Top Pharma News of the Week

Amgen And CytomX Therapeutics Announce Strategic Collaboration in Immuno-Oncology


October 3, 2017

Amgen and CytomX Therapeutics, Inc. has announced that the companies have entered into a strategic collaboration in immuno-oncology. The companies will co-develop a CytomX Probody™ T-cell engaging bispecific against the Epidermal Growth Factor Receptor (EGFR), a highly validated oncology target expressed on multiple human cancer types. Probody T-cell engaging bispecifics are antibody constructs capable of directing cytotoxic T-cells in tumor microenvironments. In preclinical studies, CytomX’s Probody versions of EGFRxCD3 bispecific therapeutics induced tumor regressions and increased the therapeutic window for this high potential cancer target.

Roche launches NAVIFY Tumor Board solution to provide decision support to oncology care teams


03 October 2017

Roche has announced the launch of the NAVIFY Tumor Board solution, a clinical workflow and decision support software that optimizes decision-making for cancer patient case reviews in tumor boards, or multi-disciplinary team meetings. The solution fundamentally changes the way these meetings are organized and conducted. It is initially available in the US, UK, Germany, Spain, Sweden, and Switzerland.

Lilly Receives U.S. FDA Approval of Verzenio™ (abemaciclib)


October 4, 2017

Eli Lilly and Company (NYSE: LLY) has announced that the U.S. Food and Drug Administration (FDA) has approved Verzenio™ (abemaciclib) in combination with fulvestrant for the treatment of women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer with disease progression following endocrine therapy, and as monotherapy for the treatment of adult patients with HR+, HER2- advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting. It is the first and only CDK4 & 6 inhibitor FDA approved in combination with fulvestrant and as monotherapy. The approval of Verzenio was received on September 28, 2017.

First Randomized Study to Evaluate IMLYGIC® (Talimogene Laherparepvec), An Oncolytic Viral Therapy, In Combination with A Checkpoint Inhibitor Published in The Journal of Clinical Oncology


October 5, 2017

Amgen has announced that the Journal of Clinical Oncology has published positive results from the IMLYGIC® (talimogene laherparepvec) Phase 2 ‘264 study. The study met its primary endpoint of objective response rate (ORR), demonstrating that IMLYGIC in combination with YERVOY® (ipilimumab) more than doubled ORR, defined as the proportion of patients with tumor size reduction, compared to ipilimumab alone in patients with unresectable stage IIIB-IV melanoma (39 percent versus 18 percent; odds ratio=2.9, 95 percent CI: 1.5, 5.5; p=0.002). Patients in the combination arm also experienced nearly double the complete response rate compared to ipilimumab alone (13 percent versus 7 percent).

Pfizer Launches Novel Programs to Put Important Support Services at The Fingertips of Cancer Patients


October 5, 2017

Pfizer has unveiled enhanced offerings to help patients manage their life with cancer. Pfizer Oncology Together is a first-of-its-kind program for patients taking Pfizer Oncology medicines that offers dedicated social workers called ‘Care Champions’ to help navigate the complexities that accompany treatment, such as identifying resources to help find emotional support, and workplace transition, transportation and financial assistance.  Pfizer is also launching This is Living with Cancer™, a program that provides tools and resources to support those who have been affected by cancer, including a mobile app, LivingWith, designed to help manage some of the daily challenges faced by people living with cancer.

FDA approves Roche cobas Zika as first commercially-available donor screening test for Zika virus


October 6, 2017

Roche has announced that it has received approval from the U.S. Food and Drug Administration (FDA) for the cobas® Zika test for use on the cobas 6800/8800 Systems. The cobas Zika test is the first commercially available test for the detection of the Zika virus RNA in samples of human plasma intended for use in screening blood donations. This approval marks an important milestone in the effort to protect the blood supply from Zika virus in the U.S.

Flexion Therapeutics Announces FDA Approval of Zilretta™ (triamcinolone acetonide extended-release injectable suspension) for Osteoarthritis (OA) Knee Pain


October 6, 2017

Flexion Therapeutics, Inc. has announced that the U.S. Food and Drug Administration (FDA) approved Zilretta™ (triamcinolone acetonide extended-release injectable suspension), the first and only extended-release, intra-articular injection for osteoarthritis knee pain. Zilretta is a non-opioid medicine that employs Flexion’s proprietary microsphere technology to provide proven pain relief over 12 weeks.

The European Medicines Agency accepts marketing authorization application for Imfinzi in locally-advanced unresectable non-small cell lung cancer


October 9, 2017

AstraZeneca, along with MedImmune, its global biologics research and development arm, has announced that the European Medicines Agency (EMA) has accepted a Marketing Authorisation Application (MAA) for Imfinzi (durvalumab) for the treatment of patients with locally-advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy. This is the first registrational submission for Imfinzi in the European Union.

Tagrisso granted breakthrough therapy designation by US FDA for the 1st-line treatment of patients with EGFR mutation-positive non-small cell lung cancer


October 9, 2017

AstraZeneca has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Tagrisso (osimertinib) for the 1st-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC).

Top Pharma News of the Week last edit: 2017-10-10T20:16:52+00:00 da Luca

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