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 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that the U.S. Food and Drug Administration (FDA) approved BRACAnalysis CDx for use as a companion diagnostic by healthcare professionals to identify patients with HER2-negative metastatic breast cancer who have a germline BRCA mutation and are candidates for treatment with the PARP inhibitor Lynparza (olaparib), marketed by AstraZeneca and Merck, known as MSD outside of the U.S. and Canada (Press release, Myriad Genetics, JAN 12, 2018, View Source [SID1234523106]). BRACAnalysis CDx is the first and only FDA-approved test for use in this indication.

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"This important advance underscores the need for patients with HER2-negative metastatic breast cancer to know their BRCA status with an FDA approved test to help ensure that they will receive the best available therapy," said Johnathan Lancaster, M.D., Ph.D., chief medical officer of Myriad Genetics. "As shown in the OlympiAD study, Myriad’s BRACAnalysis CDx test was proven to accurately identify those patients who had a germline BRCA mutation and may benefit from Lynparza."

The approval also adds to the body of knowledge about the clinical use and value of companion diagnostics to enable personalized medicine for people with cancer.

"We congratulate AstraZeneca and Merck on obtaining FDA approval of Lynparza for patients with metastatic breast cancer, which is the first approval of a PARP inhibitor outside of ovarian cancer. As the pioneers in identifying likely responders to PARP inhibitors, we are excited to broaden the use of BRACAnalysis CDx as the companion diagnostic for this important new indication," said Mark C. Capone, president and CEO, Myriad Genetics. "We will be actively working with all stakeholders to raise awareness so that patients can be immediately tested to determine if they are likely to benefit from Lynparza."

Approximately one in eight women are diagnosed with breast cancer in the United States, and one-third are diagnosed with or will progress to the metastatic stage of the disease.

"There are more than 155,000 patients with metastatic breast cancer in the United States, and we estimate that 125,000 do not know their BRCA status," said Lancaster. "This new FDA approval of BRACAnalysis CDx for patients with metastatic breast cancer significantly expands the population who can access BRCA testing and potentially benefit from PARP inhibition therapy."

The collaboration with AstraZeneca to develop a novel companion diagnostic test to identify candidates for treatment with olaparib began in 2007. The new metastatic breast cancer indication is the second FDA approval of BRACAnalysis CDx for use in conjunction with Lynparza. In Dec. 2014, Myriad received FDA approval for BRACAnalysis CDx to help identify patients with advanced ovarian cancer who are eligible for fourth-line treatment with olaparib. BRACAnalysis CDx is Myriad’s first FDA-approved companion diagnostic and was the first-ever laboratory developed test approved by the FDA.

About BRACAnalysis CDx

BRACAnalysis CDx is an in vitro diagnostic device intended for the qualitative detection and classification of variants in the protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole blood specimens collected in EDTA. Single nucleotide variants and small insertions and deletions (indels) are identified by polymerase chain reaction (PCR) and Sanger sequencing. Large deletions and duplications in BRCA1 and BRCA2 are detected using multiplex PCR. Results of the test are used as an aid in identifying breast and ovarian cancer patients with deleterious or suspected deleterious germline BRCA variants, who are or may become eligible for treatment with Lynparza (olaparib). Detection of deleterious or suspected deleterious germline BRCA variants by the BRACAnalysis CDx test in ovarian cancer patients is also associated with enhanced progression-free survival (PFS) from Zejula (niraparib)maintenance therapy. This assay is for professional use only and is to be performed only at Myriad Genetic Laboratories, a single laboratory site located at 320 Wakara Way, Salt Lake City, UT 84108. Learn more at: View Source

About Lynparza

Lynparza (olaparib) is an innovative, first-in-class oral poly ADP-ribose polymerase (PARP) inhibitor that exploits tumor DNA damage response (DDR) pathway deficiencies to preferentially kill cancer cells. Lynparza is the foundation of AstraZeneca’s industry-leading portfolio of compounds targeting DNA damage response (DDR) mechanisms in cancer cells. Lynparza is currently approved in the United States for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy and for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. Patients are selected for therapy based on Myriad’s FDA-approved companion diagnostic. It is also approved by regulatory health authorities in the EU for use as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

In July 2017, AstraZeneca and Merck announced a global strategic oncology collaboration to jointly co-develop and co-commercialize Lynparza.

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 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 Jan. 11, 2018 /Forty Seven Inc., a clinical-stage company focused on developing the next generation of transformational immuno-oncology treatments to enable patient’s immune systems to defeat their cancer, reported an agreement with Genentech Inc., a member of the Roche Group., for Genentech to sponsor two clinical trials combining Forty Seven’s CD47 antibody, Hu5F9-G4, with Genentech’s PD-L1 antibody, atezolizumab (TECENTRIQ), in patients with acute myeloid leukemia (AML) and with urothelial (bladder) cancer (Press release, Hoffmann-La Roche, JAN 11, 2018, View Source [SID1234531337]).

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CD47 is an immune modulator molecule overexpressed on cancer cells that sends inhibitory signals to macrophages. Binding of Hu5F9-G4 to CD47 takes the brakes off macrophages enabling them to phagocytose, or swallow, tumor cells.

Craig Gibbs, Ph.D., M.B.A., Chief Business Officer at Forty Seven Inc. said, "There is a large unmet medical need for new therapies for AML and bladder cancer patients, particularly those who are elderly or have compromised organ function and are not able to withstand the side-effects of chemotherapy. We are excited to evaluate these novel combinations in collaboration with a global leader in oncology."

References
CD47 blockade as another immune checkpoint therapy for cancer. Robert H. Vonderheide, Nature Medicine 21, 1122, 2015.

TECENTRIQ (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.