BMS

BMS Reports Five-Year Data of Opdivo (nivolumab) + Yervoy (ipilimumab) in P-III CheckMate -214 for the Treatment of Advanced or Metastatic Renal Cell Carcinoma

Shots: The P-III CheckMate -214 trial evaluates Opdivo (3mg/kg) + Yervoy (1mg/kg, q3w for 4 doses) vs sunitinib in 1096 patients with previously untreated advanced/mRCC Results: @median follow-up of 67.7mos., combination showed superior OS in intermediate, poor risk patients & randomized or ITT population; m-OS (47.0 vs 26.6mos.) & (55.7 vs 38.4mos.); ORR (42% vs …

BMS Reports Five-Year Data of Opdivo (nivolumab) + Yervoy (ipilimumab) in P-III CheckMate -214 for the Treatment of Advanced or Metastatic Renal Cell Carcinoma Read More »

ONO and BMS Report Submission of sBLA for Opdivo (nivolumab) + Yervoy (ipilimumab) as 1L Treatment of Unresectable Advanced or Recurrent ESCC in Japan

Shots: The application is based on P-III CheckMate -648 study evaluating Opdivo (3mg/kg, q2w, IV) + Yervoy (1mg/kg, q6w up to 24mos.) or Opdivo + CT vs CT alone in patients with unresectable advanced or recurrent ESCC The results demonstrated an improvement in OS at pre-specified interim analysis in patients with tumor cell PD-L1 expression …

ONO and BMS Report Submission of sBLA for Opdivo (nivolumab) + Yervoy (ipilimumab) as 1L Treatment of Unresectable Advanced or Recurrent ESCC in Japan Read More »

BMS Reports Three-Year Data of Opdivo (nivolumab) + Yervoy (ipilimumab) in P-III CheckMate -743 Trial for 1L Treatment of Unresectable Malignant Pleural Mesothelioma

Shots: The P-III CheckMate -743 trial evaluates Opdivo (3mg/kg, q2w) + Yervoy (1mg/kg, q6w) vs CT in 605 patients with previously untreated unresectable MPM. The results will be presented at ESMO 2021 The result showed an improvement in OS with a reduction in risk of death, patients were alive (23% vs 15%) @3yrs., improvement in …

BMS Reports Three-Year Data of Opdivo (nivolumab) + Yervoy (ipilimumab) in P-III CheckMate -743 Trial for 1L Treatment of Unresectable Malignant Pleural Mesothelioma 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 »

BMS Exercised Its Option to License Evotec’s EVT8683 for the Treatment of Neurodegenerative Disease

Shots: Evotec receives $20M as an option fee & is eligible to receive ~$250M as milestones along with royalties. BMS will be responsible for further development & commercialization of a product BMS has exercised its option to license Evotec’s EVT8683 after 4.5yrs. of collaboration. Evotec’s iPSC platform allows screening of human iPSC-based disease models at …

BMS Exercised Its Option to License Evotec’s EVT8683 for the Treatment of Neurodegenerative Disease 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 »

PharmaShots Weekly Snapshots (August 16 – 20, 2021)

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 …

PharmaShots Weekly Snapshots (August 16 – 20, 2021) Read More »

BMS’ Abecma (Idecabtagene Vicleucel) Receives EC’s Conditional Approval for Relapsed and Refractory Multiple Myeloma

Shots: The conditional approval is based on KarMMa study evaluating Abecma (single infusion with a target dose of 420 x 106 CAR T cells) in 128 patients with r/r MM prior treated with 3L therapies including an immunomodulatory agent, a proteasome inhibitor & an anti-CD38 Ab and who are refractory to their last treatment Results: …

BMS’ Abecma (Idecabtagene Vicleucel) Receives EC’s Conditional Approval for Relapsed and Refractory Multiple Myeloma Read More »

BMS Reports EMA’s Validation of MAA for Opdivo (nivolumab) + Yervoy (ipilimumab) and Opdivo + CT to Treat Esophageal Squamous Cell Carcinoma

Shots: The applications are based on P-III CheckMate -648 trial evaluates Opdivo (3 mg/kg, q2w) + Yervoy (1 mg/kg, q6w up to 24mos.) or Opdivo (nivolumab) + CT vs CT alone in patients with unresectable advanced or metastatic ESCC Results: Both combinations showed OS benefit over CT at the pre-specified interim analysis in patients with …

BMS Reports EMA’s Validation of MAA for Opdivo (nivolumab) + Yervoy (ipilimumab) and Opdivo + CT to Treat Esophageal Squamous Cell Carcinoma 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 »

Have a chat to help others through loneliness

Looking back over the past 18 months, the Joni Mitchell lyric ‘you don’t know what you’ve got til it’s gone’ comes to mind. It’s only now, having been isolated, that we can appreciate how much small moments of contact with family and friends can mean. Bristol Myers Squibb’s Janice Creasy discusses how  and help reduce feelings …

Have a chat to help others through loneliness 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 »

BridgeBio Enters into Clinical Collaboration with BMS to Evaluate BBP-398 + Opdivo for Advanced Solid Tumors with KRAS Mutations

Shots: The companies will initiate P-I/II study evaluating the safety and preliminary efficacy of BBP-398 in combination with both Opdivo as dual therapy & Opdivo + KRASG12C inhibitor as triplet therapy in NSCLC patients with KRAS mutations, as 1L & 2L treatment options BridgeBio will sponsor the study while BMS will provide nivolumab to the …

BridgeBio Enters into Clinical Collaboration with BMS to Evaluate BBP-398 + Opdivo for Advanced Solid Tumors with KRAS Mutations Read More »

PharmaShots’ Key Highlights of Second Quarter 2021

The second quarter of 2021 witnesses major acquisitions, approvals, and clinical data. There are major alliances in this quarter which include Merck signed ~$1.2B supply agreement with US Government for Molnupiravir to treat COVID-19 The big acquisition took place during the quarter including Microsoft acquired Nuance for ~$19.7B, MorphoSys acquired Constellation for ~$1.7B Our team …

PharmaShots’ Key Highlights of Second Quarter 2021 Read More »

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 31 – June 4, 2021) Read More »

BMS Presents Results of Opdivo (nivolumab) + CT or Yervoy (ipilimumab) in P-III CheckMate -648 Trial for Unresectable Advanced or Metastatic ESCC at ASCO 2021

Shots: The P-III CheckMate -648 trial evaluating Opdivo + CT or Opdivo (3 mg/kg, q2w) + Yervoy (1 mg/kg, q6w up to 24mos.) in patients with unresectable advanced or metastatic ESCC Results: Both combinations showed OS benefits over CT in PD-L1 positive & all-randomized populations, m-OS for Opdivo + CT (13.7 vs 9.1 mos. & …

BMS Presents Results of Opdivo (nivolumab) + CT or Yervoy (ipilimumab) in P-III CheckMate -648 Trial for Unresectable Advanced or Metastatic ESCC at ASCO 2021 Read More »

BMS’ Abecma (idecabtagene vicleucel) Receives the Health Canada’s Approval as the First Anti-BCMA CAR T Cell Therapy for Relapsed and Refractory Multiple Myeloma

Shots: The conditional approval is based on the results of the P-II KarMMa study involves assessing Abecma in 122 patients with RRMM prior treated with 3L+ therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 Ab and who are refractory to their last treatment Results: @median follow-up of 13.3 mos., ORR (74%); CR …

BMS’ Abecma (idecabtagene vicleucel) Receives the Health Canada’s Approval as the First Anti-BCMA CAR T Cell Therapy for Relapsed and Refractory Multiple Myeloma 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 »

BMS’ Zeposia (ozanimod) Receives the US FDA’s Approval for Ulcerative Colitis

Shots: The approval is based on a P-III True North trial assess Zeposia (0.92 mg) vs PBO in an adult with mod. to sev. active UC The trial met its 1EPs & 2EPs i.e Zeposia as an induction & maintenance therapy demonstrates clinical remission (18% vs 6% & 37% vs 19%), clinical response (48% vs …

BMS’ Zeposia (ozanimod) Receives the US FDA’s Approval for Ulcerative Colitis Read More »

ONO and BMS’ Opdivo + Yervoy Receive Approval for 1L Treatment for Unresectable Advanced or Recurrent Malignant Pleural Mesothelioma

Shots: The approval is based on P-III CheckMate -743 study assessing Opdivo + Yervoy vs SOC Pt. based CT in patients with previously untreated unresectable malignant pleural mesothelioma The combination regimen has demonstrated significant extension of OS vs CT. The safety profile of combination treatment was consistent with those previously reported in the studies for …

ONO and BMS’ Opdivo + Yervoy Receive Approval for 1L Treatment for Unresectable Advanced or Recurrent Malignant Pleural Mesothelioma Read More »

BMS and Xencor Collaborate to Use Xtend XmAb Technology in SARS-CoV-2 Neutralizing mAb Combination for COVID-19

Shots: BMS to get non-exclusive access to Xencor’s Xtend Fc technology to extend the half-life of a novel Ab combination therapy that is intended to neutralize the SARS-CoV-2 virus to prevent COVID-19 BMS will solely lead research, development, regulatory and commercial activities for SARS-CoV-2 mAb Duo. Xencor is eligible to receive royalties from the sales …

BMS and Xencor Collaborate to Use Xtend XmAb Technology in SARS-CoV-2 Neutralizing mAb Combination for COVID-19 Read More »

New Cell & Gene Therapy Collective seeks to boost UK adoption

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 …

New Cell & Gene Therapy Collective seeks to boost UK adoption Read More »

BMS Receive the CHMP’s Positive Opinion Recommending Approval of Opdivo (nivolumab) + Yervoy (ipilimumab) for dMMR or MSI-H mCRC After Prior Chemotherapy

Shots: The opinion is based on P-II CheckMate -142 study assessing Opdivo + Yervoy in patients with mismatch repair deficient or microsatellite instability–high metastatic colorectal cancer whose disease had progressed during or after prior treatment with CT If approved, Opdivo in combination with Yervoy will be the first dual immunotherapy approved in the EU in …

BMS Receive the CHMP’s Positive Opinion Recommending Approval of Opdivo (nivolumab) + Yervoy (ipilimumab) for dMMR or MSI-H mCRC After Prior Chemotherapy 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 »

BMS Extends its 2019 Collaboration with Exscientia for AI Driven Drug Discovery

Shots: Exscientia to receive ~$50M as up front, ~$125M as milestones and additional clinical, regulatory, and commercial milestones of over $1.2B along with royalties on net sales of any marketed therapies resulting from the collaboration The expanded collaboration has the potential to add to the BMS drug pipeline whilst enhancing Exscientia’s portfolio of shared assets. …

BMS Extends its 2019 Collaboration with Exscientia for AI Driven Drug Discovery Read More »

BMS Signs an Exclusive Global License with Agenus for its Anti-TIGIT Bispecific Antibody Program

Shots: Agenus to receive a $200M as up front & ~$1.36B as development, regulatory and commercial milestones plus royalties on net sales of the therapies. Agenus will retain options to conduct clinical studies and combination studies with other pipeline assets and to co-promote AGEN1777 in the US BMS will be solely responsible for the development …

BMS Signs an Exclusive Global License with Agenus for its Anti-TIGIT Bispecific Antibody Program Read More »

BMS Presents Results of Mavacamten in P-III Study for Obstructive Hypertrophic Cardiomyopathy at ACC 2021

Shots: The P-III EXPLORER-HCM study involves assessing Mavacamten vs PBO in 251 patients in a ratio (1:1) with symptomatic oHCM (LVOT gradient ≥50 mmHg and NYHA Class II-III) for 30wks, followed by an 8-week washout Results: @30wks. change in KCCQ OSS in greater than PBO arm; KCCQ OSS ≥20 points (36% vs 15%); a greater …

BMS Presents Results of Mavacamten in P-III Study for Obstructive Hypertrophic Cardiomyopathy at ACC 2021 Read More »

PharmaShots Weekly Snapshots (May 03 – 07, 2021)

AstraZeneca Reports Results of Imfinzi (durvalumab) and Imfinzi + Tremelimumab in P-III POSEIDON Study as 1L Treatment for Stage IV Non-Small Cell Lung Cancer Published: May 7, 2021 | Tags: AstraZeneca, Imfinzi, durvalumab, Tremelimumab, P-III, POSEIDON Study, Stage IV Non-Small Cell Lung Cancer Merck and Fusion Pharmaceuticals Enter into a Clinical Collaboration for FPI-1434 + …

PharmaShots Weekly Snapshots (May 03 – 07, 2021) Read More »

BMS Signs a Research Collaboration with DarwinHealth to Discover Novel Cancer Target Initiative

Shots: DarwinHealth will receive an upfront and eligible to receive as a commercial milestone, as part of the NCTI collaboration The focus of the collaboration is to identify NCTs across tumor subtypes for different cancer types by using quantitative systems biology-based algorithms, databases, and technologies and leads to the development of drugs with multi-subtype indications …

BMS Signs a Research Collaboration with DarwinHealth to Discover Novel Cancer Target Initiative Read More »

BMS Presents Clinical and RWE Data of Mavacamten for Obstructive Hypertrophic Cardiomyopathy at ACC 2021

