Category: Biogen
Digital health company Happify has signed a partnership with another biopharma company, joining forces with Biogen on a toolkit to help people with multiple sclerosis manage their illness. The digital toolkit is designed to keep patients informed of new treatments, help them adhere to their prescribed therapies, encourage behaviours aimed at improving their wellbeing and […]
Biogen has ducked out of a four-year-old collaboration with Karyopharm on a drug candidate for the neurodegenerative disease amyotrophic lateral sclerosis that could have been worth up to $217 million to the US biotech. The 2018 deal giving Biogen rights to the oral selective inhibitor of nuclear export (SINE) compound KPT-350 included a $10 million […]
Biogen has added a preclinical-stage drug candidate for Parkinson’s disease via a $722.5 million licensing agreement with Alectos Therapeutic, as it continues to rebuild a pipeline behind its side-lined Alzheimer’s therapy Aduhelm. The deal includes a $15 million upfront payment that gives Biogen global rights to selective GBA2 inhibitor AL01811, which it says has the […]
Shares in Praxis Precision Medicines were in freefall today after the company’s efforts to develop a new therapy for major depressive disorder (MDD) ended in failure, forcing a restructuring and staff cuts. The selloff followed the announcement of the phase 2/3 Aria study results with PRAX-114 as a monotherapy for MDD, which showed the GABA […]
Roche and PTC Therapeutics’ Evrysdi for spinal muscular atrophy (SMA) has been approved by the FDA for younger children with the rare disease, extending its use to include infants less than two months of age. The new label means that Evrysdi (risdiplam) can now be used across all ages – from newborns to adults – […]
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 […]
Biogen has licensed rights to a digital therapeutic (DTx) developed by MedRhythms which combines sensors, software, and music to help people with multiple sclerosis tackle mobility problems. The biopharma company – which is one of the top players in MS drug therapies – is paying $3 million upfront to claim rights to the DTx, known […]
Biogen struck a deal that could bring a digital therapeutic to its multiple sclerosis product portfolio. The drugmaker is partnering with startup MedRhythms in the development of a therapy that combines sensors, software, and music to improve walking problems in multiple sclerosis patients.
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 troubled Alzheimer’s therapy Aduhelm cease. Michel Vounatsos The headline news in the company’s first-quarter results statement (PDF) was Vounatsos’ departure, although he will remain at the helm of Biogen until […]
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 disease. Dunn on Tuesday appeared at “Accelerated Approvals & the Pathway to Treatments,” a virtual event hosted by The Hill aimed at discussing the future of treatment for Alzheimer’s disease. […]
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 clear the current data for the drug is not sufficient to get it past the EMA’s Committee for Medicinal Products for Human Use (CHMP). The decision does not come as […]
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 a European Medicines Commission committee last December. The company was unable to persuade European regulators to change their minds about the drug.
Patients with relapsing-remitting multiple sclerosis (RRMS) in England, Wales and Northern Ireland can now access treatment with Biogen’s oral therapy Vumerity, after NICE recommended the drug for routine NHS use. The decision means that Vumerity (diroximel fumarate) – a follow-up to Biogen’s older oral therapy Tecfidera (dimethyl fumarate) – is now available to eligible patients […]
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 of limiting use of the drug, but the agency said its decision provides clarity on what drug companies need to show in order to secure Medicare coverage.
