Treatment

Zogenix Presents Results of Fintepla’s (fenfluramine) Study Highlighting the Impact of Treatment on Dravet Syndrome Patients, Caregivers, and Families at AAN 2021

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Shots: The P-III study is designed to assess caregivers’ perspectives on the long-term seizure & non-seizure-related benefits of Fintepla on patients with Dravet syndrome and on their caregivers and families Results: seizure-related benefits noted by caregivers include a reduction in frequency, seizure activity, and shorter… Read More »Zogenix Presents Results of Fintepla’s (fenfluramine) Study Highlighting the Impact of Treatment on Dravet Syndrome Patients, Caregivers, and Families at AAN 2021

Roche’s Evrysdi (risdiplam) Receives Health Canada’s Approval for Spinal Muscular Atrophy in Adults and Children

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Shots: The approval is based on two studies i.e. FIREFISH & SUNFISH. The FIREFISH study involves assessing Evrysdi in infants aged 2-7mos. with symptomatic Type 1 SMA, and the SUNFISH study assesses Evrysdi in children & young adults aged 2-25yrs. with Type 2 or 3… Read More »Roche’s Evrysdi (risdiplam) Receives Health Canada’s Approval for Spinal Muscular Atrophy in Adults and Children

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

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

Innovent and Lilly Present Results of Tyvyt (sintilimab) in P-III ORIENT-3 Trial as 2L Treatment for Advanced or Metastatic Squamous NSCLC at AACR 2021

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Shots: The P-III ORIENT-3 trial involves assessing the efficacy and safety of Tyvyt (sintilimab) vs docetaxel (q3w) in 290 patients in a ratio (1:1) as a 2L treatment for advanced or m-sqNSCLC The trial met its 1EP i.e improvement in OS, mOS (11.79 vs 8.25… Read More »Innovent and Lilly Present Results of Tyvyt (sintilimab) in P-III ORIENT-3 Trial as 2L Treatment for Advanced or Metastatic Squamous NSCLC at AACR 2021

AstraZeneca’s Tagrisso (osimertinib) Receives the NMPA’s Approval for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer

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Shots: The approval is based on results from the P-III ADAURA trial assessing Tagrisso (80mg, qd) vs PBO in 682 patients with stage IB, II, IIIA EGFRm NSCLC following complete tumor resection and adjuvant chemotherapy as indicated for three years or until disease recurrence Results:… Read More »AstraZeneca’s Tagrisso (osimertinib) Receives the NMPA’s Approval for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer

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

Horizon Presents Results of Uplizna (inebilizumab-cdon) in N-MOmentum Trial for NMOSD at AAN 2021

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Shots: The company reported the data from the N-MOmentum trial involves assessing Uplizna in patients with NMOSD The results from the N-MOmentum trial demonstrated a reduction in pain, long-term safety, and efficacy outcomes. Additional results from the new survey demonstrated NMOSD patient attitudes towards diagnosis… Read More »Horizon Presents Results of Uplizna (inebilizumab-cdon) in N-MOmentum Trial for NMOSD at AAN 2021

mAbxience’s MB02 (biosimilar, bevacizumab) Receives EC’s Approval for the Treatment of Cancer

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Shots: The EC has approved MB02 biosimilar to Avastin (Bevacizumab) in the EU for the treatment of carcinoma of the colon or rectum, BC, NSCLC, RCC, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix Mabxience’s MB02 to be marketed as… Read More »mAbxience’s MB02 (biosimilar, bevacizumab) Receives EC’s Approval for the Treatment of Cancer

Taiho Oncology’s Futibatinib (TAS-120) Receives the US FDA’s Breakthrough Therapy Designation for Advanced Cholangiocarcinoma

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Shots: The designation is based on efficacy & safety results from the P-II FOENIX-CCA2 study involves assessing futibatinib (TAS-120) in patients with advanced cholangiocarcinoma. The findings will be presented at AACR 2021 The preliminary clinical evidence showed improvement on at least one clinical EPs over… Read More »Taiho Oncology’s Futibatinib (TAS-120) Receives the US FDA’s Breakthrough Therapy Designation for Advanced Cholangiocarcinoma

Acceleron Presents Results of Sotatercept in P-II PULSAR Trial for the Treatment of Pulmonary Arterial Hypertension, Published in NEJM

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Shots: The P-II PULSAR trial involves assessing Sotatercept (0.3 mg/kg or 0.3 mg/kg, SC, q3w) vs PBO in 106 patients in a ratio (3:3:4) with PAH. The results were published in NEJM The results of the P-II PULSAR study that demonstrated sotatercept has the potential… Read More »Acceleron Presents Results of Sotatercept in P-II PULSAR Trial for the Treatment of Pulmonary Arterial Hypertension, Published in NEJM

Revance Presents Results of DaxibotulinumtoxinA for Injection in P-III ASPEN-1 Trial for the Treatment of Cervical Dystonia at AAN2021

