Top Pharma News – July 2016


Bristol-Myers Squibb Acquires Cormorant Pharmaceuticals

Bristol Cormorant

July 5, 2016

Bristol-Myers Squibb Company and Cormorant Pharmaceuticals have announced that Bristol-Myers Squibb has acquired all of the outstanding capital stock of Cormorant, which is a private, Stockholm, Sweden-based pharmaceutical company that focuses on the development of therapies for cancer and rare diseases. This acquisition allows Bristol-Myers Squibb gain full rights to Cormorant’s HuMax-IL8 antibody program and the lead candidate HuMax-IL8, a Phase 1/2 monoclonal antibody targeted against interleukin-8 (IL-8) representing a potentially complementary immuno-oncology mechanism of action to T-cell directed antibodies and co-stimulatory molecules.

European Union Approves Biogen and AbbVie’s Once-Monthly ZINBRYTA™ (daclizumab) for the Treatment of Multiple Sclerosis


Jul 05, 2016

Biogen and AbbVie have announced that the European Commission (EC) has granted marketing authorization for ZINBRYTA™ (daclizumab) for treating adult patients with relapsing forms of multiple sclerosis (RMS). ZINBRYTA is a once-monthly, subcutaneous, self-administered injection.

Positive Top-Line Results Announced by Pfizer from Phase 3 S-TRAC Trial of SUTENT® (sunitinib) as Adjuvant Therapy in Patients at High Risk of Recurrent Renal Cell Carcinoma

Pfizer Igea Luca Dezzani

July 8, 2016

Pfizer Inc. has announced that the S-TRAC clinical trial (Sunitinib Trial in Adjuvant RenalCancer), a Phase 3 study of SUTENT versus placebo in the adjuvant setting, met its primary endpoint of improving disease-free survival (DFS)            in patients with renal cell carcinoma (RCC) who are at high risk for recurrence after surgery. This S-TRAC trial is the first RCC trial of a tyrosine kinase inhibitor (TKI) to prolong DFS in the adjuvant setting. Adjuvant therapy can help lower the risk of cancer recurrence in patients with cancer at an early-stage.

FDA Gives Rare Pediatric Disease Designation to AbbVie for Investigational ABT-414 for the Treatment of a Type of Pediatric Brain Tumor


July 11, 2016

AbbVie, a global biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease Designation for ABT-414, an investigational antibody drug conjugate (ADC) that targets the epidermal growth factor receptor (EGFR) for the treatment of pediatric patients with EGFR-amplified Diffuse Intrinsic Pontine Glioma (DIPG). This is recognized as the highly aggressive and difficult to treat brain tumors found at the base of the brain.

Bayer Expands its Drug Discovery Collaboration with X-Chem to Discover Novel Medicines


July 12, 2016

Bayer and X-Chem, Inc., a privately held biotechnology company that focuses on applying its innovative drug discovery capabilities to the generation of novel small molecule therapeutics, have entered into an expanded global collaboration for drug discovery across multiple therapeutic areas and target classes. This new agreement will extend Bayer’s access to X-Chem’s DEX™ technology which is based on DNA-encoded libraries of small molecules with more than 120 billion molecules. The main goal of the collaboration is to discover innovative lead structures for complex drug targets in areas of high unmet medical need.

Amgen and Daiichi Sankyo Announce Agreement for Commercializing Biosimilars in Japan

Amgen-Daiichi Sanko

July 13, 2016

Amgen and Daiichi Sankyo Company, Limited have announced the execution of an exclusive agreement for commercializing nine biosimilars in Japan. This deal comprises several biosimilars in late-stage development, including biosimilars of adalimumab, trastuzumab, and bevacizumab.

AstraZeneca’s Tagrisso met primary endpoint in phase III 2nd-line lung cancer trial


July 18, 2016

AstraZeneca has announced that the Phase III AURA3 trial met its primary endpoint that demonstrates superior progression-free survival (PFS) in comparison to standard platinum-based doublet chemotherapy. The AURA3 randomized trial assessed the safety and efficacy of Tagrisso as a 2nd-line treatment in more than 400 patients with EGFR T790M mutation-positive, locally-advanced or metastatic NSCLC, whose disease had progressed following 1st-line EGFR tyrosine kinase inhibitor (TKI) therapy. Tagrisso also demonstrated a safety profile consistent with previous trials. At an upcoming medical meeting, the results of a full evaluation of AURA3 data, including an analysis of overall survival (OS), will be presented.

