The Pharma Data

NOVEMBER 2, 2020

FDA Approves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis. an international research-focused healthcare Group (Chiesi Group), received U.S. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder. in March, 2021.

FDA Approval 52

FDA Approval FDA Pharmaceutical Companies Therapies 52

The Pharma Data

MAY 18, 2021

VENTANA MMR RxDx Panel is the first immunohistochemistry predictive test in endometrial cancer for treatment with the anti-PD1 immunotherapy JEMPERLI ( dostarlimab-gxly ). Food and Drug Administration (FDA) approval of the VENTANA MMR RxDx Panel for advanced or recurrent endometrial cancer patients.

FDA Approval 40

FDA Approval FDA DNA Therapies 40

The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. Patients with symptomatic chronic heart failure and reduced ejection fraction have a high risk for hospitalization after experiencing symptoms of heart failure requiring outpatient IV diuretic treatment or hospitalization. KENILWORTH, N.J.–(BUSINESS

FDA Approval 52

FDA Approval FDA Hospitals Treatment 52

Drug Discovery World

SEPTEMBER 14, 2023

As the second quarter of 2023 draws to a close, DDW’s Megan Thomas reviews key updates and results from three top pharmaceutical companies. In July 2023, AstraZeneca and Ionis Pharmaceuticals expanded their existing collaboration on eplontersen to also include Latin America. billion, a decrease of $15.0

Vaccine 148

Vaccine FDA Approval Drugs Licensing 148

New Drug Approvals

DECEMBER 19, 2022

FDA 12/1/2022, To treat adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, Rezlidhia Olutasidenib , sold under the brand name Rezlidhia , is an anticancer medication used to treat relapsed or refractory acute myeloid leukemia. [1] Rigel Pharmaceuticals. Hz, 1 H), 4.62−4.75

FDA Approval 52

FDA Approval FDA Treatment International 52

The Pharma Data

OCTOBER 14, 2020

. (“Harmony”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced the U.S. Drug Enforcement Administration. Jacobs , Harmony’s President and Chief Executive Officer.

FDA Approval 52

FDA Approval FDA Treatment Pharmaceutical Companies 52

New Drug Approvals

DECEMBER 24, 2023

Eplontersen , sold under the brand name Wainua , is a medication used for the treatment of transthyretin-mediated amyloidosis. [1] 1] It was developed to treat hereditary transthyretin amyloidosis by Ionis Pharmaceuticals and AstraZeneca. [2] 2] [3] [4] [5] It was approved for medical use in the United States in December 2023. [6]

Clinical Trials 62

Clinical Trials FDA Clinical Pharmacology Pharmacokinetics 62

Drug Discovery World

AUGUST 3, 2023

For example, the FDA has not approved a marketing application for cannabis for the treatment of any disease or condition to date 1. There is, however, one cannabis-derived drug product that the FDA has approved, which is Epidiolex (cannabidiol).

Clinical Trials 130

Clinical Trials Regulations Production FDA 130

The Pharma Data

AUGUST 19, 2021

Oral presentation at the International Association for the Study of Lung Cancer’s (IASLC) 2021 World Conference on Lung Cancer (WCLC) shows evidence that the bispecific mechanism of action for RYBREVANT TM can provide anti-tumor activity against either EGFR-mutated or MET-mutated non-small cell lung cancer. 1 Treatment-related Grade ?3

Treatment 52

Treatment FDA Approval Pharmacokinetics FDA 52

New Drug Approvals

SEPTEMBER 20, 2023

To use with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma Motixafortide , sold under the brand name Aphexda , is a medication used for the treatment of multiple myeloma. [1] 1] It is given by subcutaneous injection. [1]

FDA Approval 52

FDA Approval FDA International Clinical Trials 52

New Drug Approvals

OCTOBER 24, 2023

Molecular Weight: 631.700 FDA APPROVED, To treat moderately to severely active ulcerative colitis in adults, 10/12/2023 Velsipity Etrasimod , sold under the brand name Velsipity , is a medication that is used for the treatment of ulcerative colitis (UC). [1] 1] [9] [10] Names Etrasimod is the international nonproprietary name.

FDA 57

FDA FDA Approval International Pharmacokinetics 57

PLOS: DNA Science

JANUARY 4, 2024

The end-of-year FDA approval of the first CRISPR-based therapy , for sickle cell disease, came a mere dozen years after Jennifer Doudna and Emmanuelle Charpentier introduced the technology. Sickle Cell Disease The CRISPR-based treatment for sickle cell disease is Casgevy , from CRISPR Therapeutics and Vertex Pharmaceuticals.

