On March 13, 2018 Medtronic plc (NYSE:MDT), the global leader in medical technology, reported it will participate in the Oppenheimer 28th Annual Healthcare Conference on Tuesday, March 20, 2018, in New York City (Press release, Medtronic, MAR 13, 2018, View Source;p=RssLanding&cat=news&id=2337864 [SID1234524735]).

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Hooman Hakami, executive vice president and group president of Medtronic’s Diabetes Group, will answer questions about the company beginning at 8:35 a.m. EDT (7:35 a.m. CDT).

A live audio webcast of the presentation will be available on March 20, 2018, by clicking on the Investor Events link at View Source An archive of the session will be available on the same webpage later in the day.

On March 13, 2018 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that the U.S. Food and Drug Administration (FDA) has accepted a new supplemental Biologics License Application (sBLA) and granted Priority Review for KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy (Press release, Merck & Co, MAR 13, 2018, View Source [SID1234524713]). The application is seeking approval for KEYTRUDA as a treatment for patients with advanced cervical cancer with disease progression on or after chemotherapy. This is the first filing acceptance and Priority Review granted for an anti-PD-1 therapy in cervical cancer and the 14th regulatory submission accepted by the FDA for KEYTRUDA. The FDA has set a PDUFA, or target action, date of June 28, 2018.

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"Advanced cervical cancer is an illness with a poor prognosis and a high unmet medical need. We look forward to working with the FDA on the review of this application to help bring KEYTRUDA to previously-treated patients with advanced cervical cancer," said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories.

The application, which is seeking accelerated approval for this new indication, is based in part on data from the phase 2 KEYNOTE-158 trial. KEYNOTE-158 is an ongoing global, open-label, non-randomized, multi-cohort, multi-center study evaluating KEYTRUDA in patients with multiple types of advanced solid tumors – including cervical cancer – that have progressed on standard of care therapy.

Merck is executing an extensive clinical development program in a broad range of cancers that affect women. To date, the program includes numerous studies evaluating KEYTRUDA (pembrolizumab) as monotherapy or in combination with other anti-cancer treatments across various types of breast and gynecological cancers.

About Cervical Cancer

Cervical cancer forms in the cells lining the cervix, or the lower part of the uterus. In 2017, approximately 12,820 cases of cervical cancer were diagnosed in the U.S. The five-year survival rate of women with stage IV disease is an estimated 15-16 percent. Any woman can develop cervical cancer, but it is more commonly diagnosed in women between the ages of 35 and 44. While screenings and vaccinations have resulted in declining cervical cancer rates, the disease continues to affect women in the U.S. and throughout the world.

On March 13, 2018 Heat Biologics, Inc. ("Heat") (NASDAQ: HTBX), a biopharmaceutical company developing drugs designed to activate a patient’s immune system against cancer,.reported that it will present at the BIO-Europe Spring Conference in Amsterdam (Press release, Heat Biologics, MAR 13, 2018, View Source [SID1234524969]). Jeff Hutchins, Ph.D., and Chief Scientific and Operating Officer for Heat, will present at 9:30 a.m. CET/3 p.m. ET, on Wednesday, March 14, 2018. Dr. Hutchins will also be available to participate in one-on-one meetings with biotech/pharmaceutical executives registered to attend the conference.

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BIO-Europe brings together some of the world’s most innovative leaders across biotech, finance and pharma for high-level networking, partnering meetings, strategic panels discussions and more

Verastem has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Verastem, 2018, MAR 13, 2018, View Source [SID1234524710]).

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On March 13, 2018 IDEAYA Biosciences, Inc., an oncology-focused biotechnology company committed to the discovery of breakthrough synthetic lethality medicines and immuno-oncology therapies, reported that it has entered into a partnership agreement with Cancer Research UK’s (CRUK) Commercial Partnerships Team and the Drug Discovery Unit at the Cancer Research UK Manchester Institute, part of the University of Manchester, UK, to develop small molecule inhibitors of Poly(ADP-ribose) glycohydrolase (PARG) (Press release, Ideaya Biosciences, MAR 13, 2018, View Source [SID1234525131]). PARG is a cellular enzyme that breaks down Poly(ADP-ribose), a post-translational modification that modulates protein function required for DNA repair. Inhibition of PARG in cancer cells with highly-active PARP results in depletion of cellular NAD. NAD is an essential cofactor in cellular respiration, and its depletion results in a dramatic decrease in cellular ATP and cancer cell death.

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"We are thrilled to be able to partner with one of the leading cancer research institutions in CRUK, who has had a prolific history in the space of DNA repair, including its scientific contributions to PARP biology and its associated biomarker BRCA," said Yujiro S. Hata, chief executive officer of IDEAYA. "We look forward to collaborating with this exceptional organization as we advance novel, small molecule inhibitors of PARG towards the clinic."

"The Drug Discovery Unit at the Cancer Research UK Manchester Institute are delighted to be working alongside IDEAYA to further develop our PARG inhibitor program," said Allan Jordan, head of chemistry in the Drug Discovery Unit. "Stemming from fundamental biological discoveries made in our own Institute, PARG inhibitors offer a new way of compromising the ability of cancer cells to survive and resist treatment. We believe that these agents will offer a truly novel and clinically meaningful therapy for patients fighting against cancer.

"This new collaboration with IDEAYA, a leading biotechnology company, will accelerate the translation of discoveries from one of our major drug discovery units," said Iain Foulkes, Ph.D., Cancer Research UK’s executive director of research and innovation. "We’re excited to focus our combined expertise on this unique program of research. This is one of several partnerships in our growing portfolio of projects that we hope will result in vital new treatments for cancer patients."

IDEAYA and Cancer Research UK also announced today that data from the PARG program will be presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting to be held April 14-18, 2018 in Chicago, IL. The presentation details are as follows:

Title: PARG inhibitors exhibit synthetic lethality with XRCC1 deficiency and a cellular mechanism of action that is distinct from PARP inhibition
Date and Time: Monday, April 16, 8:00 AM – 12:00 PM CDT
Abstract Number: 1943
Presenting author: Lisa Belmont, Ph.D.
Session Category: Experimental and Molecular Therapeutics