Late last week Fiercebiotech reported on XBiotech likely getting rejected by the European Medicines Agency. Last week the company revealed its lead candidate is closer to obtaining FDA approval while saying it is tentatively targeting Q4 to launch and NDA. CytRx Corporation gained 40.82 percent last week to finish at $0.61 per share.
Data on Clinical Trials and Studies Described by Researchers at Fred Hutchinson Cancer Research Center. According to news reporting originating in Seattle, Washington, by NewsRx editors, the research stated, "Before the 2009 Biologics Price Competition and Innovation Act that enabled the U.S. Federal Drug Administration to create the 351 Biologic L
Reddy s Laboratories Ltd., announced on April 21, 2017 that it has launched Progesterone Capsules, 100 mg and 200 mg in U.S. market Dr. Reddy s Laboratories Ltd. announced on April 21, 2017, that it has launched Progesterone Capsules, 100 mg and 200 mg, a therapeutic equivalent generic version of Prometrium* capsules in the United States mark
April 23 Drug delivery company SteadyMed Ltd. has raised $30 million in a private placement led by Adage Capital Management, OrbiMed, Deerfield Management and Kingdon Capital Management. SteadyMed is a specialty pharmaceutical company focused on the development of drug product candidates to treat orphan and high-value diseases with unmet delivery
By a News Reporter-Staff News Editor at Medical Letter on the CDC& FDA New Haven, Conn. The U.S. Food and Drug Administration reviews and approves new medicines in a shorter timeframe than its peer agency in Europe, the European Medicines Agency, says a Yale researcher. This finding, which comes at a time when the FDA is under renewed pressure
By a News Reporter-Staff News Editor at Heart Disease Weekly BOSTON, NEW YORK, and MELBOURNE, Australia, Boston Children's Hospital, the pediatric teaching hospital of Harvard University, and Mesoblast Limited announced that the United States Food and Drug Administration has cleared the commencement of a 24- patient trial combining Mesoblast's.
April 23 EnsoData, a Madison health IT company barely two years old, has won clearance from the U.S. Food and Drug Administration to sell its sleep-analysis software. "It's probably the biggest milestone for our company so far," said CEO and co-founder Chris Fernandez, 24. "We can legally sell it... all across the United States." EnsoSleep has b
Acceleron Pharma, Cambridge, Massachusetts, and Dyax, Burlington, Massachusetts, have been assigned a patent developed by seven co-inventors for "polynucleotides encoding an actriib antibody." The co-inventors are Ravindra Kumar, Acton, Massachusetts, Asya Grinberg, Lexington, Massachusetts, Monique Davies, Harpswell, Maine, Diana Martik, Cambridge
Achillion Pharmaceuticals, Inc. announced today the presentation of updated results from the ongoing phase 2 604 Study being conducted by Alios BioPharma Inc., part of the Janssen Pharmaceutical Companies. These results were presented as an oral presentation during the European Association for the Study of the Liver 2017 International Liver
Arbutus Biopharma Corporation, an industry-leading Hepatitis B Virus therapeutic solutions company, presented results of the first three cohorts of a Phase II study of its RNAi agent, ARB-1467, at the European Association for the Study of the Liver in Amsterdam, The Netherlands.. We are very pleased to present updated Phase II results for ARB-
By a News Reporter-Staff News Editor at Obesity, Fitness& Wellness Week- Astellas Pharma Inc. and Ogeda SA announced that Astellas and Ogeda shareholders have entered into a definitive agreement under which Astellas has agreed to acquire Ogeda a privately owned drug discovery company. Under the agreement, Astellas has agreed to pay up to a total
-Atara Biotherapeutics, Inc., a biopharmaceutical company focused on developing meaningful therapies for patients with severe and life-threatening diseases, today announced that it has entered into a clinical trial collaboration agreement with Merck, to evaluate Atara Bios allogeneic Epstein-Barr virus- specific cytotoxic T lymphocytes, or ATA129,
-BeiGene, Ltd., a clinical-stage biopharmaceutical company developing molecularly targeted and immuno-oncology drugs for the treatment of cancer, today announced that the first patient was dosed in a pivotal clinical trial of BGB-A317, an investigational anti-PD-1 antibody, in Chinese patients with relapsed or refractory classical Hodgkin lymphoma.
-Cempra, Inc., a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced the company is presenting eight abstracts highlighting solithromycin and the need for new treatments for community-acquired bacterial pneumonia at the 27th...
ContraVir Pharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, today presented data demonstrating the synergistic antiviral activity from the combination of its two investigational drugs for the treatment of hepatitis B viral infection, tenofovir exalidex a...
St. Clair County State's Attorney Brendan Kelly filed the 159- page suit Thursday against Purdue Pharma and Abbott Laboratories, accusing them of deceptive advertising and consumer fraud that contributed to opioid and heroin overdoses while maximizing their profit. Similar lawsuits against Purdue and other pharmaceutical companies have been filed b
A Free Shred Day hosted by Fibre Federal Credit Union takes place from 10 a.m. to 2 p.m. Saturday, April 22, at 812 12th Ave., behind the main branch of Fibre Federal Credit Union. A fundraiser to benefit the Rainier Junior/Senior High School History Club takes place from 8 a.m. to 4 p.m. Saturday, April 22, in the J&R Sales Parking Lot, 215 W B St
This is the first FDA product release for electroCore in the U.S.. "Cluster headache is a rare, debilitating and difficult to treat disorder with few effective acute therapies, said Stephen Silberstein, MD, Director, Headache Center, Jefferson University, Philadelphia, PA." The FDA release of gammaCore is an important advance in the treatment of t
In case you missed it, the Huffington Post today released a story highlighting U.S. Sen. In March, Brown introduced sweeping prescription drug legislation the Huffington Post notes, "combines every policy idea drug lobbyists hate." The legislation follows specific steps Brown outlined to Trump in a December 2016 letter outlining specific steps his.
Sawai Pharmaceutical will buy the generics business of U.S. drugmaker Upsher-Smith Laboratories for $1.05 billion, the Japanese company said Thursday, eager to make up for lost time after its first push into the American market stalled. The company chose Upsher-Smith "because of its nearly 100- year history, as well as its high name recognition in
April 22 Northbrook- based Marathon Pharmaceuticals has dropped out of the pharmaceutical industry's main lobbying group following controversy over the company's recent attempt to price a muscular dystrophy drug at $89,000 a year. Holly Campbell, a spokeswoman for the Pharmaceutical Research and Manufacturers of America, confirmed Friday that...
Merck, known as MSD outside of the United States and Canada, today announced the first sustained virologic response 1 results 12 weeks after completion of therapy from C-SURGE, an ongoing, open label Phase 2 clinical trial evaluating MK-3682B, the company s investigational triple-combination therapy in treatment-experienced patients with hepatit
Much has been made about opioid addition and there is no shortage of finger pointing about the causes. Some are blaming patients, as though the addicted person is to blame for craving the medication he or she was initially prescribed. Others blame the doctors or pharmaceutical companies as if the patient didn t have a mind of his or her own.
-NewLink Genetics Corporation, a biopharmaceutical company focused on bringing novel immuno-oncology therapies to patients with cancer, today reported that two abstracts will be presented at the 2017 American Society of Clinical Oncology Annual Meeting in Chicago. NewLink Genetics is a biopharmaceutical company at the forefront of discovering,...