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News Breaks
February 12, 2013
07:17 EDTSNY, GSKBig Pharma focued on Africa's middle class, Reuters reports
The shifting nature of Africa's disease burden is luring Big Pharma (SNY, GSK) as new opportunities open up for treating chronic diseases afflicting the middle classes, rather than just fire-fighting infection. European companies, in particular, hope to reap rewards by investing early in a region where many of them already have historic commercial ties, reports Reuters.Reference Link
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April 22, 2014
05:23 EDTGSKNovartis divests Vaccines business to GSK for $7.1B
Novartis (NVS) has agreed to divest its Vaccines business to GSK (GSK), currently excluding its flu business, for $7.1B plus royalties. The $7.1B consists of $5.25B upfront and up to $1.8B in milestones. As a part of a value-maximization strategy in the context of the portfolio review, Novartis has initiated a separate sales process for its flu business.
05:20 EDTGSKNovartis to acquire GSK oncology products for $14.5B
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April 21, 2014
11:33 EDTSNYAward of $16M to Sanofi, Abbott for damages upheld on appeal
The Court of Appeals for the Federal Circuit affirmed a lower court ruling that Glenmark Pharmaceuticals infringed a patent related to the antihypertension drug Tarka that is owned by or exclusively licensed to Sanofi (SNY), Abbott Labs (ABT), and their related companies. In the prior case, Glenmark admitted infringement and the jury awarded $15.2M in lost profits and about $800K in price erosion damages. The appeals court affirmed the district court's jurisdiction in the matter, as well as its judgment and related rulings. Reference Link
08:36 EDTSNYAastrom announces definitive agreement to acquire Sanofi's CTRM business
Aastrom Biosciences (ASTM) announced that it has entered into a definitive agreement to acquire Sanofi's (SNY) Cell Therapy and Regenerative Medicine, or CTRM, business for a purchase price of $6.5M, with $4M payable in cash at closing and $2.5M payable in the form of a promissory note. The acquisition is subject to customary closing conditions and is scheduled to close in approximately three weeks. Through the CTRM acquisition, Aastrom is acquiring global commercial rights to three marketed autologous cell therapy products. Aastrom will also acquire global manufacturing and production centers located in the United States and Denmark.
08:32 EDTSNYAastrom announces definitive agreement to acquire Sanofi's CTRM business
07:21 EDTSNYFDA Pediatric Advisory Committee to hold a meeting
The Committee discusses pediatric-focused safety reviews including MDT's Activa Dystonia Therapy, (BAX's Advate and Tisseel, NVS' Famvir, Tibotec's (JNJ subsidiary) Intelence, UCB Pharma's Keppra, MRK's Maxalt, BAYRY's Natazia, Digestive Care's Pertzye, JNJ's Prezista, BMY's Reyataz, SNY's Sklice, PFE's Torisel, Aptalis' Ultresa, and GILD's Viread in a meeting being held in Bethesda, Maryland on April 21 at 8 am. Webcast Link
April 17, 2014
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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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.
07:20 EDTGSKGlaxoSmithKline opens internal probe of bribery allegations, WSJ says
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April 16, 2014
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.
April 15, 2014
14:29 EDTGSKGlaxoSmithKline confirms FDA approval for Tanzeum
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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.
08:23 EDTGSKLeerink's pharma and biotech analysts hold an analyst/industry conference call
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08:06 EDTGSKProsonix, Mylan enter licensing deal for generic version of Flixotide, Flovent
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06:32 EDTSNY, GSKPatients 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
06:40 EDTGSKGlaxoSmithKline paid bribes to Polish doctors to promote Seretide, BBC says
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April 11, 2014
07:06 EDTSNYVIVUS announces avanafil clinical data presentation
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April 10, 2014
11:42 EDTGSKReport claims Tamiflu, Relenza do little to prevent the spread of flu
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April 9, 2014
07:09 EDTSNYReckitt Benckiser may be frontrunner for Merck unit, Bloomberg reports
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