The Pharma Data

SEPTEMBER 28, 2020

This approval comes after GSK submitted results from its Phase 3 trial which enrolled 108 patients. Nucala was first approved in 2015 to treat severe eosinophilic asthma as an add-on maintenance therapy for the condition, and for the treatment of eosinophilic granulomatosis with polyangiitis.

FDA Approval 52

FDA Approval FDA Treatment Therapies 52

The Pharma Data

DECEMBER 15, 2020

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. Food and Drug Administration (FDA) has approved Klisyri (tirbanibulin) for the topical treatment of actinic keratosis (AK) on the face or scalp. The FDA approval of Klisyri is a significant milestone for Athenex.

FDA Approval 52

FDA Approval FDA Treatment Small Molecule 52

The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. Armstrong, cardiologist and Distinguished University Professor of Medicine at the Canadian VIGOUR Centre, University of Alberta, and study chair of the VICTORIA trial. KENILWORTH, N.J.–(BUSINESS Verquvo (vericiguat) 2.5

FDA Approval 52

FDA Approval FDA Hospitals Treatment 52

The Pharma Data

SEPTEMBER 6, 2020

Basel, 7 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the United States (US) Food and Drug Administration (FDA) has approved Gavreto (pralsetinib) for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.

FDA Approval 52

FDA Approval FDA Treatment Therapies 52

New Drug Approvals

SEPTEMBER 10, 2024

Deuruxolitinib C 17 H 18 N 6 , 314.422 Fda approved Leqselvi , 7/25/2024, To treat severe alopecia areata C-21543, CTP 543, CTP-543, CTP543 (3r)-3-(2,2,3,3,4,4,5,5-d8)cyclopentyl-3-(4-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)-1h-pyrazol-1-yl)propanenitrile 1h-pyrazole-1-propanenitrile,beta.-(cyclopentyl-2,2,3,3,4,4,5,5-d8)-4-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)-,

FDA Approval 52

FDA Approval FDA Treatment Clinical Trials 52

The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1] Haematologica.

FDA Approval 52

FDA Approval FDA Treatment Pharmaceutical Companies 52

The Pharma Data

OCTOBER 14, 2020

WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. WAKIX received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019.

FDA Approval 52

FDA Approval FDA Treatment Pharmaceutical Companies 52

Drug Discovery World

APRIL 23, 2024

More than 413,000 service members were diagnosed with a TBI between 2000 and Q3 of 2019. Concussive injuries have been overlooked and as a consequence, clinical trials for novel therapeutic approaches are just starting to appear. Over 80% of these were concussions.

Therapies 147

Therapies Drugs Laboratories Medical Schools 147

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] World Health Organization (2019).

FDA Approval 52

FDA Approval FDA Treatment International 52

The Pharma Data

NOVEMBER 12, 2020

12 November 2020 — The CALAVI Phase II trials for Calquence (acalabrutinib) in patients hospitalised with respiratory symptoms of COVID-19 did not meet the primary efficacy endpoint. No new safety signal for Calquence was observed in the trials. No new safety signal for Calquence was observed in the trials.

Trials 52

Trials Clinical Trials Immune Response FDA Approval 52

Drug Discovery World

AUGUST 14, 2023

A Mutual Recognition Agreement (MRA) 2 for inspections of manufacturing sites for certain human medicines, signed and implemented by the United States and EU in July 2019, served as an important milestone in harmonising certain regulatory aspects in developing a global drug. Archiving samples from the early manufacturing stages is key.

Marketing 130

Marketing DNA Therapies FDA 130

The Pharma Data

MAY 7, 2021

regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. This includes the most recent analyses from the pivotal Phase 3 clinical trial, where the vaccine’s efficacy and favorable safety profile were observed up to six months after the second dose. AUTHORIZED USE IN THE U.S.:

Licensing 52

Licensing Licensing Vaccine FDA Approval 52

Advarra

AUGUST 16, 2022

Orphan drugs have historically faced a number of barriers, such as limited research and development (R&D) investment due to an expected lack of profitability as well as challenges in clinical trial design and recruitment. Food and Drug Administration (FDA) approval. The FDA Since 1983.

Disease 52

Disease Clinical Trials FDA Approval FDA 52

The Pharma Data

JUNE 6, 2022

1] [2] In recent years, measles outbreaks have occurred in the US and globally, with more than 400,000 cases confirmed in 2019, reversing decades of progress toward measles elimination in many countries. [3]. The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions.

