The Pharma Data

DECEMBER 13, 2020

During the meeting, the FDA provided encouraging feedback regarding the Phase 3 study of omidubicel pertaining to the pre-specified primary and secondary endpoints. The FDA also recommended that Gamida Cell generate additional manufacturing-related data prior to requesting a pre-Biologics License Application (BLA) meeting.

Licensing 52

Licensing Licensing Clinical Trials FDA 52

New Drug Approvals

APRIL 2, 2025

1] [2] It was developed by Vertex Pharmaceuticals , [5] and was approved for medical use in the United States in January 2025. [2] 2] [6] Suzetrigine is the first medication to be approved by the US Food and Drug Administration (FDA) in this new class of pain management medicines. [2] Suzetrigine is taken by mouth. [1]

FDA 62

FDA Therapies Trials Treatment 62

The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. The increase in survival observed with Zokinvy was derived from two open-label clinical trials (N=62) conducted at Boston Children’s Hospital. PALO ALTO, Calif.,

FDA Approval 52

FDA Approval FDA Clinical Trials Disease 52

The Pharma Data

AUGUST 20, 2020

Patient dosing has begun in a Phase III clinical programme investigating GlaxoSmithKline’s 5-in-1 meningitis (MenABCWY) vaccine candidate compared to licensed meningococcal vaccines, Bexsero and Menveo. Invasive Meningococcal Disease (IMD) is uncommon, with country-specific reported cases ranging from 0.1

FDA Approval 52

FDA Approval Vaccine Trials Licensing 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 Treatment FDA Pharmaceutical Companies 52

The Pharma Data

DECEMBER 16, 2020

The Company will initiate its trial during the first quarter of 2021 to investigate the efficacy of Berubicin in adults with GBM who have failed first-line therapy. and 2 trials planned by our sublicensee WPD in Poland. . and 2 trials planned by our sublicensee WPD in Poland. About CNS Pharmaceuticals, Inc.

FDA Approval 52

FDA Approval FDA Pharmaceuticals Clinical Trials 52

The Pharma Data

MAY 13, 2021

NIH trial seeks answers. ( Third time’s the charm as Heron wins FDA nod for non-opioid anesthetic Zynrelef ( Endpoints ). Amgen, AstraZeneca bolster their case for breakthrough asthma program as FDA considers taking up a review ( Endpoints ). In Focus: International. Purdue’s Ch.

FDA Approval 52

FDA Approval FDA Vaccine Trials 52

Codon

JULY 14, 2024

However, the subsequent death of another patient thrust Denys into a contentious trial. Despite the high costs, researchers in Kyoto generated enough cultured platelets in 2022 to transfuse a 55-year-old woman for an initial human trial. The results of the trial are expected at the end of 2024. Data from Rousseau G.F.

Production 140

Production Clinical Trials Trials Therapies 140

The Pharma Data

JANUARY 24, 2021

This has been borne out in a Phase 2 clinical trial, which demonstrated evidence that prophylactic administration of Quercis’ investigational drug reduced levels of key markers of coagulation, without observed VTE or major bleeding events 2. ZUG, Switzerland , Jan. Chief Medical Officer of Quercis Pharma.

Licensing 40

Licensing Licensing Clinical Trials Medical Schools 40

The Pharma Data

OCTOBER 9, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking expanded approval of STELARA® (ustekinumab) to treat pediatric patients ages 5 years and older with juvenile psoriatic arthritis (jPsA).

FDA Approval 52

FDA Approval Treatment FDA Pharmaceutical Companies 52

The Pharma Data

JULY 29, 2021

Additionally, mepolizumab was the first biologic therapy indicated for adults with eosinophilic granulomatosis with polyangiitis (EGPA) and also the first biologic to be approved for patients aged 12 years and older with hypereosinophilic syndrome (HES). With 41 clinical trials, mepolizumab has been studied in over 4,000 patients.

