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Pharma news roundup and Larvol updates

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Category: Larvol Pulse News

Daily Top News – August 7, 2020

August 7, 2020

llllllllll paxalisib (GDC-0084) / Kazia
US FDA Grants Rare Pediatric Disease Designation (RPDD) to Paxalisib for DIPG (PRNewswire) – Aug 7, 2020 – “Kazia Therapeutics Limited…is pleased to announce that the United States Food and Drug Administration (FDA) has awarded Rare Pediatric Disease Designation (RPDD) to Kazia’s paxalisib (formerly GDC-0084) for the treatment of Diffuse Intrinsic Pontine Glioma (DIPG), a rare and highly-aggressive childhood brain cancer…In October 2018, St Jude Children’s Research Hospital in Memphis, TN commenced a phase I clinical trial of paxalisib in DIPG (NCT03696355)….The study has completed recruitment, and initial efficacy data is anticipated during the second half of calendar 2020.”

 

llllllllll aducanumab (BIIB037) / Eisai, Biogen
FDA Accepts Biogen’s Aducanumab Biologics License Application for Alzheimer’s Disease with Priority Review (GlobeNewswire) – Aug 7, 2020 – “Biogen…and Eisai, Co., Ltd….today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for aducanumab, an investigational treatment for Alzheimer’s disease. The application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date on March 7, 2021, and the FDA has stated that, if possible, it plans to act early on this application under an expedited review.”

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Daily Top News – August 6, 2020

August 6, 2020

llllllllll Blenrep (belantamab mafodotin) / GSK
FDA approves GSK’s BLENREP (belantamab mafodotin-blmf) for the treatment of patients with relapsed or refractory multiple myeloma (GSK Press Release) – Aug 6, 2020 – “GlaxoSmithKline…announced the US Food and Drug Administration (FDA) has approved BLENREP (belantamab mafodotin-blmf) as a monotherapy treatment for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory agent. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials…The approval of BLENREP was based on six-month primary results from the pivotal DREAMM-2 study…”

 

llllllllll zalifrelimab (AGEN1884) / Recepta, Agenus; balstilimab (AGEN2034) / Agenus, Recepta
Agenus Provides R&D Update & Second Quarter Financial Report (Agenus Inc. Press Release) – Aug 6, 2020 – P1, N=86; NCT03860272; Sponsor: Agenus Inc; “Balstilimab BLA filing to be initiated in current quarter; Zalifrelimab actives responses in PD-1 refractory tumors…Ph2 expansion trial in angiosarcoma underway; AGEN1181 combo w bali achieves CR with both primary and metastatic tumors confirmed by PET scan…Updated Ph1 achieves a total of 2 CRs & clinical benefit (CR/PR/SD) in ~65% patients…Expansion cohorts in NSCLC, MSS tumors, melanoma, and RCC launched”

 

llllllllll omburtamab I-131 (131 I-8H9) / Y-mAbs Therap
Y-mAbs Announces Completion of Submission of Omburtamab Biologics License Application to FDA (GlobeNewswire) – Aug 6, 2020 – “Y-mAbs Therapeutics, Inc…announced that on August 5, 2020, the Company completed the submission of its Biologics License Application (‘BLA’) under the FDA’s Rolling Review process for omburtamab…The omburtamab BLA is for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma. The submission is based on the safety and efficacy results of the pivotal Phase 2 studies 101 and 03-133, which the Company expects to present at a venue later this year….’we are currently planning a Phase 2 study for diffuse intrinsic pontine glioma, as we believe omburtamab could potentially be developed for wider compartmental use.'”

 

llllllllll Adaptive Biotechnologies Receives Expanded FDA Clearance for the clonoSEQ Assay to Assess Minimal Residual Disease (MRD) in Patients with Chronic Lymphocytic Leukemia (GlobeNewswire) – Aug 6, 2020 – “Adaptive Biotechnologies Corporation…received clearance from the U.S. Food and Drug Administration (FDA) for its clonoSEQ® Assay to detect and monitor minimal residual disease (MRD) in blood or bone marrow from patients with chronic lymphocytic leukemia (CLL)….Today’s clearance expands the existing FDA-cleared uses of clonoSEQ, as the FDA previously granted the assay De Novo designation for the detection and monitoring of MRD in bone marrow from multiple myeloma and B-cell acute lymphoblastic leukemia (ALL) patients.”