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Shots: The P-III ASPEN-1 trial evaluating the efficacy and safety of DaxibotulinumtoxinA (either 125 unit or 250 unit dose) for injection vs PBO in adults with cervical dystonia, patients followed for a maximum of 36 wks in post-treatment The results showed median duration effect of… Read More »Revance Presents Results of DaxibotulinumtoxinA for Injection in P-III ASPEN-1 Trial for the Treatment of Cervical Dystonia at AAN2021

Sanofi’s Sarclisa (isatuximab-irfc) + Carfilzomib and Dexamethasone Receives the US FDA’s Approval for the Treatment of R/R Multiple Myeloma

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Shots: The approval is based on P-III IKEMA study involves assessing of Sarclisa + carfilzomib and dexamethasone(kd) vs SOC in 302 patients with RRMM who had received 1 to 3 prior lines of treatment The result demonstrated a reduction in the risk of disease progression… Read More »Sanofi’s Sarclisa (isatuximab-irfc) + Carfilzomib and Dexamethasone Receives the US FDA’s Approval for the Treatment of R/R Multiple Myeloma

Bayer’s Vitrakvi Receives MHLW’s Approval for the Treatment of NTRK Fusion-Positive Advanced or Recurrent Solid Tumors

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Shots: The approval is based on the P-III NAVIGATE trial in adult and adolescent patients and P- I/II pediatric SCOUT trial involves assessing Vitrakvi for NTRK fusion-positive advanced or recurrent solid tumors The P-III NAVIGATE trial showed ORR (65.2%), CR (16.9%), and P-I/II SCOUT trial… Read More »Bayer’s Vitrakvi Receives MHLW’s Approval for the Treatment of NTRK Fusion-Positive Advanced or Recurrent Solid Tumors

Incyte’s Pemazyre (pemigatinib) Receives MHLW’s Approval for Unresectable Biliary Tract Cancer with a FGFR2 Fusion Gene

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Shots: The approval is based on the P-II FIGHT-202 study that involves assessing Pemazyre (13.5mg, qd, on a 21-day cycle) in adults aged ≥18yrs. with previously treated, LA/m- cholangiocarcinoma with documented FGFR2 fusion or rearrangement The study has three cohorts: Cohort A (FGFR2 fusions), Cohort… Read More »Incyte’s Pemazyre (pemigatinib) Receives MHLW’s Approval for Unresectable Biliary Tract Cancer with a FGFR2 Fusion Gene

Zealand’s Zegalogue (dasiglucagon) Receives the US FDA’s Approval for the Treatment of Severe Hypoglycemia

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Shots: The approval is based on efficacy results from P-III studies involve assessing Zegalogue vs PBO in children aged 6-17yrs. and in adults with T1D The study met its 1EPs showed an increase in blood glucose of ≥20 mg/dL within 45 minutes, the median time… Read More »Zealand’s Zegalogue (dasiglucagon) Receives the US FDA’s Approval for the Treatment of Severe Hypoglycemia

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

Kiniksa’s Arcalyst (rilonacept) Receives the US FDA’s Approval for the Treatment of Pericarditis

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Shots: The approval is based on the P-III RHAPSODY trial involves assessing Arcalyst (SC, qw, 300mg followed by 160mg) vs PBO in adults and children aged ≥12yrs. in a ratio (1:1) with recurrent pericarditis The result showed a 96% reduction in the risk, with pain-… Read More »Kiniksa’s Arcalyst (rilonacept) Receives the US FDA’s Approval for the Treatment of Pericarditis

Kiniksa’s Arcalyst (rilonacept) Receives the US FDA’s Approval for the Treatment of Pericarditis

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Shots: The approval is based on the P-III RHAPSODY trial involves assessing Arcalyst (SC, qw, 300mg followed by 160mg) vs PBO in adults and children aged ≥12yrs. in a ratio (1:1) with recurrent pericarditis The result showed a 96% reduction in the risk, with pain-… Read More »Kiniksa’s Arcalyst (rilonacept) Receives the US FDA’s Approval for the Treatment of Pericarditis

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

BioXcel’s BXCL501 Receives the US FDA’s Breakthrough Therapy Designation for Acute Treatment of Agitation Associated with Dementia

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Shots: The BTD is based on a P-Ib/II TRANQUILITY study assessing BXCL501 in patients with acute treatment of agitation associated with dementia, including AD The results demonstrated significant reductions in agitation measures @2hrs. post-dose with both 30 and 60 mcg doses as measured by multiple… Read More »BioXcel’s BXCL501 Receives the US FDA’s Breakthrough Therapy Designation for Acute Treatment of Agitation Associated with Dementia

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

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

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

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

Astellas Reports NDA Submission of Enfortumab Vedotin to the MHLW for Locally Advanced or Metastatic Urothelial Cancer in Japan

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Shots: The submission is based on EV-301 and EV-201 trials in Japan. The P-III EV-301 trial assessing Enfortumab Vedotin vs CT in ~ 600 patients with LA/m-UC, prior treated with platinum-based CT and PD-1/L1 inhibitor The P-II EV-201 trial assessing Enfortumab Vedotin in ~128 patients… Read More »Astellas Reports NDA Submission of Enfortumab Vedotin to the MHLW for Locally Advanced or Metastatic Urothelial Cancer in Japan

