2020 was a peculiar year for drug approvals, partly because the ongoing COVID-19 pandemic delayed many clinical trials. Category: Events. Category: Events. US FDA will simultaneously review the vaccines, with Moderna’s advisory committee set a week after Pfizer’s. FDA Approvals; Industry News; Upcoming Events. 3 Top Biotech Stocks with FDA Approvals on the Horizon Apr 19, 2020 Boston Scientific to buy surgical business of Lumenis for $1.07 bln 3 days ago … Date of Approval: March 2, 2021Treatment for: Attention Deficit Hyperactivity Disorder (ADHD). Ukoniq (umbralisib) is a dual inhibitor of phosphoinositide 3 kinase (PI3K) delta and casein kinase 1 (CK1) epsilon for the treatment of marginal zone lymphoma (MZL) and follicular Lymphoma (FL). Sesen is currently sitting strong. Category: Events. Jan. 28, 2020 9:00 AM ET Sesen Bio, Inc. (SESN) 32 Comments 5 Likes. It is self-administered once a month at home via the Sensoready autoinjector pen. Drug Status. outpatient IV diuretics, in adults with symptomatic chronic HF and Maya Sasson - April 19, 2020, 7:01 AM EDT. Company: Durect Corporation Biohaven’s Nurtec has a definite advantage there. Novel FDA approvals and their outsourcing rise in the shadow of the pandemic. Upcoming events; Medtech; Therapy Areas; About. Innovation drives progress. Statista projects peak sales in 2021 of $3.074 billion, with sales dropping afterwards to $1.729 billion in 2026. The approval includes clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Azstarys (dexmethylphenidate and serdexmethylphenidate) is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older. Congress directed almost $10 billion toward Operation Warp Speed through supplemental funding and has appropriated other funds as well. FDA Approvals; Upcoming Events. Horizon’s Tepezza for Thyroid Eye Disease. It also reported positive data from the National Institute of Allergy and Infectious Diseases’ (NIAID) trial. Biotech Earnings Calendar. That is a rare disease where the muscles and fatty tissues behind the eye become inflamed. prostate cancer. Evkeeza (evinacumab-dgnb) is an angiopoietin-like 3 (ANGPTL3) inhibitor indicated as an adjunct to other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and pediatric patients, aged 12 years and older, with homozygous familial hypercholesterolemia (HoFH). Gemtesa (vibegron) is a once-daily beta-3 adrenergic agonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults. Category: Events. It is the only approved spingosine-1-phosphate (S1P) receptor modulators for RMS patients with no genetic test and no label-based first-dose observation required for patients. It was the first FDA-approved product for the company. Some of them may make a comeback in 2021 or later, but they did not hit the mark for one reason or another in 2020. Some analysts project it could bring in $2.5 billion to $3 billion at its peak. FDA Calendar. This causes the eyes to bulge outwards and forward. Company: Bristol-Myers Squibb Company All supporting data can be copied to the clipboard or downloaded as a CSV file. FDA granted IND clearance today for the commencement of a Phase 1 safety and pharmacokinetic study for STI-2099 (COVIDROPS™) in healthy volunteers and outpatients with mild COVID-19 disease with or without a simultaneous intravenous injection of STI-2020 (COVI-AMG™). The serology test uses a single drop of fingertip blood to detect IgG antibodies to the virus in 15 minutes in point-of-care settings, meaning it does not require any offsite lab work. New … Date of Approval: February 3, 2021Treatment for: Non-Small Cell Lung Cancer. Company: G1 Therapeutics, Inc. The BioPharmCatalyst Biotech Earnings Calendar … FDA Grants Emergency Use Authorization for Home Collection Kit for Advanta Dx SARS-CoV-2 RT-PCR Assay . It is administered daily at home in liquid form by mouth or feeding tube. Date of Approval: December 17, 2020Treatment for: non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Wegener's Granulomatosis, Microscopic Polyangiitis. At the beginning of 2020, nobody knew how bad COVID-19 would be or that Gilead Sciences’ remdesivir, which had failed to work in Ebola, would turn out to be the first drug granted Emergency Use Authorization (EUA) for COVID-19 in spring 2020 and then full approval on October 22, 2020. The program took 10 years and involved more than 2,300 patients globally. Includes newly approved drugs and new indications for drugs already approved. Date of Approval: December 14, 2020Treatment for: Actinic Keratosis. The following drugs have recently been approved by the FDA. MDLinx | Feb 18. Date of Approval: January 22, 2021Treatment for: Lupus Nephritis. TNBC cells don’t have estrogen or progesterone hormone receptors or the human epidermal growth factor receptor 2 (HER2-). In August, Nestlé acquired Aimmune for $2.6 billion, and became the point pharmaceutical business for Nestlé Health Science. https://www.biospace.com/article/biggest-novel-drug-approvals-in-2020, https://www.pharmalive.com/wp-content/uploads/2021/01/Biggest-Novel-Drug-Approvals-in-2020-BioSpace-1-4-21.jpeg, https://www.pharmalive.com/wp-content/uploads/2020/01/Pharmalive_4c-300x37.png, © Copyright - PharmaLive and Outcomes LLC |, Inovio expects to begin late-stage Covid-19 vaccine study in Q2 2021. Use our tools on your road to profit in the stock market. Track the performance of past biotech IPOs and keep an eye out for upcoming listings. Category: Events. View Full Calendar. Date of Approval: February 5, 2021Treatment for: Marginal Zone Lymphoma; Follicular Lymphoma. Company: Sarepta Therapeutics Roche’s Evrysdia for Spinal Muscular Atrophy. ACIP emergency meeting scheduled for 1 December with vote likely on distribution priority for health care personnel. On November 22, the FDA granted Regeneron Pharmaceuticals’ antibody cocktail casirivimab and imdevimab, together REGN-COV2, EUA for mild to moderate COVID-19 in adults and pediatric patients at least 12 years of age and weighing at least 40 kg. The drug was approved based on two trials of 170 patients with active thyroid eye disease. The drug is a survival of motor neuron 2 (SMN2) splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to SMN protein deficiency. Thu Mar 4, 2021 San Antonio Breast Cancer Conference Update 2021. We comply with the HONcode standard for trustworthy health information -, FDA Approves Azstarys (serdexmethylphenidate and dexmethylphenidate) Capsules for the Once-Daily Treatment for ADHD, FDA Approves Nulibry (fosdenopterin) to Reduce the Risk of Mortality in Patients with Molybdenum Cofactor Deficiency (MoCD) Type A, FDA Approves Pepaxto (melphalan flufenamide) for Patients with Relapsed or Refractory Multiple Myeloma, FDA Approves Amondys 45 (casimersen) Injection for the Treatment of Duchenne Muscular Dystrophy (DMD) in Patients Amenable to Skipping Exon 45, FDA Approves Cosela (trilaciclib) to Decrease the Incidence of Chemotherapy-Induced Myelosuppression, FDA Approves Evkeeza (evinacumab-dgnb) for Patients with Homozygous Familial Hypercholesterolemia, FDA Approves Ukoniq (umbralisib) for Marginal Zone Lymphoma and Follicular Lymphoma, FDA Approves Breyanzi (lisocabtagene maraleucel) CAR-T Cell Therapy for Adults with Relapsed or Refractory Large B-cell Lymphoma, FDA Approves Tepmetko (tepotinib) as the First and Only Once-daily Oral MET Inhibitor for Patients with Metastatic NSCLC with METex14 Skipping Alterations, FDA Approves Posimir (bupivacaine) for Post-Surgical Pain Reduction for up to 72 Hours Following Arthroscopic Subacromial Decompression, FDA Approves Lupkynis (voclosporin) for Adult Patients with Active Lupus Nephritis, FDA Approves Cabenuva (cabotegravir and rilpivirine) Long-Acting Injectable HIV Treatment and Vocabria (cabotegravir) Oral HIV Treatment, FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction, FDA Approves Gemtesa (vibegron) Tablets for the Treatment of Patients with Overactive Bladder (OAB), FDA Approves Ebanga (ansuvimab-zykl) for the Treatment of Zaire Ebolavirus Infection, FDA Approves Orgovyx (relugolix) as the First Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist for Advanced Prostate Cancer, FDA Approves Riabni (rituximab-arrx), a Biosimilar to Rituxan, FDA Approves Margenza (margetuximab-cmkb) for Patients with Pretreated Metastatic HER2-Positive Breast Cancer, FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. Bernstein analysts projected the total market for anti-COVID