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FDA accepts Mundipharma EDO's Investigational New Drug Application for EDO-S101

Mundipharma EDO GmbH (Early Development in Oncology) is pleased to announce that the United States Food and Drug Administration has accepted the company's Investigational New Drug Application ("IND") for EDO-S101, a fusion molecule to treat relapsed/refractory haematologic malignancies and solid tumours.

31 Jul 2015

Eisai, Halozyme partner to evaluate eribulin and PEGPH20 in HER2-negative metastatic breast cancer

Eisai Inc. announced today that its parent company Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito) and Halozyme Therapeutics, Inc. (Headquarters: San Diego, California, President and CEO: Dr. Helen Torley) have signed a clinical collaboration agreement to evaluate Eisai's agent eribulin mesylate (brand name: Halaven, "eribulin") in combination with Halozyme's investigational drug PEGPH20 (PEGylated recombinant human hyaluronidase) in first line HER2-negative metastatic breast cancer.

31 Jul 2015

Takeda completes post-marketing commitment and data submission for pioglitazone containing medicines

Takeda Pharmaceutical Company Limited today announced the completion of the study to fulfill the post-marketing commitment and submissions of data to regulatory authorities from the Pan European Multi-Database Bladder Cancer Risk Characterization Study, a large (n= 112,674), multi-database retrospective matched cohort study, conducted in four European countries, for pioglitazone containing medicines, including ACTOS with up to 10 years of follow-up.

31 Jul 2015

Tissue Regenix strengthens position in post-acute wound care market with Medicare coverage for Dermapure

Tissue Regenix Group, the regenerative medical devices company, announces that it has further strengthened its position within the post-acute wound care market as Tissue Regenix Wound Care Inc. has received further approval for DermaPure under Medicare administrator, First Coast Service Options Inc. whose jurisdiction includes Florida, Puerto Rico and the US Virgin Islands.

30 Jul 2015

Roche submits cobas EGFR v2 test PMA to FDA as companion diagnostic test for AZD9291

Roche today announced it has submitted the cobas EGFR Mutation Test v2 for Premarket Approval (PMA) to the U.S. Food and Drug Administration, as a companion diagnostic test for AZD9291, an AstraZeneca investigational therapy for non-small cell lung cancer patients with an acquired resistant mutation.

30 Jul 2015

Study sheds light on certain antagonist drugs that block physiological responses

Members of the Consolidated Research Group of Molecular Neurobiology of the Department of Biochemistry and Molecular Biology of the University of Barcelona (UB), affiliated with the Centre for Networked Biomedical Research on Neurodegenerative Diseases (CIBERNED), have published a study in the journal Proceedings of the National Academy of Sciences (PNAS) about the formation of G protein-coupled receptors (GPCRs) which allows understanding the unexpected behaviour of some antagonists that block physiological responses.

30 Jul 2015

Commonly prescribed drug also lowers blood pressure when combined with diuretic

With the growth of electronic medical records, research utilizing data from a large number of patients, known as big data studies, can provide important information which may be unattainable via clinical trials which tend to be costly, time-consuming and involve fewer patients.

30 Jul 2015

ACP supports for eliminating non-medical vaccination exemptions

Support for eliminating existing exemptions, except for medical reasons, from immunization laws was among the policy recommendations adopted last weekend at the summer meeting of the Board of Regents of the American College of Physicians.

30 Jul 2015

Vismodegib therapy effective against medulloblastoma

A targeted therapy already used to treat advanced skin cancer is also effective against the most common subtype of the brain tumor medulloblastoma in adults and should be considered for treatment of newly diagnosed patients, according to research led by St. Jude Children's Research Hospital.

30 Jul 2015

Aeterna Zentaris selects optimized Erk inhibitor molecule for further development

Aeterna Zentaris Inc. today announced it has selected an optimized Erk inhibitor molecule for development, thus achieving another important milestone in the development of a new class of potential cancer therapies.

29 Jul 2015

World Health Organization recognizes unique pharmacological nature of Can-Fite's CF101, grants new generic name

Can-Fite BioPharma Ltd., a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, today announced that the World Health Organization's International Nonproprietary Name group has accepted the proposed generic name "piclidenoson" for its lead drug candidate, CF101.

29 Jul 2015

PDL BioPharma signs revenue interest assignment agreement with ARIAD Pharmaceuticals

PDL BioPharma, Inc. today announced that it has entered into a revenue interest assignment agreement (the "Agreement") in which it has agreed to provide ARIAD Pharmaceuticals, Inc. with up to $200 million in revenue interest financing in exchange for royalties on the net revenues of Iclusig (ponatinib).

