1. Sanofi and Regeneron announce FDA Approval of Kevzara® (sarilumab) for the treatment of moderately to severely active rheumatoid arthritis in adult patientsSanofi and Regeneron Pharmaceuticals, Inc. have announced the U.S. Food and Drug Administration (FDA) approval of Kevzara® (sarilumab) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX). Kevzara is a human monoclonal antibody that binds to the interleukin-6 receptor (IL-6R), and has been shown to inhibit IL-6R mediated signaling. IL-6 is a cytokine in the body that, in excess and over time, can contribute to the inflammation associated with RA.
2. Roche launches NAVIFY Tumor Board solution to provide decision support to oncology care teamsRoche (SIX: RO, ROG; OTCQX:RHHBY), has announced the launch of the NAVIFY Tumor Board solution, a clinical workflow and decision support software that optimises decision-making for cancer patient case reviews in tumor boards, or multi-disciplinary team meetings. The solution fundamentally changes the way these meetings are organised and conducted. It is initially available in the US, UK, Germany, Spain, Sweden, and Switzerland.
3. FDA approves new Pfizer biosimilarPfizer Inc. (NYSE:PFE) announced that the United States (U.S.) Food and Drug Administration (FDA) has approved IXIFI™ (PF-06438179, infliximab-qbtx), a chimeric human-murine monoclonal antibody (mAb) against tumor necrosis factor, as a biosimilar to Remicade® (infliximab) for all eligible indications of the reference product.
4. Boehringer Ingelheim builds Digital Lab "BI X" with focus on innovative digital solutions in healthcareWith the founding of BI X as independent subsidiary Boehringer Ingelheim will focus on breakthrough innovative digital solutions in healthcare from idea to pilot. The start-up will work closely together with all three business units of the company - Human Pharma, Animal Health and Biopharmaceuticals. It will provide a platform for collaborating with specialists in the field of data science, agile software development and user experience design.
5. FDA approves first cancer treatment for any solid tumor with a specific genetic featureThe U.S. Food and Drug Administration today granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker). This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated.
6. FDA approves first biosimilar for the treatment of cancerThe U.S. Food and Drug Administration today approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer. Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer.
7. First collaborative definition of patient centricityAstraZeneca announced that BMJ Innovations has published the first collaborative definition of patient centricity for the pharmaceutical industry. The definition was co-developed with patients and caregivers using research led by AstraZeneca and patient community advocates to ensure a deep understanding of patient needs and values. Ten associated patient-centric principles were also identified and published in BMJ Innovations to provide the pharmaceutical industry with a consistent reference point to sustain meaningful and mutually beneficial engagement with patients.
8. Amgen and CytomX Therapeutics announce strategic collaboration in immuno-oncologyAmgen (NASDAQ:AMGN) and CytomX Therapeutics, Inc., (NASDAQ:CTMX) today announced that the companies have entered into a strategic collaboration in immuno-oncology. The companies will co-develop a CytomX ProbodyTM T-cell engaging bispecific against the Epidermal Growth Factor Receptor (EGFR), a highly validated oncology target expressed on multiple human cancer types.
9. New analysis shows Novartis Entresto improves glycemic control in reduced ejection fraction heart failure patients with diabetesNovartis has announced results of a new post-hoc analysis in a subgroup of patients with reduced ejection fraction heart failure (HFrEF) and diabetes suggesting that Entresto® (sacubitril/valsartan) tablets improved glycemic control, as assessed by hemoglobin A1c (HbA1c) testing, compared to ACE-inhibitor enalapril. HFrEF is also known as systolic heart failure (HF).
10. Novartis confirms 5 year data for first and only fully-human IL-17A inhibitor Cosentyx® reinforcing sustained efficacy and safety profile in psoriasisNovartis, a global leader in Immunology & Dermatology, confirmed today positive 5 year efficacy and safety results for Cosentyx® from a Phase III long-term extension study in patients with moderate-to-severe plaque psoriasis. Data will be presented at a key medical congress in the second half of 2017. 5 year Phase III data are a recognized milestone for assessing long-term efficacy and safety of innovative treatments.
