IDEAYA Biosciences Appoints Julie Hambleton, M.D., as Senior Vice President and Chief Medical Officer, Head of Development

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 the appointment of Julie Hambleton, M.D., as senior vice president and chief medical officer, head of development (Press release, Ideaya Biosciences, MAR 13, 2018, View Source [SID1234525130]). Dr. Hambleton brings more than 20 years of experience in clinical drug development, ranging from pre-clinical studies through Phase 4 and post-marketing studies. She has extensive experience working with regulatory agencies, including the U.S. FDA and the European Medicines Agency (EMA), and in filing of investigational new drug applications (INDs), biologics license applications (BLAs), and special protocol assessments (SPAs).

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"Dr. Hambleton is an accomplished industry executive and a leading oncology drug developer, and we welcome her to the leadership team at IDEAYA," said Yujiro S. Hata, chief executive officer of IDEAYA. "Dr. Hambleton’s unique clinical background in both immuno-oncology and synthetic lethality will strengthen our organization’s capabilities as we advance multiple first-in-class programs into the clinic, leveraging our clinical strategy in patient selection and combinations."

Julie Hambleton, M.D.

"Over the past two decades, I have been involved in the development of numerous targeted and biomarker enabled therapies, including Avastin and Rubraca, and first-in-class immuno-oncology agents that have been developed in combination with checkpoint inhibitors," said Dr. Hambleton. "IDEAYA’s diverse pipeline of biomarker enabled synthetic lethality programs and immunotherapies targeting immuno-metabolism and innate immunity have the potential to transform oncology care and deliver on our mission to bring innovative personalized therapies to cancer patients."

Dr. Hambleton was previously vice president, head of US medical at Bristol-Myers Squibb, overseeing medical & health economic and outcomes research activities in support of the oncology, immuno-oncology, specialty and cardiovascular marketed portfolios. From 2012 to 2016, she was executive vice president and chief medical officer at Five Prime Therapeutics, where she led clinical, clinical operations, regulatory, preclinical and translational and process development and was a member of the executive committee. From 2010 to 2012, Dr. Hambleton was vice president, clinical development, at Clovis Oncology, where she oversaw clinical development programs and managed clinical and pharmacokinetic functions, including the development of Rubraca, a PARP inhibitor, developed with a diagnostic for BRCA and HRD. From 2003 to 2010, she was at Genentech, most recently as group medical director, global clinical development, leading a cross-functional group conducting multiple Phase 2 and 3 trials of Avastin.

Prior to joining industry, Dr. Hambleton served from 1993 to 2003 in academic positions in the division of hematology-oncology at the University of California, San Francisco (UCSF), most recently as associate professor of clinical medicine. She completed post-graduate training at UCSF, where she served as medical resident, chief medical resident and fellow in the division of hematology-oncology. She received a B.S. from Duke University in nursing, an M.D. from Case Western Reserve University School of Medicine, and was board-certified in hematology and internal medicine.

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Synta Pharmaceuticals 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, Synta Pharmaceuticals, 2018, MAR 13, 2018, View Source [SID1234524717]).

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Roche Annual General Meeting 2018

On March 13, 2018 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that its shareholders approved all proposals of the Board of Directors at its ordinary Annual General Meeting (AGM) (Press release, Hoffmann-La Roche, MAR 13, 2018, View Source [SID1234524733]). The 880 attending shareholders, representing 86,42% of the total of 160,000,000 shares, approved the Management Report, the Financial Statements and the Consolidated Financial Statements for 2017.

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Christoph Franz was confirmed as Chairman of the Board of Directors with 99,89% of the votes.

"2017 was a good year for Roche. The launch of Ocrevus for people with multiple sclerosis and the approval of Hemlibra for the treatment of people with haemophilia A were outstanding. In particular, we made significant progress in the areas of personalised healthcare and digitization. In this field, we have entered into important partnerships that complement our own expertise. I believe Roche is very well prepared for the future," said Christoph Franz, Chairman of Roche’s Board of Directors.

Shareholders also authorised the ratification of the Board of Directors’ actions and approved an increase in the gross dividend for the past financial year to 8.30 Swiss francs (gross) per share and non-voting equity security. This is the 31st consecutive dividend increase.

Shareholders endorsed the total amount of bonuses paid to the Corporate Executive Committee for 2017 with 99,62% of the votes, as well as the bonus paid to the Chairman of the Board of Directors for 2017, which was approved by 99,51% of the votes. They also approved the maximum total amount of future remuneration of the Board of Directors, which was confirmed by 99,62% of the votes, and the maximum total amount of future remuneration for the Corporate Executive Committee until the 2019 ordinary Annual General Meeting by 99,64% of the votes.

In addition to Christoph Franz, all other Board members who stood for re-election were confirmed for a term of one year:

André Hoffmann
Professor Sir John Bell
Julie Brown
Paul Bulcke
Anita Hauser
Professor Dr Richard P. Lifton
Dr Andreas Oeri
Bernard Poussot
Dr Severin Schwan
Dr Claudia Süssmuth Dyckerhoff
Peter R. Voser

The following Board members were elected to the Remuneration Committee:

Dr Christoph Franz
André Hoffmann
Professor Dr Richard P. Lifton
Bernard Poussot
Peter R. Voser

KPMG AG was elected as external auditor for the financial year 2018 and BDO AG was elected as independent voting proxy until the conclusion of the next regular AGM in 2019.

FDA Grants Priority Review to Merck’s Supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab) for Treatment of Advanced Cervical Cancer

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.

Heat Biologics to Present at the BIO-Europe Spring Conference, March 12-14, 2018, in Amsterdam

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