Merck Reports the US FDA’s Acceptance of NDA for Review of Gefapixant to Treat Refractory or Unexplained Chronic Cough

Shots:

  • The NDA submission is based on two P-III studies (COUGH-1 & -2) involves assessing gefapixant (45/15mg, bid) vs PBO in 2,044 patients with RCC & UCC
  • In both the studies, gefapixant resulted in the reduction of in 24hrs.-cough frequency @12 & 24wks respectively. Data were presented at ERS 2020
  • Gefapixant is a selective P2X3 receptor antagonist for the potential treatment of refractory or unexplained chronic cough. The anticipated PDUFA date is Dec 21, 2021

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: The Morning Call

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Regeneron Reports IDMC Clearance of Efficacy for REGEN-COV (Casirivimab + Imdevimab) in P-III COVID-19 Outpatient Outcomes Trial

Shots:

  • Regeneron reported changes to the P-III study assessing REGEN-COV in non-hospitalized patients with COVID-19, following recommendations from the IDMC
  • The IDMC found clear clinical efficacy in reducing the rate of hospitalization and death with both doses (1,200 & 2,400 mg) of REGEN-COV vs PBO. The company will immediately stop enrolling patients in the PBO group, following the IDMC’s recommendation
  • The trial will continue to enroll patients in both treatment arms. IDMC has also reassured that REGEN-COV effectively neutralizes emerging strains of the virus in its preclinical data

Click here ­to­ read full press release/ article | Ref: Regeneron | Image: The Print

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Otsuka and Click Initiate Digital Study in Adults with Major Depressive Disorder

Shots:

  • Otsuka and Click have reported the initiation of the Mirai study which is a fully remote clinical trial to investigate the effectiveness of digital therapeutics in reducing depressive symptoms in adults diagnosed with MDD who are on antidepressant monotherapy. The study will enroll ~540 patients globally
  • The trial will run fully remotely utilizing the Verily Project Baseline platform, a first-of-its-kind trial design for MDD. Participation will be of 10wks. and efficacy will be evaluated as a change from baseline in the MADRS total score
  • The companies’ collaboration with Verily enables the trial to proceed efficiently and safely during the pandemic

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Contract Pharma

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Intra-Cellular Reports the Expansion of Pipeline with the Addition of ITI-1284

Shots:

  • Following the completion of a P-I program, the company plans to initiate P- II studies to evaluate ITI-1284 ODT-SL for the treatment of behavioral disturbances in dementia, dementia-related psychosis and certain depressive disorders in the elderly
  • The P-I single and multiple ascending dose studies in healthy volunteers including elderly subjects aged >65yrs. evaluated the safety, tolerability and PK of ITI-1284 and reported no SAEs in either age group
  • TI-1284 is a deuterated form of lumateperone, delivered sublingually as an ODT-SL and offer pharmacologic benefits and ease of use for patients, particularly in elderly populations

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: The Science of Parkinson’s

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Pfizer Reports the US FDA’s Acceptance and Priority Review of BLA for Ticovac (Tick-Borne Encephalitis Vaccine)

Shots:

  • The US FDA has accepted the PR of BLA for TicoVac to prevent TBE in patients aged ≥1year with an anticipated PDUFA date in Aug 2021. If approved, the vaccine may help reduce the risk of TBE for people traveling to endemic areas
  • The BLA is based on clinical trials that assess TicoVac across two age groups (aged 1-15yrs. and 16-65yrs.). The studies showed pooled seropositivity rates 99-100% and 94-99% following three doses respectively
  • The real-world studies demonstrated that the vaccine is 96-99% effective in people who have received at least 2 doses of the vaccine and 2-3 doses of the vaccine were shown to be sufficient to provide a long-lasting immune memory

Click here ­to­ read full press release/ article | Ref: Pfizer | Image: Pfizer

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Amgen Reports sNDA Submission of Otezla (apremilast) to The US FDA’s for Adults with Mild to Moderate Plaque Psoriasis

Shots:

  • The sNDA filing is based on P-III ADVANCE trial data, assessing Otezla (30 mg, bid) vs PBO in 595 patients in a ratio (1:1) with mild-to-moderate plaque psoriasis
  • The P-III ADVANCE study results: @16wks., improvement in its 1EPs of sPGA score; achieve 2EPs i.e, 75% improvement in BSA, change in PASI score
  • Otezla is a selective PDE4 inhibitor, approved therapy for mod. to sev. plaque psoriasis who are candidates for phototherapy or systemic therapy, for active PsA, and for with oral ulcers associated with Behçet’s Disease

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Conejo Valley Guide

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Incyte Reports the US FDA’s Acceptance of sNDA for Priority Review of Jakafi (ruxolitinib) to Treat Chronic Graft Versus Host Disease

Shots:

  • The sNDA submission is based on the P-III REACH3 study assessing ruxolitinib vs best available therapy in adult and pediatric patients ≥12yrs. with steroid-refractory chronic GVHD. The findings were recently presented at the 62nd ASH Annual Meeting & Exposition
  • The study showed greater ORR @24wks. i.e 1EPs (49.7% vs 25.6%); @24wks. mFFS (not reached vs 5.7 mos.); greater symptom improvement per mLSS (24.2% vs 1.0%); no new safety signals were observed while AEs were consistent
  • The PR shortens the review period from 10 to 6mos. The anticipated PDUFA date is Jun 22, 2021

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: The Business Journals

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Incyte Reports the US FDA’s Acceptance of NDA for Priority Review of Ruxolitinib Cream to Treat Atopic Dermatitis

Shots:

  • The NDA is based on two P-III TRuE-AD 1 & 2 assessing ruxolitinib cream (0.75%/1.5%, bid) vs vehicle (non-medicated cream) in 600 patients aged ≥12yrs. in a ratio (2:2:1) diagnosed with AD for at least 2yrs. and who were candidates for topical therapy
  • Patients who completed an assessment @8wks. were offered participation in the 44wks. long-term safety treatment extension period with ruxolitinib cream (0.75%/1.5%, bid)
  • The company submitted PRV along with NDA to the FDA which shortens the review period by 4mos. The anticipated PFUFA date is Jun 21, 2021

Click here ­to­ read full press release/ article | Ref: BusinessWire | Image: BusinessWire

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Astellas Reports Results of Fezolinetant in Two P-III Studies for the Nonhormonal Treatment of VMS in Postmenopausal Women

Shots:

  • The P-III studies SKYLIGHT 1 & 2 involves assessing fezolinetant (30 & 45mg, qd) vs PBO in women with mod. to sev. vasomotor symptoms (VMS) for the first 12wks. followed by 40wks. active treatment extension periods
  • Both the trials met all four co-1EPs demonstrating a significant reduction from baseline in the frequency and severity of moderate to severe VMS to week 4 and week 12
  • Fezolinetant is an NK3R antagonist targeting NKB binding on the KNDy neuron to moderate neuronal activity in the brain to treat VMS associated with menopause

Click here ­to­ read full press release/ article | Ref: Astellas | Image: Nasdaq

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Astellas and Seagen Reports Submission of Two BLA to the US FDA for Padcev (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer

Shots:

  • The first BLA submission is based on P-III EV-301 trial which involves assessing of Padcev vs CT in 600 patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based CT and a PD-1/L1 inhibitor. The 1EP of the study was OS
  • The second BLA submission is based on P-II cohort 2 of EV-201 trial which involves assessing of Padcev in 128 patients with locally advanced or metastatic urothelial cancer who had received prior immunotherapy treatment but not eligible for cisplatin. The 1EP’s study was ORR
  • The submissions will be reviewed under RTOR for both the trials and results were presented at the ASCO GU’ 2021

Click here ­to­ read full press release/ article | Ref: Astellas | Image: Astellas

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BeiGene Reports the US FDA’s Acceptance of sNDA for Brukinsa (zanubrutinib) in Waldenström’s Macroglobulinemia

Shots:

  • The sDNA submission is based on a P-III APSEN study assessing Brukinsa vs ibrutinib in 351 patients with WM and includes a pivotal P-II trial of zanubrutinib in r/r WM conducted in China and P- I/II trial in patients with B-cell malignancies
  • Additionally, safety data from 779 patients in 6 trials of Brukinsa were included in the submission with the anticipated PDUFA date as Oct 18, 2021. Brukinsa is also under regulatory review in the EU, Canada, Australia, China, Taiwan, and South Korea
  • Currently, 20+ marketing applications of Brukinsa have been submitted covering 45 countries globally including the US, EU & China

Click here ­to­ read full press release/ article | Ref: BusinessWire | Image: Switzerland Global Enterprise

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Lilly Reports Results of Tirzepatide in P-lll SURPASS-3 and 5 Trials for Type-2 Diabetes

Shots:

  • The P-lll SURPASS-3 study involves assessing Tirzepatide (5/10/15 mg) vs titrated insulin degludec in 1444 participants in a ratio (1:1:1:1) with T2D treated with metformin with or without an SGLT-2 inhibitor for 52wks.
  • The P-lll SURPASS-5 study involves assessing Tirzepatide (5/10/15 mg) vs PBO in 475 participants in a ratio (1:1:1:1) in adults with inadequately controlled T2D already being treated with insulin glargine with or without metformin
  • The SURPASS-3 & 5 shows A1C reduction: (-1.93% /-2.20%/-2.37% vs- 1.34%) & (-2.23%/-2.59%/ -2.59% vs -0.93%); Weight reduction: (-8.1%/ -11.4%/-13.9% vs +2.7%) & (-6.6%/-8.9%/-11.6% vs +1.7%) respectively

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Fortune

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Roche Reports Results of Faricimab in Four P-III Studies for Diabetic Macular Edema and Age-Related Macular Degeneration

Shots:

  • The P-III YOSEMITE & RHINE studies involve assessing faricimab (6mg at personalized dosing intervals of up to 4mos. and at fixed 2mos. intervals) vs aflibercept (2mg, fixed 2mos. intervals) in 1891 patients with DME
  • The P-III TENAYA & LUCERNE studies assessing faricimab (6mg administered at fixed intervals of every 2,3 & 4mos. based on objective assessment of disease activity @20 & 24wks.) vs aflibercept in 1329 patients with nAMD
  • The studies showed, i.e faricimab demonstrated non-inferior visual acuity gains and shows greater reductions in CST, thus reducing the treatment burden for patients and was well tolerated with no new safety signals identified

Click here ­to­ read full press release/ article | Ref: Roche | Image: Pharmaceutical Technology

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Johnson & Johnson Reports EUA Submission to US FDA’s for its Single Shot COVID-19 Vaccine Candidate

Shots:

  • The EUA submission is based on P-III ENSEMBLE trial assessing the safety and efficacy of the COVID-19 vaccine in protecting adults aged ≥18yrs. against both mod. and sev. COVID-19 disease with assessment of efficacy as of day 14 and as of day 28 as co-1EPs
  • The study demonstrated that single-dose vaccine met all 1EPs & 2EPs. The company has initiated rolling submissions with several health agencies outside the US, and will submit a cMAA with the EMA in the coming weeks
  • The company intends to distribute vaccine to the US government imminently, following the authorization, and expects to supply 100M doses to the US in the H1’21

Click here ­to­ read full press release/ article | Ref: J&J | Image: Yahoo Finance

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Janssen Reports CHMP’s Acceptance for Accelerated Assessment of Cilta-cel’s MAA to Treat Patients with Heavily Pretreated Multiple Myeloma

Shots:

  • The MAA submission is based on a P-Ib/II CARTITUDE-1 study assessing the safety and efficacy of cilta-cel in adults with r/r MM. The company is expected to submit MAA to EMA in H1’21
  • The accelerated approval milestone in EU follows the rolling submission for cilta-cel to the US FDA in Dec’2020
  • Cilta-cel is an investigational BCMA-directed CAR-T therapy in development for the treatment of adults with r/r MM. CHMP’s accelerated assessment can reduce the review timelines to evaluate an MAA

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Businesswire

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Janssen Reports Results of Amivantamab in P-I CHRYSALIS Study for Metastatic or Unresectable NSCLC and EGFR Exon 20 Insertion Mutations

Shots:

  • The P-I CHRYSALIS study involves assessing of amivantamab (RP2D of 1050 mg [1400 mg for a patient weight of ≥80 kg]) as a monothx. and in combination with lazertinib in 460 patients with metastatic or unresectable NSCLC and EGFR exon 20 insertion mutations whose disease progressed on or after platinum-based CT
  • Results: ORR (40%); mPFS (8.3 mos.); mOS (22.8 mos.), clinical benefit rate (74%), mDoR (11.1 mos.). The data showed robust activity and durable responses with a tolerable and manageable safety profile
  • The company has filed regulatory submissions in the US and EU seeking approval of amivantamab

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: The Pharma Letter

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Bio-Thera Solutions Reports the US FDA’s Acceptance of BLA for BAT1706 (Proposed Biosimilar to Avastin)

Shots:

  • The BLA submission is based on data from P-III clinical comparison study that demonstrated BAT1706 is highly similar to reference bevacizumab in clinical efficacy, safety, and immunogenicity. The anticipated BsUFA date is Nov 27, 2021
  • The BLA seeks approval of BAT1706 for mCC in combination with fluorouracil-based CT, 1L treatment for nsq. NSCLC, recurrent glioblastoma, mRCC in combination with interferon alfa and persistent, recurrent or metastatic cervical cancer
  • The FDA’s acceptance brings Bio-Thera closer to providing cancer patients in the US with a high-quality, low-cost treatment option

Click here ­to­ read full press release/ article | Ref: Business Wire | Image: Business Wire

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Eli Lilly and AbCellera Report Results of Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV16) in P-II/III BLAZE-1 Study for Preventing COVID-19

Shots:

  • The P-II/III BLAZE-1 trial involves assessing of Bamlanivimab + Etesevimab (2800 mg) vs PBO in 1035 patients recently diagnosed with COVID-19 in the ambulatory setting
  • The results demonstrated an 70% reduction in risk of COVID-19 related hospitalizations and deaths in high-risk patients and improvements in all 2EPs including reductions in viral load and accelerated symptom resolution
  • The data from the BLAZE-1 study are both compelling and entirely consistent with the interim data that were the basis for EUA of bamlanivimab (700mg) in the US, Canada, and EU for mild to mod. COVID-19 in patients aged ≥12yrs. who are at high risk for progressing to severe COVID-19 or hospitalization

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Catalio Capital Management

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Incyte Reports Acceptance and Priority Review of BLA for Retifanlimab to Treat Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC)

Shots:

  • The BLA submission is based on P-II POD1UM-202 trial involves assessing of retifanlimab (500 mg, q4w) in 94 patients with locally advanced or metastatic SCAC who have progressed on or are intolerant of standard platinum-based CT
  • The study demonstrates 14% ORR for retifanlimab monotherapy as determined by ICR using RECIST v1.1 and mDOR of 9.5mos
  • Retifanlimab has received FDA’s ODD for the treatment of anal cancer along with PR which shortens the review period by 4mos vs Standard Review. The PDUFA target action date is Jul 25, 2020

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Technical.ly

The post Incyte Reports Acceptance and Priority Review of BLA for Retifanlimab to Treat Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC) first appeared on PharmaShots.

