Report

Bayer Reports Results of Aliqopa (copanlisib) + Rituximab in P-III CHRONOS-3 Study for Relapsed Indolent Non-Hodgkin’s Lymphoma

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Shots: The P-III CHRONOS-3 study involves assessing Aliqopa (IV) + rituximab vs PBO + rituximab in 458 patients with relapsed iNHL in extending PFS who have received at least one or more lines of prior rituximab-containing treatment Results: @median follow-up of 19.2mos., mPFS (21.5 vs… Read More »Bayer Reports Results of Aliqopa (copanlisib) + Rituximab in P-III CHRONOS-3 Study for Relapsed Indolent Non-Hodgkin’s Lymphoma

Roche Report Results of Ab Cocktail (Casirivimab + Imdevimab) in P-III REGN-COV 2069 Trial for Symptomatic COVID 19 Infection

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Shots: The P-III REGN-COV 2069 trial involves assessing the efficacy and safety of Ab cocktail (casirivimab (1200 mg, SC) + imdevimab (1200 mg, SC) vs PBO in 1,505 people to prevent symptomatic infection in household contacts of individuals infected with COVID-19 The trial met its… Read More »Roche Report Results of Ab Cocktail (Casirivimab + Imdevimab) in P-III REGN-COV 2069 Trial for Symptomatic COVID 19 Infection

Merck Report Results of Keytruda (pembrolizumab) in P-III KEYNOTE-564 Trial as Adjuvant Treatment for Renal Cell Carcinoma

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Shots: The P-III KEYNOTE-564 trial involves assessing Keytruda (200 mg, IV, on day1 of each 3wks. cycle for up to 17 cycles) as adjuvant therapy vs PBO in 950 patients with RCC, following nephrectomy and resection of metastatic lesions The study showed improvement in 1EPs… Read More »Merck Report Results of Keytruda (pembrolizumab) in P-III KEYNOTE-564 Trial as Adjuvant Treatment for Renal Cell Carcinoma

Alnylam Report Results of Lumasiran in P-III ILLUMINATE-A Study for Primary Hyperoxaluria Type 1, Published in NEJM

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Shots: The P-III ILLUMINATE-A Study involves assessing Lumasiran vs PBO in 39 patients with age 6 or older in a ratio (2:1) for PH1 The study met its 1EPs demonstrated a 53.5% reduction in urinary oxalate excretion from baseline to 6 mos. i.e. change in… Read More »Alnylam Report Results of Lumasiran in P-III ILLUMINATE-A Study for Primary Hyperoxaluria Type 1, Published in NEJM

Astellas and Seagen Report EMA’s Acceptance of MAA for Enfortumab Vedotin to Treat Locally Advanced or Metastatic Urothelial Cancer

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Shots: The MAA is based on the P-III EV-301 trial which involves assessing Enfortumab Vedotin vs CT in ~ 600 patients with LA/m-UC, prior treated with Pt.-based CT and a PD-1/L1 inhibitor The 1EPs of the trial is OS and 2EPs include PFS, ORR, DoR,… Read More »Astellas and Seagen Report EMA’s Acceptance of MAA for Enfortumab Vedotin to Treat Locally Advanced or Metastatic Urothelial Cancer

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

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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… 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

Pfizer and Myovant Report Results of Relugolix Combination Therapy in P-III LIBERTY Withdrawal Study in Women with Uterine Fibroids

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Shots: The P-III LIBERTY withdrawal study involves assessing Relugolix combination therapy [relugolix (40 mg) + estradiol (1.0mg) & norethindrone acetate (0.5mg)] vs PBO in women with uterine fibroids for 24wks. The study met its 1EPs i.e. achieving the sustained responder rate @76wks. (menstrual blood loss… Read More »Pfizer and Myovant Report Results of Relugolix Combination Therapy in P-III LIBERTY Withdrawal Study in Women with Uterine Fibroids