 

llllllllll aviptadil intravenous (RLF-100 IV) / Relief Therap, NeuroRx
FDA grants inhaled use IND for RLF-100 (aviptadil) to treat patients with moderate and severe COVID-19 aiming to prevent progression to respiratory failure (PRNewswire) – Aug 6, 2020 – “NeuroRx, Inc. and Relief Therapeutics Holdings AG…announced that NeuroRx has been granted Investigational New Drug (IND) permission to test RLF-100 (aviptadil) for inhaled use in patients with moderate and severe COVID-19….The first phase will commence with patients hospitalized for severe COVID-19….The clinical trial of the inhaled formulation of RLF-100 is expected to begin on or before September 1, 2020.”

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Daily Top News – August 5, 2020

August 5, 2020

llllllllll Lu AF11167 / Lundbeck
Lundbeck discontinues phase II proof of concept study of Lu AF11167 in patients with negative symptoms of schizophrenia (Lundbeck Press Release) – Aug 5, 2020 – “H. Lundbeck A/S (Lundbeck) announces the decision to discontinue the phase II proof of concept clinical study of Lu AF11167 in patients with schizophrenia, who are experiencing persistent negative symptoms (NCT03793712). The decision to stop the trial is based on the results of a futility interim analysis, which concluded that the trial is unlikely to achieve statistical significance on its primary endpoint, mean change from baseline to week 12 on the Brief Negative Symptom Scale (BNSS). The recommendation to stop the trial is not based on safety concerns.”

 

llllllllll IONIS-ENAC-2.5Rx / Ionis
Ionis reports second quarter 2020 financial results and recent business achievements (Ionis Pharmaceuticals Press Release) – Aug 5, 2020 – “Initiate a Phase 2 study of IONIS-ENaC-2.5Rx in patients with chronic obstructive pulmonary disease (COPD)”

 

llllllllll fasinumab (REGN475) / Teva, Mitsubishi Tanabe, Regeneron
REGENERON REPORTS SECOND QUARTER 2020 FINANCIAL AND OPERATING RESULTS (Regeneron Pharmaceuticals Press Release) – Aug 5, 2020 – P3, N=3,307, FACT OA1 (NCT03161093); P3, N=1,650; FACT OA2 (NCT03304379); Sponsor: Regeneron Pharmaceuticals; “Fasinumab, an antibody to NGF: Two Phase 3 trials, FACT OA1 and FACT OA2, achieved the co-primary endpoints for fasinumab 1 mg monthly, demonstrating significant improvements in pain and physical function over placebo at week 16 and week 24, respectively….Additional longer-term safety data from the ongoing trials are being collected and are expected to be reported early next year.”

 

llllllllll reboxetine (AXS-12) / Axsome Therap
Axsome Therapeutics Receives FDA Breakthrough Therapy Designation for AXS-12 for the Treatment of Narcolepsy (GlobeNewswire) – Aug 5, 2020 – “Axsome Therapeutics, Inc….today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for AXS-12 for the treatment of cataplexy in patients with narcolepsy….The Breakthrough Therapy designation for AXS-12 for the treatment of cataplexy in narcolepsy was supported by the positive results from the Phase 2 CONCERT study…’We look forward to meeting with the FDA as soon as possible to discuss the continued development of AXS-12 in light of this significant milestone.'”

 

llllllllll Roche announces FDA authorisation for the first Epstein-Barr virus quantitative test on the cobas 6800/8800 Systems to improve care for transplant patients (GlobeNewswire) – Aug 5, 2020 – “FDA granted de novo class II for cobas EBV test following the agency’s Breakthrough Device designation…Roche…today announced that the U.S. Food and Drug Administration (FDA) has authorised the cobas® EBV test. This is the first quantitative in vitro diagnostic test for Epstein-Barr virus (EBV) DNA in the United States….’Monitoring of Epstein-Barr virus DNA can help prevent progression of life-threatening diseases, such as cancer in transplant patients’…”

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Daily Top News – August 4, 2020

August 4, 2020

llllllllll imatinib / Generic mfg.; Qinlock (ripretinib) / Deciphera
Zai Lab Announces NDA for Ripretinib Granted Priority Review by China’s NMPA (GlobeNewswire) – Aug 4, 2020 – “Zai Lab Limited…announced that the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) has granted priority review status to the New Drug Application (NDA) for ripretinib for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.”

