Takeda

Takeda Signs an Agreement with Calithera to Acquire Sapanisertib and Mivavotinib

Shots: Takeda is eligible to receive $10M up front in addition to $35M in Calithera Series A preferred stock and is eligible to receive clinical development, regulatory, and sales milestone for both programs along with royalties The acquisition will bolster Calithera’s precision oncology pipeline of clinical-stage targeted therapies i.e., sapanisertib (TORC 1/2 inhibitor) and mivavotinib …

Takeda Signs an Agreement with Calithera to Acquire Sapanisertib and Mivavotinib Read More »

Takeda Amend its Collaboration with Wave Life Sciences to Advance CNS Programs

Shots: Wave to receive $22.5M for research & preclinical expenses and is eligible to receive opt-in payment, development & commercial milestone & will lead the manufacturing & joint clinical co-development activities. Both companies will share global costs & 50:50 profits Takeda’s gets an option to co-develop & co-commercialize CNS therapies for 3 targets, C9orf72, HTT …

Takeda Amend its Collaboration with Wave Life Sciences to Advance CNS Programs Read More »

PharmaShots Weekly Snapshots (October 11 – 15, 2021)

Bristol Myers Squibb’s Zeposia (ozanimod) Receives CHMP’s Positive Opinion for Adult Patients with Moderately to Severely Active Ulcerative Colitis Published: 15 Oct, 2021 | Tags: Bristol Myers Squibb, Zeposia, ozanimod, CHMP, Positive Opinion, Adult Patients with Moderately to Severely Active Ulcerative Colitis Gan & Lee Completes P-III Studies of GL-GLA for Patients with T1D & …

PharmaShots Weekly Snapshots (October 11 – 15, 2021) Read More »

Takeda Signs an Exclusive License Agreement with Poseida for Novel Non-Viral In Vivo Gene Therapies

Shots: The parties will initially develop up to 6 in vivo gene therapy programs utilizing Poseida’s piggyBac, Cas-CLOVER & biodegradable nanoparticle technology for 6 liver & HSC directed indications. Takeda has an option to add 2 additional programs and is obligated to provide funding for all program’s R&D costs Poseida to receive $45M up front …

Takeda Signs an Exclusive License Agreement with Poseida for Novel Non-Viral In Vivo Gene Therapies Read More »

Takeda Receives the US FDA Advisory Committee’s Recommendation for TAK-620 (maribavir) to Treat CMV Infection in Post-Transplant Recipients

Shots: The US FDA’s AMDAC voted to recommend the use of maribavir (TAK-620) to treat refractory CMV infection and disease with/out genotypic resistance to ganciclovir, valganciclovir, foscarnet, or cidofovir in transplant recipients The recommendations were based on the results from the P-II & III TAK-620-303 (SOLSTICE) trials of maribavir while the NDA submission of maribavir …

Takeda Receives the US FDA Advisory Committee’s Recommendation for TAK-620 (maribavir) to Treat CMV Infection in Post-Transplant Recipients Read More »

FDA panel backs Takeda’s CMV drug for transplant patients

Takeda is closing on a first FDA approval in the treatment of refractory cytomegalovirus (CMV) infections in organ transplant patients, after agency advisors voted unanimously in favour of its antiviral maribavir. Maribavir (TAK-620) should be approved for refractory CMV infections in people with solid organ transplants as well as haematopoietic stem cell transplants (HSCT), regardless …

FDA panel backs Takeda’s CMV drug for transplant patients Read More »

ViewPoints Interview: Takeda’ Salomé Juethner Shares Insights on the Clinical Data of Takhzyro Presented at EASL 2021

In an interview with PharmaShots, Salomé Juethner, Senior Medical Director, Rare Diseases at Takeda shared his views on the P-III HELP study of Takhzyro for the prevention of hereditary angioedema attacks in the Journal Allergy Shots: The P-III HELP OLE study evaluates the safety & efficacy of Takhzyro (300mg, q2w) in 212 patients aged ≥12yrs. …

ViewPoints Interview: Takeda’ Salomé Juethner Shares Insights on the Clinical Data of Takhzyro Presented at EASL 2021 Read More »

Takeda halts trial of orexin drug in narcolepsy on safety grounds

Japanese drugmaker Takeda has suspended dosing in phase 2 trials of its orexin agonist TAK-994, saying it had encountered a “safety signal” in the study. The future of the programme seems to be in jeopardy, as Takeda also indicated it decided to stop both studies early and said it is “committed to advancing its multi-asset …

Takeda halts trial of orexin drug in narcolepsy on safety grounds Read More »

Takeda Enters into a License Agreement with Selecta to Develop Gene Therapies for the Treatment of Lysosomal Storage Disorders

Shots: Selecta to receive up front and ~$1.124B upon the achievement of development or commercial milestones or Takeda’s election continue its activities at specified development stages. Selecta is also eligible to receive royalties on future commercial sales The collaboration will utilize Selecta’s ImmTOR platform that accelerates transgene expression and addresses AAV vector immunogenicity to deliver …

Takeda Enters into a License Agreement with Selecta to Develop Gene Therapies for the Treatment of Lysosomal Storage Disorders Read More »

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

BMS Reports EMA’s Validation of MAA for Relatlimab and Nivolumab as 1L Treatment for Unresectable or Metastatic Melanoma Published: Oct 1, 2021 | Tags: BMS, EMA, MAA, Relatlimab, Nivolumab, Metastatic Melanoma Merck and Ridgeback Report Interim Results of Molnupiravir in P-III MOVe-OUT Trial for the Treatment of COVID-19 Published: Oct 1, 2021 | Tags: Merck, …

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

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, …

PharmaShots’ Key Highlights of Third Quarter 2021 Read More »

Takeda Signs an Exclusive License Agreement with JCR to Commercialize JR-141 for the Treatment of Hunter Syndrome