FDA Approval 52

FDA Approval Clinical Trials FDA Treatment 52

The Pharma Data

AUGUST 21, 2020

The FDA has approved Genmab and Janssen’s Darzalex (daratumumab) as a treatment for relapsed and refractory multiple myeloma, when combined with carfilzomib and dexamethasone, in patients who have previously received between one and three lines of therapy. Multiple myeloma affects 26,000 new patients in America every year.

FDA Approval 52

FDA Approval Drugs Licensing Licensing 52

The Pharma Data

JUNE 18, 2021

Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Following today’s FDA approval, the U.S.

Vaccine 52

Vaccine FDA Approval FDA Disease 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 Clinical Trials FDA 52

The Pharma Data

JANUARY 13, 2021

Fast Track designation is well-timed, as we anticipate starting our Phase 2 clinical trial in hospitalized COVID-19 patients this month, and should help bring Brilacidin to patients faster in these dire times.”. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A.

Clinical Trials 52

Clinical Trials Trials Treatment Pharmaceuticals 52

New Drug Approvals

SEPTEMBER 10, 2024

2] Vorasidenib was approved for medical use in the United States in August 2024. [2] 2] [3] It is the first approval by the US Food and Drug Administration (FDA) of a systemic therapy for people with grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 or isocitrate dehydrogenase-2 mutation. [2]

FDA Approval 62

FDA Approval FDA Clinical Trials Trials 62

The Pharma Data

NOVEMBER 30, 2020

The lead candidate, HTL0022562, has advanced through preclinical development demonstrating promising and differentiated properties for further investigation in human trials. Biohaven acquires exclusive global rights to a portfolio of novel, small-molecule CGRP antagonists. TOKYO and CAMBRIDGE, England , Dec.

Small Molecule 40

Small Molecule Licensing Licensing Treatment 40

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 40

FDA Approval FDA Treatment Clinical Trials 40

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] 1] It is taken by mouth. [1] Hz, 1 H), 4.62−4.75

FDA Approval 52

FDA Approval FDA Treatment Pharmaceuticals 52

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

MARCH 4, 2021

There are currently no FDA-approved treatments for AA. ” Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly. It is approved and commercially available as OLUMIANT in the U.S. Lymphopenia – Absolute lymphocyte count (ALC) <500 cells/mm 3 were reported in Olumiant clinical trials.

Trials 52

Trials Treatment Therapies Clinical Trials 52

The Pharma Data

AUGUST 17, 2021

Second FDA approved indication for dostarlimab in 2021 GARNET study demonstrated objective response rate of 41.6% This indication received accelerated approval based on tumour response rate and durability of response. The GARNET trial is a multicentre, non-randomised, multiple parallel-cohort, open-label study.

FDA 52

FDA FDA Approval Treatment DNA 52

The Pharma Data

JUNE 7, 2022

The new findings from the Phase 3 clinical trials (ADvocate 1 and 2) showed eight out of ten patients who achieved clinical response (EASI-75*) with lebrikizumab monotherapy at 16 weeks maintained skin clearance at one year of treatment with the once every two weeks or four weeks regimen. Almirall S.A.’s Source link: [link].

Trials 40

Trials Clinical Trials Licensing Licensing 40

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

New Drug Approvals

SEPTEMBER 8, 2024

1] Palopegteriparatide was approved for medical use in the European Union in November 2023, [2] and in the United States in August 2024. [1] 5] History The effectiveness of palopegteriparatide was evaluated in a 26-week, randomized, double-blind, placebo-controlled trial that enrolled 82 adults with hypoparathyroidism. [5]

FDA 62

FDA International Trials FDA Approval 62

New Drug Approvals

SEPTEMBER 6, 2024

2 , 3 Lazertinib was first approved in South Korea on January 18, 2021, for the treatment of EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) with EGFR mutations. 1 It was approved by the FDA on August 19, 2024. 1 It was approved by the FDA on August 19, 2024. Food and Drug Administration (FDA).