PREZISTA® (darunavir) of Janssen is Approved by U.S. FDA for Use in Pregnant Women with HIV


July 18, 2016

Janssen Therapeutics, Division of Janssen Products, LP (Janssen), has announced that the U.S. Food and Drug Administration (FDA) has approved PREZISTA® (darunavir) to be used during pregnancy and the postpartum period. Previously, a human immunodeficiency virus (HIV-1) protease inhibitor, PREZISTA® was indicated for the treatment of HIV-1 infection in adult and pediatric patients three years of age and older in combination with ritonavir with other antiretroviral agents. The recent label update includes dosing recommendations for pregnant women with HIV. Clinical data demonstrates that PREZISTA® taken with ritonavir has been found to be well-tolerated during pregnancy and the postpartum period.

Roche updates on phase III study of Gazyva/Gazyvaro in people with previously untreated diffuse large B-cell lymphoma

Roche Igea Luca Dezzani

18 July 2016

Roche has announced that the phase III GOYA study that evaluates Gazyva®/Gazyvaro® (obinutuzumab) plus CHOP chemotherapy (G-CHOP) in people with previously untreated diffuse large B-cell lymphoma (DLBCL) did not meet its primary endpoint to significantly reduce the risk of disease worsening or death compared to MabThera/Rituxan (rituximab) plus CHOP chemotherapy (R-CHOP). It was observed that adverse events with MabThera/Rituxan and Gazyva/Gazyvaro were consistent with those seen in previous clinical trials when each was combined with various chemotherapies. At an upcoming medical meeting, data from the GOYA study will be presented.

Top-Line Results from Phase 3 Study Announced by Amgen and Allergan Evaluating ABP 980 in Patients with Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer


July 21, 2016

Amgen and Allergan plc have announced results from a Phase 3 study that evaluates safety and efficacy of ABP 980 compared with trastuzumab in patients with human epidermal growth factor receptor 2-positive (HER2-positive) early breast cancer. Based on its primary efficacy endpoint of the difference of the percentage of patients with a pathologic complete response (pCR), the results ruled out inferiority compared to trastuzumab but could not rule out superiority. The primary endpoint had a pre-specified equivalence margin of +/- 13 percent and the observed upper end of the confidence interval was 13.4 percent.

Antibiotic Zavicefta of AstraZeneca met primary endpoints in Phase III trial for treating hospital-acquired pneumonia


21 July 2016

AstraZeneca has announced that the results were positive from the Phase III REPROVE trial for Zavicefta (ceftazidime-avibactam), a new combination antibiotic for treating a broad range of serious Gram-negative bacterial infections in hospitalized patients. Zavicefta has been developed in response to the urgent need for new antibiotics for treating serious infections that are increasingly becoming resistant to current antibiotics commonly used for serious infections, such as polymixins and carbapenems, including colistin.

AbbVie and Bristol-Myers Squibb Collaborate to Evaluate the Combination of Rova-T plus Opdivo and Opdivo + Yervoy Regimen


July 25, 2016

AbbVie and Bristol-Myers Squibb Company have announced a clinical trial collaboration for evaluating the safety, efficacy, and tolerability of investigational biomarker-specific antibody drug conjugate Rova-T (rovalpituuzumab tesirine) of AbbVie in combination with Opdivo (nivolumab) and Opdivo + Yervoy (ipilimumab) regimen of Bristol-Myers Squibb as a treatment for relapsed extensive-stage small cell lung cancer (SCLC).

Bristol-Myers Squibb Collaborates with Janssen in Immuno-Oncology Research Focused on Lung Cancer


July 26, 2016

Bristol-Myers Squibb Company has announced a new clinical research collaboration with Janssen Biotech, Inc. to evaluate Bristol-Myers Squibb’s Immuno-Oncology (I-O) agent Opdivo (nivolumab) and Janssen’s Live Attenuated Double–Deleted (LADD) Listerial monocytogenes cancer immunotherapy, expressing mesothelin and EGFRvIII (JNJ-64041757), in patients with non-small cell lung cancer (NSCLC).

Top Pharma News – July 2016 last edit: 2016-08-08T17:39:07+00:00 da Luca

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