ProQR Reports Results of QR-421 in P-I/II Stellar Trial for Usher Syndrome

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Shots: The P-I/II Stellar trial involve assessing QR-421a in 20 patients with usher syndrome and non-syndromic retinitis pigmentosa (nsRP) due to USH2A exon 13 mutations for 24mos. Results: QR-421 demonstrated benefit on multiple measures of vision, including best-corrected visual activity (BCVA), static perimetry, and retinal… Read More »ProQR Reports Results of QR-421 in P-I/II Stellar Trial for Usher Syndrome

EirGenix Report Results of EG12014 (biosimilar, trastuzumab) in P-III Trial for HER2-Positive Breast Cancer

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Shots: The P-III trial involves assessing the safety, immunogenicity and PK of EG12014 (trastuzumab, biosimilar) vs Herceptin in 807 patients in a ratio (1:1) for HER2-positive breast cancer The trial met its 1EPs showed equivalent efficacy to Herceptin in regards to clinical response (pCR) in… Read More »EirGenix Report Results of EG12014 (biosimilar, trastuzumab) in P-III Trial for HER2-Positive Breast Cancer

AstraZeneca Reports Results of AZD1222 in Primary Analysis of P-III Trial for the Prevention of COVID-19

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Shots: The P-III D8110C00001 study involves assessing AZD1222 vs PBO in 32,449 participants in a ratio (2:1) aged ≥18yrs. across 88 trial centers in the US, Peru and Chile to prevent COVID-19. his primary efficacy analysis included the accrual of 190 symptomatic cases of COVID-19… Read More »AstraZeneca Reports Results of AZD1222 in Primary Analysis of P-III Trial for the Prevention of COVID-19

BioMarin Report Results of Vosoritide in P-III OLE Study for the Treatment of Children with Achondroplasia at ENDO 2021

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Shots: The ongoing P-III OLE study involves assessing Vosoritide (15 mcg/kg) vs PBO in 119 children with achondroplasia. The CHMP opinion is expected in Europe in June 2021 The results demonstrated increased AGV, baseline mean AGV of 4.28 cm/year, sustained restoration of a major portion… Read More »BioMarin Report Results of Vosoritide in P-III OLE Study for the Treatment of Children with Achondroplasia at ENDO 2021

Sarepta Therapeutics Report Results of SRP-9003 for the Treatment of Limb-Girdle Muscular Dystrophy Type 2E

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Shots: The ongoing study involves assessing SRP-9003 (IV, with a one-time infusion) in children aged 4-15yrs. with LGMD2E. The study has cohort 1 (low dose-dose cohort, 1.85×1013 vg/kg) and cohort 2 (high-dose cohort, 7.41×1013 vg/kg), post-treatment biopsies were taken @60days The cohort 1 @24mos. showed… Read More »Sarepta Therapeutics Report Results of SRP-9003 for the Treatment of Limb-Girdle Muscular Dystrophy Type 2E

Sarepta Therapeutics Report Results of SRP-9003 for the Treatment of Limb-Girdle Muscular Dystrophy Type 2E

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Shots: The ongoing study involves assessing SRP-9003 (IV, with a one-time infusion) in children aged 4-15yrs. with LGMD2E. The study has cohort 1 (low dose-dose cohort, 1.85×1013 vg/kg) and cohort 2 (high-dose cohort, 7.41×1013 vg/kg), post-treatment biopsies were taken @60days The cohort 1 @24mos. showed… Read More »Sarepta Therapeutics Report Results of SRP-9003 for the Treatment of Limb-Girdle Muscular Dystrophy Type 2E

Novartis and Molecular Partners Report Inclusion of Ensovibep (MP0420) in NIH-Sponsored ACTIV-3 Trial for the Treatment of COVID 19

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Shots: The P-III ACTIV-3 trial plan to evaluate the safety & efficacy of Ensovibep (MP0420) vs PBO in 300 patients hospitalized with mild to moderate COVID-19. The first patient dosing is anticipated in Q2’21 If the ensovibep treatment has a positive benefit/risk profile, the trial… Read More »Novartis and Molecular Partners Report Inclusion of Ensovibep (MP0420) in NIH-Sponsored ACTIV-3 Trial for the Treatment of COVID 19