11. AstraZeneca marks a key milestone with the ‘topping out’ of new global R&D centre and HQ in Cambridge, UKAstraZeneca marks a key milestone in its successful move to Cambridge, UK, with the 'topping out' of its new, state-of-the-art, strategic R&D centre and global corporate headquarters at the heart of the Cambridge Biomedical Campus (CBC). The Company, including its biologics research and development arm, MedImmune, already has 2,000 employees actively engaged in the city’s vibrant scientific, academic, clinical and business community.
12. Sanofi and Boehringer Ingelheim confirm Closing of business swapSanofi and Boehringer Ingelheim confirmed that the strategic transaction signed in June 2016, which consists of an exchange of Sanofi's animal health business (Merial) and Boehringer Ingelheim's consumer healthcare (CHC) business, has been successfully closed in most markets on January 1st 2017. This closing marks the successful outcome of the business swap which started with exclusive negotiations in December 2015.
13. FDA approves drug to treat Parkinson's diseaseThe U.S. Food and Drug Administration has approved Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson's disease who are currently taking levodopa/carbidopa and experiencing "off" episodes. An "off" episode is a time when a patient’s medications are not working well, causing an increase in Parkinson's symptoms, such as tremor and difficulty walking.
14. FDA approves Roche's OCREVUS™ (ocrelizumab) for relapsing and primary progressive forms of multiple sclerosisRoche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) approved OCREVUS™ (ocrelizumab) as the first and only medicine for both relapsing and primary progressive forms of multiple sclerosis. The majority of people with MS have a relapsing form or primary progressive MS at diagnosis.
15. Amgen announces Repatha® (evolocumab) significantly reduced the risk of cardiovascular events in FOURIER outcomes studyAmgen (NASDAQ:AMGN) has announced that the FOURIER trial evaluating whether Repatha® (evolocumab) reduces the risk of cardiovascular events in patients with clinically evident atherosclerotic cardiovascular disease (ASCVD) met its primary composite endpoint (cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or coronary revascularization) and the key secondary composite endpoint (cardiovascular death, non-fatal MI or non-fatal stroke).
16. AstraZeneca and Merck establish strategic oncology collaborationAstraZeneca and Merck & Co., Inc., (Merck; known as MSD outside of the US and Canada) today announced that they have entered a global strategic oncology collaboration to co-develop and co-commercialise AstraZeneca's Lynparza (olaparib) for multiple cancer types. Lynparza is an innovative, first-in-class oral poly ADP ribose polymerase (PARP) inhibitor currently approved for BRCA-mutated ovarian cancer in multiple lines of treatment.
17. FDA takes action against 14 companies for selling illegal cancer treatmentsThe U.S. Food and Drug Administration today posted warning letters addressed to 14 U.S.-based companies illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer. The products are marketed and sold without FDA approval, most commonly on websites and social media platforms.
18. Merck Foundation establishedMerck, a leading science and technology company, today announced the establishment of the Merck Foundation. Through this foundation Merck combines many of its corporate responsibility activities under one roof and considerably expands its scope to address health, social and economic challenges of the 21st century.
19. Novartis drug Zykadia receives FDA Priority Review for first-line use in patients with ALK+ metastatic NSCLCNovartis today announced that the US Food and Drug Administration (FDA) accepted the Company's supplemental New Drug Application (sNDA) for filing, and granted Priority Review for the expanded use of Zykadia® (ceritinib) as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
20. FDA approval brings first gene therapy to the United StatesThe U.S. Food and Drug Administration issued a historic action today making the first gene therapy available in the United States, ushering in a new approach to the treatment of cancer and other serious and life-threatening diseases. The FDA approved Kymriah (tisagenlecleucel) for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL).