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Emergence of drug resistance to ARVs has potential to 'curb, and even reverse' gains against HIV

Noting that the "roll-out of antiretroviral treatment for HIV in sub-Saharan Africa has been accompanied by rising rates of drug resistance," Raph Hamers, a global health research fellow at the Academic Medical Centre of the University of Amsterdam, and colleagues "call for improved patient management and the integration of population-based drug resistance surveillance into national treatment programs" in this BMJ analysis.

20 Jun 2012

FDA provides Orphan Drug Designation to Alnylam’s ALN-TTR02

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that the U.S. Food & Drug Administration (FDA) has provided Orphan Drug Designation to ALN-TTR02 as a therapeutic for the treatment of familial amyloidotic polyneuropathy (FAP), one of the predominant clinical manifestations of transthyretin (TTR)-mediated amyloidosis (ATTR).

20 Jun 2012

KPT-SINEs might offer new treatment for people with acute leukemia

A novel family of experimental agents that blocks a molecule from shuttling proteins out of the cell nucleus might offer a new treatment for people with acute leukemia, according to a study by researchers at the Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute.

20 Jun 2012

Grunenthal to commercialize Horizon Pharma's DUEXIS in Latin America

Horizon Pharma, Inc. a biopharmaceutical company developing and commercializing innovative medicines to target unmet therapeutic needs in arthritis, pain and inflammatory diseases, today announced that it entered into an exclusive agreement with Grunenthal for the commercialization of DUEXIS in Latin America.

19 Jun 2012

FDA, EMA grant orphan drug designation to bluebird bio's gene therapy product for adrenoleukodystrophy

bluebird bio, a leader in the development of innovative gene therapies for severe genetic disorders, announced today that both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have granted an orphan drug designation to its investigational gene therapy product for the treatment of adrenoleukodystrophy (ALD).

19 Jun 2012

AstraZeneca, Rigel enter global license agreement for R256 inhaled JAK inhibitor to treat chronic asthma

AstraZeneca and Rigel Pharmaceuticals Inc. today announced an exclusive worldwide license agreement for the global development and commercialization of R256, Rigel's inhaled JAK inhibitor shown to inhibit IL-13 and IL-4 signalling, which is being investigated as a treatment for moderate to severe chronic asthma. In preclinical research, R256 has been shown to reduce airway inflammation and improve lung function.

19 Jun 2012

New clinical data for ZEVALIN Injection for intravenous use presented at 17th EHA Congress

Spectrum Pharmaceuticals, Inc., a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology and hematology, today announced new clinical data presented in an oral presentation for ZEVALIN (ibritumomab tiuxetan) Injection for intravenous use at the 17th Congress of the European Hematology Association (EHA).

19 Jun 2012

US Court of Appeals confirms District Court decision in Watson's Sanctura XR patent suit

Watson Pharmaceuticals, Inc. today confirmed that the United States Court of Appeals for the Federal Circuit has affirmed the United States District Court for the District of Delaware's March 31, 2012 decision that the asserted claims of U.S. Patent Nos. 7,410,978; 7,759,359; 7,781,448; 7,781,449 and 7,763,635 relating to Sanctura XR (trospium chloride extended-release capsules) are invalid.

19 Jun 2012

Pfizer receives FDA Complete Response Letter for tafamidis meglumine NDA

Pfizer Inc. announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) on its New Drug Application (NDA) for tafamidis meglumine.

19 Jun 2012

Mylan's new online resource seeks to dispel common misconceptions about generic drugs

Mylan Pharmaceuticals ULC, the Canadian subsidiary of Mylan Inc., announced today the introduction of a new online resource, ChoosingGenerics.ca, to help Canadians learn more about the value, reliability and quality of generic pharmaceuticals. The website is a public awareness tool that seeks to dispel common misconceptions and help Canadians learn more about the benefits of generic drugs.

18 Jun 2012

Vicks announces OTC aid for occasional sleeplessness, ZzzQuil

The makers of VicksNyQuil announced today the newest non-habit forming, over-the-counter sleep-aid that provides relief for occasional sleeplessness. ZzzQuil - It's not for colds, it's not for pain, it's just for sleep.

18 Jun 2012

Edluar for insomnia treatment receives regulatory approval in Europe

Orexo AB is pleased to report that Edluar has received regulatory approval in Europe, according to information supplied by Meda AB, Orexo's global commercial partner for the product.

