• First Phase III trial evaluating the addition of an immune checkpoint
inhibitor to standard of care in first-line ovarian cancer
• New investigational regimen will evaluate avelumab in extending
progression-free survival in treatment-naïve women
Darmstadt, Germany, and New York, US, July 6, 2016 – Merck and Pfizer (NYSE: PFE) today announced the initiation of a Phase III study, JAVELIN Ovarian 100, to evaluate the efficacy and safety of avelumab* in combination with, and/or as follow-on (maintenance) treatment to, platinum-based chemotherapy in patients with locally advanced or metastatic disease (Stage III or Stage IV) with previously untreated epithelial ovarian cancer. JAVELIN Ovarian 100 is the first Phase III study evaluating
the addition of an immune checkpoint inhibitor to standard-of-care in first-line treatment for this aggressive disease. read more
In support of the President’s Precision Medicine Initiative, the U.S. Food and Drug Administration today issued two draft guidances that, when finalized, will provide a flexible and streamlined approach to the oversight of tests that detect medically important differences in a person’s genomic makeup.
The powerful new technology, known as next generation sequencing (NGS), can scan a person’s DNA to detect genomic variations that may determine whether a person has or is at risk of disease or may help to inform treatment decisions. While current regulatory approaches are appropriate for conventional diagnostics that measure a limited number of substances associated with a disease or condition, such as blood glucose or cholesterol levels, the new sequencing technologies can examine millions of DNA variants at a time, and thus require a flexible approach to oversight that is adapted to the novel nature of these tests.
Orexo welcomes increased access to treatment for patients with opioid dependence in the US
Uppsala, Sweden – July 7, 2016 – Orexo AB applauds the Administration’s announcement yesterday to increase access to the treatment of opioid dependence in the US, by increasing the cap on the number of patients that can be treated by physicians from 100 to 275, starting 30 days after publication in the Federal Register. Additionally, we commend the strong bipartisan Congressional support of this announcement. We look forward to Congress passing additional legislation further supporting increased access to appropriate patient care.
More than 5 million US citizens are misusing opioids and at least 2 million are opioid dependent. Today about 640,000 patients are in treatment with buprenorphine. Many struggle to find a qualified physician due to the patient cap which has been a significant hurdle in many regions of the US. In several instances, the lack of access to a qualified physician has led to a vicious cycle forcing patients to obtain their treatment on the street in a drug abusing environment perpetuating the risk of continued addiction.
Orexo strongly believes that medication assisted treatment with buprenorphine containing products, prescribed by a qualified physician should be used as part of a comprehensive treatment plan, which includes counseling and psychosocial support. With the initiative announced, opioid dependence treatment takes an important step towards open and affordable access to treatment in an appropriate clinical setting.
Recipharm appoints new General Manager in Research Triangle Park, USA
Recipharm, the contract development and manufacturing organisation (CDMO), has appointed Ann Flodin as General Manager of its wholly owned new subsidiary Recipharm Laboratories Inc. in Research Triangle Park, North Carolina, USA, formerly Cirrus Pharmaceuticals Inc.
Following the acquisition of Kemwell’s US development business in April 2016, Ann Flodin will be responsible for managing daily operations in Recipharm in Research Triangle Park and will focus on expanding and strengthening the development services Recipharm offers its customers in the US.
Vertex and Moderna Establish Exclusive Collaboration to Discover and Develop mRNA Therapeutics(TM) for Cystic Fibrosis
-Collaboration to explore use of mRNA Therapeutics to treat the underlying cause of CF by enabling cells to produce functional CFTR proteins in the lungs-
– Moderna to receive $40 million upfront, made up of a $20 million cash payment and a $20 million convertible note investment, with potential for up to additional $275 million in milestones plus royalty payments-
BOSTON & CAMBRIDGE, Mass. –(BUSINESS WIRE)– Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and Moderna Therapeutics today announced that the two companies have entered into an exclusive research collaboration and licensing agreement aimed at the discovery and development of messenger Ribonucleic Acid (mRNA) Therapeutics™ for the treatment of cystic fibrosis (CF). The three-year collaboration will focus on the use of mRNA therapies to treat the underlying cause of CF by enabling cells in the lungs to produce functional copies of the cystic fibrosis transmembrane conductance regulator (CFTR) protein, which is known to be defective in people with CF. Through the collaboration, the companies will explore the potential utilization of pulmonary mRNA delivery.
EISAI LAUNCHES IN-HOUSE DEVELOPED NOVEL ANTICANCER AGENT LENVIMA® IN MEXICO
Discovered at Eisai’s Tsukuba Research Laboratories and developed in-house, Lenvima is a molecular targeted agent with a novel binding mode. Lenvima is approved as a treatment for refractory thyroid cancer in over 40 countries including the United States, Japan, in Europe, South Korea and Canada. In Mexico, Lenvima was approved for treatment of locally progressive or metastatic, recurrent, radioactive iodine-refractory differentiated thyroid cancer in May 2016 read more
Carmot Therapeutics Enters into Discovery Collaboration with Genentech
SAN FRANCISCO–(EON: Enhanced Online News)–Carmot Therapeutics announced today that it has entered into a drug discovery collaboration and license agreement with Genentech, a member of the Roche Group. During the collaboration, Carmot will apply its proprietary lead-identification technology, Chemotype Evolution, to discover novel drug hits. Carmot and Genentech will work together to identify lead candidates, while Genentech will be solely responsible for lead optimization, pre-clinical and clinical development, manufacturing, and commercialization activities.
Under the terms of the agreement, Carmot will receive an undisclosed upfront payment and is eligible to receive milestone payments based on achievement of certain predetermined pre-clinical and clinical milestones. In addition, Carmot is eligible to receive royalties on sales of certain products resulting from the license agreement. Financial terms have not been disclosed.