Shots: The company presented new analysis data from the P-III EXPLORER-HCM trial assessing mavacamten in patients with oHCM that tested the impact of the therapy on patients’ health status i.e symptoms, function, and QoL The company unveils the interim results from MAVA-LTE, 5yrs. extension study of the EXPLORER-HCM. The study demonstrated improvement in LVOT gradients, …

BMS Presents Clinical and RWE Data of Mavacamten for Obstructive Hypertrophic Cardiomyopathy at ACC 2021 Read More »

BMS Reports the US FDA’s Acceptance of Opdivo’s sBLA for Priority Review to Treat Muscle Invasive Urothelial Carcinoma

Shots: The filing is based on results from the P-III CheckMate -274 trial evaluating Opdivo (240mg, q2w for up to 1 yrs.) vs PBO in a ratio (1:1) in 709 patients with muscle-invasive urothelial cancer who are at a high risk of recurrence after radical surgery The study demonstrated the improvement in DFS regardless of …

BMS Reports the US FDA’s Acceptance of Opdivo’s sBLA for Priority Review to Treat Muscle Invasive Urothelial Carcinoma Read More »

BMS Presents Results of Deucravacitinib in Two P- III Trials for Moderate to Severe Plaque Psoriasis at AAD2021

Shots: The two P-III POETYK PSO-1 and POETYK PSO-2 trials evaluating deucravacitinib (6mg, qd) vs PBO & Otezla (30mg, bid) @16wks. and vs Otezla @24wks. in 666 and 1,020 patients with the mod. to sev. plaque psoriasis respectively The trials met its co-1EPs & 2EPs i.e @16wks., PASI 75 (58.7% and 53.6%) vs (12.7% and …

BMS Presents Results of Deucravacitinib in Two P- III Trials for Moderate to Severe Plaque Psoriasis at AAD2021 Read More »

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 Weekly Snapshots (Apr 19 – 23, 2021) Read More »

BMS’ Opdivo + Yervoy and Onureg Receive EC’s CHMP Positive Opinion for MPM and AML

Shots: The CHMP has recommended the approval of Opdivo (nivolumab) + Yervoy (ipilimumab) as 1L treatment for unresectable MPM and is based P-III CheckMate -743 trial that met its 1EPs of OS The opinion for Onureg is based P-III QUAZAR AML-001 study assessing Onureg (300mg, qd) vs PBO in 472 patients in a ratio (1:1) …

BMS’ Opdivo + Yervoy and Onureg Receive EC’s CHMP Positive Opinion for MPM and AML Read More »

PharmaShots Weekly Snapshots (Apr 12 – 16, 2021)

ThermoFisher to Acquire PPD for ~$17.4B Published: Apr 16, 2021 | Tags: ThermoFisher, Acquire, PPD, ~$17.4B Roche’s Evrysdi (risdiplam) Receives Health Canada’s Approval for Spinal Muscular Atrophy in Adults and Children Published: Apr 16, 2021 | Tags: Roche, Evrysdi (risdiplam), Receives, Health Canada, Approval, Spinal Muscular Atrophy, Adults, Children GSK Discontinues the P-II Trials of …

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

BMS’ Opdivo (nivolumab) + Cabometyx (cabozantinib) Receive EC’s Approval for 1L Treatment of Advanced Renal Cell Carcinoma

Shots: The approval is based on P-III CheckMate -9ER trial involves assessing Opdivo + Cabometyx vs sunitinib in 651 patients with previously untreated advanced or metastatic RCC Results: @median follow-up of 10.6 mos.; m-PFS (16.6 vs 8.3mos.), ORR (55.7% vs 27.1%); CR (9.3% vs 4.3%); OS (40% reduction in risk of death), Grade 3+ AEs …

BMS’ Opdivo (nivolumab) + Cabometyx (cabozantinib) Receive EC’s Approval for 1L Treatment of Advanced Renal Cell Carcinoma Read More »

BMS Presents Results of Opdivo (nivolumab) + CT in P-III CheckMate-816 Trial for Resectable NSCLC at AACR2021

Shots: The P-III CheckMate-816 study involves assessing Opdivo (360mg) + CT (q3w for 3 doses) vs CT, followed by surgery as a neoadjuvant treatment in 358 patients with resectable stage Ib to IIIa NSCLC The study met its 1EPs, i.e. improvement in pCR (24% vs 2.2%) and showed improvement in 2EPs i.e. MPR (36.9% vs …

