Complete Response Letter

ARS Pharma Announces Favorable Topline Results from Repeat Dosing Study of neffy® (Epinephrine Nasal Spray) Under Nasal Allergen Challenge Conditions, Readies Data for Response to FDA’s Complete Response Letter

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Tuesday, February 20, 2024
Allergy, Epinephrine autoinjector, SAN, EMA, PD, Caregiver, Committee, CRL, Doctor of Philosophy, RN, ARS, Absorption, FDA, Food, File, Anaphylaxis, Heart rate, NAC, PDUFA, Agency, Entrepreneurship, Complete Response Letter, FARE, Symantec Endpoint Protection, Safety, Health, Lower respiratory tract infection, University, Rhinitis, Nasal mucosa, CHMP, European Medicines Agency, Nitrosamine, Patient, Pediatrics, IM, Adrenaline, Translational research, Trial of the century, Pharmaceutical industry

SAN DIEGO, Feb. 20, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (NASDAQ: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, today announced topline results from its clinical study comparing repeat doses of neffy (epinephrine nasal spray) to repeat doses of epinephrine intramuscular (IM) injection, as requested by the FDA with and without nasal allergen challenge (NAC) conditions.

Key Points: 
  • “The study objective was to compare twice dosing with epinephrine injection and twice dosing with neffy under normal conditions and after nasal allergen challenge.
  • With these results, we are completing the necessary work to submit our response to FDA in the next couple of months.
  • The repeat dose study under NAC conditions was designed with the FDA to address the Agency’s outstanding questions regarding neffy as described in the Complete Response Letter (CRL) from September 2023.
  • In addition, multiple PADAC members highlighted the favorable profile of neffy in our single dose NAC study.

Global Oncology Cancer Drugs Market Revenue Projected To Surpass $289 Billion By 2030

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Tuesday, January 9, 2024
Pancreatic cancer, Research, Biology, Prostate cancer, Cancer, Cytokine release syndrome, CRS, AML, Population Reference Bureau, Audit committee, AMGN, NK, Neoplasm, ADC, Acute myeloid leukemia, Paracetamol, PMR, NKG2D, NSCLC, Disease, Safety, Conditional sentence, Brain, Lung cancer, Breast, PALM, Cytarabine, Senior, Prevalence, Genetics, Nonsteroidal anti-inflammatory drug, Drug discovery, Graft-versus-host disease, Ruxolitinib, TSX, Therapy, Kidney cancer, Ageing, Patient, Stomach, Complete Response Letter, Fentanyl, Breast cancer, Novartis, Society, Eli Lilly, News, Food, Cancer pain, Johnson & Johnson, Morphine, FDA, Ovarian cancer, New Drug Application, ASH, ONC, Pharmaceutical industry

Cancer is a non-treatable chronic disease that has posed a challenge to the medical fraternity for decades.

Key Points: 
  • Cancer is a non-treatable chronic disease that has posed a challenge to the medical fraternity for decades.
  • The entire medical research fraternity has prioritized cancer research in order to find new ways of treatment and analysis.
  • According to Nova one advisor, the global Oncology Cancer Drugs market was valued at USD 147.2 billion in 2021 and it is expected to hit around USD 289.2 billion by 2030 with a CAGR of 8.4% during the forecast period 2022 to 2030.
  • The article continued: “Drugs such as morphine, fentanyl, acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), and others are used extensively in treating cancer pain in patients with lung cancer, bone cancer, and other types of cancer.

Coherus BioSciences Reports Third Quarter 2023 Financial Results and Business Highlights

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Monday, November 6, 2023
Complete Response Letter, COGS, CCR8, FDA, Element, Research, Sale, IND, Food, PIN, Biologics license application, Medicare, SG, Cisplatin, Injector, Symantec Endpoint Protection, Surface, Conference, PD-1, GAAP, CHRS, Acquisition, HIV disease progression rates, Exercise, NPC, R, CRL, Adalimumab, Ranibizumab, Neoplasm, Risk, Webcast, Tumor microenvironment, Conference call, Investment, IL-27, BLA, Investigational New Drug, Rare-earth element, Video game, Pharmaceutical industry, Medical device, Online shopping, Q2

REDWOOD CITY, Calif., Nov. 06, 2023 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS), today reported financial results for the quarter ended September 30, 2023, and recent business highlights:

Key Points: 
  • – Conference call today at 5:00 p.m. Eastern Time –
    REDWOOD CITY, Calif., Nov. 06, 2023 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS), today reported financial results for the quarter ended September 30, 2023, and recent business highlights:
    CIMERLI® (ranibizumab-eqrn) net product sales increased in the third quarter 2023 to $40.0 million compared to $26.7 million in the second quarter.
  • UDENYCA® (pegfilgrastim-cbqv) net product sales increased in the third quarter 2023 to $33.0 million compared to $31.7 million in the second quarter.
  • Market share grew to 16.5% in the third quarter 2023, an increase of 4.3 market share percentage points compared to the prior quarter.
  • Coherus anticipates demand will continue to rise with significantly improved commercial and Medicare Advantage formulary coverage in the fourth quarter of 2023 and in 2024.

