On January 12, 2018 Ipsen (Euronext: IPN; ADR: IPSEY) reported the appointment of Richard Paulson as Executive Vice-President and Chief Executive Officer of Ipsen North America, responsible for all commercial operations throughout the region. Mr Paulson will assume oversight of all areas supporting the North American business effective from February 5th (Press release, Ipsen, JAN 12, 2018, View Source [SID1234523076]). The role reports directly to David Meek, CEO of Ipsen, and Mr Paulson will be a member of the Ipsen Executive Leadership Team. He joins Ipsen from Amgen where he most recently served as Vice-President and General Manager of the Oncology Business Unit.

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David Meek, Ipsen’s CEO, commented, "We are extremely delighted to welcome Richard to Ipsen, to drive the continued growth of our North American business and further our development as a leading biopharma company focused on innovation and specialty care. Richard brings a wealth of great leadership experience, vision, and a track record of exceptional execution in leading and growing businesses, both in the US and internationally. He will bring great passion and energy to our work with patients."

During a 10-year career at Amgen, Richard Paulson held a number of positions in the company, including General Manager, Central and Eastern Europe, and subsequently General Manager Germany, before assuming leadership positions in Amgen’s Oncology Business Unit. Prior to joining Amgen, he held international positions in general management, marketing and market access with Pfizer. He also served in a number of sales and marketing roles with increasing seniority for GlaxoWellcome in Canada. He holds an MBA from the University of Toronto.

Richard Paulson added: "I am honored to join Ipsen at this time of rapid transformation and growth, as the company progresses in its evolution as a leading global biopharma company. Throughout my career, in markets around the world, I have been passionate about building and leading diverse, high-performing teams, and driving innovation for patients. I am extremely excited to join this dynamic company, with its clear mission and commitment to developing patient-focused solutions that put the patients’ needs first."

With the former President North America Cynthia Schwalm leaving Ipsen to pursue other interests, Ipsen would like to thank Cynthia for her many contributions to the growth of Ipsen’s North American business, and wishes her well in her future endeavors

On January 12, 2018 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported that it has updated the VARUBI (rolapitant) injectable emulsion package insert in collaboration with the U.S. Food and Drug Administration (FDA) (Press release, TESARO, JAN 12, 2018, View Source [SID1234523148]). VARUBI injectable emulsion is a substance P/neurokinin (NK-1) receptor antagonist indicated for the prevention of delayed nausea and vomiting associated with chemotherapy in adults. The changes to the labeling include modifications to the CONTRAINDICATIONS, WARNINGS and PRECAUTIONS, and ADVERSE REACTIONS sections.

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Following its introduction in late November 2017, TESARO estimates that at least 7,000 doses of VARUBI injectable emulsion have been administered to patients receiving emetogenic chemotherapy in the United States. Anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions have been reported in the postmarketing setting, some requiring hospitalization. These reactions have occurred during or soon after the infusion of VARUBI injectable emulsion. Most reactions have occurred within the first few minutes of administration.

Patient safety is a paramount priority for TESARO. In its commitment to ensuring patients and healthcare professionals are aware of the label update, TESARO has issued a Dear Healthcare Professional (DHCP) letter. This letter, as well as the updated full prescribing information, has been posted on the VARUBI website (www.varubirx.com). Additionally, members of the TESARO field force will be calling on healthcare professionals to communicate this important new safety information.

Healthcare providers and patients are encouraged to report adverse events in patients taking VARUBI injectable emulsion to TESARO at 1-844-4-TESARO (1-844-483-7276). TESARO’s medical information department may be reached at 1-844-4-TESARO (1-844-483-7276) to address any questions from healthcare providers about the information contained in this release, or the safe and effective use of VARUBI injectable emulsion.

VARUBI Indication and Important Safety Information

VARUBI, in combination with other antiemetic agents, is indicated in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.

VARUBI is contraindicated in patients taking CYP2D6 substrates with a narrow therapeutic index, such as thioridazine and pimozide. VARUBI can significantly increase the plasma concentrations of thioridazine and pimozide, which may result in QT prolongation and Torsades de Pointes.

VARUBI is a moderate inhibitor of CYP2D6 and significantly increases the plasma concentrations of CYP2D6 substrates for at least 28 days, with inhibitory effects expected to persist for an unknown duration. Monitor for adverse reactions when VARUBI is coadministered with CYP2D6 substrates without a narrow therapeutic index (avoid coadministration with CYP2D6 substrates with a narrow therapeutic index, thioridazine and pimozide; see Contraindication).

