Pharmaceutical News

RSS

Promising antimicrobial agent kills viruses, stimulates immune system

A promising antimicrobial agent already known to kill bacteria can also kill viruses and stimulate the innate immune system, according to researchers at National Jewish Health.

4 Jun 2009

FDA moves towards greater openness

The Associated Press reports that FDA Commissioner Margaret Hamburg "announced Tuesday she has created a task force to make recommendations on how the agency can release more information in such areas as drug evaluation and enforcement matters. She wants a report in six months."

3 Jun 2009

Lilly resubmits Cymbalta supplemental NDA for chronic pain to FDA

Eli Lilly and Company has resubmitted its supplemental New Drug Application (sNDA) for Cymbalta (duloxetine HCl) for the management of chronic pain to the U.S. Food and Drug Administration (FDA).

3 Jun 2009

Schering-Plough announces European filing of Sycrest (asenapine) for schizophrenia and bipolar I disorder

Schering-Plough Corporation has announced that the European Medicines Agency (EMEA) has validated (accepted for review) the company's Marketing Authorization Application (MAA) for Sycrest (asenapine) sublingual tablets for the treatment of schizophrenia and manic episodes associated with bipolar I disorder. The application will follow the Centralized Procedure.

2 Jun 2009

Impact of Medicare Part D on access to and cost sharing for specialty biologic medications for beneficiaries with rheumatoid arthritis

Biologic disease-modifying antirheumatic drugs (DMARDs) such as adalimumab, etanercept and infliximab are effective at reducing symptoms and slowing progression of rheumatoid arthritis (RA). These drugs act more quickly, require less laboratory monitoring, and are better tolerated than nonbiologic DMARDs, but they are also up to 100 times more expensive.

1 Jun 2009

FDA approves Reclast (zoledronic acid) for osteoporosis in postmenopausal women

Reclast (zoledronic acid) Injection has been approved by the US Food and Drug Administration (FDA) as the first and only therapy to prevent postmenopausal osteoporosis for two years with a single dose. Reclast is already approved as a once-yearly infusion for the treatment of postmenopausal osteoporosis.

1 Jun 2009

States consider scaling back funding for Medicare drug benefit amid economic crisis

At least six states have considered eliminating or reducing financial assistance for those enrolled in the Medicare prescription drug benefit program who are affected by the "doughnut hole," or gap in coverage, the AP/Boston Herald reports.

28 May 2009

FDA approves Besivance as a treatment for bacterial conjunctivitis

The U.S. Food and Drug Administration today approved Besivance (besifloxacin ophthalmic suspension 0.6 percent) for the treatment of bacterial conjunctivitis (non-viral), a contagious condition marked by irritation of the eyes and a discharge from the mucous membranes.

28 May 2009

Sanofi Pasteur receives seed virus to produce new H1N1 vaccine

Sanofi Pasteur announced today it has received the new influenza A(H1N1) seed virus, enabling the world's leading manufacturer of influenza vaccines to begin the production process for an A(H1N1) vaccine.

27 May 2009

Dementia drugs Aricept, Exelon and Reminyl may put some patients at risk

Side effects associated with several commonly-prescribed dementia drugs may be putting elderly Canadians at risk, says Queen's University Geriatrics professor Sudeep Gill.

27 May 2009

FDA grants full approval for Sprycel (dasatinib) for chronic myeloid leukemia

Bristol-Myers Squibb Company has announced that the U.S. Food and Drug Administration (FDA) has granted full approval for Sprycel (dasatinib) for the treatment of adults in all phases of chronic myeloid leukemia (CML) (chronic, accelerated, or myeloid or lymphoid blast phase) with resistance or intolerance to prior therapy including Gleevec (imatinib mesylate).

27 May 2009

ImmunoVaccine Technologies partners with FIT Biotech to advance therapeutic HIV vaccine

ImmunoVaccine Technologies Inc. (IVT), a Canadian vaccine development company, announced a research partnership with FIT Biotech, a Finland-based , clinical stage company that develops DNA vaccines. This research will formulate FIT Biotech's GTU MultiHIV DNA plasmid with IVT's DepoVax vaccine delivery system to advance a therapeutic HIV vaccine.

26 May 2009

Development of innovative nanotechnology drug delivery system for the treatment of pain

Z-Cube Srl, the corporate venture arm of Zambon Company SpA, and Yissum Research Development Company Ltd., the technology transfer company of the Hebrew University of Jerusalem, announced today that they have entered into a license agreement for Z-Cube to develop and commercialize an innovative nanotechnology drug delivery system for the treatment of pain.

25 May 2009

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

Pharmaceutical News

Promising antimicrobial agent kills viruses, stimulates immune system

FDA moves towards greater openness

Lilly resubmits Cymbalta supplemental NDA for chronic pain to FDA

Schering-Plough announces European filing of Sycrest (asenapine) for schizophrenia and bipolar I disorder

Impact of Medicare Part D on access to and cost sharing for specialty biologic medications for beneficiaries with rheumatoid arthritis

FDA approves Reclast (zoledronic acid) for osteoporosis in postmenopausal women

States consider scaling back funding for Medicare drug benefit amid economic crisis

FDA approves Besivance as a treatment for bacterial conjunctivitis

Sanofi Pasteur receives seed virus to produce new H1N1 vaccine

Dementia drugs Aricept, Exelon and Reminyl may put some patients at risk

FDA grants full approval for Sprycel (dasatinib) for chronic myeloid leukemia

ImmunoVaccine Technologies partners with FIT Biotech to advance therapeutic HIV vaccine

Development of innovative nanotechnology drug delivery system for the treatment of pain

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

Redefining control and consistency in anaerobic microbiome workflows

AI in Healthcare: How generative tools are transforming clinical practice

The future of automation: Machine learning–driven hepatocyte and organoid counting

Latest News