Category: Biogen

  • Biogen and Happify partner on digital support for MS patients

    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 waves bye to $217m ALS partnership with Karyopharm

    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 bolsters pipeline again with Alectos deal

    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 […]

  • Praxis wields the axe as lead depression drug fails

    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 puts pressure on SMA rivals with new FDA approval

    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 – […]

  • 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 […]

  • Biogen grabs MS music therapy from MedRhythms in $120m deal

    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 […]

  • Vounatsos heading for exit as Biogen sidelines Aduhelm

    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 […]

  • Biogen pulls EU application for Alzheimer’s drug Aduhelm

    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 […]

  • NICE backs Biogen’s Vumerity for multiple sclerosis

    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 […]

  • CMS decision on Aduhelm is in, and it’s bad news for Biogen

    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 […]

  • New blow for ALS pipeline as Biogen and Ionis candidate fails Phase 1 trial

    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 […]

  • Ex-Biogen R&D head Sandrock takes the top job at Voyager

    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 […]

  • Biogen finally publishes its phase 3 Aduhelm data

    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 […]

  • 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 – […]

  • 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. […]

  • 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 […]

  • Sage, Biogen’s zuranolone looks approvable, but will it sell?

    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 […]

  • 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) […]

  • Lilly defers Alzheimer’s drug filing after CMS’ ‘disappointing’ decision

    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 […]

  • Biogen’s former R&D chief Al Sandrock resurfaces at Voyager

    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 […]

  • Biogen exits biosimilar JV with Samsung, raising $2.3bn

    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 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) […]

  • 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), […]

  • CMS proposes limited coverage of Biogen Alzheimer’s drug, only in clinical trials

    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 […]

  • Biogen looks beyond Spinraza in SMA with Ionis deal

    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, 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 […]

  • 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 […]

  • Biogen slashes price of Alzheimer’s drug by half as CMS coverage decision looms

    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 takes axe to Aduhelm price in a bid to drive take-up

    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 […]

  • 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 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 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.

  • Biogen puts $15m into digital health alliance with TheraPanacea

    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 […]

  • PharmaShots Weekly Snapshots (November 15 – 19, 2021)

    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, […]

  • 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 […]

  • AbbVie’s Humira tops ICER’s list of unwarranted price hikes again

    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, […]

  • In shock move, Biogen chief medical officer Al Sandrock will stand down

    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 […]

  • 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 […]

  • Biogen’s Aduhelm rollout goes from bad to worse

    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 […]

  • Biogen, Sage prep 2022 filing for depression drug zuranolone

    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 […]

  • Blow to Biogen as ALS hope tofersen flunks phase 3 trial

    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 […]

  • Insights+ Key Biosimilars Events of September 2021

    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 […]

  • Sage and Biogen Present Results of Zuranolone in LANDSCAPE and NEST Clinical Development Programs for the Treatment of MDD and PPD at ECNP 2021

    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 […]

  • PharmaShots’ Key Highlights of Third Quarter 2021

    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, […]

  • 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, […]

  • PharmaShots Weekly Snapshots (September 20 – 24, 2021)

    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 builds evidence for Evrysdi’s benefits younger SMA patients

    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 […]

  • FDA OKs first biosimilar of Roche’s blockbuster AMD drug Lucentis

    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 […]

  • Exclusive Interview with PharmaShots: Ron Elwell of Shares Insight on the Simplification of Patient Recruitment by Applying AI and ML to Real-World Data

    In an interview with PharmaShots, Ron Elwell, President, and Founder of Swoop and 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 accelerates clinical investigation & commercialization of precision medicines leveraging AI […]

  • Biogen admits slow Aduhelm launch, as scientists question label again

    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 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 […]

  • Top 20 Immunology Companies Based on 2020 Immunology Segment Revenue

    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 […]

  • Lilly sets out its stall on donanemab as filing approaches

    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 […]

  • 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 […]

  • Angelman syndrome Pipeline: Unmet needs call for a robust pipeline

    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 bites back at critics of Aduhelm after drug’s slow start

    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 […]

  • PharmaShots Weekly Snapshots (July 12 – 16, 2021)

    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 […]

  • 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 […]

  • 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 […]

  • Biogen reaches across globe and pays $125M to land its next new MS drug

    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 considers coverage of Biogen’s costly new Alzheimer’s drug

    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 builds MS pipeline via $125m deal with China’s InnoCare

    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. […]

  • 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 […]

  • 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 […]

  • 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 […]

  • ICER revises its view of Aduhelm’s price – but not by much

    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 […]

  • ICER revises its view of Aduhelm’s price – but not by much

    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 […]

  • Insights+ Key Biosimilars Events of June 2021

    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 […]

  • PharmaShots Weekly Snapshots (June 14 – 18, 2021)

    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, […]