Roche Reports the US FDA’s Acceptance of sNDA and Granted Priority Review for Esbriet (pirfenidone) to Treat UILD

Shots:

  • The sNDA submission is based on a P-II study that involves assessing Esbriet vs PBO in patients aged ≥18-85yrs. with progressive fibrosing UILD for 24wks. The anticipated PDUFA date is May’2021
  • Results: Over 24wks. predicted median change in FVC measured by home spirometry (-87.7 vs -157.1 mL); change in percent predicted DLco and 6MWD are in favor of Esbriet. Additionally, less loss to lung function and exercise capacity was observed
  • Esbriet is an oral therapy for IPF and is available in more than 60+ countries globally. FDA has granted ODD and BTD to the therapy in 2020

Click here ­to­ read full press release/ article | Ref: Roche| Image: The Indian Express

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Omeros Reports the US FDA’s Acceptance and Priority Review of BLA for Narsoplimab (OMS721) to Treat HSCT-TMA

Shots:

  • The US FDA has accepted the BLA and granted the PR with an anticipated PDUFA date as Jul 17, 2021
  • The BLA filing marks the milestone on the path to commercialization of narsoplimab
  • Narsoplimab is an investigational mAb targeting MASP-2 has received the US FDA’s BTD and ODD to the FDA for each of HSCT-TMA and IgA nephropathy

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Omeros

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Cardiff Oncology Report Results of Onvansertib in P- Ib/II Study for KRAS-Mutated Metastatic Colorectal Cancer

Shots:

  • The P-Ib/II study involves assessing of Onvansertib + Folfiri and bevacizumab in 44 patients with 2L treatment of KRAS-mutated mCRC. The company also provided an additional data update from its mCRC clinical program and initial findings from its EAP
  • Out of the 12 P-1b patients, 42% achieved PR & 67% have shown a durable response ranging from 6.1-13.7mos. The RP2D has been established at 15mg/m2 and the P-II segment of the ongoing trial is open to full enrollment of ~26 patients across 6 sites in the US
  • In the EAP, 66% of the initial 9 patients treated have shown tumor shrinkage and remain on treatment to-date with durable responses lasting an avg. of 6 mos.

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Cardiff oncology

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BioMarin Reports Results of Valoctocogene Roxaparvovec in P-III GENEr8-1 Study for Hemophilia A

Shots:

  • The ongoing P-III GENEr8-1 study involves assessing of valoctocogene roxaparvovec (6e13 vg/kg dose) in 134 patients with with severe hemophilia A. The patients received a single dose of valoctocogene roxaparvovec and completed a year or more of follow-up
  • The study met 1EPs & 2EPs i.e. reduction in ABR by 84% demonstrating superiority to factor VIII prophylaxis and reduced mean annualized factor VIII infusion rate by 99%. In subset dosed >2yrs. ago, rate of decline in factor VIII expression is slow
  • Mean ABR in the population was 0.9 over these two-plus yrs. BioMarin plans to meet with EMA to discuss the submission of 1yrs. data and the FDA to review 2yrs. data-request

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Northbay Biz

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Sarepta Reports Mixed Results of SRP-9001 (rAAVrh74.MHCK7.micro-dystrophin) in Part 1 of Study 102 for DMD

Shots:

  • The Study 102 involves assessing of SRP-9001 vs PBO in 41 patients in a ratio (1:1) with DMD aged 4-7yrs.
  • Results: @12wks. post treatment, the study met its 1EPs of micro-dystrophin protein expression, as measured by western blot. @48wks. increase in NSAA total score, however, the study did not achieve significance on the primary functional endpoint of improvement in NSAA total score @48wks. post-treatment
  • The pre-specified analysis of patients aged 4-5yrs. showed improvement in NSAA total score (4.3 vs 1.9 points). No new safety signals identified for SRP-9001, reinforcing the favorable safety profile

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: The Business Journals

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Pfizer Reports the First Patients Dosing of PF-06939926 in P-III CIFFREO Study for DMD

Shots:

  • The first patient has been dosed in P-III CIFFREO study assessing PF-06939926 vs PBO in 99 ambulatory male patients aged 4-7yrs. with DMD across 55 sites in 15 countries.
  • The first patient was dosed at a site in Barcelona, Spain on Dec 29, 2020. The 1EPs of the study is the change in NSAA @1yr, while patients will be followed in the CIFFREO study for 5yrs. after treatment with PF-06939926
  • PF-06939926 is an investigational rAAV9 capsid carrying a shortened version of the human dystrophin gene (mini-dystrophin) under the control of a human muscle-specific promotor and has received the US FDA’s FT designation in Oct’2020 and ODD & RPD in May’2017

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Wall Street Journal

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Alnylam Reports Results of Vutrisiran in P-III HELIOS-A Study for Patients with hATTR Amyloidosis with Polyneuropathy

Shots:

  • The P-III HELIOS-A study assessing vutrisiran (25mg, SC, once every 3mos.) vs patisiran (0.3 mg/kg, IV, q3w) in 164 patients in a ratio (3:1) with hATTR amyloidosis with polyneuropathy
  • The study met its 1EPs & 2EPs i.e. change from baseline in the mNIS+7 @9mos. & changes in QoL assessed by Norfolk QoL-DN and gait speed assessed by the timed 10-MWT respectively. Additionally, therapy showed improvements in the 9mos. exploratory cardiac endpoint of NT-proBNP
  • The company plans to submit NDA to the US FDA in H1’21, following the regulatory filing in Brazil and Japan. Moreover, Alnylam intends to submit MAA in the EU on obtaining the results of 18mos. analysis, anticipated in late 2021

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Bloomberg

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Astellas Reports the US FDA’s Acceptance of Priority Review for its NDO Therapy

Shots:

  • The US FDA has accepted the PR for NDA of mirabegron (oral suspension) and sNDA for Myrbetriq (mirabegron, tablets) for neurogenic detrusor overactivity (NDO) in pediatric patients aged ≥ 3yrs. with anticipated PDUFA date as Mar 28, 2021
  • The NDA & sNDA is based on P-III study assessing efficacy, safety, tolerability and PK of mirabegron in children and adolescents aged 3-<18yrs. with NDO and using clean intermittent catheterization
  • In 2012, Myrbetriq tablets were initially approved in the US for adults with overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Financial Times

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AbbVie Reports Results of Skyrizi (Risankizumab) in P-III Studies for Active Psoriatic Arthritis

Shots:

  • The two P-III studies KEEPsAKE-1 & -2 involves assessing Skyrizi (150mg) vs PBO followed by risankizumab (150mg, @24wks.) in patients with active PsA who had an inadequate response or intolerant to at least one biologic therapy and/or non-biologic DMARDs respectively
  • Results: ACR20 (57% & 51% vs 34% & 27%); ACR50 (33% & 26% vs 11% & 9%); ACR70 (15% & 12% vs 5% & 6%); PASI 90 (52% & 55% vs 10% & 10%); HAQ-DI (-0.31 & -0.22 vs -0.11 & -0.05); MDA (25% & 26% vs 10% & 11%) respectively
  • The safety profile is consistent with the known profile of risankizumab in psoriasis patients. Skyrizi is an IL-23 inhibitor, being developed in collaboration with Boehringer Ingelheim

Click here ­to­ read full press release/ article | Ref: Abbvie | Image: Modern Healthcare

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Pfizer and OPKO Reports the US FDA’s Acceptance of BLA for Somatrogon to Treat Pediatric Patients with Growth Hormone Deficiency

Shots:

  • The BLA submission is based on P-lll study assessing the safety and efficacy of Somatrogon (0.66 mg/kg, qw) vs Somatropin (0.034 mg/kg, qd) in 224 pediatric patients in the ratio of (1:1) with GHD
  • The study met its 1EPs of non-inferiority as measured by annual height velocity @12mos.; least square mean (10.12 vs 9.78 cm/year); the treatment difference in height velocity was 0.33 cm/yr
  • The anticipated PDUFA date is Oct 2021 and is approved, the therapy is served as a once-weekly treatment option

Click here ­to­ read full press release/ article | Ref: Business Wire | Image: The Wire

The post Pfizer and OPKO Reports the US FDA’s Acceptance of BLA for Somatrogon to Treat Pediatric Patients with Growth Hormone Deficiency first appeared on PharmaShots.

Provention Bio Reports Submission of BLA and Priority Review to the US FDA for Teplizumab to Prevent T1D

Shots:

  • The BLA for teplizumab to delay or prevention of clinical T1D in at-risk individuals has been filed to the US FDA. The FDA has also granted Provention’s request for Priority Review and assigned anticipated PDUFA date as Jul 02, 2021
  • The company is actively working with the FDA to support their review while planning to launch the therapy in Q3’21
  • Teplizumab is an investigational anti-CD3 mAb and has previously received the US FDA’s BT designation. If approved, teplizumab will be the first disease-modifying therapy for T1D

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: ProventionBio

The post Provention Bio Reports Submission of BLA and Priority Review to the US FDA for Teplizumab to Prevent T1D first appeared on PharmaShots.

Antengene Reports NDA Submission for ATG-010 (selinexor) to Treat RRMM and RR DLBCL in South Korea

Shots:

  • The NDA is based on STORM and SADAL studies. The P-IIb STORM study involves assessing of ATG-010 + low-dose dexamethasone in patients with rrMM prior treated with at least 4 prior therapies and whose disease is refractory to at least 2 proteasome inhibitors, 2 immunomodulatory agents, and an anti-CD38 mAb
  • The P-II SADAL study involves assessing ATG-010 in patients with rrDLBCL, including DLBCL arising from FL, who have received at least 2 prior therapies. The studies demonstrated efficacy with a manageable safety profile for ATG-010
  • ATG-010 (Xpovio) is a first-in-class oral SINE and is the first FDA approved drug for use in both MM and DLBCL

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: PRNewswire

The post Antengene Reports NDA Submission for ATG-010 (selinexor) to Treat RRMM and RR DLBCL in South Korea first appeared on PharmaShots.

RedHill Reports Results of Yeliva (opaganib) in P-II Study for COVID-19

Shots:

  • The P-II US study involves assessing Opaganib + SOC vs PBO + SOC in 40 patients requiring oxygen support in a ratio (1:1) and were followed up for ~42days post-treatment initiation
  • The study demonstrated improvement in reaching room air within 14days (52.6% vs 22.2%); improvement in reduction to 50% supplemental oxygen by Day 14 (89.5% vs 66.7%); a higher proportion of patients discharged by Day 14 (73.7% vs 55.6%), reduction in the median total oxygen requirement (AUC) over 14 days (68.0% vs 46.7%)
  • The results from the global P-II/III study in 270 hospitalized patients expected in Q1’21 and an interim DSMB futility analysis is expected in the coming weeks

Click here ­to­ read full press release/ article | Ref: Redhill Bio | Image: PR Newswire UK

The post RedHill Reports Results of Yeliva (opaganib) in P-II Study for COVID-19 first appeared on PharmaShots.

Health Canada Accelerates the Review for AstraZeneca’s COVID-19 Vaccine

Shots:

  • Health Canada expedite the review of AstraZeneca’s COVID-19 vaccine after the vaccine received the UK’s MHRA approval for emergency use
  • Following an agreement to supply 20M of doses for the Government of Canada, AstraZeneca seek out Health Canada’s clearance in Oct’2020, leading to data submission done on a rolling basis for accelerating the review process
  • Health Canada is looking to give Canadians access to COVID-19 vaccines asap without compromising its safety, efficacy, and quality standards

Click here ­to­ read full press release/ article | Ref: Newswire Canada | Image: Money Control

The post Health Canada Accelerates the Review for AstraZeneca’s COVID-19 Vaccine first appeared on PharmaShots.

Sorrento Reports Submission of MAA to COFEPRIS for COVI-STIX Rapid Detection Test

Shots.

  • The company has submitted MAA to COFEPRIS (the health regulatory authority for Mexico) for its COVI-STIX rapid diagnostic test to detect SARS-CoV-2 virus nucleocapsid antigen in nasal samples of patients
  • The test provides results in 15min. with positive detection as quickly as 2min for patient samples with high viral load.
  • Additionally, Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including COVI-GUARD, COVI-AMG, COVI-SHIELD, Gene-MAb, COVI-MSC and COVI-DROPS and diagnostic test solutions, including COVI-TRACK, COVI-STIX and COVI-TRAC

Click here ­to­ read full press release/ article | Ref: Sorrento | Image: Sorrento

The post Sorrento Reports Submission of MAA to COFEPRIS for COVI-STIX Rapid Detection Test first appeared on PharmaShots.

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 treat CF in patients aged ≥12yrs. who have at least one copy of the F508del mutation in the CFTR gene

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Vertex

The post Vertex Reports Health Canada’s Acceptance of Trikafta’s NDA for Priority Review to Treat Cystic Fibrosis first appeared on PharmaShots.

Sinopharm’s COVID-19 Vaccine Demonstrates 79% Efficacy in P-III Study

Shots:

  • The results of an interim analysis of P-III study showed that the safety of the new coronavirus inactivated vaccine after inoculation
  • All patients produced high-titer Abs, the neutralizing Ab positive conversion rate was 99.52% while vaccine efficacy was 79.34%
  • The vaccine has been granted authorization in several countries and has also been rolled out in part in China. The company is now seeking full approval in China

Click here ­to­ read full press release/ article | Ref: Sinopharm | Image: Sinopharm

The post Sinopharm’s COVID-19 Vaccine Demonstrates 79% Efficacy in P-III Study first appeared on PharmaShots.

Regeneron’s Antibody Cocktail Demonstrate Promising Results in Hospitalized Patients on Low-Flow Oxygen

Shots:

  • The company reported encouraging initial data from an ongoing P-I/II/III trial of its casirivimab + imdevimab (8,000/2,400mg) in hospitalized COVID-19 patients requiring low-flow oxygen. The results passed the futility analysis as seronegative patients treated with the Ab cocktail had a lower risk of death or receiving mechanical ventilation
  • In seronegative patients, the cocktail reduced the time-weighted average daily viral load through day 7 by -0.54 log10 copies/mL & through day 11 by -0.63 log10 copies/mL, at day 5, the relative reduction vs PBO was -1.1 log10 copies/mL
  • Both the Ab cocktail doses were well-tolerated. The Ab cocktail is designed to block the infectivity of SARS-CoV-2

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Knowledge Ecology International

The post Regeneron’s Antibody Cocktail Demonstrate Promising Results in Hospitalized Patients on Low-Flow Oxygen first appeared on PharmaShots.

