEWuXi PharmaTech names Steve Yang as COO and Executive VP
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07:49 EDTJNJJohnson & Johnson reports Q1 Domestic sales up 2.2%; Intl sales up 4.5%
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07:47 EDTJNJJohnson & Johnson raises FY14 EPS to $5.80-$5.90, consensus $5.83
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07:46 EDTJNJJohnson & Johnson reports Q1 adjusted EPS $1.54, consensus $1.48
Reports Q1 revenue $18.1B, consensus $18.0B
07:35 EDTNVSAlnylam outlook not affected by Novartis decision, says JMP Securities
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07:22 EDTSHPG, NVSNovartis to Shire said to mull offers for ThromboGenics, Bloomberg says
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06:36 EDTNVSRanbaxy inspection failures add $900M to heart drug costs, Bloomberg says
A gap in U.S. patent law has kept cheap copies of Novartis' (NVS) heart drug Diovan off the market for 18 months, which has cost U.S. consumers and insurers as much as $900M in possible savings, reported Bloomberg. Ranbaxy (RBXLY) is the only company permitted to sell a generic version of Diovan, and hasnít been able to manufacture and market them after four factories it runs in India failed U.S. inspections. Reference Link
06:32 EDTJNJ, SNY, BMY, NVS, MRK, GSK, PFEPatients paying much more for specialty drugs, NY Times says
The amount that patients with certain diseases must pay for specialty drugs has increased significantly, a research firm reported, according to The New York Times. Meanwhile, consumers' use of health care increased in 2013 for the firm time in three years, the newspaper quoted the firm, the IMS Institute for Healthcare Informatics, as saying. Publicly traded drug makers include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Publicly traded health insurers include AMERIGROUP (AGP), Aetna (AET), Centene (CNC), Cigna (CI), Health Net (HNT), Healthspring (HS), Humana (HUM), Molina Healthcare (MOH), UnitedHealth (UNH), WellCare (WCG) and WellPoint (WLP).Reference Link
April 14, 2014
18:00 EDTMRKU.S. FDA approves Merck's GRASTEK
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15:17 EDTJNJNotable companies reporting before tomorrow's open
Notable companies reporting before tomorrow's market open, with earnings consensus, include Johnson & Johnson (JNJ), consensus $1.48; Coca-Cola (KO), consensus 44c; Charles Schwab (SCHW), consensus 22c; Northern Trust (NTRS), consensus 78c; Comerica (CMA), consensus 72c; Westamerica (WABC), consensus 58c; Comverse (CNSI), consensus 49c; Pep Boys (PBY), consensus 5c.
14:42 EDTNVSAlnylam slips after Novartis reportedly cuts back RNAi development
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13:25 EDTJNJEarnings Preview: J&J looking for another strong performance in pharmaceuticals
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11:48 EDTNVSNovartis significantly reducing RNAi development efforts, FierceBiotech says
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10:02 EDTJNJOn The Fly: Analyst Downgrade Summary
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09:05 EDTPFEGlycoMimetics presents GMI-1070 data
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09:05 EDTABTAbbott announces FDA clearance for test to diagnose diabetes
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08:15 EDTBMYBristol-Myers submits NDA for Reyataz-cobicistat combo for HIV-1
Bristol-Myers Squibb (BMY) announced the submission of a new drug application, or NDA, on April 4 to the FDA for a fixed-dose combination of atazanavir sulfate, a protease inhibitor marketed as Reyataz, and cobicistat, an investigational pharmacokinetic enhancer, or boosting agent, that can increase the level of certain HIV-1 medicines in the blood and make them more effective. Bristol-Myers Squibb is seeking approval of the fixed-dose combination tablet for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. If approved, atazanavir sulfate and cobicistat could offer patients living with HIV-1 a single tablet that eliminates the need to take a boosting agent in a separate tablet. Cobicistat is being developed by Gilead Sciences (GILD). Under the terms of a previously announced agreement, Bristol-Myers Squibb and its affiliates are responsible for the formulation, manufacturing, registration, distribution and commercialization of the atazanavir sulfate and cobicistat fixed-dose combination product worldwide. Gilead retains sole rights for the manufacture, development and commercialization of cobicistat as a stand-alone product and for use in combination with other agents.
