Fierce Pharma

DECEMBER 13, 2024

Even though AI-designed drugs arent yet a household term for FDA-approved, commercially available therapies, they are a reality in clinical development pipelines.

FDA Approval 82

FDA Approval Clinical Development Drugs Development 82

Pharmaceutical Technology

MARCH 30, 2023

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research and the Lupus Accelerating Breakthroughs Consortium (Lupus ABC) have launched the Lupus Research Alliance (LRA) in a bid to advance research for the condition. Asian, Hispanic, and Native American women are also at higher risk.

Development 162

Development Drugs FDA Approval Clinical Development 162

BioSpace

NOVEMBER 2, 2021

Food and Drug Administration accepted Investigational New Drug Applications for multiple companies, clearing the way for clinical development. This week, the U.S.

FDA Approval 77

FDA Approval Drugs Clinical Development Development 77

XTalks

DECEMBER 10, 2021

Zavegepant is an antibody drug that prevents binding of the calcitonin gene-related peptide (CGRP) to the CGRP receptor. CGRP receptor antagonists are a new class of antibody drugs used for migraine treatment. Related: Nerivio: New Drug-Free Wearable Technology Used to Treat Migraines.

FDA Approval 98

FDA Approval Trials Drugs Sales 98

Pharmaceutical Technology

AUGUST 18, 2022

The US Food and Drug Administration (FDA) has granted approval for bluebird bio ’s Zynteglo (betibeglogene autotemcel, beti-cel) for the treatment of the underlying genetic cause of beta?thalassemia thalassemia in adult and paediatric patients.

Gene Therapy 246

Gene Therapy Gene Genotype In-Vivo 246

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 88

FDA Approval Drugs Clinical Development Development 88

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.

FDA Approval 96

FDA Approval Drugs Trials Development 96

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.

FDA Approval 102

FDA Approval Clinical Trials Clinical Trials Trials 102

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.

FDA Approval 98

FDA Approval Drugs Clinical Development Development 98

pharmaphorum

SEPTEMBER 3, 2020

UK biotech Compass Pathways is planning a $100 million US IPO as it seeks to further develop its depression treatment based on psilocybin – an active ingredient that can be found in magic mushrooms. The post Compass plans $100m IPO to fund magic mushroom depression drug appeared first on.

Drugs 116

Drugs Life Science Clinical Development Regulation 116

pharmaphorum

AUGUST 10, 2020

Roche is hoping to undercut hugely expensive rivals after the FDA approved its oral spinal muscular atrophy (SMA) drug Evrysdi (risdiplam). The FDA approved Evrysdi for the treatment of spinal muscular atrophy (SMA) in adults and children two months of age and older. Zolgensma costs about $2.1m

FDA Approval 59

FDA Approval Drugs Gene Therapy Protein 59

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.

Development 147

Development Drugs Clinical Trials Clinical Trials 147

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.

FDA Approval 78

FDA Approval Drugs Trials Development 78

Pharmaceutical Technology

FEBRUARY 8, 2023

This document delved into aspects related to manufacturing, preclinical, and clinical trial design for all phases of clinical development. In 2022, 54% of FDA new drug approvals were for rare diseases , a significant increase in proportion of approvals in the recent years.

Gene Therapy 264

Gene Therapy Gene Trials Clinical Trials 264

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 92

FDA Approval Branding Development Drugs 92

Outsourcing Pharma

JULY 19, 2024

Phathom Pharmaceuticals, Inc.dedicated to developing and commercializing treatments for gastrointestinal (GI) diseases, announced today that the US Food and Drug Administration (FDA) has approved Voquenza (vonoprazan) 10mg tablets for the relief of heartburn associated with non-erosive gastroesophageal reflux disease (non-erosive GERD) in adults.

FDA Approval 88

FDA Approval Development Drugs Clinical Development 88

Pharmaceutical Technology

JUNE 7, 2023

The US Food and Drug Administration (FDA) has granted approval for a new indication for Merck’s PREVYMIS (letermovir) to prevent cytomegalovirus (CMV) disease in high-risk adult kidney transplant recipients. The latest move follows a priority review of a supplemental new drug application (sNDA) for the therapy.

FDA Approval 130

FDA Approval Clinical Development Drugs Medicine 130

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 81

FDA Approval Branding Development Drugs 81

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.

FDA Approval 85

FDA Approval Drugs Clinical Development Development 85

XTalks

JANUARY 6, 2025

Just before the end of 2024, Novo Nordisk nabbed US Food and Drug Administration (FDA) approval for its awaited hemophilia drug Alhemo (concizumab-mtci). In 2020, the FDA ordered Novo to pause clinical trials of the drug following reports of blood clots in three patients.

FDA Approval 105

FDA Approval Antibody Drugs Clinical Trials 105

The Pharma Data

JUNE 2, 2023

Food and Drug Administration (FDA) for the treatment of adult patients with deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). Patients should be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA. In the U.S., For the U.S.

FDA Approval 52

FDA Approval HR Trials Hormones 52

pharmaphorum

SEPTEMBER 21, 2020

Compass Pathways and its potential magic mushroom depression drug went public last week – and now psychedelic therapy firm Mind Medicine is aiming to follow suit by up-listing its shares on the Nasdaq. UK-based Compass has a patented synthetic version of psilocybin, the active ingredient in magic mushrooms, and raised around $127.5

Medicine 134

Medicine FDA Approval Clinical Trials Clinical Trials 134

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.

