Category: Astellas
Astellas’ oral HIF-PH inhibitor Evrenzo has become the first drug in the class to be recommended for routine NHS use as a treatment for anaemia in chronic kidney disease (CKD), ahead of rivals from Otsuka and GlaxoSmithKline. The decision by cost-effectiveness watchdog NICE means that Evrenzo (roxadustat) is the first oral alternative to treatment with […]
Three years after Daiichi Sankyo’s FLR3 inhibitor quizartinib was rejected by the FDA, the drugmaker has reported the results of a new phase 3 trial that is key to getting the drug to the US market and chasing down rival drugs from Astellas and Novartis. Data from the QuANTUM-First trial presented at the EHA congress […]
Astellas has become the latest big pharma company to sink some money into immuno-oncology start-up GO Therapeutics, forging an alliance to develop antibodies targeting two glycoprotein targets. The Japanese drugmaker is paying $20.5 million upfront to get the ball rolling, while milestone and other payments could take the total value of the deal up to […]
Astellas has said it will book a $170 million impairment charge in its fourth quarter results as a result of a decision to halt the development of three gene therapy candidates for Duchenne muscular dystrophy in preclinical development. The write-down comes in the wake of problems affecting the Japanese drugmaker’s AT132 gene therapy candidate for […]
Astellas looks to be in pole position to bring a new non-hormonal therapy for symptoms of menopause to market, after its candidate fezolinetant cleared a phase 3 safety study. The SKYLIGHT 4 was investigating the safety and tolerability of fezolinetant – an orally-active neurokinin-3 (NK3) receptor antagonist – over 52 weeks in women with vasomotor […]
Astellas and Seagen’s Padcev is on course to move further up the treatment pathway in bladder cancer, thanks to a positive readout in the EV-103 clinical trial. Padcev (enfortumab vedotin) is already approved as a second-line therapy for urothelial carcinoma (UC) after cisplatin chemotherapy and immunotherapy with checkpoint inhibitors, but Seagen and Astellas are working […]
With the safety of gene therapies thrown into the spotlight by a series of FDA clinical holds, Astellas has said that an interim readout in a phase 1/2 trial of its Pompe disease candidate AT845 hasn’t found any cause for concern. The FORTIS trial is investigating whether AT845, an adeno-associated virus (AAV) therapy, can deliver […]
This episode of the pharmaphorum podcast is the second in a limited series focused on patient engagement that’s being led by clinician, consultant and patient advocate, Mark Duman. Joining him to discuss the importance of patient engagement are Johnson & Johnson’s global patient engagement leader Katherine Capperella, Novartis’ head of patient engagement Mark Boutin, and […]
Words matter. In the pharma industry, “patient engagement” and “patient centricity” might seem like interchangeable bits of corporate jargon. But the difference between them is not like the choice between “agreeing” and “aligning” or “getting together later” and “taking this offline.” Going from the vital activity of patient engagement to the more encompassing state of […]
Bayer’s Nubeqa is making headway as a treatment for castration-resistant prostate cancer (CRPC), but could be on track to expand the eligible patient population for the drug thanks to new phase 3 data. Just released results from the ARASENS trial show that adding Nubeqa (darolutamide) to docetaxel chemotherapy and androgen deprivation therapy (ADT) to switch […]
Astellas has signed another bolt-on deal to build its gene therapy pipeline, agreeing a deal with Dyno Therapeutics to tap into its adeno-associated virus (AAV) vector platform for delivering genes to skeletal and cardiac muscle. The Japanese drugmaker is paying $18 million upfront to exercise an option on the AAV platform – which my help […]
Mig Sleeper, vice president, Global Pricing for Astellas Pharma Europe, explains why we must rethink how value is defined as we enter a new technological era for medicines. Why is a new access model so pressing, and has the pandemic accelerated the situation? Yes, it has. Although the need for a change in the […]
