Acceptance

Regeneron Reports the US FDA’s Acceptance of Priority Review for REGEN-COV for the Treatment and Prophylaxis of COVID-19

Shots: The US FDA has accepted for priority review a BLA for REGEN-COV (casirivimab and imdevimab) to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals The BLA is based on P-III study assessing efficacy & safety of REGEN-COV to treat non-hospitalized patients already infected with SARS-CoV-2, and to prevent symptomatic infection in …

Regeneron Reports the US FDA’s Acceptance of Priority Review for REGEN-COV for the Treatment and Prophylaxis of COVID-19 Read More »

Polpharma Biologics Reports the US FDA’s Acceptance of BQ201’s (biosimilar, ranibizumab) BLA for Review to Treat Wet Age-Related Macular Degeneration

Shots: The US FDA has issued a notification to Polpharma Biologics for the acceptance of BQ201’s (biosimilar, ranibizumab) BLA to treat wet AMD with an anticipated PDUFA date in Aug’22 The launch of biosimilar ranibizumab may increase market competition, reduce cost & expand patient access with proven analytical & clinical similarity to Lucentis Coherus will …

Polpharma Biologics Reports the US FDA’s Acceptance of BQ201’s (biosimilar, ranibizumab) BLA for Review to Treat Wet Age-Related Macular Degeneration Read More »

Polpharma Biologics Reports the US FDA’s Acceptance of BQ201’s (biosimilar, ranibizumab) BLA for Review to Treat Wet Age-Related Macular Degeneration

Shots: The US FDA has issued a notification to Polpharma Biologics for the acceptance of BQ201’s (biosimilar, ranibizumab) BLA to treat wet AMD with an anticipated PDUFA date in Aug’22 The launch of biosimilar ranibizumab may increase market competition, reduce cost & expand patient access with proven analytical & clinical similarity to Lucentis Coherus will …

Polpharma Biologics Reports the US FDA’s Acceptance of BQ201’s (biosimilar, ranibizumab) BLA for Review to Treat Wet Age-Related Macular Degeneration Read More »

Formycon and Bioeq Report the US FDA’s Acceptance of BLA for FYB201 (biosimilar, ranibizumab)

Shots: The US FDA has accepted the BLA for FYB201, a biosimilar referencing Lucentis for review and assigned a target action date for the application for Aug’2022 Following the approval, Coherus will commercialize FYB201 in the US whereas Formycon will participate economically in US sales through its interest in royalties paid by Coherus to Bioeq …

Formycon and Bioeq Report the US FDA’s Acceptance of BLA for FYB201 (biosimilar, ranibizumab) Read More »

Agios Reports the US FDA’s Acceptance of NDA and Priority Review for Mitapivat to Treat Pyruvate Kinase Deficiency

Shots: The NDA & MAA submissions are based on ongoing 2 studies i.e., ACTIVATE & ACTIVATE-T evaluates safety, tolerability & efficacy of mitapivat vs PBO in patients with PKD Results: 40% of patients achieved a hemoglobin response, 33% reduction in transfusion burden @ 24wks. fixed dose period & safety profile was consistent with previously reported …

Agios Reports the US FDA’s Acceptance of NDA and Priority Review for Mitapivat to Treat Pyruvate Kinase Deficiency Read More »

Dermavant Reports the US FDA’s Acceptance of NDA for Tapinarof Cream to Treat Plaque Psoriasis

Shots: The NDA is based on P-III PSOARING 1 & 2 along with interim results from PSOARING 3 OLE study evaluating the safety & efficacy of tapinarof vs vehicle in patients with PsO In PSOARING 1 & 2 results: patients achieved a PGA score of 0 or 1 (35.4% vs 6% & 40.2% vs 6.3%) …

Dermavant Reports the US FDA’s Acceptance of NDA for Tapinarof Cream to Treat Plaque Psoriasis Read More »

Roche Reports the US FDA’s Acceptance of BLA for Faricimab to Treat Diabetic Macular Edema and Neovascular Age-Related Macular Degeneration

Shots: The BLA submission is based on four P-III studies i.e TENAYA, LUCERNE, YOSEMITE & RHINE evaluating the efficacy & safety of faricimab vs aflibercept in patients with nAMD & DME. The LTE studies for faricimab are underway The studies demonstrated non-inferior visual acuity gains and greater reductions in CST, ~50% of patients can extend …

Roche Reports the US FDA’s Acceptance of BLA for Faricimab to Treat Diabetic Macular Edema and Neovascular Age-Related Macular Degeneration Read More »

