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Trends, opportunities and threats in the life science industry: an interview with Bob Coughlin, CEO, MassBio

We were extremely excited to launch the Impact 2020 report at our annual meeting. Our five-year strategic plan is focused on value, early-stage financing and ensuring more patient-centered discussions.

5 May 2014

FDA grants Orphan Drug Designation to Advaxis' ADXS-HPV for treatment of invasive cervical cancer

Advaxis, Inc., a leader in developing cancer immunotherapies, announced today that it has been granted Orphan Drug Designation from the U.S. Food and Drug Administration Office of Orphan Products Development (OOPD) for ADXS-HPV, its lead immunotherapy drug candidate, for the treatment of Stage II-IV invasive cervical cancer.

2 May 2014

Ruthigen files IND Application to FDA for lead drug candidate RUT58-60

Ruthigen, Inc., a biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics designed to prevent and treat infection in invasive applications, today announced that the Company has submitted an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration for its lead drug candidate RUT58-60.

2 May 2014

Acorda gets FDA Complete Response Letter for PLUMIAZ Nasal Spray NDA

Acorda Therapeutics, Inc. today announced that the U.S. Food and Drug Administration has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for PLUMIAZ (diazepam) Nasal Spray for the treatment of people with epilepsy who experience cluster seizures.

2 May 2014

New findings show combination of statins and omega-3 fatty acid may potentially reduce cardiovascular risk

New findings from an in vitro study, led by researchers at Brigham and Women's Hospital (BWH), show that the combination of statins and eicosapentaenoic acid (EPA), an omega-3 fatty acid, may potentially reduce cardiovascular risk.

2 May 2014

Findings suggest usage of statins after surgery may reduce risk of prostate cancer recurrence

Men who begin taking statins after prostate cancer surgery are less likely to have a recurrence of their cancer, according to a retrospective analysis led by researchers at Duke Medicine.

2 May 2014

LUNGevity Foundation welcomes FDA approval of Zykadia drug for advanced stages of lung cancer

LUNGevity Foundation applauds the FDA approval of Zykadia™ for the subset of anaplastic lymphoma kinase-positive (ALK+) patients with advanced cases of non-small cell lung cancer who have progressed on or are intolerant to crizotinib.

2 May 2014

Purdue Pharma seeks FDA authorization to market once-daily hydrocodone bitartrate tablet

Purdue Pharma L.P. announced that it has filed a New Drug Application (NDA) with the U.S. Food & Drug Administration seeking authorization to market a once-daily, single-entity hydrocodone bitartrate tablet (HYD).

30 Apr 2014

Scientific data confirms therapeutic potential of Anavex's S1R agonist against Parkinson’s disease

Anavex Life Sciences Corp., a clinical stage biopharmaceutical company developing novel drug candidates to treat Alzheimer’s, other diseases of the central nervous system (CNS) and various types of cancer, today announced the findings of a research study published in the current issue of peer-reviewed scientific journal Brain.

30 Apr 2014

Vertex: Conditions of PBAC recommendation may limit Australians who could benefit from KALYDECO

The Pharmaceutical Benefits Advisory Committee has again recommended KALYDECO (ivacaftor) for listing on the Pharmaceutical Benefits Scheme (PBS). However, Vertex is deeply disappointed in the conditions the PBAC has attached to the recommendation. These conditions fail to reflect the substantial clinical benefits recognised by the PBAC, and would result in limiting the number of eligible Australians who would be able to receive KALYDECO.

30 Apr 2014

Otsuka's Deltyba gets EC marketing authorization for MDR-TB treatment

Otsuka Pharmaceutical Co., Ltd. today announced that the European Commission has granted a marketing authorization for Deltyba (delamanid) for use as part of an appropriate combination regimen for pulmonary multidrug-resistant tuberculosis (MDR-TB) in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.

30 Apr 2014

Real-time information from drug monitoring systems improves adherence to medication regimen

Most people want to take mediations as prescribed, even if they sometimes need a little help remembering. For them, an automated system that monitors drug taking and provides feedback after the fact may be more useful than one that nags people when it is time to take a pill, researchers at Carnegie Mellon University say.

30 Apr 2014

Armetheon reaches agreement with FDA on SPA for final pivotal trial of tecarfarin

Armetheon, Inc., today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the final pivotal trial of tecarfarin.

