New Drug Approvals

MAY 8, 2025

MORE US10918622 US10695323 US10464905 US10342780 US12109193 Medical uses In the United States, pirtobrutinib is indicated to treat relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor. [1] 5] It is taken by mouth. [1] 2] PATENTS Guisot, N.

FDA Approval 52

FDA Approval FDA Therapies Trials 52

The Pharma Data

JULY 18, 2021

Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in January 2022.

Licensing 52

Licensing Licensing Vaccine FDA 52

The Pharma Data

DECEMBER 13, 2020

Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious hematologic diseases, today announced that the company conducted a Type B Meeting for omidubicel with the U.S. The revised plan could support a potential commercial launch of omidubicel in the United States as early as mid-2022.

Licensing 52

Licensing Licensing Clinical Trials FDA 52

New Drug Approvals

MAY 17, 2025

Jump up to: a b New Drug Therapy Approvals 2023 (PDF). January 2022). It is administered as an intrathecal injection. [3] 3] The most common side effects include fatigue, arthralgia (joint pain), increased cerebrospinal (brain and spinal cord) fluid white blood cells, and myalgia (muscle pain). [3] 25 April 2023. January 2024.

FDA Approval 62

FDA Approval FDA Treatment Clinical Trials 62

New Drug Approvals

APRIL 25, 2025

2022 Dec 22;65(24):16589-16621. Epub 2022 Dec 1. 3] Primary endocrine resistance was defined as relapse while on the first two years of adjuvant endocrine therapy (ET) and secondary endocrine resistance was defined as relapse while on adjuvant ET after at least two years or relapse within twelve months of completing adjuvant ET. [3]

FDA 57

FDA FDA Approval Therapies Trials 57

The Pharma Data

JUNE 24, 2025

One of the signature initiatives launched during the partnership was the Bayer Microfunding Program , introduced in 2022. Oncology remains a core priority, reflecting the rising global burden of cancer and the need for more effective, targeted therapies. Source link

Pharma R&D 40

Pharma R&D Pharmaceutical Companies Pharmaceuticals Science 40

The Pharma Data

JUNE 14, 2023

With our oncology strategy, we are dedicated to accelerating the research and development of novel cancer therapies that have the potential to make a meaningful difference in the lives of patients.” In fiscal 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros. billion euros. Source link: [link]

Licensing 40

Licensing Licensing Small Molecule Science 40

FDA Law Blog: Drug Discovery

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

Therapies 59

Therapies Engineering Production FDA 59

Drug Target Review

APRIL 4, 2024

The animal model is based on creating a dopamine-deficient state, by a specific lesion of dopaminergic cells, and then exposing it to repeated substitution therapy with L-DOPA. Nicholas served as the CEO of IRLAB Sweden between 2012 and 2022 and for IRLAB therapeutics 2016-2022. In 2013, Nicholas co-founded IRLAB Sweden.

Disease 105

Disease Treatment Licensing Licensing 105

LifeSciVC

JANUARY 16, 2024

By Aimee Raleigh, Principal at Atlas Venture, as part of the From The Trenches feature of LifeSciVC Just in time for new years’ reflections and resolutions, this year’s JPM felt like a refreshing burst of enthusiasm for a sector that has seen its challenges in 2022 and 2023 but also some green shoots. Join the club.

Small Molecule 143

Small Molecule Trials Therapies Disease 143

The Pharma Data

JANUARY 27, 2021

. – Preclinical Data Underscore Treatment Potential for PBFT02 in Frontotemporal Dementia with Granulin (GRN) Mutations, a Devastating, Progressive Disorder Impacting Adults with No Approved Disease-Modifying Therapy Options. FTD is a debilitating form of early onset dementia that currently has no approved disease-modifying therapies. “We

Therapies 52

Therapies Treatment Clinical Trials FDA 52

DrugBank

OCTOBER 4, 2024

This involves assessing the strength and breadth of patents, evaluating the potential for future patent challenges, and analyzing the value derived from licensing agreements and royalty streams. GlaxoSmithKline's spin-off of its consumer healthcare division , Haleon, in 2022 is a case in point.

Pharmaceuticals 98

Pharmaceuticals Pharmaceutical Companies Therapies Marketing 98

The Pharma Data

NOVEMBER 25, 2020

The majority of the work will be completed in 2021 to start clinical trials as early as possible during 2022. The main project, the antibody CAN04, is being studied clinically as combination therapy with chemotherapy or immune therapy with a primary focus on non-small cell lung cancer and pancreatic cancer. About BioInvent.

