Eisai steps up beyond-the-pill approach to dementia in Japan
More and more pharma companies are looking “beyond the pill” when it comes to providing care for patients, few more so than Eisai, which is […]
More and more pharma companies are looking “beyond the pill” when it comes to providing care for patients, few more so than Eisai, which is […]
The FDA has started an accelerated review of Eisai and Biogen’s a new amyloid-targeting antibody lecanemab for Alzheimer’s disease, with a 6 January deadline that […]
Eisai’s digital tool to allow self-assessment of cognitive performance – NouKNOW – will be used in a Japanese project aimed at improving the management of […]
Eisai’s first-ever attempt at developing an antibody-drug conjugate for cancer was rewarded with a $3.1 billion licensing deal from Bristol-Myers Squibb, and new data reported […]
Here we go again. With Aduhelm largely sidelined, Biogen and Eisai are hoping for a better fortunes with their next Alzheimer’s disease therapy lecanemab, which […]
Idorsia has become the first drugmaker in the EU to claim approval for a drug for chronic insomnia in the dual orexin receptor antagonist class, […]
A group of pharma companies and academic groups have joined forces with the Digital Medicine Society (DiMe) to develop standardised, digital clinical measures that can […]
Japanese pharma Eisai has backed away from its 50:50 profit-sharing arrangement with Biogen for troubled Alzheimer’s therapy Aduhelm, handing over full responsibility to its US […]
With prospects of an early, accelerated approval for Roche’s Alzheimer’s disease candidate gantenerumab looking diminished, the drugmaker has launched a new four-year trial in the […]
Japanese drugmaker Eisai has published comments filed with the US Centers for Medicare & Medicaid Services over its restrictive coverage proposal for beleaguered Alzheimer’s drug […]
Biogen and Eisai have increased the earning potential of their Alzheimer’s drug Aduhelm by expanding the post-marketing trial of the drug required by the FDA […]
Biogen’s difficult launch of controversial Alzheimer’s therapy Aduhelm has been made even harder by a proposal by Medicare to cover the drug only for certain […]
Swiss biotech Idorsia has claimed FDA approval for its first product – insomnia treatment Quviviq – setting up a market challenge to class rivals from […]
Roivant is the latest pharma group to take a position in the emerging field of therapies targeted at RNA splicing, licensing exclusive rights to a […]
Biogen and Eisai head towards the end of the year with some much-needed good news in their Alzheimer’s programmes, as the FDA awards a fast-track […]
The Japanese regulator looks like it could follow the European Commission and reject approval of Biogen and Eisai’s Alzheimer’s disease therapy Aduhelm, leaving the FDA […]
The EMA’s human medicines committee has said it cannot approve Biogen and Eisai’s Alzheimer’s disease therapy Aduhelm, saying it was unconvinced by the data submitted […]
Biogen and partner Eisai have said they will provide details next March for the confirmatory trial that will be needed to upgrade the drug’s accelerated […]
Six months after Biogen was awarded regulatory approval for its Alzheimer’s disease drug Aduhelm, the company the company is laying out a timeline for the […]
Japanese drugmaker Eisai has teamed up with Fujitsu spin-out FCNT, which makes smartphones aimed at older consumers, on digital tools to support people with dementia. […]
Biogen and Eisai have said that the EMA’s human medicines committee looks unlikely recommended approval of their Alzheimer’s drug Aduhelm when it comes up for […]
Eisai Presents Results of Lecanemab in P-IIb Study 201 Study for the Treatment of Alzheimer’s Disease at CTAD 2021 Published: Nov 12, 2021 | Tags: […]
Eli Lilly has followed through on its plan to file for approval of its Alzheimer’s disease candidate donanemab, and is planning to take on Biogen […]
A software platform developed by Altoida that uses augmented reality and artificial intelligence to diagnose neurological diseases in their earliest stages is being tested in […]
BMS Reports EMA’s Validation of MAA for Relatlimab and Nivolumab as 1L Treatment for Unresectable or Metastatic Melanoma Published: Oct 1, 2021 | Tags: BMS, […]
Eisai is seeking accelerated FDA approval of lecanemab, an Alzheimer’s disease drug that is part of a research alliance with Biogen. The drug is following […]
Shots: The submission is based on clinical, biomarker & safety data of Study 201 POC study evaluates lecanemab (10mg/kg, q2w) in 856 patients with MCI […]
Biogen and Eisai’s first Alzheimer’s disease drug Aduhelm is facing an uphill battle in the US market, but the partners are forging ahead with their […]
Junshi and Coherus’s Toripalimab Receive the US FDA’s Breakthrough Therapy Designation as 1L Treatment of Nasopharyngeal Carcinoma Published: Aug 13, 2021 | Tags: Junshi, Coherus, […]
FDA approval of a therapy that pairs drugs from Eisai and Merck allows the combination to become a first-line treatment for renal cell carcinoma. It’s […]
