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Takeda visits managed care professionals to promote its two new drugs

According to SDI, a leading healthcare market insight and analytics firm, in spring 2009, Takeda made more visits to managed care professionals than any other pharmaceutical manufacturer, accounting for almost 7% of contacts recorded in SDI’s Managed Care Pharmacy Executive and Managed Care Medical Director audits.

31 Aug 2009

Cancer researcher to serve as Peregrine Pharmaceuticals' clinical advisor for bavituximab cancer program

Peregrine Pharmaceuticals, Inc., today announced that noted cancer researcher Bruce Chabner, M.D., will serve as a clinical advisor to the company on the design of clinical trials for the bavituximab cancer program.

31 Aug 2009

Tianyin Pharmaceutical to discuss its diversified product portfolio at the Rodman & Renshaw Annual Global Investment Conference

Tianyin Pharmaceutical Co. Inc., a developer, manufacturer and supplier of modernized traditional Chinese medicine ("TCM") and generic pharmaceuticals in China, today announced that it will present at the Rodman & Renshaw Annual Global Investment Conference, to be held September 9-11, 2009, at the New York Palace Hotel in New York City.

31 Aug 2009

New Drug Application for VIMOVO accepted by U.S. Food and Drug Administration

POZEN Inc. (NASDAQ:POZN), today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for VIMOVO™ (enteric-coated naproxen / immediate release esomeprazole magnesium, formerly know as PN 400).

31 Aug 2009

Doxorubicin granted orphan drug designation by the FDA

Delcath Systems, Inc., a medical technology company testing its proprietary treatment method for primary and metastatic cancers to the liver, announced that the U.S. Food & Drug Administration granted Delcath's request for orphan drug designation for doxorubicin for the treatment of hepatocellular carcinoma (HCC), also known as primary liver cancer. Clinicians in the U.S. diagnose nearly 20,000 cases of HCC annually.

31 Aug 2009

IntelGenx Technologies shareholder conference call to update shareholders on CPI-300

Horst G. Zerbe, President and CEO of IntelGenx Technologies Corp. ("IntelGenx") will be holding a shareholder conference call to update shareholders on the company's CPI-300 product and remark on related legal proceedings. The call will be held on Tuesday September 1, 2009 at 2.30 p.m. Eastern Standard Time.

31 Aug 2009

Nuevolution partners with Novartis for drug research

Nuevolution A/S today announced that it has entered into a drug discovery collaboration with Novartis.

31 Aug 2009

FDA approves the usage of Valcyte for preventing CMV disease in pediatric patients

Roche announced today that the U.S. Food and Drug Administration (FDA) has approved Valcyte(R) (valganciclovir hydrochloride) for the prevention of cytomegalovirus (CMV) disease in pediatric kidney and heart transplant patients (4 months to 16 years of age) at high risk of developing CMV disease.

31 Aug 2009

Oral dabigatran etexilate reduces the risk of stroke and systemic embolism

Boehringer Ingelheim today announced data from the landmark RE-LY® study - the largest atrial fibrillation (AF) outcomes trial ever conducted (18,113 patients in 44 countries worldwide) - presented for the first time at the European Society of Cardiology Congress and published online in the New England Journal of Medicine. Results show that dabigatran etexilate 150mg BID significantly reduces the risk of stroke and systemic embolism by 34% (p<0.001) in patients with atrial fibrillation compared to well-controlled warfarin without increasing the risk of major bleeding.

31 Aug 2009

Intermediate dosages of otamixaban reduce acute coronary complications

Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that the investigational anti-Xa intravenous anticoagulant otamixaban reduced by 27 to 42 percent the odds of the composite primary endpoint of death, myocardial infarction, urgent revascularization or rescue GPIIb/IIIa use in 4 out of the 5 otamixaban tested doses, versus standard UFH/eptifibatide combination in [non-ST] ACS patients suitable for invasive strategy.

30 Aug 2009

Court reverses the summary judgement decision on ANDA Patent litigation between Ortho McNeil and Caraco Pharmaceutical Laboratories

Caraco Pharmaceutical Laboratories, Ltd. announced today that a US Federal Circuit Court has reversed a portion of a previously decided summary judgment on ANDA Patent litigation between Ortho McNeil and Caraco regarding Ultracet(R).

29 Aug 2009

Office of Orphan Products Development of the FDA grants Orphan Drug Designation to Quinazoline495

Families of Spinal Muscular Atrophy (Libertyville, IL) announced today that the Office of Orphan Products Development of the Food and Drug Administration (FDA) has granted Orphan Drug Designation to Quinazoline495 for the treatment of Spinal Muscular Atrophy.

