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Jazz Pharmaceuticals Initiates Rolling NDA Submission for Vyxeos (CPX-351) Expects to Complete NDA Submission by Early 2017

(Yahoo! Finance) Oct 3, 2016 - Jazz Pharmaceuticals plc today announced the initiation of a rolling submission of a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) on September 30, 2016, seeking marketing approval of Vyxeos™ (cytarabine and daunorubicin liposome injection), an investigational agent for the treatment of acute myeloid leukemia (AML).
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TRACON Pharmaceuticals Announces Successful Meetings with FDA and EMA for TRC105 (carotuximab) in Angiosarcoma

(StreetInsider) Oct 3, 2016 - Company reaches agreement with regulatory agencies on key elements of Phase 3 program; Phase 3 program expected to begin by year-end.
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Practice-Changing Data to Feature at ESMO 2016

(Medscape Medical News) Oct 3, 2016 - The latest clinical trial data and public health issues regarding access to novel therapies across Europe will form the backbone of the largest oncology meeting in Europe, taking place in Copenhagen.
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Checkpoint Therapeutics Initiates Phase 1/2 Study of CK-101 – A Novel Third-Generation EGFR Inhibitor

(Yahoo! Finance) Oct 3, 2016 - Checkpoint Therapeutics, Inc. today announced that the first patient has been dosed in a Phase 1/2 clinical study of CK-101, its novel, oral, third-generation epidermal growth factor receptor (“EGFR”) inhibitor product candidate.
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Cancer Patients And Survivors Can Have Trouble With Intimacy

(USA Today) Oct 2, 2016 - Major cancer centers now include centers addressing sexuality, but most community hospitals still do not. The topic rarely is discussed unless the patient is particularly bold or the doctor has made a special commitment.
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Doctors Don't Communicate Well About Terminally Ill Patients

( Health) Sept 30, 2016 - Cancer specialists and primary care physicians are not communicating very well about the end-of-life concerns of the patients they share - and according to one new study, they often rely on those patients to convey information back and forth.
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IL-34: A New, Possible Target To Tackle Drug-Resistant Cancer Cells

(Hokkaido University [Japan]) Oct 3, 2016 - A team of researchers has discovered that chemoresistant lung cancer cells suppress immune functions and strengthen resistance to chemotherapy by producing interleukin-34 (IL-34)—a type of cytokine.
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New Standard of Care Emerging for Merkel Cell Carcinoma

(Medscape Medical News) Sept 30, 2016 - For patients with advanced Merkel cell carcinoma, immunotherapies targeting the PD-1/PD-L1 axis are emerging as what will likely be the new standard of care.
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Ovarian Removal To Prevent Ovarian Cancer Should Not Be An Option For Most Premenopausal Women, Research Finds

(Mayo Clinic) Sept 29, 2016 - A Mayo Clinic research team has found evidence suggesting that the controversial practice of ovary removal in premenopausal women to prevent ovarian cancer should be discontinued in women who are not at high risk of cancer.
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Breast Cancer Treatments Vary Widely In Cost And Complications

(Reuters Health) Sept 30, 2016 - Women with early-stage breast cancer may have fewer treatment complications and lower costs when they don’t get a mastectomy followed by reconstructive surgery, a U.S. study suggests.
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New Prostate Cancer Tests Aim To Reduce The Death Rate

( Oct 3, 2016 - About a dozen new medical tests are coming to market that aim to more accurately diagnose prostate cancer and go well beyond the standard PSA (prostate-specific antigen) blood screenings used today.
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New Research Takes Aim At Deadliest Form Of Breast Cancer

(Las Vegas Review-Journal/Associated Press) Oct 3, 2016 - Forget the pink ribbons. Spitting in a tube for science is what unites a growing group of breast cancer patients taking part in a unique project to advance treatment for the deadliest form of the disease.
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First Phase III Data On Roche’s Tecentriq (Atezolizumab) To Feature At The 2016 European Society For Medical Oncology (ESMO) Congress

(Roche) Oct 3, 2016 - Superiority results from the phase III OAK study comparing Tecentriq® to chemotherapy in a difficult to treat type of lung cancer will be highlighted at the ESMO Presidential Symposium; investigational cancer immunotherapy-based combination approaches across a range of cancer types to be showcased during the congress.
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Congressional Leaders Put Medical-Research Bill on Priority List

(Wall Street Journal) Sept 29, 2016 - Congressional leaders said Thursday that legislation to inject billions of dollars into federal biomedical research and ease drug approvals is a main priority for the lame-duck session after the November elections.
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The Health Care ‘Public Option’ Is Back. Can It Help Obamacare?