BMS Presents Results of Opdivo (nivolumab) + CT in P-III CheckMate-816 Trial for Resectable NSCLC at AACR2021 Read More »

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 …

PharmaShots Weekly Snapshots (Apr 05 – 09, 2021) Read More »

BMS and PsiOxus Therapeutics Expand their 2016 Immuno-Oncology Collaboration

Shots: In the P-I SPICE study, the companies will evaluate the clinical combination of BMS’ Opdivo with PsiOxus’ NG-641 and optimize the combination IV dosing regimen in late-stage cancer patients to treat a range of tumor types PsiOxus will be responsible to conduct P-I study with patient recruitment expected to initiate in Q3’21 NG-641 is …

BMS and PsiOxus Therapeutics Expand their 2016 Immuno-Oncology Collaboration Read More »

PharmaShots Weekly Snapshots (Mar 29 – Apr 02, 2021)

Pfizer and BioNTech Report Results of BNT162b2 to Prevent COVID-19 Published: Apr 2, 2021 | Tags: Pfizer and BioNTech, Report, Results, BNT162b2, Prevent, COVID-19 Acceleron Presents Results of Sotatercept in P-II PULSAR Trial for the Treatment of Pulmonary Arterial Hypertension, Published in NEJM Published: Apr 2, 2021 | Tags: Acceleron, Presents, Results, Sotatercept, P-II PULSAR …

PharmaShots Weekly Snapshots (Mar 29 – Apr 02, 2021) Read More »

BMS and bluebird bio’s Abecma (idecabtagene vicleucel) Receive the US FDA’s Approval as the First Anti-BCMA CAR T Cell Therapy for R/R Multiple Myeloma

Shots: The approval is based on the P-II  KarMMa trial that involves assessing Abecma in 127 patients with r/r MM prior treated with 3L+ therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 Ab Results: ORR (72%); sCR (28%); mDoR (11mos.); responses were rapid and durable, with a median time to response of …

BMS and bluebird bio’s Abecma (idecabtagene vicleucel) Receive the US FDA’s Approval as the First Anti-BCMA CAR T Cell Therapy for R/R Multiple Myeloma 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 »

Bristol Myers Squibb SVP Ho Sung Cho highlights legacy and ongoing research in protein degradation  [Sponsored]

Cho discusses Bristol Myers Squibb’s research efforts in the field of protein degradation to advance potential treatments for a broad range of diseases. In a recent MedCity Pivot Podcast, he also shared insights on his approach to drug discovery, perspectives on dealing with failure, and some of the work his teams are doing in the …

Bristol Myers Squibb SVP Ho Sung Cho highlights legacy and ongoing research in protein degradation  [Sponsored] Read More »

BMS Report Results of Relatlimab + Opdivo (nivolumab) in P-II/III RELATIVITY-047 Study in Patients with Previously Untreated Metastatic or Unresectable Melanoma

Shots: The P-II/III RELATIVITY-047 (CA224-047) study involves assessing the FD combination of relatlimab (160 mg) + Opdivo (480mg) vs Opdivo (480mg, IV, q4w) alone in 714 patients in a ratio (1:1) with previously untreated metastatic or unresectable melanoma The study met its 1EPs of the PFS while the follow-up for 2EPs of OS and ORR …

BMS Report Results of Relatlimab + Opdivo (nivolumab) in P-II/III RELATIVITY-047 Study in Patients with Previously Untreated Metastatic or Unresectable Melanoma Read More »

In MedCity Pivot podcast, biopharma researcher talks about protein degradation, recent success tied to Covid-19 [Sponsored]

Ho Sung Cho, senior vice president of Biodiscovery Therapeutics at Bristol Myers Squibb, talks about lessons learned from drug discovery, recent success tied to Covid-19, and how the company is leveraging its expertise in protein degradation to develop novel therapies for blood cancers, solid tumors and other important therapeutic areas.