Gilead Present Results of Lenacapavir in P-II/III CAPELLA Trial for the Treatment of HIV at CROI

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Shots: The P-II/III CAPELLA trial involves assessing lenacapavir (SC, every 6mos.) vs PBO in 36 participants in a ratio (2:1) with multi-drug resistant HIV-1 infection The study demonstrated virologic suppression @26wks., viral load reduction from baseline of ≥ 0.5 log10 copies/mL for 14days functional monothx.… Read More »Gilead Present Results of Lenacapavir in P-II/III CAPELLA Trial for the Treatment of HIV at CROI

Sorrento Collaborates with Mount Sinai to Develop Ab Combination for Neutralizing SARS-CoV-2 and other Emerging Variants of COVID-19

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Shots: The companies signed an exclusive license agreement to develop COVISHIELD + two mAb cocktail against emerging variants of SARS-CoV-2 including UK (B.1.1.7), South Africa (B.1.351), and Japan/Brazil (B.1.128) variants The pre-clinical development of Ab combination (IV and intranasal) including Sorrento and Mount Sinai Abs… Read More »Sorrento Collaborates with Mount Sinai to Develop Ab Combination for Neutralizing SARS-CoV-2 and other Emerging Variants of COVID-19

ViiV Healthcare Presents Results of GSK3640254 (GSK’254) in P-IIa study for the Treatment of HIV at CROI

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Shots: The P-IIa POC study involves assessing GSK3640254 (GSK’254, qd) in 34 treatment-naïve adults with HIV. The study is divided into 2 parts- in part 1, patients received GSK’254 (10/200mg) vs PBO for 10days and in part 2, patients got GSK’254 (40/80140 mg) vs PBO… Read More »ViiV Healthcare Presents Results of GSK3640254 (GSK’254) in P-IIa study for the Treatment of HIV at CROI

ViewPoints Interview: Lumen’s Brian Finrow Shares Insight on Need for the Cheaper Methods to Engineer Antibodies as a Treatment for COVID-19

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In an interview with PharmaShots, Brian Finrow, Co-Founder and CEO of Lumen Bioscience shared his views on the critical need for a scalable and cheaper method to engineer antibodies as a potential treatment for Covid-19. He also shed light on why it is time for… Read More »ViewPoints Interview: Lumen’s Brian Finrow Shares Insight on Need for the Cheaper Methods to Engineer Antibodies as a Treatment for COVID-19

Roche’s Ventana ALK (D5F3) CDx Assay Receives the US FDA’s Approval for the Treatment of ALK-Positive NSCLC

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Shots: The US FDA has granted approval of Ventana ALK (D5F3) as a CDx assay to identify ALK+ NSCLC patients eligible for treatment with Pfizer’s drug Lorbrena (lorlatinib) The label expansion approval strengthens Roche’s commitment to personalized healthcare by providing lung cancer patients with access… Read More »Roche’s Ventana ALK (D5F3) CDx Assay Receives the US FDA’s Approval for the Treatment of ALK-Positive NSCLC

ViiV Healthcare Present Results of Long- Acting Cabotegravir and Rilpivirine in P-IIIb ATLAS-2M Study for HIV at CROI 2021

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Shots: The P- IIIb ATLAS-2M study involves assessing long-acting cabotegravir and rilpivirine regimen for the treatment of HIV The ATLAS-2M 96wks. data reinforce the 1EPs @48wks. demonstrated the efficacy of every 2mos. dosing (q8w) was non-inferior to monthly dosing (q4w) dosing with (2.1% & 1.1%)… Read More »ViiV Healthcare Present Results of Long- Acting Cabotegravir and Rilpivirine in P-IIIb ATLAS-2M Study for HIV at CROI 2021

Roche’s Actemra/RoActemra (tocilizumab) Receives the US FDA’s Approval as the First Biologic for Systemic Sclerosis-Associated Interstitial Lung Disease

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Shots: The approval is based on P-III focuSSced trial assessing Actemra (SC, 162mg) vs PBO in a ratio (1:1) in 212 adults with SSc. The data from P-I/II fascinate study also supported the approval The P-III study did not meet its 1EPs i.e. change from… Read More »Roche’s Actemra/RoActemra (tocilizumab) Receives the US FDA’s Approval as the First Biologic for Systemic Sclerosis-Associated Interstitial Lung Disease

Pfizer’s Lorbrena (lorlatinib) Receives FDA’s Approval for Expanding its Indication to Treat ALK-Positive Metastatic Lung Cancer

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Shots: The approval is based on P-III CROWN study assessing Lorbrena vs Xalkori (crizotinib) monthx in 296 people in a ratio (1:1) with prior untreated advanced ALK-positive NSCLC The P-III study resulted in a 72% reduction in risk of progression or death as assessed by… Read More »Pfizer’s Lorbrena (lorlatinib) Receives FDA’s Approval for Expanding its Indication to Treat ALK-Positive Metastatic Lung Cancer

BeiGene’s Brukinsa (zanubrutinib) Receives Health Canada’s Approval for Waldenström’s Macroglobulinemia