(New York Times/Upshot blog) Sept 29, 2016 - On the campaign trail and in the halls of policy wonks, the health care term of the moment is “the public option.”
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A Golden Ticket That Fast-Tracks A Drug Through The FDA

(Kaiser Health News) Sept 29, 2016 - Drugmaker Sarepta Therapeutics won a big victory when its $300,000 muscular dystrophy drug was recently approved, but the company had other reasons to celebrate, too.
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Wall St. Closes Lower as Drug-Price Scrutiny Intensifies

(New York Times/Associated Press) Sept 29, 2016 - Stocks on Wall Street skidded Thursday as drug companies and banks absorbed large losses. Drugmakers faced scrutiny over price increases, while banks fell as investors worried about the stability of Deutsche Bank and other financial institutions.
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Physician Recommendations for HPV Vaccine Can Affect Parents’ Choices

(AACR) Sept 30, 2016 - The language a physician uses when recommending the human papillomavirus (HPV) vaccine appears to influence parents’ willingness to have their children vaccinated, according to a study published in Cancer Epidemiology, Biomarkers & Prevention, a journal of the American Association for Cancer Research.
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Press Release: New Edition of ESMO/ASCO Global Curriculum in Medical Oncology – Setting Standards for Modern Training

(ESMO) Sept 30, 2016 - ESMO, the leading European professional organisation for medical oncology, in collaboration with the American Society of Clinical Oncology (ASCO), published today the 2016 edition of the ESMO/ASCO Recommendations for a Global Curriculum (GC) in Medical Oncology (1), a set of common guidelines to offer a global perspective of the clinical training required for physicians to qualify as medical oncologists.
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Need to Revisit Cervical Cancer Screening Guidelines: JAMA Oncology Study

(AJMC) Sept 29, 2016 - Untreated human papillomavirus (HPV) infection has been identified as a leading cause of developing cervical intraepithelial neoplasia (CIN), which can lead to invasive cervical cancer. While several studies have documented the success of HPV vaccination in preventing the viral infection and development of low-grade and high-grade CIN, the impact of subsequent reduced screening rates have not been examined.
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Why Is Pancreatic Cancer So Hard to Kill?

(Philadelphia Inquirer/Health blog) Sept 30, 2016 - It’s a time of excitement in the world of cancer. For the first time in history, we seem to be making great strides in effective treatments.
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NICE Rejects Lilly's Portrazza, but Backs Bayer's Xofigo and Amgen's Imlygic

(PharmaTimes [UK]) Sept 30, 2016 - Patients with lung cancer will not be able to access Eli Lilly's Portrazza on the National Health Service in England and Wales, after a final rejection from the National Institute for Health and Care Excellence.
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Scientists Find Lethal Vulnerability in Treatment-Resistant Lung Cancer

(UT Southwestern) Sept 29, 2016 - Researchers working in four labs at UT Southwestern Medical Center have found a chink in a so-called “undruggable” lung cancer’s armor – and located an existing drug that might provide a treatment.
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Flicking the Switch On Cancer’s Immaturity

(Cancer Research UK/Science blog) Sept 29, 2016 - Cancers are often born from just one cell that became faulty, developing into a tumour by copying itself over and over again.
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Death While on Radiation Therapy

(Medscape Medical News) Sept 29, 2016 - The news coverage "really scared everyone," said Dr Russo, who was inspired to publish his first academic article on safety in 2010. He revealed that he had a lawyer review the manuscript before publication.
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