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Researchers develop new malaria vaccine strategy based on ingestion of genetically modified starch

Researchers from two laboratories in northern France have successfully vaccinated and protected mice by feeding them starch derived from green algae and genetically modified to carry vaccine proteins.

21 Dec 2010

Auspex, Teva Pharmaceutical to develop deuterium-containing drug

Auspex Pharmaceuticals, announced today that it has signed a deal involving a promising deuterium-containing drug with Teva Pharmaceutical Industries.

21 Dec 2010

New predictive medicine product for hereditary pancreatic and related cancers

Myriad Genetics, Inc. today announced the launch of PANEXIA™, a predictive medicine product for hereditary pancreatic and related cancers. PANEXIA is a comprehensive analysis of the PALB2 and BRCA2 genes for assessing a person's risk of developing pancreatic cancer later in life. PANEXIA, Myriad's ninth molecular diagnostic product, is the second product launched by the Company this year.

21 Dec 2010

EpiCept receives Israeli Ministry of Health approval for Ceplene

EpiCept Corporation today announced that the Israeli Ministry of Health has approved the marketing application for Ceplene®, indicated for remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia (AML) in first remission. Megapharm Ltd. is EpiCept's partner in Israel and upon Ministry of Health approval of labeling and other technical matters the company is expected to launch Ceplene® in the first quarter of 2011.

21 Dec 2010

PharMEDium introduces pre-labeled, ready-to-use Propofol in tamper evident syringe admixture system

PharMEDium Services LLC, announced the addition of Propofol to its custom operating room anesthesia syringe preparation services. PharMEDium is the first compounder to offer Propofol in a pre-labeled, single patient, ready-to-use, tamper evident syringe admixture system. Healthcare organizations recognize benefits of PharMEDium's prefilled operating room syringes including compliance with regulatory requirements for proper labeling of all medications, and improved economic efficiency by reducing waste.

21 Dec 2010

Hemispherx to manufacture and supply Alferon N Injection to GP Pharm in Argentina

Hemispherx Biopharma, Inc. announced that the Company has entered into an agreement with GP Pharm Latinoamerica, an affiliate company of Spanish GP Pharm SA for the marketing of Alferon N Injection®, the Company's natural interferon injection product which has been FDA approved for a category of sexually transmitted diseases in Argentina with an option for other Latin American countries upon receipt of those respective countries' regulatory approval for any use of the product.

21 Dec 2010

Lilly completes acquisition of Avid

Eli Lilly and Company today announced that it has completed the acquisition of Avid Radiopharmaceuticals, Inc., a privately held company developing novel molecular imaging compounds intended for the detection and monitoring of chronic human diseases. The transaction, first announced on November 8, 2010, has received the approval of Avid stockholders and clearance under the Hart-Scott-Rodino Antitrust Improvements Act. All other closing conditions have also been met.

20 Dec 2010

Brilinta – AstraZeneca’s new blood thinner faces FDA hurdle

AstraZeneca’s new blood thinner that was pitched against Plavix, the world’s second-best selling drug failed to live up to expectations making stocks drop to a two year low, the steepest decline since Nov. 21, 2008, and the worst performance today on the 18-company Bloomberg Europe Pharmaceutical Index.

20 Dec 2010

Forest acquires all rights held by Gruenenthal for colistin

The Gruenenthal Group and Forest Laboratories, Inc., today announced that Forest Healthcare B.V., a wholly owned subsidiary of Forest Laboratories, Inc. and Gruenenthal GmbH, have entered into an agreement whereby Forest has acquired all rights currently held by Gruenenthal for colistin and all rights previously licensed by Forest to Gruenenthal for Colobreathe.

20 Dec 2010

Isotechnika, Paladin receive screening acceptance for Voclera for approval in Canada

Isotechnika Pharma Inc. and Paladin Labs Inc. announced today that they have submitted the dossier and received screening acceptance for VocleraTM (voclosporin) for approval in the Canadian market. VocleraTM is a novel immunosuppressive drug in the class of calcineurin inhibitors and is indicated for the treatment of moderate to severe psoriasis.

20 Dec 2010

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