Novo Nordisk Reports Submission of Label Extension Application to the EMA for Semaglutide (once weekly, 2.0 mg) for T2D

Shots:

  • The submission is based on SUSTAIN FORTE trial assessing Ozempic (2.0mg, qw) vs Ozempic (1.0mg) in 961 people with T2D in need of treatment intensification
  • Result: 2.0 mg of dose achieved significant and superior reduction in HbA1c @40wks., both the doses are safe and well-tolerated
  • Ozempic is a glucagon-like peptide-1 (GLP-1) analogue and is currently approved in the EU for 0.5 mg and 1.0 mg doses to treat T2D in adults

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Facebook

The post Novo Nordisk Reports Submission of Label Extension Application to the EMA for Semaglutide (once weekly, 2.0 mg) for T2D first appeared on PharmaShots.

Algernon’s Last Patient Out in NP-120 (Ifenprodil) P-IIb/III Study for COVID-19

Shots:

  • The last patient is out from the P-IIb part of its multinational P-IIb/III study of NP-120 for the COVID-19 has now completed treatment with 2wk follow up
  • The company reports positive interim results for the P-IIb part of it P-IIb/III Ifenprodil COVID-19 study and expecting the final data set by end of Feb 2021
  • NP-120 (Ifenprodil) is an NMDA receptor antagonist specifically targeting the NMDA-type subunit 2B, & prevents glutamate signaling. The NMDA receptor is found on many tissues including lung cells, T-cells & neutrophils

Click here ­to­ read full press release/ article | Ref: GlobeNewswire  | Image: Algernon

The post Algernon’s Last Patient Out in NP-120 (Ifenprodil) P-IIb/III Study for COVID-19 first appeared on PharmaShots.

Ocular Therapeutix Reports sNDA Submission of Dextenza (dexamethasone ophthalmic insert) to the US FDA for Ocular Itching

Shots:

  • The sNDA submission is based on P-II/P-III Clinical trial assessing Dextenza(dexamethasone ophthalmic insert, 0.4mg) vs PBO for the treatment of Ocular Itching associated with allergic conjunctivitis
  • Result: At 1EPs for the pooled analysis of P-III clinical trial at Day 8; ocular itching favored DEXTENZA treated participants compared with PBO at all 3-time points: 3 min (1.85 vs 2.55), 5 min (1.90 vs 2.63), and 7 min (1.84 vs 2.61)
  • Dextenza is a corticosteroid intracanalicular insert placed in the punctum, a natural opening in the inner portion of the lower eyelid, and into the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives

Click here ­to­ read full press release/ article | Ref: Ocular Therapeutix  | Image: Ocutx

The post Ocular Therapeutix Reports sNDA Submission of Dextenza (dexamethasone ophthalmic insert) to the US FDA for Ocular Itching first appeared on PharmaShots.

AstraZeneca’s Tezepelumab Fails to Meet its Primary Endpoint in P-III SOURCE Study for Asthma

Shots:

  • The P-III SOURCE study involves assessing Tezepelumab (210mg, q4w) vs PBO in 150 adult patients as add-on therapy with patients maintained on their currently prescribed ICS + LABA, with/ out other asthma controller therapy for 48wks.
  • The trial did not meet its 1EPs i.e., reduction in the daily OCS dose, without loss of asthma control, the safety profile was consistent with previous trials. The therapy’s other efficacy parameters were similar to those observed in previous trials, including the P-III NAVIGATOR trial
  • Tezepelumab is a human mAb targeting TSLP, being developed in collaboration with AstraZeneca and Amgen

Click here ­to­ read full press release/ article | Ref: AstraZeneca  | Image: Physicians Practice

The post AstraZeneca’s Tezepelumab Fails to Meet its Primary Endpoint in P-III SOURCE Study for Asthma first appeared on PharmaShots.

Roche Reports Results of Faricimab in Two Global P-III Studies for Diabetic Macular Edema

Shots:

  • The P-III YOSEMITE & RHINE studies assessing faricimab vs aflibercept in 1891 people living with DME. The studies include 3 treatment arms: faricimab (6mg) administered at personalized dosing intervals of ~16wks and at fixed 8wks. intervals & aflibercept (2mg) at fixed 8wks. intervals
  • The studies met its 1EPs i.e faricimab in both the doses demonstrated non-inferior visual acuity gains compared to aflibercept and was well tolerated with no new safety signals identified
  • Faricimab is the first investigational bispecific Ab targeting 2 distinct pathways i.e., Ang-2 and VEGF-A, currently being evaluated in P-III TENAYA and LUCERNE studies for nAMD

Click here ­to­ read full press release/ article | Ref: GlobeNewswire  | Image: Forbes

The post Roche Reports Results of Faricimab in Two Global P-III Studies for Diabetic Macular Edema first appeared on PharmaShots.

Amgen Reports NDA Submission of Sotorasib to the US FDA for Advanced/Metastatic NSCLC With KRAS G12C Mutation

Shots:

  • The NDA submission is based P-II CodeBreaK 100 study assessing Sotorasib in patients with KRAS G12C-mutated NSCLC prior treated with CT and immunotherapy
  • The study provided durable anticancer activity with a positive benefit-risk profile
  • The US FDA has reviewed the NDA under RTOR pilot program, which aims to explore efficient review process that ensures safe and effective treatments are made available to patients as early as possible

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Axios

The post Amgen Reports NDA Submission of Sotorasib to the US FDA for Advanced/Metastatic NSCLC With KRAS G12C Mutation first appeared on PharmaShots.

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

Shots:

  • The US FDA has accepted the NDA and granted PR for TAK-721 for the treatment of EoE. If approved, TAK-721 will be the first FDA-approved treatment for EoE and Takeda plans to launch it under the trade name Eohilia
  • The NDA filing is based on P-III ORBIT-1 and ORBIT-2 studies which evaluated the safety and efficacy of TAK-721 in adolescent and adult patients (11-55 yrs. of age) with EoE
  • TAK-721 is a novel mucoadherent topically active oral viscous formulation of budesonide and has earlier received the US FDA’s BT and ODD

Click here ­to­ read full press release/ article | Ref: Takeda | Image: CNBC

The post Takeda Reports the US FDA’s Acceptance of NDA for TAK-721 (budesonide oral suspension) to Treat Eosinophilic Esophagitis first appeared on PharmaShots.

Novartis’ Ruxolitinib Fails to Meet its Primary Endpoint in P-lll RUXCOVID Study for COVID-19

Shots:

  • The P-lll RUXCOVID study involves assessing Ruxolitinib (5mg, bid) + SoC therapy vs PBO + SoC therapy in 432 patients aged ≥12 yrs. in a ratio (2:1) hospitalized for COVID-19 and not intubated or receiving ICU care prior to randomization
  • The study did not meet its 1EPS of reducing the number of hospitalized COVID-19 patients who experienced severe complications @29days (death, mechanical ventilation or ICU care i.e. (12% vs 11.8%). The trial did not show benefits among 2EPs and exploratory endpoints including mortality rate @Day29 and time to recovery
  • Ruxolitinib is an oral JAK 1 and JAK 2 tyrosine kinases inhibitor and is approved under the name Jakavi in EU and other countries for PV & MF

Click here ­to­ read full press release/ article | Ref: Novartis | Image: Financial Times

The post Novartis’ Ruxolitinib Fails to Meet its Primary Endpoint in P-lll RUXCOVID Study for COVID-19 first appeared on PharmaShots.

Roche Presents Results of Tecentriq (atezolizumab) in P-III IMvigor010 Study for MIUC at ESMO 2020

Shots:

  • Roche reports an exploratory analysis of P-III IMvigor010 study assessing efficacy and safety of adjuvant treatment with Tecentriq vs observation in 809 people with MIUC, who are at high risk of recurrence following resection
  • Results: in people with ctDNA, DFS Median (5.9 vs 4.4 mos.); median OS (25.8 vs 15.8 mos.). As presented in ASCO, the study did not meet its 1EPs of DFS (19.4 vs 16.6 mos.) in IIT population
  • In general, people with MIUC who had detectable ctDNA were more likely to benefit from treatment with adjuvant Tecentriq monothx. compared with those without ctDNA

Click here ­to­ read full press release/ article | Ref: Roche | Image: Mint

The post Roche Presents Results of Tecentriq (atezolizumab) in P-III IMvigor010 Study for MIUC at ESMO 2020 first appeared on PharmaShots.

Biogen Reports NDA Submission of Aducanumab (BIIB037) to the MHLW for Alzheimer’s Disease

Shots:

  • The submission is based on P-lll EMERGE and ENGAGE study assessing aducanumab vs PBO in patients with AD. The studies evaluate the efficacy of monthly doses of aducanumab in reducing cognitive and functional impairment
  • The secondary objectives of the study were to assess the effect of monthly doses of aducanumab on the clinical decline as measured by MMSE, ADAS-Cog 13 & ADCS-ADL-MCI. MHLW will review the application through the standard review process
  • Aducanumab is an investigational mAb that is under the US FDA’s PR with an anticipated PDUFA date as Mar 7, 2021 and is also under review with the EMA

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Barron’s

The post Biogen Reports NDA Submission of Aducanumab (BIIB037) to the MHLW for Alzheimer’s Disease first appeared on PharmaShots.

Novartis Reports Results of Kisqali in P-III MONALEESA-7 Trial to Treat HR+/HER2- Metastatic Breast Cancer

Shots:

  • The P-III MONALEESA-7 trial involves assessing Kisqali + endocrine therapy (goserelin + either an aromatase inhibitor or tamoxifen) as initial treatment vs endocrine therapy alone in patients with HR+/HER2- m-BC
  • Result: @53.5 mos. follow-up, m-OS (58.7 vs 48.0 mos.); similar m-OS (58.7 vs 47.7 mos.) observed in IIT population; @ 42 mos. follow-up, estimated survival rate (70.2% vs 46%)
  • The US FDA and EC has approved Kisqali in Mar’2017 and Aug’2017 as initial endocrine-based therapy for postmenopausal women with HR+/HER2- LA/m-BC in combination with an aromatase inhibitor based on findings from the pivotal MONALEESA-2 trial

Click here to­ read the full press release/ article | Ref: PRNewswire | Image: BioProcess International

The post Novartis Reports Results of Kisqali in P-III MONALEESA-7 Trial to Treat HR+/HER2- Metastatic Breast Cancer first appeared on PharmaShots.

Lilly Reports Results of Tirzepatide in P-lll SURPASS-1 Monotherapy Trial for Type-2 Diabetes

Shots:

  • The P-lll SURPASS-1 study involves assessing Tirzepatide as monothx. (5/10/15 mg) vs PBO in 478 patients in the ratio of (1:1:1:1) with T2D inadequately controlled with diet and exercise alone
  • Results: A1C reduction: (-1.75% /-1.71%/-1.69% vs- 0.09%); Weight reduction: 6.3/7.0/7.8kg vs 1.0 kg; percentage of participants achieving A1C <7%: 81.8%/84.5%/ 78.3% vs 23.0%; percentage of participants achieving A1C <5.7%: 30.9% /26.8%/38.4% vs 1.4% respectively
  • The highest dose led to A1C reduction of 2.07 % with a reduction in body weight by 9.5 kg (11 %), 51.7 % of patients achieved an A1C less than 5.7 %

Click here to­ read full press release/ article | Ref: PRNewswire | Image: Diario AS

The post Lilly Reports Results of Tirzepatide in P-lll SURPASS-1 Monotherapy Trial for Type-2 Diabetes first appeared on PharmaShots.

AstraZeneca Reports Results of AZD1222 in Interim Analysis of P-lll Program for COVID-19

Shots:

  • The results of an interim of P-III program demonstrated that AZD1222 is safe & effective at preventing symptomatic COVID-19 and hospitalization. The interim analysis for efficacy was based on ~11,636 participants accruing 131 symptomatic infections from the P-III UK and Brazil trials
  • The 1EPs based on the pooling of two dosing regimens showed vaccine is 70.4% effective at preventing COVID-19 occur >14days after receiving 2 doses of the vaccine. 2EPs of prevention demonstrated no cases of severe infections in the vaccine group
  • A further analysis showed that vaccine efficacy was 62.1% and 90.0% in participants who received a half dose followed by a full dose. Regulatory submissions are underway to support approval of vaccines

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: US News & World Report

The post AstraZeneca Reports Results of AZD1222 in Interim Analysis of P-lll Program for COVID-19 first appeared on PharmaShots.

Novartis’ Asciminib (ABL001) Demonstrate Superiority Over Pfizer’s Bosulif in Chronic Myeloid Leukemia Trial

Shots:

  • The P-lll ASCEMBL study involves assessing Asciminib (40mg, bid) vs Bosulif (bosutinib, 500mg, qd) in 223 patients with Ph+ CML-CP prior treated with two or more TKIs and the data were presented at 62nd (ASH) Annual Meeting & Exposition
  • Results: @ 24 wks. MMR rate (25.5% vs 13.2%) tCCyR rate (40.8% vs 24.2%); DMR rate were higher with patients achieving MR4 and MR5(10.8% and 8.9% vs 5.3% and 1.3%); Grade ≥3 AEs (50.6% and 60.5%) respectively, presented at ASH
  • The US FDA has granted FT designation for Asciminib while the regulatory submission to the US and EU health authorities is planned for H1’21

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: PMLiVE

The post Novartis’ Asciminib (ABL001) Demonstrate Superiority Over Pfizer’s Bosulif in Chronic Myeloid Leukemia Trial first appeared on PharmaShots.

AbbVie Reports Results of Imbruvica (ibrutinib) in Two P-III Studies as 1L Treatment for Chronic Lymphocytic Leukemia

Shots:

  • AbbVie reported pooled analysis and long-term integrated analysis of the P-lll RESONATE-2 and ILLUMINATE study evaluating Imbruvica as 1L treatment of high-risk patients with CLL. The data is presented at ASH 2020
  • Results from an integrated analysis of two clinical trials ~6.5 yrs. of long-term follow-up demonstrate similar PFS and ORR in patients with/ out high-risk genomic features
  • A pooled analysis across four clinical trials with ~8yrs. of follow-up result (RESONATE-2, iLLUMINATE, E1912), and PCYC-1122e study showed sustained, long-term efficacy with high 4-year PFS rates in high-risk CLL patients. Additionally, real-world data indicate low biomarker testing rates for these patients

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Seeking Alpha

The post AbbVie Reports Results of Imbruvica (ibrutinib) in Two P-III Studies as 1L Treatment for Chronic Lymphocytic Leukemia first appeared on PharmaShots.

Roche Reports of Polivy + Bendamustine and MabThera / Rituxan in P-lb/ll GO29365 Study for R/R Diffuse Large B-Cell Lymphoma

Shots:

  • The P-lb/ll GO29365 study involves assessing of Polivy (polatuzumab vedotin) + BR vs BR as monthx. in 106 patients with r/r DLBCL who are not eligible for stem cell transplant
  • Result: @48.9mos. CR rate (42.5% vs 17.5%); m-PFS (9.2 vs 3.7 mos.); m-OS (12.4 vs 4.7 mos.); New data from the extension cohort, in 37 patients with 2L DLBCL showed Polivy + BR is effective across a broad range of patients and showed m-PFS (6.6 mos.); median OS (12.5 mos.)
  • Sub-group analyses showed that combination was effective in different patient populations with the results from the pooled Polivy + BR arms achieving an m-OS of 7.6mos. in primary refractory patients and 32.0mos. in non-primary refractory patients

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Reuters

The post Roche Reports of Polivy + Bendamustine and MabThera / Rituxan in P-lb/ll GO29365 Study for R/R Diffuse Large B-Cell Lymphoma first appeared on PharmaShots.