Eli Lilly Report Result of Donanemab in P-II TRAILBLAZER-ALZ Study for Alzheimer’s Disease

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Shots: The P-II TRAILBLAZER-ALZ study involves assessing donanemab vs PBO in 272 patients with early symptomatic AD who were selected based on cognitive assessments in conjunction with amyloid plaque imaging and tau staging by PET imaging The study met its 1EPs, showed a slowing of… Read More »Eli Lilly Report Result of Donanemab in P-II TRAILBLAZER-ALZ Study for Alzheimer’s Disease

Eli Lilly and Incyte Report Results of Olumiant (baricitinib) in P-III BRAVE-AA2 Study for Severe Alopecia Areata

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Shots: The P-III BRAVE-AA2 study involves assessing Baricitinib (2mg & 4mg, qd) vs PBO in 546 adults with a SALT score ≥ 50 (i.e., who had ≥50% scalp hair loss) and a current episode of severe AA lasting at least 6mos. but no >8yrs. The… Read More »Eli Lilly and Incyte Report Results of Olumiant (baricitinib) in P-III BRAVE-AA2 Study for Severe Alopecia Areata

AstraZeneca and Amgen Report Results of Tezepelumab in P-III NAVIGATOR Trial for Severe Asthma

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Shots: The P-III NAVIGATOR study involves assessing Tezepelumab + SOC vs PBO + SOC in 1061 adults (18–80yrs.) & adolescents (12–17yrs.) with severe, uncontrolled asthma, who were receiving treatment with medium/high dose ICS + at least 1 additional controller medication with/ out OCS The trial… Read More »AstraZeneca and Amgen Report Results of Tezepelumab in P-III NAVIGATOR Trial for Severe Asthma

GSK Report Results of Otilimab in P-II OSCAR Study to Treat Hospitalized Patients with COVID-19

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Shots: The P-IIa POC OSCAR study involves assessing the efficacy and safety of otilimab (90mg, IV) + SOC vs PBO + SOC in 806 hospitalized adults with aged 18-79yrs. with severe COVID-19 related pulmonary disease The study showed a 5.3% overall treatment difference in all… Read More »GSK Report Results of Otilimab in P-II OSCAR Study to Treat Hospitalized Patients with COVID-19

MatriSys Report Results of MSB-0221 in P-I study for the Topical Treatment of Atopic Dermatitis

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Shots: The P-I trial involves assessing MSB-0221 (ShA9) or vehicle applied topically on forearm skin in 54 adults with staphylococcus aureus-positive AD for 1week The expression of mRNA for psmα was inhibited from S. aureus isolated from all participants while the correlation was observed within… Read More »MatriSys Report Results of MSB-0221 in P-I study for the Topical Treatment of Atopic Dermatitis

AbbVie Report Results of Rinvoq (upadacitinib) in Second P-III Induction Study for Ulcerative Colitis

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Shots: The P-III U-ACCOMPLISH induction study involves assessing upadacitinib (45 mg, qd) vs PBO in patients with mod. to sev. UC The study met its 1EPs @8wks. i.e, patients achieved clinical remission (per Adapted Mayo Score) (31% vs 4%); met its 2EPs i.e clinical response… Read More »AbbVie Report Results of Rinvoq (upadacitinib) in Second P-III Induction Study for Ulcerative Colitis

Dermavant Report Results of Tapinarof Cream in P-III PSOARING 3 Study with Durable and Remittive Benefits for Plaque Psoriasis

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Shots: The P-III PSOARING 3 is an OLE study assessing Tapinarof (1%) in patients with plaque psoriasis for ~40wks. and a 4wks. safety follow-up period The interim analyses showed 57.3% of study participants who entered the study with a PGA of ≥ 2 achieved a… Read More »Dermavant Report Results of Tapinarof Cream in P-III PSOARING 3 Study with Durable and Remittive Benefits for Plaque Psoriasis

