Outsourcing Pharma

DECEMBER 19, 2023

The US Food and Drug Administration (FDA) has approved a topical foam developed by Arcutis Biotherapeutics and branded as Zoryve for the skin condition seborrheic dermatitis in people aged nine years and up.

FDA Approval 73

FDA Approval Branding Development Drugs 73

Drug Discovery World

MAY 15, 2023

We are excited to support the acceleration of CytoAgents’ clinical development efforts and look forward to generating meaningful clinical data in patients.” CytoAgents anticipates the clinical trial to launch at its first trial site in the summer of 2023.

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Outsourcing Pharma

DECEMBER 18, 2023

The oral treatment belzutifan, developed by MSD (known as Merck in the US) and branded as Welireg, has received the green light from the US Food and Drug Administration (FDA) for the treatment of an advanced form of renal cell carcinoma (RCC).

FDA Approval 83

FDA Approval Branding Development Drugs 83

pharmaphorum

MAY 16, 2022

The findings were made via Lilly’s SURPASS phase 3 global clinical development programme, which comprised studies ranging from 40 to 52 weeks. These examined Mounjaro in 5mg, 10mg and 15 mg doses in five clinical trials, used either as a stand-alone therapy or as an add-on to other diabetes medicines.

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FDA Approval Insulin Drugs Hormones 109

Drug Discovery World

SEPTEMBER 20, 2022

SKYSONA has become the first FDA approved therapy to slow the progression of neurologic dysfunction in boys with cerebral adrenoleukodystrophy (CALD). The post FDA approves gene therapy for rare neurological disorder appeared first on Drug Discovery World (DDW).

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Gene Therapy FDA Approval Gene Clinical Trials 52

Outsourcing Pharma

DECEMBER 14, 2023

Mission Therapeutics, a clinical-stage biotech developing first-in-class therapeutics targeting mitophagy, has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) to proceed with a phase 2 trial for its kidney treatment MTX652.

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FDA Approval Drugs Trials Development 90

Pharmaceutical Technology

SEPTEMBER 23, 2022

While a handful of therapies have launched since then, late-stage pipeline therapies that are currently in development reveal that drug developers are exploring a broad set of mechanisms of action (MOAs), many of which are innovative, to tackle DES.

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Outsourcing Pharma

DECEMBER 14, 2023

Mission Therapeutics, a clinical-stage biotech developing first-in-class therapeutics targeting mitophagy, has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) to proceed with a phase 2 trial for its kidney treatment MTX652.

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FDA Approval Drugs Trials Development 69

Outsourcing Pharma

NOVEMBER 13, 2023

A small molecule, oral targeted therapy for adults with metastatic colorectal cancer (CRC) has been approved by the US Food and Drug Administration (FDA).

FDA Approval 78

FDA Approval Drugs Clinical Development Development 78

Outsourcing Pharma

FEBRUARY 19, 2024

Patients in the US with epidermal growth factor receptor mutated (EGFRm) advanced lung cancer can now receive an important new treatment option delaying disease progression by nearly nine additional months.

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FDA Approval Clinical Development Development 79

The Pharma Data

NOVEMBER 30, 2020

Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. is undertaking clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. GAITHERSBURG, Md., Source link.

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The Pharma Data

JUNE 28, 2023

FDA Approves Pfizer’s NGENLA™, a Long-Acting Once-Weekly Treatment for Pediatric Growth Hormone Deficiency NEW YORK & MIAMI–(BUSINESS WIRE)– Pfizer Inc. NGENLA is approved for the treatment of pediatric GHD in more than 40 markets including Canada, Australia, Japan, and EU Member States.

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Hormones FDA Approval Clinical Development Medicine 40

pharmaphorum

OCTOBER 5, 2020

The FDA has approved Opdivo (nivolumab) and Yervoy (ipilimumab), as the first and only immunotherapy for previously untreated unresectable malignant pleural mesothelioma. The post FDA approves BMS’ Opdivo and Yervoy combination in first-line mesothelioma appeared first on.

