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- Read more about CHMP issued negative opinion for Genmab’s Arzerra for treatment of patients with relapsed CLL
Genmab announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a negative opinion for the use of Arzerra® (ofatumumab) as maintenance therapy for patients with relapsed chronic lymphocytic leukemia (CLL). The Marketing Authorization Application (MAA) was submitted by Novartis in July 2015 under the ofatumumab collaboration between Novartis and Genmab.

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- Read more about Supernus receives US patent covering Oxtellar XR
Supernus Pharmaceuticals, Inc., a specialty pharmaceutical company, announced the issuance on June 21, 2016 of a seventh patent (number 9,370,525) by the United States Patent and Trademark Office (USPTO) covering Oxtellar XR, its novel once-daily extended-release oxcarbazepine product. The patent provides protection for the product with expiration that is no earlier than 2027.
- Read more about Mycobacterium in olive oil for cancer treatment
Researchers at the Universitat Autònoma de Barcelona (UAB) with the collaboration of the Institute for Bioengineering of Catalonia (IBEC), led by the professor of the UAB Department of Genetics and Microbiology Esther Julián, announced one year ago that the cells of the Mycobacterium brumae offer an improved alternative to current bladder cancer treatments such as BCG (an immunotherapy based on the Mycobacterium bovis), which can cause infections.
- Read more about Development of drugs for local treatment of oral conditions
the 94th General Session & Exhibition of the International Association for Dental Research, researcher W. Peter Holbrook, University of Iceland, will present a study titled "Development of Drugs for Local Treatment of Oral Conditions." The IADR General Session is being held in conjunction with the 3rd Meeting of the IADR Asia Pacific Region and the 35th Annual Meeting of the IADR Korean Division.
- Read more about Government withdrawn Drugs and Cosmetics Amendment Bill, 2013
The Union Cabinet, chaired by the Prime Minister Shri Narendra Modi, has decided to withdraw the Drugs and Cosmetics (Amendment) Bill, 2013, which had been introduced in the Rajya Sabha in 2013 by UPA government. The Bill had been examined by the Standing Committee of Parliament which had made a number of recommendations for changing the provisions of the Bill.
- Read more about Angiochem End-of-Phase 2 Meeting with FDA for ANG1005
Angiochem, a biotechnology company developing proprietary peptide-drug conjugates uniquely capable of crossing the blood-brain barrier, announced the successful completion of an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for ANG1005. As a result, the company is in final preparation stages to commence its Phase 3 trial to support a New Drug Application (NDA) for ANG1005 in patients with leptomeningeal carcinomatosis (LC) from breast cancer.
- Read more about Incyte’s Ruxolitinib in GVHD receive Breakthrough Therapy Designation by FDA
Incyte Corporation announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for ruxolitinib (Jakafi®) for the treatment of patients with acute graft-versus-host disease (GVHD). There are currently no approved treatments for patients with acute GVHD.
- Read more about Long-term opioids may not be best pain management option for all sickle cell patients
In a small study looking at pain assessments in adults with sickle cell disease, researchers at Johns Hopkins says overall, those treated long-term with opioids often fared worse in measures of pain, fatigue and curtailed daily activities than those not on long-term opioids.
- Read more about Need to reform clinical research
Most clinical research is not useful to clinicians. This could change.Many billions of dollars are spent on clinical research every year, yet much of the knowledge produced is not useful for guiding clinical decision making. Because many of the features that make clinical research reliable as a basis for clinical practice can be identified, more useful clinical research could easily be produced at the same or even at massively reduced cost, according to John Ioannidis from Stanford University, US, in an Essay published in PLOS Medicine.
- Read more about Insulin-sensitive fat leads to obesity
SORLA is a protein that influences the balance of metabolic processes in adipose tissue, a particular form of fat. Too much of it makes fat cells overly sensitive to insulin, which leads them to break down less fat. SORLA was previously known for its protective role in Alzheimer's disease.