antibodies of about $3 billion in 2021, with Lilly and Regeneron splitting them, but overall sales are expected to plunge quickly to about $805 million. The drug was approved for the treatment of adults with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary disease. Category: Events. Biohaven Pharmaceutical’s Nurtec for Acute Migraine. They it projected to bring in $2.3 billion in 2026 sales. Gilead stated that it had already invested more than $1 billion into the drug’s development and expects to invest even more next year into scaling up manufacturing globally. Editorial team; NME approvals. Moderna Gets To Watch And Learn From Pfizer’s COVID-19 Vaccine Advisory Committee. Estimated sales for 2024 are $1.28 billion. At the time of the EUA, it was really the only available treatment, but few physicians or analysts were particularly impressed with the drug’s effectiveness. Date of Approval: February 5, 2021Treatment for: Large B-Cell Lymphoma. Roche’s Evrysdia for Spinal Muscular Atrophy. See also: Generic approvals, Approval process, New indications & dosage forms, Company: KemPharm, Inc. Date of Approval: January 19, 2021Treatment for: Heart Failure with Reduced Ejection Fraction (HFrEF). 1-5 FDA is focused on the conduct of clinical trials and embracing GCPs as a “Quality System Approach to New Drug Development and Approvals”- (Figure 3). Lupkynis (voclosporin) is a calcineurin-inhibitor immunosuppressant indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis (LN). It was approved for use in patients with a confirmed diagnosis of peanut allergy, for patients aged 4 through 17 years. antagonist indicated for the treatment of adult patients with advanced As I have reiterated before, the best way to trade bio-pharmas are on upcoming catalysts. Advisory Committee dates included. With over $57 million in working capital (cash and cash equivalents) the Company is in a comfortable position to continue operations without concerns through the end of Q4 2020. oral therapy for patients who will miss planned injection dosing with Cabenuva. Category: Events. Roche’s Evrysdi (risdiplam) was approved on August 10 by the FDA for spinal muscular atrophy (SMA) in adults and children two months of age and older. BioPharmCatalyst provides a pharmaceutical data bank that keeps track of Biotech stocks, FDA approvals, Advisory Committee activity, PDUFA and Phase 2 & 3 Trial data. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 2020 drug approvals rise despite Covid-19 . PDUFA dates (FDA Approval) for all US publicly listed biotech companies. Recent and upcoming US FDA advisory committee meetings and a summary of topics covered. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Ofatumumab was first approved by the FDA in 2009 for chronic lymphocytic leukemia (CLL) as an intravenous infusion. Others, such as Public Citizen, a consumer group, argue that the prices are too high given that the federal government invested $70 million in the drug and sponsored the only major trial comparing it with a placebo; $70 million is a minuscule amount of money compared to what the government’s Operation Warp Speed, the program to advance therapies and vaccines against COVID-19, has spent. Orgovyx (relugolix) is an oral gonadotropin-releasing hormone (GnRH) receptor Select one or more newsletters to continue. PDUFA dates and FDA Panel Review dates are very important catalysts because they are ‘make or break events’ for biotech stocks. Affiliates. Without the SMN protein, nerve cells do not function correctly, which leads to muscle weakness over time. The FDA approved Esperion’s Nexletol (bempedoic acid) in February 2020 for lowering LDL-cholesterol (LDL-C). But a clinical trial by the World Health Organization (WHO) reported that the drug does not have any particular effect on a patient’s survival. Company: Athenex, Inc. Of the patient receiving Tepezza, 71% in Study 1 and 83% in Study 2 demonstrated a greater than 2-millimeter reduction in eye protrusion compared to 20$ and 10% in the placebo groups, respectively. While GCP places emphasis on the clinical accuracy of results, it also deals with the importance of the processes used to conduct clinical trials. Category: Events. Biotech IPO Calendar. 