Eisai

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 developing a package of products and services in Japan for people living with dementia. Its latest venture is an alliance with Tokyo-based Lifenet Insurance Co, which aims to develop a …

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Eisai/Biogen could get FDA verdict on new Alzheimer’s drug by 6 Jan

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 keep them ahead of closest rival Eli Lilly. The US regulator has been reviewing lecanemab as a treatment for patients with early-stage Alzheimer’s and amyloid plaques in the brain under …

Eisai/Biogen could get FDA verdict on new Alzheimer’s drug by 6 Jan Read More »

Eisai’s brain health tool NouKNOW used in Tokyo dementia project

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 dementia. The smartphone app – which uses a cognition-checking algorithm developed by Australian digital health company Cogstate – will be deployed in Bunkyo City, Tokyo in a dementia monitoring programme. …

Eisai’s brain health tool NouKNOW used in Tokyo dementia project Read More »

ASCO22: New data backs BMS’ investment in Eisai’s first cancer ADC

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 at ASCO has given a glimpse into its potential. Farletuzumab ecteribulin – also known as MORAb-202 – is being developed to treat tumours that overexpress folate receptor alpha (FRα), and …

ASCO22: New data backs BMS’ investment in Eisai’s first cancer ADC Read More »

Exit Aduhelm, enter lecanemab. Biogen and Eisai have another go

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 is now fully filed with the FDA. The two partners have also requested a priority review for the Biologics License Application (BLA) for lecanemab, which if granted by the FDA …

Exit Aduhelm, enter lecanemab. Biogen and Eisai have another go Read More »

Idorsia is first to EU market with orexin insomnia drug

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, ahead of rival drugs from Merck & Co and Eisai. The new drug – Quviviq (daridorexant) – has been approved by the European Commission for adults who have been suffering …

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Pharma group seeks digital measure standards for Alzheimer’s

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 be used in the development of therapies for Alzheimer’s disease and related dementias. According to the consortium – which includes drugmakers Biogen, Eisai, Eli Lilly and Merck & Co – …

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Eisai hands off responsibility for Aduhelm to Biogen

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 counterpart. The changes to the terms of their longstanding collaboration on Aduhelm (aducanumab) means that Eisai’s profit-share converts to a simple royalty rate on revenues from 1 January next year. …

Eisai hands off responsibility for Aduhelm to Biogen Read More »

Roche starts new four-year trial of Alzheimer’s drug gantenerumab

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 hope of building its case for the drug. The new placebo-controlled SKYLINE study will enrol 1,250 people aged 60 to 80 with the earliest biological signs of Alzheimer’s – in …

Roche starts new four-year trial of Alzheimer’s drug gantenerumab Read More »

Eisai bites back against restricted coverage plan for Aduhelm

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 Aduhelm, saying it undermines well-established FDA processes. The letter to CMS’ director of coverage ad analysis Tamara Syrek Jensen said the decision to impose a coverage with evidence development (CED) …

Eisai bites back against restricted coverage plan for Aduhelm Read More »

Biogen tweaks confirmatory trial of Alzheimer’s drug Aduhelm

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 – which could be the primary source of income for the drug. If the provisional reimbursement decision by the Centre for Medicare and Medicaid Services (CMS) is finalised, Aduhelm (aducanumab) …

Biogen tweaks confirmatory trial of Alzheimer’s drug Aduhelm Read More »

Medicare limits Aduhelm coverage to clinical trial participants

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 patients enrolled in clinical trials. Biogen and partner Eisai had been hoping for good news from the review of Aduhelm (aducanumab) by the Centre for Medicare and Medicaid Services (CMS), …

Medicare limits Aduhelm coverage to clinical trial participants Read More »

Dream result for Idorsia as FDA clears its insomnia drug

Swiss biotech Idorsia has claimed FDA approval for its first product – insomnia treatment Quviviq – setting up a market challenge to class rivals from Merck & Co and Eisai. The US regulator has cleared two doses of dual orexin receptor antagonist (DORA) Quviviq (daridorexant) – 25 mg and 50 mg – for the treatment …

Dream result for Idorsia as FDA clears its insomnia drug Read More »