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 a few thousand patients enrolled in clinical trials. The final verdict from the CMS dashes any remaining hopes that Biogen may have held that it would be able to build […]
Less than six months after the late-stage failure of tofersen, Biogen and Ionis have suffered further disappointment in the amyotrophic lateral sclerosis (ALS) pipeline after BIIB078 (IONIS-C9Rx) failed to demonstrate clinical benefit in a Phase 1 trial. In the randomised, placebo-controlled, dose-escalating trial, researchers evaluated the efficacy of the investigational antisense oligonucleotide BIIB078 as a […]
Voyager Therapeutics has lost little time in elevating Al Sandrock to the chief executive position, with the appointment coming just a few weeks after he joined the biotech’s board. Sandrock announced he was ending a 23-year career at Biogen last November, in the wake of the company’s controversial approval and disastrous rollout of Alzheimer’s therapy […]
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 journal, allowing physicians to look at the data and make their own judgment on its efficacy and safety. The choice of journal looks like it could however add to the […]
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 – […]
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. […]
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 […]
Last year, the first phase 3 trial of Sage Therapeutics and Biogen’s antidepressant hopeful zuranolone hit its efficacy targets, but raised doubts about the durability of the response. Now, a second phase 3 trial has followed the same pattern, doing nothing to quell debate about its commercial prospects. The latest study – called CORAL and […]
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) […]
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 of Biogen’s first-to-market Aduhelm has made going down the accelerated approval route all-but pointless. The company has planned to filed for speedy approval of donanemab based on the results of […]
Al Sandrock’s shock departure from Biogen in November sparked speculation about where he would show up next, and the answer came in today – gene therapy specialist Voyager Therapeutics. He has been appointed to Voyager Therapeutics’ board as well as a new executive committee alongside interim CEO Michael Higgins and interim chief scientific officer Glenn […]
Recent rumours that Biogen was about to acquired by Samsung proved unfounded, but it turns out a deal has been in preparation. The South Korean firm just agreed to buy Biogen out of their biosimilar joint venture – Samsung Bioepis – for $2.3 billion. The two companies have been partnered on Samsung Bioepis for the […]
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’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), […]
The Center for Medicare and Medicaid Services proposes covering Biogen Alzheimer’s disease drug Aduhelm only for people enrolled in a clinical trial. In explaining this proposal, the agency cited the unclear benefit to patients as well as the documented safety risks associated with the drug, which can be best monitored within the context of a […]
Spinal muscular atrophy (SMA) therapy Spinraza has been a key earner for Biogen in recent years, but with sales now heading into reverse, the company is looking to extend its franchise. Its latest move is a $60 million upfront licensing deal with longstanding partner Ionis to exercise an option on BIIB115 (ION306), a longer-acting antisense […]
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 […]
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 […]
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 recommendation on coverage is expected early next year. Meanwhile, Biogen is preparing corporate measures projected to save $500 million annually, cost-cutting made necessary in part due to slow market uptake […]
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 reimbursement review of the drug by the US government. The price reduction for Aduhelm (aducanumab) comes into play from 1 January and comes on the back of the “feedback of […]
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 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 […]
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.
Biogen has made a $15 million investment in digital health company TheraPanacea, which will go towards a project to find digital health tools aimed at neurological diseases. There’s another $41 million in possible future payments if the partnership progresses as planned, said Biogen, which is getting exclusive rights to TheraPancea’s machine learning and artificial intelligence […]
Jazz’ Sunosi (solriamfetol) Receives NICE Recommendation for the Treatment of Excessive Daytime Sleepiness Caused by Narcolepsy Published: Nov 19, 2021 | Tags: Jazz, Sunosi, solriamfetol, NICE, Recommendation, Excessive Daytime Sleepiness, Narcolepsy Antengene’s Selinexor (ATG-010) Receives NMPA’s IND Approval for P-I/II SWATCH Study to Treat Non-Hodgkin Lymphoma Published: Nov 19, 2021 | Tags: Antengene, Selinexor, ATG-010, […]
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 […]
With drug pricing controls back on the legislative table in the US, the influential Institute for Clinical and Economic Review (ICER) has published its third report on “unsupported” price increases – with AbbVie’s Humira top of the list. ICER estimates that price hikes for Humira (adalimumab) increased US healthcare spending by $1.4 billion in 2020, […]
Shots: The approval is based on the data from PK bridging studies and P-III EVOLVE-MS-2 study to evaluate the GI tolerability of Vumerity vs Tecfidera in patients with relapsing-remitting MS In the EVOLVE-MS-2 study, the therapy demonstrated a low rate of overall treatment discontinuation due to GI tolerability (1.6% vs 6%). Additionally, flushing was reported […]
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 architect of many of Biogen’s biggest-selling drugs, Sandrock is bowing out as Biogen is still struggling with the rollout of its controversial new Alzheimer’s disease therapy Aduhelm (aducanumab). He will […]
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 […]
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 seems to be going into reverse. As it turned out, Aduhelm (aducanumab) made just $300,000 in the three-month period from July to September, against analysts’ estimates of $12 million, suggesting […]
The renaissance of Biogen and Sage Therapeutics antidepressant zuranolone continues, with the companies indicating they now plan to start a rolling submission for the drug early next year. Two years ago things were looking bleak for zuranolone after the oral GABAA receptor modulator failed the phase 3 MOUNTAIN trial in major depressive disorder (MDD), raising […]
Biogen amyotrophic lateral sclerosis drug, tofersen, failed a Phase 3 clinical trial, but the drug showed improvement according to secondary and exploratory goals of the study. Based on those results, the company said it is talking with regulators to find a path forward for the drug.