In clinical trials, the most common adverse reactions reported were neutropenia, hiccups, decreased appetite and dizziness. IV administration of VARUBI was also associated with infusion-related symptoms (e.g., sensation of warmth, abdominal pain, dizziness, and paresthesia).

Avoid use of VARUBI in patients who require chronic administration of strong CYP3A4 inducers (e.g., rifampin), as significantly reduced plasma concentrations of VARUBI can decrease the efficacy of VARUBI.

VARUBI given as an oral dose is an inhibitor of breast cancer resistance protein (BCRP) and P-glycoprotein (P-gp). Increased plasma concentrations of BCRP substrates (e.g., methotrexate, topotecan, or irinotecan) and P-gp substrates (e.g., digoxin) with a narrow therapeutic index may result in potential adverse reactions. Monitor digoxin concentrations with concomitant use of VARUBI, and adjust the dosage as needed to maintain therapeutic concentrations.

Monitor INR and prothrombin time and adjust the dosage of warfarin, as needed, to maintain target INR.

VARUBI is available by prescription only. Please see full prescribing information, including additional important safety information, available at www.varubirx.com.

On January 12, 2018 Halozyme Therapeutics Inc presented at the 36th Annual J.P. Morgan healthcare conference (Presentation, Halozyme, JAN 12, 2018, View Source [SID1234523105]).

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On January 11, 2018 Ziopharm presented Presentation of the Company (Press release, Ziopharm, JAN 11, 2018, View Source [SID1234523066]).

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On January 11, 2018 Novartis reported that Elizabeth (Liz) Barrett, currently Global President Oncology at Pfizer, Inc., has been appointed CEO Novartis Oncology and a member of the Executive Committee of Novartis, effective February 1, 2018 (Press release, Novartis, JAN 11, 2018, View Source [SID1234523064]). She will be based in Basel. Mrs. Barrett succeeds Bruno Strigini who decided to retire from Novartis for personal reasons.

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Vasant (Vas) Narasimhan, designated CEO of Novartis, said: "Liz is a highly accomplished and recognized oncology and people leader with an impressive record of building successful business organizations in the US, Europe and globally. She has been instrumental in creating new commercial models, driving innovation in close partnership with research and development and leveraging business development opportunities. Her long-time commercial pharma industry experience, marketing skills and perspectives make Liz a great fit to further develop our oncology business."

Mrs. Barrett said: "I feel honored to join Novartis, a recognized pioneer in the oncology area. It is key to me to contribute to transformative advancements in oncology, and to serve in a highly impactful leadership role to this end."

Mrs. Barrett has held numerous leadership positions in the pharmaceutical industry as well as in the consumer sector. In her most recent role at Pfizer, she led the oncology business through a significant period of growth achieved in less than three years. Before joining Pfizer in 2009, she worked at Cephalon, Inc. and Johnson & Johnson. She started her career at Kraft Foods Group, Inc. in 1984.

Mrs. Barrett is a US citizen and has lived and worked in the US and Europe. She obtained an MBA in Marketing from the Saint Joseph’s University in Philadelphia and a BSc in Business Administration from the University of Louisiana.

Novartis also announced today that Robert Kowalski, Pharm.D., Head of Global Regulatory Affairs, will assume ad interim leadership of the Drug Development Organization, effective February 1, 2018. Dr. Kowalski has been Head of Global Regulatory Affairs for Novartis since February 2016 and has played an important leadership role in securing approvals for several breakthrough medicines including our revolutionary CAR-T therapy Kymriah. The definitive Head of Global Drug Development will be announced in due course.

Disclaimer

This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, . Forward-looking statements can generally be identified by words such as "effective," "will," "to further develop," or similar expressions, or by express or implied discussions regarding potential future sales or earnings of the Novartis Group. You should not place undue reliance on these statements. Such

forward looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward looking statements. There can be no guarantee that Novartis will be commercially successful in the future, or achieve any particular financial results. In particular, our expectations could be affected by, among other things: regulatory actions or delays or government regulation generally; the potential that the strategic benefits, synergies or opportunities expected from the significant reorganizations of recent years may not be realized or may take longer to realize than expected; the uncertainties inherent in the research and development of new healthcare products; our ability to obtain or maintain proprietary intellectual property protection on key products; safety, quality or manufacturing issues; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; uncertainties regarding actual or potential legal proceedings; and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.