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FDA approves Samsca (tolvaptan) to treat hyponatremia

The U.S. Food and Drug Administration has approved Samsca tablets (tolvaptan) to treat hyponatremia, an abnormally low concentration of sodium in the blood.

22 May 2009

Comparison key to lower drug costs, better outcomes

Patients can expect significant savings and better outcomes from their prescription medications when health care professionals use comparative effectiveness research, according to researchers at the University of Illinois at Chicago.

22 May 2009

Comparative effectiveness necessary to weigh new drugs against old ones, opinion piece says

Patients and physicians "need to know not just whether a new drug outperforms a placebo, but whether it's a real advance on what's already on the market," Richard Friedman, a professor of psychiatry at Weill Cornell Medical College, writes in a New York Times opinion piece.

20 May 2009

Vermont Legislature passes law regulating all drug/device company marketing, requiring disclosure of gifts to doctors

The Vermont Legislature has passed legislation (S 48) that bans nearly all gifts from pharmaceutical and medical device companies to health care providers, administrators and facilities in the state, the New York Times reports.

20 May 2009

Genentech and Biogen Idec submit applications to FDA for Rituxan in chronic lymphocytic leukemia

Genentech, Inc. and Biogen Idec today announced that the companies submitted two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for Rituxan (rituximab) plus standard chemotherapy for people with previously untreated or treated chronic lymphocytic leukemia (CLL).

20 May 2009

Cancer Research UK and Glaxosmithkline join forces to trial new anti-cancer drug

Cancer Research UK and Cancer Research Technology (CRT) today announced they will begin a phase I clinical trial of an anti-cancer drug from GlaxoSmithKline (GSK).

19 May 2009

Sixteen States, DOJ join whistle-blower lawsuits alleging Wyeth defrauded Medicaid programs

The U.S. Department of Justice and 16 states have joined two whistle-blower lawsuits filed in federal District Court in Massachusetts alleging that Wyeth defrauded the government by not offering the same discounts on two medications to Medicaid that it offered to hospitals, the Wall Street Journal reports.

19 May 2009

New flu compound

What happens if the next big influenza mutation proves resistant to the available anti-viral drugs? This question is presenting itself right now to scientists and health officials this week at the World Health Assembly in Geneva, Switzerland, as they continue to do battle with H1N1, the so-called swine flu, and prepare for the next iteration of the ever-changing flu virus.

19 May 2009

Biovail acquires worldwide rights to Tetrabenazine

Biovail Corporation today announced a wholly owned subsidiary has entered into a definitive agreement to acquire worldwide development and commercialization rights to the entire portfolio of tetrabenazine products, including Xenazine/Nitoman (tetrabenazine tablets), and the associated intellectual property rights held by Cambridge Laboratories (Ireland) Ltd and its affiliates.

18 May 2009

A.P. Pharma submits NDA for APF530 in chemo-induced nausea and vomiting

A.P. Pharma, Inc. has announced that it has submitted a New Drug Application (NDA) for its lead product, APF530, to the U.S. Food and Drug Administration (FDA). APF530 is being developed for the prevention of chemotherapy-induced nausea and vomiting (CINV) and is a long-acting formulation of granisetron that utilizes the Company's proprietary Biochronomer drug delivery system.

18 May 2009

Rituximab linked to viral brain infection

The 57-year-old lawyer in New York had handily completed the New York Times' Saturday crossword puzzle - the hardest of the week - for years. But one Saturday morning, suddenly he couldn't retrieve the words to fill in the squares.

18 May 2009

Oxford BioTherapeutics and GSK form alliance to develop cancer therapeutic antibodies

Oxford BioTherapeutics (OBT) today announced a strategic alliance with GlaxoSmithKline to discover, develop and commercialise novel, therapeutic antibodies for the treatment of primary, metastatic and recurring forms of cancer.

18 May 2009

Onyx Pharmaceuticals files complaint against Bayer on fluoro-sorafenib

Onyx Pharmaceuticals, Inc. today announced that it has filed a complaint in the United States District Court for the Northern District of California asserting its rights to a Phase 2 anti-cancer compound discovered during joint research between Onyx and Bayer.