Already struggling to make headway with its recently launched Alzheimer’s drug, Biogen suffered a major late-stage pipeline setback after its tofersen drug for amyotrophic lateral sclerosis (ALS) missed the mark in a late-stage study. Tofersen missed its primary objective in the VALOR study, with patients on the drug failing to seen a statistically significant improvement […]
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 During the month of September, Sandoz entered into a commercialization and license […]
Shots: The LANDSCAPE and NEST clinical development program evaluates the efficacy and safety of zuranolone in patients with MDD and PPD. The presentations also include data from the P-III WATERFALL & open-label SHORELINE study for MDD The studies showed a reduction in depressive symptoms including improvements in depressive moods & rapid onset of significant effect […]
The third quarter of 2021 highlights the approvals, clinical data & acquisitions. The new alliance observed in third quarter includes AzurRx signed a reverse triangular merger agreement to acquired First Wave Bio for ~$229M The key highlights of the big acquisition in this quarter includes Merck acquired Acceleron for ~$11.5B, Baxter acquired Hillrom for ~$10.5B, […]
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 the same path blazed earlier this year with FDA approval of Biogen Alzheimer’s drug Aduhelm.
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, […]
Everest’s SPR206 Receives the NMPA’s IND Approval for the Treatment of MDR Gram-Negative Bacterial Infections Published: Sept 24, 2021 | Tags: Everest, SPR206, NMPA, IND, Approval, MDR Gram-Negative Bacterial Infections GE Healthcare to Acquire BK Medical for ~ $1.45B Published: Sept 24, 2021 | Tags: GE Healthcare, Acquire, BK Medical, ~ $1.45B Roche Presents Results […]
Roche has highlighted new data with its oral treatment for spinal muscular atrophy (SMA) – Evrysdi – showing its benefits when given to pre-symptomatic babies with the rare disease. The updated results come from the open-label RAINBOWFISH study, which investigate the effects of Evrysdi (risdiplam) in children from birth to six weeks who had yet […]
Shots: The approval is based on a totality of evidence including analytical, non-clinical/clinical data from the P-III study evaluates the efficacy, safety, PK & immunogenicity of SB11 (0.5mg) vs Lucentis in a ratio (1:1) in 705 patients with wet AMD The results showed LS mean change in BCVA from baseline @52wks. (9.79 vs 10.41 letters) […]
The FDA has approved the first biosimilar that references the blockbuster Roche drug Lucentis. The Biogen and Samsung BioLogics joint venture that developed the biologic product have approval to treat three eye conditions that lead to vision loss.
