Treatment

Sepsis Opportunities: Lessons from the COVID-19 Pandemic

Sepsis is the body’s extreme response to an infection. It is a life-threatening medical emergency. Sepsis happens when an infection you already have triggers a chain reaction throughout your body. Infections that lead to sepsis most often start in the lung, urinary tract, skin, or gastrointestinal tract. Without timely treatment, sepsis can rapidly lead to …

Sepsis Opportunities: Lessons from the COVID-19 Pandemic Read More »

Analysis: Care for the unvaccinated may be costing U.S. healthcare system $2.3B

The report, released by Kaiser Family Foundation and the Peterson Center on Healthcare, details the high cost of Covid care for the unvaccinated. In fact, the analysis indicates the figure could be even higher than $2.3 billion, as the authors did not take into account the cost of outpatient treatment for Covid-19.

Why Do You Hear Music In Your Ears & How To Get Rid Of It?

If someone told you that they could hear music in their ears while stimulated by absolutely no melodies in the real world, you might think it to be cool. It’s like you always have your very own, private party. If that’s what you would think about it, though, then it means that you haven’t actually …

Why Do You Hear Music In Your Ears & How To Get Rid Of It? Read More »

Dermavant Presents Results of Tapinarof in Two P-III Trials for the Treatment of Psoriasis at AAD2021

Shots: The two P-III PSOARING 1 and PSOARING 2 trials involve evaluating Tapinarof (1% dosed, qd) vs vehicle (qd) in 1,025 patients aged 18-75yrs. with plaque psoriasis Results: 2EPs & PRO, @12wks., PASI90 (18.8% and 20.9%) vs (1.6% and 2.5%), ≥4-point NRS improvement (67.5% and 59.7%) vs (46.1 and 31.3%), improvement in QoL as measured …

Dermavant Presents Results of Tapinarof in Two P-III Trials for the Treatment of Psoriasis at AAD2021 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 »

Claritas Collaborates with CMAX to Initiate P-I Study of R-107 for Pulmonary Arterial Hypertension

Shots: The P-I study will evaluate the PK and safety profile of R-107 vs PBO in patients with PAH. Earlier, Claritas licensed R-107 from Salzman Group and collaborated with it, under which get an exclusive WW right to develop R-107 for the treatment of PAH CMAX will initiate a P-Ia study for R-107 (IM) and …

Claritas Collaborates with CMAX to Initiate P-I Study of R-107 for Pulmonary Arterial Hypertension Read More »

LEXEO Therapeutics Receives the US FDA’s Fast Track Designation for LX1001 to Treat APOE4 Associated Alzheimer Disease

Shots: The US FDA has granted FT Designation to LX1001 for the treatment of APOE4 associated AD. The designation evaluates to facilitate the development and expedite the review of drug The company has initiated P-I trial to assess the safety and toxicity of LX1001 as a potential one-time treatment for early-stage AD patients with mild …

LEXEO Therapeutics Receives the US FDA’s Fast Track Designation for LX1001 to Treat APOE4 Associated Alzheimer Disease Read More »

GW Pharmaceuticals’ Epidyolex (cannabidiol) Receives EC’s Approval for the Treatment of Seizures Associated with Tuberous Sclerosis Complex

Shots: The approval is based on P-III study evaluating cannabidiol (25 mg/kg/day) vs PBO in patients aged ≥2yrs. as an adjunctive treatment of seizures associated with TSC The study met its 1EPs i.e reduction in seizure frequency (49% vs 27%). The 2EPs supports the effects on 1EPs and safety profile was consistent with findings from …

GW Pharmaceuticals’ Epidyolex (cannabidiol) Receives EC’s Approval for the Treatment of Seizures Associated with Tuberous Sclerosis Complex Read More »

Janssen Presents Results of Nipocalimab (M281) in P-II Vivacity-MG Study for Adults with Generalized Myasthenia Gravis at AAN2021

Shots: The P-II Vivacity-MG study involves assessing the safety, tolerability, efficacy, PK, PD, and immunogenicity of nipocalimab in addition to SoC vs PBO in a ratio (1:1:1:1:1) in 68 patients with gMG The 1EPs of the study include safety, tolerability, and efficacy assessed by (MG-ADL) ADL score. The 2EPs includes the efficacy as measured by …

Janssen Presents Results of Nipocalimab (M281) in P-II Vivacity-MG Study for Adults with Generalized Myasthenia Gravis at AAN2021 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

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 recovery time while non-seizure benefits include improvements in executive functions …

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

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

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 SMA Evrysdi demonstrated improvement in motor function, 29.3% of participants …

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

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

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 mos.), mPFS (4.30 vs 2.79 mos.), ORR (25.5% vs 2.2%), …

