Pharmaceutical News

RSS

OXIS International files patent application to strengthen Ergothioneine intellectual property portfolio

OXIS International, Inc., today announced that is has filed a patent application titled "Methods and Compositions Using Ergothioneine to Treat a Variety of Health Related Factors" with the U.S. Patent and Trademark Office (USPTO).

20 Dec 2010

King submits ACUROX NDA to FDA

King Pharmaceuticals®, Inc. and Acura Pharmaceuticals, Inc. today announced that King has submitted a New Drug Application (NDA) for ACUROX® (oxycodone HCl) Tablets to the U.S. Food and Drug Administration (FDA), including a request for priority review classification. ACUROX® is an immediate release tablet containing oxycodone HCl intended for the relief of moderate to severe pain.

20 Dec 2010

VIVUS seeks marketing approval of QNEXA in the EU

VIVUS, Inc. today announced that the company filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for QNEXA® (phentermine/topiramate) Controlled Release Capsules in the European Union (EU). The proposed indication in the EU is for the treatment of obesity, including weight loss and maintenance of weight loss, and should be used in conjunction with a mildly hypocaloric diet.

20 Dec 2010

Novartis' Gilenya uptake to increase

A study published this week by ITG revealed that Novartis recently approved drug, Gilenya, has already taken share from market leaders in the multiple sclerosis (MS) market, and uptake is expected to increase significantly over the next year. Gilenya came onto the market in late September as the first FDA-approved oral disease-modifying MS drug, and Novartis initially faced safety concerns and monitoring requirements that deterred some physicians from adopting the new drug.

20 Dec 2010

FDA moves to curb Avastin's approval for breast cancer

The Food and Drug administration on Thursday revoked its approval of Roche drug Avastin for the treatment of breast cancer. The agency's action, based on findings that did not confirm that the medicine helped patients with this disease, has drawn criticism from patients and politicians.

20 Dec 2010

InterMune's MAA for Esbriet receives positive CHMP opinion

InterMune, Inc. today announced additions to its senior leadership team to prepare for the commercialization of Esbriet™ (pirfenidone) in Europe. InterMune's Marketing Authorization Application (MAA) for Esbriet received a positive CHMP opinion that is now awaiting ratification by the European Commission.

20 Dec 2010

EpiTherapeutics, Abbott to develop new anti-cancer drugs

EpiTherapeutics and Abbott today announced a collaboration agreement to develop new anti-cancer drugs by making small-molecule inhibitors against selected epigenetic oncology targets.

20 Dec 2010

RXi's dermal anti-scarring candidate selected to advance into development

RXi Pharmaceuticals Corporation, a recognized leader in RNAi-based therapeutic discovery and development, today announced the selection of its first RNAi therapeutic product candidate to advance into development.

20 Dec 2010

Scientists suggest targeting ion channels could offer effective pain relief

University at Buffalo neuroscience researchers conducting basic research on ion channels have demonstrated a process that could have a profound therapeutic impact on pain.

20 Dec 2010

Mylan confirms lawsuit by Shionogi Pharma and CIMA LABS relating to generic Orapred ODT ANDA

Mylan Inc. today confirmed that the company and its subsidiary Mylan Pharmaceuticals Inc. have been sued by Shionogi Pharma Inc. and CIMA LABS INC. in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Prednisolone Sodium Phosphate Orally Disintegrating Tablets, 10 mg, 15 mg and 30 mg.

17 Dec 2010

Taiho receives CHMP positive opinion on Teysuno in combination with cisplatin for advanced gastric cancer

Taiho Pharmaceutical Co., Ltd., and its parent company, Otsuka Holdings Co., Ltd., announced today that the Committee for Medicinal Products for Human Use (CHMP), a division of the European Medicines Agency (EMA), has issued an opinion recommending approval of Teysuno™ (S-1), a novel oral anti-cancer agent, intended for the treatment of advanced gastric cancer in adults when given in combination with cisplatin.

17 Dec 2010

FDA's decision on Avastin will take away choice for many patients, says Breastcancer.org

Dr. Marisa Weiss, president and founder of Breastcancer.org and a breast oncologist in the Philadelphia area submitted a letter to the U.S. Food and Drug Administration prior to the Oncology Drug Advisory Committee (ODAC) meeting to review data for Avastin's use in metastatic HER2-negative breast cancer. In light of today's news that the FDA has recommended removing Avastin's approval to treat breast cancer, Breastcancer.org is making public Dr. Weiss' ODAC letter in its entirety.

17 Dec 2010

Antidepressants may have adverse effect on elders when prescribed for the first time

More than half of older Americans who were prescribed antidepressants for the first time were already taking a medication that could adversely interact with the antidepressant, according to a new study from Thomson Reuters.

17 Dec 2010

Genentech confirms EMA, FDA updates on Avastin for metastatic breast cancer

Genentech, a member of the Roche Group, confirmed that following the reviews of Avastin® (bevacizumab) in metastatic breast cancer by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), the following regulatory announcements were made by the individual health authorities:

17 Dec 2010

AFFiRiS AG receives 475,000 MJFF grant for Parkinson vaccine development

With a grant of USD 475,000, the Michael J. Fox Foundation is funding preclinical development of a vaccine against Parkinson's disease by AFFiRiS AG. The vaccine, known as PD01, targets the protein alpha-synuclein and might offer for the first time a possibility for a treatment that can slow or stop the progression of Parkinson's disease.

17 Dec 2010

Bayer's SAFYRAL oral contraceptive receives FDA approval

Bayer HealthCare Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved a new oral contraceptive (OC), SAFYRAL™ (drospirenone 3 mg/ ethinyl estradiol 30 mcg/ levomefolate calcium 451 mcg tablets and levomefolate calcium 451 mcg tablets). In women who choose an OC for birth control, SAFYRAL raises folate levels for the purpose of reducing the risk of rare neural tube defects (NTDs) in a pregnancy conceived while taking SAFYRAL or shortly after discontinuing it.

17 Dec 2010

FDA recommends removal of breast cancer indication from Avastin label

The U.S. Food and Drug Administration announced today that the agency is recommending removing the breast cancer indication from the label for Avastin (bevacizumab) because the drug has not been shown to be safe and effective for that use.

17 Dec 2010

Researchers discover allium vegetable consumption may lower hip osteoarthritis

Researchers at King's College London and the University of East Anglia have discovered that women who consume a diet high in allium vegetables, such as garlic, onions and leeks, have lower levels of hip osteoarthritis

16 Dec 2010

FDA issues CRL for AstraZeneca's ticagrelor NDA

AstraZeneca announced today that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the New Drug Application (NDA) for ticagrelor (BRILINTA™).

16 Dec 2010

Watson, PregLem enter licensing agreement to develop, market Esmya in the U.S. and Canada

Watson Pharmaceuticals, Inc. and Gedeon Richter Plc today announced that Watson's subsidiary, Watson Laboratories, Inc. has entered into an exclusive licensing agreement with PregLem, S.A., ("Preglem") the wholly owned subsidiary of Richter, to develop and market Esmya™ (ulipristal acetate) in the U.S. and Canada.

16 Dec 2010