Samsung Bioepis and Biogen have claimed the first FDA approval for a biosimilar version of Roche and Novartis’ Lucentis (ranibizumab) for leading causes of blindness, raising the prospect of a cheaper treatment option for US patients. The US green light for Byooviz (formerly SB11) covers the treatment of wet age-related macular degeneration (AMD) and two […]
In an interview with PharmaShots, Ron Elwell, President, and Founder of Swoop and IPM.ai shared his views on the Real Chemistry Clinical Trial Recruitment System that is designed to accelerate clinical investigations and lead to faster patient outcomes with less risk. Shots: Real Chemistry’s IPM.ai accelerates clinical investigation & commercialization of precision medicines leveraging AI […]
Shots: The P-II CONVEY withdrawal study evaluates efficacy & safety of vixotrigine (200/350 mg, bid) vs PBO in 265 patients with SFN for 12wks. The study met its 1EPs i.e., 200mg dose showed a reduction in mean ADP & worst daily pain score @12wks. while 350mg dose did not meet its 1EPs of mean change […]
Shots: The P-IIIb ASCEND study will evaluate the clinical outcomes & safety of the higher doses of nusinersen in 135 patients aged 5-39yrs. with SMA prior treated with Evrysdi at MRD (5mg). Patients will receive 2 loading doses of nusinersen (50mg, 2wks. apart), followed by a maintenance dose of 28mg, q4mos. in study period & […]
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 its controversial Alzheimer’s disease therapy Aduhelm. Speaking at a Morgan Stanley conference yesterday, Vounatsos said Biogen may have to revisit its sales forecasts for Aduhelm (aducanumab), which were already “very […]
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 […]
Immunology deals with physiological functioning of the immune system in states of both health and disease as well as malfunctions of the immune system in immunological disorders With the new advancement in immune sector, global pharmaceuticals continue to grow in the field despite the disruption during the COVID-19. As in 2019, Abbvie again secured the […]
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, although it has acknowledged it will have to overcome reservations about anti-amyloid drugs. Lilly’s chief scientific officer Dan Skovronsky said on the company’s second-quarter results call that the results of […]
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 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 […]
The necessity of a robust Angelman syndrome pipeline is indispensable at the current moment because of a shortage of any approved therapy option available in the market. The Angelman Syndrome current treatment landscape consists of symptomatic therapy options worth USD 330.2 million in 2017. Treatment entirely focuses on the management of symptoms and supporting 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 what it says is “extensive misinformation and misunderstanding” about the drug. In an open letter, R&D chief Al Sandrock tackled a number of the criticisms levelled at the FDA’s decision […]
Eli Lilly Signs an Agreement with Banner Alzheimer’s Institute to Evaluate Donanemab in P-III TRAILBLAZER-ALZ 3 Trial for Alzheimer’s Disease Published: July 16, 2021 | Tags: Eli Lilly, Banner Alzheimer’s Institute, Donanemab, P-III, TRAILBLAZER-ALZ 3 Trial, Alzheimer Disease AcelRx Signs a License Agreement with Aguettant to Commercialize Dzuveo in EU and for Two Pre-Filled Syringe […]
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 […]
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 […]
By paying $125 million up front for rights to multiple sclerosis drug candidate orelabrutinib, Biogen secures a place among those companies trying to treat the disease by targeting a particular enzyme highly expressed in the central nervous system. But Biogen still has some catching up to do.
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 the drug’s effectiveness. Not to mention, its hefty price tag — $56,000 — could drive up Medicare spending.
Biogen has moved to shore up its besieged multiple sclerosis franchise by licensing a BTK inhibitor from Chinese biotech InnoCare currently in mid-stage clinical testing. InnoCare gets $125 million upfront in return for sharing rights to orelabrutinib, an orally-active BTK drug that is able to cross the blood-brain barrier and penetrate the central nervous system. […]
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 […]
Shots: InnoCare to receive $125M as up front & is eligible to receive ~ $812.5M as development & commercial milestones, following the achievement of definite milestones along with royalties on sales of any product resulting from the collaboration Biogen to get exclusive rights for orelabrutinib to treat MS globally & other autoimmune diseases outside of […]
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 […]
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 […]
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 neurodegenerative disorder. The change aligns the prescribing information with the patient population studied in clinical trials.
