Medical Tidbits, Merck and Pfizer Initiate Phase III Trial to Evaluate Avelumab as First-line Treatment for Ovarian Cancer

clinical trials for ovarian cancer

• 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

FDA advances Precision Medicine Initiative by issuing draft guidances on next generation sequencing-based tests

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.

Sprint Bioscience Enters into Collaboration with US Drug Development Company on Tumor Metabolism Program

STOCKHOLM–(BUSINESS WIRE)–Sprint Bioscience AB (publ) (Sprint Bioscience) (STO:SPRINT) and a US drug development company (Company) have entered into a collaboration and license agreement for the research, development, and commercialization of Sprint Bioscience’s PIP4K2a program targeting tumor metabolism. As a result of a tumor’s uncontrolled growth, cancer cells exhibit an altered metabolism (tumor metabolism) and thereby are often resistant to conventional radiation- and chemotherapy. Sprint Bioscience has developed molecules inhibiting PIP4K2a, an enzyme involved in regulation of cellular metabolism. Such inhibitors can potentially be developed into new effective anti-cancer treatments by selectively affecting the growth and survival of cancer cells.

Thermo Fisher Scientific Announces Next-Generation Sequencing Assay for Liquid Biopsy Research

Oncomine Cell-Free DNA Assay is designed to target and detect mutations down to 0.1 percent allele frequencies from whole blood derived from lung cancer tumors

CARLSBAD, Calif.–(BUSINESS WIRE)–Clinical oncology researchers who need to draw more meaningful genetic data, now have access to the new Oncomine Lung Cell-Free DNA (cfDNA) Assay designed to target mutations in non-small cell lung cancer (NSCLC) samples derived from circulating cfDNA in blood. When combined with Thermo Fisher Scientific’s Ion S5 System, the research assay meets a critical need for a multi-targeted, next-generation sequencing (NGS)-based solution that enables highly sensitive detection across a broad set of gene variants.

EISAI LAUNCHES IN-HOUSE DEVELOPED NOVEL ANTICANCER AGENT LENVIMA® IN MEXICO

 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that its pharmaceutical sales subsidiary in Mexico, Eisai Laboratorios, S. de R.L. de C.V. (Location: Mexico City, “Eisai Mexico”) has launched its in-house developed novel anticancer agent Lenvima® (lenvatinib mesylate) 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

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