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FDA grants orphan drug designation to EffRx Pharmaceuticals' EX404 for treatment of PCOS

EffRx Pharmaceuticals SA, a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration has granted orphan drug designation to its proprietary metformin-based product candidate, EX404, for the treatment of pediatric polycystic ovary syndrome (PCOS).

11 Jun 2014

InSite and Senju collaborate to develop and market azithromycin ophthalmic solution using DuraSite

InSite Vision Incorporated and Senju Pharmaceutical Co., Ltd. today announced that they have entered into a collaboration and license agreement to develop and market InSite's azithromycin ophthalmic solution using DuraSite® including AzaSite® 1% and AzaSite XtraTM 2% ocular antibiotics in Japan. Senju has agreed to pay InSite an upfront license fee, additional development milestones fees, and a percentage royalty on net sales.

10 Jun 2014

Alkermes initiates FORWARD-3 and FORWARD-4 efficacy studies in pivotal clinical program for ALKS 5461

Alkermes plc today announced the initiation of FORWARD-3 and FORWARD-4, two of the three planned phase 3 core efficacy studies in the pivotal clinical program for ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder (MDD).

10 Jun 2014

PaxVax partners with UC to develop combination vaccine to prevent genital HSV infections

PaxVax Inc., a specialty vaccine company with a commercial focus on travel and biodefense and a social mission to ensure global access to its vaccines, today announced that it has entered into a research and development collaboration with the University of California, San Diego to develop a combination vaccine to prevent genital herpes simplex virus (HSV) infections.

10 Jun 2014

Celsion signs definitive asset purchase agreement to acquire EGEN

Celsion Corporation (Celsion) (NASDAQ: CLSN), an oncology drug development company, and EGEN, Inc. (EGEN), a privately-held biopharmaceutical company focused on the development of nucleic acid-based therapeutics for the treatment of cancer and other difficult to treat diseases, today announced the signing of a definitive asset purchase agreement in which Celsion will acquire substantially all of the assets of EGEN, including its Phase Ib DNA-based immunotherapy product candidate EGEN-001 and its therapeutic platform technologies, TheraPlas™ for delivery of DNA and mRNA, TheraSilence™ for delivery of RNA, and RAST™ for Cell Enabled Expression and Secretion of RNA.

10 Jun 2014

New therapeutic interventions could render addiction into manageable disease

Neuroscientists agree that abuse of drugs hijacks circuits in the brain that are crucial for decision-making, but society as a whole tends to stigmatize addicted people for lacking self-control.

10 Jun 2014

Synthetic, Enterome partner to study effects of beta-lactam antibiotics on gastrointestinal microflora

Synthetic Biologics, Inc., a developer of novel anti-infective biologic and drug candidates targeting specific pathogens that cause serious infections and diseases, and Enterome Bioscience SA, a pioneer in the development of innovative disease management solutions based on a deep understanding of the gut microbiome, today announced that they have entered into an agreement to conduct metagenomic research on the effects of beta-lactam antibiotics on the gastrointestinal microflora (microbiome) of human patients.

10 Jun 2014

School prevention program can dramatically cut teen cigarette smoking in Italy

Results from a new multi-year initiative provide further evidence that a school prevention program called Botvin LifeSkills Training (LST) can dramatically cut teen cigarette smoking. After identifying LST as the top-rated prevention program, researchers in Italy translated the LST program into Italian and adapted it for Italian youth.

10 Jun 2014

Under health law, states serve as testing grounds for innovation

Media outlets report on a range of issues related to the measure's implementation, including how some states are finding opportunities in the overhaul to pursue their own health system changes.

10 Jun 2014

Chronic sleep loss can cause certain neurotoxic molecules to permeate into brain tissue

The longer the insomnia, junctions of cerebral blood vessels begin to degrade. In search of the answer to why do we sleep, research conducted at the Mexican Metropolitan Autonomous University (UAM) revealed that chronic sleep loss can cause certain neurotoxic molecules, which normally circulate in the blood, to be transported to the central nervous system and interfere with the function of neurons.