Shots: JCR to receive an up front for the Ex-US license & additional development & commercial milestones along with royalties on the sales of JR-141 Takeda will exclusively commercialize JR-141 outside of the US, including the EU, Canada & other regions (Ex-Japan and other Asia-Pacific countries). Additionally, Takeda has entered into an option agreement under …

Takeda Signs an Exclusive License Agreement with JCR to Commercialize JR-141 for the Treatment of Hunter Syndrome Read More »

Takeda bags Japanese approval for Crohn’s cell therapy Alofisel

Takeda has chalked up another milestone for its Alofisel cell therapy for a complication of Crohn’s disease, becoming the first allogeneic stem cell therapy to be approved in Japan. Alofisel (darvadstrocel) has been cleared by the Ministry of Health, Labour and Welfare (MHLW) for the treatment of complex perianal fistulas in patients with non-active or …

Takeda bags Japanese approval for Crohn’s cell therapy Alofisel Read More »

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 …

PharmaShots Weekly Snapshots (September 20 – 24, 2021) Read More »

Takeda Enters into an Exclusive License Agreement with Mirum to Develop and Commercialize Maralixibat for Rare Pediatric Liver Diseases in Japan

Shots: Takeda will lead the regulatory approval and commercialization of maralixibat in Japan & will also be responsible for the development, including conducting clinical studies in cholestatic indications The collaboration will utilize Takeda’s leadership in rare disease, gastroenterology, and hepatology to advance the product in Japan Mirum has submitted a maralixibat’s NDA to the US …

Takeda Enters into an Exclusive License Agreement with Mirum to Develop and Commercialize Maralixibat for Rare Pediatric Liver Diseases in Japan Read More »

Takeda gets a win for its Wave1 pipeline, as Exkivity nabs FDA approval

Takeda has had a run of bad luck with its Wave1 pipeline of new drug candidates of late, but can now celebrate a vestry after getting FDA approval for first-in-class lung cancer therapy Exkivity. The US regulator has cleared the tyrosine kinase inhibitor (TKI) as a second-line treatment for locally advanced or metastatic non-small-cell lung …

Takeda gets a win for its Wave1 pipeline, as Exkivity nabs FDA approval Read More »

Takeda’s Exkivity (mobocertinib) Receives the US FDA’s Approval as the First Oral Therapy for EGFR Exon20 Insertion+ NSCLC

Shots: The approval is based on the P-I/II trial evaluating Exkivity (160 mg) in 114 patients with EGFR Exon20 insertion+ NSCLC who received prior Pt-based therapy The results demonstrated ORR (28%) as assessed by IRC & 35% as per investigator, m-DoR (17.5mos.), m-OS (24mos.), and m-PFS (7.3mos.) as per IRC Exkivity is a TKI inhibitor …

Takeda’s Exkivity (mobocertinib) Receives the US FDA’s Approval as the First Oral Therapy for EGFR Exon20 Insertion+ NSCLC Read More »

PharmaShots Weekly Snapshots (August 30 – September 03, 2021)

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 …

PharmaShots Weekly Snapshots (August 30 – September 03, 2021) Read More »

PharmaShots Weekly Snapshots (August 30 – September 03, 2021)

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 …

PharmaShots Weekly Snapshots (August 30 – September 03, 2021) Read More »

Gamble by Takeda on unproven cancer mechanism draws a blank

Takeda says a phase 3 trial of its cancer candidate pevonedistat – a class-leading NEDD8-activating enzyme inhibitor – has failed to show a benefit in patients with blood cancers, placing its future in doubt. The PANTHER trial looked at the combination of pevonedistat in combination with azacitidine chemotherapy as first-line treatment for patients with higher-risk …

Gamble by Takeda on unproven cancer mechanism draws a blank Read More »

Takeda’s Pevonedistat Fails to Meet Primary Endpoints in P-III PANTHER Trial as 1L Treatment for Patients with Rare Bone Marrow Cancer

Shots: The P-III PANTHER trial evaluates pevonedistat + azacitidine vs azacitidine alone in patients with higher-risk MDS, CMML and AML The study did not achieve its pre-defined 1EPs of EFS, the safety profile was consistent with previously reported data of the combination regimen Pevonedistat is an NAE inhibitor that leads to cancer cell death by …

Takeda’s Pevonedistat Fails to Meet Primary Endpoints in P-III PANTHER Trial as 1L Treatment for Patients with Rare Bone Marrow Cancer Read More »

PharmaShots Weekly Snapshots (August 23 – 27, 2021)

Ascendis’ Skytrofa (lonapegsomatropin-tcgd) Receives the US FDA’s Approval for Pediatric Growth Hormone Deficiency Published: Aug 27, 2021 | Tags: Ascendis, Skytrofa, lonapegsomatropin-tcgd, US, FDA, Approval, Pediatric Growth Hormone Deficiency Amgen Presents Results of Repatha (evolocumab) in P-III HUYGENS Study for the Treatment of Acute Coronary Syndrome at ESC 2021 Published: Aug 27, 2021 | Tags: …

PharmaShots Weekly Snapshots (August 23 – 27, 2021) Read More »

Takeda Signs a License Agreement with Genevant to Develop and Commercialize Novel Nonviral Gene Therapies for Liver Diseases

Shots: Genevant is eligible to receive ~$303M up front and milestone along with royalties on future product sales Takeda gets exclusive rights to use Genevant’s LNP technology for the development and commercialization of specified nonviral gene therapies for up to two undisclosed rare liver diseases The collaboration follows the initial 2021 agreement in which companies …

Takeda Signs a License Agreement with Genevant to Develop and Commercialize Novel Nonviral Gene Therapies for Liver Diseases Read More »

PharmaShots Weekly Snapshots (Aug 09 – 13, 2021)

