Top Pharma News of the Week

Bayer and Loxo Oncology to develop and commercialize two novel oncology therapies selectively targeting genetic drivers of cancer

November 14, 2017

Bayer has announced that the company has entered into an exclusive global collaboration with Loxo Oncology, Inc., a biopharmaceutical company based in Stamford, Connecticut, US, for the development and commercialization of larotrectinib (LOXO-101) and LOXO-195. Both compounds are being investigated in global studies for the treatment of patients with cancers harboring tropomyosin receptor kinase (TRK) gene fusions, which are genetic alterations across a wide range of tumors resulting in uncontrolled TRK signaling and tumor growth.

Fasenra (benralizumab) receives US FDA approval for severe eosinophilic asthma

November 14, 2017

AstraZeneca and its global biologics research and development arm, MedImmune, have announced that the US Food and Drug Administration (FDA) has approved Fasenra (benralizumab) for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.

Faslodex receives US FDA approval for the treatment of advanced breast cancer in combination with abemaciclib

November 15, 2017

AstraZeneca has announced that the US Food and Drug Administration (FDA) has approved a new indication for Faslodex (fulvestrant), expanding the indication to include use with abemaciclib, a CDK4/6 inhibitor, for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer (MBC) in women with disease progression after endocrine therapy.

FDA approves Roche’s Hemlibra (emicizumab-kxwh) for haemophilia A with inhibitors

November 16, 2017

Roche has announced that the US Food and Drug Administration (FDA) has approved Hemlibra® (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with haemophilia A with factor VIII inhibitors. Nearly one in three people with severe haemophilia A can develop inhibitors to factor VIII replacement therapies, putting them at greater risk for life-threatening bleeds or repeated bleeds that can cause long-term joint damage. In two of the largest pivotal clinical studies for people with haemophilia A with inhibitors, Hemlibra was shown to substantially reduce bleeds in adults and children.

New Real-World Analysis Shows INVOKANA® (canagliflozin) and Other SGLT2 Inhibitors Reduced the Risk of Death and Cardiovascular Events Compared to Other Diabetes Medicines

November 17, 2017

A new real-world analysis of adults with type 2 diabetes and established cardiovascular disease (CVD) shows adult patients who initiated therapy with INVOKANA® (canagliflozin) or another sodium glucose cotransporter-2 inhibitor (SGLT2i) had a 43 percent reduced risk for all-cause mortality (ACM) and hospitalization for heart failure (HHF) after an average of 1.6 years, compared to similar patients who initiated treatment with a non-SGLT2i medication using an intent-to-treat (ITT) approach. Additionally, patients who initiated SGLT2i therapy had a 33 percent reduced risk of major adverse cardiovascular events (MACE), including ACM, non-fatal myocardial infarction (MI) and non-fatal stroke. This new retrospective analysis from the EASEL (Evidence for cArdiovascular outcomes with Sodium glucose co-transporter 2 inhibitors in the rEal worLd) study is based on data from the U.S. Department of Defense Military Health System and was published this week in Circulation.

Pfizer receives FDA approval for Sutent® (sunitinib malate) as first and only adjuvant treatment for adult patients at high risk of recurrent renal cell carcinoma

November 16, 2017

Pfizer Inc. has announced that the U.S. Food and Drug Administration has approved a new indication expanding the use of SUTENT® (sunitinib malate) to include the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy (surgical removal of the cancerous kidney). The approval was based on results from the S-TRAC trial that demonstrated a significant reduction in the risk of a disease-free survival (DFS) event (defined as the interval between randomization and tumor recurrence, or secondary primary cancer or death from any cause) for patients at high risk of RCC recurrence who received SUTENT compared to placebo in the adjuvant setting.

Celgene Corporation and bluebird bio Announce bb2121 Anti-BCMA CAR-T Cell Therapy Has Been Granted Breakthrough Therapy Designation from FDA and Prime Eligibility from EMA for Relapsed and Refractory Multiple Myeloma

November 16, 2017

Celgene Corporation and bluebird bio, Inc. have announced that bb2121, a chimeric antigen receptor T-cell (CAR-T) therapy targeting b-cell maturation antigen (BCMA) in previously treated patients with multiple myeloma, has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) and PRIority MEdicines (PRIME) eligibility by the European Medicines Agency (EMA).

FDA approves Roche’s Gazyva for previously untreated advanced follicular lymphoma

November 17, 2017

Roche has announced that the US Food and Drug Administration (FDA) approved Gazyva® (obinutuzumab) in combination with chemotherapy, followed by Gazyva alone in those who responded, for people with previously untreated advanced follicular lymphoma (stage II bulky, III or IV). The approval is based on results from the phase III GALLIUM study, which showed superior progression-free survival (PFS) for patients who received this Gazyva-based regimen compared with those who received a Rituxan® (rituximab)-based regimen as an initial (first-line) therapy. Follicular lymphoma, the most common slow-growing (indolent) form of non-Hodgkin lymphoma (NHL), is incurable and becomes harder to treat each time it returns. Gazyva is an engineered monoclonal antibody designed to attach to CD20.

Phase III IMpower150 study showed Roche’s TECENTRIQ (atezolizumab) and Avastin (bevacizumab) plus chemotherapy significantly reduced the risk of disease worsening or death in the initial treatment of people with a type of advanced lung cancer

November 20, 2017

Roche has announced that the Phase III IMpower150 study met its co-primary endpoint of progression-free survival (PFS) and demonstrated that the combination of TECENTRIQ® (atezolizumab) and Avastin® (bevacizumab) plus chemotherapy (paclitaxel and carboplatin) provided a statistically significant and clinically meaningful reduction in the risk of disease worsening or death (PFS) compared to Avastin plus chemotherapy in the first-line treatment of people with advanced non-squamous non-small cell lung cancer (NSCLC). Initial observations for the co-primary endpoint of overall survival (OS) are encouraging.

Novartis drug Tasigna® (nilotinib) secures EU approval for first and second-line treatment of Ph+ CML-CP in children

 

November 20, 2017

Novartis announced today that the European Commission (EC) approved Tasigna® (nilotinib) for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP) and pediatric patients with Ph+ CML-CP with resistance or intolerance to prior therapy including imatinib. Tasigna is the only second-generation tyrosine kinase inhibitor (TKI) currently approved in the European Union (EU) for the treatment of Ph+ CML-CP in children. The approval follows a positive opinion issued by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on September 14, 2017 and applies to all EU member states.

Top Pharma News of the Weeklast edit: 2017-11-22T17:04:00+00:00da Luca

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