June 26, 2017
Seattle Genetics says that its flagship therapy, Adcetris, combined with a trio of standard drugs beat a 4-drug mainstay cocktail therapy in frontline Hodgkin disease for modified progression-free survival over a lengthy two-year stretch. The Adcetris package excluded bleomycin, which has been linked to a higher rate of lung toxicity and was used in the 4-drug combo control.
- Sandoz receives approval in Europe for Erelzi® (biosimilar etanercept) to treat multiple inflammatory diseases
June 27, 2017
Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, announced has that the European Commission (EC) has approved Erelzi® (biosimilar etanercept) for use in Europe. Erelzi is approved for rheumatoid arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis), plaque psoriasis, and psoriatic arthritis, as well as juvenile idiopathic arthritis and pediatric plaque psoriasis.
June 27, 2017
Merck managed to shock the industry with news that their CETP heart drug Anacetrapib came through a 30,000-patient study with convincing data of its effectiveness. In a brief statement on the topline results, the pharma giant noted that its drug significantly reduced the risk of a coronary event – a composite of coronary death, myocardial infarction, and coronary revascularization – among high-risk patients who had already been through LDL-lowering therapy effectively.
June 29, 2017
Amgen has announced that the U.S. FDA has approved the supplemental Biologics License Application (sBLA) for Vectibix® (panitumumab) for patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic colorectal cancer (mCRC) as first-line therapy in combination with FOLFOX and as monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy. Vectibix is the first-and-only fully human monoclonal anti-epidermal growth factor receptor (EGFR) antibody approved by the FDA for this patient population.
- Novartis receives EU approval for first-line use of Zykadia® in ALK-positive advanced non-small cell lung cancer (NSCLC)
June 29, 2017
Novartis today announced the European Commission approved expanding the use of Zykadia® (ceritinib) to include the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive. Approval follows a positive opinion granted in May by the Committee for Medicinal Products for Human Use (CHMP), and is applicable to all 28 European Union member states plus Iceland, Lichtenstein, and Norway.
30 June 2017
Roche and mySugr announced that the two partners have signed an agreement under which Roche acquired all shares of mySugr GmbH. Counting more than one million users globally, mySugr is one of the leading mobile diabetes platforms in the market and will become an integral part of Roche’s new patient-centered digital health services platform in diabetes care. The acquisition allows Roche to expand its leading position in the area of diabetes management.
- Besponsa® approved in the EU for adult patients with relapsed or refractory b-cell precursor acute lymphoblastic leukemia
June 30, 2017
Pfizer Inc. has announced that the European Commission has approved BESPONSA® (inotuzumab ozogamicin) as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL). This indication includes treatment of adults with Philadelphia chromosome positive (Ph+) as well as Philadelphia chromosome negative (Ph-) relapsed or refractory B-cell precursor ALL. With this approval, BESPONSA becomes the first and only antibody drug conjugate (ADC) available for patients with this type of leukemia in the European Union (EU).