Junshi and Coherus’s Toripalimab Receive the US FDA’s Breakthrough Therapy Designation as 1L Treatment of Nasopharyngeal Carcinoma Published: Aug 13, 2021 | Tags: Junshi, Coherus, Toripalimab, US, FDA, Breakthrough Therapy Designation, Nasopharyngeal Carcinoma Celltrion’s Regdanvimab (CT-P59) Receives the ANVISA’s EUA for the Treatment of COVID-19 in Brazil Published: Aug 13, 2021 | Tags: Celltrion, Regdanvimab, …

PharmaShots Weekly Snapshots (Aug 09 – 13, 2021) Read More »

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 …

Top 20 Immunology Companies Based on 2020 Immunology Segment Revenue Read More »

Takeda to Advance FIN-524 Development Program in Ulcerative Colitis

Shots: Takeda will lead the development of FIN-524/TAK-524 to treat UC prior to the start of its clinical program & will leverage its expertise in IBD throughout the development process Finch plans to provide ongoing technical support through the P-I trial of FIN-524/TAK-524 in the same indication. The companies will continue to advance the program …

Takeda to Advance FIN-524 Development Program in Ulcerative Colitis Read More »

PharmaShots Weekly Snapshots (Aug 02 – 06, 2021)

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 …

PharmaShots Weekly Snapshots (Aug 02 – 06, 2021) Read More »

Takeda Publishes the Results of Takhzyro (lanadelumab) in P-III HELP Study for the Prevention of Hereditary Angioedema Attacks in the Journal Allergy

Shots: The P-III HELP OLE study evaluates the safety & efficacy of Takhzyro (300mg, q2w) in 212 patients aged ≥12yrs. with HAE attacks for ~2.5yrs. Results: 87.4% mean reduction in attack rate compared to baseline; attacks requiring acute treatment (93.4%); mod. or sev. attacks (84.3%); HAE attack-free (97.7%) with a duration of the attack-free period …

Takeda Publishes the Results of Takhzyro (lanadelumab) in P-III HELP Study for the Prevention of Hereditary Angioedema Attacks in the Journal Allergy Read More »

PharmaShots Weekly Snapshots (July 26 – 30, 2021)

Roche Publishes the Results of Evrysdi (risdiplam) in FIREFISH Study to Treat of Type 1 SMA at NEJM Published: July 30, 2021 | Tags: Roche, Evrysdi, risdiplam, FIREFISH Study, Type 1 SMA, NEJM BeiGene Reports Results of Brukinsa (zanubrutinib) in P-III SEQUOIA Trial for the Treatment of Chronic Lymphocytic Leukemia Published: July 30, 2021 | …

PharmaShots Weekly Snapshots (July 26 – 30, 2021) Read More »

Takeda spins norovirus vaccine out into separate company

Takeda has decided development of its norovirus vaccine candidate outside Japan will be more efficient if it is spun out into a dedicated company. The Japanese drugmaker has partnered with venture capital company Frazier Healthcare Partners to form HilleVax, which comes into being with full and exclusive ex-Japanese development and commercial rights to TAK-214 (now …

Takeda spins norovirus vaccine out into separate company Read More »

Takeda’s TAK-994 Receives Breakthrough Therapy Designation for the Treatment of Narcolepsy Type 1

Shots: The BTD is based on early and preliminary clinical data involves assessing TAK-994 for the treatment of EDS that may demonstrated substantially improved objective and subjective measurements of daytime wakefulness in NT1 patients TAK-994 is being evaluated in an ongoing P-II TAK-994-1501 study while the completed data from study will be presented at a …

Takeda’s TAK-994 Receives Breakthrough Therapy Designation for the Treatment of Narcolepsy Type 1 Read More »

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 …

PharmaShots Weekly Snapshots (July 12 – 16, 2021) Read More »

Takeda Presents Results of Takhzyro (lanadelumab) in P-III HELP Study Open-Label Extension to Treat Hereditary Angioedema Attacks at EAACI 2021

Shots: The P-III HELP OLE study evaluating the safety & efficacy of Takhzyro (300mg, q2w) in 212 patients aged ≥12yrs. with HAE attacks for ~2.5 yrs. Results: 87.4% mean reduction in attack rate compared to baseline & median reduction was 97.7%. Additionally, @70 day steady-state, attack rates were further reduced to a mean of 92.4% …

Takeda Presents Results of Takhzyro (lanadelumab) in P-III HELP Study Open-Label Extension to Treat Hereditary Angioedema Attacks at EAACI 2021 Read More »

Rare disease: industry, patients and tech join forces on diagnosis

Takeda’s Adam Zaeske discusses how cross-sector collaboration is shaping a brighter future for rare disease diagnosis. Diagnosis can sometimes be the most difficult part of a rare disease patient’s journey, and it’s with good reason that the process is often referred to as an ‘odyssey’ in these communities. “We’re dealing with very small populations of …

Rare disease: industry, patients and tech join forces on diagnosis Read More »

PharmaShots Weekly Snapshots (June 07 – 11, 2021)

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

PharmaShots Weekly Snapshots (June 07 – 11, 2021) Read More »

PharmaShots Weekly Snapshots (May 24 – 28, 2021)

Seelos’ SLS-005 (Trehalose) Receives EC’s Orphan Drug Designation to Treat Amyotrophic Lateral Sclerosis Published: May 28, 2021 | Tags: Seelos, SLS-005, Trehalose, EC, Orphan Drug Designation,  Amyotrophic Lateral Sclerosis The US FDA’s EMDAC Supports Provention Bio’s Teplizumab in Delaying Diabetes Published: May 28, 2021 | Tags: US, FDA, EMDAC, Provention Bio, Teplizumab, Delaying Diabetes uniQure …

PharmaShots Weekly Snapshots (May 24 – 28, 2021) Read More »