Hutchmed Reports the US FDA’s Acceptance of Surufatinib’s NDA for Advanced Neuroendocrine Tumors

Shots: The NDA is based on two P-III studies of surufatinib in patients with pancreatic and extra-pancreatic NET in China. The anticipated PDUFA date is April 30, 2022 The same data from the studies will be used to file MAA to the EMA imminently, based on scientific advice from the EMA’s Committee for Medicinal Products …

Hutchmed Reports the US FDA’s Acceptance of Surufatinib’s NDA for Advanced Neuroendocrine Tumors Read More »

MannKind and United Therapeutics Reports the US FDA’s Acceptance of NDA for Priority Review of Tyvaso DPI to Treat PAH and PH-ILD

Shots: The NDA is based on data from the BREEZE study evaluating Tyvaso DPI in 51 patients with PAH transitioning from Tyvaso inhalation solution which demonstrates the safety & tolerability of Tyvaso DPI Additionally, a separate PK study in 36 healthy volunteers demonstrates comparable treprostinil exposure b/w Tyvaso DPI & Tyvaso Inhalation Solution while FDA …

MannKind and United Therapeutics Reports the US FDA’s Acceptance of NDA for Priority Review of Tyvaso DPI to Treat PAH and PH-ILD Read More »

BeiGene Reports NMPA’s Acceptance of sBLA for Tislelizumab to Treat MSI-H or dMMR Solid Tumors

Shots: The sBLA submission is based on results from a P-II study evaluating the efficacy & safety of tislelizumab (200 mg, IV, q3w) as monothx in 80 patients with previously treated LA, unresectable or metastatic MSI-H or dMMR solid tumors The results demonstrated that the therapy treatment was consistent & durable across tumor types and …

BeiGene Reports NMPA’s Acceptance of sBLA for Tislelizumab to Treat MSI-H or dMMR Solid Tumors Read More »

BioXcel Reports the US FDA’s Acceptance of BXCL501’s NDA for the Acute Treatment of Agitation Associated with Schizophrenia and Bipolar Disorders I and II

Shots: The NDA submission is based on P-III studies (SERENITY I & II) assessing BXCL501 (120 & 180mcg doses) vs PBO for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II, respectively Results: BXCL501 met its 1EPs & 2EPs in both the studies, demonstrating rapid, and durable improvements from baseline …

BioXcel Reports the US FDA’s Acceptance of BXCL501’s NDA for the Acute Treatment of Agitation Associated with Schizophrenia and Bipolar Disorders I and II Read More »

Amgen Reports the US FDA’s Acceptance of sNDA for Review of Otezla (apremilast) to Treat Mild-To-Moderate Plaque Psoriasis

Shots: The acceptance is based on a P-III ADVANCE trial assessing the efficacy of Otezla (30 mg, bid) vs PBO in 595 patients in a ratio (1:1) with mild-to-moderate plaque psoriasis for the first 16wks. All patients then received Otezla during an OLE phase through week 32. Results: @16wks., improvement in its 1EPs of sPGA …

Amgen Reports the US FDA’s Acceptance of sNDA for Review of Otezla (apremilast) to Treat Mild-To-Moderate Plaque Psoriasis Read More »

Astellas and Seagen Report the US FDA’s Acceptance of Two sBLA for Padcev (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer

Shots: The first sBLA is based on the P-III EV-301 trial assessing Padcev vs CT in ~ 600 patients with LA or mUC prior treated with PD-1/L1 inhibitor and platinum-based therapy. The first sBLA seeks to convert PADCEV’s accelerated approval to regular approval The second sBLA is based on cohort 2 of the P-II EV-201 …

Astellas and Seagen Report the US FDA’s Acceptance of Two sBLA for Padcev (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer Read More »

Exelixis Reports the US FDA’s Acceptance of IND for XB002 in Patients with Advanced Solid Tumors

Shots: The US FDA has accepted IND to assess the safety, tolerability, PK, and preliminary antitumor activity of XB002 in patients with advanced solid tumors. The P-I trial is expected to initiate in Q2’21 The preclinical data demonstrated that XB002 binds to tissue factors without affecting the coagulation cascade, in contrast with prior therapies in …

Exelixis Reports the US FDA’s Acceptance of IND for XB002 in Patients with Advanced Solid Tumors Read More »