FDA Approval 52

FDA Approval Vaccine FDA Disease 52

New Drug Approvals

SEPTEMBER 20, 2023

Jump up to: a b “Aphexda approval letter” (PDF). World Health Organization (2019). “Motixafortide and G-CSF to mobilize hematopoietic stem cells for autologous transplantation in multiple myeloma: a randomized phase 3 trial” Nature Medicine. 8 September 2023. BioLineRx Ltd. 11 September 2023.

FDA Approval 52

FDA Approval FDA International Clinical Trials 52

The Pharma Data

AUGUST 25, 2020

In August 2017, Bristol Myers Squibb received full approval in the U.S. Food and Drug Administration (FDA)-approved test. IDHIFA is the first and only FDA-approved therapy for patients with R/R AML and positive for an IDH2 mutation, which represents up to 19 percent of AML patients. Important Safety Information.

Trials 52

Trials FDA Approval Therapies Treatment 52

The Pharma Data

OCTOBER 26, 2020

EYSUVIS is the first FDA-approved corticosteroid specifically for dry eye disease treatment. The FDA approved EYSUVIS based on the positive results from one Phase II and three Phase III trials. in January 2019 and is similar to EYSUVIS except at a higher 1% concentration of LE for post-surgery, versus.25%

FDA 52

FDA Disease Treatment FDA Approval 52

The Pharma Data

OCTOBER 26, 2020

FDA Actions. FDA Approval: Last week the FDA approved Veklury (remdesivir) for the treatment of COVID-19 requiring hospitalization in adults and pediatric patients (12 years of age and older). Food and Drug Administration greenlit the restart of AstraZeneca’s Phase III COVID-19 vaccine trial, the U.K.-based

Vaccine 52

Vaccine FDA Approval FDA 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] June 2019). 1] It is taken by mouth. [1] 11] SYN ACS Med. .

FDA 57

FDA FDA Approval International Pharmacokinetics 57

The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. The primary clinical objective of this initial analysis was to determine if there was sufficient efficacy in these patients to warrant continuing the trial (i.e., futility analysis).

Hospitals 52

Hospitals Trials Clinical Trials Production 52

The Pharma Data

NOVEMBER 15, 2020

Federal Drug Administration (FDA) for vibegron in December 2019 after reporting positive data from its 12-week Phase III EMPOWUR study. Results of a phase Ib trial completed by Ion Channel Innovations in 2017 indicated dose-dependent improvements in urinary urgency and frequency.

Science 52

Science Small Molecule FDA Approval FDA 52

Drug Discovery World

APRIL 14, 2023

He is being recognised for his celebrated contributions to the understanding and targeting of pancreas cancer metastasis, including work that has assisted with the development of minnelide, a pro-drug of triptolide for the treatment of pancreas and gastrointestinal cancers that is currently in Phase II clinical trials.

Clinical Trials 130

Clinical Trials Research Science Clinical Research 130

The Premier Consulting Blog

NOVEMBER 12, 2023

In 2019, the FDA published a discussion paper on a proposed regulatory framework for modification to AI/ML-based software as a medical device (SaMD), which received a significant amount of feedback from stakeholders. The number of drug submissions involving AI/ML has also increased.

FDA 52

FDA Drug Development Regulations FDA Approval 52

PerkinElmer

JANUARY 7, 2022

Furthermore, nearly one third of drugs get withdrawn from the market post approval due to safety concerns. 2 Toxic to the Heart One of the top reasons for drug withdrawal from clinical trials and the market is cardiotoxicity, which can be defined as toxicity that has a detrimental impact on the heart. Sci Rep 9, 18911 (2019).

Drugs 52

Drugs Pharmacokinetics FDA Approval Drug Development 52

The Pharma Data

NOVEMBER 8, 2021

MBA, trial investigator and managing medical director at Charité Universitätsmedizin in Berlin. 4,5 Aimovig is the first FDA-approved migraine preventive treatment that targets the CGRP receptor.6 4,5 Aimovig is the first FDA-approved migraine preventive treatment that targets the CGRP receptor.6 versus 38.9%).

Therapies 52

Therapies FDA Approval Small Molecule Treatment 52

The Pharma Data

DECEMBER 10, 2020

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the New England Journal of Medicinehas published safety and final efficacy results from the pivotal Phase 3 trial of BNT162b2, their mRNA-based COVID-19 vaccine candidate. Chief Medical Officer and Co-founder of BioNTech. There were no COVID-19 related deaths.