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 drug last month, and a swift update to its deliberations won’t be much comfort to the company. The cost-effectiveness watchdog has revised its calculation of a fair price range […]
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 drug last month, and a swift update to its deliberations won’t be much comfort to the company. The cost-effectiveness watchdog has revised its calculation of a fair price range […]
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 During the month of Jun, Celltrion launched Remsima SC (biosimilar, infliximab) for […]
Lineage Signs an Exclusive Option Agreement with Amasa Therapeutics to Supply and Use of Clinical-Grade Hystem Published: June 18, 2021 | Tags: Lineage, Option Agreement, Amasa Therapeutics, Clinical-Grade Hystem BioNTech Reports First Patient Dosing in P-II Clinical Trial of BNT111 to Treat Advanced Melanoma Published: June 18, 2021 | Tags: BioNTech, P-II, Clinical Trial, BNT111, […]
Shots: The first patient has been dosed in the P-III TOPAZ-1 study evaluating efficacy & safety of BIIB059 vs PBO in 540 adults with active SLE for 52 wks. The trial is expected to conduct at ~135 sites globally The 1EPs of study are to demonstrate a reduction in disease activity, proportion of patients achieve […]
Shots: The P-II TANGO study evaluating the safety & efficacy of gosuranemab vs PBO in 654 patients aged 50–80 yrs with MCI due to AD or with mild AD for 78 wks across 97 sites, followed by a dose-blind long term extension period The trial did not meet its 1EPs i.e change from baseline on […]
Biogen has four other Alzheimer’s candidates in its clinical pipeline behind recently-approved Aduhelm, but one of them – anti-tau antibody gosuranemab – has just been canned. The decision comes on the back of the phase 2 TANGO study of gosuranemab (also known as BIIB092), which showed that the antibody was unable to show a benefit […]
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 about the FDA’s approval of the drug – and it wants the scalps of those responsible. In a letter to Secretary of Health and Human Services Xavier Becerra, the director […]
Sage Therapeutics and Biogen’s antidepressant candidate zuranolone has hit its objectives in a phase 3 trial, but a falloff in efficacy over time has raised concerns about the commercial potential of the drug. The WATERFALL trial of zuranolone showed that a two-week course of the oral GABAA receptor modulator significantly reduced symptoms of depression compared […]
Shots: The P-III WATERFALL study involves assessing the efficacy and safety of zuranolone (50mg, once-nightly for 2wks.) in 543 adults aged 18-64yrs. with MDD with a HAMD-17 total score ≥24 at screening and day 1 prior to dosing The study met its 1EPs demonstrating improvement in depressive symptoms @day15 as assessed by the HAMD-17 total […]
When Biogen acquired Nightstar Therapeutics in 2019, it added a pair inherited retinal disorder (IRD) gene therapies that it hoped would accelerate a push into the fast-evolving category. Just over two years later, both of those candidates have failed late-stage clinical trials, leaving Biogen’s $800 million investment in Nightstar looking like a poor deal. The […]
Shots: The P-III STAR study involves assessing the safety and efficacy of a single subretinal injection of timrepigene emparvovec (BIIB111/AAV2-REP1) in 169 adult males with a genetically confirmed diagnosis of choroideremia The study did not meet its 1EPs i.e. improvement of at least 15 letters from baseline in BCVA @12mos. post-treatment as measured by the […]
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 […]
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 in protest. The latest to depart the FDA’s Peripheral and Central Nervous System Drugs panel is Aaron Kesselheim of Harvard Medical School, joining fellow committee members Joel Perlmutter and David […]
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 against doing so. Washington University neurologist Joel Perlmutter was the first to announce he was stepping down from the Peripheral and Central Nervous System Drugs Advisory Committee on the day […]
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 broader implications for the industry as a whole? Analysts at RBC Capital Markets say that the decision points to an unprecedented shift in position for the FDA when it comes […]
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 to a timeline set by the regulator, that clinical trial is not expected to be complete until 2029.
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. That was the damning conclusion of the influential Institute for Clinical and Economic Review (ICER) in the US to yesterday’s approval of Aduhelm (aducanumab), the first new treatment for Alzheimer’s […]
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 […]
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 as Aduhelm, is the first new FDA-approved Alzheimer’s treatment since 2003.