Novartis Report Results of Kesimpta (ofatumumab) Sensoready autoinjector pen for Multiple Sclerosis

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Shots: The multicenter survey involves assessing Kesimpta Sensoready autoinjector pen in 80 MS patients and 50 MS nurses, with RMS who received a disease modifying treatment through a subcutaneous/intramuscular injection via an autoinjector The result shows MS patients and nurses prefer the Kesimpta Sensoready autoinjector… Read More »Novartis Report Results of Kesimpta (ofatumumab) Sensoready autoinjector pen for Multiple Sclerosis

Exelixis Report Results of Cabometyx (cabozantinib) in P-II PAPMET Study for Patients with Metastatic Papillary Renal Cell Carcinoma

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Shots: The P-II SWOG S1500/PAPMET trial involves assessing cabometyx (60 mg, qd with dose reductions to 40 & 20mg ), crizotinib, and savolitinib vs sunitinib in a ratio (1:1:1:1) for patients with advanced or metastatic PRCC The results demonstrated significant improvement in PFS. The trial… Read More »Exelixis Report Results of Cabometyx (cabozantinib) in P-II PAPMET Study for Patients with Metastatic Papillary Renal Cell Carcinoma

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

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

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

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

Merck’s Report Results of Keytruda (pembrolizumab) in Combination With Ipilimumab vs Keytruda Monotherapy in P-III KEYNOTE-598 for Metastatic Non-Small Cell Lung Cancer Patients

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Shots: The P- III trial involves assessing of Keytruda in combination with ipilimumab vs Keytruda monothx in 568 patients in a ratio (1:1) as 1L treatment for metastatic NSCLC patients without EGFR or ALK genomic tumor aberrations and whose tumors express PD-L1 Results: @ median… Read More »Merck’s Report Results of Keytruda (pembrolizumab) in Combination With Ipilimumab vs Keytruda Monotherapy in P-III KEYNOTE-598 for Metastatic Non-Small Cell Lung Cancer Patients

BioInvent Report Results of BI-1206 + Rituximab in P- I/IIa Study for Relapsed or Refractory B-cell Non-Hodgkin’s Lymphoma

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Shots: The P- I/IIa study assess BI-1206 + rituximab in patients with indolent r/r B-cell NHL. The study consists of 2 parts: P- l with dose escalation cohorts using a 3+3 dose-escalation and selection of the recommended RP2D and P-IIa which is an expansion cohort… Read More »BioInvent Report Results of BI-1206 + Rituximab in P- I/IIa Study for Relapsed or Refractory B-cell Non-Hodgkin’s Lymphoma

Pfizer’s Xeljanz (tofacitinib) Fails to Meet its Co-Primary Endpoint in ORAL Surveillance Safety Study

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Shots: The post marketing Oral Surveillance involves assessing the safety of tofacitinib at two doses (5 mg, bid and 10mg, bid) vs TNFi in 4362 patients in subjects with RA aged ≥ 50yrs. and had at least one additional CV risk factor The primary analyses… Read More »Pfizer’s Xeljanz (tofacitinib) Fails to Meet its Co-Primary Endpoint in ORAL Surveillance Safety Study

Regeneron Reports Results of REGEN-COV Antibody Cocktail Used as Passive Vaccine to Prevent COVID-19

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Shots: The ongoing P-III trial involves assessing REGEN-COV (casirivimab & imdevimab) in 2000+ participants used as a passive vaccine to prevent COVID-19. An exploratory analysis, conducted on the first ~400 individuals, randomized to receive passive vaccination with REGEN-COV (1200mg, SC) vs PBO Reduction in overall… Read More »Regeneron Reports Results of REGEN-COV Antibody Cocktail Used as Passive Vaccine to Prevent COVID-19

Novo Nordisk Report Submission of label Expansion Application to US FDA’s for Ozempic (semaglutide) for T2D

