FDA Approves New DPP-4 Drug for Type 2 Diabetes

WASHINGTON (MedPage Today) — The FDA today approved saxagliptin (Onglyza) for type 2 diabetes treatment, making it the first gliptin-class competitor for sitagliptin (Januvia).

Medicago announces positive results for H1N1 pandemic vaccine candidate

Medicago today announced that it has achieved additional positive results with its vaccine candidate for the Influenza A (H1N1) virus, also known as Swine flu. Results showed that a single dose of 5 micrograms induced a positive immune response against a new emerging strain of this virus in 100% of vaccinated animals.

Lobbyists Continue Pressing Their Cases

Pharmaceutical companies, hospitals, advocacy groups and others with a stake in health reform continue to lobby in hopes of winning concessions in the overhaul, or at least surviving the changes unscathed. “One of the groups key to working any deal is the pharmaceutical industry, which has been quite active behind the scenes,” National Public Radio [...]

Health Overhaul Ads Intensify Emotional Messages

“The healthcare overhaul fight in Washington is bursting into America’s living rooms, and interests from many bands on the political spectrum are trying to transform an often wonky debate over 1,000-page bills into an emotional pitch that can be captured in 30 seconds,” The Boston Globe reports.

AstraZeneca Submits New Drug Applications For ZACTIMA(TM) In Second-Line Advanced Non-Small Cell Lung Cancer

AstraZeneca (NYSE: AZN) announced the company has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) and a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMEA) for an investigational drug, vandetanib 100 mg for use in combination with chemotherapy for the treatment of advanced non-small cell lung cancer [...]

FDA Approves TYVASO (Treprostinil) Inhalation Solution For The Treatment Of Pulmonary Arterial Hypertension

United Therapeutics Corporation (Nasdaq: UTHR) announced that the United States Food and Drug Administration (FDA) has approved TYVASO (treprostinil) Inhalation Solution for the treatment of pulmonary arterial hypertension (PAH) using the TYVASO Inhalation System (which includes the Optineb-ir device and accessories).

Anadys Pharmaceuticals Receives FDA Clearance Of Phase II Protocol To Study ANA598 In Combination With Interferon-Alpha And Ribavirin In HCV Patients

Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) announced finalization of the protocol for the Company’s Phase II trial of ANA598 in combination with pegylated interferon-alpha and ribavirin in hepatitis C patients. Allowance of the protocol has been received from the United States Food and Drug Administration (FDA), and patient dosing is expected to commence within the [...]

U.S. decision on use of adjuvants could reduce world supply of H1N1 vaccine, says Lancet editorial

“A U.S. plan to rely on swine flu vaccines without ingredients to stretch the supply [known as adjuvants] would reduce the number of available shots just when other countries need them most, the British journal Lancet said in an editorial,” Bloomberg writes.

Industry lobby wars heighten as reform efforts progress

“Healthcare companies are spending millions of dollars and marshaling armies of lobbyists to influence a landmark debate in the U.S. Congress that could dramatically change the way they do business,” Reuters reports.

Medicago announces positive results for H1N1 pandemic vaccine candidate

Medicago today announced that it has achieved additional positive results with its vaccine candidate for the Influenza A (H1N1) virus, also known as Swine flu. Results showed that a single dose of 5 micrograms induced a positive immune response against a new emerging strain of this virus in 100% of vaccinated animals.