October 31, 2017
AstraZeneca and its haematology research and development centre of excellence, Acerta Pharma, have announced that the US Food and Drug Administration (FDA) has granted accelerated approval to Calquence (acalabrutinib). Calquence is a kinase inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Calquence is approved under the FDA’s accelerated approval pathway, based on overall response rate, which allows for earlier approval of medicines that treat serious conditions and that fill an unmet medical need based on a surrogate endpoint. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
November 1, 2017
Merck KGaA today announced the signing of a Memorandum of Understanding (MoU) with Samsung BioLogics for a strategic alliance on biopharmaceutical manufacturing and biologics process development. The alliance would accelerate process development and clinical material production at small biotech start-ups focusing on novel drug development for which Samsung BioLogics acts as a contract manufacturer. Under the agreement, Merck would provide process development and support technical training, in addition to its Mobius® single-use systems to Samsung BioLogics.
November 1, 2017
AstraZeneca and its global biologics research and development arm, MedImmune, have announced the top-line results of the Phase III STRATOS 2 and TROPOS trials for tralokinumab, an anti-interleukin-13 (IL-13) human monoclonal antibody, in severe, uncontrolled asthma. In STRATOS 2, tralokinumab did not achieve a statistically-significant reduction in the annual asthma exacerbation rate (AAER), the primary endpoint, in patients with severe, uncontrolled asthma and elevated levels of a biomarker, Fractional exhaled Nitric Oxide (FeNO), compared to placebo.
November 2, 2017
GlaxoSmithKline plc has announced that it has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for GSK2857916 monotherapy in patients with multiple myeloma who have failed at least three prior lines of therapy, including an anti-CD38 antibody and are refractory to a proteasome inhibitor and an immunomodulatory agent. In October, the European Medicines Agency (EMA) granted PRIME designation to GSK2857916 for the treatment of relapsed and refractory multiple myeloma patients whose prior therapy included a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody. GSK2857916 is an anti B-cell maturation agent (BCMA) monoclonal antibody-drug conjugate. GSK2857916 has also received orphan drug designation from the EMA and FDA for multiple myeloma.
November 2, 2017
Novartis, Amgen and the Banner Alzheimer’s Institute (BAI) have announced an expanded collaboration to initiate a new trial – the Alzheimer’s Prevention Initiative (API) Generation Study 2. This trial follows the launch of the Generation Study 1, and will determine whether the BACE1 inhibitor CNP520 can prevent or delay the onset of Alzheimer’s disease symptoms in a high-risk population. BACE1 is an enzyme that plays an important role in the production of Amyloid ß, a protein which accumulates in the brains of individuals with AD years before clinical symptoms begin.
November 2, 2017
Boehringer Ingelheim and Dicerna Pharmaceuticals, a leading developer of investigational RNA interference (RNAi) therapeutics, have announced a research collaboration and license agreement to discover and develop novel GalXC™ RNAi therapeutics for the treatment of chronic liver diseases. The partnership will initially focus on nonalcoholic steatohepatitis (NASH), a devastating, chronic liver disease for which there is no approved treatment option.
November 4, 2017
Merck KGaA today announced results of the two-year primary analysis of FORWARD, a five-year, multicenter Phase II study of sprifermin in patients with knee OA. The study of 549 patients met its primary endpoint, demonstrating statistically- significant, dose-dependent increases in MRI total femorotibial joint cartilage thickness from baseline in the two sprifermin groups receiving the highest doses as compared with the placebo group after the two-year treatment period.
November 5, 2017
Eli Lilly and Company and Incyte Corporation have announced that patients with moderate-to-severe rheumatoid arthritis (RA) treated with baricitinib reported greater improvements in pain control when compared to Humira®* (adalimumab) or placebo.
November 6, 2017
Novartis has announced that the company has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for CTL019 (tisagenlecleucel) for two indications. The application is for the treatment of children and young adults with relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (ALL) and for adult patients with r/r diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant (ASCT). CTL019 is a novel immunocellular therapy and a one-time treatment that uses a patient’s own T cells to fight cancer.Top Pharma News of the Weeklast edit: 2017-11-06T19:34:51+00:00da