In an interview with PharmaShots, Txema Sanz, Senior Vice President and Head of the Global Medical Specialties at Astellas shared his views on the EC’s approval of Evrenzo (roxadustat) for the Treatment of Symptomatic Anemia Associated with Chronic Kidney Disease Shots: The approval is based on the P-III program including 8 studies evaluating Evrenzo in […]
BMS Reports EMA’s Validation of MAA for Relatlimab and Nivolumab as 1L Treatment for Unresectable or Metastatic Melanoma Published: Oct 1, 2021 | Tags: BMS, EMA, MAA, Relatlimab, Nivolumab, Metastatic Melanoma Merck and Ridgeback Report Interim Results of Molnupiravir in P-III MOVe-OUT Trial for the Treatment of COVID-19 Published: Oct 1, 2021 | Tags: Merck, […]
There has been a fourth patient fatality in Astellas’ clinical trial of its AT132 gene therapy for the rare disease X-linked myotubular myopathy (XLMTM), which has been halted twice due to safety concerns. The latest suspension came after abnormal liver function tests (LFTs) were seen in a boy receiving the gene therapy, who has since […]
Forte’s FB-401 Fails to Meet Primary Endpoints in P-II Clinical Trial For the Treatment of Atopic Dermatitis Published: Sept 3, 2021 | Tags: Forte, FB-401, P-II, Clinical Trial, Atopic Dermatitis Novartis Cosentyx (secukinumab) Receives NICE Recommendation for Patients with Plaque Psoriasis Published: Sept 3, 2021 | Tags: Novartis, Cosentyx, secukinumab, NICE Recommendation, Plaque Psoriasis Pfizer […]
Forte’s FB-401 Fails to Meet Primary Endpoints in P-II Clinical Trial For the Treatment of Atopic Dermatitis Published: Sept 3, 2021 | Tags: Forte, FB-401, P-II, Clinical Trial, Atopic Dermatitis Novartis Cosentyx (secukinumab) Receives NICE Recommendation for Patients with Plaque Psoriasis Published: Sept 3, 2021 | Tags: Novartis, Cosentyx, secukinumab, NICE Recommendation, Plaque Psoriasis Pfizer […]
Shots: Astellas discontinue the dosing in the ASPIRO trial that evaluates AT132 in 24 participants (7 at the 1.3×1014 vg/kg dose and 17 at the 3.5×1014 vg/kg dose) with XLMTM. The participant has a history of intermittent cholestasis The discontinuation is due to serious AEs in a study that demonstrated abnormal LFTs in patients who […]
Astellas has halted dosing in a study of its AT132 gene therapy for the rare disease X-linked myotubular myopathy (XLMTM) for the second time after another serious adverse event (SAE) linked to possible liver damage. The ASPIRO trial of AT132 has been paused after abnormal liver function tests (LFTs) were seen in a patient receiving […]
Janssen Presents Results of Rybrevant (amivantamab-vmjw) in P-I CHRYSALIS Study for Advanced NSCLC with METex14 Mutations at WCLC Published: Aug 20, 2021 | Tags: Astellas, FibroGen, Evrenzo, Roxadustat, EC, Approval, Symptomatic Anemia, Chronic Kidney Disease Astellas and FibroGen’s Evrenzo (roxadustat) Receive EC’s Approval for Symptomatic Anemia Associated with Chronic Kidney Disease Published: Aug 20, 2021 […]
The EU regulator has approved FibroGen and Astellas Evrenzo for adults with anaemia caused by chronic kidney disease (CKD), just days after the FDA turned down the drug in the US. The decision makes Evrenzo (roxadustat) the first oral HIF-PH inhibitor to be cleared for use in the EU, ahead of rival candidates daprodustat from […]
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 […]
Medtronic to Acquire Intersect ENT for ~$1.1B Published: Aug 6, 2021 | Tags: Medtronic, Intersect ENT, ~$1.1B Kite Signs a License Agreement with Appia to Develop Allogeneic Cell Therapies for the Treatment of Cancer Published: Aug 6, 2021 | Tags: Kite, Appia, Allogeneic Cell Therapies, Cancer Polpharma & Bioeq Report BLA Submission to the US […]
Shots: Minovia receives a $20M up front and is eligible to receive ~$420M per product in development, regulatory & commercial milestone for mitochondrial cell therapies caused by mitochondrial dysfunction The collaboration is to accelerate the allogeneic mitochondrial cell therapy programs & extend Astellas’ capabilities in mitochondrial biology. The collaboration follows the recent acquisition of Mitobridge […]
In an interview with PharmaShots, Dr. Andrew Krivoshik, Senior Vice President and Oncology Therapeutic Area Head at Astellas, shared his views on the P-II FAST study result published in the journal Gastric Cancer and highlights the data published in Annals of Oncology. Shots: The data from P-II FAST study evaluating zolbetuximab + EOX in 1L […]
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 […]