29 Aug 2009

Genzyme’s supplemental NDA for treating adult AML with Clolar to be discussed by the FDA

Genzyme Corporation (Nasdaq: GENZ) announced today that its supplemental New Drug Application for Clolar® (clofarabine) will be discussed Tuesday, September 1 at a public meeting of the FDA’s Oncologic Drugs Advisory Committee in Silver Spring, Maryland. The panel is expected to consider the clinical trial results Genzyme submitted to support the approval and labeling of Clolar to treat older adult patients with acute myeloid leukemia (AML), the most common type of acute leukemia in adults.

29 Aug 2009

FDA approves Watson Pharmaceuticals' ANDA for Levonorgestrel tablets

Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, today announced that its subsidiary, Watson Laboratories, Inc., has received approval today from the United States Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Levonorgestrel Tablets, 0.75 mg for over-the-counter use in women ages 17 and above, as well as for prescription use in women under the age of 17.

29 Aug 2009

Milestone reached in Biotie Wyeth collaboration for the development of PDE10 inhibitors for schizophrenia

Biotie announced today that it has reached a milestone in its collaboration with Wyeth for the development of PDE10 (phosphodiesterase 10) inhibitors for schizophrenia, triggering a USD 1.0 million milestone payment to Biotie.

28 Aug 2009

U.S. FDA agrees to the study design for cardiovascular outcomes trial of alogliptin

Takeda Pharmaceutical Company Limited ("Takeda") and Takeda Global Research & Development Center, Inc., a wholly owned United States (U.S.) subsidiary, today jointly announced that the latter has received notification that the U.S. Food and Drug Administration (FDA) has agreed to the study design for a cardiovascular (CV) outcomes trial titled EXAMINE (EXamination of CArdiovascular OutcoMes: AlogliptIN vs. Standard of CarE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome) for alogliptin, a selective dipeptidyl peptidase IV inhibitor under investigation for the treatment of type 2 diabetes as an adjunct to diet and exercise.

28 Aug 2009

Sagent Pharmaceuticals adds fluconazole injection to its line of premixed bags

Sagent Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, today announced that it has launched fluconazole injection in premix bags. IMS Health estimates that 2008 U.S. sales of fluconazole injection approximated $18 million. Sagent will begin marketing and shipping fluconazole bags immediately.

28 Aug 2009

Kenya launches malaria campaign; PBS' newshour airs segment on drug-resistance in Cambodia

Kenya on Thursday launched a national malaria campaign to encourage Kenyans to sleep under insecticide-treated nets (ITNs) every night to prevent infection, the Daily Nation reports.

28 Aug 2009

Elorac offers Zithranol-RR for treating plaque psoriasis

Now patients with mild to moderate plaque psoriasis have a new topical treatment option available by prescription. Zithranol™-RR (anthralin rapid release microcrystalline encapsulated cream, 1.2%), is an innovative topical therapy for plaque psoriasis according to Elorac, Inc., a privately held emerging dermatology company. Zithranol™-RR provides an advanced delivery system for anthralin achieving long remission times with no long-term side effects in a steroid-free, silky cream.

28 Aug 2009

AVANIR raises funds to develop and commercialize Zenvia for PBA

AVANIR Pharmaceuticals, Inc. (NASDAQ:AVNR) today announced it had raised gross proceeds of approximately $10.6 million via the sale of approximately 4.5 million shares of common stock at a weighted average price of $2.34 per share.

28 Aug 2009

Pharmaceutical News

Takeda visits managed care professionals to promote its two new drugs

Cancer researcher to serve as Peregrine Pharmaceuticals' clinical advisor for bavituximab cancer program

Tianyin Pharmaceutical to discuss its diversified product portfolio at the Rodman & Renshaw Annual Global Investment Conference

New Drug Application for VIMOVO accepted by U.S. Food and Drug Administration

Doxorubicin granted orphan drug designation by the FDA

IntelGenx Technologies shareholder conference call to update shareholders on CPI-300

Nuevolution partners with Novartis for drug research

FDA approves the usage of Valcyte for preventing CMV disease in pediatric patients

Oral dabigatran etexilate reduces the risk of stroke and systemic embolism

Intermediate dosages of otamixaban reduce acute coronary complications

Court reverses the summary judgement decision on ANDA Patent litigation between Ortho McNeil and Caraco Pharmaceutical Laboratories

Office of Orphan Products Development of the FDA grants Orphan Drug Designation to Quinazoline495

Genzyme’s supplemental NDA for treating adult AML with Clolar to be discussed by the FDA

FDA approves Watson Pharmaceuticals' ANDA for Levonorgestrel tablets

Milestone reached in Biotie Wyeth collaboration for the development of PDE10 inhibitors for schizophrenia

U.S. FDA agrees to the study design for cardiovascular outcomes trial of alogliptin

Sagent Pharmaceuticals adds fluconazole injection to its line of premixed bags

Kenya launches malaria campaign; PBS' newshour airs segment on drug-resistance in Cambodia

Elorac offers Zithranol-RR for treating plaque psoriasis

AVANIR raises funds to develop and commercialize Zenvia for PBA

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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