Takeda Reports Long-Term Safety and Efficacy Results of its Dengue Vaccine Candidate

Shots: The P-III TIDES study involves assessing two doses of TAK-003 (0.5mL, SC on day 1 & 90) vs PBO to prevent laboratory-confirmed symptomatic dengue fever of any severity and due to any of the four dengue virus serotypes in 20,000+ children and adolescents Results: @36mos. after the second dose, 62.0% VE against VCD; 65.0% …

Takeda Reports Long-Term Safety and Efficacy Results of its Dengue Vaccine Candidate Read More »

After Sanofi’s setbacks, Takeda eyes finish line with its dengue vaccine

Takeda has revealed long-term clinical trial results with its dengue vaccine that reinforce its safety and efficacy – and help to differentiate it from Sanofi’s challenged Dengvaxia shot. Updated results from the large-scale TIDES trial of TAK-003 show that three years after dosing it was 62% effective at warding off dengue symptoms and prevented more …

After Sanofi’s setbacks, Takeda eyes finish line with its dengue vaccine Read More »

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 …

PharmaShots Weekly Snapshots (May 17 – 21, 2021) Read More »

Takeda Presents Results of Mobocertinib in P-I/II Study for Patients with EGFR Exon20 Insertion+ mNSCLC

Shots: The P-I/II study involves assessing Mobocertinib (160mg, PO) in patients with EGFR Exon20 insertion+ mNSCLC who received prior Pt-based CT The results showed mobocertinib continued to demonstrate clinically meaningful benefit after over 1yr of follow up and will be presented at the ASCO. The updated results demonstrated an encouraging ORR (28%), DoR (17.5mos.), OS …

Takeda Presents Results of Mobocertinib in P-I/II Study for Patients with EGFR Exon20 Insertion+ mNSCLC Read More »

The US FDA Grants Priority Review to Takeda’s Mobocertinib (TAK-788) for EGFR Exon20 Insertion+ Metastatic Non-Small Cell Lung Cancer

Shots: The US FDA has granted PR for mobocertinib’s NDA to treat adult patients with EGFR Exon20 insertion+ mNSCLC, as detected by an FDA-approved test, who have received prior Pt-based CT. The anticipated PDUFA date is Oct 26, 2021 The NDA is based on a P-I/II study assessing mobocertinib (PO) in patients with mNSCLC. The …

The US FDA Grants Priority Review to Takeda’s Mobocertinib (TAK-788) for EGFR Exon20 Insertion+ Metastatic Non-Small Cell Lung Cancer Read More »

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’ Key Highlights of First Quarter 2021 Read More »

Seqster bags $12m funding for patient data platform

Digital health player Seqster has raised $12 million in first-round financing that will be used to develop its data platform, which aims to put all a patient’s medical history in one easily-accessible place.  The Series A was led by OmniHealth Holdings, with repeat investor Takeda and Anne Wojcicki – chief executive and founder of genetic …

Seqster bags $12m funding for patient data platform Read More »

ViewPoints Interview: Takeda’s Nirav Desai Shares Insight on Data of TAK-721 Presented at ACG 2021

In an interview with Nirav Desai, Global Clinical Development Lead at Takeda shared his views on Tak-721 presented at ACG 2021 and its implications for patients and HCPs. The presentation includes post hoc analyses from a 12-week, randomized, double-blind, placebo-controlled Phase 3 clinical trial that investigated the safety and efficacy of BOS in patients with EoE 11 to 55 …

ViewPoints Interview: Takeda’s Nirav Desai Shares Insight on Data of TAK-721 Presented at ACG 2021 Read More »

PharmaShots Weekly Snapshots (Mar 22 – 26, 2021)

Pfizer and BioNTech Initiate COVID-19 Vaccine Trial in Children Under 12 Published: Mar 26, 2021 | Tags: Pfizer and BioNTech, Initiate, COVID-19 Vaccine Trial, Children, Under 12 Tetra Bio-Pharma Initiates Additional Studies of ARDS-003 in Neuroinflammation and Antiviral Diseases Published: Mar 26, 2021 | Tags: Tetra Bio-Pharma, Initiates, Additional Studies, ARDS-003,  Neuroinflammation, Antiviral Diseases Immunai …

PharmaShots Weekly Snapshots (Mar 22 – 26, 2021) Read More »

Takeda Reports EMA’s Acceptance of TAK-003 for the Prevention of Dengue

Shots: The submission is based on a P-III TIDES trial assessing TAK-003 (0.5ml, SC) vs PBO in 20,000+ healthy children & adolescents aged 4-16yrs. to prevent dengue fever of any severity and due to any of the four dengue virus serotypes The trial met its 1EPs showed overall vaccine efficacy against VCD @12 mos. follow-up …

Takeda Reports EMA’s Acceptance of TAK-003 for the Prevention of Dengue Read More »

Takeda Collaborates with Evotec on RNA Targeting Drug Development

Shots: Evotec to receive research funding and will be eligible for $160M/program as discovery, pre/ clinical, a commercial milestone along with royalties on sales of product emerges from the collaboration The collaboration will utilize Evotec’s RNA targeting platform to identify RNA sequences to target with small-molecule ligands aligned that can be developed into the first-in-class …

Takeda Collaborates with Evotec on RNA Targeting Drug Development Read More »

PharmaShots Weekly Snapshots (Mar 15 – 19, 2021)

Takeda Collaborates with Anima to Discover and Develop mRNA Translation Modulators for Neurological Diseases Published: Mar 19, 2021 | Tags: Takeda, Collaborates, Anima, Discover, Develop, mRNA Translation Modulators, Neurological Diseases Kiniksa’s Arcalyst (rilonacept) Receives the US FDA’s Approval for the Treatment of Pericarditis Published: Mar 19, 2021 | Tags: Kiniksa, Arcalyst (rilonacept), Receives, US, FDA, …

