Evotec and Exscientia Initiate Human Clinical Trials of their Novel Immuno-Oncology Drug Published: Apr 9, 2021 | Tags: Evotec and Exscientia, Initiate, Human Clinical Trials, Novel, Immuno-Oncology Drug PlantForm Signs Research and Development Agreement with Bio-Manguinhos/Fiocruz to Develop Biosimilar Pembrolizumab Published: Apr 9, 2021 |… Read More »PharmaShots Weekly Snapshots (Apr 05 – 09, 2021)
Biogen Signs a License and Commercialization Agreement with Bio-Thera for BAT1806 (biosimilar, tocilizumab) to Treat Moderate to Severe Rheumatoid Arthritis
Shots: Bio-Thera to receive $30M up front following the achievement of P-III satisfactory results and is eligible for commercial milestones along with royalties. The transaction is expected to close in Q2’21 Biogen to get exclusive regulatory, manufacturing, and commercial rights of BAT1806 in all countries… Read More »Biogen Signs a License and Commercialization Agreement with Bio-Thera for BAT1806 (biosimilar, tocilizumab) to Treat Moderate to Severe Rheumatoid Arthritis
Biogen’s Tysabri (natalizumab, SC) Receives EC’s Marketing Authorization to Treat Relapsing-Remitting Multiple Sclerosis
Shots: The EC’s approval is based on data from DELIVER and REFINE studies evaluating the efficacy, PK, and PD of Tysabri (300mg, SC, q4w) vs Tysabri (300mg, IV, q4w) in patients with RRMS The results demonstrated that the Tysabri (SC) in both studies showed clinical… Read More »Biogen’s Tysabri (natalizumab, SC) Receives EC’s Marketing Authorization to Treat Relapsing-Remitting Multiple Sclerosis
The FDA got too close to Biogen during the development of the Alzheimer’s drug aducanumab, according to its own expert advisers who are urging the regulator to reject it in the coming weeks. With the deadline for a regulatory decision approaching for aducanumab in June,… Read More »FDA grew too close to Biogen during Alzheimer’s drug development, doctors say
ViewPoints Interview: Biogen’s Wildon R. Farwell Shares Insight on Phase 4 RESPOND Study of Spinraza
In an interview with PharmaShots, Wildon R. Farwell, M.D., MPH, Global Medical Head of Neuromuscular Diseases at Biogen shared his views on the P-IV RESPOND study that assesses the benefits of Spinraza in patients treated with Zolgensma. Shots: RESPOND is a two-year, open-label study to… Read More »ViewPoints Interview: Biogen’s Wildon R. Farwell Shares Insight on Phase 4 RESPOND Study of Spinraza
While the pandemic has been the focus of R&D attention for much of 2020, that is slowly beginning to shift towards other projects in the big pharma pipeline. pharmaphorum’s news editor, Richard Staines, discusses the success stories and failures in R&D that have emerged during… Read More »Pharma’s pipeline continues to provide drama as investors look beyond COVID in Q4
This year J.P. Morgan 39th Annual Healthcare Conference was conducted virtually and we witnessed multiple announcements from numerous Biopharma companies An analysis of events and catalysts that were announced at the conference during these days are included in the report. Most of the deals occurred… Read More »Insights+: Key Deals of JP Morgan Healthcare Conference 2021
Life sciences companies are gearing up to enter new markets as they look to secure their positions after a spate of M&A, licensing, and research partnerships in 2020 Artios partnered with Merck with an option to license up to 8 oncology programs proving to be… Read More »Top 20 Life Sciences Deals of 2020 by Total Deal Value
In its report released last Tuesday, a nonprofit drug pricing research group claims that seven drugs have prices that do not align with any newly discovered increase in clinical benefit, leading to over $1.2 billion in excess drug spending in 2019, alone.