Innate Pharma Announces New Clinical Data for Lacutamab and SAR443579/IPH6101 at ASH 2023

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Friday, November 3, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, CR, Society for Hematology and Stem Cells, Acute lymphoblastic leukemia, Acute myeloid leukemia, Bone marrow, PTCL, CD123, PFS, Cohort, Skin, CRS, Complete Response Letter, Poster, IPH, Society, Notifiable disease, ASH, Euronext Paris, Abstract, Blood, ORR, CBR, IPHA, Safety, Exposition, DLS, AML, Pharmaceutical industry, Patient, Sanofi

Clinical Benefit Rate (CBR, defined as CR+PR+SD) was 87.5 % (n=49; 95% CI 76.4-93.8).

Key Points: 
  • Clinical Benefit Rate (CBR, defined as CR+PR+SD) was 87.5 % (n=49; 95% CI 76.4-93.8).
  • Continued evaluation of this promising new targeted treatment option for patients with Sezary Syndrome is warranted.
  • The poster will display preclinical combination data supporting anti-tumor activity and rationale for the exploration of lacutamab in combination with approved and novel therapies in patients with PTCL.
  • SAR443579 was well tolerated up to doses of 6000 μg/kg QW with observed clinical benefit in patients with R/R AML.

Single and Repeat Dose Clinical Study of neffy (epinephrine nasal spray) Published in the Journal of Allergy and Clinical Immunology

Retrieved on: 
Tuesday, October 3, 2023
Blood pressure, Exercise, Cleveland Clinic, University, Pediatrics, ARS, Symantec Endpoint Protection, Clinical trial, NDA, VAS, American Academy, American Academy of Allergy, Asthma, and Immunology, Trial of the century, Committee, Asthma, Rhinitis, Literature, The Journal of Allergy and Clinical Immunology, Journal, Patient, Translational research, Anaphylaxis, Adrenaline, SAN, Irritation, Epinephrine autoinjector, HR, AAAAI, Cleveland, Heart rate, Caregiver, FDA, Safety, Complete Response Letter, Emax, Palladium, Pharmaceutical industry, Vaccine, SBP, PD, Allergy, Immunology, Medicine

JACI is the official scientific publication of the American Academy of Allergy, Asthma and Immunology and the most cited journal in the field of allergy and clinical immunology.

Key Points: 
  • JACI is the official scientific publication of the American Academy of Allergy, Asthma and Immunology and the most cited journal in the field of allergy and clinical immunology.
  • The clinical study evaluated single and repeat doses of neffy compared to single and repeat doses of approved injection products in healthy subjects.
  • For repeat doses of neffy, mean maximum changes in PD responses for both blood pressure and heart rate were statistically greater than repeat doses of EpiPen.
  • In addition, the PK profile for a second dose of neffy was approximately dose-proportional, unlike EpiPen, where the second dose delivered less incremental epinephrine exposure than the first dose.

Wugen Presents Initial Data from First-in-Human Phase 1/2 Trial of WU-CART-007 at the European Hematology Association (EHA) 2023 Congress

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Friday, June 9, 2023
Science, Other Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Clinical Trials, Pancytopenia, Complete Response Letter, Graft-versus-host disease, Intraparenchymal hemorrhage, European Hematology Association, CRS, Relapse, Encephalopathy, DLT, EMD, Rhizomucor, Dexamethasone, LBL, Congress, AML, Hematological Cancer Research Investment and Education Act, Cytokine release syndrome, EHA, Symantec Endpoint Protection, Mortality, Partial-response maximum-likelihood, Tumor microenvironment, Natural killer T cell, Acute myeloid leukemia, ORR, Safety, Disease, Pharmaceutical industry, Vaccine, Patient

“We are very encouraged by these initial safety and efficacy data from our ongoing Phase 1/2 trial of WU-CART-007 in patients with R/R T-ALL/LBL,” said Jan Davidson-Moncada, M.D., Ph.D., Chief Medical Officer of Wugen.

Key Points: 
  • “We are very encouraged by these initial safety and efficacy data from our ongoing Phase 1/2 trial of WU-CART-007 in patients with R/R T-ALL/LBL,” said Jan Davidson-Moncada, M.D., Ph.D., Chief Medical Officer of Wugen.
  • Many children and adults relapse after first line therapy and are left with very limited treatment options thereafter, often leading to high mortality.
  • Prior to enrollment, all patients had been heavily pretreated, with a median of 5 prior lines of therapy.
  • No cases of Graft versus Host Disease (GvHD), prolonged T-cell aplasia, or pancytopenia in the absence of disease were reported.