Roivant joins RNA splicing push with Eisai deal

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 drug developed by a unit of Japanese drugmaker Eisai.  The compound, called H3B-8800, is currently in phase 1 testing in the US and Europe in patients with myelodysplastic syndrome (MDS) …

Roivant joins RNA splicing push with Eisai deal Read More »

Biogen, Eisai Alzheimer’s drug lecanemab fast tracked by FDA

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 designation to lecanemab, their follow-up to recently approved Aduhelm. The anti-amyloid drug, which also claimed a breakthrough tag from the FDA in July, is being developed for the treatment of …

Biogen, Eisai Alzheimer’s drug lecanemab fast tracked by FDA Read More »

Japan looks set to follow EU in rejecting Alzheimer’s drug Aduhelm

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 an outlier in its stance on the drug. An advisory committee to the Ministry of Health, Labour and Welfare (MHLW) has declined to approve Aduhelm (aducanumab), saying the data from …

Japan looks set to follow EU in rejecting Alzheimer’s drug Aduhelm Read More »

Biogen’s Alzheimer’s drug Aduhelm is rejected by EU advisors

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 for the drug. The companies had already indicated that the CHMP looked likely to turn down their marketing application for Aduhelm (aducanumab), but the decision nevertheless is a heavy blow, …

Biogen’s Alzheimer’s drug Aduhelm is rejected by EU advisors Read More »

Biogen updates on its confirmatory Aduhelm trial

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 approval for controversial Alzheimer’s drug Aduhelm to a full one. Aduhelm (aducanumab) was approved by the FDA in June, but has been held back by a glacial rollout as clinicians …

Biogen updates on its confirmatory Aduhelm trial Read More »

Biogen projects confirmatory study for Alzheimer’s drug will take four years

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 post-marketing study to confirm whether the drug works. The projected four-year study will enroll more than 1,300 patients and will include a placebo control arm.

Eisai forges alliance with FCNT on digital tools for dementia

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. Eisai has licensed rights to a cognition-checking algorithm developed by Australian digital health company Cogstate, which it uses in an app – called NouKNOW – that allows people to check …

Eisai forges alliance with FCNT on digital tools for dementia Read More »

CHMP minded to turn down Alzheimer’s drug Aduhelm, says Biogen

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 discussion next month. The CHMP had a “negative trend vote” on the drug at a meeting last week which included an “oral explanation” of Aduhelm (aducanumab), which was approved in …

CHMP minded to turn down Alzheimer’s drug Aduhelm, says Biogen Read More »

PharmaShots Weekly Snapshots (November 08 – 12, 2021)

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: Eisai, Lecanemab, P-IIb, Study 201 Study, Alzheimer’s Disease, CTAD 2021 Novo Nordisk’s Wegovy (semaglutide) Receives CHMP’s Recommendation for Approval to Treat Obesity Published: Nov 12, 2021 | Tags: Novo Nordisk, …

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Lilly files Alzheimer’s drug donanemab as Cortexyme rival fails trial

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 and Eisai with a head-to-head trial against their recently-approved Aduhelm drug. Lilly has also picked up an accelerated review for donanemab from the FDA, which is assessing the drug under …

Lilly files Alzheimer’s drug donanemab as Cortexyme rival fails trial Read More »

Eisai-backed trial will assess Altoida’s digital test for early Alzheimer’s

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 a five-year trial involving thousands of patients. The trial – which will be supported by pharma company Eisai and Ionian University in the US – will see if the test …

Eisai-backed trial will assess Altoida’s digital test for early Alzheimer’s Read More »

PharmaShots Weekly Snapshots (September 27 – October 01, 2021)

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, EMA, MAA, Relatlimab, Nivolumab, Metastatic Melanoma Merck and Ridgeback Report Interim Results of Molnupiravir in P-III MOVe-OUT Trial for the Treatment of COVID-19 Published: Oct 1, 2021 | Tags: Merck, …

PharmaShots Weekly Snapshots (September 27 – October 01, 2021) Read More »

Eisai Initiates Rolling Submission of BLA to the US FDA for Lecanemab to Treat Alzheimer’s Disease

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 due to AD with confirmed presence of amyloid pathology. The BLA is being submitted under accelerated approval The results showed a reduction in brain amyloid by 0.306 SUVr units @18mos. …

