Pharmaceutical News

RSS

NanoViricides submits letter of intent to file Orphan Drug Application with EMA for DengueCide

NanoViricides, Inc. announced today that it has submitted its letter of intent to file an Orphan Drug Application with the European Medicines Agency for DengueCide, its drug candidate for the treatment of dengue and dengue hemorrhagic fever.

1 Jul 2013

First Edition: July 1, 2013

Today's headlines include a variety of weekend news reports, including coverage of the Obama administration's final contraceptive coverage rule as well as a range of other stories on health law implementation issues.

1 Jul 2013

Researchers find new treatment option for schizophrenia

A research group led by professor Jesper Ekelund showed that by giving a very large dose of famotidine (200 mg daily), sufficient amounts of the drug are able to penetrate the so-called blood-brain barrier to affect the histamine system in the brain.

1 Jul 2013

Bayer, Onyx submit sNDA to FDA, marketing authorization application to EMA for Nexavar tablets

Bayer HealthCare and Onyx Pharmaceuticals today announced the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration and an application for marketing authorization to the European Medicines Agency for the oral multi-kinase inhibitor Nexavar (sorafenib) tablets for the treatment of locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer.

1 Jul 2013

New report shows steady progress in research and development for HIV vaccines

Recent breakthroughs in HIV prevention research have confirmed the promise of new options to help end the AIDS epidemic and highlight the urgent need for ongoing research to develop additional prevention options and support rapid rollout of proven ones.

1 Jul 2013

Study indicates "statin-intolerant" patients can reduce cholesterol by visiting lipid clinic treatment

Up to 15 percent of patients who take cholesterol-lowering statin medications experience muscle pain or other side effects, and many patients simply stop taking the drugs.

30 Jun 2013

Biomolecular interactions of nanoparticles can improve drug development, optical sensors and more

In chemical reactions, left and right can make a big difference. A "left-handed" molecule of a particular chemical composition could be an effective drug, while its mirror-image "right-handed" counterpart could be completely inactive.

30 Jun 2013

Transplanted bone marrow stem cells in patients with type 2 diabetes reduce insulin use

A study carried out in India examining the safety and efficacy of self-donated (autologous), transplanted bone marrow stem cells in patients with type 2 diabetes (TD2M), has found that patients receiving the transplants, when compared to a control group of TD2M patients who did not receive transplantation, required less insulin post-transplantation.

30 Jun 2013

State highlights: Maine to permit Rx drugs from Canada; Ore. to levy hospital, nursing home assessment tax

For the first time in several years, a state has acted to allow its citizens to purchase prescription drugs by mail from other countries. The idea is to take advantage of those nations' lower prices, which can be half the cost of those at American pharmacies (Rovner, 6/27).

29 Jun 2013

High court moves tentatively toward hearing case on abortion-inducing drugs

The Supreme Court asked Oklahoma's Supreme Court to clarify a law that state judges had struck down as an unwarranted curb on medical practice and the right to abortion.

29 Jun 2013

Feds shut down more than 1,600 fake online pharmacies

Authorities from the Food and Drug Administration closed these illegal pharmacy websites and sent letters to hundreds more that sell counterfeit prescription drugs and dangerous supplements.

29 Jun 2013

Federal judge orders permanent injunction against Med Prep Consulting

A federal judge from the U.S. District Court for New Jersey has entered a consent decree of permanent injunction against Med Prep Consulting, Inc., a pharmacy licensed by the state of New Jersey, and Gerald R. Tighe, the company's president and owner.

29 Jun 2013

Appeals court green lights Hobby Lobby's legal challenge to contraceptive coverage rule

A federal appeals court in Denver said Thursday that companies, whether they are for profit or not, have religious rights and that the challenge brought by Hobby Lobby Stores Inc. and its sister company can go forward.

29 Jun 2013

Brisdelle receives FDA approval to treat hot flashes associated with menopause

The U.S. Food and Drug Administration today approved Brisdelle (paroxetine) to treat moderate to severe hot flashes (vasomotor symptoms) associated with menopause. Brisdelle, which contains the selective serotonin reuptake inhibitor paroxetine mesylate, is currently the only non-hormonal treatment for hot flashes approved by the FDA.

29 Jun 2013

Study shows "bioadhesive" coating can increase intestinal uptake of protein-based drugs

For protein-based drugs such as insulin to be taken orally rather than injected, bioengineers need to find a way to shuttle them safely through the stomach to the small intestine where they can be absorbed and distributed by the bloodstream.

28 Jun 2013

New resource guide to tackle prescription drug abuse among youth

To help tackle the serious problem of youth prescription drug abuse, high school teachers will have free access to a new resource guide, Rx for Understanding: Preventing Prescription Drug Abuse.

28 Jun 2013

EMA's CHMP issues positive opinion for approval of Genzyme's LEMTRADA in Europe

Genzyme, a Sanofi company, announced today that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion for approval of LEMTRADA (alemtuzumab) for the treatment of adult patients with relapsing remitting multiple sclerosis with active disease defined by clinical or imaging features.

28 Jun 2013

Janssen receives complete response letter from FDA for XARELTO sNDA

Janssen Research & Development, LLC today announced the U.S. Food and Drug Administration has issued a complete response letter for the supplemental New Drug Application for XARELTO (rivaroxaban) to reduce the risk of stent thrombosis in patients with acute coronary syndrome.

28 Jun 2013

Hospira receives positive opinion from EMA's CHMP for EC approval of Inflectra

Hospira, the world's leading provider of injectable drugs and infusion technologies, today received a positive opinion from the European Medicines Agency Committee for Medicinal Products for Human Use, recommending the European Commission approval of Inflectra (infliximab) for rheumatoid arthritis, inflammatory bowel disease and plaque psoriasis.

28 Jun 2013

First Edition: June 28, 2013

Today's headlines include reports that the high court sent a tentative signal Thursday that it was moving toward hearing a case on the regulation of abortion-inducing drugs.

28 Jun 2013

Pharmaceutical News

NanoViricides submits letter of intent to file Orphan Drug Application with EMA for DengueCide

First Edition: July 1, 2013

Researchers find new treatment option for schizophrenia

Bayer, Onyx submit sNDA to FDA, marketing authorization application to EMA for Nexavar tablets

New report shows steady progress in research and development for HIV vaccines

Study indicates "statin-intolerant" patients can reduce cholesterol by visiting lipid clinic treatment

Biomolecular interactions of nanoparticles can improve drug development, optical sensors and more

Transplanted bone marrow stem cells in patients with type 2 diabetes reduce insulin use

State highlights: Maine to permit Rx drugs from Canada; Ore. to levy hospital, nursing home assessment tax

High court moves tentatively toward hearing case on abortion-inducing drugs

Feds shut down more than 1,600 fake online pharmacies

Federal judge orders permanent injunction against Med Prep Consulting

Appeals court green lights Hobby Lobby's legal challenge to contraceptive coverage rule

Brisdelle receives FDA approval to treat hot flashes associated with menopause

Study shows "bioadhesive" coating can increase intestinal uptake of protein-based drugs

New resource guide to tackle prescription drug abuse among youth

EMA's CHMP issues positive opinion for approval of Genzyme's LEMTRADA in Europe

Janssen receives complete response letter from FDA for XARELTO sNDA

Hospira receives positive opinion from EMA's CHMP for EC approval of Inflectra

First Edition: June 28, 2013

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

Latest News