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 »

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: …

PharmaShots Weekly Snapshots (Mar 01 – 05, 2021) Read More »

BMS’ Opdivo (nivolumab) + Cabometyx (cabozantinib) Receive CHMP’s Positive Opinion as 1L Treatment for Advanced Renal Cell Carcinoma

Shots: The CHMP recommendation is based on P-III CheckMate -9ER trial involves assessing Opdivo + Cabometyx vs sunitinib in 651 patients with previously untreated advanced or metastatic RCC The P-III result showed improvements in PFS, OS and ORR with consistent efficacy benefits observed across key subgroups of patients and was well tolerated, with a low …

BMS’ Opdivo (nivolumab) + Cabometyx (cabozantinib) Receive CHMP’s Positive Opinion as 1L Treatment for Advanced Renal Cell Carcinoma 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 »

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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The Paradox of Rare: Chalking out Challenges in the Rare Disease Market

How is a Rare disease defined? Well, it depends on the geography in question, since there is no universal definition, even so, the definition revolves around the point of prevalence or incidence of rare disease. However, despite the changing attributes in the definition, there is one common ground every country faces‒challenges in mapping the patient …

The Paradox of Rare: Chalking out Challenges in the Rare Disease Market 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 »

BMS Collaborate with Molecular Templates to Develop Engineered Toxin Body Therapies for Cancer

Shots: MTEM to receive $70M up front and is also eligible to receive ~$1.3B as development, regulatory and sales milestone along with royalties on future sales MTEM will be responsible for research activities to discover next generation ETBs for multiple targets, of which BMS selected the first target. BMS to get an option to obtain …

BMS Collaborate with Molecular Templates to Develop Engineered Toxin Body Therapies for Cancer Read More »

Top 20 Biopharma Deal Terminations of 2020 Based on Total Deal Value

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 …

Top 20 Biopharma Deal Terminations of 2020 Based on Total Deal Value Read More »

BMS Report Results of Opdivo (nivolumab) + Cabometyx (cabozantinib) in P-III CheckMate -9ER Trial for 1L Treatment of Advanced Renal Cell Carcinoma

Shots: The P-III CheckMate -9ER trial involves assessing Opdivo + Cabometyx vs sunitinib in 651 patients with previously untreated advanced or metastatic RCC Results: @median follow-up of two years (23.5 mos.); median PFS (17.0 vs 8.3mos.), ORR (54.8% vs. 28.4%); Disease control rate (88.2% vs. 69.9%); CR (9.3% vs 4.3%); OS (34% reduction in risk …

BMS Report Results of Opdivo (nivolumab) + Cabometyx (cabozantinib) in P-III CheckMate -9ER Trial for 1L Treatment of Advanced Renal Cell Carcinoma Read More »

BMS’ Inrebic (fedratinib) Receives EC’s Approval for Patients with Newly Diagnosed and Previously Treated Myelofibrosis

Shots: The EC approval is based on JAKARTA and JAKARTA2 studies. The pivotal JAKARTA study involves assessing Inrebic (500mg) vs PBO in 289 patients with intermediate-2 or high-risk primary or secondary myelofibrosis with splenomegaly The P-II JAKARTA 2 study involves assessing of Inrebic (400mg, qd) in 97 patients with intermediate or high-risk primary or secondary …

BMS’ Inrebic (fedratinib) Receives EC’s Approval for Patients with Newly Diagnosed and Previously Treated Myelofibrosis Read More »

PharmaShots Weekly Snapshot (Feb 01-05, 2021)

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 …

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BMS’ Deucravacitinib Demonstrate Superiority Over Otezla (apremilast) in P-III POETYK PSO-2 Study for Plaque Psoriasis

Shots: The P-III POETYK PSO-2 study involves assessing deucravacitinib (6mg, qd) vs PBO & Otezla (30mg, bid) in 1,020 patients with moderate to severe plaque psoriasis The trial met its co-1EPs & 2EPs demonstrating deucravacitinib was superior to Otezla (apremilast) in the patients reaching a PASI 75 and sPGA 0/1 @16wks. The overall safety profile …

BMS’ Deucravacitinib Demonstrate Superiority Over Otezla (apremilast) in P-III POETYK PSO-2 Study for Plaque Psoriasis Read More »

ViewPoints Interview: BMS Foundation’s Patricia Mae Doykos Shares Insights on COVID Advocacy Exchange

In a recent interview with PharmaShots, Patricia Mae Doykos, Lead, Health Equity Initiative, and Director, BMS Foundation at Bristol Myers Squibb shared her views on the promotion of health equity and improvement in health outcomes of populations disproportionately affected by serious diseases and conditions. Shots: CAE is a virtual platform that convenes advocacy groups, patients, …

ViewPoints Interview: BMS Foundation’s Patricia Mae Doykos Shares Insights on COVID Advocacy Exchange Read More »

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 …

Top 20 Life Sciences Deals of 2020 by Total Deal Value Read More »