PharmaShots Weekly Snapshots (Mar 15 – 19, 2021) Read More »

PharmaShots Weekly Snapshots (Mar 15 – 19, 2021)

Takeda Collaborates with Anima to Discover and Develop mRNA Translation Modulators for Neurological Diseases Published: Mar 19, 2021 | Tags: Takeda, Collaborates, Anima, Discover, Develop, mRNA Translation Modulators, Neurological Diseases Kiniksa’s Arcalyst (rilonacept) Receives the US FDA’s Approval for the Treatment of Pericarditis Published: Mar 19, 2021 | Tags: Kiniksa, Arcalyst (rilonacept), Receives, US, FDA, …

PharmaShots Weekly Snapshots (Mar 15 – 19, 2021) Read More »

Takeda Collaborates with Anima to Discover and Develop mRNA Translation Modulators for Neurological Diseases

Shots: Anima to receive ~ $120M up front, preclinical milestones and ~$1.1B as clinical and commercial milestones along with royalties on each product emerge under the collaboration Takeda gets an exclusive right to develop and commercialize the mRNA transational modulators and has a time limited option to expands the collaboration for three additional targets for …

Takeda Collaborates with Anima to Discover and Develop mRNA Translation Modulators for Neurological Diseases Read More »

Takeda Collaborates with Anima to Discover and Develop mRNA Translation Modulators for Neurological Diseases

Shots: Anima to receive ~ $120M up front, preclinical milestones and ~$1.1B as clinical and commercial milestones along with royalties on each product emerge under the collaboration Takeda gets an exclusive right to develop and commercialize the mRNA transational modulators and has a time limited option to expands the collaboration for three additional targets for …

Takeda Collaborates with Anima to Discover and Develop mRNA Translation Modulators for Neurological Diseases Read More »

Takeda Signs a License Agreement with Genevant to Develop Novel Nucleic Acid Therapeutics for Liver Fibrosis

Shots: Genevant to receive up to $600M up front and milestone as well as royalties on future product sales Takeda get exclusive rights to access Genevant’s LNP technology for a specified number of selected hepatic stellate cells targets The companies collaborated to discover, develop and commercialize the LNP-delivered nucleic acid therapeutics directed to previously inaccessible …

Takeda Signs a License Agreement with Genevant to Develop Novel Nucleic Acid Therapeutics for Liver Fibrosis Read More »

PharmaShots Weekly Snapshots (Mar 08 – 12, 2021)

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: …

PharmaShots Weekly Snapshots (Mar 08 – 12, 2021) Read More »

Takeda Reports NDA Submission of Lanadelumab to the MHLW as a Preventive Treatment for Hereditary Angioedema Attack in Japan

Shots: The submission is based on P-III HELP study evaluating lanadelumab (300mg, q2w & q4w) vs PBO in 125 patients with HAE attack for 26wks. It also based on P-III HELP OLE study and interim results of P-III study that evaluated lanadelumab in Japanese patients. If approved, lanadelumab will be available as a pre-filled syringe …

Takeda Reports NDA Submission of Lanadelumab to the MHLW as a Preventive Treatment for Hereditary Angioedema Attack in Japan Read More »

Takeda Reports NDA Submission of Lanadelumab to the MHLW as a Preventive Treatment for Hereditary Angioedema Attack in Japan

Shots: The submission is based on P-III HELP study evaluating lanadelumab (300mg, q2w & q4w) vs PBO in 125 patients with HAE attack for 26wks. It also based on P-III HELP OLE study and interim results of P-III study that evaluated lanadelumab in Japanese patients. If approved, lanadelumab will be available as a pre-filled syringe …

Takeda Reports NDA Submission of Lanadelumab to the MHLW as a Preventive Treatment for Hereditary Angioedema Attack in Japan Read More »

Insights+: Breakthrough Therapy Designation by the US FDA in 2020

Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012 The Breakthrough Designation is granted to the drug candidates as monotherapy or in combination with other drugs intended to treat serious or life-threatening diseases and has shown substantial improvement over available …

Insights+: Breakthrough Therapy Designation by the US FDA in 2020 Read More »

Takeda buys Maverick as T-Cell engager research hots up

Takeda is taking its option to buy the privately held biotech Maverick Therapeutics and its T-Cell engager cancer therapies for $525 million, as research into the technology gathers pace. San Francisco-based Maverick’s technology is designed to target solid tumours with a T-cell attack that focuses on cancerous tissues while leaving healthy tissue alone. Standard T-cell …

Takeda buys Maverick as T-Cell engager research hots up Read More »

Takeda to Acquire Maverick for ~$525M

Shots: Takeda exercised its option to acquire Maverick for up to $525M up front as well as development and regulatory milestones including Takeda’s current equity stake and Maverick debt. The acquisition is expected to finalize in Q1’21 The acquisition will expand Takeda’s I-O portfolio with the addition of two development candidates (MVC-101 & MVC-280) and …

Takeda to Acquire Maverick for ~$525M Read More »

PharmaShots Weekly Snapshots (Mar 01 – 05, 2021)

Eli Lilly and Incyte Report Results of Olumiant (baricitinib) in P-III BRAVE-AA2 Study for Severe Alopecia Areata Published: Mar 5, 2021 | Tags: Eli Lilly and Incyte, Report, Results, Olumiant (baricitinib), P-III, BRAVE-AA2, Study, Severe, Alopecia Areata Takeda Reports NDA Submission to Import and Distribute Moderna’s mRNA-1273 in Japan Published: Mar 5, 2021 | Tags: …

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Takeda Reports NDA Submission to Import and Distribute Moderna’s mRNA-1273 in Japan