 

llllllllll Avelas Announces Top-Line Data Showing Pegloprastide (AVB-620) Can Significantly Improve Cancer Detection in Real Time During Breast Cancer Surgery (Businesswire) – Aug 4, 2020 – P2/3, N=92; NCT03113825; Sponsor: Avelas Biosciences, Inc; “Avelas Biosciences, Inc…announced…positive top-line data demonstrating that the company’s recently completed Phase 2/3 registration study of the use of pegloprastide (AVB-620) during surgery met its primary endpoint of detecting cancer in margin specimens in real time (p<0.001)….Top-line data showed the planned re-excision rate for patients who underwent breast cancer surgery with pegloprastide was 6%, much lower than the typical re-excision rate of 20-40%.”

 

llllllllll Kymriah (tisagenlecleucel-T) / Novartis
Novartis announces Kymriah meets primary endpoint at interim analysis of pivotal study in follicular lymphoma (GlobeNewswire) – Aug 4, 2020 – P2, N=97; ELARA (NCT03568461); Sponsor: Novartis Pharmaceuticals; “ELARA trial findings will be included in regulatory submissions, with filing in the US anticipated in 2021, and the EU following….Novartis today announced positive results from the Phase II ELARA trial of Kymriah® (tisagenlecleucel) in patients with relapsed or refractory (r/r) follicular lymphoma (FL). At the interim analysis, the global study met its primary endpoint of complete response rate (CRR), as assessed by independent review committee.”

 

llllllllll ELX-02 / Eloxx Pharma
Eloxx Pharmaceuticals Receives U.S. Orphan Drug Designation for ELX-02 for the Treatment of Cystic Fibrosis (GlobeNewswire) – Aug 4, 2020 – “Eloxx Pharmaceuticals…today announced that the U.S. Food and Drug Administration (FDA) has granted the Company orphan drug designation for ELX-02 for the treatment of Cystic Fibrosis…in our Phase 2…We look forward to reporting top line results as soon as feasible, and believe that this will be a major value inflection point for our Company.”

 

llllllllll Darzalex Faspro (daratumumab/hyaluronidase) / J&J
Janssen Announces Health Canada Approval of DARZALEX SC, a New Subcutaneous Formulation for the Treatment of Patients with Multiple Myeloma (Canada Newswire) – Aug 4, 2020 – “The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that Health Canada has approved DARZALEX® SC (daratumumab), a new subcutaneous formulation of daratumumab.1 DARZALEX® SC is approved in four regimens across five indications in patients with multiple myeloma, most notably newly diagnosed, transplant-ineligible patients as well as relapsed or refractory patients…The approval is based on data from the Phase 3 COLUMBA and Phase 2 PLEIADES studies.”

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Daily Top News – August 3, 2020

August 3, 2020

llllllllll Rozlytrek (entrectinib) / Roche
Rozlytrek, Roche’s first tumour-agnostic therapy, approved in Europe for people with NTRK fusion-positive solid tumours and for people with ROS1-positive advanced non-small cell lung cancer (Roche Press Release) – Aug 3, 2020 – “Roche…announced that the European Commission has granted conditional marketing authorisation for Rozlytrek® (entrectinib) for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have not received a prior NTRK inhibitor, who have no satisfactory treatment options. The European Commission has also approved Rozlytrek for the treatment of adults with ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.”

 

llllllllll Spravato (esketamine intranasal) / J&J
Janssen Announces U.S. FDA Approval of SPRAVATO (esketamine) CIII Nasal Spray to Treat Depressive Symptoms in Adults with Major Depressive Disorder with Acute Suicidal Ideation or Behavior (PRNewswire) – Aug 3, 2020 – “The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for SPRAVATO® (esketamine) CIII nasal spray, taken with an oral antidepressant, to treat depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior….SPRAVATO® carries a Boxed Warning regarding a Risk Evaluation and Mitigation Strategy (REMS) and the risk of suicidal thoughts and behaviors.”

