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. We are thrilled with the FDA’s approval of Letybo.

FDA Approval 52

FDA Approval Marketing Botox 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. In the third quarter of 2021, Nurtec sales totalled $136 million , a 46 percent jump from the previous quarter.

FDA Approval 98

FDA Approval Trials Drugs Sales 98

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.

FDA Approval 59

FDA Approval Drugs Gene Therapy Protein 59

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

Pharmaceutical Technology

FEBRUARY 8, 2023

In 2020, the FDA released a guidance document for the industry with recommendations for sponsors developing gene therapies for rare diseases. This document delved into aspects related to manufacturing, preclinical, and clinical trial design for all phases of clinical development.

Gene Therapy 264

Gene Therapy Gene Trials Clinical Trials 264

Delveinsight

SEPTEMBER 9, 2021

For each component, Adaptimmune has agreed to supervise clinical candidates development by using its induced pluripotent stem cell (iPSC) derived allogeneic platform for production of T-cells (iT cells). The latest fundraising gets the total amount raised by Owlstone Medical from the market to more than USD 150 Million.

FDA Approval 73

FDA Approval Development Research Production 73

Pharmaceutical Technology

SEPTEMBER 23, 2022

While Restasis and Xiidra have been in use in the US market for a long time, both treatments have been associated with patient satisfaction issues such as a non-favorable tolerability profile and a slow onset of action. This gap in the market is what the late-stage pipeline therapies are currently targeting. Novaliq’s CyclASol (0.1%

Development 147

Development Drugs Clinical Trials Clinical Trials 147

pharmaphorum

SEPTEMBER 3, 2020

In a filing with the US financial regulator Compass laid out its plans to develop the drug known as COMP360, which is a crystalline formulation of psilocybin in phase 2b clinical development in patients who have not responded to standard therapy for depression.

Drugs 116

Drugs Life Science Clinical Development Regulation 116

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

MARCH 1, 2023

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. More importantly, they were the first mRNA vaccines to reach the market for any indication worldwide.

RNA 147

RNA Vaccine Vaccination Genetics 147

XTalks

NOVEMBER 5, 2024

Trading began on the Nasdaq Capital Market under the ticker “PLRZ” on October 29, 2024. Proceeds from the IPO will fund preclinical and clinical development for Polyrizon’s innovative hydrogel product candidates, supporting further research and development (R&D). The IPO, priced at $4.38

Drug Delivery 111

Drug Delivery Drugs Immune Response Allergies 111

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.

FDA Approval 52

FDA Approval Containment Clinical Development Trials 52

The Pharma Data

OCTOBER 31, 2020

.” According to Global Data, the global market for influenza antivirals reached 2.34 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.

FDA Approval 52

FDA Approval Marketing Clinical Development Development 52

pharmaphorum

JANUARY 5, 2022

Now, Pfizer and BioNTech are joining forces to try to grab a slice of the market. Pfizer is paying $225 million upfront to its partner to get the ball rolling on the project, including $75 million in cash and $150 million in equity, offset by $25 million from BioNTech in return for an antigen technology that will be used to develop the shot.

Vaccine 105

Vaccine Vaccination Sales Clinical Development 105

Delveinsight

MARCH 1, 2021

After decades since the passage of the Orphan Drug Act, over 500 drugs have received orphan status from the FDA. While more than 150 orphan drugs have been approved in the EU. Thus, it can be conveniently said that the Rare disease market, which was once barren land has now become fertile ground. Source: FDA ).

Marketing 52

Marketing Clinical Trials Clinical Trials Drugs 52

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

Pharmaceutical Technology

OCTOBER 25, 2022

Pharmaceutical companies – and the FDA – are embracing FDCs. From 1990 through 2013, the FDA approved 131 FDC products, on average 5.7 The potential to extend the patent life and market exclusivity of a company’s APIs is a potent financial incentive. More FDC products flowing into pharma pipelines.

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Manufacturing Production Packaging Packaging 130

Delveinsight

AUGUST 17, 2020

The Gastroparesis market size in the 7MM was found to be USD 3,170.01 million in 2019 and is anticipated to increase at a CAGR for the study period 2017-2030 owing to dynamic pipeline therapies in the mid-/ late-stage clinical development and rising gastroparesis prevalence.