Shots: Takeda has submitted an NDA to MHLW to import and distribute Moderna’s (mRNA-1273/ TAK-919) in Japan Takeda is conducting a P- I/II study assessing the safety and immunogenicity of two vaccinations of TAK-919 (100μg, given 28 days apart) in 200 participants aged ≥20yrs. followed through 12mos. after the second vaccination. Takeda has completed enrollment …

Takeda Reports NDA Submission to Import and Distribute Moderna’s mRNA-1273 in Japan Read More »

PharmaShots Weekly Snapshots (Feb 22- 26, 2021)

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 | …

PharmaShots Weekly Snapshots (Feb 22- 26, 2021) Read More »

Switch data back Chiesi/Protalix long-acting Fabry drug

Chiesi and Protalix have built the case for their long-acting enzyme replacement therapy (ERT) for Fabry disease PRX-102, as the FDA’s review of the drug continues towards a decision due by 27 April.  New data from the phase 3 BRIGHT study of PRX-102 (pegunigalsidase alfa) shows that patients can be switched to the new drug …

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Takeda Reports First Patients Dosing in P-I/II Study of Novavax’s COVID-19 Vaccine Candidate in Japan

Shots: Takeda is providing rapid & sustained access to COVID-19 vaccines in Japan through partnerships with Novavax and Moderna. Earlier, Takeda has completed enrollment in the P-I/II study of TAK-919 in Japan The studies are designed to include 200 healthy Japanese adults followed by 12mos. after the second vaccination with primary results expected in CY2021. …

Takeda Reports First Patients Dosing in P-I/II Study of Novavax’s COVID-19 Vaccine Candidate in Japan Read More »

PharmaShots Weekly Snapshots (Feb 15- 19, 2021)

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, …

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Merck, Eisai in renal cancer market; G1 Therapeutics on Cosela’s approval; Takeda’s Maribavir; Astellas/Seagen Padcev

Merck’s Keytruda-Eisai’s Lenvima Combo Make the Cut in Renal Cancer Numerous immunotherapy-based combinations are already trying in the old game of gleek to stake up some share in previously untreated, metastatic kidney cancer; however, the market seems to expand as the new entrants continue to make their entry.  Merck and the partner Eisai presented investigational …

Merck, Eisai in renal cancer market; G1 Therapeutics on Cosela’s approval; Takeda’s Maribavir; Astellas/Seagen Padcev Read More »

Takeda Report Results of TAK-620 (maribavir) in P-III SOLCTICE Trial for the Treatment of Post-Transplant Patients with Cytomegalovirus Infection

Shots: The P-III TAK-620-303 (SOLSTICE) trial involves assessing TAK-620 (400mg) vs conventional antiviral therapies (IAT) in HCT and SOT recipients in a ratio (2:1) with R/R CMV infection refractory with/ out resistance, to one or a combination of the conventional antiviral therapies The 1EPs study shows confirmed CMV viremia clearance @ 8wk; (55% vs 26.1% …

Takeda Report Results of TAK-620 (maribavir) in P-III SOLCTICE Trial for the Treatment of Post-Transplant Patients with Cytomegalovirus Infection Read More »

PharmaShots Weekly Snapshots (Feb 08 – 12, 2021)

Visby’s POC COVID-19 Test Receives the US FDA’s EUA for Use in CLIA Waived Settings Published: Feb 12, 2020 | Tags: Visby, POC, COVID-19, Test, Receives, US, FDA, EUA, Use, CLIA, Waived, Settings Takeda Collaborates with Ensoma to Accelerate Next-Generation In Vivo Gene Therapies Published: Feb 12, 2020 | Tags: Takeda, Collaborates, Ensoma, Accelerate, Next-Generation, Vivo Gene …

PharmaShots Weekly Snapshots (Feb 08 – 12, 2021) Read More »

Takeda Collaborates with Ensoma to Accelerate Next-Generation In Vivo Gene Therapies

Shots: Ensoma to receive $100M in up front & preclinical research payment, $10M in equity investment, and is eligible to receive $1.25B as development and commercialization milestones along with royalties on sales of each product Takeda to get an exclusive WW rights Ensoma’s Engenious vectors for up to five rare disease indications. Ensoma to conduct …

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PharmaShots Weekly Snapshots (Jan 18 – 22, 2021)

Takeda’s Alunbrig (brigatinib) Receives MHLW’s Approval as a 1L and 2L Treatment for ALK+ Advanced or Recurrent NSCLC Published: Jan 22, 2020 | Tags: Takeda, Alunbrig, (brigatinib), Receives, MHLW, Approval,1L and 2L, Treatment, ALK+ Advanced or Recurrent NSCLC MTPA and Aquestive Sign a License and Supply Agreement for Exservan (riluzole) to Treat ALS in the …

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Takeda’s Alunbrig (brigatinib) Receives MHLW’s Approval as a 1L and 2L Treatment for ALK+ Advanced or Recurrent NSCLC

Shots: The approval is based on P-II Brigatinib-2001 (J-ALTA) assessing Alunbrig in 72 Japanese patients with ALK+ NSCLC and P-III AP26113-13-301 (ALTA-1L) study assessing Alunbrig (180mg, qd with seven-day lead-in at 90mg, qd) vs crizotinib (250mg, bid) in 275 patients with ALK+ advanced NSCLC prior not treated with an ALK inhibitor The therapy showed effectiveness …

Takeda’s Alunbrig (brigatinib) Receives MHLW’s Approval as a 1L and 2L Treatment for ALK+ Advanced or Recurrent NSCLC Read More »

Scotland backs Roche’s Rozlytrek for ROS1 lung cancer

The Scottish Medicines Consortium (SMC) has given a green light to Roche’s Rozlytrek for a rare form of lung cancer, almost seven months after NICE backed the drug in England. Rozlytrek (entrectinib) can now be used by the NHS in Scotland as a treatment option for ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously …

