On April 3, 2018 AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) reported that the European Medicines Agency has validated for review the Marketing Authorisation Application (MAA) for Lynparza (olaparib) for use in patients with deleterious or suspected deleterious BRCA-mutated, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting (Press release, AstraZeneca, APR 3, 2018, View Source [SID1234525155]).

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This is the first regulatory submission for a poly ADP-ribose polymerase (PARP) inhibitor in breast cancer in Europe. If approved, the identification of a patient’s BRCA status could become a critical step in the management of their disease alongside current consideration of their hormone receptor and HER2 status. The MAA includes data from the randomised, open-label, Phase III OlympiAD trial, which investigated Lynparza versus chemotherapy (physician’s choice of capecitabine, eribulin or vinorelbine). In the trial, Lynparza significantly prolonged progression-free survival compared with chemotherapy and reduced the risk of disease progression or death by 42% (HR 0.58; 95% CI 0.43-0.80; P=0.0009 median 7.0 vs. 4.2 months).

In January 2018, Lynparza was approved by the US Food and Drug Administration for use in the treatment of BRCA-mutated HER2-negative metastatic breast cancer, becoming the first PARP inhibitor to be approved beyond ovarian cancer. Lynparza is available in nearly 60 countries and has been used to treat more than 20,000 patients. AstraZeneca and MSD are working together to bring Lynparza to more patients across multiple cancers.

On April 3, 2018 Cancer Therapeutics CRC (CTX) is reported that appointment of Brett Carter as Chief Executive Officer (Press release, Cancer Therapeutics CRC, APR 3, 2018, View Source [SID1234525374]).

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Brett will succeed Dr Warwick Tong who has led CTX for the past 6 years and who will continue to provide services to the organisation in an advisory capacity. These changes reflect a transition plan agreed between Dr Tong and the CTX Board to evolve the organisation from a Federally supported Cooperative Research Centre (CRC) into an independent and self-sustainable organisation.

Commenting on the appointment, Dr Tony Evans Chair of CTX, said
:
"We are delighted to appoint Brett as Chief Executive Officer. Brett has excellent management skills, extensive industry experience and a track record of executing pharmaceutical deals, making him the ideal candidate to lead CTX moving forward. I would like to thank Warwick for his dedicated leadership of the organisation over the past 6 years. Warwick has made many contributions to CTX however I would like to specifically highlight his involvement in the PRMT5 licensing deal to Merck, which was one of Australia’s largest ever pre-clinical asset licensing deals."

Commenting on the appointment, Mr Carter, said:
"Cancer is Australia’s leading cause of pre-mature death and CTX’s unique and highly successful business model has resulted in the development of drug products that have the potential to provide cures for cancer patients. I am very excited to be taking over the leadership of an organisation with such a strong culture of innovation and delivery.
To move from a medical research hub to a global biotechnology leader, Australia needs organisations like CTX, that build the drug discovery and development capability necessary to translate the country’s world class medical research into clinical and commercial outcomes.

I want to thank Warwick for his mentorship over the past year and I look forward to working with the CTX team and stakeholders as we embark on the next stage of the organisation’s evolution."

On April 2, 2018 Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH) a clinical stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, reported that company management will give a corporate presentation at the H. C. Wainwright Annual Global Life Sciences Conference on Monday, April 9 at 10:40 a.m. CEST at Le Meridien Beach Plaza Hotel in Monte Carlo, Monaco (Press release, Tetraphase, APR 2, 2018, View Source [SID1234525121]).

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Live audio webcasts of the presentation will be available on the company’s website at View Source Archived presentations will be available for 30 days.

On April 2, 2018 Merck (NYSE:MRK), known as MSD outside the United States and Canada, reported that it will hold its first-quarter 2018 sales and earnings conference call with institutional investors and analysts at 8:00 a.m. EDT on Tuesday, May 1 (Press release, Merck & Co, FEB 2, 2018, View Source [SID1234525122]). During the call, company executives will provide an overview of Merck’s performance for the quarter.

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Institutional investors and analysts can participate in the call by dialing (706) 758-9927 or (877) 381-5782 and using ID code number 9499465. Members of the media are invited to monitor the call by dialing (706) 758-9928 or (800) 399-7917 and using ID code number 9499465. Journalists who wish to ask questions are requested to contact a member of Merck’s Media Relations team at the conclusion of the call.

On 2, April Abeona Therapeutics Inc. (NASDAQ:ABEO), a leading clinical-stage biopharmaceutical company focused on developing novel cell and gene therapies for life-threatening rare genetic diseases, reported the appointment of Carsten Thiel, Ph.D., as Chief Executive Officer. Timothy J. Miller, Ph.D., will remain President and assume the position of Chief Scientific Officer in charge of the company’s expanding clinical and preclinical research programs (Press release, Abeona Therapeutics, APR 2, 2018, View Source [SID1234525106]). Dr. Thiel most recently served as the Executive Vice President and Chief Commercial Officer of Alexion Pharmaceuticals, Inc. where he led global commercial operations bringing innovative and life-transformative therapies for rare diseases to patients.

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"The past year has been an extraordinary time in the history of Abeona, including significant progress in our clinical development programs and establishment of our new manufacturing facility in Cleveland," said Steven Rouhandeh, Executive Chairman of Abeona. "As CEO, Carsten Thiel brings a unique combination of extensive experience in research and global rare disease commercialization to Abeona. In his recent positions, he successfully created value by building cohesive talented teams, driving the commercial success of multiple products globally and fostering entrepreneurial culture; all key aspects that will be critical to our success in these areas in the years ahead. We are very grateful to Tim Miller for his vision and leadership that have brought us to this pivotal stage in our business growth."

Dr. Thiel brings 25 years of proven global biopharmaceutical industry experience, including rare and orphan diseases, to Abeona. Prior to leading his most recent position at Alexion, he served as its Senior Vice President, Europe/Middle East/Africa and Asia Pacific where he was responsible for driving Alexion’s global commercial operations in these regions, including maximizing the current rare disease portfolio as well as guiding the launch of anticipated new products and indications.

"I am thrilled to be joining Abeona during a period of major growth and momentum in the company’s range of promising development programs," said Dr. Thiel. "I look forward to bringing my experience in business development, biomedical research and commercialization to the outstanding Abeona team at a time when the company is ideally positioned to rapidly expand these areas."

Prior to joining Alexion, Dr. Thiel served as Vice President, Head of Europe at Amgen. In this role, he led regional operations and was responsible for multiple products in hematology/oncology, nephrology, and bone disorders, and prepared for new product launches in inflammation and cardiology. He also held various other senior leadership positions at Amgen, including General Manager, Germany, and General Manager, CEE, where he led all markets in Eastern Europe and established Amgen’s operations in Russia. He also served as Head of the Oncology franchise in Europe during the time of several blockbuster product launches. Prior to Amgen, Dr. Thiel held several sales and marketing leadership roles across Europe at Roche.

"As Abeona expands our innovative science and clinical research programs into new areas, I look forward to working more closely with our research and product development teams to fuel even greater success for developing novel gene and cell therapies," said Dr. Miller. "We welcome Carsten to our team at Abeona, and remain confident that our clinical advancements and strategic decisions have solidly positioned us to plan for many promising opportunities in global product commercialization and business strategy."

Dr. Thiel earned his doctorate in molecular biology & biochemistry at Max Planck Institute for Biophysical Chemistry in Goettingen, Germany.