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, …

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

PharmaShots’ Key Highlights of Fourth Quarter 2020

The fourth quarter of 2020 contains multiple initiations of clinical trials, big approvals, and numerous deals. COVID-19 related news remains at the peak in this quarter Multiple companies received regulatory bodies’ EUA for their vaccines and treatments for COVID-19. Initiating with, Regeneron sought the US FDA’s EUA for REGN-COV2 Ab combination while Health Canada accelerated …

PharmaShots’ Key Highlights of Fourth Quarter 2020 Read More »

PharmaShots Weekly Snapshot (Nov 23 – 27, 2020)

Merck Collaborates with Siemens for the Digitalization of Production Published: Nov 26, 2020 | Tags: Agreement, Collaborative, Digitalization, Merck, Siemens, Sign CoSara Receives CDSCO’s Approval for its Saragene COVID-19 2-Gene Multiplex Test Published: Nov 26, 2020 | Tags: approval, CDSCO, Co-Diagnostics JV CoSara, COVID-19 2-gene multiplex RT-PCR, India, Manufacture, receives, Saragene, Sell, Test PostEra Collaborates …

PharmaShots Weekly Snapshot (Nov 23 – 27, 2020) Read More »

Schrödinger Signs a $2.7B Agreement with BMS to Develop and Commercialize Therapies in Multiple Disease Areas

Shots: Schrödinger to receive $55M upfront and is eligible to receive $2.7B as preclinical, development, regulatory & commercial milestones along with royalties on sales of each product commercialized by BMS Schrödinger to grant BMS exclusive WW rights to develop & commercialize the development candidates emerges from the collaboration The collaboration will merge Schrödinger’s computational platform …

Schrödinger Signs a $2.7B Agreement with BMS to Develop and Commercialize Therapies in Multiple Disease Areas Read More »

PharmaShots Weekly Snapshot (Nov 02-06, 2020)

AstraZeneca’s Brilinta (ticagrelor) Receives the US FDA’s Approval to Reduce the Risk of Stroke in Patients with an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack Published: Nov 6, 2020 | Tags: AstraZeneca, Brilinta, ticagrelor, Receives, US FDA, Approval, Acute, High,Risk, Transient, Ischaemic, Stroke Novo Nordisk to Acquire Emisphere Technologies for $1.8B Published: Nov 6, …

PharmaShots Weekly Snapshot (Nov 02-06, 2020) Read More »

BMS’ Deucravacitinib (BMS-986165) Demonstrate Superiority Over Amgen’ Otezla (apremilast) in P-III POETYK PSO-1 Study for Plaque Psoriasis

Shots: The P-III POETYK PSO-1 study involves assessing deucravacitinib (6mg, qd) vs PBO & Otezla (apremilast) in 666 patients with moderate to severe plaque psoriasis The trial met its co-1EPs & 2EPs demonstrating deucravacitinib was superior to Otezla (apremilast) in the patients reaching a PASI 75 and sPGA 0/1 @16wks. The overall safety profile of …

BMS’ Deucravacitinib (BMS-986165) Demonstrate Superiority Over Amgen’ Otezla (apremilast) in P-III POETYK PSO-1 Study for Plaque Psoriasis Read More »

BMS Signs a Five-Year Agreement with Insitro to Develop Therapies for ALS and Frontotemporal Dementia

Shots: Insitro to receive $50M as up front, $20M as near-term operational milestones and is eligible to receive ~$2B+ as discovery, development, regulatory and commercial milestones along with royalties on sales of the therapies BMS will lead the clinical development, regulatory submissions, and commercialization activities. Insitro will apply its insitro Human (ISH) platform, to create …

BMS Signs a Five-Year Agreement with Insitro to Develop Therapies for ALS and Frontotemporal Dementia 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 …

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Insights+: The US FDA New Drug Approvals in September 2020

The US FDA has approved 6 NDAs in Sept 2020, 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 85 novel products so far in 2020, including 6 in Sept 2020. Additionally, last year …

Insights+: The US FDA New Drug Approvals in September 2020 Read More »

BMS’ Zeposia (ozanimod) Receives Health Canada Approval for Relapsing Remitting Multiple Sclerosis

Shots: The approval is based on P-lll SUNBEAM & RADIANCE part B study which involves the assessing of Zeposia (0.92mg and 0.46 mg) vs Avonex (qw, IM) in 1,346 & 1313 patients with RMS for 12 & 24mos. across 158 & 150 sites in 20 & 21 countries respectively Result: relative reduction in ARR (48% …

BMS’ Zeposia (ozanimod) Receives Health Canada Approval for Relapsing Remitting Multiple Sclerosis Read More »