AstraZeneca Reports Long-Term Efficacy and Tolerability of Calquence (acalabrutinib) in P-ll ACE-LY-004 Study for MCL

Shots:

  • AstraZeneca reported long-term follow-up from the positive P-ll ACE-LY-004 study involves assessing Calquence (acalabrutinib) in adult patients with r/r MCL
  • Result: @median follow up (38.1mos.) 44% of patients either remained on treatment or continued to be followed for survival; median DOR (28.6 mos.); estimated DOR rate @36 mos. (41.9%); m-PFS (22 mos.); estimated PFS rate @6mos. (37.2%); presented at ASH
  • Calquence is a selective BTK inhibitor, binds BTK thereby inhibiting its activity, and is approved for CLL and SLL in the US and for CLL in the EU and several other countries globally

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Royal Haskoning

The post AstraZeneca Reports Long-Term Efficacy and Tolerability of Calquence (acalabrutinib) in P-ll ACE-LY-004 Study for MCL first appeared on PharmaShots.

Roche Reports Long-Term Benefits of Venclexta/Venclyxto Based Combination for R/R Chronic Lymphocytic Leukemia

Shots:

  • Five-year data from P-III MURANO trial shows sustained PFS with Venclexta/Venclyxto + MabThera/Rituxan vs BR in patients with r/r CLL
  • The data showed a reduction in the risk of disease progression or death by 81%, m-OS (82.1% vs 62.2%), patients who completed 2yrs. of treatment without the progressive disease, 63.8% had uMRD
  • The P-III CLL14 study also confirms the potential of MRD measurements to predict future outcomes for people with prior untreated CLL who were treated with fixed-duration Venclexta/Venclyxto + Gazyva/Gazyvaro vs Gazyva/Gazyvaro + chlorambucil

Click here ­to­ read full press release/ article | Ref: Roche | Image: Fierce Pharma

The post Roche Reports Long-Term Benefits of Venclexta/Venclyxto Based Combination for R/R Chronic Lymphocytic Leukemia first appeared on PharmaShots.

Kite Reports Results of Yescarta in P-II ZUMA-5 Study for Adult Patients with R/R Indolent Non-Hodgkin lymphoma

Shots:

  • The P-II ZUMA-5 study involves assessing Yescarta (axicabtagene ciloleucel) in patients with r/r iNHL after at least 2L of systemic therapy. After a single infusion of Yescarta, 92% of patients responded, including 76% of patients achieving a CR @median follow-up of 17.5 mos., results presented at ASH
  • The data supports the US FDA’s acceptance of BLA and is currently under PR for r/r FL, MZL, after two or more prior lines of systemic therapy, with an anticipated PDUFA date as Mar 5, 2021
  • Yescarta is the first CAR T-cell therapy to be approved by the US FDA for patients with r/r large B-cell lymphoma after two or more lines of systemic therapy

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Seek Vector Logo

The post Kite Reports Results of Yescarta in P-II ZUMA-5 Study for Adult Patients with R/R Indolent Non-Hodgkin lymphoma first appeared on PharmaShots.

Janssen Reports Long-Term Benefits of Imbruvica (ibrutinib) as 1L Treatment for High-Risk Chronic Lymphocytic Leukemia

Shots:

  • Janssen reported pooled analyses of long-term follow-up from multiple clinical trials evaluating the use of Imbruvica monothx. and in combination as a 1L treatment for patients with CLL with high-risk features
  • Results from an integrated analysis of two clinical trials with ~79mos. of follow-up demonstrated PFS rates (63%-82%) @42mos.; median duration of treatment across high-risk subgroups (35.7-43.8 mos.)
  • Additionally, data with a median follow-up of >4yrs. were presented from a pooled analysis of 89 patients with high-risk CLL bearing TP53 aberrations from 4 trials. Further, data from the RWE studies highlight the benefit of ibrutinib-based therapies in a 1L setting

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: LBC

The post Janssen Reports Long-Term Benefits of Imbruvica (ibrutinib) as 1L Treatment for High-Risk Chronic Lymphocytic Leukemia first appeared on PharmaShots.

AstraZeneca to Unveil its Robust Pipeline of Breast Cancer at SABCS

Shots:

  • AstraZeneca will divulge new developments across BC at the 2020 SABCS. The key abstract includes data of P-ll DESTINY-Breast01 study reinforcing the efficacy seen with Enhertu in HER2+ mBC following 2+ prior anti-HER2 based regimens
  • The company will present data of P-I SERENA-1 study demonstrating the efficacy & safety of AZD9833 as a monothx. and in combination with the palbociclib in HR+, HER2- negative advanced BC
  • AstraZeneca will present RWE to understand outcomes for patients with germline BRCA mutations and treatment patterns among patients with HER2+ mBC. The company will also showcase data on the role of AI & digital pathology in measuring levels of HER2 expression in patients with BC

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: Stat

The post AstraZeneca to Unveil its Robust Pipeline of Breast Cancer at SABCS first appeared on PharmaShots.

AstraZeneca Initiates P-IIb Study of ION449 (AZD8233) to Lower LDL-cholesterol

Shots:

  • The P-IIb study will evaluate three dose levels of ION449 (once a month, SC) vs PBO and will enroll ~108 patients aged 18-75yrs., who have LDL-C levels b/w 70-190 mg/dL and are receiving moderate/ high-intensity statin therapy
  • The P-I study results demonstrated dose-dependent mean reductions in circulating plasma PCSK9 and LDL-C levels of >90% and ~70% respectively
  • AstraZeneca granted $20M as a milestone to Ionis for the initiation of the P-II study. ION449 is antisense therapy designed to reduce blood cholesterol levels in patients with dyslipidemia by targeting PCSK9

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: The New York Times

The post AstraZeneca Initiates P-IIb Study of ION449 (AZD8233) to Lower LDL-cholesterol first appeared on PharmaShots.

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

Shots:

  • Amgen, UCB, and Takeda reported that the first patient has been enrolled in the COMMUNITY trial. The study will test whether Amgen’s Otezla, Takeda’s lanadelumab, and UCB’s zilucoplan can reduce the severity of COVID-19 in hospitalized patients by moderating the immune system’s response to the disease
  • The focus of the trial is to identify an effective treatment for hospitalized COVID-19 patients, who are Grade 2 to Grade 5 on a clinical severity status 8-point ordinal scale. Trial sites are being established in hospitals across the globe to support enrollment in communities
  • This is the first time that the global pharmaceutical has come together to launch an adaptive clinical trial

Click here ­to­ read full press release/ article | Ref: Takeda | Image: Stat

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Merck KGaA Reports EMA’s Validation of MAA for Tepotinib to Treat Advanced NSCLC with METex14 Skipping Alterations

Shots:

  • The MAA is based on a P-II VISION study assessing Tepotinib as monothx. in patients with advanced NSCLC of METex14 skipping alterations, prospectively assessed by liquid biopsy or tissue biopsy
  • With the validation, the application is complete, and the EMA will now initiate the review procedure.
  • Tepotinib is an oral MET inhibitor that inhibits the oncogenic MET receptor signaling caused by MET alteration. The FDA is reviewing the application under PR and through the Real-Time Oncology Review pilot program

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: FIerce Pharma

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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 tolerated and did not lead to worsening of IBS symptoms
  • Vibegron is (PO,qd) is a beta-3 agonist that is being evaluated for OAB, OAB+BPH in men & for abdominal pain associated with IBS

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Urovant

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Russia’s Sputnik V Demonstrates 91.4% Efficacy Against COVID-19

Shots:

  • The ongoing P-lll study involves assessing of Sputnik V vaccine vs PBO in 40,000 patients in a ratio (1:3) with COVID-19. The efficacy of the vaccine is 91.4%, based on the second interim analysis of data obtained 28 days after administering the first dose
  • Preliminary data from volunteers obtained 42days after the first dose (corresponds with 21days after the second dose) indicates the efficacy of the vaccine above 95%.
  • The data will be published by the Gamaleya Center team in peer-reviewed medical journals. Following the completion of P-lll clinical trials, Gamaleya Center will provide access to the full clinical trial report

Click here ­to­ read full press release/ article | Ref: Sputnik | Image: Anadolu Agency

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Targovax Reports Results of ONCOS-102 in P-l/ll Study as 1L and 2L Treatment for Malignant Pleural Mesothelioma

Shots:

  • The exploratory P-l/ll study involves the assessment of ONCOS-102 + SoC CT (pemetrexed/cisplatin) as a 1L and 2L treatment in 31 patients with MPM
  • Result: @18mos. follow up showed that mOS (18.2mos. vs 14.2mos.) and showed broad and powerful immune activation, associated with better survival outcome. The next survival analysis is planned in H1’21
  • Targovax and Merck are currently reviewing the next steps for combining ONCOS-102 and Keytruda in MPM

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Targovax

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AstraZeneca’s AZD1222 Meets its Primary Endpoint in Preventing COVID-19

Shots:

  • Interim analysis results of COV002 & COV003 study of AZD1222 in the UK & Brazil showed the vaccine is effective in preventing COVID-19 and no hospitalizations/ severe cases of the disease were reported
  • One dosing regimen showed an efficacy of 90% when AZD1222 was given as a half dose, followed by a full dose of at least 1 mos. apart & another dosing regimen showed 62% efficacy when given as 2 full doses at least 1 mos. apart. The combined analysis from both dosing regimens resulted in the efficacy of ~70%
  • AZ will plan regulatory submission of the data across the globe and will seek an Emergency Use Listing from the WHO for an accelerated pathway to vaccine availability in low-income countries

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: NBC News

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Innovent Reports Results of Tyvyt + Byvasda (biosimilar, bevacizumab) in P-lll ORIENT-32 Study as 1L Treatment for HCC

Shots:

  • The P-lll ORIENT-32 study involves assessing of Tyvyt (sintilimab) + Byvasda vs sorafenib as a 1L treatment in 571 patients in a ratio (2:1) with advanced HCC and the result were released in an oral presentation at the ESMO Asia Virtual Congress 2020
  • Result: Reduction in risk of all-cause mortality (43.1%); the median OS (not reached vs 10.4 mos.); reduction in risk of progression (43.5%); m-PFS (4.6 vs 2.8 mos.), results was presented at ESMO 2020
  • The improved OS and PFS benefits of the dual regimen were generally consistent across all subgroups and showed an acceptable safety profile with no new safety signals

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: The Pharma Letter

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ViiV’s PROgress Study Demonstrates Inclusion of PROs into Clinical Practice Can Improve HIV Care

Shots:

  • In the PROgress study, 200 people living with HIV were provided with a pre-visit survey to guide their conversation with their HCP and assess PROs covering a range of measures, including treatment adherence, mental health, substance abuse, and intimate partner violence
  • Results: the inclusion of the pre-visit survey made their visit better overall (82%), reminded them of health concerns to raise (81%), and helped them discuss issues that were difficult to speak frankly about (71%).
  • The PROgress study program released an implementation toolkit and resources to assist HCPs with the adoption of PROs into their clinical practices

Click here ­to­ read full press release/ article | Ref: ViiV Healthcare | Image: ViiV Healthcare

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Moderna’s mRNA-1273 Demonstrates 94.5% Efficacy in Preventing Symptomatic COVID-19

Shots:

  • The P-lll COVE study involves the assessing of mRNA-1273 (100 µg dose level) in 30,000 patients with COVID-19 in the ratio of (1:1) aged > 18 yrs. in the US
  • The study met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5% in the first interim analysis of the P-III COVE study. The first interim analysis included 95 participants with confirmed cases of COVID-19
  • Moderna plans to submit a EUA with US FDA in the coming weeks and expects the EUA to be based on the final analysis of 151 cases and a median follow-up of >2mos.

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Stat

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CureVac Publishes Results of CVnCoV in Interim P-l Study for COVID-19

Shots:

  • The P-l study involves assessing CVnCoV in patients with COVID-19. The interim data showed that CVnCoV (2-12µg) was well tolerated and induced strong binding and neutralizing Ab responses to the first indication of T cell activation
  • The immune response was found to be comparable to recovered COVID-19 patients, closely mimicking the immune response after natural COVID-19 infection. The manuscript is available on medRxiv and will be submitted for publication in a peer-reviewed journal
  • The P-l clinical study began in June 2020 in Germany and Belgium in collaboration with the CEPI. CureVac plans to initiate a pivotal P-IIb/III clinical study by the end of 2020

Click here ­to­ read full press release/ article | Ref: CureVac | Image: CNN

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

Shots:

  • The P-III NAVIGATOR study involves assessing Tezepelumab + SOC vs pbo + SOC in adults (18–80yrs.) & adolescents (12–17yrs.) with severe, uncontrolled asthma, who were receiving treatment with medium/high dose ICS + at least 1 additional controller medication with or without OCS
  • Trial met its 1EPs i.e. reduction in AAER @52wks. in the overall population. The study also met 1EPs in patients with low levels of eosinophils i.e. <300 & 150 cells/microlitre
  • Tezepelumab is mAb that inhibits the action of TSLP and has received US FDA’s BT designation in Sept’2018 for patients with severe asthma, without an eosinophilic phenotype

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: The Indian Express

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The US FDA’s Advisory Panel Slams Biogen’s Aducanumab for Alzheimer’s Disease

Shots:

  • The advisory committee voted 1-8, with 2 members voting uncertain that EMERGE study (without regard for ENGAGE study) provides strong evidence, supporting the effectiveness of aducanumab as a treatment for AD. The committee also voted 0-7 with 4 members voting uncertain that PRIME study provides supporting evidence for aducanumab
  • The committee voted 5-0 and 6 uncertain on showing PD effect of aducanumab on AD pathophysiology. Finally, the committee voted 0-10 & 1 for exploratory analyses of Study 301 & 302, along with study 103 and evidence of a PD effect on AD pathophysiology
  • Following the committee’s opinion, the US FDA is expected to make a decision on approval of aducanumab’s BLA by Mar 7, 2021

Click here ­to­ read full press release/ article | Ref: Biogen | Image: The Conversation

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Formycon Reports BLA Resubmission Strategy for FYB201 (biosimilar, ranibizumab)

Shots:

  • Formycon & Bioeq reported the BLA resubmission strategy for FYB201 (biosimilar referencing Lucentis) has been adjusted
  • With the revised submission strategy, the companies expect a simplification of the approval procedure. The modified submission dossier is anticipated to be filed with the US FDA in H1’21
  • The adjustment of the regulatory strategy while optimizing the commercial supply chain is not expected to have any impact on the timing of the anticipated launch of FYB201 in the US & EU

Click here to­ read the full press release/ article | Ref: Formycon | Image: Formycon

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Novartis Reports Results of Cosentyx (secukinumab) in P-IIIb ULTIMATE Study for Psoriatic Arthritis