10 Jun 2014

Researchers solve structure of key protein that drives DNA copying in plasmids

Staph infections that become resistant to multiple antibiotics don't happen because the bacteria themselves adapt to the drugs, but because of a kind of genetic parasite they carry called a plasmid that helps its host survive the antibiotics.

10 Jun 2014

Combined chemo and radionuclide therapy stops neuroendocrine tumors

Advanced cancer of the neuroendocrine system can lead to dismal prognoses, but a novel therapy is packing a punch by uniting powerful radionuclide treatment and chemotherapy drugs, revealed researchers at the Society of Nuclear Medicine and Molecular Imaging's 2014 Annual Meeting.

10 Jun 2014

Isis Pharmaceuticals begins ISIS-DMPK Rx Phase 1 study for treatment of Myotonic Dystrophy Type 1

Isis Pharmaceuticals, Inc. announced today that it has initiated a Phase 1 study for ISIS-DMPKRx. Isis earned a $14 million milestone payment from Biogen Idec associated with this achievement.

9 Jun 2014

FDA accepts Pharmacyclics' IMBRUVICA sNDA for review

Pharmacyclics, Inc. today announced that the U.S. Food and Drug Administration has accepted for filing its supplemental New Drug Application (sNDA) to support the review of IMBRUVICA (ibrutinib) in the treatment of patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) who have received at least one prior therapy for a full approval.

9 Jun 2014

Seres Health closes $10 million Series B financing, signs research collaboration with Mayo Clinic

Seres Health, a clinical-stage therapeutics company developing novel products to treat a host of disease conditions based on scientific findings related to the human microbiome, announced today that it has closed its $10 million Series B financing that included existing investors Flagship Ventures and Enso Ventures, and included new investors, Mayo Clinic, Alexandria Venture Investments, and several private investors. The company has also entered into an exclusive research collaboration with the Mayo Clinic.

9 Jun 2014

Celsus’ expert highlights serious side effects of topical corticosteroids

A 2013 Mayo Clinic study involving more than 140,000 patients revealed that skin disorders are the most common nonacute reason Americans seek health care.

9 Jun 2014

Protein-kinase interactions offer a new way to fight antimalarial drug resistance

When it comes to the emergence of antimalarial drug resistance, it's not a question of 'if' but 'when'. In order to keep up with the quickly evolving Plasmodium parasite - the cause of malaria - new ways to treat and control the disease must be found.

9 Jun 2014

Drugs News and Research

FDA grants orphan drug designation to EffRx Pharmaceuticals' EX404 for treatment of PCOS

InSite and Senju collaborate to develop and market azithromycin ophthalmic solution using DuraSite

Alkermes initiates FORWARD-3 and FORWARD-4 efficacy studies in pivotal clinical program for ALKS 5461

PaxVax partners with UC to develop combination vaccine to prevent genital HSV infections

Celsion signs definitive asset purchase agreement to acquire EGEN

New therapeutic interventions could render addiction into manageable disease

Synthetic, Enterome partner to study effects of beta-lactam antibiotics on gastrointestinal microflora

School prevention program can dramatically cut teen cigarette smoking in Italy

Under health law, states serve as testing grounds for innovation

Chronic sleep loss can cause certain neurotoxic molecules to permeate into brain tissue

Researchers solve structure of key protein that drives DNA copying in plasmids

Combined chemo and radionuclide therapy stops neuroendocrine tumors

Isis Pharmaceuticals begins ISIS-DMPK Rx Phase 1 study for treatment of Myotonic Dystrophy Type 1

FDA accepts Pharmacyclics' IMBRUVICA sNDA for review

Seres Health closes $10 million Series B financing, signs research collaboration with Mayo Clinic

Celsus’ expert highlights serious side effects of topical corticosteroids

Protein-kinase interactions offer a new way to fight antimalarial drug resistance

NIDA review offers new insights into the negative health effects of marijuana

BioDelivery Sciences receives approval of NDA for BUNAVAIL from FDA

Merck enters into definitive agreement with Idenix

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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