pausarir hacia adelante
Approvals
12-16-2008 |  15:18 hs.
Abbott Laboratories announced it has received approval from the U.S. drug regulator for TriLipix, an oral drug indicated to lower LDL (bad) cholesterol, lower triglycerides, and raise HDL (good) cholesterol. TriLipix belongs to a class of drugs called fibrates, and it’s indicated for stand-alone use or in combination with statins.

More...

12-03-2008 |  07:42 hs.

The European Medicines Agency (EMEA) has approved Alcon’s fixed combination eye drop, Azarga (brinzolamide 10mg/ml + timolol 5mg/ml) ophthalmic suspension, for treatment of elevated intraocular pressure (IOP) associated with open-angle glaucoma or ocular hypertension in adult patients for whom monotherapy provides insufficient IOP reduction.

More...

11-24-2008 |  15:30 hs.

More...

Chronic immune thrombocytopenic purpura drug
11-21-2008 |  13:00 hs.
British drugmaker GlaxoSmithKlkine announced that the Food and Drug Administration granted accelerated approval Promacta (eltrombopag), for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Promacta is the first oral thrombopoietin (TPO) receptor agonist approved for adult patients with the condition. Further details.

More...

11-21-2008 |  10:15 hs.
Japanese drugmaker Eisai Co. announced that the Food and Drug Administration granted approval for anticonvulsant Banzel (rufinamide) as an adjunctive treatment for of seizures associated with a severe form of epilepsy, Lennox-Gastaut syndrome (LGS), in patients aged four years and older.

More...

11-13-2008 |  09:23 hs.
AstraZeneca Plc schizophrenia drug Seroquel, won European approval for wider use of both the original and the new version (XR) of its blockbuster antipsychotic in treating major depressive episodes in bipolar disorder. Seroquel XR has also been cleared for the treatment of moderate to severe manic episodes in bipolar disorder.

More...

Novo Nordisk´s Norditropin (somatropin)
11-05-2008 |  09:57 hs.
Danish drugmaker Novo Nordisk announced that the U.S. Food and Drug Administration has approved their drug Norditropin injection (somatropin, rDNA origin) for marketing in the U.S., a treatment for short stature in children born Small for Gestational Age (SGA).

More...

Apriso, to be launched first-quarter 2009
11-03-2008 |  10:56 hs.
Salix Pharmaceuticals, Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Apriso (mesalamine) extended-release capsules 0.375 g., indicated for ulcerative colitis in adults.

More...

Acquired, distributed by Pfizer in U.S.
11-03-2008 |  08:12 hs.
Toviaz, a drug made by Germany´s Schwarz Pharma to treat patients with overactive bladders won approval from U.S. health officials, it was announced by the company.

More...

After EMEA/FDA rejection as diabetic pain treatment
10-29-2008 |  10:21 hs.
Belgian pharmaceutical group UCB announced U.S. health regulators have approved its Vimpat drug as an add-on therapy for the treatment of partial-onset seizures in adults, welcome news to the company after its rejection by EU regulators and the FDA as a diabetic pain treatment.

More...

Decentralized approval process
10-16-2008 |  10:20 hs.
Bayer AG announced it had been granted approval for Qlaira, a new contraceptive pill to add to Bayer´s successful group of existing birth control pills obtained as part of the giant German company´s takeover of Schering.

More...

Rival to Sanofi-Aventis´ blockbuster Lovenox
10-01-2008 |  10:41 hs.
Bayer AG announced the European Commission has approved their blood thinning pill Xarelto (rivaroxaban) for the prevention of blood clots after hip or knee replacement surgery. Clinical trials are underway by Bayer and partner Johnson & Johnson testing the drug as a treatment for acute coronary syndrome (ACS) in order to expand its use. Bayer has estimated future earnings could reach some $ 3 billion dollars annually. Further details.

More...

09-23-2008 |  08:34 hs.
Sanofi-Aventis SA announced that the Food and Drug Administration has approved Nasacort AQ Nasal Spray (triamcinolone) for children aged 2-5 years old for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis. Further details.

More...

09-15-2008 |  08:53 hs.
Belgian pharma group UCB said on Monday morning that U.S. health authorities had approved epilepsy drug Keppra XR. The company expects the drug to be available in U.S. pharmacies at the end of September 2008, on sale just before its mother drug loses patent protection. Further Details.

More...

08-25-2008 |  09:54 hs.

Eisai Corporation of North America and its partner Helsinn Healthcare SA today announced that the Food and Drug Administration has approved a new oral formulation of Aloxi for the prevention of chemotherapy-induced nausea and vomiting.

More...

The Medicines Company Shares Jump
08-04-2008 |  14:55 hs.
Medicines Co announced the FDA has cleared its injectable blood pressure drug Cleviprex, the first new intravenous treatment for acute hypertension to be approved in a decade. The Medicines Company shares jump 6 percent touching a year-high

More...

Organon Biosciences´ Bridion (sugammadex)
07-30-2008 |  09:57 hs.
The European Medicines Agency (EMEA) has approved Bridion, the drug that reverses neuromuscular block induced by anesthesia after surgery some ten times faster than older drugs. Bridion (sugammadex) was acquired by Schering-Plough through their purchase of the drug´s makers, Organon Biosciences. Further details.

More...

Dyslipidemia and primary hypercholesterolemia treatment
07-11-2008 |  12:45 hs.
Merck & Co. announced that their drug Tredaptive (nicotinic acid/laropiprant) 1 g/20 mg modified-release tablets, a new lipid-modifying therapy for patients with dyslipidemia and primary hypercholesterolemia, has been approved for marketing in the European Union (EU), Iceland and Norway.

More...

In Europe, marketed as Primovist
07-08-2008 |  16:34 hs.

More...

07-07-2008 |  09:55 hs.
The EMEA has granted Wyeth and Progenics Pharmaceuticals approval to market their subcutaneous injection Relistor for the management of opioid-induced constipation in the European Union. The product was cleared in the U.S. in April this year

More...