BMS Report Results of Opdivo (nivolumab) + CT in P-III CheckMate-816 Trial for Resectable Non-Small Cell Lung Cancer

Shots: The P-III CheckMate-816 study involves assessing of Opdivo (360mg) + CT (q3w for 3 doses) vs CT (q3w for 3 doses), followed by surgery as a neoadjuvant treatment in 358 patients with resectable NSCLC The study met its 1EPs of improved pathologic complete response. The positive results marks the first time an immune checkpoint …

BMS Report Results of Opdivo (nivolumab) + CT in P-III CheckMate-816 Trial for Resectable Non-Small Cell Lung Cancer Read More »

BMS to Acquire MyoKardia for ~$13.1B

Shots: BMS to acquire all the outstanding shares of MyoKardia’s common stock for $225.00/ share in cash, making a total deal value of ~$13.1B. The transaction is expected to be close in Q4’20 The acquisition will foster BMS’ CV portfolio with the addition of MyoKardia’s mavacamten. BMS expects to explore mavacamten in additional indications, including …

BMS to Acquire MyoKardia for ~$13.1B Read More »

PharmaShots Weekly Snapshot (Sept 28 – Oct 1, 2020)

Sobi & Selecta Report Results of SEL-212 in P-II COMPARE Study for Chronic Refractory Gout Published: Oct 1, 2020 | Tags: Chronic Refractory Gout, COMPARE Study, Important Clinical Improvement, P-II, patients, reports, results, SEL-212, Selecta Biosciences, Sobi 2. Moderna’s mRNA-1273 COVID-19 Vaccine Demonstrate Immune Responses in Older Adults Published: Oct 1, 2020 | Tags: COVID-19, …

PharmaShots Weekly Snapshot (Sept 28 – Oct 1, 2020) Read More »

BMS to Acquire Forbius for its AVID200 to Expand its Footprints in Oncology and Fibrosis

Shots: Forbius will receive up front and milestones while BMS will acquire Forbius’s TGF-beta program, including the lead investigational asset, AVID200. The transaction is expected to be closed in Q4’20 Prior to closing, Forbius’ non-TGF-beta assets will be transferred to a newly formed private company, which will be retained by Forbius’ existing shareholders AVID200 is …

BMS to Acquire Forbius for its AVID200 to Expand its Footprints in Oncology and Fibrosis Read More »

PharmaShots Weekly Snapshot (Aug 17 -21 2020)

1. BioMarin Reports NDA Submission to the US FDA for Vosoritide to Treat Children with Achondroplasia Published: Aug 20, 2020 | Tags:  BioMarin, Reports, NDA, Submission, US, FDA, Vosoritide, Children, Achondroplasia 2. Junshi and Impact to Establish Joint Venture for Senaparib (IMP4297) in China Published: Aug 20, 2020 | Tags:  Junshi, Impact, Establish, Joint Venture, …

PharmaShots Weekly Snapshot (Aug 17 -21 2020) Read More »

BMS Signs an Exclusive Worldwide License Agreement with Dragonfly Therapeutics for DF6002

Shots: Dragonfly to receive $475M as up front and is eligible to receive development, regulatory and commercial milestones in addition to 24% royalties on global sales of the therapy. BMS to get exclusive WW license to Dragonfly’s IL-12 investigational immunotherapy program, including its extended half-life cytokine DF6002 BMS will be responsible for the development & …

BMS Signs an Exclusive Worldwide License Agreement with Dragonfly Therapeutics for DF6002 Read More »

BMS’ Opdivo (nivolumab) + Yervoy (ipilimumab) + CT Receive Health Canada Approval for Metastatic Non-Small Cell Lung Cancer

Shots: The approval is based on P-III CheckMate -9LA study assessing Opdivo + Yervoy combined with two cycles of platinum-doublet CT vs CT (four cycles followed by optional pemetrexed maintenance therapy if eligible) as a 1L treatment in patients with metastatic/ recurrent NSCLC regardless of PD-L1 expression and histology The study met its 1EPs & …

BMS’ Opdivo (nivolumab) + Yervoy (ipilimumab) + CT Receive Health Canada Approval for Metastatic Non-Small Cell Lung Cancer Read More »

Top 20 Prescription Drugs Based on 2019 Revenue

The average life expectancy span of Human Beings are increased due to better medical facilities and drugs developed by Biopharma companies. Pharmaceutical products or drugs or medicines are being produced for a wide range of medical sectors. It includes the lifesaving drugs or the major therapy area including immunology, cardiology, and neurology but are they …

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