3 FDA Dates Biotech Investors Should Circle in 2021 These biotech stocks could sink or soar following some important approval decisions slated for the new year. Reporting a net loss of$13.1 million in Q3, the company has seen consistent spending across quarters and expects to continue spending for 2020. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Cabenuva (cabotegravir and rilpivirine) is a long-acting, injectable regimen of the HIV-1 integrase strand transfer inhibitor (INSTI) cabotegravir, and the HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine indicated as a complete regimen for the treatment of HIV-1 infection in adults. Our enhanced FDA calendar integrates PDUFA dates, clinical trial primary completion dates, and working capital runway estimates into a single timeline that covers all companies facing upcoming PDUFA dates. hospitalization following a hospitalization for heart failure or need for Gilead has set a price of $3,120 for a course of treatment of Veklury for private insurers and $2,340 for government payers. On the other hand, the pandemic and the astonishing innovations of numerous pharmaceutical companies created drugs to treat COVID-19 in record time. On November 9, 2020, the FDA granted Eli Lilly’s neutralizing antibody bamlanivimab EUA for mild to moderate COVID-19 in adults and pediatric patients 12 years and older who are at high risk for progressing to severe COVID-19 and/or hospitalization. Here’s a look at the top 10 novel drug approvals of 2020, loosely based on projected earnings in the upcoming years. Tepmetko (tepotinib) is an oral MET inhibitor for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. Date of Approval: December 21, 2020Treatment for: Zaire Ebolavirus Infection. Biotech Stock Catalyst and FDA Calendar for your biotech stock investing. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox. The Institute for Clinical and Economic Review’s own estimate had been $2,800 as a fair price and said Gilead’s price was a “responsible pricing decision.” But that was based on if the drug ultimately demonstrated it significantly decreased death rates, which has not happened. View FDA Calendar. Thu Mar 4, 2021 San Antonio Breast Cancer Conference Update 2021. Trodelvy binds to Trop-2 and delivers SN-38, an anti-cancer drug. FDA Watch: Approvals … Worries about a stricter US FDA come to nothing, as last year’s approval total beats 2019’s. 5 new FDA-approved drugs every physician should have on their radar. Date of Approval: December 16, 2020Treatment for: Breast Cancer. Another reason is because several of the highly anticipated drug approvals for the year were surprising failures, such as Novartis’ inclisiran for hyperlipidemia in adults, FibroGen’s roxadustat for anemia in chronic kidney disease, and Gilead Sciences’ filgotinib in rheumatoid arthritis. Videos you watch may be added to the TV's watch history and influence TV recommendations. Company: MacroGenics, Inc. In terms of clinical improvement, the trial showed the time to clinical improvement for 50% of patients was 10 days in the 5-day cohort and 11 days in the 10-day cohort. The companies’ application to the FDA was based on results from a phase 1 study published in The Lancet Oncology, as well as results from a phase 2 study that will be presented in detail at the upcoming San Antonio Breast Cancer Symposium this month. The approval was based on data from the Phase III ASCLEPIOS I and II trials. It is a single quick-dissolving tablet provides fast relief within one hour and delivers sustained efficacy up to 48 hours for many patients. Aimmune’s pharmaceutical expertise and infrastructure complements Nestlé Health Science’s existing focus on nutrition science, and a holistic approach to treat food allergies. Company: Urovant Sciences Eli Lilly’s Bamlanivimab for COVID-19 and Regeneron’s REGN-COV2. Company: ViiV Healthcare Web page provides quick links to everything from acronyms to wholesale distributor and third-party logistics providers reporting. Roche’s Evrysdi (risdiplam) was approved on August 10 by the FDA for spinal muscular atrophy (SMA) in adults and children two months of age and older. The drug is an antibody-drug conjugate (ADC) directed