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Shots: The approval is based on SUSTAIN FORTE trial assessing Ozempic (2.0mg, qw) vs Ozempic (1.0mg) in 961 people with T2D in need of treatment intensification Result: 2.0 mg dose achieved significant and superior reduction in HbA1c, both doses are safe and well-tolerated profiles Ozempic… Read More »Novo Nordisk Report Submission of label Expansion Application to US FDA’s for Ozempic (semaglutide) for T2D

Nanobiotix Presents Results of NBTXR3 (PEP503) in P-Ib/II Study for Rectal Cancer at ASCO-GI 2021

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Shots: The complete dose-finding part of P-Ib/II study assessed the safety, feasibility, and RP2D of NBTXR3 (intratumoral inj.) in 20 patients with LA (T3 to T4) or unresectable rectal cancer The study showed ORR after CCRT in >70% patients, 90% patients underwent total mesorectal excision… Read More »Nanobiotix Presents Results of NBTXR3 (PEP503) in P-Ib/II Study for Rectal Cancer at ASCO-GI 2021

aTyr Reports Results of ATYR1923 in P-ll Study for COVID-19 Patients with Severe Respiratory Complications

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Shots: The P-ll study involves assessing of ATYR1923 (1.0 & 3.0 mg/kg) vs PBO in 32 hospitalized COVID-19 patients in the ratio of (1:1:1) with severe respiratory complications who do not require mechanical ventilation in the US and Puerto Rico Result: the study met its… Read More »aTyr Reports Results of ATYR1923 in P-ll Study for COVID-19 Patients with Severe Respiratory Complications

Pfizer Report the US FDA’s Acceptance and Priority Review of sNDA for Lorbrena (lorlatinib) to treat (ALK)-Positive (NSCLC)

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Shots: The US FDA has accepted for Priority Review the sNDA is based on the pivotal CROWN study and is being reviewed by the FDA under its Real-Time Oncology Review (RTOR) CROWN is P-lll, parallel 2-arm trial in which 296 previously untreated advanced ALK-positive NSCLC… Read More »Pfizer Report the US FDA’s Acceptance and Priority Review of sNDA for Lorbrena (lorlatinib) to treat (ALK)-Positive (NSCLC)

Janssen Report MAA Submission of Amivantamab to EMA for Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

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Shots: The EMA Submission is based on P-l CHRYSALIS study to evaluate the safety and efficacy of Amivantamab as a monotherapy and in combination with Lazertinib in adult patients for the treatment of advanced NSCLC Result of CHRYSALIS Study assessed efficacy using overall response rate… Read More »Janssen Report MAA Submission of Amivantamab to EMA for Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Henlius Report the NMPA’s Acceptance of HLX15 (biosimilar, Daratumumab) to Treat Multiple Myeloma

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Shots: The NMPA has accepted HLX15’s IND to be used in the treatment of multiple myeloma. HLX15 is Henlius’ second self-developed product around blood tumor treatment The company evaluated the biosimilar in a head to head clinical studies demonstrating that HLX15 is highly similar to… Read More »Henlius Report the NMPA’s Acceptance of HLX15 (biosimilar, Daratumumab) to Treat Multiple Myeloma

AstraZenca’s Calquence (acalabrutinib) Fails to Meet its Primary Endpoint in P-II Studies for COVID-19

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Shots: The P-ll CALAVI programme involves assessing Calquence + BSC vs BSC as monothx. in patients in a ratio (1:1) hospitalized with respiratory complications of COVID-19 in the ratio of 1:1. The trials conducted in the US and in multiple other countries across the world… Read More »AstraZenca’s Calquence (acalabrutinib) Fails to Meet its Primary Endpoint in P-II Studies for COVID-19

Pfizer Reports Results of Abrocitinib in Fifth P-lll JADE REGIMEN Across Different Dosing Regimens

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Shots: The P-lll JADE REGIMEN study involves assessing of Abrocitinib (100/ 200mg) vs PBO in 1233 patients aged ≥ 12 yrs. in a ratio (1:1:1) with mod. to sev. AD following response to initial open-label induction treatment with abrocitinib (200mg) Result: The study met its… Read More »Pfizer Reports Results of Abrocitinib in Fifth P-lll JADE REGIMEN Across Different Dosing Regimens