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Shots: The approval is based on a P-III APSEN study involve assessing Brukinsa vs ibrutinib in 201 patients with r/r or TN WM who harbor an MYD88 mutation (MYD88MUT). The recommended dose of the therapy is 320mg and is expected to be available in Canada… Read More »BeiGene’s Brukinsa (zanubrutinib) Receives Health Canada’s Approval for Waldenström’s Macroglobulinemia

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

Sanofi’s Dupixent (dupilumab) Receives Health Canada Approval as the First Biologic to Treat Atopic Dermatitis in Children

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Shots: Health Canada has approved Dupixent for the treatment of mod. to sev. AD in children aged 6 to 11yrs. whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable The approval marks the fifth indication for Dupixent… Read More »Sanofi’s Dupixent (dupilumab) Receives Health Canada Approval as the First Biologic to Treat Atopic Dermatitis in Children

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

The US FDA Approves Patient Specific Talus Spacer to Treat AVN of Ankle Joint as a Humanitarian Use Device

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Shots: The FDA has approved Patient-Specific Talus Spacer 3D-printed talus implant for humanitarian use. The FDA reviewed data through the HDE process Data supporting the safety of implant include results from 31 patients and 32 talus replacement surgeries with the implant. Post-operation @3yrs, pain decreased… Read More »The US FDA Approves Patient Specific Talus Spacer to Treat AVN of Ankle Joint as a Humanitarian Use Device

Fresenius Kabi Launches Idacio (biosimilar, adalimumab) for Multiple Chronic Inflammatory Conditions in Canada

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Shots: Health Canada has authorized Idacio on Oct 30, 2020, for marketing in Canada and is now available for all indications of the reference (Humira) in the field of rheumatology, gastroenterology and dermatology Health Canada’s approval was based on analytical, pre/ clinical data that demonstrated… Read More »Fresenius Kabi Launches Idacio (biosimilar, adalimumab) for Multiple Chronic Inflammatory Conditions in Canada

Celltrion Receives EC’s Approval for Yuflyma (biosimilar, adalimumab) for the Treatment of Multiple Chronic Inflammatory Diseases

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Shots: The EC approval follows CHMP’s positive recommendation for Yuflyma (high concentration formulation) granted in Dec’2020. The approval covers all 13 intended indications to treat multiple chronic inflammatory diseases The approval is based on analytical, pre/ clinical studies, demonstrating that Yuflyma is comparable to the… Read More »Celltrion Receives EC’s Approval for Yuflyma (biosimilar, adalimumab) for the Treatment of Multiple Chronic Inflammatory Diseases

Pfizer’s Panzyga Receives the US FDA’s Approval of sBLA for Chronic Inflammatory Demyelinating Polyneuropathy

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Shots: The approval is based on the P-III study that involves assessing Panzyga (IVIg) in 142 patients with CIDP. The study evaluated more than one maintenance dosing option while the efficacy, safety, and tolerability were observed during 7 maintenance infusions @3wks. intervals over a 6mos.… Read More »Pfizer’s Panzyga Receives the US FDA’s Approval of sBLA for Chronic Inflammatory Demyelinating Polyneuropathy

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

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

ViiV Healthcare’s Rukobia (fostemsavir) Receives Marketing Authorization for the Treatment of Adults with Multidrug-Resistant HIV

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Shots: The MAA is based on P-III BRIGHTE study assessing Rukobia (600mg, bid) + OBT vs PBO in 371 HTE adults living with multidrug-resistant HIV. Participants were enrolled in either a randomized or nonrandomized cohort In the randomized cohort, 60% achieved undetectable HIV viral load… Read More »ViiV Healthcare’s Rukobia (fostemsavir) Receives Marketing Authorization for the Treatment of Adults with Multidrug-Resistant HIV

Celltrion’s Regdanvimab (CT-P59) Receives Korean MFDS Conditional Marketing Authorization for COVID-19

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Shots: The CMA is based on P-II/III study assessing CT-P59 vs PBO in patients with COVID-19. The CMA allows the emergency use of CT-P59 in patients aged ≥ 60yrs. with medical condition & mild symptoms of COVID-19, and adult with mod. symptoms of COVID-19 The… Read More »Celltrion’s Regdanvimab (CT-P59) Receives Korean MFDS Conditional Marketing Authorization for COVID-19

Celltrion Receives Health Canada’s Approval for Remsima SC (biosimilar, infliximab) for Rheumatoid Arthritis

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Shots: The Health Canada has granted a NOC which is based on clinical evidence for Remsima/CT-P13 SC vs CT-P13 IV up to 1year in patients with RA. The results demonstrated that switching patients from Remsima IV to its SC formulation @30wks. is comparable to maintaining… Read More »Celltrion Receives Health Canada’s Approval for Remsima SC (biosimilar, infliximab) for Rheumatoid Arthritis

Medtronic Receives the US FDA’s Approval for DiamondTemp Ablation System to Treat Atrial Fibrillation