Novartis’ Ligelizumab (QGE031) Receives the US FDA’s Breakthrough Designation for Patients with Chronic Spontaneous Urticaria Published: Jan 15, 2020 | Tags: Novartis’, Ligelizumab (QGE031), Receives ,US FDA’s, Breakthrough Designation for Patients , Chronic Spontaneous Urticaria Philips Collaborates with Merck KGaA to Advance Personalized Fertility Treatment… Read More »PharmaShots Weekly Snapshots (Jan 11 – 15, 2021)
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… Read More »Could Lilly’s donanemab readout in Alzheimer’s boost Biogen’s prospects?
US cost effectiveness watchdog ICER found 10 examples of substantial price rises for top-selling medicines in 2019, and concluded that seven of those were not backed by any clinical evidence. The cost to the American taxpayer from those increases? Around $1.2 billion for the seven… Read More »Amgen’s Enbrel heads ICER list of unjustified US price rises
US biotech Atalanta Therapeutics has come out of stealth mode backed with $110m from Biogen and Roche, who have also signed separate partnerships to develop new therapies for neurological diseases using RNA interference (RNAi) technology. While there are RNAi products on the marketplace, with Alnylam… Read More »RNAi biotech Atalanta debuts with $110m plus Biogen and Roche CNS tie-ups
Shots: Biogen and Apple collaborated to evaluate the role of Apple Watch and iPhone in monitoring cognitive performance and screening for the decline in cognitive health including mild cognitive impairment (MCI) The study will initiate in late 2021 and will enroll participants including young and… Read More »Biogen and Apple Collaborate to Launch Virtual Study on Cognitive Decline
Biogen plans to launch a virtual study with Apple this year to identify early signs of mild cognitive impairment. The study is expected to launch in the second half of 2021.
Almirall and Tyris Collaborate to Develop Next Generation Gene Therapies Published: Jan 7, 2020 | Tags: Almirall, Tyris, Collaborate, Develop, Next Generation, Gene Therapies Sarepta Reports Mixed Results of SRP-9001 (rAAVrh74.MHCK7.micro-dystrophin) in Part 1 of Study 102 for DMD Published: Jan 7, 2020 | Tags:… Read More »PharmaShots Weekly Snapshot (Jan 4-8, 2020)
Shots: ViGeneron to receive an up front and R&D funding for the mutually agreed workplan and will receive development, regulatory and commercial milestone payments along with royalties on sales of products arising from the collaborations ViGeneron will optimize and validate in vitro therapeutic candidates for… Read More »Biogen Signs a License Agreement with ViGeneron for Ophthalmic Gene Therapy Development
Roche’s Phesgo (Perjeta + Herceptin) Receives EC’s Approval for the Treatment of HER2-Positive Breast Cancer Published: Dec 23, 2020 | Tags: (Perjeta + Herceptin), EC’s Approval, HER2-positive Breast Cancer, Phesgo, receives, Roche, Treatment AMO Pharma Initiates P-II REACH-CDM study of AMO-02 (tideglusib) to treat Congenital… Read More »PharmaShots Weekly Snapshots (Dec 21-23, 2020)
Shots: The approval is based on data assessing bioequivalence and AEs associated with IM administration vs SC administration of Plegridy in healthy volunteers Result: The data showed that participants receiving therapy through IM experienced fewer injection site reactions (14.4 vs 32.1 %), safety profiles were… Read More »Biogen’s Plegridy (peginterferon beta-1a, IM) Receives EC’s Approval for Relapsing-Remitting MS
Roche Launches Elecsys SARS-CoV-2 Antigen Test to Support High-Volume COVID-19 Testing Published: Dec 11, 2020 | Tags: Antigen, COVID-19, High, Laboratory, Launch, patients, Roche, SARS-CoV-2, Support, Suspected, Test, Testing, Volume Chugai In-Licenses Roche’s Antibody Cocktail for COVID-19 in Japan Published: Dec 10, 2020 | Tags:… Read More »PharmaShots Weekly Snapshots (Dec 7-11, 2020)
Shots: The submission is based on P-lll EMERGE and ENGAGE study assessing aducanumab vs PBO in patients with AD. The studies evaluate the efficacy of monthly doses of aducanumab in reducing cognitive and functional impairment The secondary objectives of the study were to assess the… Read More »Biogen Reports NDA Submission of Aducanumab (BIIB037) to the MHLW for Alzheimer’s Disease
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the… Read More »Insights+ Key Biosimilars Events of November 2020
The contracts are complicated and full of risks for drug companies. But there’s also a risk to steering clear of the arrangements — reduced or restricted access to a company’s medication.