Scotland backs Roche’s Rozlytrek for ROS1 lung cancer Read More »

J&J’s Darzalex Faspro is first US therapy for rare blood disorder

Johnson & Johnson’s Darzalex Faspro has become the first product approved by the FDA to treat light chain (AL) amyloidosis, a rare and often fatal blood cell disorder. The new indication is the second for Darzalex Faspro, a subcutaneous version of blockbuster intravenous therapy Darzalex (daratumumab) which is used to treat multiple myeloma on its …

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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, …

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Takeda and KSQ Collaborate to Develop and Commercialize Novel Immuno-Oncology Therapies

Shots: KSQ to receive $100M+ as up front and preclinical milestones and up to $400M+/ program in option payment and development & commercialization milestones along with royalties on sales of each approved products The deal includes two KSQ’s previously identified & validated T-cell targets with the potential to introduce two additional targets to the collaboration …

Takeda and KSQ Collaborate to Develop and Commercialize Novel Immuno-Oncology Therapies Read More »

PharmaShots Weekly Snapshots (Dec 14-18, 2020)

Sandoz to Launch Hyrimoz (biosimilar, adalimumab) in Canada Published: Dec 17, 2020 | Tags: Authorization, Biosimilar, canada, health, Humira, Hyrimoz, Launch, receives, Sandoz Amgen’s Riabni (biosimilar, rituximab) Receives the US FDA’s Approval for Multiple Diseases Published: Dec 17, 2020 | Tags: Adult, Amgen, approval, Biosimilar, CLL, GPA, MPA, NHL, patients, receives, RIABNI, Rituxan, Rituximab, rituximab-arrx, …

PharmaShots Weekly Snapshots (Dec 14-18, 2020) Read More »

Takeda Reports the US FDA’s Acceptance of NDA for TAK-721 (budesonide oral suspension) to Treat Eosinophilic Esophagitis

Shots: The US FDA has accepted the NDA and granted PR for TAK-721 for the treatment of EoE. If approved, TAK-721 will be the first FDA-approved treatment for EoE and Takeda plans to launch it under the trade name Eohilia The NDA filing is based on P-III ORBIT-1 and ORBIT-2 studies which evaluated the safety …

Takeda Reports the US FDA’s Acceptance of NDA for TAK-721 (budesonide oral suspension) to Treat Eosinophilic Esophagitis Read More »

Pandemic has little impact on pharma’s reputation, says report

The pandemic has had very little positive impact on the public’s perceptions of pharma although the industry has fared much better than politicians, according to a report. According to the report from Takeda UK, only 17% of respondents said their impression of pharmaceutical companies had improved, based on how the industry had reacted to the …

Pandemic has little impact on pharma’s reputation, says report Read More »

5 big healthcare lawsuits of 2020

Some of the biggest legal stories of the year include patients attempting to mount a class action lawsuit against Mayo Clinic after an employee improperly viewed more than 1,600 health records and the Supreme Court hearing opening arguments in a case challenging the constitutionality of the ACA’s individual mandate.

BASE10 Collaboration; Advaxis Public offerings; Takeda’s CABOMETYX Japan approval; TheraPharm Acquisition

BASE10 Collaborates with DNA Link for COVID-19 Antibody Test Research US-based BASE10 Genetics and Korean firm DNA Link announced a collaboration on a research project to appraise the usability of the DNA Link’s antibody test, AccuFind COVID-19 IgG, in a healthcare setting. Currently, most antibody tests available in the market need the samples to be …

BASE10 Collaboration; Advaxis Public offerings; Takeda’s CABOMETYX Japan approval; TheraPharm Acquisition Read More »

Member of COVID R&D Alliance Report the First Patient Enrollment in COMMUNITY Study

Shots: Amgen, UCB, and Takeda reported that the first patient has been enrolled in the COMMUNITY trial. The study will test whether Amgen’s Otezla, Takeda’s lanadelumab, and UCB’s zilucoplan can reduce the severity of COVID-19 in hospitalized patients by moderating the immune system’s response to the disease The focus of the trial is to identify …

Member of COVID R&D Alliance Report the First Patient Enrollment in COMMUNITY Study Read More »

Egle Identifies First Novel Regulatory T-cell Targets Under its Collaboration with Takeda

Shots: Egle has achieved the first milestone in its research agreement with Takeda, signed in June’2020. Egle will validate novel tumor-infiltrating regulatory T-cell targets while Takeda will develop the potential therapies Egle has leveraged its unique bioinformatic & translational capabilities to identify targets Following the achievement of the target identification, Egle will receive an R&D …

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Takeda to partner on patient-centric data with Seqster

Takeda has partnered with patient data firm Seqster in a drive to improve care through better access and understanding of patient-level data. The partnership follows Takeda’s investment in the US startup earlier this year. The pharma firm said it wants to leverage the company’s technology across its business San Diego-based Seqster has developed a portal …

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ViewPoints Interview: Takeda’s Andrea Stancati Shares Insights on Entyvio (vedolizumab) SC Formulation

In a recent interview with PharmaShots, Andrea Stancati, Vice President, Head GI Global Medical Franchise shares his insights and highlights of Entyvio (vedolizumab) Shots: The ongoing P-IIIb VISIBLE OLE study involves assessing of Entyvio (SC) in adult patients with UC or CD, following enrolment and participation in the VISIBLE 1 (UC) or VISIBLE 2 (CD) …

ViewPoints Interview: Takeda’s Andrea Stancati Shares Insights on Entyvio (vedolizumab) SC Formulation Read More »

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 …

Top 20 Immunology Companies Based 2019 Immunology Segment Revenue Read More »

PharmaShots Weekly Snapshot (Oct 12-16, 2020)

