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Pharma news roundup and Larvol updates

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Category: Larvol Pulse News

Daily Top News – September 29, 2020

September 29, 2020

paclitaxel / Generic mfg.; vactosertib (TEW-7197) / National OncoVenture, Medpacto
FDA grants ODD status to Medpacto’s combination therapy (Korea Biomedical Review) – Sep 29, 2020 – “Medpacto said that the U.S. Food and Drug Administration has granted orphan drug designation (ODD) to combination therapy of Vactosertib and paclitaxel for treating metastatic gastric adenocarcinoma….With the ODD designation, the company expects to accelerate the commercialization of Vactosertib and paclitaxel’s combination therapy…’The company expects that the market value of Vactosertib will increase according to the orphan drug designation.'”

 

VERU-111 / Veru Inc
Veru Completes Enrollment of Phase 2 Clinical Trial of VERU-111, Novel Oral Drug for Metastatic Prostate Cancer (GlobeNewswire) – Sep 29, 2020 – “Veru Inc…announced that it has fully enrolled its Phase 2 clinical study of VERU-111, its novel, oral, alpha and beta tubulin targeting drug for metastatic castration and novel androgen receptor targeting agent resistant prostate cancer. The study enrolled a total of 40 men at 13 clinical sites in the United States….’we plan to submit the final Phase 3 pivotal registration study to FDA in Q4 2020 and meet with EMA in Q1 2021.'”

 

difamilast (MM36) / Otsuka, Medimetriks
Medimetriks Announces that Otsuka has Submitted MM36 (difamilast) New Drug Application for Approval in Japan (PRNewswire) – Sep 29, 2020 – “‘Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that a new drug application has been submitted to the Pharmaceuticals and Medical Devices Agency in Japan to seek manufacturing and marketing approval for difamilast (OPA-15406) in patients with atopic dermatitis….’Given the positive outcome of our recent U.S. FDA Type C meeting, Medimetriks is preparing to begin one, final Phase 3 Pivotal Trial in the U.S.'”

 

Abraxane (albumin-bound paclitaxel) / BMS, Otsuka; Tecentriq (atezolizumab) / Roche; eganelisib (IPI-549) / Infinity Pharma
Infinity Receives Fast Track Designation for Eganelisib in Combination with a Checkpoint Inhibitor and Chemotherapy for First-Line Treatment of Advanced TNBC (Businesswire) – Sep 29, 2020 – “Infinity Pharmaceuticals, Inc…announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for eganelisib (IPI-549) in combination with a checkpoint inhibitor and chemotherapy for the treatment of patients with inoperable locally advanced or metastatic triple-negative breast cancer (TNBC), in the first-line setting… Infinity is currently enrolling patients in MARIO-3…to evaluate eganelisib in a novel triple combination front-line regimen with Tecentriq® and Abraxane® in TNBC…We look forward to presenting these important data later this year…The study is designed to enroll approximately 60 patients across two cohorts, approximately 30 patients with programmed death-ligand 1 (PDL1) positive disease based on immunohistochemistry (IHC) and 30 patients with PDL1 negative disease based on IHC.”

 

Reblozyl (luspatercept-aamt) / Acceleron, BMS
Health Canada Approves REBLOZYL (luspatercept), New Class of Treatment for Adult Patients Living with Beta Thalassemia (Businesswire) – Sep 29, 2020 – “Bristol Myers Squibb Canada (BMS) and Acceleron Pharma Inc….announced today that Health Canada has approved REBLOZYL® (luspatercept) for the treatment of adult patients with red blood cell (RBC) transfusion-dependent anemia associated with beta(β)-thalassemia. REBLOZYL® is the first and only erythroid maturation agent in Canada, representing a new class of treatment….Health Canada’s approval of REBLOZYL® is based upon findings from the phase 3, double-blind, randomized, placebo-controlled BELIEVE study…”

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Daily Top News – September 28, 2020

September 28, 2020

Zynrelef (bupivacaine/meloxicam ER) / Heron Therapeutics
Heron Therapeutics Receives European Commission Authorization for ZYNRELEF (HTX-011) for the Treatment of Postoperative Pain (PRNewswire) – Sep 28, 2020 – “Heron Therapeutics, Inc….today announced that the European Commission has granted a marketing authorization for ZYNRELEF (formerly known as HTX-011) for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. The marketing authorization follows the European Medicines Agency’s (EMA) positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in July 2020. Heron currently expects to make ZYNRELEF available to patients in the European Union (EU) during 2021.”

