| Today | ||||
Johnson & Johnson… Story temporarily locked. | ||||
Biogen announced new data… Biogen announced new data from its portfolio of multiple sclerosis therapies to be presented at the American Academy of Neurology 2021 Virtual Annual Meeting, April 17-22. The presentations include data on quality of life benefits and analyses of extended interval dosing with TYSABRI as well as new real-world experience data from VUMERITY. The research adds to the vast clinical knowledge Biogen continues to advance as part of its commitment to the care of people living with MS. Analyses Demonstrate Improved Quality of Life Outcomes with TYSABRI and Further Evaluate Extended Interval Dosing : To better understand clinically meaningful quality of life benefits following treatment with TYSABRI, MS PATHS researchers analyzed patient reported data on 12 different domains on the Neuro-QoL questionnaire such as sleep disturbance, anxiety, fatigue, depression and participation in daily activities. Results included: In people treated with TYSABRI or Ocrevus with baseline impairment, statistically significant improvements were seen in 10 of 12 and 8 of 12 Neuro-QoL domains, respectively. In 11 of 12 domains on the Neuro-QoL questionnaire, the adjusted annualized rate of improvement was greater with TYSABRI as compared to Ocrevus. The difference between the two therapies was statistically significant in favor of TYSABRI in three of the domains: satisfaction with social roles and activities, participation in social roles and activities (p=0.0001) and emotional and behavioral dyscontrol. Neuro-QoL is an independently validated set of patient-reported outcome measurements that assess the physical, mental and social effects of people living with neurological conditions such as MS. Biogen established the MS PATHS network to foster collaboration between leading MS centers in Europe and the U.S. to help transform patient care by generating standardized data from a diverse, real-world patient population. Additionally, results from two new analyses investigating EID with natalizumab may help further inform the drug's benefit-risk profile. Biogen continues to evaluate the efficacy, safety and tolerability of natalizumab EID through the prospective NOVA trial with initial results expected in 2021. From an analysis of data in MS PATHS, natalizumab patients receiving either EID or Standard Interval Dosing had comparable real-world effectiveness on quantitative magnetic resonance imaging outcomes. An updated analysis of data from the TOUCH Prescribing Program demonstrated in the primary analysis that EID is associated with a significant 88% reduction in the risk of progressive multifocal leukoencephalopathy in comparison to the approved every four-week dose. The data, which included more patients followed for a longer period and with slightly greater exposures, reinforces results from earlier analyses of EID. Data Confirm Positive Gastrointestinal Tolerability Profile With VUMERITY in Real-World Setting: New findings on the use of VUMERITY in a real-world setting reinforce the benefits of improved gastrointestinal tolerability and confirm that the experience in clinical trials is consistent with clinical practice. In a retrospective analysis of data from December 2019 to August 2020 of 160 patients with relapsing MS, the treatment discontinuation rate due to GI side effects was low with 88.6% estimated to still be on therapy at the end of analysis and a high rate of adherence. In a subgroup of patients who switched from TECFIDERA to VUMERITY, the majority of patients switched as a result of gastrointestinal tolerability with most remaining on therapy. | ||||
| Yesterday | ||||
CDC advisers are… CDC advisers are tentatively set to reconvene late next week to resume their talks of how to respond to a rare side effect of Johnson & Johnson's Covid vaccine, Bloomberg's Angelica LaVito reports, citing the chairman of the panel. The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices will likely meet Thursday or Friday of next week, chairman Jose Romero said in a telephone interview. The group is weighing recommendations for J&J's shot, which has been linked to rare blood clots in the brain. Reference Link | ||||
Biogen announced that… Biogen announced that China's National Medical Products Administration has approved TECFIDERA for the treatment of relapsing multiple sclerosis. First introduced in 2013, TECFIDERA has demonstrated a well-established safety and efficacy profile with more than 10 years of data from clinical trials and real-world experience. It has been used to treat more than 500,000 individuals with MS worldwide. The approval brings a new treatment option to people in China living with relapsing MS and also continues to expand the company's presence in the country. "It is truly a milestone to bring this well-established treatment to China and be able to help people living with relapsing multiple sclerosis," said Rachid Izzar, President, Intercontinental Region at Biogen. "We thank the NMPA for undertaking priority review to approve TECFIDERA. We are committed to expanding our presence in China and working with the MS community to address unmet medical needs through innovative therapies and solutions." | ||||