06:40 EDTGSKGlaxoSmithKline paid bribes to Polish doctors to promote Seretide, BBC says
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06:08 EDTMRKMerck volatility elevated into Q1 and outlook
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05:56 EDTJNJJohnson & Johnson downgraded to Hold from Buy at Jefferies
Jefferies downgraded its rating on Johnson & Johnson (JNJ) to Hold citing the recent outperformance of shares. The firm keeps a $105 price target for the stock.
April 11, 2014
18:44 EDTJNJJ&J halting development of Botox competitor, WSJ says
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09:03 EDTCELGCelgene shares can unlock big value, says RBC Capital
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07:19 EDTPFEAcura Pharma to host conference call
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07:06 EDTSNYVIVUS announces avanafil clinical data presentation
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05:22 EDTMRKMerck says Hepatitis C combination therapy shows antiviral activity
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April 10, 2014
17:44 EDTMRKMerck stock could return 20%, Barron's says
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11:42 EDTGSKReport claims Tamiflu, Relenza do little to prevent the spread of flu
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10:05 EDTCELGCelgene CEO Hugin says 'excited' about guidance for the year
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09:37 EDTMRKActive equity options trading on open
Active equity options trading on open according to Track Data: SIRI RAD AAPL AMZN AA FB TSLA MRK CVX C
09:21 EDTMRKOn The Fly: Pre-market Movers
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08:34 EDTABTAbbott completes enrollment of Absorb clinical trials in U.S., Japan and China
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08:10 EDTCELGCelgene likely to prevail in patent case, says Stifel
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08:03 EDTMRKXencor Merck receives milestone payment from Merck for using XmAb antibody
Xencor (XNCR) announced that the company has received a milestone payment from Merck (MRK), through a subsidiary, triggered by the initiation of a Phase 1 clinical trial for an undisclosed biologic drug candidate that uses Xencor's XmAb antibody engineering intellectual property. Under the terms of the agreement signed in June 2013, Xencor granted Merck a non-exclusive license to certain Xencor patents for use in an undisclosed product, as well as an option to license the same intellectual property for future products. Xencor received an upfront payment and continues to receive annual maintenance fees. Xencor is also eligible to receive milestone payments associated with the successful development of Merck product candidates, as well as royalties on sales of any potential products that may result from this agreement.
07:33 EDTCELGCelgene antibody could open door for new area of focus, says Wells Fargo
Wells Fargo believes that Celgene is developing an anti-CD47 antibody that could enable the company to enter the immune-oncology space and pivot into biologics. The firm views the stock as undervalued, and believes that Celgene has many viable opportunities that could enable the stock to rise over the long-term. The firm keeps an Outperform rating on the shares and identifies it as a top pick.
07:04 EDTBMYBristol-Myers presents Phase III data on all-oral Daclatasvir and Asunaprevir
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06:17 EDTPFEAcura Pharma announces return of product rights from Pfizer
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05:27 EDTMRKMerck announces data from C-WORTHy study
Merck announced additional data from the ongoing C-WORTHy study, a multi-arm Phase 2 clinical trial evaluating the efficacy and safety of a once-daily, all-oral regimen combining MK-5172, an investigational hepatitis C virus, or HCV, NS3/4A protease inhibitor, and MK-8742, an investigational HCV NS5A replication complex inhibitor, among patients with chronic HCV Genotype 1 infection, or GT1. In an interim analysis of treatment-naÔve, non-cirrhotic patients administered a 12-week regimen of MK-5172/MK-8742, with and without ribavirin, or RBV, a sustained viral response, or SVR, was observed in 98% of patients administered MK-5172/MK-8742 alone and 94% in those administered MK-5172/MK-8742 plus RBV.
April 9, 2014
12:12 EDTCELGMarkman documents appear to favor Celgene, The Street says
Public documents for the pre-trial Markman hearing appear to favor Celgene over Natco, the generic drugmaker challenging some of Celgene's Revlimid patents, The Street's Adam Feuerstein reports. Shares of Celgene are up 5% to $145.33 in mid-day trading. Reference Link
11:43 EDTABT, BMY, MRKGilead defended by analysts after recent pullback
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07:23 EDTJNJ, BMY, MRKEuropean Association for the Study of the Liver to hold annual meeting
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07:09 EDTMRK, SNY, NVSReckitt Benckiser may be frontrunner for Merck unit, Bloomberg reports
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07:09 EDTJNJJohnson & Johnson outlook positive into Q1 results, says Bernstein
Bernstein expects Johnson & Johnson's Q1 EPS to come in slightly above the consensus estimate, with strength in pharmaceuticals more than offsetting lackluster Medical Devices & Diagnostics growth, according to the firm. Bernstein keeps an Outperform rating on the stock.
April 8, 2014
11:03 EDTBMY, GSK, SNY, PFE, MRKPiper Jaffray's biopharm analyst holds an analyst/industry conference call
Biopharm Analyst Schimmer discusses PCSK9 Inhibitors and other atherosclerosis approaches on an Analyst/Industry conference call. Relevant companies AEGR, ALNY, AMGN, ARNA, AZN, BMY, CBST, LLY, ESPR, GSK, ICPT, ISIS, MNKD, MRK, OREX, PFE, REGN, RHHBY, SNY and VVUS may be included on the Analyst/Industry conference call to be held on April 10 at 3 pm.
08:46 EDTGSKTeva announces first approval, launch of generic Lovaza capsules in the U.S.
Teva (TEVA) announces the approval of the generic equivalent to Lovaza in the United States. Teva believes it is first-to-file and thus far is the only company to receive an approval from FDA. Teva plans to commence shipping immediately. Lovaza Capsules, marketed by GlaxoSmithKline (GSK), had annual sales of approximately $1.1B in the United States, according to IMS data as of December 2013.
07:26 EDTJNJElsevier Business Intelligence to hold a conference
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07:22 EDTNVS, GSKCaSA-ISPE to hold a conference
21st Annual Lilfe Sciences Technology Conference is being held in Raleigh, North Carolina on April 8.
April 7, 2014
17:28 EDTPFEPfizer sell-off unwarranted, Barron's says
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16:28 EDTPFEOn The Fly: Closing Wrap
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14:18 EDTGSKGlaxoSmithKline reports 14.1% stake in Applied Genetic Technologies
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12:15 EDTPFEOn The Fly: Midday Wrap
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10:40 EDTPFEPfizer trades near lows of the day, levels to watch
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09:10 EDTPFEOn The Fly: Pre-market Movers
HIGHER: Questcor (QCOR), up 27% after agreeing to be bought by Mallinckrodt (MNK) for cash, stock valued at $86.10 per Questcor share... Agios Pharmaceuticals (AGIO), up 25% after program shows "promising clinical activity" for advanced blood cancers, shares upgraded at JPMorgan... Vocus (VOCS), up 47% after agreeing to be acquired by GTCR for $446.5M, or $18.00 per share... Pandora (P), up 1.3% following upgrade at Wedbush. LOWER: MannKind (MNKD), down 13% after announcing FDA extension of PDUFA date for Afrezza... American Eagle (AEO), down 2.2% following downgrade at Cowen... Pfizer (PFE), down 2.8% after announcing data for palbociclib in metastatic breast cancer... Mattel (MAT), down 3% following downgrade at BMO Capital... WWE (WWE), down 1.2% after cautious mention in Barron's, company announcing WrestleMania 30 grossed $10.9M.
09:09 EDTPFEConfusion on Pfizer Palbo could create buying opportunity, says BMO Capital
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09:01 EDTSHPGGenocea names Jonathan Poole as CFO
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09:00 EDTPFEPfizer falls 2.8%
Pfizer is down 2.8%, or 90c, to $31.25
08:09 EDTMRKAlnylam's McSwiggen patent upheld in European opposition proceedings
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08:06 EDTBMYBristol-Myers submits NDAs for Daclatasvir and Asunaprevir to FDA
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07:27 EDTPFE, NVS, MRKAmerican Association of Cancer Research to hold annual meeting
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05:32 EDTNVSNovartis Bexsero vaccine receives FDA Breakthrough Therapy designation
Novartis announced that Bexsero, Meningococcal Group B Vaccine, has received a Breakthrough Therapy designation from the FDA. Bexsero is already approved in Europe, Canada and Australia to help protect against invasive meningococcal disease caused by serogroup B. Novartis plans to file for U.S. licensure of Bexsero as early as Q2; exact timing will depend on guidance from the FDA. This is the fourth Breakthrough Therapy designation for Novartis, underscoring leadership in developing innovative therapies and vaccines. This announcement comes on the heels of a landmark decision from regulators in the UK, where the Joint Committee on Vaccination and Immunisation recommended the inclusion of Bexsero in the country's National Immunisation Programme for routine use in infants from two months of age.