FDA Approval 48

FDA Approval FDA International Clinical Trials 48

The Pharma Data

MAY 4, 2021

Lilly is offering donations of baricitinib to the Indian government through Direct Relief while simultaneously working with local Indian pharmaceutical companies to execute royalty-free voluntary licensing agreements to accelerate the manufacturing and distribution of the medicine in India during the pandemic. Increases of ALT ?5x

Licensing 40

Licensing Licensing Therapies Laboratories 40

The Pharma Data

APRIL 4, 2022

If approved, Actemra/RoActemra would be the first U.S. FDA approval is expected in the second half of this year. About the Actemra®/RoActemra® (tocilizumab) COVID-19 Clinical Trial Programme Roche’s clinical trial programme evaluated the safety and efficacy of Actemra/RoActemra in hospitalised patients with COVID-19.

Treatment 52

Treatment FDA Approval Clinical Trials FDA 52

New Drug Approvals

DECEMBER 24, 2023

2] [3] [4] [5] It was approved for medical use in the United States in December 2023. [6] S2CID 250989659. ^ “Eplontersen: FDA-Approved Drugs” U.S. Food and Drug Administration (FDA). Retrieved 21 December 2023. ^ “Wainua (eplontersen) granted regulatory approval in the U.S. 88 (12): 5389–5398.

Clinical Trials 62

Clinical Trials FDA Clinical Pharmacology FDA Approval 62

The Pharma Data

NOVEMBER 29, 2020

Y-mAbs Therapeutics has a target action date of November 30 for its Biologics License Application (BLA) for Danyelza (naxitamab) for patients with relapsed/refractory high-risk neuroblastoma. The drug was developed by researchers at Memorial Sloan Kettering Cancer Center and exclusively licensed to Y-mAbs.

FDA 52

FDA Licensing Licensing Pharmaceuticals 52

The Pharma Data

NOVEMBER 22, 2020

The FDA approved it under the brand name Gavreto on September 4. The FDA granted Breakthrough Therapy Designation to the drug for RET fusion-positive NSCLC that has progressed after platinum-based chemotherapy, and RET mutation-positive MTC that requires systemic treatment and for which there are no alternative treatments.

FDA 52

FDA Licensing Licensing Treatment 52

New Drug Approvals

SEPTEMBER 20, 2023

1] Motixafortide was approved for medical use in the United States in September 2023. [2] 4 Similar in mechanism to the previously approved plerixafor , motixafortide is an inhibitor of C-X-C Motif Chemokine Receptor 4 (CXCR4), a protein that helps to anchor stem cells to bone marrow matrix. 1] It is given by subcutaneous injection. [1]

FDA Approval 52

FDA Approval FDA International Clinical Trials 52

The Pharma Data

DECEMBER 29, 2020

Phase III BRIDGE open-label, switch-over clinical trial met key objectives for safety and efficacy. ” In May 2020 , Protalix and Chiesi Global Rare Diseases announced the submission of a Biologics License Application (BLA) to the U.S. Protalix has licensed to Pfizer Inc. CARMIEL, Israel and BOSTON , Dec.

Clinical Trials 52

Clinical Trials Disease Treatment Trials 52

The Pharma Data

JANUARY 21, 2021

Results from these trials were presented at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI). Trademarks are owned by or licensed to Janssen and the ViiV Healthcare group of companies. Global Head, Janssen Research & Development, Johnson & Johnson.

FDA Approval 52

FDA Approval Treatment RNA FDA 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

DECEMBER 20, 2020

It was approved on December 15, 2020. The submission included data from two positive pivotal Phase III trials. Athenex and Almirall have a license deal with Almirall having the license to research, develop and commercialize the drug in the U.S. and Europe, including Russia. Most Read Today. Source link.

FDA 52

FDA FDA Approval Licensing Licensing 52

The Pharma Data

JANUARY 5, 2021

RAD011 is a pivotal-trial ready synthetic cannabidiol oral solution with potential utilization in multiple endocrine and metabolic orphan diseases. Prader-Willi syndrome (“PWS”) will be the initial indication, which has been granted Orphan Drug and Fast Track Designation by the FDA. Disease Highlights.

Disease 52

Disease FDA Approval Clinical Trials Trials 52