Top Pharma News of the Week

European Commission Extends License for Janssen’s ZYTIGA Plus Prednisone / Prednisolone to Include Earlier Stage Prostate Cancer Patients

November 20, 2017

Janssen-Cilag International NV (Janssen) has announced that the European Commission (EC) has granted approval to broaden the existing marketing authorization for ZYTIGA® (abiraterone acetate) plus prednisone / prednisolone to include an earlier stage of metastatic prostate cancer than its current indications. Abiraterone acetate plus prednisone / prednisolone can now be used for the treatment of newly-diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT).

Roche’s Hemlibra significantly reduced bleeds in phase III study in haemophilia A

November 20, 2017

Roche has announced positive results from the phase III HAVEN 3 study evaluating Hemlibra® (emicizumab) in adults and adolescents (aged 12 years or older) with haemophilia A without inhibitors to factor VIII. The study met its primary endpoint, showing a statistically significant and clinically meaningful reduction in the number of treated bleeds over time in people receiving Hemlibra prophylaxis every week compared to those receiving no prophylaxis. The study also met key secondary endpoints, including a statistically significant and clinically meaningful reduction in the number of treated bleeds over time with Hemlibra prophylaxis dosed every two weeks compared to no prophylaxis.

Juluca® (dolutegravir and rilpivirine) approved in US as first 2-drug regimen, once-daily, single pill – a complete regimen for the maintenance treatment of virologically suppressed HIV-1 infection

 

November 21, 2017

ViiV Healthcare, the global specialist HIV company, majority owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as shareholders, have announced that the US Food and Drug Administration (FDA) has approved Juluca®, indicated as a complete regimen for the maintenance treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral (ART) regimen for at least six months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Juluca.

Janssen Submits Application to U.S. FDA to Expand Indication for DARZALEX (daratumumab) Combination Therapy for Patients with Newly Diagnosed Multiple Myeloma who are Transplant Ineligible

November 21, 2017

Janssen Biotech, Inc. has announced that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for DARZALEX® (daratumumab). This application seeks to expand the current indication, using DARZALEX in combination with bortezomib (a proteasome inhibitor [PI]), melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation (ASCT). If approved, this would be the fifth indication for DARZALEX in the U.S. and its first in the frontline setting.

Novartis’ Ultibro® Breezhaler® significantly improved COPD patients’ lung function after direct switch from Seretide®

 

November 27, 2017

Novartis has announced positive results from the FLASH study examining the safety and efficacy of directly switching chronic obstructive pulmonary disease (COPD) patients from Seretide® (salmeterol/fluticasone) 50/500 mcg to Ultibro® Breezhaler® (indacaterol/glycopyrronium) 110/50 mcg. The study met the primary endpoint demonstrating that switching patients to Ultibro Breezhaler resulted in significantly improved lung function (trough FEV1).

AstraZeneca makes regulatory submission for Tagrisso in 1st-line EGFR-mutated non-small cell lung cancer in Japan

November 27, 2017

AstraZeneca has announced the submission of a supplemental new drug application (sNDA) to Japan’s Pharmaceuticals and Medical Devices Agency for the use of Tagrisso (osimertinib), a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with clinical activity against central nervous system (CNS) metastases, for the 1st-line treatment of patients with inoperable or recurrent EGFR mutation-positive (EGFRm) non-small cell lung cancer (NSCLC).

AstraZeneca and Chinese Future Industry Investment Fund establish joint venture to develop new medicines in China

November 27, 2017

AstraZeneca has announced a strategic joint venture with the Chinese Future Industry Investment Fund (FIIF) to form an equally-owned, stand-alone company in China to discover, develop and commercialise potential new medicines to help meet unmet needs globally, and to bring innovative new medicines to patients in China faster. FIIF is managed by the SDIC Fund Management Company (SDIC Fund), a private equity management company.

Top Pharma News of the Weeklast edit: 2017-11-27T17:36:03+00:00da Luca

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