Japanese drugmaker Eisai has teamed up with UK biotech Wren Therapeutics on an R&D programme seeking drugs for neurodegenerative disorders. The two companies will focus their efforts on alpha-synuclein, a pathway that has been implicated in disorders such as dementia with Lewy bodies (DLB) and… Read More »Eisai forges CNS alliance with UK’s Wren Therapeutics
With the prospects for its Alzheimer’s drug aducanumab still up in the air, Biogen has moved to shore up its late-stage pipeline with a $3 billion licensing deal with Sage that adds drugs for depression and neurological disorders. The licensing agreement gives Biogen rights to… Read More »Biogen bulks up pipeline with Sage drugs in $3bn deal
Novartis/Genentech’s eye drug Lucentis could be the next big blockbuster to face competition from cheaper biosimilars after its US patent expired this year – and Samsung Bioepis and Biogen are closing in after the FDA accepted a filing for their cut-price rival. Lucentis (ranibizumab) was… Read More »FDA begins review of Samsung Bioepis/Biogen’s Lucentis biosimilar
Samsung Bioepis and Biogen Announces FDA Filing Acceptance of Lucentis’ Biosimilar, SB11 for Retinal Vascular Disorders
Shots: EMA accepted the review of MAA for SB11 in Oct 2020. If approved, SB11 will add to the biosimilars portfolio developed by Samsung Bioepis and commercialized by Biogen, including three widely prescribed anti-TNF biosimilars in EU: BENEPALI, IMRALDI, and FLIXABI In Nov 2019, Samsung… Read More »Samsung Bioepis and Biogen Announces FDA Filing Acceptance of Lucentis’ Biosimilar, SB11 for Retinal Vascular Disorders
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-… Read More »PharmaShots Weekly Snapshots (Nov 09-13, 2020)
Janette Curlis is a Multiple Sclerosis Nurse Advisor (MSNA) at Biogen, helping to support the company’s Multiple Sclerosis (MS) field teams and developing patient and Healthcare Professional (HCP) materials. We spoke to her about being a bridge between pharma and the NHS and the challenges… Read More »Bridging the gap between pharma and the NHS in MS
The FDA may have been minded to approve Biogen and Eisai’s Alzheimer’s candidate aducanumab, but its clinical advisors have little doubt that the evidence for the drug is lacking. The much-anticipated advisory committee meeting held on Friday to discuss the marketing application for aducanumab proved… Read More »FDA panel unimpressed with data for Alzheimer’s drug aducanumab
Shots: The advisory committee voted 1-8, with 2 members voting uncertain that EMERGE study (without regard for ENGAGE study) provides strong evidence, supporting the effectiveness of aducanumab as a treatment for AD. The committee also voted 0-7 with 4 members voting uncertain that PRIME study… Read More »The US FDA’s Advisory Panel Slams Biogen’s Aducanumab for Alzheimer’s Disease
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 trying to succeed on a front where others have failed.