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 Read More »

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

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: Improvement in DFS in all population, 83% reduction in the …

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

Roche and Biocorp Launch Mallya Smart Insulin Pen for Patients with Diabetes in France

Shots: The companies launched the Mallya smart insulin pen device in France to support patients with diabetes. The smart insulin pen is available in pharmacies and is compatible with any disposable insulin pens The device collects and transfers insulin data with 100% accuracy and is rechargeable via its USB port. Mallya automatically collects insulin data …

Roche and Biocorp Launch Mallya Smart Insulin Pen for Patients with Diabetes in France Read More »

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

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 i.e DFS while the trial will continue to evaluate its …

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

Passage Bio’s PBKR03 Receives EC’s Orphan Drug Designation for Krabbe Disease

Shots: The EC has granted ODD for PBKR03 for the treatment of Krabbe disease. The ODD was based on an EMA’s COMP positive opinion The designation provides potential benefits to the company, which include clinical protocol assistance, reduced regulatory fees, research grants, and up to 10 years of market exclusivity following regulatory approval The company …

Passage Bio’s PBKR03 Receives EC’s Orphan Drug Designation for Krabbe Disease Read More »

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

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 and treatment Uplizna is the first FDA-approved B-cell depleter to …

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

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

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 Alymsys and Oyavas both show comparable quality, safety & efficacy …

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

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

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 available therapy Futibatinib (TAS-120, PO) is a covalently-binding FGFR inhibitor …

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

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

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 to provide benefits to patients with PAH on top of …

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

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

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 up to 24 wks, as determined by time to loss …

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

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

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 or death by 45%. At pre-planned interim analysis, median PFS …

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

Chugai’s Polivy Receives MHLW’s Approval for Relapsed or Refractory Diffuse Large B-cell Lymphoma

Shots: The approval is based on results from P- Ib/II GO29365 study assessing Polivy (IV, 30 & 140mg) + BR vs BR alone in 80 DLBCL patients and P-II JO40762/P-DRIVE study that evaluated Polivy + BR therapy in 35 patients with R/R DLBCL not eligible for ASCT The P-II part of GO29365 study demonstrated CRR …

Chugai’s Polivy Receives MHLW’s Approval for Relapsed or Refractory Diffuse Large B-cell Lymphoma Read More »

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

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 showed ORR (88.9%), CR (22.2%). In general, the studies demonstrated …

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

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

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 B (other FGF/FGFR genetic alterations) or Cohort C (no FGF/FGFR …

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

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

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 to blood glucose recovery (10min vs 30-45min), following injection of …

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

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

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 of the growing deficit and improved height z-score through the …

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

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

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- free or minimal pain days (92% vs 40%), sustained reductions …

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

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

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- free or minimal pain days (92% vs 40%), sustained reductions …

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

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

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 a mean beta-SG expression (54% vs 36%); IF positive fibers …

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

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

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 a mean beta-SG expression (54% vs 36%); IF positive fibers …

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

GSK Initiates P-III Study of GSK3511294 (GSK’294) for the Treatment of Severe Asthma

Shots: The first patient has been dosed in the P-III SWIFT-2 trial assessing the safety and efficacy of GSK3511294 (GSK’294) in SEA The planned P-III program involves three studies, SWIFT 1, SWIFT 2 and the NIMBLE study that will assess the efficacy and safety of GSK’294 in ~2,450 patients with severe eosinophilic asthma GSK’294 (SC, …

GSK Initiates P-III Study of GSK3511294 (GSK’294) for the Treatment of Severe Asthma Read More »

GSK Initiates P-III Study of GSK3511294 (GSK’294) for the Treatment of Severe Asthma

Shots: The first patient has been dosed in the P-III SWIFT-2 trial assessing the safety and efficacy of GSK3511294 (GSK’294) in SEA The planned P-III program involves three studies, SWIFT 1, SWIFT 2 and the NIMBLE study that will assess the efficacy and safety of GSK’294 in ~2,450 patients with severe eosinophilic asthma GSK’294 (SC, …

GSK Initiates P-III Study of GSK3511294 (GSK’294) for the Treatment of Severe Asthma Read More »

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

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 will enroll an additional 700 patients. Ensovibep is currently being …

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

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

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 scales. The dose dependent response has the potential to support …

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

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

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

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

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

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

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

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

Shots: The submission is based on EV-301 and EV-201 trials in Japan. The P-III EV-301 trial assessing Enfortumab Vedotin vs CT in ~ 600 patients with LA/m-UC, prior treated with platinum-based CT and PD-1/L1 inhibitor The P-II EV-201 trial assessing Enfortumab Vedotin in ~128 patients with LA/m-UC, prior treated with PD-1/L1 inhibitor, including those who …