Clinical Trials 52

Clinical Trials Licensing Licensing International 52

The Premier Consulting Blog

OCTOBER 21, 2024

Accelerated approval is an expedited regulatory pathway designed to hasten the availability of drugs (including biologics) that treat serious conditions, offer advantages over existing therapies, and address unmet medical needs. This approach ensures timely completion of confirmatory trials in closer proximity to the initial approval.

Trials 52

Trials FDA Clinical Trials Pharma Companies 52

The Pharma Data

JULY 22, 2021

We share Pfizer’s deep commitment to people with breast cancer and are thrilled to partner with them to develop this potentially best-in-class therapy. Endocrine therapy is a backbone of ER+ breast cancer treatment and is used as monotherapy or as combination therapy as a standard of care across treatment settings.

Targeted Protein Degradation 52

Targeted Protein Degradation Therapies Clinical Trials Treatment 52

New Drug Approvals

DECEMBER 24, 2023

“Characteristics of Patients with Hereditary Transthyretin Amyloidosis-Polyneuropathy (ATTRv-PN) in NEURO-TTRansform, an Open-label Phase 3 Study of Eplontersen” Neurology and Therapy. December 2022). . | Facebook Twitter FACEBOOK join me on twitter Anthony Melvin Crasto Dr. | twitter +919321316780 call whatsaapp EMAIL.

Clinical Trials 62

Clinical Trials FDA Clinical Pharmacology FDA Approval 62

The Pharma Data

APRIL 19, 2022

tumour response rate If approved, Enhertu to provide patients with a much-needed targeted therapy option. 1 The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for their regulatory decision, is during the third quarter of 2022. The application has also been granted Priority Review.

Trials 52

Trials Treatment Therapies FDA 52

FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

The statutory Accelerated Approval provisions were amended in 2023 as part of the Food and Drug Omnibus Reform Act of 2022 (“FDORA”) to, among other things, give FDA greater authority to expedite the withdrawal of approval of an Accelerated Approval product if clinical benefit is not confirmed post-NDA or -BLA approval. FDA-2022-E-3124 ).

FDA 59

FDA Production FDA Approval Licensing 59

The Pharma Data

JANUARY 18, 2021

The European sales and marketing infrastructure is being put in place to be ready for commercial launch as early as the beginning of 2022. At the same time, we continue to prepare for the filing of the Biologics License Application with the U.S. Temporary Authorization for Use (ATU) of LUMEVOQ ®. GenSight Biologics S.A.

Treatment 40

Treatment Therapies Clinical Trials Marketing 40

The Pharma Data

APRIL 27, 2023

It is also an off-the-shelf therapy, meaning that people do not have to wait for cell collection and genetic engineering before starting treatment, which could be particularly important for patients who are at a high-risk of their disease progressing. “New Columvi has the potential to change the current standard of care in DLBCL.

Therapies 40

Therapies Treatment Clinical Development FDA 40

The Pharma Data

MARCH 27, 2022

In February 2022, the U.S. European Union and Japan in 2022. “In 2022, OLUMIANT could become the first medicine ever approved to treat adults with alopecia areata. OLUMIANT, a once-daily, oral JAK inhibitor was discovered by Incyte and licensed to Lilly. Lilly expects regulatory decisions in the U.S.,

Licensing 40

Licensing Licensing Disease FDA Approval 40

The Pharma Data

NOVEMBER 24, 2020

Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. The study aims to conclude in the beginning of 2022.

FDA 40

FDA Clinical Trials Drugs Therapies 40

The Pharma Data

MAY 2, 2022

Under the terms of the settlement agreement, the litigation between the parties in the United States District Court for the District of New Jersey will be ended, and Lupin will have a license to sell its generic product beginning April 2033, or earlier under certain circumstances. On March 9, 2022, the U.S.

Pharmaceuticals 52

Pharmaceuticals Production Treatment Disease 52

Drug Target Review

JUNE 3, 2024

Results from these preclinical studies were published in the peer-reviewed publication, Journal of Immunology in August 2022 as a “Top Read” article. Could you explain the development of CNP-108 for T cell immunogenicity in gene therapy, and how it induces the immune system to build a tolerance to gene therapy treatments?

Disease 49

Disease Therapies Pharmaceuticals Clinical Trials 49

The Pharma Data

JULY 21, 2021

Biovac will obtain drug substance from facilities in Europe, and manufacturing of finished doses will commence in 2022. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

New Drug Approvals

APRIL 18, 2025

2] The US Food and Drug Administration (FDA) granted the application for crinecerfont fast track , breakthrough therapy , orphan drug , and priority review designations. [2] New Drug Therapy Approvals 2024 (PDF). 1 November 2022). 17 February 2022). 1] [2] [5] Names Crinecerfont is the international nonproprietary name.