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Shots: The approval is based on DIAMOND-AF trial assessing the safety and efficacy of the DTA system vs contact force-sensing ablation system in 482 patients with recurrent, symptomatic, PAF whose condition is unresponsive to drug therapy Results: patient complication rate (96.7% vs 93.4%); primary effectiveness… Read More »Medtronic Receives the US FDA’s Approval for DiamondTemp Ablation System to Treat Atrial Fibrillation

Gan & Lee Receives the US FDA’s Fast Track Designation for GLR2007 for the Treatment of Patients with Glioblastoma

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Shots: The US FDA has granted FTD for GLR2007 for the treatment of patients with glioblastoma and application is eligible for Rolling Review and for Accelerated Approval and Priority Review The Designation evaluate to facilitate the development and expedite the review of drugs to treat… Read More »Gan & Lee Receives the US FDA’s Fast Track Designation for GLR2007 for the Treatment of Patients with Glioblastoma

Amgen’s Sotorasib Receives NMPA’s Breakthrough Therapy Designation in China for the Treatment of Advanced NSCLC With KRAS G12C Mutation

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Shots: The BT designation is based on P-II CodeBreaK 100 study assessing Sotorasib in 126 patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who have received at least one prior systemic therapy. The findings will be presented at the IASLC 2020 WCLC Presidential Symposium… Read More »Amgen’s Sotorasib Receives NMPA’s Breakthrough Therapy Designation in China for the Treatment of Advanced NSCLC With KRAS G12C Mutation

Eli Lilly Collaborates with GSK and VIR to Evaluate Bamlanivimab (LY-CoV555) with VIR-7831 (GSK4182136) for COVID-19

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Shots: Lilly has expanded its ongoing BLAZE-4 trial to assess the administration of bamlanivimab (700mg) with VIR-7831 (500mg) for symptomatic COVID-19 in the outpatient setting. These are two neutralizing Abs that bind to different epitopes of the SARS-CoV-2 spike protein The companies reported the first… Read More »Eli Lilly Collaborates with GSK and VIR to Evaluate Bamlanivimab (LY-CoV555) with VIR-7831 (GSK4182136) for COVID-19

AbbVie’s Rinvoq (upadacitinib) Receives the EC’s Approval for Psoriatic Arthritis and Ankylosing Spondylitis

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Shots: The approval is based on data from three pivotal clinical trials P-II SELECT-PsA 1& 2 and P-II/III SELECT-AXIS 1 involves assessing of Rinvoq in patients with PsA and AS. The studies demonstrated that it met all 1EPs & 2EPs with a safety profile consistent… Read More »AbbVie’s Rinvoq (upadacitinib) Receives the EC’s Approval for Psoriatic Arthritis and Ankylosing Spondylitis

Merck’s Keytruda (pembrolizumab) Receives EC’s Approval as 1L Treatment for Metastatic Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer

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Shots: The approval is based on pivotal P-III KEYNOTE-177 study involves assessing of Keytruda (200mg, q3w) vs CT regimen in 307 patients in a ratio (1:1) with previously untreated metastatic MSI-H or dMMR colorectal cancer Results: reduction in the risk of disease progression or death… Read More »Merck’s Keytruda (pembrolizumab) Receives EC’s Approval as 1L Treatment for Metastatic Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer

Exelixis Cabometyx (cabozantinib) + Opdivo (nivolumab) Receives US FDA’s Approval as a 1L Treatment for Patients with Advanced Renal Cell Carcinoma

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Shots: The approval is based on results from CheckMate -9ER, P-III pivotal trial involves assessing of Cabometyx + Opdivo vs sunitinib in 651 patients previously untreated advanced or metastatic RCC. Results: @ median follow-up of 18.1 mos. patients treated with the combination achieved PFS of… Read More »Exelixis Cabometyx (cabozantinib) + Opdivo (nivolumab) Receives US FDA’s Approval as a 1L Treatment for Patients with Advanced Renal Cell Carcinoma

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

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

Lundback’s Vyepti (eptinezumab, IV) Receives Health Canada’s Approval for Preventive Treatment of Migraine

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Shots: The approval follows P-III trials (PROMISE-1 in episodic migraine & PROMISE-2 in chronic migraine) assessing Vyepti vs PBO in 2,076 adult patients for the preventive treatment of migraine who have at least 4 migraine days/mos. The studies met its 1EPs of decrease in mean… Read More »Lundback’s Vyepti (eptinezumab, IV) Receives Health Canada’s Approval for Preventive Treatment of Migraine

Vertex Reports Health Canada’s Acceptance of Trikafta’s NDA for Priority Review to Treat Cystic Fibrosis

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Shots: Vertex’ new drug submission for Trikafta has been accepted for Priority Review by Health Canada for the treatment of CF in people aged ≥12yrs. With PR, the conventional review timeline of 300 days is reduced to 180 days. The expected Health Canada’s approval is… Read More »Vertex Reports Health Canada’s Acceptance of Trikafta’s NDA for Priority Review to Treat Cystic Fibrosis

Amyrt’s AP103 Receives the US FDA’s Orphan Drug designation for Dystrophic Epidermolysis Bullosa (DEB)