Shots:

  • The P-IIIb ULTIMATE study involves assessing Cosentyx (300/150mg) vs PBO weekly for a mos. with treatment starting @4wks., followed by a once-a-month dose for the next 11mos. in 166 biologic-naïve patients in a ratio (1:1) with active PsA
  • The study reduction of synovitis @12wks. with an early improvement observed as 1wk., ACR20 (68% vs 34%); ACR50 (46% vs 9%,) & enthesitis (change in SPARCC, -2.4 vs -1.7); safety profile was consistent with previous studies @12wks.
  • Cosentyx is the first & only fully-human biologic that directly inhibits IL-17A. Novartis anticipates disclosing full 24-week data from the ongoing ULTIMATE trial at the EULAR in 2021 and final analysis at ACR 2021

Click here to­ read the full press release/ article | Ref: Novartis | Image: GMP News

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Jounce Stops Enrollment in P-II EMERGE Study Evaluating Vopratelimab for Lung Cancer

Shots:

  • The company will not expand the P-II EMERGE study that assesses Vopratelimab + ipilimumab in PD-(L)1 inhibitor experienced NSCLC patient. Early evaluation of the study showed that the trial will not meet pre-specified interim criteria for continuation of enrollment
  • The company also reported the first patient dosing in P-II SELECT study assessing Vopratelimab + JTX-4014 vs JTX-4014 alone in 75 immunotherapy naïve NSCLC patients who have been pre-selected with the TISvopra predictive biomarker with its expected preliminary efficacy data in 2021
  • Vopratelimab is a mAb that binds to and activates ICOS which is a protein on the surface of certain T cells found in many solid tumors

Click here to­ read the full press release/ article | Ref: Jounce Therapeutics | Image: Cowen

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Biomarin Reports the US FDA’s Acceptance of Vosoritide’s NDA to Treat Children with Achondroplasia

Shots:

  • The acceptance marks the first marketing application accepted for achondroplasia in the US with an anticipated PDUFA date as of Aug 20, 2021. The US FDA is not planning to hold an advisory committee meeting to discuss the application
  • Additionally, the company is expecting to complete enrollment in a P-II study assessing vosoritide in ~70 infants and young children with achondroplasia, aged 0-<60mos., for 52wks.
  • Vosoritide (qd) is an investigational injection analog of C-type Natriuretic Peptide (CNP) for children with achondroplasia and has received the US FDA’s & EMA’s ODD for the same

Click here to­ read the full press release/ article | Ref: PRNewswire | Image: BioMarin Careers

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

Shots:

  • The P-III POETYK PSO-1 study involves assessing deucravacitinib (6mg, qd) vs PBO & Otezla (apremilast) in 666 patients with moderate to severe plaque psoriasis
  • The trial met its co-1EPs & 2EPs demonstrating deucravacitinib was superior to Otezla (apremilast) in the patients reaching a PASI 75 and sPGA 0/1 @16wks. The overall safety profile of deucravacitinib was consistent with previously reported P-II results
  • Deucravacitinib (BMS-986165, PO) is the first & only novel selective TYK2 inhibitor, currently being evaluated in psoriasis, PsA, lupus, and IBD

Click here to­ read the full press release/ article | Ref: Businesswire | Image: Fierce Biotech

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Novartis Reports Results of Kisqali (ribociclib) in P-III MONALEESA-7 Study in Women with HR+/HER2- Advanced Breast Cancer

Shots:

  • The pivotal P-III MONALEESA-7 study assessing Kisqali + endocrine therapy vs PBO + endocrine therapy, in pre- & perimenopausal women with HR+/HER2- advanced or metastatic-BC
  • The study met its 2EPs of OS, demonstrating a significant improvement in OS, and is consistent for the NSAI population & across exploratory subgroups, m-OS was not reached while the median duration of follow-up was 34.6 mos.
  • Kisqali is a selective cyclin-dependent kinase inhibitor, acts by inhibiting two proteins called CDK4/6

Click here ­to­ read full press release/ article | Ref: Novartis | Image: Law

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Tetra Therapeutics Reports Positive Results of BPN14770 in P-II Study for Fragile X Syndrome

Shots:

  • The P-II study is a two-way crossover study assessing BPN14770 (25mg, bid) vs PBO in 30 adult male patients aged 18-45yrs. with FXS due to >200 CGG repeats in the FMR1 gene
  • The study demonstrated benefits in oral reading recognition (+2.80), picture vocabulary (+5.79), cognition crystallized composite score (+5.29), benefits were maintained up to 12wks. and was well tolerated
  • BPN14770 is a novel therapy that selectively inhibits PDE4D to increase the levels of cAMP. In preclinical trials, it promotes the maturation of connections between neurons, which is impaired in patients with FXS and has received the US FDA’s ODD as well as approved for investigational use in the US

Click here to­ read the full press release/ article | Ref: Businesswire | Image: Tetra Therapeutics

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Janssen Reports sNDA Submission of Paliperidone Palmitate 6-Month (PP6M) to the US FDA for Schizophrenia

Shots:

  • The sNDA submission is based on P-lll Route-6 study assessing PP6M vs PP3M in 702 patients with schizophrenia previously stabilized on corresponding doses of PP1M or PP3M across 20 countries
  • Results demonstrated non-inferior efficacy of PP6M to PP3M on the 1EPs of time to relapse at the end of the 12mos. period in both intent-to-treat and per-protocol analysis sets, the safety profile is consistent with no new safety signals
  • If approved, PP6M will be the first and only long-acting injectable schizophrenia treatment with a twice-yearly dosing regimen. Additionally, Janssen plans to submit an MAA extension to the EMA for PP6M in the coming months

Click here to­ read the full press release/ article | Ref: PRNewswire | Image: Canal Ideal

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UCB Reports Results of Bimekizumab in P-III BE SURE Study for Moderate-to-Severe Psoriasis

Shots:

  • The P-III BE SURE study involves assessing bimekizumab vs Humira (adalimumab) for 24wks. is followed until 56wks. in 478 adult patients with chronic PsO for at least 6 mos. before screening & with an affected body surface area of at least 10%, PASI of at least 12 & IGA score equal to or > 3 on a 5point scale
  • Results: The study met its 1EPs & 2EPs, @16wks. PASI 90 (86.2% vs 47.2%); IGA 0/1 (85.3 % vs 57.2%); PASI 100 (60.8% vs 23.9%); PASI 100 @24wks. (66.8% vs 29.6%); PASI 90, PASI 100 and IGA 0/1 response rates were maintained through 1year with both q4w & q8w; skin clearance rates increased in patients who switched from adalimumab to bimekizumab @24wks., with response rates @56wks. comparable to patients treated with bimekizumab throughout the study
  • Bimekizumab is an investigational humanized IgG1 mAb that selectively inhibits both IL-17A & IL-17F

Click here to­ read the full press release/ article | Ref: PRNewswire | Image: Pharma Journalist

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AbbVie Reports Results of SKYRIZI (risankizumab) in P-III LIMMitless Study in Patients with Moderate to Severe Plaque Psoriasis

Shots:

  • The P-III LIMMitless study is designed to evaluate the long-term safety & efficacy assessing risankizumab (150 mg q12wks.) continuous risankizumab with a loading dose in adults with moderate to severe plaque psoriasis. The analysis includes integrated data from five P-II & III studies (ultIMMa-1, ultIMMa-2, SustaIMM, IMMvent and NCT03255382) and the LIMMitless study
  • Results: ~63% of patients with moderate to severe plaque psoriasis treated with SKYRIZI achieved completely clear skin for 172 wks., as measured by 100% improvement from baseline in the PASI 100. New results from the P-III LIMMitless study were presented at the 29th EADV Virtual Congress
  • Risankizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. It is part of a collaboration between Boehringer Ingelheim & AbbVie, with AbbVie leading development & commercialisation globally

Click here to­ read the full press release/ article | Ref: Abbvie | Image: Seeking Alpha

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Lilly Reports Results of Bamlanivimab (LY-CoV555) in P-II BLAZE-1 Study in New England Journal of Medicine

Shots:

  • The P-II BLAZE-1 study assesses bamlanivimab (700, 2800 & 7000 mg) vs PBO in the outpatient setting in patients with mild or moderate symptoms of COVID-19 as well as a positive SARS-CoV-2 test based on a sample collected no more than 3 days prior to drug infusion
  • Results: The study showed that bamlanivimab may be effective in treating COVID-19 by reducing viral load, symptoms and the risk of hospitalization in patients recently diagnosed with mild to moderate COVID-19
  • LY-CoV555 is a neutralizing IgG1 mAb directed against the spike protein of SARS-CoV-2 & designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially preventing & treating COVID-19

Click here to­ read full press release/ article | Ref: PRNewswire | Image: Business Insider

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Regeneron Reports Results of REGN-COV2 in P-ll/lll Study in Patients with COVID-19 in Outpatient Setting

Shots:

  • The P-ll/lll trial involves assessing of REGN-COV2 (8gm/2.4gm) + SOC vs PBO + SOC in 524 patients with mild-to-moderate COVID-19 in an outpatient setting
  • The study met its 1EPs & 2EPs demonstrating a reduction in viral load and patient medical visits. Moreover, Regeneron is reviewing potential changes to dosing in the ongoing outpatient clinical trial given the current limited supply of REGN-COV2
  • REGN-COV2 is a combination of two mAbs (REGN10933 + REGN10987), designed specifically to block the infectivity of SARS-CoV-2. Additionally, Regeneron has shared results with the US FDA, which is reviewing a EUA submission for the REGN-COV2 low dose in adults with mild-to-moderate COVID-19 who are at high risk for poor outcomes

Click here to­ read full press release/ article | Ref: PRNewswire | Image: MediCircle

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Sanofi Presents Results of Olipudase Alfa in Two Clinical Studies at ASHG 2020

Shots:

  • The P-II/III ASCEND trial involves assessing olipudase alfa 3 mg/kg (IV, q2w) vs PBO in 36 adult patients with ASMD type B to evaluate treatment impact on pulmonary function & spleen & liver volume for 52wks. The study demonstrated improvement in lung function (22% vs 3%), reduction in spleen volume (39.5% vs 0.5%), reduction in liver volume (31.7% vs 1.4%); improvement in platelet counts (16.8% vs 2.5%)
  • The P-II ASCEND-Peds trial involves assessing olipudase alfa 3 mg/kg (IV) q2w for 64 wks, in 20 pediatric patients with ASMD without acute or rapidly progressive neurological abnormalities. The study demonstrated 33% increment in predicted DLCO, reduction in spleen volume & liver volume (49% & 41%); 34% increment in platelet count
  • Olipudase alfa is an investigational enzyme replacement therapy designed to replace deficient or defective ASM, allowing for the breakdown of sphingomyelin, currently being investigated to treat non-CNS manifestations of ASMD. The therapy has received FDA’s BT designation, EMA’s PRIME Designation and MHLW’s SAKIGAKE designation

Click here ­to­ read full press release/ article | Ref: Sanofi | Image: Evaluate Pharma

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Sanofi and Regeneron Report Results of Dupixent (dupilumab) in Part A of P-lll Study for Eosinophilic Esophagitis (EoE)

Shots:

  • Part A of P-lll study involves assessing of Dupixent (qw, 300mg) vs PBO in 81 patients aged≥ 12 yrs. with EoE. The study resulted in meeting its co-primary and all key 2EPs, presented at the virtual ACG 2020 and UEG Week 2020
  • Results: Patients reported significant improvement on DSQ as 4 wks. and continued to improve through 24 wks; reduced EEC (<15) eos/hpf (64% vs 8%) @24wks. Peak EEC (71% vs 3%). ET changes associated with the disease reduced (0.761 and 0.753 vs 0.001 and 0.012) reduction @24wks.; gene expression patterns associated with type 2 inflammation and EoE were reduced (1.97-fold & 2.66-fold vs 0.32-fold & 0.16-fold); SAEs (86% vs 82%)
  • Dupixent is mAb inhibiting the signaling of the IL-4 and IL-13 proteins and has received the US FDA’s BT designation for the treatment of patients ≥12yrs. with EoE

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Chemistry World

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Samsung Bioepis Reports Results of Renflexis (biosimilar, infliximab) from Two Studies in IBD Patients

Shots:

  • The company reported results from two real-world studies of Renflexis (infliximab-abda) in patients with IBD registered in the US Veteran Affairs Healthcare System database. Data were presented at ACG 2020
  • One study assesses the safety of switching from reference infliximab or infliximab-dyyb to Renflexis in patients with IBD identified from the VAHS database and demonstrated an 83% continuation rate over 1yr. with similar continuation rate in patients who underwent a single & double switch from reference infliximab
  • Second study focused on the real-world utilization pattern of infliximab products for IBD, within the context of VANF policy. The study found that Renflexis became the preferred infliximab product on VANF in Sept’2018 which was faster than the adoption of the previous biosimilar (infliximab-dyyb), listed on VANF in May’2017

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: The Investor

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Boehringer Ingelheim and Eli Lilly Report Results of Jardiance in Adults with HFrEF Regardless of Chronic Kidney Disease Status

Shots:

  • The companies present the findings from a new exploratory sub-analysis of the P-III EMPEROR-Reduced study demonstrating that Jardiance (empagliflozin) reduced the risk of adverse CV by 25% and kidney events by 50% in adults with HFrEF with/out diabetes regardless of CKD status at ASN Week 2020
  • In all patient cohorts participating in the EMPEROR-Reduced trial, the safety profile was like the well-established safety profile of Jardiance. In Mar’2020, the US FDA granted FT designation to the therapy for CKD based on its ongoing EMPA-KIDNEY study with its expected results in 2022
  • In 2019, the US FDA granted FT designation to Jardiance for the reduction of the risk of CV death and hospitalization for heart failure in people with HF based on its EMPEROR program, which consists of two P-III studies EMPEROR-Reduced & EMPEROR-Preserved

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Dialysis Patient Citizens Education Center

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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 the treatment of patients with calciphylaxis (calcific uremic arteriolopathy, or CUA). Additional data demonstrated that SNF472 strongly inhibits valvular calcification in an in vitro model of porcine aortic valve
  • SNF472 is an inhibitor of vascular calcification currently in P-III study, acts by targeting the deposition of solid calcium (hydroxyapatite, HAP) in the CV system. The company is showcasing new data on SNF472 in four presentations including one oral session and three ePoster sessions at virtual ASN Kidney Week 2020

Click here ­to­ read full press release/ article | Ref: Sanifit | Image: European Biotechnology

The post Sanifit Presents Results of SNF472 for the Treatment of Vascular Calcification at ASN Kidney Week 2020 first appeared on PharmaShots.