Shots: ExCellThera to receive up front, future contingent payments along with manufacturing and supply fees for the licensed molecules The collaboration validates the immense clinical and commercial potential of UM171 in additional fields of development The collaboration allows the ExcelThera to focus on clinical programs and commercial plans for ECT-001 cell therapy product along with […]
Already facing one rival to its blockbuster pneumococcal vaccine Prevnar, Pfizer could have another to contend with, after Affinivax reported positive phase 2 results with its ASP3772 candidate – plus a new breakthrough designation from the FDA. Last year, Pfizer made almost $6 billion from its Prevnar 13 vaccine, which covers 13 common serotypes of […]
The UK has been a global leader in introducing cell and gene therapies that can potentially transform the lives of patients with debilitating diseases – but there are still many barriers to wider adoption. These challenges often arise because these therapies go through the same value assessment processes as less complex medicines, and the infrastructure […]
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 […]
Shots: The companies reported the positive results from two studies (EV-201 and EV-103) evaluating Padcev as monothx. and in combination with Merck’s Keytruda in patients with LA or mUC who are not able to receive cisplatin CT respectively An updated analysis of EV-201 Cohort 2 showed that 51% achieved confirmed objective response with CR (22%), […]
Shots: Autobahn acquires global IP, development, and regulatory rights to ASP3652 to strengthen its brain-targeting chemistry platform. The addition of ASP3652 will accelerate the delivery of next-generation brain-targeting prodrugs for CNS disorders, particularly MS ASP3652 complements Autobahn’s brain-targeting chemistry platform, which uses FAAH-mediated prodrug conversion to enable the delivery of small molecules across the BBB. […]
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 next milestone in Seagen and Astellas’ bid to build their antibody-drug conjugate (ADC) Padcev into a blockbuster will come in August, when the FDA concludes an accelerated review of two bladder cancer filings. One of the filings is to convert the ADC’s current conditional approval as a later-line therapy for urothelial cancer in patients […]
Shots: The first sBLA is based on the P-III EV-301 trial assessing Padcev vs CT in ~ 600 patients with LA or mUC prior treated with PD-1/L1 inhibitor and platinum-based therapy. The first sBLA seeks to convert PADCEV’s accelerated approval to regular approval The second sBLA is based on cohort 2 of the P-II EV-201 […]
The US FDA has approved 7 NDAs in Mar 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 19 novel products in 2021. Additionally, last year in 2020, the US FDA has approved […]
When it comes to developing cutting-edge innovations, Astellas aims to be at the forefront. The pharma organisation prides itself on having an open, collaborative, “science first” approach to help ensure breakthrough discoveries have the very best chance of long-term success in bringing new treatment options to patients worldwide. “Our mission is to turn innovative science […]
Shots: The MAA is based on the P-III EV-301 trial which involves assessing Enfortumab Vedotin vs CT in ~ 600 patients with LA/m-UC, prior treated with Pt.-based CT and a PD-1/L1 inhibitor The 1EPs of the trial is OS and 2EPs include PFS, ORR, DoR, DCR as well as the assessment of safety/tolerability and QoL […]
PhaseBio Signs a Supply Agreement with BioVectra to Support the Development and Commercialization of Bentracimab Published: Mar 12, 2021 | Tags: PhaseBio, Signs, Supply, Agreement, BioVectra, Support, Development, Commercialization, Bentracimab Takeda Reports NDA Submission of Lanadelumab to the MHLW as a Preventive Treatment for Hereditary Angioedema Attack in Japan Published: Mar 12, 2021 | Tags: […]
Shots: The submission is based on EV-301 and EV-201 trials in Japan. The P-III EV-301 trial assessing Enfortumab Vedotin vs CT in ~ 600 patients with LA/m-UC, prior treated with platinum-based CT and PD-1/L1 inhibitor The P-II EV-201 trial assessing Enfortumab Vedotin in ~128 patients with LA/m-UC, prior treated with PD-1/L1 inhibitor, including those who […]