 

troriluzole (BHV-4157) / Portage; Nurtec ODT (rimegepant ODT) / Portage
BioShin, Biohaven’s Asia-Pacific Subsidiary, Raises $60M in Series A Funding to Advance Neuroscience Pipeline in Asia-Pacific Region (PRNewswire) – Sep 28, 2020 – “Biohaven Pharmaceutical Holding Company Ltd….announced today that BioShin Limited…has closed a $60M Series A investment round. The financing was led by OrbiMed, with participation from Cormorant Asset Management LLC….The Series A funds will be used to build out BioShin in China and advance the Biohaven clinical portfolio in the Asia-Pacific region, including the imminent start of the NURTEC™ ODT (rimegepant) Phase 3 study for the acute treatment of migraine in China and Korea. BioShin also plans to initiate sites in China to participate in the global registrational trial of troriluzole in Spinocerebellar Ataxia (SCA). BioShin expects to begin both Asia-Pacific studies in the fourth quarter of 2020.”

 

Epidaza (chidamide) / Chipscreen, Meiji Seika, Eisai, HUYA Bioscience, GNT Biotech
HUYA Bioscience International Announces Orphan Drug Designation for HBI-8000 Monotherapy Adult T-cell Leukemia-Lymphoma ATL in Japan (PRNewswire) – Sep 28, 2020 – “HUYA Bioscience…announced today the Ministry of Health, Labour and Welfare (MHLW) granted HBI-8000 orphan drug designation (ODD) in Japan as monotherapy for relapsed or refractory Adult T-cell Leukemia-Lymphoma or (ATL)…We are now preparing an application to the PMDA for approval of HBI-8000 as monotherapy for the treatment for R/R ATL.”

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Daily Top News – September 25, 2020

September 25, 2020

Kalydeco (ivacaftor) / Vertex
FDA Approves KALYDECO (ivacaftor) as First and Only CFTR Modulator to Treat Eligible Infants With CF as Early as Four Months of Age (Businesswire) – Sep 25, 2020 – “Vertex…today announced the U.S. Food and Drug Administration (FDA) approved KALYDECO® (ivacaftor) for use in children with cystic fibrosis (CF) ages four months to less than six months old who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to KALYDECO based on clinical and/or in vitro assay data….This FDA approval is based on data from a cohort in the 24-week Phase 3 open-label safety cohort (ARRIVAL)…”

 

Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
ENHERTU Approved in Japan for the Treatment of Patients with HER2 Positive Metastatic Gastric Cancer (Daiichi Sankyo Press Release) – Sep 25, 2020 – “Daiichi Sankyo…today announced the approval of ENHERTU® (trastuzumab deruxtecan), a HER2 directed antibody drug conjugate (ADC), in Japan for the treatment of patients with HER2 positive unresectable advanced or recurrent gastric cancer that has progressed after chemotherapy….Approval of ENHERTU in Japan is based on the results of the open-label, randomized phase 2 DESTINYGastric01 trial…”

 

Jyseleca (filgotinib) / Gilead
European Commission Grants Marketing Authorization for Jyseleca (Filgotinib) for the Treatment of Adults With Moderate to Severe Active Rheumatoid Arthritis (Businesswire) – Sep 25, 2020 – “Gilead Sciences, Inc….and Galapagos NV…today announced that the European Commission (EC) has granted marketing authorization for Jyseleca® (filgotinib 200 mg and 100 mg tablets), a once-daily, oral, JAK1 inhibitor for the treatment of adults with moderate to severe active rheumatoid arthritis (RA) who have responded inadequately to, or are intolerant to, one or more disease modifying anti-rheumatic drugs (DMARDs). Jyseleca may be used as monotherapy or in combination with methotrexate (MTX)….The EC’s decision is supported by data from over 3,500 patients treated with Jyseleca across the Phase 3 FINCH and Phase 2 DARWIN programs….’We look forward to bringing this important treatment to physicians and patients across Europe as quickly as possible.'”