 

llllllllll racemetyrosine (SM-88) / Tyme
TYME Announces Orphan Drug Designation for SM-88 as Potential Treatment for Patients with Pancreatic Cancer (Businesswire) – Aug 3, 2020 – “Tyme Technologies, Inc…announced that the U.S. Food and Drug Administration (FDA) has granted the company Orphan Drug Designation for its lead pipeline candidate, SM-88 (racemetyrosine), as a potential treatment for patients with pancreatic cancer.”

 

llllllllll Cosentyx (secukinumab) / Novartis
Novartis Cosentyx receives EU approval for first-line systemic treatment in pediatric psoriasis (GlobeNewswire) – Aug 3, 2020 – “Novartis…today announced the European Commission (EC) has granted the approval for Cosentyx® (secukinumab) for the treatment of moderate-to-severe plaque psoriasis in children and adolescents aged 6 to <18 years. The recommended dose for children up to 50 kg is 75 mg…and 150 mg for children 50 kg and over….The approval is based on two Phase III international studies….Novartis will also be seeking approval…in a number of other countries including Australia, Canada, Japan and the US.”

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Daily Top News – July 31, 2020

July 31, 2020

llllllllll Libtayo (cemiplimab) / Sanofi, Regeneron; BNT111 / BioNTech
BioNTech Announces Strategic Collaboration with Regeneron to Advance FixVac and Libtayo (cemiplimab) Combination in Melanoma (GlobeNewswire) – Jul 31, 2020 – “BioNTech…today announced a strategic collaboration with Regeneron for a clinical trial combining BioNTech’s BNT111 FixVac product candidate and Libtayo® (cemiplimab), a fully human anti-PD-1 therapy, for the treatment of melanoma. The companies plan to jointly conduct a randomized Phase 2 study in patients with anti-PD1-refractory/relapsed, unresectable Stage III or IV cutaneous melanoma…The companies plan to disclose more details related to the planned Phase 2 study in the third quarter of 2020, with the goal of initiating the trial in the fourth quarter of 2020….Under the terms of the agreement, development costs for the clinical trial will be shared equally and both companies will contribute their products for the trial.”

 

llllllllll Alunbrig (brigatinib) / Takeda; mobocertinib (TAK-788) / Takeda; pevonedistat (MLN4924) / Takeda; Ninlaro (ixazomib) / Takeda; TAK-007 / Takeda
Takeda Announces FY2020 Q1 Results; Confirms Management Guidance & Raises Reported Operating Profit And Reported Net Profit for the Full Year (Businesswire) – Jul 31, 2020 – “In Oncology, TAK-007 for the treatment of hematologic malignancies on an outpatient basis, with encouraging Phase 1/2 data and cohort expansion ongoing for a pivotal study planned for next year and potential approval in FY2023; Mobocertinib (TAK-788) has the potential to set a new standard of care for a subset of Non-Small Cell Lung Cancer (NSCLC) patients with EGFR exon 20 insertions; Pevonedistat (TAK-924) has the potential to be the first novel HR-MDS therapy in over a decade; anticipated Phase 3 PANTHER trial in HR-MDS readout in second half of FY2020; Reported revenue and underlying revenue growth rates for notable Q1 FY2020 contributors include: ALUNBRIG JPY 2.0 billion +26%; NINLARO JPY 22.9 billion +31%”

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Daily Top News – July 30, 2020

July 30, 2020

llllllllll Tagrisso (osimertinib) / AstraZeneca
Tagrisso granted Breakthrough Therapy Designation in the US for the adjuvant treatment of patients with Stage IB-IIIA EGFR-mutated lung cancer (AstraZeneca Press Release) – Jul 30, 2020 – “AstraZeneca’s Tagrisso (osimertinib) has been granted Breakthrough Therapy Designation (BTD) in the US for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumour resection with curative intent…The FDA granted the BTD based on data from the Phase III ADAURA trial…ADAURA is a randomised, double-blinded, global, placebo-controlled Phase III trial in the adjuvant treatment of 682 patients with Stage IB, II, IIIA EGFRm NSCLC…The data readout was originally anticipated in 2022.”

