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EMA accepts Merck and ARIAD's MAA for ridaforolimus to treat metastatic bone sarcomas

Merck, known outside the United States and Canada as MSD, and ARIAD Pharmaceuticals, Inc., today announced that the European Medicines Agency (EMA) has completed its administrative validation process for the regulatory application for ridaforolimus, an investigational oral mTOR inhibitor developed for the treatment of metastatic soft-tissue or bone sarcomas in patients who had a favorable response to chemotherapy.

18 Aug 2011

National analysis identifies Columbus as one of the Hypertension Hot Spots in the U.S.

A national analysis conducted by Sperling's BestPlaces and sponsored by Takeda Pharmaceuticals North America, Inc., identified Columbus, Ohio, as one of the nation's Hypertension Hot Spots, or cities that have hypertension risk factors and complications.

18 Aug 2011

DNDi addresses 'alarming lack' of R&D for neglected diseases

In a Center for Global Health R&D Policy Assessment blog post, the third part of the center's Product Development Partnership (PDP) mini-series, "Bernard Pecoul from the Drugs for Neglected Diseases initiative (DNDi) discusses their experience with partnerships to develop treatments for neglected diseases."

18 Aug 2011

Timing for Supreme Court's health law review unclear

The Wall Street Journal reports that the high court is likely to decide by January whether a ruling on the health law will come before or after the 2012 election. Meanwhile, Politico reports that a "conservative gadfly" has won a round in his battle against the Obama administration's health overhaul effort.

18 Aug 2011

ACS honors MIT professor with Priestley Medal for controlled-release drug discovery

Robert S. Langer, Sc.D., the David H. Koch Institute Professor at Massachusetts Institute of Technology, has been named winner of the 2012 Priestley Medal by the American Chemical Society.

18 Aug 2011

FDA approves Zelboraf (vemurafenib) for advanced skin cancer

A new drug was approved for advanced skin cancer this Wednesday by U.S. regulators, offering the first new treatment for melanoma in 13 years.

18 Aug 2011

Endo terminates collaboration and axomadol development program with Grunenthal

Endo Pharmaceuticals announced today that it is terminating its research program and collaboration related to the development of axomadol.

18 Aug 2011

Paladin to acquire Labopharm

Paladin Labs Inc. and Labopharm Inc. announced today that they have entered into a definitive agreement pursuant to which Paladin will acquire all of the issued and outstanding common shares of Labopharm at a price of $0.2857 per share in cash, which represents a premium of 57.4% over the volume-weighted average price of Labopharm's shares of $0.1815 for the 30 trading days prior to this announcement.

18 Aug 2011

Syndax receives European patent allowance for entinostat to treat metastatic breast cancer

Syndax Pharmaceuticals, a clinical-stage epigenetics oncology company, today announced allowance by the European Patent Office for the patent application titled "N-(2-AMINOPHENYL)-4[N-(PYRIDINE-3-YL) - METHOXYCARBONYL - AMINOMETHYL]-BENZAMINE (MS-275) POLYMORPH B."

18 Aug 2011

Sepracor Pharmaceuticals changes company name to Sunovion

Sunovion Pharmaceuticals Canada Inc., formerly Sepracor Pharmaceuticals, Inc., announced today that it has formally changed its name.

18 Aug 2011

New gout drug may help severely affected: Study

A new drug for gout could help very sick gout patients who don't get better with usual treatment, according to a new study. The research was designed and funded by the pharmaceutical company Savient, which markets the drug, called Krystexxa (pegloticase).

17 Aug 2011

Mylan confirms Frova patent challenge

Mylan Inc. today confirmed that the company and its subsidiary Mylan Pharmaceuticals Inc. have been sued by Endo Pharmaceuticals in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Frovatriptan Succinate EQ, 2.5 mg base tablets.

17 Aug 2011

FDA, USP co-sponsors OTC drug products workshop

Updated public standards incorporating new tests for impurities as well as more modern technologies to help ensure the quality of over-the-counter (OTC) ingredients and products will be key areas of focus for a September 8-9, 2011, workshop co-sponsored by the U.S. Food & Drug Administration (FDA) and the U.S. Pharmacopeial Convention.

17 Aug 2011

PAREXEL recognized as Company of the Year for the Pharmaceutical Industry

PAREXEL International Corporation, a leading global biopharmaceutical services provider, has been named Company of the Year for the Pharmaceutical Industry in The Eighth Annual International Business Awards, the only global, all-encompassing business awards program honoring great performances in business.

From Parexel 17 Aug 2011

GeoVax receives NIH-NIAID grant for HIV/AIDS vaccine program

GeoVax Labs, Inc., an Atlanta-based, biopharmaceutical firm developing vaccines to prevent and fight Human Immunodeficiency Virus (HIV) infections, today announced receipt of a $3.6 million annual notice of award for the Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) Grant supporting GeoVax's HIV/AIDS vaccine program.

17 Aug 2011

Registration now open for California Healthcare Institute's 2011 Annual Meeting

CHI-California Healthcare Institute announced today that registration is now open for CHI's 2011 Annual Meeting. CHI's Annual Meeting focuses on the relationship between biomedical innovation and public policy. This year's theme is Shifting Sands: Forces Reshaping the Biomedical Innovation Business Model.

17 Aug 2011

Clinical Trials Partnership Middle East Summit to take place in Dubai

Global pharmaceutical companies are currently seeking emerging markets to conduct clinical trials due to the increase in drug development costs and the demand to advance drugs faster.

From IQPC Ltd 17 Aug 2011

Pegloticase can improve clinical outcomes of patients with chronic gout

Injections of pegloticase, a modified porcine enzyme, can produce significant and sustained clinical improvements in 2 out of 5 patients with chronic gout that is resistant to conventional therapies, researchers report in the August 17, 2011, issue of JAMA.

17 Aug 2011

Study: Vitamin D directly terminates production of MS-causing protein

While for years scientists have noted an association between levels of vitamin D in a person's body and the person's ability to resist or minimize the effects of multiple sclerosis (MS), the mechanism involved has not been established.

17 Aug 2011

FDA clears Inhibikase IkT-001 Phase II trial to treat JCV infection in multiple sclerosis patients

Inhibikase Therapeutics, Inc., an emerging leader in infectious disease, announced today that it has received FDA clearance to commence a Phase II proof-of-concept trial for its lead compound IkT-001. IkT-001, a host-directed kinase inhibitor, is intended to clear JC polyomavirus (JCV) infection, the causative agent of Progressive Multifocal Leukoencephalopathy (PML).

17 Aug 2011