Top Pharma News of the Week

Sandoz proposed biosimilar rituximab accepted for review by the FDA

Novartis logo - luca dezzani

September 12, 2017

Sandoz, a Novartis Division, and the pioneer and global leader in biosimilars, has announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) under the 351 (k) pathway for a proposed biosimilar to the reference medicine, Rituxan® (rituximab). It is used to treat blood cancers including non-Hodgkin’s lymphoma (follicular lymphoma and diffuse large B-cell lymphoma) and chronic lymphocytic leukemia, as well as immunological diseases such as rheumatoid arthritis.

Merck KGaA Advances Immunology Pipeline with Evobrutinib (Bruton’s Tyrosine Kinase Inhibitor)

merck-logo

September 12, 2017

Merck KGaA, a leading science and technology company, has announced that it is continuing to advance its Immunology pipeline. Evobrutinib, a Bruton’s Tyrosine Kinase Inhibitor (BTKi) discovered by Merck, is now in Phase IIb studies across multiple immunological indications: rheumatoid arthritis (RA), multiple sclerosis (MS), and systemic lupus erythematosus (SLE).

Results of a six-month study combining Roche’s Esbriet with nintedanib in patients with IPF presented at ERS

Roche logo

September 13, 2017

Roche has announced results of a six-month study combining Esbriet (pirfenidone) and nintedanib treatment, showing a similar safety profile for the combination treatment to that expected for each treatment alone. The majority of the 89 patients included in the study tolerated the combination treatment. The study further suggested that over the six month period, lung function change from baseline was small, and quality of life scores did not deteriorate in patients who completed the 6 months of combination treatment. Data were presented at the European Respiratory Society (ERS) congress 9-13 September in Milan, Italy.

FDA Approves Amgen And Allergan’s MVASI™ (bevacizumab-awwb) For the Treatment of Five Types of Cancer

Amgen-Allergan

September 14, 2017

Amgen and Allergan plc. have announced that the U.S. Food and Drug Administration (FDA) has approved MVASI™ (bevacizumab-awwb) for all eligible indications of the reference product, Avastin® (bevacizumab). MVASI is the first anti-cancer biosimilar, as well as the first bevacizumab biosimilar, approved by the FDA. MVASI is approved for the treatment of five types of cancer, including in combination with chemotherapy for non-squamous non-small cell lung cancer (NSCLC), in combination with chemotherapy for metastatic colorectal cancer (mCRC), glioblastoma, metastatic renal cell carcinoma in combination with interferon alfa and in combination with chemotherapy for persistent, recurrent, or metastatic carcinoma of the cervix.

Pfizer And Astellas Announce Positive Top-Line Results from Phase 3 Prosper Trial of Xtandi (Enzalutamide) In Patients with Non-Metastatic Castration-Resistant Prostate Cancer

Pfizer logo

September 14, 2017

Pfizer Inc. and Astellas Pharma Inc. have announced that the Phase 3 PROSPER trial evaluating XTANDI® (enzalutamide) plus androgen deprivation therapy (ADT) versus ADT alone in patients with non-metastatic (M0) Castration-Resistant Prostate Cancer (CRPC) met its primary endpoint of improved metastasis-free survival (MFS). The preliminary safety analysis of the PROSPER trial appears consistent with the safety profile of XTANDI in previous clinical trials.

Bydureon EXSCEL trial demonstrates favourable cardiovascular (CV) safety profile and fewer CV events in patients with type-2 diabetes at wide range of CV risk

AstraZeneca Logo

September 14, 2017

AstraZeneca has announced full results from the EXSCEL (EXenatide Study of Cardiovascular Event Lowering) trial that showed cardiovascular safety with Bydureon (exenatide extended-release) in patients with type-2 diabetes (T2D) at a wide range of CV risk.

Sandoz proposed biosimilar adalimumab matches reference biologic in terms of efficacy and safety in long-term study

Novartis logo - luca dezzani

September 14, 2017

Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today announces new data on its proposed biosimilar adalimumab. Data from a long-term study of patients continuously treated with the proposed biosimilar or the reference medicine show that efficacy and safety profiles of the two medicines match throughout 51 weeks of treatment in patients with moderate-to-severe chronic plaque psoriasis. Results were presented at the 26th Congress of the European Academy of Dermatology and Venereology (EADV) in Geneva, Switzerland.

Bayer receives FDA approval for Copanlisib in adults with relapsed follicular lymphoma after two prior systemic therapies

Bayer Logo

September 14, 2017

Bayer has announced that the U.S. Food and Drug Administration (FDA) has approved copanlisib under the brand name Aliqopa™ 60 mg vial for injection for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies. Accelerated approval was granted for this indication based on overall response rate (ORR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

New FOURIER Analysis Shows Repatha® (Evolocumab) Reduces Cardiovascular Events in Patients with Diabetes

Amgen Logo

September 15, 2017

Amgen has announced that a new analysis of the cardiovascular outcomes study (FOURIER) demonstrated that lowering low-density lipoprotein cholesterol (LDL-C) levels with Repatha® (evolocumab) significantly and consistently reduced cardiovascular events in patients with and without diabetes at baseline.

Phase III data showed that Venclexta/Venclyxto plus MabThera/Rituxan helped people with previously treated chronic lymphocytic leukaemia live longer without their disease worsening compared to bendamustine plus MabThera/Rituxan

Roche logo  September 18, 2017

Roche has announced that the phase III MURANO study, which evaluated Venclexta®/Venclyxto® (venetoclax) in combination with MabThera®/Rituxan® (rituximab) in people with relapsed or refractory chronic lymphocytic leukaemia (CLL), met its primary endpoint and showed a statistically significant improvement in the time people lived without their disease progressing (progression-free survival [PFS] as assessed by investigator) when treated with Venclexta/Venclyxto plus MabThera/Rituxan compared to bendamustine plus Mabthera/Rituxan.

Top Pharma News of the Weeklast edit: 2017-09-19T18:27:11+00:00da Luca

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