GSK Presents Results of Maternal & Older Adults RSV Vaccines at IDWeek 2020

Shots:

  • GSK reported that its RSV vaccines for maternal immunization (GSK3888550A) and older adults (GSK3844766A) were well-tolerated and highly immunogenic in P-I/II clinical studies. Both the candidate vaccines contain a recombinant RSVPreF3, that triggers the required immune response
  • The GSK3844766A was first tested in 48 healthy adults (18-40yrs.) & then in 1005 healthy older adults (60-80yrs.) with different dosages of antigen & adjuvant. The interim data 1mos. post-immunization elicited a robust humoral and cellular immunity while the vaccine includes AS01 adjuvant system to boost the immune response
  • GSK3888550A was tested with 3 different doses vs PBO in 502 healthy non-pregnant women over monthly visits (day 8, 31 & 91 post immunization). The study results demonstrated that vaccine rapidly boost pre-existing immunity at all dose levels & @day8 it showed a 4-fold increase in RSV-A and RSV-B neutralizing Abs titers. P-III studies of both the vaccines are expected to initiate in the coming months

Click here ­to­ read full press release/ article | Ref: GSK | Image: Reuters

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ViiV Healthcare Present Results of Long-Acting Cabotegravir and Rilpivirine at IDWeeK 2020

Shots:

  • The company reported the positive findings of a pooled analysis of six ongoing clinical studies which includes P-IIb/IIIb LATTE-2, ATLAS, ATLAS-2M, FLAIR, POLAR, and CUSTOMIZE studies evaluating long-acting cabotegravir and rilpivirine regimen in 1,744 patients with HIV-1 infection across 16 countries
  • The positive findings showed 93% of participants maintained their injection visits amid the COVID-19 with no instances of virologic failure or development of resistance and showed good tolerability
  • Long-acting regimen of cabotegravir and rilpivirine is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in patients who are virologically stable and suppressed (HIV-1 RNA <50 copies/mL) and has received Health Canada’s approval in Mar’2020

Click here ­to­ read full press release/ article | Ref: ViiV Healthcare | Image: Fierce Pharma

The post ViiV Healthcare Present Results of Long-Acting Cabotegravir and Rilpivirine at IDWeeK 2020 first appeared on PharmaShots.

Jazz Reports Results of Xywav (calcium, magnesium, potassium, and sodium oxybates) in P-III Study for Cataplexy or EDS in Patients with Narcolepsy

Shots:

  • The P-III study involves assessing Xywav vs PBO in patients aged ≥ 7yrs. with cataplexy or EDS with narcolepsy
  • Results: study met its 1EPs & 2EPs i.e. differences in median change in a weekly number of cataplexy attacks and ESS scores. Results were published at World Sleep 2019
  • Xywav is an oxybate product with a unique composition of cations resulting in 92% less sodium or ~1,000- 1,500 mg/night less than sodium oxybate at the recommended dosage range of 6-9gms. The company expects to launch in Q4’20, following RESM implementation

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: GMP News

The post Jazz Reports Results of Xywav (calcium, magnesium, potassium, and sodium oxybates) in P-III Study for Cataplexy or EDS in Patients with Narcolepsy first appeared on PharmaShots.

NeuClone Reports Positive Results of NeuLara (biosimilar, ustekinumab) in P-l Study for Autoimmune Diseases

Shots:

  • The P-I clinical trial involves assessing of a single dose of either NeuLara, US- or EU-sourced Stelara in ~200 healthy volunteers. NeuLara is NeuClone’s second biosimilar to have met all 1EPs & 2EPs in a three-arm P-I study
  • Result: the study met all co-primary PK endpoints for Cmax and AUC. For all PK 1EPs, CI (90%) of the GMR within the pre-specified (80%-125%) acceptance limits for all 3 pairwise comparisons. Additionally, the safety, immunogenicity and tolerability profiles were similar in all three treatment arms
  • NeuLara is a biosimilar referencing Stelara, being developed to treat patients with PsO, PsA, CD and UC. The biosimilar is being co-developed by NeuClone and its strategic manufacturing partner, Serum Institute of India

Click here ­to­ read full press release/ article | Ref: Neuclone | Image: Business Wire

The post NeuClone Reports Positive Results of NeuLara (biosimilar, ustekinumab) in P-l Study for Autoimmune Diseases first appeared on PharmaShots.

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 until disease recurrence in the adjuvant treatment of 682 patients with stage IB, II, IIIA EGFRm NSCLC following complete tumour resection & adjuvant CT as indicated. Unprecedented results showed reduction in the risk of disease recurrence or death by 80% and improvement in DFS
  • Tagrisso is an irreversible EGFR-TKI with clinical activity against CNS metastases with its expected PDUFA date in Q1’21

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: The Print

The post AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s Priority Review for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer first appeared on PharmaShots.

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

Shots:

  • The P-III CHRONOS-3 study involves assessing of Aliqopa + rituximab vs PBO + rituximab in 458 patients with relapsed indolent NHL who have received at least one or more lines of prior rituximab-containing treatment
  • The P-II study met its 1EP of prolonged PFS, safety is consistent with previously published data on the individual components of the combination, no new safety signals were identified
  • Aliqopa is a PI3K inhibitor with inhibitory activity predominantly against PI3K-α and PI3K-δ isoforms expressed in malignant B cells and is an approved treatment for patients with relapsed FL prior treated with two systemic therapies

    Click here to­ read the full press release/ article | Ref: Businesswire Image: Business Insider

The post Bayer Report Results of Aliqopa (copanlisib) + Rituximab in P-III CHRONOS-3 Study for Relapsed Indolent Non-Hodgkin’s Lymphoma first appeared on PharmaShots.

Polarean Reports the NDA Submission of Hyperpolarised 129Xenon Gas Drug-Device Diagnostic to the US FDA for Lung Imaging

Shots:  

  • The company reports NDA submission and request for PR to the US FDA for hyperpolarised 129Xenon gas used to evaluate the pulmonary function and to visualize the lung using MRI. The NDA submission follows the completion of two P-III studies, demonstrating the effective measurement of regional lung ventilation
  • Both the studies met their 1EPs showing pre-defined equivalence of hyperpolarised 129Xenon MRI vs 133Xenon Scintigraphy and displayed a benign safety profile
  • 129Xenon gas MRI was used to measure regional pulmonary function in patients with lung diseases who were being evaluated for possible lung resection/ transplant surgery and is administered as an inhaled gas that is given to patients in a 10sec breath-hold MRI procedure

Click here ­to­ read full press release/ article | Ref: Polarean | Image: Polarean

The post Polarean Reports the NDA Submission of Hyperpolarised 129Xenon Gas Drug-Device Diagnostic to the US FDA for Lung Imaging first appeared on PharmaShots.

BioNTech and Pfizer Initiates Rolling Submission to EMA for SARS-CoV-2 Vaccine Candidate, BNT162b2

Shots:

  • The Rolling Submission is based on the preliminary results from pre-clinical and early clinical studies in adults, which shows that BNT162b2 triggers the production of neutralizing antibodies and TH-1 dominant CD4+ and CD8+ T cells that target SARS-CoV-2. BioNTech and Pfizer plan to work with the EMA’s CHMP to complete the rolling review process to facilitate the final MAA
  • BNT162b2 vaccinated participants showed a favorable breadth of epitopes recognized in T-cell responses specific to SARS-CoV-2 spike antigen & BNT162b2 demonstrated concurrent induction of high magnitude CD4+ & CD8+ T cell responses which are TH-1 dominant against RBD and remainder of full spike glycoprotein
  • BNT162b2 vaccine candidate (BioNTech’s proprietary mRNA technology and supported by Pfizer) encodes an optimized SARS-CoV-2 full-length spike glycoprotein (S). It is currently being evaluated in an ongoing P-III study with ~37,000 participants enrolled and 28,000 having received their second vaccination at >120 clinical sites worldwide including the US, Brazil, South Africa, and Argentina

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: King’s College London

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Novartis Reports Results of Zolgensma in P-III STR1VE-EU Study for SMA Type 1

Shots:  

  • The P-III STR1VE-EU study involves assessing Zolgensma (IV) in patients with SMA Type 1 aged <6mos. at the time of gene therapy, with 1 or 2 copies of the SMN2 backup gene and have bi-allelic SMN1 gene deletion or point mutations
  • Results: 65.6% achieved motor milestones not observed in the natural history of SMA Type 1, 66.7% were free of feeding support, 93.9% are able to swallow thin liquids, 30.3% required feeding support, 27.3% required ventilatory support; 97% patients in ITT population survived event-free, including 93.8% & 56.3% who could have reached 10.5mos. & 13.6 mos. of age respectively
  • New interim P-III STR1VE-EU data presented at WMS support the clinical evidence demonstrating a consistent, transformative benefit across Zolgensma clinical trials for the treatment of patients with SMA

Click here ­to­ read full press release/ article | Ref: Novartis | Image: Mint

Related News: Novartis’ Zolgensma (onasemnogene abeparvovec) Receives MHLW’s Approval for Spinal Muscular Atrophy

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Sobi & Selecta Report Results of SEL-212 in P-II COMPARE Study for Chronic Refractory Gout

Shots: 

  • The P-II COMPARE study assessing SEL-212 (once monthly) vs pegloticase (twice monthly) in 170 patients with chronic refractory gout
  • SEL-212 showed a numerically higher response rate on 1EP during 3 & 6 mos., but didn’t meet 1EP of superiority, higher response rate during 3 & 6mos., an overall reduction in mean SUA levels; patients with tophi at baseline showed higher responder rates with a reduction in mean SUA and is well tolerated
  • SEL-212 is a combination product candidate designed to sustain control SUA levels in patients with chronic refractory gout, potentially reducing harmful tissue urate deposits. The companies also initiate the P-III studies (DISSOLVE I& II) of SEL-212 for chronic refractory gout with its expected results in H2’22 and BLA filing in Q3’23

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Mynewsdesk

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Alnylam Reports Results of Lumasiran in P-III ILLUMINATE-B Study for Primary Hyperoxaluria Type 1 in Children Under the Age of Six

Shots:

  • The P-III ILLUMINATE-B study involves assessing Lumasiran in 18 patients with PH1 under the age of 6 (3-72mos.), with an eGFR >45 mL/min/1.73 m2 or normal serum creatinine if less than 12mos. old at 9 study sites in 5 countries across the globe
  • The study demonstrated a reduction in the hepatic production of oxalate across all ages, safety & tolerability profile is consistent with that observed in P-III ILLUMINATE-A study. The study also demonstrated positive results across 2EPs, including additional measures of urinary and plasma oxalate
  • Lumasiran (SC) RNAi therapeutic targeting HAO1 in development for the treatment of PH1 and has received the US FDA’s ODD & BT in addition to EMA’s ODD and PRIME designation

Click here ­to­ read full press release/ article | Ref: Alnylam | Image: Alnylam

The post Alnylam Reports Results of Lumasiran in P-III ILLUMINATE-B Study for Primary Hyperoxaluria Type 1 in Children Under the Age of Six first appeared on PharmaShots.

Janssen Reports the NDA Submission to the US FDA for Uptravi (selexipag, IV) to Treat Pulmonary Arterial Hypertension

Shots:  

  • The NDA submission is based on P-III UPTRAVI IV study he safety and tolerability of 20 patients with PAH temporarily switching from oral UPTRAVI to UPTRAVI IV, and then transitioning back to the initial oral dose
  • Results demonstrated that Uptravi IV is suitable to maintain continuous dosing for short periods of time when the oral formulation is not feasible. Both the formulation was well tolerated with no unexpected safety findings
  • Uptravi is a selective, prostacyclin IP receptor agonist, approved in IV formulation for PAH, WHO Group I in adults with WHO functional class (FC) II–III, who are currently prescribed oral Uptravi but are temporarily unable to take oral therapy

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Penn Today

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Bayer Reports the NDA Submission to NMPA for Vericiguat to Treat Chronic Heart Failure in China

Shots:

  • The NDA submission was submitted to NMPA’s CDE and is based on P-III VICTORIA study, seeking regulatory approval of vericiguat in China
  • In Oct’2014, Bayer and MSD signed a WW agreement for sGC modulators. The therapy is being jointly developed by both the companies as per the collaboration and has received the US FDA’s PR in Jul’2020
  • Vericiguat (BAY 1021189/ MK-1242) is an sGC-stimulator being developed to treat patients with symptomatic CHF with an ejection fraction less than 45% who have had a previous worsening HF event in combination with available HF therapies

Click here ­to­ read full press release/ article | Ref: Bayer| Image: Berkeleyside

Novartis Reports Results of Asciminib (ABL001) in P-III ASCEMBL Study for Chronic Myeloid Leukemia

Shots:

  • The P-III ASCEMBL study involves assessing of Asciminib (ABL001) vs bosutinib in patients with Ph+ CML-CP, prior treated with two or more TKIs
  • The study met its 1EPs of superiority in major molecular response (MMR) rate @24wks.
  • Asciminib (ABL001) is an investigational treatment specifically targeting the ABL myristoyl pocket (STAMP), being evaluated in multiple clinical studies addressing the needs of CML patients. The US FDA has granted FT designation for the therapy

Click here ­to­ read full press release/ article | Ref: Novartis | Image: Fortune

ReiThera Reports First Patient Dosing with its COVID-19 Vaccine Candidate in Italy

Shots:

  • The first healthy volunteer has been dosed in a P-I study of GRAd-COV2 against COVID-19 which is conducted by the Lazzaro Spallanzani National Institute for Infectious Diseases under the sponsorship of ReiThera
  • The P-I study will evaluate the safety & immunogenicity of GRAd-COV2 in 90 healthy volunteers divided equally into two age cohorts: 18-55yrs. and 65-85yrs. with participants to be monitored over a 24wks. period. The P-I study will also evaluate vaccine dose for further investigation in a P-II/III trial
  • ReiThera is expecting the results of interim safety and immunogenicity analysis by mid Q4’20 which will guide dose selection for P-II/III trial. The company plans to commence international P-II/III in countries with high rates of SARS-CoV-2 infection by the end of 2020, post-P-I outcomes

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Global Times

BioMarin Reports NDA Submission to the US FDA for Vosoritide to Treat Children with Achondroplasia

Shots:

  • BioMarin has submitted an NDA to the US FDA for vosoritide to treat children with achondroplasia
  • The company also reported that EMA has begun validation of MAA for the therapy on 13 Aug, 2020
  • Vosoritide is an investigational, once-daily injection analog of C-type Natriuretic Peptide (CNP) and is potentially the first treatment for achondroplasia in the US

Click here ­to­ read full press release/ article | Ref: Biomarin | Image: Fierce Biotech

G1 Therapeutics Reports the US FDA Acceptance and Priority Review of NDA for Trilaciclib to Treat SCLC

Shots:

  • The NDA submission is based on three clinical studies in which Trilaciclib was administered prior to chemotherapy treatment in patients with SCLC and has demonstrated robust myelopreservation benefits. The company anticipates the PDUFA date as Feb 15, 2021
  • G1 is making Trilaciclib available to SCLC patients in the US, who are unable to enter clinical trials while the NDA for the therapy is under regulatory review, pursuant to FDA’s EAP
  • Trilaciclib is an investigational therapy designed to preserve bone marrow and immune system function during CT and improve patient outcomes and has received the US FDA’s BT designation in 2019