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 disease. The accelerated approval from the US regulator has been given even though its own advisory committee comprehensively voted down the main study filed in support of the drug last […]
Tonix Pharmaceuticals Presents Results of TNX-102 SL in P-III RELIEF study for the Management of Fibromyalgia at ASCP 2021 Published: June 4, 2021 | Tags: Tonix Pharmaceuticals, TNX-102 SL, P-III, RELIEF Study, Fibromyalgia, ASCP 2021 Dermavant Submits NDA to the US FDA for Tapinarof Cream to Treat Plaque Psoriasis Published: June 4, 2021 | Tags: […]
Biogen is reaching across the Charles River, striking up a gene therapy manufacturing alliance with synthetic biology firm Ginkgo Bioworks. Ginkgo will use its technology to accelerate and make more efficient the process of manufacturing the AAV viral vectors used in gene therapies.
BeiGene Reports Results of Tislelizumab + CT in P-III RATIONALE 309 Study as 1L Treatment for Recurrent or Metastatic Nasopharyngeal Cancer Published: May 21, 2021 | Tags: BeiGene, Tislelizumab, CT, P-III, RATIONALE 309 Study, Recurrent, Metastatic Nasopharyngeal Cancer Aurinia to Present Results of Lupkynis (voclosporin) in AURORA 2 Continuation Study for Lupus Nephritis at EULAR […]
Biogen has downbeat news about its gene therapy for the rare inherited eye disease, X-linked retinitis pigmentosa, announcing the shot failed to meet its target in a phase 2/3 study. A final FDA decision on Biogen’s controversial Alzheimer’s drug aducanumab is due before the beginning of next month and the company needs some positive pipeline […]
Shots: The P-II/III XIRIUS study involves assessing subretinal injection of cotoretigene toliparvovec in males with a genetically confirmed diagnosis of XLRP. Part 1 of the study was a 24mos. dose-escalation study while part II was a 12mos. dose expansion study with a high & low dose selected from part I based on a benefit/risk assessment […]
A Biogen gene therapy for a rare, inherited eye disorder that leads to blindness has failed a key clinical trial. The preliminary results are the latest blow to the company’s efforts to expand its scope to gene therapies.
AzurRx BioPharma Reports Positive Interim P-II Data of MS1819 + PERT for Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency Published: May 14, 2021 | Tags: AzurRx BioPharma, P-II, MS1819, PERT, Cystic Fibrosis, Severe, Exocrine Pancreatic Insufficiency Goldfinch Bio Initiates P-I Clinical Trial of GFB-024 for the Treatment of Severe Insulin Resistant Diabetic Nephropathy Published: […]
Biogen has made a further push into RNA-based drug discovery via a collaboration with Envisagenics, which applies artificial intelligence RNA sequencing data to discover new drug targets and therapeutics. Cambridge, Massachusetts-based Envisagenics focuses on using AI to analyse errors in RNA splicing, a process in which a precursor form of messenger RNA (mRNA) – which […]
Shots: Biogen will utilize Envisagenics’ SpliceCore, an AI- driven RNA splicing platform to understand the regulation of different RNA isoforms in CNS cell types and will be able to access SpliceCore’s database of ~7M RNA splicing errors providing a broader perspective to evaluate splicing events The collaboration will identify and validate disease genetic targets to […]
Biogen has licensed a new drug from Japanese biotech TMS that it hopes could provide a big advance on an old treatment approach – using clot-busting thrombolytic drugs to treat ischaemic stroke. The US company has exercised an option to acquire TMS-007, which it described as a next-generation thrombolytic that could offer safety and efficacy […]
Shots: Biogen’s decision of acquisition of TMS-007 based on the safety, imaging, and clinical outcome data from the P-IIa study which showed positive impacts on both blood vessel reopening in the brain, as well as patient functional recovery with no incidence of sICH TMS to receive $18M upon acquisition of TMS-007 and is eligible to […]
Biogen paid $18 million to acquire a drug that TMS Co. of Japan tested in patients with acute ischemic stroke. The acquisition follows the report of preliminary mid-stage data showing the drug led to no cases of a potentially fatal complication associated with currently available stroke therapies.