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the… Read More »Insights+ Key Biosimilars Events of October 2020
As an influential panel of FDA-appointed experts prepares its verdict on Biogen’s Alzheimer’s drug, a little known China-based pharma is hoping to succeed where big name rivals have failed and develop a drug that is effective against the disease. For almost two decades there has… Read More »China’s Green Valley prepares US trial of Alzheimer’s drug inspired by algae
Regulatory reviews of Biogen’s Alzheimer’s drug aducanumab are now ongoing on both sides of the Atlantic, but debate is still ongoing about whether the data behind the drug is strong enough to support approval. The EMA has just kicked off its review of the anti-amyloid… Read More »Trials and tribulations in Biogen’s Alzheimer’s drug reviews
Immunology is an important branch of science which deals with the study of the immune system. The immune system is a highly regulated and balanced system and when the balance is disturbed, the disease can result. A lot of this work has importance in the… Read More »Top 20 Immunology Companies Based 2019 Immunology Segment Revenue
Scribe Therapeutics, a start-up focusing on gene-editing using CRISPR/Cas9, has burst onto the biotech scene with a $415 million deal with Biogen. Jennifer Doudna Scribe – which counts new Nobel Prize for chemistry winner Jennifer Doudna among its founders – is getting $15 million upfront… Read More »Biogen teams up with gene-editing startup Scribe on ALS programme
Shots: EMA has accepted to review the Marketing Authorisation Application for SB11, a proposed biosimilar referencing Lucentis (ranibizumab). If approved, SB11 will join a growing number of biosimilars developed by Samsung Bioepis and commercialized by Biogen In Nov 2019, Samsung Bioepis announced that it entered… Read More »Samsung Bioepis and Biogen Announce EMA Filling Acceptance of SB11 (biosimilar, Lucentis)
Study uses genomic data to trace Covid-19 ‘superspreader’ event linked to February Biogen exec meeting
The study, by researchers at Harvard, MIT, The Broad and other institutions, used genomic analysis of cases linked to the Biogen meeting, linking much of the community transmission in the Boston area to a European genetic variant of SARS-CoV-2 that first appeared at the meeting.
Roche is hoping to undercut hugely expensive rivals after the FDA approved its oral spinal muscular atrophy (SMA) drug Evrysdi (risdiplam). Evrysdi is the third treatment approved for SMA, an ultra-rare muscle wasting disease that can begin in early childhood, after Biogen’s Spinraza (nusinersen) and… Read More »Roche takes on pricey rivals as FDA approves SMA drug
Biogen’s Alzheimer’s drug aducanumab could be on the market in the next few months after the FDA accepted a clinical trial dossier and granted a fast Priority Review. The FDA reserves these quick reviews for drugs that have the potential to improve care standards for… Read More »Biogen’s shares surge again as FDA hurries Alzheimer’s drug review
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.
Biogen has bought a licence to co-develop and co-market potential Parkinson’s disease drugs with US biotech Denali, in a deal worth more than $2.1 billion. Denali has been working on small-molecule compounds capable of crossing the blood-brain barrier and Biogen has bought a licence to… Read More »Biogen signs $2.1 billion Parkinson’s disease deal with Denali
Shots: Denali to receive $560M up front, $465M as equity investment at a price of $34.94/ share, representing 11.2% of Denali’s Pro-forma outstanding stock along with $1.125B as milestones. The two companies will codevelop Denali’s LRRK2 inhibitor for PD and co-commercialize it in the US… Read More »Biogen Signs an Agreement with Denali on LRRK2 Program for Parkinson’s Disease Worth ~$2.125B
Biogen is planning to trial its Spinraza spinal muscular atrophy (SMA) drug in patients who have not responded properly to Novartis’ gene therapy Zolgensma, combining the two ultra-expensive therapies to treat the rare muscle-wasting disease. In the US, a single shot of Zolgensma (onasemnogene abeparvovec)… Read More »Biogen plans trial of Spinraza in patients not responding to SMA gene therapy
The company plans to enroll 60 patients who have received its drug, Spinraza, following suboptimal response to Novartis’ Zolgensma, which was approved last year. The trial, RESPOND, is anticipated to start enrolling in the first quarter of 2021, pending regulatory approval.
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… Read More »Biogen, Eisai complete submission of controversial Alzheimer’s drug. The ball is in FDA’s court now.