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Outlook India

PTC Reports the EMA’s Acceptance of MAA for Evrysdi (risdiplam) to Treat SMA

Shots:

  • The MAA submission is based on dose-finding Part 1 and confirmatory Part 2 of the FIREFISH and SUNFISH studies evaluating the efficacy and safety of Evrysdi (risdiplam) in symptomatic infants with type 1 SMA aged 2-7mos. and in people with types 2/3 SMA aged 2-25 yrs/ respectively
  • The submission also includes data from JEWELFISH study evaluating patients with all types of SMA aged 1-60yrs. prior treated with other SMA therapies. Exploratory efficacy analysis from SUNFISH Part 1 showed Evrysdi improved motor function @24mos. of treatment, Part 2 of the FIREFISH study met its 1EPs of infants sitting without support for 5sec by month 12, as assessed by BSID-III, Part 2 of the SUNFISH trial demonstrated that change from baseline in MFM-32 score was greater at 12mos.
  • Roche will grant $15M as milestones to PTC following MAA acceptance. Evrysdi is an SMN2-directed RNA splicing modifier designed to treat SMA caused by mutations in chromosome 5q leading to SMN protein deficiency

Click here to­ read full press release/ article | Ref: PRNewswire | Image: PTC Therapeutics

Roche Reports the US FDA’s Acceptance of sBLA for Xolair (omalizumab) Prefilled Syringe for Self-Administration Across All Indications

Shots:

  • The US FDA has accepted the sBLA for a new self-administration option for Xolair across all approved indications in the US. The company anticipates the approval of the therapy in Q1’21
  • The acceptance is based on the efficacy and safety profile of Xolair in allergic asthma and chronic idiopathic urticaria (CIA)
  • If approved, Xolair’s prefilled syringe will become available for either self-administration by select patients or administration by their caregivers.  Genentech and Novartis work together to develop and co-promote Xolair in the US

Click here ­to­ read full press release/ article | Ref: Roche | Image: Pinterest

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 to the therapy for the treatment of hypercholesterolemia in patients with HoFH in 2017
  • Evinacumab is an investigational mAb that binds to and blocks the function of ANGPTL3 and is currently being studied in patients with HoFH (ongoing P-III extension trial), refractory hypercholesterolemia (P-II) and severe hypertriglyceridemia (P-II)

Click here to­ read full press release/ article | Ref: Regeneron  | Image: CNN

Gilead Reports NDA Submission to the US FDA for Veklury (Remdesivir) to Treat COVID-19

Shots:

  • The NDA filing is based on P-III studies evaluating Veklury vs PBO, conducted by NIAID. The studies demonstrated that Veklury led to faster time to recovery and that a 5-day or 10-day treatment duration led to similar clinical improvement
  • Across multiple studies, Veklury was generally well-tolerated in both the 5-day and 10-day treatment groups, with no new safety signals identified
  • Veklury (remdesivir) is an investigational nucleotide analog with broad-spectrum antiviral activity both in vitro/ in vivo in animal models against multiple emerging viral pathogens. The therapy has been approved by multiple regulatory authorities across the globe, including the EU and Japan

Click here ­to­ read full press release/ article | Ref: Gilead  | Image: The Wire Science

Novartis Reports Results of Ofatumumab (OMB157) in P-III ASCLEPIOS Trials for Relapsing Multiple Sclerosis

Shots:

  • The two P-III studies, ASCLEPIOS I & II involves assessing of ofatumumab (20mg, monthly SC) vs teriflunomide (14mg) in 1882 patients aged 18-55yrs with MS and EDDS score b/w 0 and 5.5.  The studies were conducted across 37 countries in 350+ sites 
  • Results of ASCLEPIOS I & II: 51% & 58% reduction in ARR (0.11 vs 0.22 & 0.10 vs 0.25); reduction Gd+T1 lesions (97% & 94%); reduction in new or enlarging T2 lesions (82% & 85%); superior in reducing neuroaxonal damage in both studies, as measured by NfL serum concentrations; 34% and 32% risk reduction in 3mos. and 6mos. CDW; favorable trend in rate of 6mos. CDI; no difference in annual rate of brain volume loss
  • Ofatumumab (SC, once monthly) is a CD20 mAb, targeting CD20 molecule on the B-cell surface and inducing potent B-cell lysis and depletion with its anticipated US FDA’s approval in Sept’20 and in EU by Q2’21

Click here ­to­ read full press release/ article | Ref: Novartis | Image: Clinical Trial Arena

Related News: The US FDA Extends Review of sBLA of Ofatumumab (OMB157) for Patients with Relapsing Multiple Sclerosis




Novartis Reports Results of Kymriah (tisagenlecleucel) in P-II ELARA Study for Follicular Lymphoma

Shots:

  • The P-II ELARA study involves assessing the efficacy and safety of Kymriah in adult patients with r/r FL across 12 countries in 30 sites globally
  • At the interim analysis, the study met its 1EPs of CRR, as assessed by IRC. The company will include the results in regulatory submissions, with anticipated filing to the US FDA in 2021, and then in EU, while the results will be presented at an upcoming medical meeting
  • Kymriah has received FDA’s RMAT designation in r/r FL based on preliminary ELARA trial findings, reflecting the unmet need for additional treatment options for FL. The Therapy was developed in collaboration with the Perelman School of Medicine at the University of Pennsylvania

Click here to­ read full press release/ article | Ref: Novartis | Image: Behance

Related News: Novartis’ Kymriah Receives NICE Approval for R/R Diffuse Large B-cell lymphoma (DLBCL) in Adults




Eli Lilly Reports Results of Jardiance (empagliflozin) in P-III EMPEROR Trial for Heart Failure Patients with Reduced Ejection Fraction with and without Diabetes

Shots:

  • The P-III EMPEROR Trial involves assessing of Jardiance (10 mg) vs PBO in two studies EMPEROR-Reduced [NCT03057977, N=3,730] & EMPEROR-Preserved [NCT03057951, N=5,990] in patients with HFrEF & HFpEF respectively
  • The EMPEROR-Reduced study meets its 1EPs in reducing the risk for the composite of cardiovascular death or hospitalization due to heart failure while the overall safety profile was similar. Additionally, the full data of the stay will be presented at ESC 2020 on Aug 29, 2020, with expected regulatory submissions are planned in 2020
  • Jardiance is a prescribed drug administered along with diet and exercise to lower blood sugar in and helps in reduction of CV death in adults with T2D

Click here to read full press release/ article | Ref: Eli Lilly | Image: Pharma World




AbbVie Report Results of Rinvoq (upadacitinib) in a P-III AD Up Study for Patients with Atopic Dermatitis

Shots:

  • The P-III AD Up study involves assessing Rinvoq (15/30mg) + TCS vs PBO + TCS in patients (aged≥12) with the mod. to sev. AD who are candidates for systemic treatment. Patients receiving PBO + TCS were switched to either upadacitinib (15/30mg) + TCS @16wks.
  • Results: @16wks. EASI 75 (65%/77% vs 26%); vIGA-AD 0/1 (40%/59% vs 11%); Improvement in Worst Pruritus NRS≥4 (52%/64% vs 15%)’ high TCS-freedays
  • Rinvoq (qd) is a selective and reversible JAK inhibitor studied in several immune-mediated inflammatory diseases and has received the US FDA’s approval for patients with mod. to sev. active RA having inadequate response or intolerance to MTX. The therapy is under P-III study for AD, RA, PsA, axSpA, CD, UC, and giant cell arteritis

Click here ­to­ read full press release/ article | Ref: AbbVie | Image: Chicago SunTimes




AstraZeneca Report Results of Farxiga in P-III DAPA-CKD Study for Patients with Chronic Kidney Disease

Shots:

  • The P-III DAPA-CKD involve assessing of Farxiga ((dapagliflozin, 10mg, qd) + SOC vs PBO in 4,304 patients with CKD Stages 2–4 and elevated urinary albumin excretion, with and without T2D
  • The study met its 1EPs i.e. worsening of renal function or risk of death (defined as a composite of an eGFR decline ≥50%, the onset of ESKD and death from CV/ renal cause) and 2EPs i.e. time to first occurrence of the renal composite (sustained ≥50% eGFR decline, ESKD, and renal death
  • Farxiga (PO, qd) is an SGLT2 inhibitor indicated in adults for the treatment of insufficiently controlled T2D as both monothx. and combination therapy as an adjunct to diet and exercise to improve glycemic control, weight loss and BP reduction

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: Bloomberg Quint




BioMarin Reports the Submission of MAA to EMA for Vosoritide to Treat Children with Achondroplasia

Shots:

  • The MAA is based on P-III study assessing the efficacy and safety of vosoritide, further supported by the long-term safety and efficacy from the ongoing P-II and P-III extension studies and extensive natural history data
  • Following the completion of EMA’s validation, BioMarin expects the initiation of the MAA review to commence in Aug’2020. The company is planning to file NDA to the US FDA in Q3’20
  • Vosoritide is an investigational, once-daily injection analog of C-type Natriuretic Peptide (CNP) for children with achondroplasia and has received FDA’s and EMA’s ODD

Click here to read full press release/ article | Ref: BioMarin | Image: BioMarin




Genentech Reports Results of Port Delivery System with Ranibizumab in P-III Archway Study for Neovascular Age-Related Macular Degeneration

Shots:

  • The P-III Archway study involves assessing of PDS with ranibizumab, refilled @6mos. at fixed intervals, vs ranibizumab (0.5mg, monthly IVT) in 418 patients with nAMD, prior treated with VEGF therapy
  • Results: 98.4% of PDS patients were able to go 6mos. without needing additional treatment and achieved vision outcomes equivalent to patients receiving ranibizumab (0.5mg, monthly IVT), PDS demonstrated non-inferior and equivalent visual acuity outcomes with a favorable benefit-risk profile
  • PDS is a permanent refillable eye implant that continuously delivers a customized formulation of ranibizumab over a period of mos., potentially reducing the treatment burden associated with frequent eye injections

Click here to read full press release/ article | Ref: Genentech | Image: Twitter




AbbVie Reports Results of Rinvoq (upadacitinib) as Monotherapy in a P-III Measure Up 2 Study for Atopic Dermatitis

Shots:

  • The P-III Measure Up 2 study involves assessing of Rinvoq (15/30mg) vs PBO in adults and adolescents aged 12-18yrs. or older with mod. to sev. AD who are candidates for systemic treatment. Placebo patients were switched to either upadacitinib (15/30mg) @16wks.
  • The study met its co-1EPs @16wks. i.e. improvement in EASI 75 (60%/73% vs 13%), patient achieving vIGA-AD 0/1 (39%/52% vs 5%); reduction in itch (42%/60% vs 9%); Improvement in Worst Pruritus NRS≥4 (42%/60% vs 9%) respectively
  • Rinvoq (qd) is a selective and reversible JAK inhibitor studied in several immune-mediated inflammatory diseases and has received the US FDA’s approval for patients with mod. to sev. active RA having inadequate response or intolerance to MTX. The therapy is under P-III study for AD, RA, PsA, axSpA, CD, UC and giant cell arteritis

Click here to read full press release/ article | Ref: PRNewswire | Image: WSJ




Top 20 Prescription Drugs Based on 2019 Revenue

The average life expectancy span of Human Beings are increased due to better medical facilities and drugs developed by Biopharma companies. Pharmaceutical products or drugs or medicines are being produced for a wide range of medical sectors. It includes the lifesaving drugs or the major therapy area including immunology, cardiology, and neurology but are they not limited to only these indications and are rapidly increasing with the increasing medical needs. The drugs are developed targeting with the motive to cure, vaccinate, and alleviate the symptoms.

We have compiled a list of global top 20 drugs blockbuster prescription drugs based on their sales for last year i.e. 2019. The top position was maintained by AbbVie’s blockbuster drug Humira with $19.16B another drug grasped the second position headed by Merck’s Keytruda with $11.08B following the third was occupied by BMS’s Revlimid with $9.37B while ended at the low end by Gilead’s Truvada.

If you have any questions or see something we might have missed? Please reach out to Senior Editor, Shiwani Sharma by email.

Product – Truvada

First Approved – US (Aug 02, 2004), EU (Feb 20, 2005)

Indications Approved – HIV-1

Company – Gilead Sciences

Total Revenue – $2.81B

Truvada is a combination of tenofovir disiproxil fumarate (tenofovir DF) and emtricitabine used for HIV treatment and pre-exposure prophylaxis for PrEP (pre-exposure prophylaxis) that can help reduce the risk of getting HIV-1 through sex. On July 23, 2019, Gilead presented new findings on the profile of Descoy for potential use as HIV Pre-exposure Prophylaxis compared with Truvada. Descovy and Truvada are only 2 FDA-approved pills for PrEP.

Product Neulasta    

First Approved US (Jan 31, 2002), EU (Aug 22, 2002)

Indications Approved – Febrile Neutropenia

Company Amgen

Total Revenue $3.22B

Neulasta is a PEGylated form of the recombinant human granulocyte colony-stimulating factor analogue filgrastim. Neulasta has been steadily losing market share due to the launch of multiple biosimilars and the utilization of Neulasta’s OnPro on-body injector (the dominant player at > 55%) has been relatively steady.

Product Victoza                                                                                             Company Novo Nordisk

First Approved US (Jan 25, 2010), EU (Jun 30, 2009)                       Total Revenue $3.29B

Indications Approved – Glycemic control in type 2 diabetes mellitus patients, Reduce adverse cardiovascular events in adults with type 2 diabetes mellitus

Victoza or liraglutide belongs to a class of drugs called glucagon-like peptide-1 agonists (GLP-1). Recently Novo Nordisk’s patent on Victoza is been reviewed as Mylan has claimed that its invalid because it covers an obvious invention. Mylan has challenged the Victoza patent with an aim to launch the low-cost copy of the drug.

Product Lyrica                                                                                                Company Pfizer

First Approved US (Dec 30, 2004), EU (Jul 05, 2004)                       Total Revenue $3.32 B

Indications Approved – Neuropathic pain associated with diabetic peripheral neuropathy, Postherpetic neuralgia                

Lyrica is an anticonvulsant or an anti-seizure drug that can treat a range of conditions, including epilepsy, fibromyalgia, and nerve pain. The recent update on May 28, 2019, Pfizer announced that its epilepsy drug Lyrica (pregabalin), failed to meet the primary endpoint in P-III study, assessing it as adjunctive therapy in epilepsy patients (aged 5 to 65 years) with primary generalized tonic-clonic (“PGTC”) seizures.

Product Imbruvica                                                                                       Company Johnson & Johnson

First Approved US (Nov 13, 2013), EU (Nov 21, 2014)                    Total Revenue $3.41B

Indications Approved – Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia

Imbruvica is an oral therapy which inhibits Bruton’s tyrosine kinase (BTK) and has received its 10 FDA approval. In Apr 2020, US FDA approved Imbruvica (ibrutinib) plus Rituximab for the treatment of patients with Chronic Lymphocytic Leukemia (CLL) 

Product Genvoya                                                                                         Company – Gilead Sciences

First Approved – US (Nov 05, 2015), EU (Nov 19, 2015)                    Total Revenue $3.93 B

Indications Approved – HIV-1

Genvoya is a combination of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide targeting HIV. In Aug 2018, The CNDA approved Gilead’s Genvoya (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg or E/C/F/TAF) for treating HIV Infection.