Shots: Capsigen to receive $15M up front and is eligible to receive up to ~$42M as research milestones and ~$1.25B as additional payments upon the achievement of development and sales milestones along with royalties on net sales of products resulting from the collaboration Biogen to get an exclusive license under Capsigen’s technology for CNS and […]
BMS’ Opdivo + Yervoy and Onureg Receive EC’s CHMP Positive Opinion for MPM and AML Published: Apr 23, 2021 | Tags: BMS, Opdivo, Yervoy, Onureg, Receive, EC, CHMP, Positive Opinion, MPM, AML Gilead Reports NDA Submission of Filgotinib to PMDA for Ulcerative Colitis in Japan Published: Apr 23, 2021 | Tags: Gilead, Reports, NDA, Submission, […]
The first quarter of 2021 highlights new approvals, M&A, and the clinical data of COVID-19 vaccines. The companies expand their working in COVID-19 by targeting South African & Brazil variants along with other emerging variants Starting with the latest acquisition, Amgen acquired Five Prime for $1.9B, Jazz acquired JW while Boston acquired Preventice. This quarter […]
In an interview with PharmaShots, Monica Mann, Head of Global Medical, Multiple Sclerosis at Biogen shares her views on the Plegridy and how it works on MS patients. She also shed light on the approval of the therapy in the US and EU. Shots: The approval of Plegridy (IM) by the EC and the US […]
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 […]
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 | Tags: PlantForm, Signs, Research, Development Agreement, Bio-Manguinhos/Fiocruz, Develop, Biosimilar Pembrolizumab […]
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 excluding China (includes Hong Kong, Macau, and Taiwan) Biogen will […]
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 benefits and well-characterized safety profile. The SC option expands the […]
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, three doctors who took part in the expert advisory board […]
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 evaluate the efficacy and safety of Spinraza (nusinersen) in infants […]
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 the Q4 results period. Quarterly results announcements are a good […]
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 in the first two days of the conference Our PharmaShots […]
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 the highest valued deal of 2020 with a total deal […]
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 Published: Jan 15, 2020 | Tags: Philips, Collaborates, Merck KGaA, […]
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, […]
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 drugs alone, says the organisation, which also found that for […]
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 becoming the first company to get a product approved in […]
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 aging adults with a range of cognitive performance The study […]
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: Sarepta, Reports, Mixed Results, SRP-9001, (rAAVrh74.MHCK7.micro-dystrophin), Part 1, Study 102, […]
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 undisclosed target to treat inherited eye disease while Biogen has […]
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 Myotonic Dystrophy Published: Dec 22, 2020 | Tags: AMO Pharma, […]
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 similar. The frequency of injection site reactions and AEs were […]
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: Casirivimab, Chugai, Commercialization, COVID-19, Development, Imdevimab, In-License Agreement, Japan, Roche, […]
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 effect of monthly doses of aducanumab on the clinical decline […]
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 providers are more likely to adopt biosimilars as a “reference […]
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 Parkinson’s disease (PD). DLB and PD are both so-called synucleinopathies, […]
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 Sage’s zuranolone (SAGE-217) for psychiatric disorders including depression, and SAGE-324 […]
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 first FDA approved in 2006 for wet age-related macular degeneration […]
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 Bioepis entered into a new commercialization agreement with Biogen for […]
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 […]
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 that are facing Multiple Sclerosis Nurses (MSNs) and patients today. […]
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 to be a fractious affair, with both the companies’ data […]
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 provides supporting evidence for aducanumab The committee voted 5-0 and […]
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 providers are more likely to adopt biosimilars as a “reference […]
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 been no progress with new therapies for Alzheimers – the […]
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 therapy, following in the footsteps of the FDA in the […]
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 development of new therapies and treatments that can handle or […]
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 from Biogen for an alliance focusing on the development of […]
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 into a new commercialization agreement with Biogen for two ophthalmology […]
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 Novartis’ Zolgensma (onasemnogene abeparvovec). But Spinraza costs $750,000 in the […]
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 serious diseases. There have been no new drugs approved for […]
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 co-develop and co-market compounds known as LRRK2 inhibitors in Parkinson’s […]
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 and China while Biogen has the right to commercialize the […]
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) costs $2.1 million, while Spinraza (nusinersen) costs $750,000 in its […]
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.
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.