Eisai Initiates Rolling Submission of BLA to the US FDA for Lecanemab to Treat Alzheimer’s Disease Read More »

Biogen, Eisai double down on Alzheimer’s with lecanemab filing

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 second candidate lecanemab, starting a rolling submission to the FDA. Like Aduhelm (aducanumab) lecanemab – also known as BAN2401 – is another amyloid-directed antibody but has a slightly different mechanism, …

Biogen, Eisai double down on Alzheimer’s with lecanemab filing Read More »

PharmaShots Weekly Snapshots (Aug 09 – 13, 2021)

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, Toripalimab, US, FDA, Breakthrough Therapy Designation, Nasopharyngeal Carcinoma Celltrion’s Regdanvimab (CT-P59) Receives the ANVISA’s EUA for the Treatment of COVID-19 in Brazil Published: Aug 13, 2021 | Tags: Celltrion, Regdanvimab, …

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Health insurer Excellus will not fund Alzheimer’s drug Aduhelm

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 been shown to be medically effective. The company – said to be the largest health insurer in New York – said in a statement that Aduhelm (aducanumab) remains an investigational …

Health insurer Excellus will not fund Alzheimer’s drug Aduhelm Read More »

Biogen and Eisai unveil details for five-year, real-world Aduhelm clinical trial

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 study, which is one of three post-marketing clinical programs planned to generate more data about the drug

Biogen adds real-world test for Aduhelm to its confirmatory trial

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 drug’s efficacy following its controversial approval. The ICARE AD-US study will provide information on the long-term effectiveness and safety of Aduhelm (aducanumab) as prescribed in routine clinical practice within the …

Biogen adds real-world test for Aduhelm to its confirmatory trial Read More »

Insights+: The US FDA New Drug Approvals in June 2021

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 Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 37 novel products in 2021 Additionally, last year in 2020, the US FDA …

Insights+: The US FDA New Drug Approvals in June 2021 Read More »

FDA staffers defend Aduhelm approval in JAMA editorial

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 to do otherwise would have left millions of patients in limbo for years. The trio say that the decision to approve Aduhelm (aducanumab) was extremely challenging as “evidence was strongly …

FDA staffers defend Aduhelm approval in JAMA editorial Read More »

US starts review of Aduhelm coverage amid fears of Medicare hit

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 if a national strategy needs to be adopted. At the moment, the coverage for $56,000-a-year Aduhelm (aducanumab) is currently determined at the local level by Medicare administrative contractors representing 12 …

US starts review of Aduhelm coverage amid fears of Medicare hit Read More »

Aduhelm approval controversy dials up as FDA seeks probe

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 executives. The acting FDA commissioner has sent a letter to the Department of Health and Human Services (HHS) inspector general Christi Grimm on Friday, asking for a review of the …

Aduhelm approval controversy dials up as FDA seeks probe Read More »

FDA whittles back Aduhelm approval amid concern over broad label

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 of the drug in a broader group of patients than was included in clinical trials. Now, it has backtracked on that decision. The updated label for Aduhelm (aducanumab) says it …

FDA whittles back Aduhelm approval amid concern over broad label Read More »

PharmaShots’ Key Highlights of Second Quarter 2021

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 agreement with US Government for Molnupiravir to treat COVID-19 The big acquisition took place during the quarter including Microsoft acquired Nuance for ~$19.7B, MorphoSys acquired Constellation for ~$1.7B Our team …

PharmaShots’ Key Highlights of Second Quarter 2021 Read More »

BMS pays $650m upfront for Eisai’s first ADC candidate for cancer

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 out at more than $3.1 billion.  BMS is making a hefty $650 million upfront payment to Eisai for global co-development and co-commercialisation rights to MORAb-202, which couples an anti-folate receptor …

BMS pays $650m upfront for Eisai’s first ADC candidate for cancer Read More »

PharmaShots Weekly Snapshots (June 07 – 11, 2021)

Vertex and CRISPR Therapeutics Present New Data of CTX001 from 22 Patients with TDT and SCD at EMA 2021 Published: June 11, 2021 | Tags: Vertex, CRISPR Therapeutics, CTX001, TDT, SCD, EMA 2021 AbbVie Reports Results of Four-Year Follow-Up Analysis in P-III CLL14 Trial for Venclyxto/Venclexta to Treat Chronic Lymphocytic Leukemia Published: June 11, 2021 …