Product – Remicade                                                                                       Company – Johnson & Johnson

First Approved US (Aug 24, 1998), EU (Aug 13, 1999)                     Total Revenue $4.38B

Indications Approved – Crohn’s Disease, Rheumatoid Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Psoriatic Arthritis, Pediatric Ulcerative Colitis, Pediatric Crohn’s Disease

Remicade or infliximab is a tumour necrosis factor (TNF-alpha or TNF-α) blocker and a chimeric monoclonal IgG1 antibody. In June 2019, Janssen’s Remicade was issued a Civil Investigative Demand to Johnson & Johnson by FTC for investigating whether its contracting practices violate federal antitrust.

Product – Ibrance                                                                                            Company – Pfizer

First Approved US (Feb 03, 2015), EU (Nov 09, 2016)                    Total Revenue $4.96B

Indications Approved – HER2 Negative Advanced Breast Cancer

Ibrance PO is CDKs 4 and 6 inhibitors indicated for HR+, HER2- advance or mBC and has been prescribed up xto 160,000 patients with approval in 85 countries worldwide. On May 29, 2020, the Data Monitoring Committee (DMC) of the collaborative P-III early breast cancer PALbociclib CoLlaborative Adjuvant Study (PALLAS) determined that the trial failed in the primary endpoint of invasive disease-free survival (iDFS). Eli Lilly’s Verzenio has been chasing Ibrance in the metastatic setting since it hit the market and it now its ahead of Ibrance which recently took a big blow.

Product – Enbrel                                                                                              Company – Amgen

First Approved US (Nov 02, 1998), EU (Feb 02, 2000)                    Total Revenue $5.22B

Indications Approved – Rheumatoid Arthritis, Polyarticular-Course Juvenile Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis

Enbrel is a TNF inhibitor drug that treats autoimmune diseases by interfering with tumour necrosis factor by acting as a TNF inhibitor. Enbrel was the drug of choice for multiple autoimmune indications. On Jul 01, 2020, the US Court of Appeals for the Federal Circuit held in Amgen’s favour on the validity of 2 patents that describe and claim Enbrel’s methods.

Product – Prevnar 13                                                                                       Company – Pfizer

First Approved US (Feb 24, 2010), EU (Dec 12, 2009)                     Total Revenue $5.84B

Indications Approved – S. Pneumoniae Infection

Prevnar 13 or Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein is a vaccine approved for adults 18 years of age and older for the prevention of pneumococcal pneumonia and invasive disease caused by 13 Streptococcus pneumonia strains. In June 2020, Pfizer started four P-III clinical trials for investigational vaccines including Prevnar 13.

Product – Herceptin                                                                                       Company – Roche

First Approved – US (Sep 25, 1998), EU (Aug 28, 2000)                      Total Revenue – $6.23 B

Indications Approved – Metastatic Breast Cancer, Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma  

Herceptin or trastuzumab is a mAb that binds to HER2 receptors on the surface of HER2-positive tumor cells, blocking them from receiving growth signals and flagging them for destruction by the immune system. It is on the WHO’s List of Essential Medicines, the safest and most effective medicines needed in a health system. On 29 June 2020, Roche got the approval of Phesgo, a fixed-dose combination of Perjeta (pertuzumab) and Herceptin with hyaluronidase, administered by SC injection in combination with IV chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer. This is the first time that Roche has combined two mAbs that can be administered by a single SC injection.

Product – Stelara                                                                                             Company – Johnson & Johnson

First Approved – US (Sep 25, 2009), EU (Jan 15, 2009)                       Total Revenue – $6.36B

Indications Approved – Plaque Psoriasis, Psoriatic Arthritis, Crohn’s Disease, Ulcerative Colitis

Stelara or ustekinumab is a mAb with a novel mechanism of action that targets the p40 subunit of cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23). In Apr 2020, Johnson & Johnson received NICE’s positive Final Appraisal Document (FAD) recommending Stelara (ustekinumab) for the treatment of ulcerative colitis.

Product – Rituxan                                                                                             Company – Roche

First Approved – US (Nov 26, 1997), EU (Jun 02, 1998)                      Total Revenue – $6.69B

Indications Approved – Non-Hodgkin’s lymphoma, Chronic Lymphocytic Leukemia, Rheumatoid Arthritis, Granulomatosis with Polyangiitis, Microscopic Polyangiitis, Pemphigus Vulgaris

Rituxan or rituximab is a mAb used to target cancer cells with CD20 markers in patients. In Sep 2019, The US FDA approved Roche’s Rituxan (rituximab) in combination with glucocorticoids for treating granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) disorders.

Product – Opdivo                                                                                             Company – Bristol-Myers Squibb

First Approved – US (Dec 22, 2014), EU (Jun 19, 2015)                      Total Revenue – $7.20B

Indications Approved – Metastatic Melanoma, Non-Small Cell Lung Cancer,Melanoma, Small Cell Lung Cancer, Renal Cell Carcinoma, Hodgkin Lymphoma, Squamous Cell Carcinoma of the Head and Neck, Urothelial Carcinoma, Mismatch Repair Deficient Metastatic Colorectal Cancer, Hepatocellular Carcinoma, Esophageal Squamous Cell Carcinoma

Opdivo or nivolumab is a PD-1 immune checkpoint inhibitor targeted for cancer cells and is approved in 65 countries including the US, EU, Japan & China. In Jun 2020, the US FDA granted approval for Opdivo (nivolumab) following the P-III ATTRACTION-3 study results evaluate it in comparison with taxane CT (docetaxel/paclitaxel) to treat patients with unresectable advanced, recurrent or ESCC, refractory/ intolerant to at least one prior fluoropyrimidine & platinum-based CT.

Product – Avastin                                                                                             Company – Roche

First Approved – US (Feb 26, 2004), EU (Jan 12, 2005)                       Total Revenue – $7.30B

Indications Approved Metastatic Carcinoma, Metastatic Colorectal Cancer, Non–Small Cell Lung Cancer, Glioblastoma, Metastatic Renal Cell Carcinoma, Metastatic Cervical Cancer, Primary Peritoneal Cancer, Hepatocellular Carcinoma

Avastin or bevacizumab is a tumour-starving (anti-angiogenic) therapy targeted for preventing tumour growth. In Jun 2020, Roche received the US FDA’s approval for a combination of Avastin (bevacizumab) + Tecentriq (atezolizumab) to treat patients with Unresectable Or Metastatic Hepatocellular Carcinoma (HCC) who have not received prior systemic therapy, which lead to a novel immunotherapy approval for the indication. The approval followed the P-III IMbrave150 study results assessing the combination.

Product – Eylea                                                                                                 Company – Regeneron Pharmaceuticals

First Approved – US (Nov 18, 2011), EU (Nov 21, 2012)                     Total Revenue – $7.54B

Indications Approved – Age-Related Macular Degeneration, Macular Edema, Diabetic Macular Edema, Diabetic Retinopathy

Eylea or aflibercept is one form of anti-VEGF therapy administered by injection into the eye. Recently, Bayer launched Eylea (aflibercept) pre-filled syringe in all 27 states of the EU including the UK, Iceland, Norway, and Liechtenstein in Apr 2020. In May 2019, Regeneron’s Eylea injection received the US FDA’s approval to treat all stages of Diabetic Retinopathy (DR) further reducing the risk of blindness.

Product – Eliquis                                                                                               Company – Bristol Myers Squibb  

First Approved – US (Dec 28, 2012), EU (May 18, 2011)                    Total Revenue – $7.92B

Indications Approved – Stroke, Systemic Embolism, Deep Vein Thrombosis, Pulmonary Embolism, Recurrence of DVT and PE

Eliquis or apixaban is an anticoagulant that reduces blood clotting. Eliquis stood on the fourth-highest selling product with $7.92B in 2019. In late 2019, the US FDA approved BMS’ Eliquis tablets to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

Product – Revlimid                                                                                          Company – Bristol-Myers Squibb

First Approved – US (Dec 27, 2005), EU (Jun 14, 2007)                      Total Revenue – $9.37B

Indications Approved – Anemia, Multiple Myeloma, Myelodysplastic Syndromes, Mantle Cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma

Revlimid or lenalidomide is a thalidomide analogue candidate which reported WW sales of $9.37B. In Feb 2020, BMS’ Revlimid received the National Institute for Health and Care Excellence (NICE) approved it targeting to treat previously treated follicular lymphoma in combination with MabThera (rituximab).

Product – Keytruda                                                                                         Company – Merck & Co

First Approved – US (Sep 04, 2014), EU (Jul 17, 2015)                        Total Revenue – $11.08B

Indications Approved – Metastatic Melanoma, Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Head, and Neck Squamous Cell Cancer, Hodgkin Lymphoma, Mediastinal Large B-Cell Lymphoma, Urothelial Carcinoma, Deficient Cancer, Colorectal Cancer, Gastric Cancer, Esophageal Cancer, Cervical Cancer, Hepatocellular Carcinoma, Merkel Cell Carcinoma, Renal Cell Carcinoma, Endometrial Carcinoma, Tumor Mutational Burden-High Cancer, Cutaneous Squamous Cell Carcinoma

Keytruda or pembrolizumab is a mAb serving as an anti-PD-1 therapy for the tumour cells blocking the interaction between PD-1 and its ligands, PD-L1, and PD-L2. It initially received FDA accelerated approval for refractory, advanced melanoma in September 2014. Subsequently, it has received approval for the treatment of many other oncologic conditions, and many more are currently in clinical development.

Keytruda acquired the second position in the WW sales list of 2019. In Jul 2020, the US FDA granted Priority Review to Merck’s Keytruda for its sBLA to treat patients with 2L+ Relapsed or Refractory Classical Hodgkin Lymphoma (cHL). The designation follows P-III KEYNOTE-204 study results and the expected PDUFA date as Oct 30, 2020. In Jun 2020, Merck’s Keytruda receives the US FDA’s approval to treat patients with 1L Unresectable or Metastatic MSI-H or dMMr Colorectal Cancer.

Product Name – Humira                                                                                Company Name – AbbVie

First Approved – US (Dec 31, 2002), EU (Aug 09, 2003)                     Total Revenue – $19.16B

Indications Approved – Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn’s Disease, Ulcerative Colitis, Plaque Psoriasis, Hidradenitis Suppurativa, Uveitis

Humira (adalimumab) is a mAb blocking TNF-a protein targeted for the inflammatory response of immune-mediated diseases. Humira has recorded the highest selling product sales with a generated revenue of $19.16B in 2019. Humira continues to be the leader of the commercial drug market and keeping its first position with the crown of the most lucrative drug in the history of the pharmaceutical market. In Jun 2020, AbbVie reported results of ABBV-3373, an ADC comprising novel glucocorticoid receptor modulator (GRM) vs Humira in patients with Moderate to Severe Rheumatoid Arthritis and resulted in similar profile with the original product.




Eli Lilly Reports Results of Mirikizumab in P-III OASIS-2 Study to Treat Moderate to Severe Plaque Psoriasis

Shots:

  • The P-III OASIS-2 study involves assessing mirikizumab vs PBO & Cosentyx (secukinumab) in 1,465 patients with mod. to sev. PsO. The patients were randomized in a (4:4:4:1) ratio to one of the following induction and maintenance period treatments: mirikizumab (250mg) @ 0, 4, 8, 12wks. followed by 250 & 125mg, q8w starting @16wks; 300mg secukinumab @ 0, 1, 2, 3, 4wks. followed by 300mg, q4w starting @4wks.; PBO @ 0, 4, 8, 12 wks. followed by 250mg mirikizumab q4w starting @16wks. through 32wks. followed by q8w thereafter
  • Results: @16wks. sPGA(0,1) (79.7% vs 6.3% & 76.3%), PASI 90 (74.4% vs 6.3% & 72.8%); PASI 100 (37.7% vs 1.8% & 36.6%). In general, the study resulted in meeting its 1EPs and all key 2EPs vs PBO @16wks. and all key 2EPs vs Cosentyx (secukinumab) @16wks. (non-inferiority) and @52wks. (superiority)
  • Mirikizumab is an IgG4 mAb binding p19 subunit of IL-23 and being evaluated for immune diseases, including psoriasis, UC and CD

Click here to read full press release/ article | Ref: Eli Lilly | Image: Glassdoor




MorphoSys Reports Submission of Tafasitamab’s BLA to the US FDA to Treat Relapsed or Refractory Diffuse Large B Cell Lymphoma (r/r DLBCL)

Shots:

  • The BLA submission is based on L-MIND P-II trial data results assessing Tafasitamab + lenalidomide in patients with r/r DLBCL and retrospective observational matched control cohort Re-MIND evaluating efficacy outcomes of r/r DLBCL patients who received Tafasitamab + lenalidomide vs lenalidomide monothx
  • Re-MIND has met its 1EPs and has shown improved ORR of the tafasitamab/lenalidomide combination vs lenalidomide monothx. In Oct 2017, Tafasitamab + Lenalidomide received the US FDA’s Breakthrough Therapy Designation
  • Tafasitamab (MOR208) is an investigational Fc-engineered mAb directed against CD19 and is being evaluated in B-MIND P-III trial in combination with bendamustine vs rituximab + bendamustine in patients with r/r DLBCL

Click here to read full press release/ article | Ref: MorphoSys | Image: Behance

Clover Reports First Patient Dosing in P-III Trial with SCB-808 (biosimilar, etanercept) in China

Shots:

  • The P-III study involves assessing of SCB-808
    (SC) vs Enbrel (SC) in patients with ankylosing spondylitis (radiographic axial
    spondyloarthritis) to evaluate its safety, efficacy and PK
  • The company utilizes its Trimer-Tag technology
    platform to develop novel therapies targeting trimerization-dependent pathways
    and is also leveraging its cGMP biomanufacturing capabilities to develop biosimilars
  • SCB-808 is mAb being developed as a prefilled
    syringe ready-for-injection self-administered for the treatment of rheumatoid
    arthritis and other autoimmune diseases

Click here to read full press release/ article | Ref: GlobeNewswire| Image: Signbox

Clover Reports Dosing of SCB-808 (biosimilar, etanercept) in P-III Trial in China

Shots:

  • The P-III study involves assessing of SCB-808 vs Enbrel in patients with AS (axSpA) via SC administration
  • SCB-808 is being developed in the prefilled syringe formulation which is ready for injection and can be self-administered by the patients, thus overwhelming the current Enbrel biosimilar which are available in lyophilized powder formulation in China
  • Clover has new state-of-the-art 35,000m2 cGMP biomanufacturing facility, with initial 2 x 2,000L bioreactor capacity and further expandable to address the unmet medical needs of Chinese patients suffering from autoimmune diseases

Click here to read full press release/ article | Ref: Clover | Image: Signbox