Health insurer Excellus BlueCross BlueShield has said it will not cover treatment with Biogen and Eisai’s new Alzheimer’s disease drug Aduhelm because it has not […]
Patients taking new Alzheimer’s disease drug Aduhelm will be evaluated in a real-world study lasting up to five years. Biogen announced plans for the observational […]
Biogen and partner Eisai have said they will run a large-scale observational study of Alzheimer’s drug Aduhelm in the US to build evidence for the […]
The US FDA has approved 6 NDAs and 2 BLAs in 2021, leading to treatments for patients and advances in the health care industry The […]
Three FDA figures at the centre of the fallout over the approval Biogen and Eisai’s Alzheimer’s disease therapy Aduhelm have defended their actions, arguing that […]
The US government has started a review of how Biogen and Eisai’s pricey new Alzheimer’s disease therapy Aduhelm will be covered by Medicare, to see […]
In another twist to the Aduhelm approval tale, FDA’s Janet Woodcock has called for an independent investigation into the relationship between agency staffers and Biogen […]
One of the criticisms levelled at the FDA over its approval of Biogen and Eisai’s Alzheimer’s disease drug Aduhelm was its decision to clear use […]
The second quarter of 2021 witnesses major acquisitions, approvals, and clinical data. There are major alliances in this quarter which include Merck signed ~$1.2B supply […]
Japan’s Eisai has hit the jackpot with its first ever antibody-drug conjugate (ADC) drug candidate, attracting a licensing deal from Bristol-Myers Squibb that could top […]
Vertex and CRISPR Therapeutics Present New Data of CTX001 from 22 Patients with TDT and SCD at EMA 2021 Published: June 11, 2021 | Tags: […]
Shots: The approval is based on the two P-III clinical trials i.e EMERGE and ENGAGE along with P-Ib PRIME study involves assessing the efficacy of […]
AstraZeneca Reports Results of Imfinzi (durvalumab) and Imfinzi + Tremelimumab in P-III POSEIDON Study as 1L Treatment for Stage IV Non-Small Cell Lung Cancer Published: […]
Shots: The 1st sNDA and sBLA is based on results from the P-III CLEAR Study evaluating Lenvima + Keytruda or in combination with everolimus vs […]
Shots: Voluntis enters into a license agreement with Eisai to design & develop DTx for patients and healthcare professionals to support cancer treatment, utilizing the […]
Shots: The P-IIb POC Study 201 involves assessing lecanemab in patients with early AD Results: @18mos, prespecified analysis showed a consistent reduction of clinical decline […]
Deutsches Zentrum fur Neurodegenerative Erkrankungen and Eisai Co., Ltd. today announced that both parties have entered into a research collaboration agreement aiming to create potential […]
New phase 3 data have shored up the position of Merck & Co’s cancer immunotherapy Keytruda in the increasingly competitive first-line kidney cancer market. The […]
When Eli Lilly reported results for donanemab in Alzheimer’s disease earlier this week it was hailed as a rare win for the amyloid hypothesis, although […]
Richter Acquires Janssen’s Evra Transdermal Contraceptive Patch Assets for $263.5M Published: Dec 3, 2020 | Tags: Asset Purchase Agreement, Evra, Gedeon Richter, Janssen Pharmaceutical, Signs, […]
Shots: The companies entered into an exclusive research agreement for the discovery of novel small molecules targeting α-synuclein for the potential treatment of synucleinopathies including […]
Shots: The approval of additional indication is based on a P-lll study involve the assessing the efficacy and safety of Humira targeting the patients with […]
Eli Lilly and Incyte Receive FDA’s EUA for Baricitinib + Remdesivir to Treat Hospitalized Patients with COVID-19 Published: Nov 20,2020 | Tags: baricitinib, COVID-19, Eli […]
Qiagen Launches Portable Digital SARS-CoV-2 Antigen Test in the US Published: Nov 13,2020 | Tags: Antigen Test, Digital, Launches, Portable, Qiagen, SARS-CoV-2, US GSK and […]
Merck & Co and Eisai are to file results from a phase 3 trial testing a combination of the former’s immunotherapy Keytruda, combined with the […]
Shots: The P-II 218 study involves assessing Lenvima (14mg, qd) + everolimus (5mg, qd) vs Lenvima (18mg, qd) + everolimus (5mg qd) in patients with […]
The nonbinding panel recommendation to reject the drug goes against what FDA scientists presented but they throw up another obstacle for the drug, which is […]
Shots: Eisai gets the global development rights and exclusive commercialization rights of all cognitive function tests developed by Cogstate, including the CBB for use in […]
Biogen and Eisai said the FDA had accepted and given priority review to their application for aducanumab. The drug will undergo an advisory committee meeting […]
A smartphone app developed by medical software specialist Allm is being trialled in Japan to see if it can help patients with milder coronavirus symptoms […]
The FDA has 60 days to decide whether or not to accept the application. An analyst wrote that the agency accepting it with a priority […]
Shots: The P-III SUNRISE 1 (Study 304) study involves assessing of DAYVIGO (lemborexant, 5 or 10 mg) vs an active comparator or PBO in 1,006 […]
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