FDA Approval 52

FDA Approval DNA Clinical Trials Therapies 52

The Pharma Data

JANUARY 6, 2021

7, 2021 /PRNewswire/ — UNION therapeutics A/S ( UNION ) today announces that the US Food and Drug Administration (FDA) has approved an Investigational New Drug program (IND) for oral orismilast; a next generation PDE4-inhibitor for the treatment of plaque psoriasis in adults. One step closer to a novel treatment.

FDA Approval 52

FDA Approval FDA Clinical Development Clinical Research 52

The Pharma Data

JANUARY 19, 2021

19, 2021 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. or (973) 890-8355 (International), conference ID 1580376. SOURCE Regeneron Pharmaceuticals, Inc. TARRYTOWN, N.Y. , financial markets open. The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day. Source link.

FDA Approval 52

FDA Approval Laboratories Pharmaceuticals Disease 52

The Pharma Data

NOVEMBER 30, 2020

30, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. or (973) 890-8355 (International), conference ID 7442859. SOURCE Regeneron Pharmaceuticals, Inc. TARRYTOWN, N.Y. , Conference Call Information To access this call, dial (888) 660-6127 ( U.S. ) View original content: [link]. Source link.

FDA Approval 52

FDA Approval Laboratories Pharmaceuticals Disease 52

The Pharma Data

APRIL 27, 2021

Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced that that the U.S. Patients with EGFR Exon20 insertion+ mNSCLC face considerable challenges, as current treatment options provide limited benefit, resulting in poor survival outcomes,” said Christopher Arendt, head, Oncology Therapeutic Area Unit, Takeda.

FDA 52

FDA Treatment Pharmaceutical Companies FDA Approval 52

Drug Discovery World

APRIL 27, 2023

Over 450 life science companies including top pharmaceutical manufacturers are concentrated in the region. Pegcetacoplan, an injectable treatment, is the first medication to use targeted C3 therapy to diffuse the harmful three- pronged “complement cascade” triggered by GA, a physiological response that attacks and destroys healthy tissue.

Small Molecule 130

Small Molecule Science Drugs FDA Approval 130

Drug Discovery World

APRIL 14, 2023

Pettit Nassi and Perlmutter will be honoured during the AACR Annual Meeting 2023 Opening Ceremony on Sunday April 16 at 8am ET. Wherry’s award lecture will be held on Monday April 17 at 3:30pm ET. Simon’s award lecture will be held on Sunday April 16 at 3pm ET. Schietinger’s award lecture will be held on Tuesday April 18 at 4:45pm ET.

Clinical Trials 130

Clinical Trials Research Science Clinical Research 130

The Pharma Data

AUGUST 25, 2020

While we are disappointed by the outcome of the IDHENTIFY study, we remain confident in IDHIFA ’s established role as a treatment option for patients with relapsed or refractory AML with an IDH2 mutation and are grateful to all those who participated in the study,” said Noah Berkowitz, M.D., Food and Drug Administration (FDA)-approved test.

Trials 52

Trials FDA Approval Therapies Treatment 52

The Pharma Data

NOVEMBER 16, 2020

16, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

FDA Approval 52

FDA Approval Science Disease Laboratories 52

The Pharma Data

OCTOBER 29, 2020

Regeneron Pharmaceuticals, Inc. NASDAQ: REGN ) today announced that the company was once again ranked as the top company to work for by Science magazine in its annual Top Employers Survey of the global biotech and pharmaceutical industry. SOURCE Regeneron Pharmaceuticals, Inc. Schleifer , M.D., View original content: [link].

Science 40

Science FDA Approval Pharmaceuticals Disease 40

The Pharma Data

JULY 21, 2021

mg, 5 mg, and 10 mg) is indicated for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilized after a recent decompensation event requiring intravenous (IV) therapy. Bayer also issued a news release earlier today announcing the EC approval. In the EU, VERQUVO (2.5

Treatment 52

Treatment Production FDA Approval Hospitals 52

The Pharma Data

MAY 7, 2021

Adcomm splits slightly in favor of FDA approving ChemoCentryx’s rare disease drug ( Endpoints ). In Focus: International. WHO approves emergency use of China’s Sinopharm Covid vaccine ( FT ). In Focus: International. What happens now? Coronavirus Pandemic.

Vaccine 52

Vaccine Compounding Pharmacies Regulations Drugs 52

The Pharma Data

NOVEMBER 30, 2020

1, 2020 /PRNewswire/ — Sosei Group Corporation (“the Company”) (TSE: 4565) announces it has entered into a global collaboration and license agreement with Biohaven Pharmaceutical Holding Company Ltd. (“Biohaven”, NYSE: BHVN). NURTEC is a trademark of Biohaven Pharmaceutical Ireland DAC. About CGRP.

Small Molecule 40

Small Molecule Licensing Licensing Clinical Trials 40

The Pharma Data

DECEMBER 8, 2020

The fully integrated pharmaceutical company creates value through China’s specialty pharmaceutical markets with focus on iron deficiency, pain management and respiratory. RayzeBio is also funneling cash into expanding its HQ in San Diego with plans to further develop internal R&D. . SciNeuro Pharmaceuticals .

