Aduhelm’s loss is a win for value-based drug pricing
Value-based pricing could have shown us with more certainty the real level of effectiveness of Aduhelm. Maybe it is worth paying something for; and value-based […]
Value-based pricing could have shown us with more certainty the real level of effectiveness of Aduhelm. Maybe it is worth paying something for; and value-based […]
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 […]
Progressives are criticizing the Biden administration’s recent announcement that the 2022 Medicare premium will not be cut despite lower-than-expected costs for a new Alzheimer’s medicine. […]
Health and Human Services Secretary Xavier Becerra announced on Friday that Medicare premiums would be adjusted for 2023 following a report that found the cost […]
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 […]
Biogen has announced a major revamp of its business that will see chief executive Michel Vounatsos depart the company, and all commercial activities related to […]
Rep. Neal Dunn (R-Fla.) on Tuesday said the controversial federal approval of the Alzheimer’s medication Aduhelm “muddied the waters” for other potential treatments for the […]
Biogen has given up on seeking approval for its Alzheimer’s disease therapy Aduhelm in the EU, saying that discussions with EU regulators had made it […]
Biogen withdrew an application seeking approval in Europe for Alzheimer’s disease drug Aduhelm, a move that follows a negative opinion on the therapy issued by […]
Biogen’s Alzheimer’s disease drug Aduhelm will only be covered for Medicare beneficiaries participating in a clinical trial. The final coverage determination will have the effect […]
The US Centres for Medicare and Medicaid Services (CMS) has firmed up its draft decision to limit reimbursement of Biogen’s Alzheimer’s disease therapy Aduhelm to […]
After months of debate about the validity of its phase 3 clinical trials for Alzheimer’s therapy Aduhelm, Biogen has published the results in a peer-review […]
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 […]
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 […]
Eli Lilly has backed away from plans to file Alzheimer’s drug donanemab in the first quarter of this year, saying the proposal to limit reimbursement […]
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 […]
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 price of Biogen Alzheimer’s disease drug Aduhelm will be cut in half at the start of 2022, a move that comes as a Medicare […]
Biogen has cut the list price of its Alzheimer’s disease therapy in half from $56,000 to $28,200 a year, before the outcome of an ongoing […]
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 […]
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 […]
Biogen’s chief medical officer Al Sandrock has announced he will retire at the end of the year, ending a 23-year career at the biotech. The […]
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 […]
Analysts were predicting sales of Biogen’s recently approved Alzheimer’s therapy Aduhelm may start to gather a little momentum in the third quarter, but the drug […]
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 […]
Shares in Biogen have come under pressure after chief executive Michel Vounatsos admitted that the company is facing a much slower than anticipated rollout of […]
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 […]
The FDA’s approval of Biogen’s Aduhelm for Alzheimer’s disease emboldened Eli Lilly to move forward plans to file its own candidate donanemab later this year, […]
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 […]
Biogen has reported $2m in sales for newly-launched Alzheimer’s therapy Aduhelm that came in below its expectations, prompting the company to issue a rebuke to […]
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 […]
CMS plans to review and determine coverage for Biogen’s Aduhelm, the first new Alzheimer’s disease treatment in decades. But the jury is still out on […]
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 drug label for Biogen Alzheimer’s disease drug Aduhelm has been revised to clarify that its use is for patients with mild forms of the […]
The Institute for Clinical and Economic Review (ICER) was very damning of Biogen’s new Alzheimer’s disease therapy Aduhelm when it issued its first report on […]
The Institute for Clinical and Economic Review (ICER) was very damning of Biogen’s new Alzheimer’s disease therapy Aduhelm when it issued its first report on […]
With the first patient set to receive Biogen’s new Alzheimer’s drug Aduhelm in Rhode Island today, US consumer advocacy organisation Public Citizen is deeply unhappy […]
Date: July 12, 2021 Issue #: 1628 Summary: Aducanumab-avwa (Aduhelm – Biogen/Eisai), an IV amyloid beta-directed monoclonal antibody, has received accelerated approval from the FDA […]
The fallout over the FDA’s decision to approved Biogen’s Alzheimer’s therapy Aduhelm continues to be felt, with a third member of its advisory committee resigning […]
Two members of an FDA advisory committee have now resigned in protest over Monday’s approval of Biogen’s Alzheimer’s disease drug Aduhelm despite an overwhelming vote […]
The unexpected approval and lofty pricing of Biogen’s Alzheimer’s therapy Aduhelm is clearly the biopharma event of the year so far, but what are the […]
Biogen is still discussing with the FDA the clinical trial design to confirm the benefit offered by its newly approved Alzheimer’s disease drug, Aduhelm. According […]
The FDA “has failed in its responsibility to protect patients and families from unproven treatments with known harms” in approving Biogen’s Alzheimer’s disease drug Aduhelm. […]
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 […]
A Biogen Alzheimer’s drug that clears amyloid plaque from the brain has been granted accelerated approved by the FDA. The drug, which will be marketed […]
Biogen and Eisai have defied the naysayers and secured an historic FDA approval for their amyloid-targeting antibody aducanumab as the first-ever disease-modifying treatment for Alzheimer’s […]
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