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Shots: The US FDA has granted orphan drug designation for AP103 for the treatment of DEB Amyrt licensed a pre-clinical gene – therapy platform technology to treat patients with DEB, a subset of EB also applicable for genetic disorders in Mar 2018 AP103 is based… Read More »Amyrt’s AP103 Receives the US FDA’s Orphan Drug designation for Dystrophic Epidermolysis Bullosa (DEB)

Roche’s Phesgo (Perjeta + Herceptin) Receives EC’s Approval for the Treatment of HER2-Positive Breast Cancer

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Shots: The approval is based on P-III FeDeriCa study evaluating the pharmacokinetics, efficacy, and safety of Phesgo + CT vs Perjeta + Herceptin (IV) + CT in 500 patients with HER2-positive early breast cancer treated in the neoadjuvant (before surgery) and adjuvant (after surgery) Result… Read More »Roche’s Phesgo (Perjeta + Herceptin) Receives EC’s Approval for the Treatment of HER2-Positive Breast Cancer

Janssen’s Darzalex (daratumumab) Receives Health Canada Approval for the Treatment of Multiple Myeloma

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Shots: The approval is based on P-lll CASSIOPEIA (MMY3006) Study involve the assessing of Darzalex (daratumumab) + bortezomib, thalidomide, and dexamethasone (VTd) for the treatment of patients with multiple myeloma are eligible for (ASCT) Result: The 1EPs of sCR rate post-transplant was significantly higher (29… Read More »Janssen’s Darzalex (daratumumab) Receives Health Canada Approval for the Treatment of Multiple Myeloma

ViewPoints Interview: Novocure’s William F. Doyle Shares Insight on Company’s Accomplishments in the Treatment of Glioblastoma and Mesothelioma

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In a recent interview with PharmaShots, William F. Doyle, Executive Chairman at Novocure shared information about the company’s activities in the field of glioblastoma and mesothelioma. He also discussed the company’s technology, Tumor Treating Fields (TTFields), and its potential for broad applicability across solid tumors.… Read More »ViewPoints Interview: Novocure’s William F. Doyle Shares Insight on Company’s Accomplishments in the Treatment of Glioblastoma and Mesothelioma

Janssen Acquires Rights to Hemera’s HMR59 for Late-Stage Age-Related Macular Degeneration

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Shots: Janssen acquires rights to Hemera’s HMR59, administered as a one-time, outpatient, IVT inj. to help preserve vision in patients with geographic atrophy The acquisition will boost Janssen’s eye disease portfolio & strengthens its gene therapy capabilities HMR59 is designed to increase the ability of… Read More »Janssen Acquires Rights to Hemera’s HMR59 for Late-Stage Age-Related Macular Degeneration

PostEra Collaborates with NeuroLucent to Identify Therapies for Alzheimer’s Disease

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Shots: NeuroLucent will receive an upfront along with additional payments upon the achievement of milestones. The companies collaborated to accelerate search for a therapeutic candidate PostEra will use its ML technology to optimize NeuroLucent’s lead compounds through a series of design make test cycles that… Read More »PostEra Collaborates with NeuroLucent to Identify Therapies for Alzheimer’s Disease

Janssen’s Tremfya (guselkumab) Receives EC’s Approval as a First in Class Treatment for Active Psoriatic Arthritis

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Shots: The approval is based on P-lll DISCOVER-1 & -2 study assessing Tremfya (100mg q4w and q8w) vs PBO in 381 & 739 patients with active PsA who had an inadequate response to SOC & Who were biologic-naïve only and had an inadequate response to… Read More »Janssen’s Tremfya (guselkumab) Receives EC’s Approval as a First in Class Treatment for Active Psoriatic Arthritis

Bausch Health Initiates Second P-III Study for NOV03 (perfluorohexyloctane) to Treat DED Associated With MGD

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Shots: The enrollment of the first P-III study is currently underway & has reached 85% of its enrollment goal. In a P-II study of 336 patients, NOV03 met its 1EP of efficacy i.e. improvement of total corneal fluorescein staining over control @8wks. Additionally, NOV03 showed… Read More »Bausch Health Initiates Second P-III Study for NOV03 (perfluorohexyloctane) to Treat DED Associated With MGD

Alnylam’s Oxlumo (lumasiran) Receives the US FDA’s Approval for Treatment of Primary Hyperoxaluria Type 1 in Pediatric and Adult Patients

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Shots: The approval is based on P-III ILLUMINATE-A & -B trials. The studies demonstrating reductions in urinary oxalate and encourage safety and tolerability in pediatric and adult patients The ILLUMINATE-A showed that Oxlumo met its 1EP i.e. change in 24hrs. (65% vs 12%) compared to… Read More »Alnylam’s Oxlumo (lumasiran) Receives the US FDA’s Approval for Treatment of Primary Hyperoxaluria Type 1 in Pediatric and Adult Patients

Eiger’s Zokinvy (lonafarnib) Receives the US FDA’s Approval for Treatment of Progeria and Processing-Deficient PL

