Top Pharma News of the Week

Pfizer Announces Outcome of FDA Advisory Committee Meeting for Sutent® In Patients at High Risk of Recurrent Renal Cell Carcinoma After Surgery

September 19, 2017

Pfizer Inc. has announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drug Advisory Committee (ODAC) voted 6 in favor and 6 against the benefit-risk profile for SUTENT® (sunitinib) as adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) after nephrectomy (surgical removal of the cancer-containing kidney). The role of the Advisory Committee is to provide recommendations to the FDA. The ODAC discussions were based on the supplemental New Drug Application (sNDA) currently under review by the FDA. The FDA decision on whether or not to approve the sNDA is anticipated by January 2018.

Sanofi And NIH Researchers Develop “Three-In-One” Antibodies As A Potential Breakthrough Intervention For HIV/AIDS

September 20, 2017

In a landmark study published in the journal Science today, researchers produced genetically engineered antibodies with the highest activity and breadth of coverage yet seen against human immunodeficiency virus (HIV-1). Natural antibodies recognize a single target on a foreign protein. In this study, antibodies were engineered to recognize three different target sites in one molecule. These HIV “trispecific” antibodies were highly effective in suppressing virus growth and infection.

GSK and Innoviva report positive headline results from IMPACT study showing single inhaler triple therapy Trelegy Ellipta reduced COPD exacerbations

September 20, 2017

GlaxoSmithKline plc and Innoviva, Inc. have announced positive headline results from the landmark phase III IMPACT study of Trelegy Ellipta, the first and only FDA approved once-daily single inhaler triple therapy comprising an inhaled corticosteroid (ICS), long-acting muscarinic antagonist (LAMA) and long-acting beta agonist (LABA). Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol, FF/UMEC/VI) is approved for the long-term, once-daily, maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) who are receiving Breo (fluticasone furoate/vilanterol, FF/ VI) and require additional bronchodilation or who are receiving Breo and Incruse (umeclidinium, UMEC).

Sanofi And Alnylam Report Positive Topline Results from Apollo Phase 3 Study of Patisiran In Hereditary Attr (Hattr) Amyloidosis Patients with Polyneuropathy

September 20, 2017

Sanofi Genzyme, the specialty care global business unit of Sanofi, and Alnylam Pharmaceuticals, Inc, the leading RNAi therapeutics company, have announced that the APOLLO Phase 3 study of patisiran, an investigational RNAi therapeutic being developed for patients with hereditary ATTR amyloidosis with polyneuropathy, met its primary efficacy endpoint and all secondary endpoints. The primary endpoint for the study was the change from baseline in the modified neuropathy impairment score (mNIS+7) at 18 months.  The key secondary endpoint was improvement in quality of life assessed by the Norfolk Quality of Life Questionnaire-Diabetic Neuropathy (Norfolk QOL-DN).

Novartis drug Rydapt® (midostaurin) receives EU approval for newly diagnosed FLT3-mutated acute myeloid leukemia (AML) and three types of advanced systemic mastocytosis (SM)


September 20, 2017

Novartis has announced that the European Commission (EC) has approved Rydapt® (midostaurin) for two indications in rare, hard-to-treat cancers. Rydapt is approved for use in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single agent maintenance therapy, for adults with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive. It was also cleared for use as monotherapy for the treatment of adults with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN) or mast cell leukemia.

European Commission Approves Bavencio (Avelumab) for Metastatic Merkel Cell Carcinoma

September 21, 2017

Merck KGaA, Darmstadt, Germany, and Pfizer Inc. have announced that the European Commission (EC) has granted marketing authorization for BAVENCIO® (avelumab) as a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (mMCC), a rare and aggressive skin cancer. BAVENCIO will have marketing authorization in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland. BAVENCIO is expected to become commercially available to patients in Europe by prescription within the coming months, with initial launches in Germany and UK expected as early as October 2017.

Roche receives EU approval of TECENTRIQ® (atezolizumab) in a specific type of metastatic lung cancer and two types of metastatic bladder cancer

September 22, 2017

Roche has announced that the European Commission (EC) has granted a marketing authorization for TECENTRIQ (atezolizumab) as a monotherapy for the treatment of people with locally advanced or metastatic non-small cell lung cancer (NSCLC) after they have been previously treated with chemotherapy regardless of PD-L1 status. People with EGFR-activating mutations or ALK-positive tumor mutations should also have received targeted therapy before receiving TECENTRIQ. This approval is based on results from the large randomized Phase III OAK study and the randomized Phase II POPLAR study.

Janssen Receives Complete Response Letter from U.S. FDA for Sirukumab Biologics License Application

September 22, 2017

Janssen Biotech, Inc. (Janssen) has announced that it has received a complete response letter from the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) seeking approval of sirukumab for the treatment of moderately to severely active rheumatoid arthritis (RA). The complete response letter indicates additional clinical data are needed to further evaluate the safety of sirukumab in the treatment of moderately to severely active RA.

Roche receives EU approval of Gazyvaro for people with previously untreated advanced follicular lymphoma

September 22, 2017

Roche has announced that the European Commission has approved Gazyvaro® (obinutuzumab) in combination with chemotherapy, followed by Gazyvaro maintenance in people achieving a response, as a new treatment for previously untreated advanced follicular lymphoma.

AbbVie and Bristol-Myers Squibb Announce Clinical Research Collaboration to Evaluate a Therapeutic Regimen in Advanced Solid Tumors

September 22, 2017

AbbVie and Bristol-Myers Squibb Company have announced a clinical trial collaboration to evaluate the combination of AbbVie’s investigational antibody drug conjugate ABBV-399 and Bristol-Myers Squibb’s immunotherapy Opdivo (nivolumab) in c-Met overexpressing non-small cell lung cancer (NSCLC).

Bristol-Myers Squibb’s Opdivo® (nivolumab) Receives FDA Approval for the Treatment of Hepatocellular Carcinoma Patients Previously Treated with Sorafenib

September 22, 2017

Bristol-Myers Squibb Company has announced that the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection for intravenous use for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. Approval for this indication has been granted under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Top Pharma News of the Week last edit: 2017-09-28T18:16:12+00:00 da Luca

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