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

Vertex’s VX-880 Receives the US FDA’s Fast Track Designation for T1D

Shots: The US FDA has granted FTD for VX-880 to treat T1D. The designation is designed to facilitate the development and expedite the review of treatments for serious condition and fill an unmet medical need Additionally, the company has initiated P-I/II trial for VX-880 in ~17 patients who have T1D with severe hypoglycemia and impaired …

Vertex’s VX-880 Receives the US FDA’s Fast Track Designation for T1D Read More »

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

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. period (88% vs 17), low (150 mg/kg) and high dose …

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

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

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 is underway The collaboration follows Sorrento’s efforts to eradicate COVID-19 …

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

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

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 for 7days The study showed the antiviral activity b/w dose …

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

Novartis’ Canakinumab Fails to Meet its Primary Endpoint in P-III CANOPY-2 Study

Shots: The P-III CANOPY-2 study involves assessing canakinumab (ACZ885) + CT (docetaxel) in 237 adults with LA/m-NSCLC, prior treatment with PD-L1 inhibitors and Pt-based CT. The study did not meet its 1EPs of OS The company will continue to evaluate the therapy in ongoing P-III CANOPY-1 and CANOPY-A studies evaluating canakinumab in 1L and adjuvant …

Novartis’ Canakinumab Fails to Meet its Primary Endpoint in P-III CANOPY-2 Study 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

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 the industry to reevaluate plant-based biologics manufacturing as a possible …

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

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

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 to more treatment options The Ventana ALK (D5F3) CDx assay …

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

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

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%) participants having HIV-1 RNA ≥50 c/mL. The 2EPs @96 wks. …

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

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

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 baseline @48wks. in mRSS. In subgroup patients, decline in mean …

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

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

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 BICR. The prespecified exploratory analysis showed IC-ORR was (82% vs …

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

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

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 imminently The P-III APSEN study demonstrated clinical benefit with advantages …

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

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

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 age patients but did not reach statistically significant. The pre-planned …

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

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

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 in Canada following the approvals for AD in adults and …

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

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

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 7days b/w improvement in local eczema severity and killing of …

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

Insurance coverage and financing landscape for HIV treatment and prevention in the USA

In this article for The Lancet, KFF’s Jennifer Kates and Lindsey Dawson, and five co-authors provide an overview of the coverage and financing landscape for HIV treatment and prevention in the U.S., discuss how the Affordable Care Act has changed the domestic health care system, examine the major programs that provide coverage and services, and…More

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

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 from “mod. to sev.” prior to surgery to “mild” post-surgery, …

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

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

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 similar PK, efficacy, safety and immunogenicity to the Humira. Idacio …

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

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

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 reference product, in terms of safety, efficacy, PK/PD, and immunogenicity …

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

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

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. period The study met 1EPs i.e. 80% of patients achieved …

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

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

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

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

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 »

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

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 and clinically meaningful improvements to CD4+ T-cell count @96wks., HIV-1 …

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

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

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 study showed a reduction in risk of COVID-19 related hospitalization …

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

Reistone Report Results for SHR0302 in P-II Study to Treat Ulcerative Colitis

Shots: The P-II AMBER2 study assessing the efficacy and safety of SHR0302 (8mg qd/4mg bid/4mg qd) vs PBO in 164 adults with moderate to severe UC across 84 sites in China, US, and EU. The AMBER2 study consisted of an 8wks. induction period, followed by an 8wks. extension period The study met its 1EPs i.e. …

Reistone Report Results for SHR0302 in P-II Study to Treat Ulcerative Colitis Read More »

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

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 Remsima SC up to 54wks. The therapy has shown similar …

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

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

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 (79.1% vs 75.7%); procedural efficiencies with shorter total RF times, …

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

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

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 serious conditions and fill an unmet medical need GLR2007 is …

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

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

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 The company is currently recruiting in a P-III study (CodeBreaK …

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

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

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 patient has been dosed in the expanded study Bamlanivimab is …

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

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

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 with that seen in RA The P-III studies met its …

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

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 by 40%, median PFS (16.5mos. vs 8.2mos); ORR (44% vs …

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 Read More »

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

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 16.6 mos vs 8.3 mos for Sutent arm. Opdivo + …

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

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

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

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

AstraZeneca’s Imfinzi (durvalumab) New Dosing Option Receives Approval for NSCLC in the EU & UK

Shots: Imfinzi has been approved in the EU and the UK for an additional dosing option (1500mg, fd, q4w) in LA, unresectable NSCLC in adults whose tumors express PD-L1 on at least 1% of tumor cells and whose disease has not progressed following platinum-based CRT New option extends dosing from 2 to 4wks. thus, reducing …