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Shots: The Progeria Research Foundation and Eiger reported the US FDA’s approval of Zokinvy (lonafarnib) for the treatment of HGPS or progeria and processing-deficient progeroid laminopathies Zokinvy reduced the incidence of mortality by 60% & increased the average survival time by 2.5 yrs. Additionally, the… Read More »Eiger’s Zokinvy (lonafarnib) Receives the US FDA’s Approval for Treatment of Progeria and Processing-Deficient PL

Lilly’s Bamlanivimab (LY-CoV555) Receives Health Canada’s Interim Authorization as a Treatment for COVID-19

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Shots: The authorization is based on P-II BLAZE-1 study assessing the efficacy and safety of bamlanivimab (700/2800/7000 mg) alone or in combination with a second Ab vs PBO for the treatment of symptomatic COVID-19 in the outpatient setting Results: reduction in viral load & rates… Read More »Lilly’s Bamlanivimab (LY-CoV555) Receives Health Canada’s Interim Authorization as a Treatment for COVID-19

Novartis Signs a License Agreement with Mesoblast to Develop and Commercialize Remestemcel-L for ARDS

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Shots: Mesoblast to receive $25M up front and $25M as equity investment with additional payments and royalties on achievement of development, regulatory and commercial milestones Novartis to acquire the exclusive WW rights to develop, commercialize & manufacture remestemcel-L for ARDS & access to a cell-therapy… Read More »Novartis Signs a License Agreement with Mesoblast to Develop and Commercialize Remestemcel-L for ARDS

Lilly’s Bamlanivimab (LY-CoV555) Receives the US FDA’s EUA for the Treatment of Recently Diagnosed COVID-19

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Shots: The EUA is based on P-II BLAZE-1 study assessing bamlanivimab (700/2800/7000 mg) as monothx. vs PBO or in combination with second Ab for the treatment of symptomatic COVID-19 in the outpatient setting. The EUA is granted for bamlanivimab (LY-CoV555, 700 mg) Patients showed reduced… Read More »Lilly’s Bamlanivimab (LY-CoV555) Receives the US FDA’s EUA for the Treatment of Recently Diagnosed COVID-19

Boston Scientific’s Ranger DCB Receives the US FDA’s Approval for Peripheral Artery Disease in the SFA and PPA

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Shots: The approval is based on the RANGER II SFA pivotal study assessing the Ranger DCB vs standard PTA for the treatment in patients with PAD in the SFA & PPA The study met its both 1EPs @12mos. i.e. MAE (94.1% vs 83.5%); lesion revascularization… Read More »Boston Scientific’s Ranger DCB Receives the US FDA’s Approval for Peripheral Artery Disease in the SFA and PPA

Celltrion Presents Results of CT-P17 (biosimilar, adalimumab) in P-III Study for RA at ACR 2020

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Shots: The P-III study involves assessing CT-P17 (40mg, q2w) vs reference adalimumab for up to 24wks. in 648 patients with active moderate-to-severe RA despite MTX treatment Results demonstrated that CT-P17 has equivalent efficacy to reference adalimumab i.e. ACR20 is 82.7% for both, 2EPs include ACR20/50/70… Read More »Celltrion Presents Results of CT-P17 (biosimilar, adalimumab) in P-III Study for RA at ACR 2020

GSK’s Zejula (niraparib) Receives EC’s Approval as a Treatment in Advanced Ovarian Cancer

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Shots: The approval is based on PRIMA study assessing Zejula (300mg qd), later amended to incorporate an individualised starting dose of Zejula (200 mg or 300 mg, qd) based on the patient’s baseline weight and/or platelet count Results: The PRIMA study improved PFS for patients… Read More »GSK’s Zejula (niraparib) Receives EC’s Approval as a Treatment in Advanced Ovarian Cancer

Sanifit Presents Results of SNF472 for the Treatment of Vascular Calcification at ASN Kidney Week 2020

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Shots: The additional insight from the P-IIb CaLIPSO study showed that SNF472 slowed the progression of CAC across key subgroups of patients on hemodialysis participating in the study. The presentation highlights the PK/PD and exposure-response analyses Sanifit also presents the design of its ongoing P-III… Read More »Sanifit Presents Results of SNF472 for the Treatment of Vascular Calcification at ASN Kidney Week 2020

AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s Priority Review for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer

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Shots: AstraZeneca’s Tagrisso has received sNDA’s acceptance and has been granted PR in the US for the adjuvant treatment of patients with early-stage (IB, II, and IIIA) EGFRm NSCLC after complete tumor resection with curative intent The sNDA is based on the P-III ADAURA trial… Read More »AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s Priority Review for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer

AstraZeneca’s Trixeo Aerosphere Receives CHMP’s Recommendation for Approval to Treat COPD

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Shots: The CHMP’s positive opinion is based on P-III ETHOS & KRONOS studies, which are a part of AstraZeneca’s P-III ATHENA program assessing Trixeo Aerosphere in 15500+ patients globally across 11 trials P-III ETHOS study results reported that triple-combination therapy showed a reduction in the… Read More »AstraZeneca’s Trixeo Aerosphere Receives CHMP’s Recommendation for Approval to Treat COPD