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

Shots: The MAA is based on the P-III EV-301 trial which involves assessing Enfortumab Vedotin vs CT in ~ 600 patients with LA/m-UC, prior treated with Pt.-based CT and a PD-1/L1 inhibitor The 1EPs of the trial is OS and 2EPs include PFS, ORR, DoR, DCR as well as the assessment of safety/tolerability and QoL …

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

Takeda Reports EMA’s Acceptance of TAK-003 for the Prevention of Dengue

Shots: The submission is based on a P-III TIDES trial assessing TAK-003 (0.5ml, SC) vs PBO in 20,000+ healthy children & adolescents aged 4-16yrs. to prevent dengue fever of any severity and due to any of the four dengue virus serotypes The trial met its 1EPs showed overall vaccine efficacy against VCD @12 mos. follow-up …

Takeda Reports EMA’s Acceptance of TAK-003 for the Prevention of Dengue Read More »

Merck Reports the US FDA’s Acceptance of NDA for Priority Review of Belzutifan (MK-6482) to Treat Patients with Von Hippel-Lindau Disease Associated RCC

Shots: The NDA is based on P-II study-004 trial involves assessing Belzutifan (120 mg, PO, qd) in 61 patients with VHL disease who had at least one measurable solid tumor localized to the kidney and did not require immediate surgery Results: It showed ORR of 36.1% while the 2EPs include DCR, DoR, time to response, …

Merck Reports the US FDA’s Acceptance of NDA for Priority Review of Belzutifan (MK-6482) to Treat Patients with Von Hippel-Lindau Disease Associated RCC Read More »

Regeneron and Sanofi Report the US FDA’s Acceptance of sBLA for Review of Dupixent to Treat Moderate-to-Severe Asthma in Children

Shots: The sBLA is based on P-III study assessing Dupixent + SOC maintenance therapy in children aged 6-11yrs. with moderate-to-severe asthma with type 2 inflammation The study resulted in a reduction of severe asthma attacks and rapidly improved lung function within 2wks, safety results were generally consistent with the known safety profile of Dupixent. Dupixent …

Regeneron and Sanofi Report the US FDA’s Acceptance of sBLA for Review of Dupixent to Treat Moderate-to-Severe Asthma in Children Read More »

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 …

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

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 …

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

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 …

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

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 …

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

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 …

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

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 …

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

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 …

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

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 …

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

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 …

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

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 …

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

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

Shots: The US FDA has accepted for Priority Review the sNDA is based on the pivotal CROWN study and is being reviewed by the FDA under its Real-Time Oncology Review (RTOR) CROWN is P-lll, parallel 2-arm trial in which 296 previously untreated advanced ALK-positive NSCLC were randomized in ratio 1:1 to receive LORBRENA monotherapy (n=149) …

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

Samsung Bioepis and Biogen Announces FDA Filing Acceptance of Lucentis’ Biosimilar, SB11 for Retinal Vascular Disorders

Shots: EMA accepted the review of MAA for SB11 in Oct 2020. If approved, SB11 will add to the biosimilars portfolio developed by Samsung Bioepis and commercialized by Biogen, including three widely prescribed anti-TNF biosimilars in EU: BENEPALI, IMRALDI, and FLIXABI In Nov 2019, Samsung Bioepis entered into a new commercialization agreement with Biogen for …

Samsung Bioepis and Biogen Announces FDA Filing Acceptance of Lucentis’ Biosimilar, SB11 for Retinal Vascular Disorders Read More »

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

Shots: The NMPA has accepted HLX15’s IND to be used in the treatment of multiple myeloma. HLX15 is Henlius’ second self-developed product around blood tumor treatment The company evaluated the biosimilar in a head to head clinical studies demonstrating that HLX15 is highly similar to its reference daratumumab while the safety profiles are also similar …

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

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 …

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

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 …

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

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 …

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

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 …

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

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

Shots: The BLA is based on P-III study evaluating the efficacy and safety of evinacumab (15 mg/kg, IV, q4w) in 65 patients aged ≥12yrs. with HoFH. The 1EPs of the study is reduction of LDL-C from baseline The expected PDUFA date for the therapy as Feb 11, 2021. The US FDA has granted BT designation …

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

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

Shots: The NMPA has accepted the sNDA for Tyvyt (sintilimab) in combination with Gemzar (gemcitabine) and platinum as 1L therapy in sq. NSCLC The sNDA is based on P-III ORIENT-12 study assessing sintilimab (200mg) vs PBO in combination with Gemzar and Pt (q3w for up to 4 or 6 cycles), followed by either sintilimab or …

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