 

Ayvakit (avapritinib) / Blueprint Medicines
Blueprint Medicines Announces European Commission Approval of AYVAKYT (avapritinib) for the Treatment of Adults with Unresectable or Metastatic PDGFRA D842V Mutant Gastrointestinal Stromal Tumors (Blueprint Medicines Press Release) – Sep 25, 2020 – “Blueprint Medicines Corporation…announced that the European Commission (EC) has granted conditional marketing authorization to AYVAKYT® (avapritinib) as a monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST) harboring the platelet-derived growth factor receptor alpha (PDGFRA) D842V mutation. For the first time in Europe, there is an approved therapy for patients with PDGFRA D842V mutant GIST specifically designed to target the underlying molecular driver of their disease. The EC approval is based on efficacy results from the Phase 1 NAVIGATOR trial as well as combined safety results from the NAVIGATOR and Phase 3 VOYAGER trials.”

 

Abilify Maintena (aripiprazole depot formulation) / Otsuka, Lundbeck
Otsuka’s ABILIFY MAINTENA approved for the additional indication of bipolar I disorder in Japan (Otsuka Press Release) – Sep 25, 2020 – “Otsuka Pharmaceutical Co., Ltd. announces that it has received regulatory approval in Japan for the additional indication of suppression of recurrence and relapse of mood episodes in bipolar I disorder for ABILIFY MAINTENA (aripiprazole), a long-acting injectable suspension. The approved indication covers the 300 mg and 400 mg vials (for injection) and the 300 mg and 400 mg dual-chamber syringes…”

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Daily Top News – September 24, 2020

September 24, 2020

Zercepac (trastuzumab biosimilar) / Fosun Pharma, Intas
Accord Healthcare Launches Zercepac (trastuzumab) biosimilar in the UK (PRNewswire) – Sep 24, 2020 – “Accord Healthcare (Accord) today announced the launch of Zercepac® (trastuzumab) as a biosimilar of the reference product Herceptin®, in the UK, following approval by the European Commission in July 2020….Zercepac is indicated for the treatment of certain patients with HER2-positive early breast cancer, HER2-positive metastatic breast cancer…will be available in a 150mg single-dose vial.”

 

DKN-01 / Eli Lilly, Leap Therap
Leap Therapeutics Announces FDA Fast Track Designation Granted to DKN-01 for the Treatment of Gastric and Gastroesophageal Junction Cancer (PRNewswire) – Sep 24, 2020 – “Leap Therapeutics, Inc…announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to DKN-01 for the treatment of patients with gastric and gastroesophageal junction (G/GEJ) adenocarcinoma whose tumors express high Dickkopf-1 protein (DKK1), following disease progression on or after prior fluoropyrimidine- and platinum- containing chemotherapy and if appropriate, human epidermal receptor growth factor (HER2)/neu-targeted therapy.”

 

Orkambi (lumacaftor/ivacaftor) / Vertex; Trikafta (elexacaftor/tezacaftor/ivacaftor) / Vertex; Kalydeco (ivacaftor) / Vertex
Vertex to Present New Data at European and North American Virtual Cystic Fibrosis Conferences Highlighting Long-Term Use of CFTR Modulators (Businesswire) – Sep 24, 2020 – “An oral presentation at the ECFS Digital Conference will highlight, for the first time, interim results from the TRIKAFTA open-label extension study, which showed safety and efficacy consistent with the results of the Phase 3 pivotal studies in patients with CF ages 12 and older…Four additional scientific abstracts for ORKAMBI® and TRIKAFTA® were published in the Journal of Cystic Fibrosis as part of the ECFS conference. In addition, six scientific presentations will occur at NACFC regarding KALYDECO,® ORKAMBI and TRIKAFTA, including new data from KALYDECO in infants ages 4 to less than 6 months old.”