FDA 62

FDA FDA Approval Drugs Trials 62

The Pharma Data

JULY 23, 2021

These doses are expected to be delivered from October 2021 through April 2022. The companies expect to deliver 110 million of the additional doses by December 31, 2021, with the remaining 90 million doses to be delivered no later than April 30, 2022. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.

Vaccine 52

Vaccine Government Immune Response FDA 52

New Drug Approvals

APRIL 19, 2025

21 December 2022. 24 August 2022. New Drug Therapy Approvals 2024 (PDF). “Metoprolol Therapy and CYP2D6 Genotype” In Pratt VM, McLeod HL, Rubinstein WS, et al. Further reading Shiga T (June 2022). . ^ “Details for: Sibboran” Health Canada. 20 November 2023. Retrieved 2 April 2024.

FDA 62

FDA Clinical Trials Treatment Trials 62

The Pharma Data

JANUARY 10, 2021

Depending on the development of the escalating COVID-19 pandemic in the United States and on the resulting impact on enrollment, the Company expects to complete enrollment of this study in 2022 enabling a potential Biologics License Application (BLA) submission by 2023 under the accelerated approval pathway.

Therapies 40

Therapies Treatment Trials Disease 40

New Drug Approvals

OCTOBER 24, 2023

“Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies” Lancet. July 2022). . | Facebook Twitter FACEBOOK join me on twitter Anthony Melvin Crasto Dr. | twitter +919321316780 call whatsaapp EMAIL. 401 (10383): 1159–1171.

FDA 57

FDA FDA Approval International Pharmacokinetics 57

Agency IQ

JANUARY 12, 2024

FDA received its most recent statutory authority to collect fees through PDUFA VII on September 30, 2022, when it passed user fee reauthorization as part of the Continuing Resolution to fund the federal government. According to Downey, the timeline of pre-license inspections for biologics can create challenges.

FDA 40

FDA Drugs Production Licensing 40

The Pharma Data

DECEMBER 30, 2020

31, 2020 /PRNewswire/ — ImmVira Group Company (“the Company”), a biotechnology platform dedicated to the development of oncolytic virus(“OV”) and vector type approaches to create more effective and safer therapies against cancer, announced today the signing of Series C financing.

Virus 40

Virus International Trials Clinical Trials 40

The Pharma Data

OCTOBER 27, 2020

Nasdaq: MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced it has completed the enrollment stage of its NexoBrid ® Phase 3 pediatric clinical study (CIDS – Children Innovation Debridement Study). “We YAVNE, Israel, Oct.

Clinical Trials 40

Clinical Trials Licensing Licensing FDA 40

New Drug Approvals

DECEMBER 16, 2023

August 2022). . | Facebook Twitter FACEBOOK join me on twitter Anthony Melvin Crasto Dr. | twitter +919321316780 call whatsaapp EMAIL. 5 December 2023. . ^ [link] Archived 10 December 2023 at the Wayback Machine This article incorporates text from this source, which is in the public domain. 6 (15): 4450–4460. doi : 10.1182/bloodadvances.2022006960.

FDA 62

FDA Small Molecule FDA Approval Treatment 62

The Pharma Data

JANUARY 10, 2021

The company submitted its Biologic License Application to the FDA which has set a Prescription Drug User Fee Act (PDUFA) date for June 25, 2021. Guided by its core values of patients, science and passion, the company utilizes its TransCon technologies to create new and potentially best-in-class therapies. ?.

Clinical Trials 40

Clinical Trials Clinical Development Small Molecule Trials 40

The Pharma Data

MAY 15, 2023

Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Vabysmo® (faricimab) for the treatment of macular edema following retinal vein occlusion (RVO). 1,2 Vabysmo’s safety profile was consistent with previous trials. Review by other regulatory authorities is ongoing.

Treatment 40

Treatment FDA Therapies Clinical Development 40

Agency IQ

AUGUST 2, 2024

By Alexander Gaffney, MS, RAC | Aug 31, 2022 6:50 PM CDT | Updated Jul 29, 2024 9:45 PM CDT What we expect to be talking about in August and September The end of the fiscal year (and a budget showdown or shutdown) : The last day of the government’s fiscal year is September 30, which will mark an especially busy period for the FDA.

FDA 40

FDA Science Regulations Biosimilars 40