Novartis’ Ilaris (canakinumab) Fails to Meet its Primary Endpoints in P-lll Study for COVID-19 Pneumonia and CRS

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Shots: The P-lll CAN-COVID trial involves assessing Ilaris (canakinumab) + SOC vs PBO + SoC in 454 patients aged 18-98yrs. with COVID-19 pneumonia and cytokine release syndrome CRS, with its expected full results in early 2021 Result: The trial fails to meet its 1EPs of… Read More »Novartis’ Ilaris (canakinumab) Fails to Meet its Primary Endpoints in P-lll Study for COVID-19 Pneumonia and CRS

Novartis Reports Results of Aimovig (erenumab) in P-lV Study for Episodic and Chronic Migraine

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Shots: The P-IV HER-MES study involves assessing Aimovig (erenumab 70mg and 140mg) vs topiramate in 777 patients in a ratio (1:1) with episodic or chronic migraine (≥4 migraine days/month) prior not treated with migraine prevention treatment or previously failed up to three prophylactic migraine treatments… Read More »Novartis Reports Results of Aimovig (erenumab) in P-lV Study for Episodic and Chronic Migraine

Regeneron Pauses Dosing of Garetosmab (REGN2477) in P-II LUMINA-1 Study for Fibrodysplasia Ossificans Progressiva

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Shots: Regeneron pauses dosing of the garetosmab (REGN2477) in the ongoing P-II LUMINA-1 study in patients with FOP. The pause is due to fatal serious AEs in the study during the open-label extension during which all patients received active treatment Regeneron shared the update with… Read More »Regeneron Pauses Dosing of Garetosmab (REGN2477) in P-II LUMINA-1 Study for Fibrodysplasia Ossificans Progressiva

Galapagos & Servier’s GLPG1972/S201086 Fails to Meet its Primary Endpoint in P-II ROCCELLA Study for Knee Osteoarthritis

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Shots: The P-II ROCCELLA is a dose-ranging trial involves assessing GLPG1972/S201086 (PO, qd) in three different doses vs PBO in 932 patients with knee OA for 52wks. across 12 countries including EU, Asia, North and South America. Galapagos is responsible for ROCCELLA in the US,… Read More »Galapagos & Servier’s GLPG1972/S201086 Fails to Meet its Primary Endpoint in P-II ROCCELLA Study for Knee Osteoarthritis

Chugai Reports NDA Submission of Risdiplam to the MHLW as the First Oral Drug for SMA in Japan

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Shots: The NDA submission is based on FIREFISH study assessing Risdiplam in infants with symptomatic SMA Type 1 & SUNFISH study in children and young adults with SMA Type 2 or 3 FIRESISH study results: improvement in survival and motor milestones in infants. SUNFISH study… Read More »Chugai Reports NDA Submission of Risdiplam to the MHLW as the First Oral Drug for SMA in Japan

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

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

Amgen Report Five Year Data of Aimovig (erenumab-aooe) in Open-Label Treatment Period of P-II Study for Episodic Migraine

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Shots:   The OLE P-II study involves assessing of Aimovig monthly (70mg) vs PBO in 383 eligible adult patients with an episodic migraine for 12wks. 250 patients increasing their dosage to 140mg monthly after a protocol amendment to assess the long-term safety of the higher dose… Read More »Amgen Report Five Year Data of Aimovig (erenumab-aooe) in Open-Label Treatment Period of P-II Study for Episodic Migraine

Complimentary trend analysis report: Emerging trends in pancreatic cancer research

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Pancreatic cancer sadly remains one of the most deadly cancers in existence, partly because it often goes undiagnosed until it has already metastasized. Finding new and better therapies to fight pancreatic cancer means accelerating the research. A new report just released from Elsevier’s Professional Services… Read More »Complimentary trend analysis report: Emerging trends in pancreatic cancer research