  • Biogen abandons tau antibody for Alzheimer’s after phase 2 miss

    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 […]

  • Consumer group seeks resignation of top FDA staffers over Aduhelm okay

    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/Biogen’s zuranolone works in depression, but maybe not enough

    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 […]

  • Biogen’s ambitions in gene therapy hit by another failed pivotal trial

    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 […]

  • Biogen’s BIIB111 Fails to Meet its Primary Endpoint in P-III STAR Study for Choroideremia

    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 […]

  • 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 […]

  • And then there were three: another FDA adcomm member quits over Aduhelm

    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 […]

  • Double resignation over Aduhelm approval depletes FDA’s CNS adcomm

    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 […]

  • Aduhelm approval could signal new era for CNS drugs; analysts

    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 […]

  • FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag

    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 […]

  • Jubilation for Biogen, Eisai as FDA says ‘yes’ to aducanumab

    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 […]

  • PharmaShots Weekly Snapshots (May 31 – June 4, 2021)

    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: […]

  • PharmaShots Weekly Snapshots (May 17 – 21, 2021)

    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’s eye disease gene therapy fails ahead of FDA Alzheimer’s ruling

    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 […]

  • PharmaShots Weekly Snapshots (May 10 – 14, 2021)

    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 taps Envisagenics’ AI to speed up RNA splicing R&D

    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 […]

  • Biogen and Envisagenics Enter into a Collaboration for the Advancement of RNA Splicing Research to Treat Central Nervous System Diseases

    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 bolsters ischaemic stroke pipeline with thrombolytic from TMS

    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 […]

  • Biogen Exercises its Option to Acquire TMS-007 for Acute Ischemic Stroke

    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 […]

  • PharmaShots Weekly Snapshots (Apr 19 – 23, 2021)

    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, […]

  • PharmaShots’ Key Highlights of First Quarter 2021

    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 […]

  • PharmaShots Weekly Snapshots (Apr 05 – 09, 2021)

    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 […]

  • 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 excluding China (includes Hong Kong, Macau, and Taiwan) Biogen will […]

  • FDA grew too close to Biogen during Alzheimer’s drug development, doctors say

    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 […]

  • Pharma’s pipeline continues to provide drama as investors look beyond COVID in Q4

    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 […]

  • Insights+: Key Deals of JP Morgan Healthcare Conference 2021

    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 […]

  • Top 20 Life Sciences Deals of 2020 by Total Deal Value

    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 […]

  • PharmaShots Weekly Snapshots (Jan 11 – 15, 2021)

    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, […]

  • 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, […]

  • Amgen’s Enbrel heads ICER list of unjustified US price rises

    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 […]

  • RNAi biotech Atalanta debuts with $110m plus Biogen and Roche CNS tie-ups

    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 […]

  • Biogen and Apple Collaborate to Launch Virtual Study on Cognitive Decline

    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 […]

  • PharmaShots Weekly Snapshot (Jan 4-8, 2020)

    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, […]

  • Biogen Signs a License Agreement with ViGeneron for Ophthalmic Gene Therapy Development

    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 […]

  • PharmaShots Weekly Snapshots (Dec 21-23, 2020)

    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, […]

  • PharmaShots Weekly Snapshots (Dec 7-11, 2020)

    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, […]

  • Insights+ Key Biosimilars Events of November 2020

    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 […]

  • Eisai forges CNS alliance with UK’s Wren Therapeutics

    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, […]

  • Biogen bulks up pipeline with Sage drugs in $3bn deal

    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 […]

  • FDA begins review of Samsung Bioepis/Biogen’s Lucentis biosimilar

    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 […]

  • 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 […]

  • Bridging the gap between pharma and the NHS in MS

    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. […]

  • FDA panel unimpressed with data for Alzheimer’s drug aducanumab

    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 […]

  • The US FDA’s Advisory Panel Slams Biogen’s Aducanumab for Alzheimer’s Disease

    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 […]

  • Insights+ Key Biosimilars Events of October 2020

    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 […]

  • China’s Green Valley prepares US trial of Alzheimer’s drug inspired by algae

    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 […]

  • Trials and tribulations in Biogen’s Alzheimer’s drug reviews

    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 […]

  • Top 20 Immunology Companies Based 2019 Immunology Segment Revenue

    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 […]

  • Biogen teams up with gene-editing startup Scribe on ALS programme

    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 […]

  • Samsung Bioepis and Biogen Announce EMA Filling Acceptance of SB11 (biosimilar, Lucentis)

    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 […]

  • Roche takes on pricey rivals as FDA approves SMA drug

    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 shares surge again as FDA hurries Alzheimer’s drug review

    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 signs $2.1 billion Parkinson’s disease deal with Denali

    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 […]

  • Biogen plans trial of Spinraza in patients not responding to SMA gene therapy

    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 […]