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Biogen and Eisai’s Aduhelm (aducanumab-avwa) Receive the US FDA’s Accelerated Approval for Alzheimer Disease

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 Aduhelm vs PBO in patients with early stages of AD with confirmed presence of amyloid pathology Results: the therapy consistently showed a dose and time-dependent effect on the reduction of …

Biogen and Eisai’s Aduhelm (aducanumab-avwa) Receive the US FDA’s Accelerated Approval for Alzheimer Disease Read More »

PharmaShots Weekly Snapshots (May 03 – 07, 2021)

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: May 7, 2021 | Tags: AstraZeneca, Imfinzi, durvalumab, Tremelimumab, P-III, POSEIDON Study, Stage IV Non-Small Cell Lung Cancer Merck and Fusion Pharmaceuticals Enter into a Clinical Collaboration for FPI-1434 + …

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Merck and Eisai Receive the US FDA‘s Priority Review for Keytruda (pembrolizumab) + Lenvima (lenvatinib) Applications to Treat Advanced Renal Cell Carcinoma and Endometrial Carcinoma

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 sunitinib in a ratio (1:1:1) in 1,069 patients with advanced RCC, demonstrated improved PFS, OS, and ORR The 2nd application is based on results from the P-III KEYNOTE-775/Study 309 trial …

Merck and Eisai Receive the US FDA‘s Priority Review for Keytruda (pembrolizumab) + Lenvima (lenvatinib) Applications to Treat Advanced Renal Cell Carcinoma and Endometrial Carcinoma Read More »

Voluntis Collaborates with Eisai to Develop Digital Therapeutics for Oncology Patients

Shots: Voluntis enters into a license agreement with Eisai to design & develop DTx for patients and healthcare professionals to support cancer treatment, utilizing the Theraxium technology platform The DTx will be designed with the intent to be commercialized in the US, Japan and EU, which will boost Voluntis’ pipeline and global footprint Additionally, the …

Voluntis Collaborates with Eisai to Develop Digital Therapeutics for Oncology Patients Read More »

Biogen and Eisai Report Results of Lecanemab (BAN2401) in P-IIb Study 201 for Patients with Early Alzheimer Disease

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 across several clinical and biomarker EPs at highest doses and reduction in brain Aβ & clinical decline. The results are published in a peer-reviewed journal In March, the companies have …

Biogen and Eisai Report Results of Lecanemab (BAN2401) in P-IIb Study 201 for Patients with Early Alzheimer Disease Read More »

DZNE and Eisai Enter Into Research Collaboration Agreement Aiming for Novel Drug Discovery for Neurodegenerative Disorders

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 novel treatments for neurodegenerative disorders including Alzheimer’s disease (AD) which modulate immune competence in neurons and glia cells. DZNE is a world-leading interdisciplinary public research organization constituted with ten research …

DZNE and Eisai Enter Into Research Collaboration Agreement Aiming for Novel Drug Discovery for Neurodegenerative Disorders Read More »

Merck gets a leg-up for Keytruda in first-line kidney cancer

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 data from the KEYNOTE-581/CLEAR study reveal that the combination of PD-1 inhibitor Keytruda (pembrolizumab) with Eisai’s targeted tyrosine kinase inhibitor Lenvima (lenvatinib) reduced the risk of disease progression of death …

Merck gets a leg-up for Keytruda in first-line kidney cancer Read More »

Could Lilly’s donanemab readout in Alzheimer’s boost Biogen’s prospects?

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 there’s no shortage of candidates that have failed despite positive mid-stage trial results. Some analysts have intimated that given the small size of the study at just over 270 patients, …

Could Lilly’s donanemab readout in Alzheimer’s boost Biogen’s prospects? Read More »

PharmaShots Weekly Snapshot (Nov 30 – Dec 04, 2020)

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, Transdermal Contraceptive Patch Assets, Treat Jazz Pharma and PharmaMar’s Zepzelca Fail to Meet its Primary Endpoint in P-III ATLANTIS Study for SCLC Published: Dec 3, 2020 | Tags: ATLANTIS, Doxorubicin, …

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Eisai Sign a Research Agreement with Wren Therapeutics to Discover Potential Treatment for Synucleinopathies