Regeneron Reports IDMC Clearance of Efficacy for REGEN-COV (Casirivimab + Imdevimab) in P-III COVID-19 Outpatient Outcomes Trial Published: Feb 26, 2021 | Tags: Regeneron, Reports, IDMC, Clearance, Efficacy, REGEN-COV (Casirivimab + Imdevimab), P-III, COVID-19, Outpatient, Outcomes, Trial Daiichi Sankyo Collaborates with LYSA-LYSARC-CALYM for Valemetostat in Patients with R/R B-Cell Lymphoma Published: Feb 26, 2021 | […]
Shots: The P-III studies SKYLIGHT 1 & 2 involves assessing fezolinetant (30 & 45mg, qd) vs PBO in women with mod. to sev. vasomotor symptoms (VMS) for the first 12wks. followed by 40wks. active treatment extension periods Both the trials met all four co-1EPs demonstrating a significant reduction from baseline in the frequency and severity […]
RedHill Signs a Manufacturing Agreement with Cosmo for Movantik and RHB-204 Published: Feb 19, 2021 | Tags: RedHill, Signs, Manufacturing, Agreement, Cosmo, Movantik, RHB-204 Astellas and Seagen Reports Submission of Two BLA to the US FDA for Padcev (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer Published: Feb 19, 2021 | Tags: Astellas, Seagen, Reports, Submission, […]
Astellas and Seagen have the data they need for a full licence for their bladder cancer drug Padcev in the US, based on trial results announced over the weekend. To recap, Padcev (enfortumab vedotin) was quickly okayed by the FDA in December 2019 in advanced urothelial cancer on the basis of phase 2 response data […]
The biopharma industry saw numerous deal terminations in 2020. Clinical and regulatory results, change in control limitations, and strategic reprioritizations were among the most common reasons for deal termination. Sanofi and Hanmi’s agreement in 2015 ranked first under which Hanmi regained WW rights to its protein/peptide discovery technology, lapscovery. The second position goes to the […]
Reistone Report Results for SHR0302 in P-II Study to Treat Ulcerative Colitis Published: Feb 5, 2020 | Tags: Reiston, Report, Result, SHR0302, P-II, Study, Treat, Ulcerative Colitis Enzene Receives Marketing Authorization for Teriparatide (biosimilar) in India Published: Feb 5, 2020 | Tags: Enzene, Receives, Marketing Authorization, Teriparatide (biosimilar), India Johnson & Johnson Reports EUA Submission […]
Shots: The approval was based on P-III ADMIRAL assessing gilteritinib (120mg, qd) vs CT in 319 patients with relapsed or refractory AML. The study showed patients had significantly longer overall survival OS, mOS (9.3 vs 5.6mos.) Additionally, Chinese patient PK data from the ongoing P-III COMMODORE trial were also reviewed. The accelerated approval follows PR […]
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: The US FDA has accepted the PR for NDA of mirabegron (oral suspension) and sNDA for Myrbetriq (mirabegron, tablets) for neurogenic detrusor overactivity (NDO) in pediatric patients aged ≥ 3yrs. with anticipated PDUFA date as Mar 28, 2021 The NDA & sNDA is based on P-III study assessing efficacy, safety, tolerability and PK of […]
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: KaliVir to receive $56M as upfront & other payments supporting the research & preclinical activities of VET2-L2 & is eligible to receive $307M & $271M as development, regulatory & commercialization for VET2-L2 & second product, respectively along with royalties on sales of each licensed product The alliance integrates KaliVir’s expertise in the development of […]
The San Diego-based biopharma firm has several oncology therapies in development and has partnered in the past with the likes of Astellas, BeiGene and Bristol-Myers Squibb.
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 […]
Astellas Pharma is to buy bioelectronic medical devices firm iota Biosciences in a deal worth up to $429m, building on a previous research partnership. In August last year the companies began a joint research and development agreement based around iota’s bioelectronic devices in several indications. Bioelectronics is a field that has been investigated by Google’s […]
NICE has recommended regular NHS funding for Astellas’ Xospata (gilteritinib) monotherapy for certain adult patients with acute myeloid leukaemia. In final draft guidance NICE said that the drug is recommended for relapse or refractory FLT3 mutation-positive AML, giving patients an alternative to chemotherapy and its unpleasant side effects. However because of considerable uncertainty about long-term survival after stem cell transplant, NICE […]