Regeneron’s Inmazeb (atoltivimab, maftivimab, and odesivimab) Receives the US FDA’s Approval as the First Treatment for Ebola

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Shots: The approval is based on the PALM trial assessing Inmazeb vs Zmapp and remdesivir in 681 adult and pediatric patients including newborns of mothers who have tested positive for the infection. The study demonstrated 1EPs of mortality @28days (33.5% vs 51.3%) and 2EPs of… Read More »Regeneron’s Inmazeb (atoltivimab, maftivimab, and odesivimab) Receives the US FDA’s Approval as the First Treatment for Ebola

GSK’s Zejula (niraparib) Receives Health Canada Approval for 1L Treatment of Women with Advanced Ovarian Cancer

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Shots: The approval is based on P-III PRIMA study assessing Zejula in patients with newly diagnosed advanced ovarian cancer with complete/partial response to Pt.-based CT regardless of biomarker status The therapy is now approved in Canada for monothx. treatment of female adult patients with advanced… Read More »GSK’s Zejula (niraparib) Receives Health Canada Approval for 1L Treatment of Women with Advanced Ovarian Cancer

Roche’s Tecentriq + Bevacizumab Receive Health Canada’s Approval as 1L Treatment for Unresectable or Metastatic Hepatocellular Carcinoma

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Shots: The approval is based on P-III IMbrave150 study assessing Tecentriq (1200 mg) + bevacizumab (15 mg/kg, q3w, IV) vs sorafenib (400mg, bid) in 501 patients in a ratio (2:1) with unresectable or metastatic HCC, prior not treated with systemic therapies Results: 42% reduction in… Read More »Roche’s Tecentriq + Bevacizumab Receive Health Canada’s Approval as 1L Treatment for Unresectable or Metastatic Hepatocellular Carcinoma

Regeneron Reports the US FDA’s Acceptance of Evinacumab’s BLA for Priority Review as a Treatment for Patients with HoFH

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Shots: The BLA is based on P-III study evaluating the efficacy and safety of evinacumab (15 mg/kg, IV, q4w) in 65 patients aged ≥12yrs. with HoFH. The 1EPs of the study is reduction of LDL-C from baseline The expected PDUFA date for the therapy as… Read More »Regeneron Reports the US FDA’s Acceptance of Evinacumab’s BLA for Priority Review as a Treatment for Patients with HoFH

Janssen’s Darzalex (daratumumab, SC) Receives Health Canada Approval for the Treatment of Patients with Multiple Myeloma

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Shots: The Health Canada has approved Darzalex SC (daratumumab) in four regimens across five indications in patients with MM, notably newly diagnosed, transplant-ineligible patients as well as relapsed/refractory patients The approval is based on P-III COLUMBA and P-II PLEIADES studies. The P-III study demonstrated a… Read More »Janssen’s Darzalex (daratumumab, SC) Receives Health Canada Approval for the Treatment of Patients with Multiple Myeloma

Centus Biotherapeutics’ Equidacent (bevacizumab, biosimilar) Receives CHMP’s Positive Opinion for the Treatment of Multiple Cancer Indications

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Shots: The EMA’s CHMP has adopted a positive opinion recommending the MAA of Centus’ Equidacent (bevacizumab), a biosimilar to Roche’s Avastin to treat carcinoma of the colon or rectum, breast cancer, NSCLC, RCC, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the… Read More »Centus Biotherapeutics’ Equidacent (bevacizumab, biosimilar) Receives CHMP’s Positive Opinion for the Treatment of Multiple Cancer Indications

Mental Health and Substance Use State Fact Sheets

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This analysis and series of state fact sheets examine mental health and substance use disorder needs in the states and capacity to meet residents’ needs prior to the COVID-19 pandemic, which is expected to place additional strains on the system.

BeiGene’s Tislelizumab Receives NMPA’s Approval for the Treatment of 2L Classical Hodgkin’s Lymphoma (cHL)

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Shots: The approval is based on P-II BGB-A317-203 (NCT03209973) trial which involves assessing of tislelizumab with median follow up of 14 months The study resulted in ORR as 76.9% and CR as 61.5% with no fatal adverse reactions. BieGene’s Tislelizumab is the first drug to… Read More »BeiGene’s Tislelizumab Receives NMPA’s Approval for the Treatment of 2L Classical Hodgkin’s Lymphoma (cHL)

AstraZeneca and Merck & Co’s Lynparza Receive the US FDA’s Approval as a 1L Maintenance Treatment of Germline BRCA-Mutated Metastatic Pancreatic Cancer

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Shots: The approval follows the US FDA Oncologic drugs Advisory Committee (ODAC) on 17 Dec based on P-III POLO trial, which involves assessing of Lynparza tablets (300 mg bid) as maintenance monothx vs. PBO in 154 patients in ratio (3:2) with gBRCAm metastatic pancreatic cancer… Read More »AstraZeneca and Merck & Co’s Lynparza Receive the US FDA’s Approval as a 1L Maintenance Treatment of Germline BRCA-Mutated Metastatic Pancreatic Cancer