FDA Provides Akebia Therapeutics a Path Forward for Vadadustat

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Tuesday, May 30, 2023
Mitsubishi Tanabe Pharma, Chronic kidney disease, Civil service commission, Symantec Endpoint Protection, Vadadustat, Rockwell Medical, Health care, Clinical trial, NDA, AKBA, Hepatotoxicity, Gross metropolitan product, Dialysis, European Commission, Division, Patient, European Economic Area, Risk, Anemia, OND, Medicines and Healthcare products Regulatory Agency, United Kingdom, Webcast, CRL, FDA, Letter, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, CKD, Complete Response Letter, Food, Kidney disease, Safety, Medical device, Pharmaceutical industry, VAT, Akebia

The CRL raised a concern regarding the increased risk of thromboembolic events, driven by vascular access thrombosis (VAT).

Key Points: 
  • The CRL raised a concern regarding the increased risk of thromboembolic events, driven by vascular access thrombosis (VAT).
  • Accordingly, Akebia plans to include post-approval data from Japan in the NDA resubmission, where tens of thousands of Japanese patients with CKD have been exposed to vadadustat to date.
  • The OND's letter provides guidance on a path for the resubmission of our NDA and potential approval of vadadustat for dialysis dependent patients in the U.S. without suggesting the need to generate additional clinical data.
  • We appreciate the FDA's engagement with us throughout the appeal process," said John P. Butler, Chief Executive Officer of Akebia.

Artiva Biotherapeutics Presents Initial Data from First-in-Human Phase 1/2 Clinical Trial of AB-101 at the 2023 ASCO Annual Meeting

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Thursday, May 25, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Complete Response Letter, Rituximab, Graft-versus-host disease, Northwest Biotherapeutics, Febrile neutropenia, CRS, Umbilical cord, Cyclophosphamide, NK, Toxicity, Șaeș, ASCO, Combination therapy, Bone marrow suppression, American Society of Clinical Oncology, Patient, Standard of care, Cytopenia, Annual general meeting, Steroid, Symantec Endpoint Protection, Partial-response maximum-likelihood, Society, Neurotoxicity, ORR, Safety, Vaccine, Pharmaceutical industry, Fever

Artiva Biotherapeutics, Inc. , a clinical stage company whose mission is to deliver highly effective, off-the-shelf, allogeneic natural killer (NK) cell-based therapies, announced today the presentation of initial data from the dose-escalation stage of its ongoing Phase 1/2 clinical trial of AB-101.

Key Points: 
  • Artiva Biotherapeutics, Inc. , a clinical stage company whose mission is to deliver highly effective, off-the-shelf, allogeneic natural killer (NK) cell-based therapies, announced today the presentation of initial data from the dose-escalation stage of its ongoing Phase 1/2 clinical trial of AB-101.
  • The presentation will take place on Monday, June 5, during the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
  • Myelosuppression, consistent with standard lymphodepletion regimens, was the most common Grade ≥ 3 toxicity, but was manageable with standard of care.
  • In the combination cohort, only one unrelated Grade 3 SAE of pyrexia was noted.​ There were no treatment-related AEs leading to discontinuation of AB-101.​

Appendix 4C Quarterly Activity Report

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Friday, April 28, 2023
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NEW YORK, April 27, 2023 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an activity report for the third quarter ended March 31, 2023.

Key Points: 
  • NEW YORK, April 27, 2023 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an activity report for the third quarter ended March 31, 2023.
  • Successful completion of a global private placement primarily to Mesoblast’s existing major US, UK, and Australian shareholders raising approximately US$40 million, net of transaction costs.
  • Revenue from royalties on sales of TEMCELL® HS Inj.1 sold in Japan by our licensee for the quarter were US$1.8 million.
  • The data from both studies formed key components of Mesoblast’s recent resubmission of its remestemcel-L BLA to FDA for children with SR-aGVHD.

LadRx Announces Review of Strategic Alternatives and Provides Corporate Updates

Retrieved on: 
Wednesday, March 15, 2023
Research, FDA, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, Roth Capital Partners, Immunity, Sale, Zebra, Pancreatic cancer, Symantec Endpoint Protection, Disclosure, Complete Response Letter, LADR, Maitansine, CRL, OTCQB, Doctor of Philosophy, Therapy, DSM-IV codes, NDA, Retail, Pharmaceutical industry, Arimoclomol, Aldoxorubicin, IND

LadRx Corporation (OTCQB: LADX) (“LadRx” or the “Company”), a biopharmaceutical innovator focused on research and development of life-saving cancer therapeutics, announced today that it has initiated a process to explore a range of strategic and financing alternatives, and provided updates.

Key Points: 
  • LadRx Corporation (OTCQB: LADX) (“LadRx” or the “Company”), a biopharmaceutical innovator focused on research and development of life-saving cancer therapeutics, announced today that it has initiated a process to explore a range of strategic and financing alternatives, and provided updates.
  • LadRx has initiated a process to explore a range of strategic and financing alternatives focused on maximizing stockholder value.
  • There can be no assurance that this strategic review process will result in the Company pursuing any transaction or that any transaction, if pursued, will be completed.
  • The Company has not established a schedule for completion of this strategic review process, nor has it made any definitive decisions related to strategic alternative transactions.