Vaccine 52

Vaccine Trials Clinical Trials Therapies 52

The Pharma Data

NOVEMBER 23, 2020

The study is an open-label, exploratory phase I/II trial adding ONCOS-102 to SoC chemotherapy (pemetrexed/cisplatin) in first- and second- (and later) line treatment of MPM to assess safety, immune activation and efficacy versus SoC only. months (Baas 2020), and this is expected to serve as a benchmark for further approvals. .”

FDA Approval 40

FDA Approval Trials Treatment Virus 40

The Pharma Data

MARCH 11, 2021

Retevmo was approved under the FDA’s Accelerated Approval regulations based on the LIBRETTO-001 Phase 1/2 trial’s endpoints of overall response rate (ORR) and duration of response (DoR). LY3484356, an oral SERD, is currently being studied in a Phase 1/2 clinical trial. Pipeline Highlights.

Research 52

Research Clinical Trials FDA Approval Trials 52

The Pharma Data

SEPTEMBER 28, 2021

Also, the info from SRP-9001 have helped to optimise the planning of the upcoming phase III clinical trial trial for DMD,” said Levi Garraway, M.D., quite 4,000 patients are treated with Evrysdi in clinical trials, compassionate use, and real-world settings. Roche’s Chief medic and Head of worldwide development.

Clinical Trials 52

Clinical Trials Protein Expression FDA Therapies 52

The Pharma Data

NOVEMBER 9, 2020

Novavax expects to begin its pivotal Phase 3 clinical trial in the United States and Mexico by the end of November. Data from the event-driven trial could support global authorization and approval, including in the U.S. and globally.”. About NVX-CoV2373. and Australia. billion from the U.S. government.

Vaccine 52

Vaccine FDA Clinical Trials Immune Response 52

The Pharma Data

NOVEMBER 5, 2020

billion versus third quarter 2019 (4). billion versus third quarter 2019. billion versus third quarter 2019. REGN-COV2 trial in the COVID-19 outpatient setting met primary and key secondary endpoints. FDA approved Inmazeb for Ebola ( Zaire ebolavirus). TARRYTOWN, N.Y. , Third quarter 2020 EYLEA ® U.S.

Production 52

Production FDA FDA Approval Trials 52

The Pharma Data

OCTOBER 28, 2020

Today’s data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits. REGN-COV2 was well tolerated in the trial. TARRYTOWN, N.Y. , 28, 2020 /PRNewswire/ — . Regeneron has shared these results with the U.S.

Virus 40

Virus Trials Clinical Trials Production 40

The Pharma Data

OCTOBER 15, 2020

John Hospital, researchers compared 649 patients from two cohorts: a recent cohort (2017–2019) from the RECOVER III post-market approval (PMA) study, after the widespread adoption of the best practice of placing Impella pre-PCI, and a cohort from before PMA (2008–2014) when the practice of placing Impella pre-PCI was not yet widely adopted.

Hospitals 52

Hospitals FDA Approval FDA Treatment 52

The Pharma Data

NOVEMBER 30, 2020

Two of the three planned late-stage efficacy trials for NVX-CoV2373 sponsored by Novavax are fully enrolled, and more than 20,000 participants have been dosed to-date. In alignment with Novavax’ commitment to transparency, Phase 3 clinical trial protocols are posted to the company’s website at Novavax.com/resources upon finalization.

Clinical Development 52

Clinical Development Vaccine Clinical Trials Immune Response 52

The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) to begin a Phase I clinical trial of hAd5-COVID-19, the company’s novel COVID-19 vaccine candidate that targets both the inner nucleocapsid (N), engineered to activate T cells, and outer spike (S) protein, engineered to activate antibodies against the coronavirus (SARS-CoV-2). i,ii,iii,iv.

Vaccine 52

Vaccine Trials FDA Clinical Trials 52

Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Still, of the 34 macrocycles currently in clinical trials, only 18% are de novo designed. Balazs et al., Journal of Medicinal Chemistry 62 (21), 9418-9437.

Metabolic Stability 52

Metabolic Stability Drugs FDA Approval Treatment 52

Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Still, of the 34 macrocycles currently in clinical trials, only 18% are de novo designed. Balazs et al., Journal of Medicinal Chemistry 62 (21), 9418-9437.

Metabolic Stability 52

Metabolic Stability Drugs FDA Approval Treatment 52