FDA Approval 91

FDA Approval Development Drugs Clinical Development 91

Pfizer

JULY 8, 2022

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. Favorable safety profile observed across more than 2,200 adolescents who participated in the clinical trial. INTERCHANGEABILITY.

FDA Approval 102

FDA Approval Vaccination Vaccine Clinical Trials 102

pharmaphorum

DECEMBER 21, 2021

Novartis has joined the ranks of big pharma companies developing TIGIT-targeted drugs for cancer, and found its candidate in an existing partner, Chinese biotech BeiGene. billion in milestones – shortly after its own PD-1 drug candidate spartalizumab failed a phase 3 trial in melanoma.

Drugs 98

Drugs Antibody Pharma Companies Development 98

XTalks

JANUARY 6, 2021

Psychedelic drugs are rapidly becoming mainstream as various research supports their effectiveness in alleviating mental health problems. Psychedelic drugs such as LSD, psilocybin, ketamine and more are being studied to explore their effects on mental illnesses, like depression. Compass Pathways.

Drugs 97

Drugs Clinical Trials Clinical Trials Medicine 97

XTalks

JUNE 17, 2024

Hugel, a Korean medical aesthetics company, recently announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its botulinum toxin, Letybo (letibotulinumtoxinA-wlbg), for the treatment of glabellar lines. 134 How Does Letybo Work?

FDA Approval 52

FDA Approval Marketing Botox Clinical Trials 52

XTalks

JANUARY 22, 2025

Valneva SE, who developed the worlds first FDA-approved chikungunya vaccine , has now unveiled promising Phase III data for its single-shot chikungunya vaccine, IXCHIQ, in adolescents aged 12 to 17. Approval in Brazil would mark the vaccines first use in a region where chikungunya is widespread.

Immune Response 59

Immune Response Vaccination Vaccine Trials 59

Pharmaceutical Technology

OCTOBER 25, 2022

Understanding both the significant competitive advantages that FDC products can offer, and the difficulties and potential pitfalls associated with development and manufacturing of FDC drugs in oral solid dosage forms is a critical first step for companies exploring this approach. Of those 131 approved FDCs, 98 were oral dosage forms.

Manufacturing 130

Manufacturing Production Packaging Packaging 130

The Pharma Data

AUGUST 31, 2021

Food and Drug Administration (FDA) has converted this indication from an accelerated to a full (regular) approval. 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.

FDA Approval 52

FDA Approval Containment Clinical Development Trials 52

XTalks

JULY 3, 2023

The US Food and Drug Administration (FDA) has given its approval to Suflave, a colonoscopy preparation product developed by Braintree Laboratories, a division of Sebela Pharmaceuticals. How Can Suflave Boost Patient Compliance? Sabela Pharmaceuticals says the product will be available by prescription starting in August.

FDA Approval 97

FDA Approval Compliance Clinical Trials Clinical Trials 97

BioPharma Reporter

OCTOBER 22, 2024

The FDA has simultaneously granted approval to Astellasâ cancer drug Vyloy and to a companion diagnostic test developed by Roche.

FDA Approval 52

FDA Approval Development Drugs Clinical Development 52

Pharmaceutical Technology

FEBRUARY 24, 2023

Amivantamab is under clinical development by Johnson & Johnson and currently in Phase I for Colorectal Cancer. According to GlobalData, Phase I drugs for Colorectal Cancer have a 76% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. The drug candidate is a new molecular entity (NME).

Recombinant DNA Technology 100

Recombinant DNA Technology Production Antibody FDA Approval 100

pharmaphorum

MAY 13, 2021

There are already several drugs on the market to treat Duchenne, notably from Sarepta Therapeutics which has three FDA-approved drugs that use “exon skipping” technology. Sarepta is also developing a DMD gene therapy, although it’s a step behind Pfizer in mid-stage clinical development.

Gene Therapy 102

Gene Therapy Gene Trials Protein 102

pharmaphorum

SEPTEMBER 20, 2021

Samsung Bioepis and Biogen have claimed the first FDA approval for a biosimilar version of Roche and Novartis’ Lucentis (ranibizumab) for leading causes of blindness, raising the prospect of a cheaper treatment option for US patients. billion in sales from the drug while Novartis made $2.1 billion, but fell back to $1.4

Drugs 72

Drugs Sales FDA Approval Marketing 72

The Pharma Data

JANUARY 6, 2021

The research collaboration is aimed at identifying novel lead compounds and repurposing existing drugs for rheumatoid arthritis and nonalcoholic steatohepatitis, leveraging Standigm’s AI-powered drug discovery platforms : Standigm BEST , Standigm Insight , and Standigm ASK. Standigm is an AI-driven drug discovery company.

FDA Approval 52

FDA Approval Life Science Drugs In-Vivo 52

pharmaphorum

MARCH 10, 2021

With so many novel drug candidates for Alzheimer’s disease failing in clinical development, researchers in the US have started using artificial intelligence (AI) to screen already-approved therapies for activity against the neurodegenerative disorder. .

Clinical Trials 94

Clinical Trials Clinical Trials Trials Drugs 94