 

llllllllll Lenvima (lenvatinib) / Eisai, Merck (MSD)
APPLICATION FOR ADDITIONAL INDICATION OF ANTI CANCER AGENT LENVIMA FOR UNRESECTABLE THYMIC CARCINOMA SUBMITTED IN JAPAN (Eisai Press Release) – Jul 30, 2020 – “Eisai…and MSD…announced today that Eisai has submitted an application in Japan for the additional indication of treatment of unresectable thymic carcinoma for multiple receptor tyrosine kinase inhibitor LENVIMA ® (generic name: lenvatinib mesylate). In June 2020, LENVIMA received orphan drug designation in Japan for unresectable thymic carcinoma. This application is based on the results of an open-label, single-arm, multicenter, investigator-initiated clinical phase II study (NCCH1508) conducted in Japan…”

 

llllllllll bomedemstat (IMG-7289) / Imago BioSciences
Imago BioSciences Granted Access by European Medicines Agency to PRIME Scheme for IMG-7289 (Bomedemstat) in Myelofibrosis (Businesswire) – Jul 30, 2020 – “Imago BioSciences, Inc…announced that the European Medicines Agency (EMA) granted access to its PRIME (PRIority MEdicines) scheme for IMG-7289 (bomedemstat), a lysine-specific demethylase-1 (LSD1) inhibitor, for the treatment of intermediate-2 and high-risk patients with myelofibrosis who have become intolerant of, resistant to, or are ineligible for a Janus Kinase (JAK) inhibitor.”

 

llllllllll pevonedistat (MLN4924) / Takeda
Takeda Announces U.S. FDA Breakthrough Therapy Designation Granted for Pevonedistat for the Treatment of Patients with Higher-Risk Myelodysplastic Syndromes (HR-MDS) (Businesswire) – Jul 30, 2020 – “Takeda Pharmaceutical Company Limited…announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for its investigational drug pevonedistat for the treatment of patients with higher-risk myelodysplastic syndromes (HR-MDS)…The Breakthrough Therapy Designation is based on the final analysis of the Pevonedistat-2001 Phase 2 study, which evaluated pevonedistat plus azacitidine versus azacitidine alone in patients with rare leukemias, including HR-MDS.”

 

llllllllll Keytruda (pembrolizumab) / Merck (MSD)
Merck Announces Two US Regulatory Milestones for KEYTRUDA (pembrolizumab) in Triple-Negative Breast Cancer (TNBC) (Businesswire) – Jul 30, 2020 – “The FDA has accepted and granted priority review for a new sBLA seeking accelerated approval for KEYTRUDA in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10), based on the Phase 3 KEYNOTE-355 trial. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of Nov. 28, 2020. The FDA also accepted for standard review a new sBLA for KEYTRUDA for the treatment of patients with high-risk early-stage TNBC, in combination with chemotherapy as neoadjuvant treatment, and then as a single agent as adjuvant treatment after surgery, based on the Phase 3 KEYNOTE-522 trial. The PDUFA date for this application is March 29, 2021.”

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Daily Top News – July 29, 2020

July 29, 2020

llllllllll Nucala (mepolizumab) / GSK
GSK Second quarter 2020 (GSK Press Release) – Jul 29, 2020 – “Nucala granted priority review by FDA for hypereosinophilic syndrome (HES). Decision expected H1 2021….Total Respiratory sales were up 17% AER, 16% CER, with strong growth from…Nucala in all regions. International Respiratory sales grew 17% AER, 17% CER, including Nucala, up 42% AER, 31% CER…Sales of Nucala were £241 million in the quarter and grew 24% AER, 21% CER, with US sales up 28% AER, 26% CER to £150 million. Europe sales of £54 million grew 4% AER, 6% CER and International sales of £37 million grew 42% AER, 31% CER including growth of the at-home use application.”

 

llllllllll GSK2881078 / GSK
GSK delivers Q2 sales of £7.6 billion -2% AER, -3% CER (Pro-forma -10% CER*) (GSK Press Release) – Jul 29, 2020 – “GSK’078 for COPD muscle weakness was terminated as data did not support progression in this indication….Initial data of the proof-of-concept study on the COPD candidate vaccine showed it did not meet the primary endpoint. Work is ongoing to better understand the data; no progression to Phase III is planned.”