 

meloxicam/rizatriptan (AXS-07) / Axsome Therap
Axsome Therapeutics Presents New Data from MOMENTUM Phase 3 Trial with AXS-07 Demonstrating Rapid Onset of Action and Reduced Symptom Recurrence in the Acute Treatment of Migraine (GlobeNewswire) – Sep 24, 2020 – P3, N=1,594; MOMENTUM (NCT03896009); Sponsor: Axsome Therapeutics, Inc.; “Axsome Therapeutics, Inc….today announced that AXS-07…rapidly relieved and substantially reduced relapse of migraine pain, as compared to the potent active comparator rizatriptan, in the MOMENTUM Phase 3 trial. These findings were presented at the live sessions of the 2020 American Academy of Neurology (AAN) Science Highlights platform held virtually September 23-24….AXS-07 demonstrated faster and more durable relief of migraine pain as compared to rizatriptan. The probability of achieving pain relief with AXS-07 was greater than with rizatriptan within 30 minutes after dosing and at every time point thereafter, with a median time to migraine pain relief that was nearly 3x faster for AXS-07 compared to rizatriptan (1.5 vs. 4.0 hours, p<0.001).”

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Daily Top News – September 23, 2020

September 23, 2020

aviptadil intravenous (RLF-100 IV) / Relief Therap, NeuroRx
Relief partner NeuroRx submits request for Emergency Use Authorization for RLF-100 (aviptadil) in the treatment of patients with Critical COVID-19 and Respiratory Failure who have exhausted approved therapy (PharmiWeb) – Sep 23, 2020 – P=NA, N=51; SAMICARE (NCT04453839); Sponsor: NeuroRx, Inc.; “…NeuroRx, Inc. has submitted a request for an Emergency Use Authorization (EUA) with the US FDA for the use of RLF-100(TM) aviptadil in patients who are receiving intensive care and who have exhausted all approved treatments….The submission is based on a case-control study that compared patients who were treated with RLF-100(TM) (n=21) to those receiving maximal standard of care treatment (n=30) in the same ICU by the same medical staff. Patients treated with RLF-100(TM) demonstrated a 3-fold advantage in survival, recovery from respiratory failure, and other parameters indicative of meaningful clinical improvement.”

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Sun Pharma announces the launch of ILUMYA (tildrakizumab) for treatment of Plaque Psoriasis in Japan (Equitybulls) – Sep 23, 2020 – “Sun Pharmaceutical…today announced that its wholly-owned Japanese subsidiary has launched ILUMYA® Subcutaneous Injection 100 mg Syringe (Nonproprietary name: tildrakizumab (genetical recombination), ‘ILUMYA’) in Japan for the treatment of plaque psoriasis in adult patients who have an inadequate response to conventional therapies.”

 

Xalkori (crizotinib) / Pfizer
FDA Accepts Supplemental New Drug Application for Pfizer’s XALKORI (crizotinib) for the Treatment of Pediatric ALK-positive Anaplastic Large Cell Lymphoma (Businesswire) – Sep 23, 2020 – “Pfizer Inc…announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review to the Company’s supplemental New Drug Application(sNDA)for XALKORI® (crizotinib) for the treatment of pediatric patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive…The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is January 2020…The FDA submission is supported by the results from Study ADVL0912 (NCT00939770) and Study A8081013 (NCT01121588)….This FDA submission is in addition to the European Medicines Agency’s agreement on a Pediatric Investigational Plan (PIP) for XALKORI including the treatment of pediatric patients with relapsed or refractory systemic ALK-positive ALCL.”

