In the interview posted online since September 15, Pharma IQ asked Dr. Sherley to respond to several questions on the current state of technologies for evaluating stem cell toxicity, challenges to evaluating stem cell toxicity, and future trends in the use of stem cells for toxicological drug evaluations. Dr. Sherley was invited to lead the session
"We are so pleased to be joining the Janssen Pharmaceutical Companies of Johnson& Johnson, who have an impressive track record of bringing breakthrough drugs for viral diseases to market," said Lawrence M. Blatt, PhD, President and Chief Executive Officer of Alios BioPharma. Goldman, Sachs& Co. acted as exclusive financial advisor to Alios BioPharm
Avedro Inc., a Boston- based ophthalmic medical device and pharmaceutical company announces today that it resubmitted its New Drug Application for riboflavin ophthalmic solution/ KXL System to the U.S. The proposed indications of treatment of progressive keratoconus or corneal ectasia following refractive surgery were both granted orphan status
Brainsway Ltd. is pleased to report substantial improvement in OCD patients following Brainsway Deep TMS treatment in a clinical study held in Sheba Medical center, Tel Ha'Shomer, Israel. Joseph Zohar, who was the chairperson of the anxiety and OCD section of the World Psychiatric Association, included 41 OCD patients who did not respond adequate
A clinical study published in the August 23, 2014 issue of The Lancet demonstrated that delivery of AFLURIA with the PharmaJet Needle-Free Injector compared favorably to traditional needle and syringe delivery. In the PharmaJet study, 89 percent of the people receiving the PharmaJet Needle-Free Injection reported they would choose to receive thi
ALEXANDRIA, Va., Sept. 30 Collegium Pharmaceutical, Canton, Massachusetts, has been assigned a patent developed by five co-inventors for "amper-resistant pharmaceutical compositions of opioids and other drugs." The co-inventors are Said Saim, New Milford, Connecticut, Alison B. Fleming, North Attleboro, Massachusetts, Jane C. Hirsh, Wellesley, Ma
CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, today announced the initiation of a global Phase 2 b clinical trial evaluating aldoxorubicin compared to topotecan in subjects with extensive-stage small cell lung cancer who have relapsed or were refractory to prior chemotherapy.
WASHINGTON From research grants to travel junkets, drug and medical device companies paid doctors and leading hospitals billions of dollars last year, the government disclosed Tuesday in a new effort to spotlight potential ethical conflicts in medicine. Industry spent nearly $3.5 billion on such payments in the five-month period from August thro
TRENTON, N.J. - The maker of the world's top-selling erectile dysfunction drug on Tuesday will begin airing the first Viagra TV commercial that targets the less-obvious sufferers of the sexual condition: women.
Additionally, the FDA could also control the marketing of the drugs, which would allow drug companies to advertise only to a specific audience. Michael Domanski, the director of heart failure research at Mount Sinai School of Medicine, told The New York Times. Earlier this year, the FDA announced that they would be evaluating the risk of stroke, he
By a News Reporter-Staff News Editor at Cancer Weekly Nektar Therapeutics reported that partner AstraZeneca announced that the US Food and Drug Administration approved MOVANTIK tablets as the first once-daily oral peripherally-acting mu-opioid receptor antagonist medication for the treatment of opioid-induced constipation, in adult patients...
For generic drugmakers, Oct. 1 is crunch time, the date after which all ANDA amendment and prior-approval supplement applications must meet new performance goals under the Generic Drug User Fee Amendments of 2012.. Attendees will discover concrete examples that illustrate what ANDA sponsors can expect and must prepare for. Here's a point-by-point s
Building a World-Class Import/Export Program: How to Comply with the FDA and US Customs** Presented Encore Insight LLC and FDAnews** Oct. 27-28, 2014 Bethesda, MD http://www.fdanews.com/CustomsImportExportProgram. Former FDA import/export expert Casper "Cap" Uldriks lays out everything manufacturers need to know to take the risks, and delays out
The biological drugs market encompasses a class of medicine that is developed through genetic modification of monoclonal antibodies. Monoclonal antibodies naturally inhabit the human immune system and help the body in fighting from a variety of diseases. When these antibodies are genetically modified, they can be used to treat specific diseases.
WASHINGTON Striving to shine a light on potential ethical conflicts in medicine, the Obama administration is releasing data on drug company payments to tens of thousands of individual doctors. President Barack Obama's health care law requires manufacturers to report payments and gifts to physicians, unless they are valued at less than $10.
Demand for pediatric drugs and vaccines is growing in sync with the increasing birth rate, and the rising incidence and prevalence of various disease and disorders among children across the globe. Historically, the market for pediatric drugs remained underserved due to the high cost of drug development, the complexities of pediatric clinical trials
According to a media release, in connection with the acquisition, Horizon and Vidara have combined with the resulting parent company incorporated in Ireland and named Horizon Pharma Public Limited Company, or plc. The acquisition further accelerates Horizon's transformation into a profitable specialty biopharmaceutical company and provides a strong
Category: Baystreet Newswire Company: Accesswire-MRM ID: 420887 Date: Tuesday, September 30, 2014 Integration of Two Products Gives Pharmaceutical Companies New Tools for Automating Research of Global Chemical Patents. CAMBRIDGE, MA/ ACCESSWIRE/ September 30, 2014/ IFI CLAIMS (r) Patent Services, the leading producer of global patent databases, ana
CAMBRIDGE, MA, United States, via ETELIGIS INC., 09/30/2014 IFI CLAIMS Patent Services, the leading producer of global patent databases, analytic solutions and innovative web services, and ChemAxon, a leading provider of chemical informatics software for the biotechnology, pharmaceutical and agrochemical industries, announced a collaboration to d
Office Address: Department of Health and Human Services; Food and Drug Administration; Office of Acquisitions and Grants Services; 5630 Fishers Lane, Room 2129 Rockville MD 20857-0001. Description: Department of Health and Human Services. Office of Acquisitions and Grants Services.
Merrimack Pharmaceuticals, Inc. announced today additional clinical and biomarker data from a Phase 2 study in ER/PR-positive, HER2-negative metastatic breast cancer showing that patients with high heregulin mRNA levels achieved a statistically significant benefit from combining the novel agent MM-121 with exemestane. "As additional biomarker da
Nimbus Discovery LLC, a biotechnology company discovering novel medicines against important, but previously inaccessible drug targets, today announced the appointment of Donald Don Nicholson, Ph.D., as Chief Executive Officer. Dr. Nicholson brings more than 25 years of experience as an entrepreneurial scientist and leader with a proven track
OncoMed Pharmaceuticals, Inc., a clinical-stage company developing novel therapeutics that target cancer stem cells, or tumor-initiating cells, today announced the advancement of the first small molecule Wnt pathway inhibitor under its collaboration with Bayer Pharma AG. John Lewicki, Ph.D., OncoMed's Chief Scientific Officer, commented, "By comb
The low-t lawyers at Parilman& Associates have represented clients across the United States in litigation against drug manufacturers that have allegedly released dangerous or defective medications onto the marketplace. The firm would like to alert the public to a recent article that reveals that advisers with the FDA have recommended additional...
By a News Reporter-Staff News Editor at Life Science Weekly According to news reporting originating from Alexandria, Virginia, by NewsRx journalists, a patent by the inventor Pravata, Laurent, filed on May 12, 2010, was published online on September 16, 2014. The assignee for this patent, patent number 8835528, is Synolyne Pharma. Reporters obtai