Novartis’s Luxturna (voretigene neparvovec) Receives Health Canada Approval as the First Gene Replacement Therapy for Inherited Retinal Disease Published: Oct 15, 2020 | Tags: approval, Canada, health, Inherited Retinal Disease, Luxturna, Novartis, receives, voretigene neparvovec Galapagos & Servier’s GLPG1972/S201086 Fails to Meet its Primary Endpoint in P-II ROCCELLA Study for Knee Osteoarthritis Published: Oct 15, …

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Takeda Collaborates with Accenture and AWS to Transform into a Cloud-Based Company

Shots: Takeda has entered into a five-year agreement with Accenture and Amazon Web Services (AWS) to support the company in moving 80% of its applications to the cloud and modernizing its research tools The transition of Takeda’s applications to the cloud will enable the company to remove non-differentiating technology and create a scalable architecture. The …

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Takeda Signs ~$1B Pact with Arrowhead for ARO-AAT Targeting Alpha-1 Antitrypsin-Associated Liver Disease

Shots: Arrowhead to receive ~$300M up front, ~$740M as development, regulatory and commercial milestones and is eligible to receive royalties of 20-25% on net sales If approved, the companies will co-develop ARO-AAT and co-commercialize it in the US, under 50/50 profit sharing structure. Additionally, Takeda will lead the global commercialization strategy and get an exclusive …

Takeda Signs ~$1B Pact with Arrowhead for ARO-AAT Targeting Alpha-1 Antitrypsin-Associated Liver Disease Read More »

PharmaShots Weekly Snapshot (Aug 24 -28, 2020)

1. Taysha Gene Therapies’ TSHA-101 Receives the US FDA’s Orphan Drug Designation and Rare Pediatric Disease Designation for GM2 Gangliosidosis Published: Aug 27, 2020 | Tags:  Taysha Gene Therapies, TSHA-101, Receives, US, FDA, Orphan Drug Designation, Rare Pediatric Disease Designation, GM2 Gangliosidosis 2. Bayer Reports the NDA Submission to NMPA for Vericiguat to Treat Chronic …

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Is COVID the Rx for the Pharmaceutical Industry’s Reputation?

Darlene Dobry, Strategic Advisor, Medical Devices and Pharmaceuticals As the COVID-19 pandemic continues to bring the world’s economies, healthcare systems, and communities to their knees, the Pharma industry appears to be the shining hope to help us return to a new normal. Could the industry’s response to this global public health crisis be the Rx …

Is COVID the Rx for the Pharmaceutical Industry’s Reputation? Read More »

Takeda Collaborates with Engitix to Target Fibrotic Liver Diseases

Shots: Engitix to receive up front with additional payments based on the confirmation and functional validation of selected targets and is eligible to receive $500M as preclinical, development, regulatory and commercial milestones along with royalties on sales of therapies Takeda to get the exclusive rights to develop and commercialize the candidate emerges from the collaboration. …

Takeda Collaborates with Engitix to Target Fibrotic Liver Diseases Read More »

Takeda and Ovid Report Results of Soticlestat (TAK-935/OV935) in P-II ELEKTRA Study for Dravet Syndrome or Lennox-Gastaut Syndrome

Shots: The P-II ELEKTRA study involves assessing of soticlestat vs PBO in pediatric patients, aged 2-17 yrs., with highly refractory epileptic seizures associated with DS (convulsive seizures) or LGS (drop seizures) Results: meeting its 1EPs i.e. reduction in DS & LGS (27.8% vs 3.1% & 29.8% vs 0.0%) during the 12-wks. maintenance period & 20-wks. …

Takeda and Ovid Report Results of Soticlestat (TAK-935/OV935) in P-II ELEKTRA Study for Dravet Syndrome or Lennox-Gastaut Syndrome Read More »

Takeda agrees $2.3bn sale of Japanese consumer health unit

Takeda has joined the ranks of big pharma companies jettisoning consumer health businesses in order to concentrate on higher-margin prescription drugs. The drugmaker is divesting Takeda Consumer Healthcare, which operates mainly in Japan, to private equity group Blackstone for 242 billion yen ($2.3 billion), with the deal expected to close in March of next year. …

Takeda agrees $2.3bn sale of Japanese consumer health unit Read More »

Takeda to Divest its Consumer Health Unit to Blackstone for $2.3B in Japan

Shots: Takeda and Blackstone sign an agreement to divest it consumer health care business unit for $2.3B. The transaction expected to be closed by Mar 31, 2021 The portfolio to be divested includes OTC medicines and health products along with its lead product in the region, Alinamin. Blackstone plans to develop the business together with …

Takeda to Divest its Consumer Health Unit to Blackstone for $2.3B in Japan Read More »

Roche’s ulcerative colitis drug etrolizumab looks shaky after data roll-out

Roche’s late-stage trial programme for ulcerative colitis candidate etrolizumab has generated some positive and negative results, but leans firmly towards the latter. The Swiss drugmaker has acknowledged that the dual-acting anti-integrin antibody – which is trying to chase down Takeda’s blockbuster Entyvio in UC – generated “disappointing” results from the programme, which is billed as …

Roche’s ulcerative colitis drug etrolizumab looks shaky after data roll-out Read More »

Takeda’s Pevonedistat Receives the US FDA’s Breakthrough Therapy Designation to Treat Patients with Higher-Risk Myelodysplastic Syndrome

Shots: The BT designation is based on the final analysis of the Pevonedistat-2001 P-II study assessing pevonedistat + azacitidine vs azacitidine as monothx. in patients with rare leukemias, including HR-MDS The 1EPs of the study include OS, EFS, CR and transfusion independence, and AE profile. The designation addresses the needs of people living with HR-MDS, …

Takeda’s Pevonedistat Receives the US FDA’s Breakthrough Therapy Designation to Treat Patients with Higher-Risk Myelodysplastic Syndrome Read More »