 

Zynteglo (betibeglogene autotemcel) / bluebird bio
bluebird bio’s LentiGlobin for Sickle Cell Disease Gene Therapy (bb1111) Granted Priority Medicines (PRIME) Designation by European Medicines Agency (Businesswire) – Sep 23, 2020 – “bluebird bio, Inc….announced today that its investigational treatment for sickle cell disease (SCD), LentiGlobin™ for SCD gene therapy (bb1111), was granted eligibility to the Priority Medicines (PRIME) program by the European Medicines Agency (EMA)….Clinical data from the completed Phase 1/2 HGB-205 study, the ongoing Phase 1/2 HGB-206 study and ongoing long-term safety and efficacy follow-up study LTF-303 supported the PRIME application for LentiGlobin for SCD.”

 

Epidiolex (cannabidiol) / GW Pharma
GW Pharmaceuticals receives Australian Therapeutic Goods Administration (TGA) approval for EPIDYOLEX (cannabidiol) for the treatment of seizures in patients with two rare, severe forms of childhood-onset epilepsy (GlobeNewswire) – Sep 23, 2020 – “GW Pharmaceuticals plc…today announces that the Australian Therapeutic Goods Administration (TGA) has approved EPIDYOLEX® (cannabidiol) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age and older….The approval of GW’s cannabidiol is based on results from four randomised, controlled Phase 3 trials. These studies incorporate data from more than 714 patients with either LGS or Dravet syndrome, two rare forms of epilepsy with high morbidity and mortality rates, which place a significant burden on families and caregivers.”

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Daily Top News – September 22, 2020

September 22, 2020

bimekizumab (UCB4940) / UCB
UCB Achieves Important Regulatory Milestone for Bimekizumab (UCB Press Release) – Sep 22, 2020 – “UCB…today announced that the FDA and EMA have accepted the Biologics License Application (BLA) and Marketing Authorization Application (MAA), respectively, for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis; This accepted submission is supported by a robust data package including three Phase 3 studies which demonstrate superiority of bimekizumab to placebo, Stelara[®] (ustekinumab) and Humira[®] (adalimumab) in achieving skin clearance at week 16.”

 

CTX001 / Vertex, CRISPR Therap, Molecular Templates
CRISPR Therapeutics and Vertex Pharmaceuticals Announce Priority Medicines (PRIME) Designation Granted by the European Medicines Agency (EMA) to CTX001 for the Treatment of Sickle Cell Disease (GlobeNewswire) – Sep 22, 2020 – “CRISPR Therapeutics and Vertex Pharmaceuticals Announce Priority Medicines (PRIME) Designation Granted by the European Medicines Agency (EMA) to CTX001™ for the Treatment of Sickle Cell Disease (SCD)….PRIME designation was granted based on clinical data from CRISPR and Vertex’s ongoing Phase 1/2 trial of CTX001 in patients with severe SCD.”

 

ifenprodil (NP-120) / Algernon Pharma
Algernon Announces 50% Enrollment in Multinational 2b/3 Human Study of Ifenprodil for Treatment of COVID-19 (GlobeNewswire) – Sep 22, 2020 – “Algernon Pharmaceuticals Inc….is pleased to announce that it has now enrolled 75 patients, which is 50% of its enrollment target, for its multinational Phase 2b/3 human study of NP-120 (Ifenprodil) for the treatment of COVID-19. The Company is now projecting that the study will be completed in November 2020 with a planned data readout before the end of Q4, 2020.”

 

Sputnik-V (Gam-COVID-Vac Lyo) / Gamaleya Research Institute
India trials for Russia’s ‘Sputnik-V’ vaccine could start in next few weeks: exec (Reuters) – Sep 22, 2020 – “Dr Reddy’s Laboratories Ltd could begin late-stage Indian clinical trials of Russia’s potential coronavirus vaccine in the next few weeks….Indian trials of the Sputnik-V vaccine candidate…will enroll 1,000-2,000 participants and be conducted at multiple government and private hospitals across the country….Indian firm will conduct Phase III studies in India, pursue local regulatory approvals and, subject to approval, distribute the finished vaccine product in India….The RDIF has also reached agreements with Indian manufacturers to produce 300 million doses of the shot in India.”