AstraZeneca’s Imfinzi (durvalumab) New Dosing Option Receives Approval for NSCLC in the EU & UK Read More »

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

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 monthly migraine days (MMD) over 1-12wks and showed 50% & …

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

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

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 in H1’21 Trikafta is a triple combination regimen used to …

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

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

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 on a novel polymer-based topical delivery platform and offers potential …

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

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

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 of FeDeriCa Study: The GMR for the 1EPs (1.22) with …

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

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

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 % vs. 20 %); median follow-up (18.8 mos.); reduction in …

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

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

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. Shots: Novocure is a global oncology company working to extend …

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

reMYND Commences P-l Study of RES19-T for Alzheimer’s Disease

Shots: The P-l trial will evaluate the safety, tolerability, and PK of ReS19-T for the treatment of AD. In preclinical studies, ReS19-T has shown to robustly restore synaptic plasticity with an acute response and improve inflammation and AD pathology over a longer treatment duration reMYND has a broad pipeline of novel programs in development, with …

reMYND Commences P-l Study of RES19-T for Alzheimer’s Disease Read More »

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

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 retina cells to make a soluble form of CD59, helping …

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

AstraZeneca’s Forxiga (dapagliflozin) Receives MHLW’s Approval for Chronic Heart Failure

Shots: The approval is based on a DAPA-HF trial assessing Forxiga (10mg, qd) + SOC vs PBO + SOC in 4,744 patients with HFrEF (LVEF ≤ 40%) with/ out T2D The study demonstrated reduced the risk of the composite outcome by 26% along with a reduction in the risk of CV death or worsening of …

AstraZeneca’s Forxiga (dapagliflozin) Receives MHLW’s Approval for Chronic Heart Failure Read More »

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

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 has previously been shown to accelerate medicinal chemistry campaigns PostEra …

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

Urovant’s Vibegron Fails to Meet its Primary Endpoint in P-IIa Study for IBS Pain

Shots: The P-IIa study involves assessing vibegron (75mg,qd) in 222 women with abdominal pain due to IBS with IBS-D (diarrhea) and IBS-M (mixed IBS) across 35 sites in the US The study did not meet its 1EPs i.e. at least a 30 percent improvement in average worst abdominal pain @12wks. ( 40.9% vs 42.9%), well …

Urovant’s Vibegron Fails to Meet its Primary Endpoint in P-IIa Study for IBS Pain Read More »

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

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 SOC respectively Combined results: achieved 1EPs of ACR20 @24wks.; improvements …

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

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

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 improvement of certain symptoms, such as severity & frequency of …

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

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

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 PBO, the study also achieved significant results for all 6 …

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

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

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 FDA has issued an RPD priority review voucher to Eiger …

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

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

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 of symptoms & hospitalization, frequency & types of AEs are …

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

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

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 based platform with WW rights to a range of potential …

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

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

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 viral load & rates of symptoms & hospitalization. The EUA …

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

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

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 rate (5.5% vs 16.5%); Binary primary patency (82.9% vs 66.3%); …

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

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

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 response rates, mean DAS28, CDAI & SDAI & EULAR (CRP) …

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

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

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 treated with Zejula, regardless of biomarker status. In the HRd …

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

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

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 CALCIPHYX study evaluating the efficacy and safety of SNF472 for …

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

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 assessing Tagrisso (80mg, qd, PO) vs PBO for 3yrs. or …

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

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

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 rate of moderate or severe exacerbations compared with the Bevespi …

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

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

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 reduction in days until the virus was undetectable in the …

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

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

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 epithelial ovarian, fallopian tube, or primary peritoneal cancer who are …

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

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

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 risk of death (OS); 41% reduction the risk of disease …

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

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

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 Feb 11, 2021. The US FDA has granted BT designation …

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

Cadila Pharma Launches NuPTH Biosimilar to Forteo for the Treatment of Osteoporosis in India

Shots: Cadila has launched NuPTH an osteoporosis biosimilar of Forteo in India. The NuPTH is used for the treatment of osteoporosis and in patients with increased risk of fracture. The biosimilar NuPTH aims to be cost-effective for patients and will be available as easy to use, pre-filled disposable pen NuPTH is the third biosimilar launched …

Cadila Pharma Launches NuPTH Biosimilar to Forteo for the Treatment of Osteoporosis in India Read More »

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

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 consistent ORR (41% vs 37%), with PK & safety profile …

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

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

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 cervix Equidacent will be available as 25 mg/ml as the …

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

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

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 be approved in China and the candidate’s NDA has also …

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

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 whose disease had not progressed on at least 16 weeks …

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