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

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

Innovent and Eli Lilly Report sNDA Acceptance of Tyvyt (sintilimab) Combination Regimen as 1L Therapy in Squamous Non-Small Cell Lung Cancer in China

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Shots: The NMPA has accepted the sNDA for Tyvyt (sintilimab) in combination with Gemzar (gemcitabine) and platinum as 1L therapy in sq. NSCLC The sNDA is based on P-III ORIENT-12 study assessing sintilimab (200mg) vs PBO in combination with Gemzar and Pt (q3w for up… Read More »Innovent and Eli Lilly Report sNDA Acceptance of Tyvyt (sintilimab) Combination Regimen as 1L Therapy in Squamous Non-Small Cell Lung Cancer in China

Roche Report Mixed Results of Etrolizumab in P-III Studies for Patients with Moderately to Severely Active Ulcerative Colitis

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Shots: In the HIBISCUS I induction study, in patients without prior anti-TNF treatment, etrolizumab met its 1EPs while in HIBISCUS II study in the same kind of people, it did not meet its 1EPs. In the HICKORY study, in patients with prior anti-TNF treatment, therapy… Read More »Roche Report Mixed Results of Etrolizumab in P-III Studies for Patients with Moderately to Severely Active Ulcerative Colitis

Glenmark Report Results of FabiFlu (favipiravir) in P-III Clinical Study for Patients with Mild to Moderate COVID-19

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Shots: The P-III study assessing the efficacy and safety of Favipiravir + SSC vs SCC in 150 mild to moderate patients, randomized within a 48hour window of testing RT-PCR positive for COVID-19 Results: P-III study the improvement in 1EPs with 28.6% faster viral clearance in… Read More »Glenmark Report Results of FabiFlu (favipiravir) in P-III Clinical Study for Patients with Mild to Moderate COVID-19

AstraZeneca Report Results of Brilinta (ticagrelor) in P-III THALES Study for Patients with Acute Ischemic Stroke or Transient Ischemic Attack

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Shots: The P-III THALES study involves assessing of Brilinta (180mg as a loading dose followed by 90mg, bid) + aspirin vs aspirin as monothx. in 11,000 patients with non-cardioembolic acute ischaemic stroke or high-risk TIA for 30days Results: 17% reduction in 1EPs of stroke and… Read More »AstraZeneca Report Results of Brilinta (ticagrelor) in P-III THALES Study for Patients with Acute Ischemic Stroke or Transient Ischemic Attack

Increasing Prevalence of Chronic Diseases- Driving the Demand for Self-Administration Devices, Like Autoinjectors

Over the last decade, autoinjectors have emerged as a promising therapeutic commodity for safe administration of parenteral therapies. Patients who suffer from chronic diseases, such as diabetes, rheumatoid arthritis and multiple sclerosis, often require frequent dosing of medication which poses significant inconvenience to them for… Read More »Increasing Prevalence of Chronic Diseases- Driving the Demand for Self-Administration Devices, Like Autoinjectors

In Silico / Computer-Aided Drug Discovery Service Providers for Large Molecules

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Over time, the complexities associated with drug discovery have increased, especially in case of large molecule drugs, which are inherently more complex than conventional small molecules. As a result, an increase in the overall research and development (R&D) expenditure in the pharmaceutical / biotechnology sector… Read More »In Silico / Computer-Aided Drug Discovery Service Providers for Large Molecules

Eisai Reports Results of DAYVIGO (lemborexant) in P-III SUNRISE 1 Study in Patients with Insomnia Disorder

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Shots: The P-III SUNRISE 1 (Study 304) study involves assessing of DAYVIGO (lemborexant, 5 or 10 mg) vs an active comparator or PBO in 1,006 patients with insomnia disorder aged 55 years of age or older Results of P-III study@ 5/10 mg of DAYVIGO: headache… Read More »Eisai Reports Results of DAYVIGO (lemborexant) in P-III SUNRISE 1 Study in Patients with Insomnia Disorder