05:28 EDTSNYGenzyme to resubmit Lemtrada application for FDA review
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April 6, 2014
16:23 EDTGSKGlaxoSmithKline investigates bribery allegations in Iraq, WSJ says
GlaxoSmithKline is investigating allegations of bribery by employees in Iraq, says the Wall Street Journal, citing emails reviewed by the publication. Reference Link
13:46 EDTPFEPfizer's palbociclib significantly prolonged PFS in metastatic breast cancer
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13:37 EDTMRKMerck presents findings on clinical outcomes following treatment with MK-3475
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April 4, 2014
10:45 EDTCELGMylan rises despite Meda rejecting takeover offer
Mylan (MYL) shares are higher this morning following a Financial Times report of its desire to buy Swedish rival Meda. Subsequent to the story being published, Meda confirmed it had been in talks with Mylan but rejected the company's takeover offer. WHAT'S NEW: The Financial Times reported that Mylan was considering buying Meda, a Swedish drugmaker, in a deal that would create a $23B+ pharmaceuticals business. Mylan reportedly hired advisers to put a deal together for Meda, and though the value of a deal was not noted, sources said Mylan was likely to pay a "significant" premium to Meda's market value, which was $4.5B at the end of trading on Thursday. Mylan's market value currently stands at $18.5B. A combination of the drugmakers would create a company with annual revenues of around $9B, the FT said, noting that would be half the size of generic drug rival Teva (TEVA). WHAT'S NOTABLE: Meda's board of directors confirmed that it was contacted by Mylan regarding a proposal to merge the companies, but the board decided to reject the proposal. Meda said all discussions between the company and Mylan have been terminated "without further actions." ANALYST REACTION: Citigroup upgraded Mylan to Buy from Neutral and raised its price target on the stock to $61 from $52 this morning. The firm cited potential operational and tax benefits from an acquisition of Meda, stating that in addition to expanding Mylan's geographic presence, the deal would increase its presence in specialty, OTC and branded generics. OTHER NEWS: Mylan sued Celgene (CELG) to block that company's efforts to keep generic versions of Revlimid and Thalomid off the market, Reuters reported. PRICE ACTION: Mylan shares are up $2.98, or 5.98%, to $52.84 in mid-morning trading.
08:07 EDTMRKMerck, Ferring announce collaboration with WHO
Merck and Ferring Pharmaceuticals announced their collaboration with the World Health Organization to advance a new, proprietary formulation of carbetocin, used to prevent excessive bleeding in women after childbirth, that is designed to be stable at room temperature, even in hot and tropical climates. Currently, oxytocin, the standard medicine administered for the prevention of excessive bleeding, is temperature-sensitive and requires sustained cold distribution and storage in hot climates. The WHO will conduct a multi-country clinical study to evaluate the effectiveness of room-temperature-stable carbetocin, as compared to oxytocin. The development of a medicine that can be stored at room temperature has the potential to significantly improve management of bleeding following childbirth in the many areas of the world where cold storage is difficult to achieve and maintain, and thereby help reduce maternal deaths in those areas. Starting this year, the study will take place in 12 countries around the world and enroll approximately 29,000 women. If the results of the study are positive, the organizations will work together with the aim of making the medicine available in developing countries that have a high burden of maternal mortality at an affordable and sustainable public-sector price.
06:49 EDTCELGMylan sues Celgene for blocking Thalomid, Revlimid generics, Reuters says
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06:29 EDTGSKGlaxoSmithKline cuts China employees amid probe, WSJ reports
According to a source, as it deals with a bribery probe in Beijing, GlaxoSmithKline is cutting employees in China, the Wall Street Journal reports. It is unclear how many of Glaxo's 7,000 employees in China have been let go. Reference Link
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