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FDA Approval Trials Clinical Development Development 59

Outsourcing Pharma

SEPTEMBER 18, 2023

The small molecule drug Ojjaara (momelotinib), developed by GlaxoSmithKline, has become the first U.S. Food and Drug Administration (FDA)-approved treatment for patients with the blood cancer myelofibrosis and anemia.

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FDA Approval Development Drugs Clinical Development 81

Delveinsight

SEPTEMBER 9, 2021

A collaboration valued more than USD 3 billion, Genentech, a member of the Roche Group, declared it will collaborate with Adaptimmune for developing and commercializing allogeneic T-cell therapies to treat multiple cancer indications. TransMedics receives FDA approval for its OCS heart system.

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FDA Approval Development Research Production 73

pharmaphorum

MAY 30, 2022

Despite this, the first-ever FDA-approved KRAS G12C inhibitor has demonstrated that RAS is in fact druggable and that drugging this protein unlocks a world of successful therapeutic interventions. Continuing to advance valuable combination therapies into the clinic, and finally, crack resistance to RAS targeted therapeutics.

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Development Drugs FDA Approval Clinical Trials 52

XTalks

DECEMBER 10, 2021

Zavegepant has an advantage over the two as it’s the only CGRP receptor antagonist in both intranasal spray and oral pill formulations that is in clinical development for the treatment of acute or episodic migraines.

FDA Approval 98

FDA Approval Trials Drugs Sales 98

Outsourcing Pharma

NOVEMBER 16, 2023

The first and only enzyme replacement therapy for the treatment of a very rare and complex blood disorder has been approved by the US Food and Drug Administration.

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FDA Approval Drugs Clinical Development Development 76

The Pharma Data

MAY 26, 2023

Pfizer’s PAXLOVID™ receives FDA approval for adult patients at high risk of progression to severe COVID-19 Pfizer Inc. NYSE: PFE) announced today that the U.S. ” COVID-19 continues to cause significant burden in the U.S. Source link: [link]

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FDA Approval HR Vaccination Vaccine 40

Pharmaceutical Technology

JUNE 7, 2023

In 2017, the therapy received FDA approval for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant. The drug is given once a day as an oral tablet or as an injection for intravenous infusion.

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FDA Approval Clinical Development Drugs Medicine 130

BioPharma Reporter

AUGUST 2, 2021

The drug, intended for adult patients with moderate-to-severe systemic lupus erythematosus, is the only new therapy approved for SLE in more than a decade.

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FDA Approval Drugs Clinical Development Development 98

The Pharma Data

AUGUST 31, 2021

10), as determined by an FDA-approved test, or in patients who were not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication was approved under accelerated approval based on tumor response rate and duration of response.

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FDA Approval Containment Clinical Development Trials 52

The Pharma Data

OCTOBER 21, 2020

and Shionogi Limited as shareholders, today announced the positive findings of a pooled analysis of COVID-19-related impacts across the investigational long-acting cabotegravir and rilpivirine clinical development programme. Related Articles: Cabenuva (cabotegravir and rilpivirine) FDA Approval History. Source: GSK .

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Clinical Development Development Medicine Clinical Trials 52

Outsourcing Pharma

JANUARY 25, 2022

The agency has given the go-ahead on an IND application for a study evaluating Ananda Scientificâs Nantheia ATL5, a candidate for treating opioid use disorder.

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FDA Approval Clinical Trials Clinical Trials Trials 95

The Pharma Data

JUNE 7, 2023

FDA Approves New Indication for Merck’s PREVYMIS® (letermovir) for Prevention of Cytomegalovirus (CMV) Disease in High-Risk Adult Kidney Transplant Recipients Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Source link: [link]

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FDA Approval Drugs Clinical Development Medicine 40

XTalks

AUGUST 5, 2022

ChemoCentryx made its way into news in October 2021 when it clenched its first ever US Food and Drug Administration (FDA) approval in 24 years for the drug Tavneos (avacopan) for patients with serious autoimmune disease. The sale of Tavneos has been approved in the US, European Union, Canada and Japan.