 

llllllllll Ajovy (fremanezumab) / Otsuka, Teva
Teva Announces New Drug Application Filing in Japan for AJOVY (fremanezumab) Injection (Teva Press Release) – Jul 29, 2020 – “Teva Pharmaceutical Industries Ltd….today announced Otsuka Pharmaceutical Co., Ltd. has submitted an application to the Pharmaceuticals and Medical Devices Agency of Japan to obtain manufacturing and marketing approval in Japan for AJOVY® (fremanezumab) injection for the preventive treatment of migraine.”

 

llllllllll Jay Pharma to File IND Applications to FDA for a clinical study of proprietary formulations in Radiodermatitis and a combination Therapy in Glioblastoma (PRNewswire) – Jul 29, 2020 – “AMERI Holdings, Inc…announced that its proposed amalgamation partner Jay Pharma Inc…has announced the addition of new senior staff as the Company prepares to file two new investigational new drug (IND) applications for the treatment of radiodermatitis and glioblastoma multiforme (GBM)…’We recently announced Investigational Review Board (IRB) approval for a GBM study at the Rabin Institute in Israel’….Phase I/II human clinical trials in Israel will administer the Company’s proprietary synthetic CBD formula to 40 enrollees: half of whom will be treated with the CBD formula, and the other half will be treated with the formula in combination with clomiphene, an estrogen binding site inhibitor.”

 

llllllllll MK-6482 / Merck (MSD)
FDA Grants Breakthrough Therapy Designation to Merck’s Novel HIF-2α Inhibitor MK-6482 for Treatment of Certain Patients With Von Hippel-Lindau Disease- Associated Renal Cell Carcinoma (Businesswire) – Jul 29, 2020 – “Merck…announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor MK-6482, a novel investigational candidate in Merck’s oncology pipeline, for the treatment of patients with von Hippel-Lindau (VHL) disease-associated renal cell carcinoma (RCC) with nonmetastatic RCC tumors less than three centimeters in size, unless immediate surgery is required. The FDA also granted orphan drug designation to MK-6482 for VHL disease. These designations are based on data from a Phase 2 trial evaluating MK-6482 in patients with VHL-associated clear cell RCC, which were presented at the 2020 American Society of Clinical Oncology Annual Meeting.”

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Daily Top News – July 28, 2020

July 28, 2020

llllllllll savolitinib (HMPL-504) / AstraZeneca, Chi-Med
Chi-Med’s NDA for Savolitinib in Non-Small Cell Lung Cancer Granted Priority Review in China (Hutchison China MediTech Press release) – Jul 28, 2020 – “Hutchison China MediTech Limited (‘Chi-Med’)…announced that the China National Medical Products Administration (‘NMPA’) has granted Priority Review status to the New Drug Application (‘NDA’) for savolitinib for the treatment of non-small cell lung cancer (‘NSCLC’) with MET Exon 14 skipping mutations. This is the first NDA filing for savolitinib globally and first for a selective MET inhibitor in China.”

 

llllllllll breast cancer vaccine / Anixa Biosci
Anixa Biosciences Breast Cancer Vaccine Technology Nearing FDA Submission (PRNewswire) – Jul 28, 2020 – “Anixa Biosciences, Inc…announced that its prophylactic breast cancer vaccine is making progress towards clinical trials…Anixa and Cleveland Clinic intend to file the Investigational New Drug (IND) Application with the US Food and Drug Administration by the end of the current quarter.”

 

llllllllll CTI-1601 / Larimar Therap
Larimar Therapeutics Announces Positive Opinion on Orphan Drug Designation Received from the European Medicines Agency for CTI-1601 for the Treatment of Friedreich’s Ataxia (GlobeNewswire) – Jul 28, 2020 – “Larimar Therapeutics, Inc….today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) issued a positive opinion on the company’s application for orphan drug designation for CTI-1601, a potential treatment for Friedreich’s ataxia (FA)….Larimar expects that the European Commission, based on this positive opinion of the COMP, will formally grant the orphan drug designation for the European Union (EU) this year….’We look forward to working closely with EMA and continuing our U.S. Phase 1 trial of CTI-1601….We remain on track to report topline data in the first half of 2021.'”