 

idecabtagene vicleucel (bb2121) / bluebird bio, BMS
U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol Myers Squibb and bluebird bio Application for Anti-BCMA CAR T Cell Therapy Idecabtagene Vicleucel (Ide-cel, bb2121) (Businesswire) – Sep 22, 2020 – “Bristol Myers Squibb…and bluebird bio, Inc…announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review their Biologics License Application (BLA) for idecabtagene vicleucel (ide-cel; bb2121), the companies’ investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, for the treatment of adult patients with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of March 27, 2021…The BLA is based on results from the pivotal Phase 2 KarMMa study…”

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Daily Top News – September 21, 2020

September 21, 2020

abiraterone (DST-2970) / DisperSol Tech; Lynparza (olaparib) / Merck (MSD), AstraZeneca
Lynparza recommended for approval in the EU by CHMP for BRCA-mutated metastatic castration-resistant prostate cancer (AstraZeneca Press Release) – Sep 21, 2020 – “AstraZeneca and MSD’s Lynparza (olaparib) has been recommended for marketing authorisation in the European Union (EU) for patients with metastatic castration-resistant prostate cancer (mCRPC) with breast cancer susceptibility gene 1/2 (BRCA1/2) mutations, a subpopulation of homologous recombination repair (HRR) gene mutations…based its positive opinion on a subgroup analysis of patients with BRCA1/2 mutations from the PROfound Phase III trial….AstraZeneca and MSD are exploring additional trials in metastatic prostate cancer including the ongoing PROpel Phase III trial…in combination with abiraterone versus abiraterone alone. Data are anticipated in the second half of 2021.”

 

Mononine (human plasma derived coagulation factor IX) / CSL Behring
Mononine Soon Will No Longer Be Available to Treat Hemophilia B (Hemophilia News Today) – Sep 21, 2020 – “Mononine, a long-standing treatment to prevent and control bleeding in hemophilia B, will be discontinued due to declining demand in recent years. CSL Behring, the therapy’s manufacturer, said the decision was based on the emergence of next-generation hemophilia B treatments now in greater use….’Accordingly, we are discontinuing MONONINE….The medication is expected be available through mid-2021, based on current supply, giving patients time to move to another therapy.”

 

AB201 / ARCA Biopharma
ARCA biopharma Announces Submission of IND Application to U.S. FDA for AB201 as a Potential Treatment for COVID-19 (GlobeNewswire) – Sep 21, 2020 – “ARCA biopharma, Inc….today announced it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) under the Coronavirus Treatment Acceleration Program (CTAP) to evaluate AB201 for the treatment of patients hospitalized with COVID-19. Pending FDA feedback, ARCA anticipates initiating the Phase 2b portion of a sequential Phase 2b/3 clinical evaluation of AB201 as early as the fourth quarter of this year.”

 

Avastin (bevacizumab) / Roche; Lynparza (olaparib) / Merck (MSD), AstraZeneca
LYNPARZA (olaparib) Recommended for Approval in EU by CHMP as First-Line Maintenance Treatment with Bevacizumab for HRD-Positive Advanced Ovarian Cancer (Businesswire) – Sep 21, 2020 – “AstraZeneca and Merck, known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending LYNPARZA for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either a BRCA1/2 mutation and/or genomic instability. The positive opinion was based on a biomarker subgroup analysis of the Phase 3 PAOLA-1 trial…”

 

ArmonAir Digihaler (fluticasone propionate) / Teva; AirDuo Digihaler (salmeterol/fluticasone proprionate) / Teva
Teva Launches Two Digital Inhalers in the U.S., AirDuo Digihaler (fluticasone propionate and salmeterol) Inhalation Powder and ArmonAir Digihaler (fluticasone propionate) Inhalation Powder (Businesswire) – Sep 21, 2020 – “Teva… today announced the launch of AirDuo® Digihaler® (fluticasone propionate and salmeterol) inhalation powder and ArmonAir® Digihaler® (fluticasone propionate) inhalation powder, two digital maintenance inhalers for patients with asthma. AirDuo® Digihaler® is a prescription medicine used to control symptoms of asthma and to prevent symptoms such as wheezing in people 12 years of age and older. ArmonAir® Digihaler® is a prescription medicine for the long-term treatment of asthma in patients 12 years and older. “