17 May 2009

Washington State drops budget provision that would have cut Medicaid pharmacy payments

Washington state lawmakers this week eliminated a budgetary proposal that would have reduced Medicaid payment rates to pharmacies to the lowest levels in the country, the AP/Spokane Spokesman-Review reports.

15 May 2009

Pfizer to give away 70 of its most widely prescribed drugs to those who lost jobs

Pfizer on Thursday announced a new program that would provide some of its existing customers access to more than 70 types of medications at no cost if they have recently been laid off or lost their prescription drug coverage, USA Today reports. The program -- called MAINTAIN, or Medicines Assistance for Those who Are in Need -- will begin July 1.

15 May 2009

Morphine patches create addiction

Morphine patches are supposed to reduce use of painkillers, and provide more control over their use in chronic pain conditions. But researchers at the Norwegian University of Science and Technology (NTNU) and St. Olavs Hospital in Trondheim have found otherwise.

15 May 2009

Prescription drug use dropped in 2008, though spending increased, Medco Research indicates

Use of prescription drugs in the U.S. declined in 2008 -- the first such decrease in a decade -- but total spending on such treatments increased by 3.3%, according to a report released on Wednesday by Medco Health Solutions, the AP/Washington Post reports.

14 May 2009

Cimzia approved in U.S. for rheumatoid arthritis

UCB announced today that the U.S. Food and Drug Administration (FDA) approved Cimzia, the only PEGylated anti-TNF (Tumor Necrosis Factor), for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

13 May 2009

Baylor Research Institute receives multi-million dollar grant to develop flu vaccine

Scientists at Baylor Institute for Immunology Research (BIIR) in Dallas, part of Baylor Research Institute (BRI) and the Baylor Health Care System, announced today that they received a renewal of a multi-million dollar grant from the National Institutes of Health (NIH) to design new vaccines to prevent influenza - including swine flu (H1N1).

13 May 2009

FDA accepts Pharmaxis’ Aridol NDA for review

Pharmaxis has announced it had received notification from the United States Food and Drug Administration (FDA) that the New Drug Application (NDA) for its mannitol bronchial challenge test Aridol has been accepted for standard review. The FDA will advise the result of the review on 27 December 2009.

13 May 2009

Pharmaceutical News

FDA approves Samsca (tolvaptan) to treat hyponatremia

Comparison key to lower drug costs, better outcomes

Comparative effectiveness necessary to weigh new drugs against old ones, opinion piece says

Vermont Legislature passes law regulating all drug/device company marketing, requiring disclosure of gifts to doctors

Genentech and Biogen Idec submit applications to FDA for Rituxan in chronic lymphocytic leukemia

Cancer Research UK and Glaxosmithkline join forces to trial new anti-cancer drug

Sixteen States, DOJ join whistle-blower lawsuits alleging Wyeth defrauded Medicaid programs

New flu compound

Biovail acquires worldwide rights to Tetrabenazine

A.P. Pharma submits NDA for APF530 in chemo-induced nausea and vomiting

Rituximab linked to viral brain infection

Oxford BioTherapeutics and GSK form alliance to develop cancer therapeutic antibodies

Onyx Pharmaceuticals files complaint against Bayer on fluoro-sorafenib

Washington State drops budget provision that would have cut Medicaid pharmacy payments

Pfizer to give away 70 of its most widely prescribed drugs to those who lost jobs

Morphine patches create addiction

Prescription drug use dropped in 2008, though spending increased, Medco Research indicates

Cimzia approved in U.S. for rheumatoid arthritis

Baylor Research Institute receives multi-million dollar grant to develop flu vaccine

FDA accepts Pharmaxis’ Aridol NDA for review

Small solutions for big problems in drug discovery and delivery

Professor Nancy Ip: Pioneering New Paths in Neurodegenerative Therapy

Utilizing process Raman in optimizing cultivated meat production

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