against Trop-2, a cell-surface protein found on many solid cancers. Margenza (margetuximab-cmkb) is a HER2/neu receptor antagonist indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2- positive breast cancer. EvaluatePharma projects it will have 2026 annual sales of $1.8 billion. Company: Amgen Inc. With the Pfizer-BioNTech and Pfizer vaccines rolling out, it’s entirely possible that Gilead will be left with a drug for which there is no market. Similarly to Gilead’s remdesivir, the long-term sales potential of the neutralizing antibodies are unpredictable because of the distribution of apparently effective vaccines by Pfizer-BioNTech and Moderna. Posimir (bupivacaine) is a sustained-release anamide local anesthetic formulation indicated for post-surgical pain reduction following arthroscopic subacromial decompression shoulder surgery. Company: Oncopeptides AB January 13, 2021 GMT. Ebanga (ansuvimab-zykl) is a monoclonal antibody for the treatment of Zaire ebolavirus (Ebolavirus) infection in adults and children. March 01, 2021 08:30 ET | … Novel Drug Approvals for 2020. Data sources include IBM Watson Micromedex (updated 3 Mar 2021), Cerner Multum™ (updated 1 Mar 2021), ASHP (updated 3 Mar 2021) and others. Company: Myovant Sciences View Full Calendar. GlobalData Healthcare 22 February 2021 (Last Updated February 22nd, 2021 16:18) This increased count does not include Emergency Use Authorisations for Covid-19 such as Pfizer Inc and BioNTech’s Covid-19 vaccine. Gilead’s Veklury (Remdesivir) for COVID-19. Share Article. Genprex Achieves Major Manufacturing Milestone for REQORSA™ Immunogene Therapy for Upcoming Trials to Treat Non-Small Cell Lung Cancer . New Drug Approvals. 3 “Strong Buy” Biotech Stocks with FDA Approvals on the Horizon. Company: TG Therapeutics, Inc. Cosela (trilaciclib) is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor myelopreservation therapy for use in patients with small cell lung cancer (SCLC) who are receiving chemotherapy. oral lead-in to assess the tolerability of cabotegravir prior to administration of Cabenuva (cabotegravir; rilpivirine) extended-release injectable suspensions. In the phase 1 study, although all patients had at least one treatment-emergent adverse event, nearly 60% achieved a confirmed objective response. Affiliates . SMA is a severe, progressive neuromuscular disease that can be fatal. EvaluatePharma project 2026 annual sales of $1.4 billion. The approval was supported by a global pivotal Phase III LDL-C lowering program run in more than 3,000 patients. Riabni (rituximab-arrx) is a CD20-directed cytolytic antibody biosimilar to Rituxan indicated for the treatment of adult patients with non-Hodgkin’s Lymphoma (NHL), chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis (GPA) (Wegener’s Granulomatosis) and microscopic polyangiitis (MPA). Upcoming events – FDA approvals due for Maviret and Besponsa Joanne Fagg Welcome to your weekly digest of approaching regulatory and clinical readouts. It is also working to develop an inhaled version of the drug. Investing in biotechnology and pharmaceutical companies often comes with concerns of dilution and raises in order to continue to fund operations. Immunomedics’ Trodelvy for Metastatic Triple-Negative Breast Cancer. FDA Approvals; Industry News; Upcoming Events. Novartis’ Kesimpta for Relapsing Multiple Sclerosis. Company: BridgeBio Pharma, Inc. View Full Calendar. Estimated sales by 20224 are $1.598 billion. Though that's lower than the 59 approvals seen in 2018, the agency's decisions still provided more treatment options for patients living with cystic fibrosis, sickle cell disease and rare muscular disorders. * Drugs@FDA includes information about drugs, including biological products, approved for human use in the United States (see FAQ), but does not include information about FDA-approved products regulated by the Center for Biologics Evaluation and Research (for example, vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products). Notably, the agency ended 2019 with a flurry of earlier-than-expected decisions, bolstering the 2018 count with several drugs it was scheduled to finish review on this year.
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