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 PD and dementia with Lewy bodies The collaboration will use Wren’s network kinetics drug discovery platform along with Eisai’s experience in drug discovery for neurodegenerative disorders, to accelerate the development …

Eisai Sign a Research Agreement with Wren Therapeutics to Discover Potential Treatment for Synucleinopathies Read More »

AbbVie and Eisai’s Humira (adalimumab) Receives MHLW’s Approval for Pyoderma Gangrenosum

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 active ulcers in Japan who were diagnosed with PG but were not sufficiently effective with local treatment, or who were judged to be unsuitable for local treatment Result: The proportion …

AbbVie and Eisai’s Humira (adalimumab) Receives MHLW’s Approval for Pyoderma Gangrenosum Read More »

PharmaShots Weekly Snapshot (Nov 16-20, 2020)

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 Lilly, Emergency Use Authorization, FDA’s, Incyte, receives, Remdesivir Novartis Signs a License Agreement with Mesoblast to Develop and Commercialize Remestemcel-L for ARDS Published: Nov 20,2020 | Tags: Agreement, ARDS, Commercialize, …

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PharmaShots Weekly Snapshots (Nov 09-13, 2020)

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 Medicago Initiate P-II/III Study of its Plant-Derived COVID-19 Vaccine Published: Nov 13,2020 | Tags: COVID-19, GSK, Initiate, Medicago, P-II/III, Plant- Derived study, vaccine BD Acquires the Medical Business Assets of …

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Merck & Co/Eisai eye kidney cancer use for immunotherapy combination

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 latter’s cancer drug Lenvima in untreated patients. Keytruda (pembrolizumab) and Lenvima (lenvatinib) outperformed standard care – Pfizer’s Sutent (sunitinib) – in untreated patients with advanced renal cell carcinoma when measured …

Merck & Co/Eisai eye kidney cancer use for immunotherapy combination Read More »

Eisai Reports Results of Lenvima (lenvatinib) + Everolimus in P-II 218 Study for Advanced Renal Cell Carcinoma

Shots: The P-II 218 study involves assessing Lenvima (14mg, qd) + everolimus (5mg, qd) vs Lenvima (18mg, qd) + everolimus (5mg qd) in patients with clear-cell RCC, following treatment with an anti-angiogenic therapy, with prior anti-PD-1/PD-L1 therapy permitted In the primary analysis, @24wks. ORR (32.1% vs 34.8%) i.e. lower dose did not meet the threshold …

Eisai Reports Results of Lenvima (lenvatinib) + Everolimus in P-II 218 Study for Advanced Renal Cell Carcinoma Read More »

Eisai and Cogstate Expand their Agreement to Develop and Commercialize Digital Cognitive Assessment Technologies

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 healthcare and other markets. The agreement allows the two companies to replicate the advancements that have already been launched in Japan, where Eisai has developed and launched a new digital …

Eisai and Cogstate Expand their Agreement to Develop and Commercialize Digital Cognitive Assessment Technologies Read More »

Biogen to get speedy FDA review for Alzheimer’s drug despite not using voucher to request it

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 at an undisclosed date. Biogen’s stock rose 10%, but analysts had mixed opinions.

Japan trials app to help coronavirus patients recover at home

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 recuperate at home, without tying up healthcare resources. The app – called MySOS – provides “non-contact body monitoring”, harnessing artificial intelligence to measure vital signs such as oxygen levels in …

Japan trials app to help coronavirus patients recover at home Read More »

Biogen, Eisai complete submission of controversial Alzheimer’s drug. The ball is in FDA’s court now.

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 or standard review may signal whether the agency is seriously considering approval or has continued reservations about the amyloid beta-targeting drug’s clinical benefit.

Eisai Reports Results of DAYVIGO (lemborexant) in P-III SUNRISE 1 Study in Patients with Insomnia Disorder

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 patients with insomnia disorder aged 55 years of age or older Results of P-III study@ 5/10 mg of DAYVIGO: headache (6.4%, 4.9 % vs 6.2%, 5.3%), somnolence (4.1%, 7.1% vs …

Eisai Reports Results of DAYVIGO (lemborexant) in P-III SUNRISE 1 Study in Patients with Insomnia Disorder Read More »