Adverum Biotechnologies… Adverum Biotechnologies announced that it has filed definitive proxy materials with the U.S. Securities and Exchange Commission in connection with Adverum's 2021 Annual Meeting of Stockholders, to be held virtually on May 12 at 8:30 a.m. Pacific Time. The Adverum board of directors unanimously recommends that stockholders vote the white proxy card for Adverum's three directors standing for election - Dawn Svoronos, Reed Tuckson, M.D. and Tom Woiwode, Ph.D. In conjunction with the definitive proxy filing, Adverum is mailing a letter to stockholders detailing the significant clinical advancements the board and management team are executing to accelerate toward commercialization and create value for stockholders. In the letter, the board of directors included information on accelerating ADVM-022 toward commercialization, stating, "Your Board and management team are taking decisive action to accelerate our ADVM-022 development and commercialization plans to launch our first mass-market gene therapy to treat millions of patients with wet AMD and DME if ADVM-022 receives FDA approval. We are focused on execution, with the goal of delivering this transformative gene therapy to patients globally as early as possible." | ||||
Evelo Biosciences (EVLO)… Evelo Biosciences (EVLO) announced the appointments of Luca Scavo as Chief Financial Officer, effective June 1, and Julie McHugh to its board of directors, effective immediately. Scavo brings more than 25 years of international experience and most recently served as Senior Vice President and CFO of Roche Diagnostics (RHHBY) North America. McHugh brings more than 35 years of experience in the life sciences industry, including leading the development and commercialization of products at organizations such as Johnson & Johnson (JNJ) and Nora Therapeutics. | |
The company states:… The company states: "Merck (MRK) announced the discontinuation of development of MK-7110 for the treatment of hospitalized patients with COVID-19. Merck acquired MK-7110 in December 2020 through its acquisition of OncoImmune, a privately-held clinical-stage biopharmaceutical company. As previously reported, Merck subsequently received feedback from the US Food and Drug Administration that additional data, beyond the study conducted by OncoImmune, would be needed to support a potential Emergency Use Authorization application. Based on the additional research that would be required - new clinical trials as well as research related to manufacturing at scale - MK-7110 would not be expected to become available until the first half of 2022. Given this timeline and these technical, clinical and regulatory uncertainties, the availability of a number of medicines for patients hospitalized with COVID-19, and the need to concentrate Merck's resources on accelerating the development and manufacture of the most viable therapeutics and vaccines, Merck has determined to discontinue development of MK-7110 for COVID-19 and to focus its pandemic efforts on advancing molnupiravir and on producing Johnson & Johnson's (JNJ) COVID-19 vaccine." | |
Dr. Atul Gawande, a… Dr. Atul Gawande, a surgeon and professor at Harvard's T.H. Chan School of Public Health, told CNBC he believes the pause on Johnson & Johnson's (JNJ) COVID-19 vaccine should continue for younger populations, but should be lifted for older age groups, Emily DeCiccio reports. "I think there is enough information to know that for people over 50 this is safe... I think that that is where this may land, like you saw for AstraZeneca (AZN) in Europe," Gawande told CNBC. Reference Link | |
The recommendation that… The recommendation that Johnson & Johnson's COVID-19 vaccine should not be used in the U.S. will likely last another week because members of the Advisory Committee for Immunization practices said there is not yet enough information to change their advice, Kiran Stacey and Nikou Asgari of The Financial Times reports, citing health officials. Reference Link |
| Wednesday | ||||
The House coronavirus… The House coronavirus subcommittee will hear Thursday from three top White House health officials about the U.S.' efforts to increase vaccinations as COVID-19 cases, including those from new variants, are rising, CNBC's Kevin Breuninger reports. The hearing is set to start at 10:30 am ET and will be livestreamed, Breuninger notes. The move comes two days after dozens of states halted the administration of Johnson & Johnson's (JNJ) single dose vaccine in response to the FDA's recommendation that those shots be paused while it looks into cases of women who took the vaccine and developed a rare blood-clotting disorder, the author says. The Fly notes that the U.S. has so far approved COVID-19 vaccines from Pfizer (PFE) and BioNTech (BNTX), and Moderna (MRNA). Reference Link | ||||