 

llllllllll BDTX-189 / Black Diamond Therap
Black Diamond Therapeutics Granted Fast Track Designation by the FDA for BDTX-189 for the Treatment of Adult Patients with a Solid Tumor Harboring an Allosteric HER2 Mutation or an EGFR or HER2 Exon 20 Insertion Mutation (GlobeNewswire) – Jul 28, 2020 – “Black Diamond Therapeutics…announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to BDTX-189 for the treatment of adult patients with solid tumors harboring an allosteric human epidermal growth factor receptor 2 (HER2) mutation or an epidermal growth factor receptor (EGFR) or HER2 Exon 20 insertion mutation who have progressed following prior treatment and who have no satisfactory treatment options. BDTX-189, an orally available, irreversible small molecule inhibitor, is the Company’s lead product candidate designed to selectively inhibit the activity of a broad range of previously unaddressed oncogenic driver mutations of the ErbB kinases in EGFR and HER2.”

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Daily Top News – July 24, 2020

July 24, 2020

llllllllll brexucabtagene autoleucel (KTE-X19) / Gilead
U.S. FDA Approves Kite’s Tecartus, the First and Only CAR T Treatment for Relapsed or Refractory Mantle Cell Lymphoma (Gilead Press Release) – Jul 24, 2020 – “Kite, a Gilead Company…announced that the…FDA has granted accelerated approval to Tecartus™ (brexucabtagene autoleucel, formerly KTE-X19), the first and only approved chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). The approval of this one-time therapy follows a priority review and FDA Breakthrough Therapy Designation and is based on results of ZUMA-2, a single-arm, open-label study in which 87 percent of patients responded to a single infusion of Tecartus, including 62 percent of patients achieving a complete response (CR).”

 

llllllllll Arikace (amikacin liposome inhalation suspension) / Insmed
Insmed Receives Positive CHMP Opinion for ARIKAYCE Liposomal 590 mg Nebuliser Dispersion for the Treatment of NTM Lung Infections Caused by MAC in Non-CF Patients with Limited Treatment Options (PRNewswire) – Jul 24, 2020 – “Insmed Incorporated…today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending ARIKAYCE Liposomal 590 mg Nebuliser Dispersion for the treatment of non-tuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC) in adults…The European Commission (EC) will review the CHMP opinion, with a final decision anticipated in the second half of 2020….The CHMP opinion is based on results from the Phase 3 CONVERT study.”

 

llllllllll Imbruvica (ibrutinib) / AbbVie, J&J; Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Janssen Receives CHMP Positive Opinion for Expanded Use of IMBRUVICA (ibrutinib) in Combination with Rituximab for Previously Untreated Patients with Chronic Lymphocytic Leukaemia (CLL) (Businesswire) – Jul 24, 2020 – “The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a Positive Opinion recommending marketing authorisation for IMBRUVICA® (ibrutinib) to include the combination with rituximab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL)….The Positive Opinion is based on data from the Phase 3 E1912 study…”

 

llllllllll Jyseleca (filgotinib) / Gilead
GILEAD AND GALAPAGOS ANNOUNCE POSITIVE EUROPEAN CHMP OPINION FOR JYSELECA (FILGOTINIB) FOR THE TREATMENT OF ADULTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS (GlobeNewswire) – Jul 24, 2020 – “Gilead Sciences, Inc….announced today the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Jyseleca® (filgotinib 200 mg and 100 mg tablets), an investigational, once-daily, oral, selective JAK1 inhibitor for the treatment of adults with moderate to severe rheumatoid arthritis (RA) who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). The CHMP positive opinion is a scientific recommendation to the European Commission to grant marketing authorization in Europe….Supported by data from the Phase 3 FINCH and Phase 2 DARWIN programs…A Commission decision is expected in the third quarter of 2020.”

 

llllllllll Breztri Aerosphere (budesonide/formoterol fumarate/glycopyrronium) / AstraZeneca
Breztri Aerosphere approved in the US for the maintenance treatment of COPD (AstraZeneca Press Release) – Jul 24, 2020 – “AstraZeneca’s Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) has been approved in the US for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)…The approval by the US Food and Drug Administration (FDA) was based on positive results from the Phase III ETHOS trial in which Breztri Aerosphere…The approval was also supported by efficacy and safety data from the Phase III KRONOS trial.”

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