18 Jun 2012

Mallinckrodt, Horizon enter co-promotion agreement for DUEXIS

Mallinckrodt, the Pharmaceuticals business of Covidien, today announced that it has entered into a co-promotion agreement with Horizon Pharma, Inc. to promote DUEXIS (ibuprofen and famotidine).

18 Jun 2012

Ascepion, Debiopharm partner to develop and commercialize ASP-08126 for solid tumors

Debiopharm Group, a global biopharmaceutical development specialist that focuses on serious medical conditions and particularly oncology, and Ascepion Pharmaceuticals, Inc., a privately-held, biopharmaceutical company dedicated to the discovery and development of breakthrough small molecule drugs for the treatment of oncology and related diseases, have entered into an exclusive worldwide license agreement concerning the development and commercialization of ASP-08126 (called Debio 1144 by Debiopharm) a multikinase inhibitor currently in pre-clinical development.

18 Jun 2012

FDA completes review of compounded hydroxyprogesterone caproate products and APIs

FDA (or the Agency) approved Makena (hydroxyprogesterone caproate) in February 2011 for the reduction of the risk of certain preterm births in women who have had at least one prior preterm birth. Beginning many years before Makena was approved, a version of the active ingredient of Makena has been available to patients whose physicians requested the drug from a pharmacist who compounded the drug.

18 Jun 2012

ASH, EHA and ECPC issue common call to action to mitigate hematologic drug shortages

The American Society of Hematology (ASH) joined the European Hematology Association (EHA) and the European Cancer Patient Coalition (ECPC) today in issuing a common call to action in an effort to mitigate shortages of hematologic drugs in the United States and around the world.

18 Jun 2012

Ginger gum can cure migraine headaches

If you or someone you care about is among the one in 10 Americans who suffer with migraine headaches, recent research may provide some relief.

16 Jun 2012

Glutathione peroxidase can dramatically reduce risk of cardiovascular disease

University of Minnesota Medical School researchers have collaborated with the School of Public Health and discovered an enzyme that, when found at high levels and alongside low levels of HDL (good cholesterol), can dramatically reduce the risk of cardiovascular disease.

16 Jun 2012

Researchers engineer nanoparticles that show great promise for MM

Researchers from the University of Notre Dame have engineered nanoparticles that show great promise for the treatment of multiple myeloma (MM), an incurable cancer of the plasma cells in bone marrow.

16 Jun 2012

Health Canada approves Sunovion’s LATUDA NDA to treat schizophrenia

Sunovion Pharmaceuticals Canada Inc. today announced that the New Drug Submission (NDS) for LATUDA (lurasidone HCl), for the treatment of adult patients with acute schizophrenia has been approved by Health Canada.

16 Jun 2012

Pharmaceutical News

Emergence of drug resistance to ARVs has potential to 'curb, and even reverse' gains against HIV

FDA provides Orphan Drug Designation to Alnylam’s ALN-TTR02

KPT-SINEs might offer new treatment for people with acute leukemia

Grunenthal to commercialize Horizon Pharma's DUEXIS in Latin America

FDA, EMA grant orphan drug designation to bluebird bio's gene therapy product for adrenoleukodystrophy

AstraZeneca, Rigel enter global license agreement for R256 inhaled JAK inhibitor to treat chronic asthma

New clinical data for ZEVALIN Injection for intravenous use presented at 17th EHA Congress

US Court of Appeals confirms District Court decision in Watson's Sanctura XR patent suit

Pfizer receives FDA Complete Response Letter for tafamidis meglumine NDA

Mylan's new online resource seeks to dispel common misconceptions about generic drugs

Vicks announces OTC aid for occasional sleeplessness, ZzzQuil

Edluar for insomnia treatment receives regulatory approval in Europe

Mallinckrodt, Horizon enter co-promotion agreement for DUEXIS

Ascepion, Debiopharm partner to develop and commercialize ASP-08126 for solid tumors

FDA completes review of compounded hydroxyprogesterone caproate products and APIs

ASH, EHA and ECPC issue common call to action to mitigate hematologic drug shortages

Ginger gum can cure migraine headaches

Glutathione peroxidase can dramatically reduce risk of cardiovascular disease

Researchers engineer nanoparticles that show great promise for MM

Health Canada approves Sunovion’s LATUDA NDA to treat schizophrenia

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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