29 Apr 2014

Physicians call for large clinical trials to assess risks associated with testosterone treatment

Physicians do not have sufficient information from clinical trials to understand the risks associated with the prescription of testosterone in older men, according to a Comment in The Lancet Diabetes & Endocrinology, written by Professor Stephanie Page, of the University of Washington and Harborview Medical Center, Seattle, USA.

29 Apr 2014

Teva's DuoResp Spiromax receives EC marketing authorization for treatment of asthma, COPD

Teva Pharmaceutical Industries Ltd., announced today that the European Commission has granted marketing authorization for DuoResp Spiromax for the treatment of patients with asthma and chronic obstructive pulmonary disease (COPD) where the use of a combination of an inhaled corticosteroid and long-acting beta2-adrenoceptor agonist is appropriate.

29 Apr 2014

AAN review finds certain forms of medical marijuana can help treat some symptoms of MS

A review by the American Academy of Neurology of available scientific research on the use of medical marijuana in brain diseases finds certain forms of medical marijuana can help treat some symptoms of multiple sclerosis (MS), but do not appear to be helpful in treating drug-induced (levodopa) movements in Parkinson's disease.

29 Apr 2014

Cell Therapeutics announces launch of PIXUVRI in the UK for treatment of aggressive B-cell NHL

Cell Therapeutics, Inc. today announced the launch of PIXUVRI (pixantrone), the first new treatment for adult patients in the United Kingdom (UK) with multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (aggressive B-cell NHL), at the 54th annual scientific meeting of the British Society for Haematology.

29 Apr 2014

Actavis' subsidiary files lawsuit against FDA over Celebrex decision

Actavis plc today announced that its subsidiary, Watson Laboratories, Inc., has filed suit against the U.S. Food and Drug Administration challenging the Agency's decision regarding its entitlement to shared 180-day marketing exclusivity for its generic version of Celebrex (celecoxib) 50 mg, 100 mg, 200 mg and 400 mg capsules.

29 Apr 2014

GSK, Theravance announce availability of Anoro Ellipta in the US for COPD treatment

GlaxoSmithKline plc and Theravance, Inc. today announced that Anoro Ellipta (umeclidinium and vilanterol inhalation powder), the first once-daily product approved in the US that combines two long-acting bronchodilators in a single inhaler for the maintenance treatment of chronic obstructive pulmonary disease (COPD), is now available to retail pharmacies in the US.

28 Apr 2014

Australian and New Zealand patients with diabetes-induced vision loss to get access to new treatment

Australian and New Zealand patients suffering from vision impairment due to a type of diabetes-induced eye disease will have access to a new treatment, following a license deal between Australian biopharmaceutical company Specialised Therapeutics Australia and Alimera Sciences.

28 Apr 2014

Pharmaceutical News

Trends, opportunities and threats in the life science industry: an interview with Bob Coughlin, CEO, MassBio

FDA grants Orphan Drug Designation to Advaxis' ADXS-HPV for treatment of invasive cervical cancer

Ruthigen files IND Application to FDA for lead drug candidate RUT58-60

Acorda gets FDA Complete Response Letter for PLUMIAZ Nasal Spray NDA

New findings show combination of statins and omega-3 fatty acid may potentially reduce cardiovascular risk

Findings suggest usage of statins after surgery may reduce risk of prostate cancer recurrence

LUNGevity Foundation welcomes FDA approval of Zykadia drug for advanced stages of lung cancer

Purdue Pharma seeks FDA authorization to market once-daily hydrocodone bitartrate tablet

Scientific data confirms therapeutic potential of Anavex's S1R agonist against Parkinson’s disease

Vertex: Conditions of PBAC recommendation may limit Australians who could benefit from KALYDECO

Otsuka's Deltyba gets EC marketing authorization for MDR-TB treatment

Real-time information from drug monitoring systems improves adherence to medication regimen

Armetheon reaches agreement with FDA on SPA for final pivotal trial of tecarfarin

Physicians call for large clinical trials to assess risks associated with testosterone treatment

Teva's DuoResp Spiromax receives EC marketing authorization for treatment of asthma, COPD

AAN review finds certain forms of medical marijuana can help treat some symptoms of MS

Cell Therapeutics announces launch of PIXUVRI in the UK for treatment of aggressive B-cell NHL

Actavis' subsidiary files lawsuit against FDA over Celebrex decision

GSK, Theravance announce availability of Anoro Ellipta in the US for COPD treatment

Australian and New Zealand patients with diabetes-induced vision loss to get access to new treatment

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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