RNA 52

RNA Protein Expression Therapies Disease 52

The Pharma Data

SEPTEMBER 11, 2021

Food and Drug Administration (FDA) granted Breakthrough Therapy designation for Jardiance ® (empagliflozin) as an investigational treatment for adults with heart failure with preserved ejection fraction (HFpEF), Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced today. vice president, Product Development, Lilly.

Therapies 52

Therapies FDA Hospitals FDA Approval 52

The Pharma Data

JULY 29, 2021

The series of promising pipeline updates included the data from the landmark ZUMA-7 study for the treatment of second-line large B-cell lymphoma. Launch activities continue following the full FDA approval for second-line metastatic triple-negative breast cancer (“mTNBC”) and accelerated approval for metastatic urothelial cancer.

Science 52

Science Production Treatment FDA 52

The Pharma Data

AUGUST 27, 2020

FoundationOne Liquid CDx analyses more than 300 cancer-related genes and multiple genomic signatures to help inform treatment decisions for all solid tumour cancers. The convenience of testing a blood sample may also enable more rapid treatment decisions, so that patients can feel reassured they are not losing time to fight their disease.”.

FDA Approval 52

FDA Approval FDA DNA Therapies 52

The Pharma Data

JANUARY 21, 2021

21, 2021 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Prior to initiating treatment with CABENUVA, oral cabotegravir (VOCABRIA) and oral rilpivirine (EDURANT ® ) should be administered for approximately one month to assess the tolerability of each therapy. In the U.S.,

FDA Approval 52

FDA Approval Treatment RNA FDA 52

The Pharma Data

SEPTEMBER 7, 2020

Novartis will present 48 abstracts from its leading MS portfolio, including new data on recently FDA-approved Kesimpta ® (ofatumumab) — the first and only self-administered, targeted B-cell therapy for relapsing forms of MS (RMS )— Mayzent ® (siponimod) and Gilenya ® (fingolimod) .

Therapies 52

Therapies Clinical Trials Treatment Trials 52

The Pharma Data

JANUARY 21, 2021

Regeneron Pharmaceuticals, Inc. Through its world-class competitions, including the Regeneron Science Talent Search, the Regeneron International Science and Engineering Fair, the Broadcom MASTERS, and its award-winning magazine, Science News and Science News for Students, Society for Science is committed to inform, educate, and inspire.

Science 40

Science Engineering Molecular Biology Bioinformatics 40

The Pharma Data

SEPTEMBER 1, 2020

The trial included 2,494 patients who had previously completed a Phase 1, 2 or 3 Zeposia clinical trial and who had an average treatment time of 35.4 Gaining insight into long-term therapeutic outcomes can enable clinicians to identify the most appropriate treatment approach for their multiple sclerosis patients. Author: Harris.

Clinical Trials 52

Clinical Trials Treatment Trials Disease 52

Agency IQ

NOVEMBER 3, 2023

One non-profit organization, the International Society Association for Probiotics and Prebiotics (ISAPP) , which is dedicated to promoting research in this area, has published consensus statements that have helped to define some of these terms and their associated substances. Some probiotics are also sold as plain old conventional foods.

Therapies 40

Therapies Science FDA Production 40

The Pharma Data

FEBRUARY 24, 2022

– FDA approval marks a significant breakthrough for the approximately 3 million adults in the U.S. “Today’s approval means these demonstrated benefits can now help to address a significant unmet need for the approximately 3 million adults in the U.S. with more than 8 million cases expected by 2030. .

FDA Approval 52

FDA Approval FDA Hospitals Trials 52

The Pharma Data

NOVEMBER 5, 2020

FDA accepted for priority review Libtayo ® (cemiplimab-rwlc) for both advanced non-small cell lung cancer and basal cell carcinoma. FDA approved Inmazeb for Ebola ( Zaire ebolavirus). Regeneron Pharmaceuticals, Inc. REGN-COV2 trial in the COVID-19 outpatient setting met primary and key secondary endpoints.

Production 52

Production FDA FDA Approval Trials 52

The Pharma Data

MAY 27, 2022

Novartis today announced the US Food and Drug Administration (FDA) has granted accelerated approval for Kymriah ® (tisagenlecleucel) for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy.

FDA Approval 52

FDA Approval Therapies FDA Treatment 52

The Pharma Data

NOVEMBER 5, 2020

BRILINTA is approved in more than 110 countries for the prevention of atherothrombotic events in adult patients with acute coronary syndrome (ACS) and in more than 70 countries for the secondary prevention of cardiovascular events among patients who are at high-risk and have experienced a heart attack. INDICATIONS.

Disease 40

Disease Trials Therapies Treatment 40