29 Jul 2015

Study reveals that firms 'underinvest' in long-term research to develop cancer-fighting drugs

Pharmaceutical firms "underinvest" in long-term research to develop new cancer-fighting drugs due to the greater time and cost required to conduct such research, according to a newly published study co-authored by MIT economists.

29 Jul 2015

CMC Biologics, River Vision sign manufacturing agreement for Teprotumumab to treat Grave's Orbitopathy

CMC Biologics, a global leader in clinical and commercial manufacturing of therapeutic proteins, and River Vision Development Corporation (River Vision), a private company focused on ophthalmology, announced today that they have entered into an agreement for the process transfer and cGMP production of RV001 (Teprotumumab) – a recombinant monoclonal antibody targeting insulin-like growth factor 1 that is in development for treatment of Grave's Orbitopathy and other indications.

29 Jul 2015

Possible link discovered between common medications and falls in older men

Serious falls are more than twice as likely in older men who take medicines with anti-cholinergic properties - according to new research from the University of East Anglia.

29 Jul 2015

Shortage of meningitis C-containing vaccine threatens to limit disease control in Africa

With Africa at risk of a large meningitis outbreak, an acute shortage of meningitis C-containing vaccine threatens to severely limit the world's ability to minimize the number of people affected, four international public health organizations warned today.

29 Jul 2015

New consortium aims to develop precision medicines for globally devastating diseases

An innovative new Consortium will act as a ‘match-making’ service between pharmaceutical companies and researchers in Cambridge with the aim of developing and studying precision medicines for some of the most globally devastating diseases.

29 Jul 2015

Two-step regimen of experimental MERS vaccines show promise in mice

A two-step regimen of experimental vaccines against Middle East respiratory syndrome (MERS) prompted immune responses in mice and rhesus macaques, report National Institutes of Health scientists who designed the vaccines. Vaccinated mice produced broadly neutralizing antibodies against multiple strains of the MERS coronavirus (MERS-CoV), while vaccinated macaques were protected from severe lung damage when later exposed to MERS-CoV.

29 Jul 2015

Study demonstrates that stress hormone cortisol can reduce heroin cravings

Every addiction is characterized by a strong desire for a certain addictive substance, be it nicotine, alcohol or other drug. Researchers at the University of Basel in Switzerland recently conducted a study on heroin addiction and demonstrated that the stress hormone cortisol can reduce addictive cravings.

29 Jul 2015

TWi releases generic version of MEGACE ES (megestrol acetate oral suspension) 625mg/5ml

TWi Pharmaceuticals, Inc. today announced that it launched its generic version of Par Pharmaceutical's MEGACE ES (megestrol acetate oral suspension) 625mg/5ml after the United States District Court for the District of Maryland reinstated its finding that United States Patent No. 7,101,576 (the '576 Patent) is invalid.

29 Jul 2015

Pharmaceutical News

FDA accepts Mundipharma EDO's Investigational New Drug Application for EDO-S101

Eisai, Halozyme partner to evaluate eribulin and PEGPH20 in HER2-negative metastatic breast cancer

Takeda completes post-marketing commitment and data submission for pioglitazone containing medicines

Tissue Regenix strengthens position in post-acute wound care market with Medicare coverage for Dermapure

Roche submits cobas EGFR v2 test PMA to FDA as companion diagnostic test for AZD9291

Study sheds light on certain antagonist drugs that block physiological responses

Commonly prescribed drug also lowers blood pressure when combined with diuretic

ACP supports for eliminating non-medical vaccination exemptions

Vismodegib therapy effective against medulloblastoma

Aeterna Zentaris selects optimized Erk inhibitor molecule for further development

World Health Organization recognizes unique pharmacological nature of Can-Fite's CF101, grants new generic name

PDL BioPharma signs revenue interest assignment agreement with ARIAD Pharmaceuticals

Study reveals that firms 'underinvest' in long-term research to develop cancer-fighting drugs

CMC Biologics, River Vision sign manufacturing agreement for Teprotumumab to treat Grave's Orbitopathy

Possible link discovered between common medications and falls in older men

Shortage of meningitis C-containing vaccine threatens to limit disease control in Africa

New consortium aims to develop precision medicines for globally devastating diseases

Two-step regimen of experimental MERS vaccines show promise in mice

Study demonstrates that stress hormone cortisol can reduce heroin cravings

TWi releases generic version of MEGACE ES (megestrol acetate oral suspension) 625mg/5ml

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