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Development FDA Approval Sales Drugs 52

Outsourcing Pharma

AUGUST 8, 2023

A new treatment option for adults with metastatic colorectal cancer (mCRC) could âchange the landscapeâ for those with the disease.

FDA Approval 52

FDA Approval Clinical Development Development 52

Pharmaceutical Technology

MARCH 1, 2023

The Covid-19 pandemic led to massive developments and scientific advances within the field of messenger ribonucleic acid (mRNA) vaccines. Pfizer /BioNTech and Moderna’s mRNA-based vaccines were the first to receive emergency use authorisation (EUA) out of all other Covid-19 vaccines under development in late 2020.

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The Pharma Data

AUGUST 16, 2020

First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. First and only approved therapy for NMOSD designed to target and inhibit interleukin-6 receptor activity, using novel recycling antibody technology.

FDA Approval 52

FDA Approval Antibody Clinical Trials Clinical Trials 52

The Pharma Data

AUGUST 24, 2020

In a paper published in Molecular Therapy: Methods & Clinical Development , the team discussed why they choose this type of gene therapy to treat HIV. They said: “Recent studies in HIV controllers highlighted the importance for HIV-specific CD4 T cells in controlling HIV replication and disease progression.

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Gene Therapy Gene FDA Approval Trials 52

Roots Analysis

NOVEMBER 3, 2023

Despite their potential therapeutic benefits, NAMPT inhibitors have faced several challenges in clinical development. One of the main challenges is the development of drug resistance, as cancer cells can develop mechanisms to bypass the inhibition of NAMPT.

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Pharmaceutical Technology

AUGUST 5, 2022

The US Food and Drug Administration (FDA) approved Lynparza in March for this indication. A PARP inhibitor, Lynparza (olaparib) is said to be the first targeted therapy to hinder DNA damage response in cells/tumours with a deficiency in homologous recombination repair.

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FDA Approval DNA Clinical Trials Clinical Trials 147

pharmaphorum

MARCH 23, 2022

Merck & Co’s chief medical officer and head of clinical development Dr Roy Baynes has announced his retirement from the company to take up a new role alongside his former colleague Roger Perlmutter at biotech Eikon Therapeutics. billion last year.

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Clinical Development FDA Approval Vaccination Vaccine 97

Pfizer

AUGUST 3, 2022

Pfizer to Discontinue Development Program for PF-07265803 for LMNA-Related Dilated Cardiomyopathy. Pfizer to Discontinue Development Program for PF-07265803 for LMNA-Related Dilated Cardiomyopathy. Based on these results, the Phase 3 trial and further development of PF-07265803 will be discontinued. deliesschef.

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Development Vaccination Vaccine Production 101

The Pharma Data

OCTOBER 31, 2020

Currently the market is comprised primarily of the neuraminidase inhibitor oseltamivir and the newly developed endonuclease inhibitor baloxavir. TaiGen’s TG-1000 is poised to take full advantage of this development. About TaiGen Biotechnology. View original content: [link]. SOURCE TaiGen. Source link.

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FDA Approval Marketing Clinical Development Development 52

Outsourcing Pharma

JULY 7, 2023

It has the highest mortality rate of any psychiatric disorder, yet there is currently no FDA approved therapy for the condition. Anorexia nervosa is a notoriously difficult illness to treat.

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FDA Approval Clinical Development Development 74

XTalks

OCTOBER 31, 2023

GSK hopes to ramp up uptake of its newly minted RSV vaccine, which received approval from Health Canada in August this year after its US Food and Drug Administration (FDA) approval in May. Attendees will learn how innovative technologies and automation contribute to the advancement of vaccine development.

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Vaccination Vaccine FDA Approval Development 97