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Daily Top News – September 18, 2020

September 18, 2020

Exparel (bupivacaine liposome injectable suspension) / Pacira
PACIRA RECEIVES POSITIVE CHMP OPINION FOR EXPAREL (BUPIVACAINE LIPOSOME INJECTABLE SUSPENSION) FOR THE TREATMENT OF POSTSURGICAL PAIN (Pacira Pharmaceuticals Press Release) – Sep 18, 2020 – “Pacira BioSciences, Inc….today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization for EXPAREL for postsurgical analgesia….The European Commission will review the CHMP opinion and is expected to adopt a final decision in November 2020. The decision will be applicable to all 27 European Union member states plus the United Kingdom, Iceland, Norway and Liechtenstein.”

 

Nyvepria (pegfilgrastim-apgf) / Pfizer
European advisory group back Pfizer’s Neulasta biosimilar (SeekingAlpha) – Sep 18, 2020 – “The European Medicines Agency’s advisory group CHMP has adopted a positive opinion recommending approval of Pfizer’s (NYSE:PFE) Nyvepria (pegfilgrastim), a biosimilar to Amgen’s (NASDAQ:AMGN) Neulasta.”

 

Zejula (niraparib) / GSK, ZAI Lab, J&J, Takeda
European advisory group backs expanded use of Glaxo’s Zejula (SeekingAlpha) – Sep 18, 2020 – “The European Medicines Agency’s advisory group CHMP has adopted a positive opinion recommending approval of GlaxoSmithKline’s (GSK +0.0%) Zejula (niraparib) as monotherapy for the maintenance treatment of adult patients with advanced epithelial (Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemo.”

 

Tecentriq (atezolizumab) / Roche; Avastin (bevacizumab) / Roche
Roche receives positive CHMP opinion for Tecentriq in combination with Avastin for the treatment of people with the most common form of liver cancer (GlobeNewswire) – Sep 18, 2020 – “Roche…announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy…The recommendation from the CHMP is based on results from the Phase III IMbrave150 study…”

 

Olumiant (baricitinib) / Incyte, Eli Lilly, University of Colorado
CHMP Recommends Approval of Lilly’s Baricitinib for the Treatment of Adults with Moderate to Severe Atopic Dermatitis (PRNewswire) – Sep 18, 2020 – “Eli Lilly and Company…announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for baricitinib for the treatment of adult patients with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy….A final decision is expected from the European Commission in the next one-two months….The positive opinion was based on Lilly’s Phase 3 BREEZE-AD clinical development program for baricitinib evaluating the medicine’s potential to treat AD including BREEZE-AD1 and BREEZE-AD2, monotherapy studies…”

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Daily Top News – September 17, 2020

September 17, 2020

STK-012 / Synthekine; STK-009/SYNCAR-001 / Synthekine
Synthekine Launches with $82 Million Series A Financing to Advance Pipeline of Engineered Cytokine Therapeutics Optimized for Cancer and Autoimmune Diseases (Businesswire) – Sep 17, 2020 – “Synthekine Inc…announced the closing of an $82 million Series A financing….Proceeds from this Series A financing will be used to advance Synthekine’s lead therapeutic programs into clinical studies, expand its discovery pipeline and hone its proprietary cytokine engineering platforms. The company currently has two lead programs in IND-enabling development: STK-012, an engineered Interleukin-2 (IL-2) partial agonist for the treatment of cancer, and the combination of STK-009 and SYNCAR-001, an orthogonal IL-2 ligand and a CD-19 CAR-T-cell therapy being studied in combination….Synthekine anticipates filing an IND in 2021 for the STK-009/SYNCAR-001 combination.”

