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. 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. 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. Date of Approval: February 1, 2021Treatment for: Post-Surgical Pain. Thu Mar 4, 2021 San Antonio Breast Cancer Conference Update 2021. September 25, 2020. 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. The BioPharmCatalyst Biotech Earnings Calendar … Trodelvy binds to Trop-2 and delivers SN-38, an anti-cancer drug. Affiliates. SVB Leerink projects peak sales of about $1.3 billion for Regeneron, probably in 2021, with sales falling every year after that. It was then studied in a completely new development program in RMS because B-cells play a critical role in autoimmune diseases, such as MS. FDA Approved: Yes (First approved July 15, 2019) Brand name: AirDuo Digihaler Generic name: fluticasone propionate and salmeterol Dosage form: Inhalation Powder Company: Teva Pharmaceuticals USA, Inc. ejection fraction less than 45%. Date of Approval: January 22, 2021Treatment for: Lupus Nephritis. outpatient IV diuretics, in adults with symptomatic chronic HF and * 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). Thu Dec 17, 2020 New Rules: Key Changes for 2021. Company: Sarepta Therapeutics Aimmune’s Palforzia [Peanut (Arachis hypogaea) Allergen Power-dnfp] was approved in January 2020 as the first approved treatment for patients with peanut allergy. Bristol Myers Squibb’s Zeposia (ozanimod) was approved by the FDA in March 2020, the first approval after it completed its merger with Celgene. Biotech stocks with key binary events/catalysts - FDA Approval/PDUFA dates, Advisory Committee and Phase 2 & 3 trial data releases dates are noted. These two are being presented together because they represent a peculiarity of the COVID-19 market and the unpredictability of therapies for the disease. Videos you watch may be added to the TV's watch history and influence TV recommendations. Company: ViiV Healthcare The drug has brought in $873 million, making it Gilead’s second-best-selling drug for the third quarter of 2020. The FDA approved Esperion’s Nexletol (bempedoic acid) in February 2020 for lowering LDL-cholesterol (LDL-C). The drug was approved under Priority Review, Fast Track and Breakthrough Therapy Designation, as well as Orphan Drug designation. Congress directed almost $10 billion toward Operation Warp Speed through supplemental funding and has appropriated other funds as well. The following drugs have recently been approved by the FDA. 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. 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. Sesen is currently sitting strong. Another strong year for novel drug approvals is in the making. 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. FDA Approvals; Industry News; Upcoming Events. Biotech Earnings Calendar. Date of Approval: March 2, 2021Treatment for: Attention Deficit Hyperactivity Disorder (ADHD). Immunomedics’ Trodelvy for Metastatic Triple-Negative Breast Cancer. View Full Calendar. It is more frequently diagnosed in younger and premenopausal women and is highly prevalent in African Americans and Hispanic women. Amondys 45 (casimersen) is a phosphorodiamidate morpholino oligomer for the treatment of patients with Duchenne muscular dystrophy (DMD) who have genetic mutations that are amenable to skipping exon 45 of the Duchenne gene. 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. This report includes approvals of NDAs, BLAs, ANDAs, and approved supplements to those … Recent and upcoming US FDA advisory committee meetings and a summary of topics covered. 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. On February 28, the FDA approved Biohaven Pharmaceutical’s Nurtec ODT (Rimegepant) for the acute treatment of migraine in adults. hospitalization following a hospitalization for heart failure or need for 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. Evaluate Pharma has projected estimated 2024 sales of $897 million. 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. 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). It was approved for use in patients with a confirmed diagnosis of peanut allergy, for patients aged 4 through 17 years. The drug was a significant reason for Bristol Myers Squibb’s acquisition of Celgene—part of the payout to Celgene shareholders is related to FDA approvals for three drugs, including Zeposia. 2020 was a peculiar year for drug approvals, partly because the ongoing COVID-19 pandemic delayed many clinical trials. Biotech Stock Catalyst and FDA Calendar for your biotech stock investing. FDA approves targeted treatment for rare Duchenne muscular dystrophy mutation. 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. 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. Date of Approval: January 21, 2021Treatment for: HIV Infection. Innovation drives progress. 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. Company: Ridgeback Biotherapeutics, LP. Novel FDA approvals and their outsourcing rise in the shadow of the pandemic. Thu Apr 1, 2021 Virtual Event: Allied Professionals Event. FDA Grants Emergency Use Authorization for Home Collection Kit for Advanta Dx SARS-CoV-2 RT-PCR Assay . Email Print Friendly Share. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Credit: Shutterstock. Company: Amgen Inc. Thu Mar 4, 2021 San Antonio Breast Cancer Conference Update 2021. Allergan’s Ubrelvy (ubrogepant) is an oral therapy for migraine, but many analysts believe Nurtec is a more successful sales opportunity. 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. Roche’s Evrysdia for Spinal Muscular Atrophy. View Full Calendar. Novel Drug Approvals for 2020. Date of Approval: December 23, 2020Treatment for: Overactive Bladder Syndrome. Here’s a look at the top 10 novel drug approvals of 2020, loosely based on projected earnings in the upcoming years. All supporting data can be copied to the clipboard or downloaded as a CSV file. Investing in biotechnology and pharmaceutical companies often comes with concerns of dilution and raises in order to continue to fund operations. The approval was based on data from the Phase III ASCLEPIOS I and II trials. Date of Approval: February 5, 2021Treatment for: Large B-Cell Lymphoma. 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. Company: Myovant Sciences That is a rare disease where the muscles and fatty tissues behind the eye become inflamed. Company: Bristol-Myers Squibb Company Track the performance of past biotech IPOs and keep an eye out for upcoming listings. Clarivate projects $1.26 billion in peak sales. Back in April 2020, when the world was desperate for any drug that might help, Gilead reported encouraging results from its clinical trial of Veklury in COVID-19, with topline results from the Phase III SIMPLE trial evaluating 5-day and 10-day dosing in hospitalized patients with severe disease. The PDUFA/FDA Approval Calendar and Finding Potential FDA Approval Catalyst Dates. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. They it projected to bring in $2.3 billion in 2026 sales. Upcoming events; Medtech; Therapy Areas; About. FDA Approvals; Industry News; Upcoming Events. Horizon’s Tepezza for Thyroid Eye Disease. View FDA Calendar. 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. Category: Events.

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