 

meloxicam/rizatriptan (AXS-07) / Axsome Therap
Axsome Therapeutics Announces AXS-07 Phase 3 Migraine Trial Results Selected by the American Academy of Neurology Science Committee as Featured Presentation (GlobeNewswire) – Sep 17, 2020 – P3, N=1,594; MOMENTUM (NCT03896009); Sponsor: Axsome Therapeutics, Inc.; “Axsome Therapeutics, Inc….today announced that Phase 3 data for AXS-07 in the acute treatment of migraine has been selected as a featured presentation at the 2020 American Academy of Neurology (AAN) Science Highlights platform, to be held virtually September 23, 2020 at 12:15 PM Central Time….The presentation will highlight new insights from the Phase 3 MOMENTUM trial of AXS-07, and will be followed with live Q&A.”

 

Yervoy (ipilimumab) / Ono Pharma, BMS; Opdivo (nivolumab) / Ono Pharma, BMS; Sutent (sunitinib) / Pfizer
Four-Year Data Continue to Show Superior, Long-Term Survival Benefit with Opdivo (nivolumab) Plus Yervoy (ipilimumab) in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (Bristol-Myers Squibb Press Release) – Sep 17, 2020 – P3, N=1,390; CheckMate 214 (NCT02231749); Sponsor: Bristol-Myers Squibb; “Bristol Myers Squibb…announced that more than half of advanced renal cell carcinoma (RCC) patients treated with the Opdivo® (nivolumab) plus Yervoy® (ipilimumab) combination were alive after four years across the entire study population of the Phase 3 CheckMate -214 clinical trial. With the longest follow-up for an immunotherapy-based combination in previously untreated advanced RCC, Opdivo plus Yervoy continued to show superior, long-term overall survival (OS) and durable responses compared to sunitinib. These sustained benefits were observed across both the primary patient population, those with intermediate- and poor-risk prognostic factors, and in the intention-to-treat (ITT, i.e. all randomized) patient population.”

 

FAP-2286 / Clovis, 3B Pharma
New Data Presented at ESMO Virtual Congress 2020 Highlight Breadth and Potential of Clovis Oncology Products and Pipeline (Businesswire) – Sep 17, 2020 – “Clovis Oncology…today announced the data being presented as e-posters at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. These include…the first presentation of preclinical data for FAP-2286 Clovis’ novel peptide-targeted radionuclide therapy…FAP is highly expressed in cancer-associated fibroblasts (CAFs) present in the tumor microenvironment of most epithelial cancers and, in some cancers, its expression has also been observed in the tumor cells…Clovis Oncology plans to submit two Investigational New Drug (IND) applications in late 2020 for use of this novel radionuclide therapy as an imaging and treatment agent, respectively, and the Company has planned clinical studies in a broad spectrum of FAP-positive cancers.”

 

Rubraca (rucaparib) / Clovis
New Data Presented at ESMO Virtual Congress 2020 Highlight Breadth and Potential of Clovis Oncology Products and Pipeline (Businesswire) – Sep 17, 2020 – P3, N=564; ARIEL3 (NCT01968213); Sponsor: Clovis Oncology, Inc; “After two years of additional follow up for those patients who continued on treatment in the study, the safety profile remains consistent with previous reports, with no new safety signals identified. As of the current safety data cutoff (December 31, 2019), 33 of 372 and 1 of 189 patients in the safety population were still receiving Rubraca or placebo, respectively. Median treatment duration was 8.3 months in the Rubraca arm and 5.5 months in the placebo arm….The median duration of the first event of frequently reported TEAEs was generally <60 days.”

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Daily Top News – September 16, 2020

September 16, 2020

dexamethasone sodium phosphate (AVM0703) / AVM Biotechnology
Seattle AVM Biotechnology announces second IND for AVM0703: clinical trial permitted to treat COVID-19 and Influenza ARDS with its “supercharged” version of dexamethasone (PRNewswire) – Sep 16, 2020 – “AVM Biotechnology has received FDA permission to proceed with clinical trials to evaluate its proprietary drug AVM0703 in the treatment of Acute Respiratory Distress Syndrome (ARDS) mediated by COVID-19 or Influenza patients….This second study consists of two different ARDS patient populations: one with COVID-19-mediated moderate to severe ARDS and the other with Influenza-mediated severe ARDS.”

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