Marketing 54

Marketing Trials FDA Approval Clinical Development 54

pharmaphorum

JANUARY 6, 2022

Roche’s idiopathic pulmonary fibrosis (IPF) therapy Esbriet is already being squeezed by its main rival in the market, and could come under renewed pressure if another competitor from PureTech Health gets approved. Esbriet has been playing second fiddle to Ofev in the IPF market, making blockbuster sales of $1.2

Trials 105

Trials Marketing FDA Approval Development 105

The Pharma Data

NOVEMBER 24, 2020

FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1. Food and Drug Administration (FDA) approved Oxlumo (lumasiran) injection for subcutaneous use, the first-ever therapy available for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.

FDA Approval 52

FDA Approval Production RNA Medicine 52

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

Delveinsight

JULY 20, 2021

Seegene announces partnership with Bio-Rad to develop diagnostic testing products for the US Market. for the clinical development and commercialization of infectious disease molecular diagnostic products. On July 01, 2021, Seegene Inc., D’Andrea.

FDA Approval 96

FDA Approval Marketing Trials Gene 96

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.

Hormones 40

Hormones FDA Approval Clinical Development Medicine 40

pharmaphorum

JUNE 1, 2022

The company said Imaging Lab will provide a toolkit that is increasingly relevant for new cancer therapeutics development as the biopharma industry focuses increasingly on drugs to detect and treat cancers at an earlier stage. Bringing a new cancer drug to market costs an average of $2.8 sensitivity and 93.3%

Trials 98

Trials Clinical Trials Clinical Trials FDA Approval 98

The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that the U.S. Food and Drug Administration (FDA).

FDA Approval 52

FDA Approval Genetics Clinical Trials Clinical Trials 52

Delveinsight

FEBRUARY 5, 2021

According to the CDC, in 2018, tobacco companies spent over USD 9 Billion in just promoting and marketing their cigars and cigarettes in the US. Fortunately, there exists FDA-approved therapies and drugs that double the success rates of quitting. Smoking Cessation: What are the drugs available in the market?

Marketing 52

Marketing FDA Approval Branding Production 52

The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. This approval builds upon Merck’s proud history of developing therapies for the treatment of patients with cardiovascular disease.”. Related Articles: Verquvo (vericiguat) FDA Approval History. KENILWORTH, N.J.–(BUSINESS

FDA Approval 52

FDA Approval Production Trials Development 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 .

Clinical Development 52

Clinical Development Development Medicine Clinical Trials 52

Delveinsight

NOVEMBER 29, 2020

Recent years started witnessing the emergence of novel treatment approaches that have been keeping the Retinal vein occlusion market in a hyped-up state. Looking at the potential of the pipeline therapies they hold once approved, pharmaceutical companies are charting out a seemingly exciting course in the market.

Marketing 52

Marketing Drug Delivery Pharma Companies Clinical Trials 52

Delveinsight

AUGUST 2, 2020

The dynamics of the cancer cachexia market is expected to gain momentum as several companies are testing the waters, advancing cancer cachexia pipeline. Earlier clinical evidence showcased administration of the therapy resulted in a statistically significant and dose-proportional increase in body weight.

Marketing 94

Marketing Pharma Companies Development Hormones 94

XTalks

DECEMBER 5, 2023

Other New Treatments for NSCLC on the Market The FDA has recently approved several other medications for various subsets of NSCLC patients. The encouraging results also suggest that further clinical development of unecritinib is justified, particularly for NSCLC cases involving ALK rearrangements.

Protein 115

Protein FDA Approval Medicine Trials 115

pharmaphorum

DECEMBER 23, 2020

2020 also saw some of the first “tumour agnostic” cancer drugs get to market, with Bayer’s Vitravki (larotrectinib) getting funding in the UK for tumours with confirmed neurotrophic tyrosine receptor kinase (NTRK) gene fusions.”.

Marketing 96

Marketing Gene Gene Silencing Drugs 96

pharmaphorum

JUNE 7, 2021

Biogen and Eisai have defied the naysayers and secured an historic FDA approval for their amyloid-targeting antibody aducanumab as the first-ever disease-modifying treatment for Alzheimer’s disease. The approval of aducanumab, now given the name Aduhelm, comes after a three-month extension to the FDA’s review period.

FDA Approval 89

FDA Approval Drugs Trials Clinical Trials 89

pharmaphorum

FEBRUARY 21, 2022

Oral, non-steroidal mineralocorticoid receptor (MR) antagonist Kerendia claimed its first regulatory approval in the US last summer, the culmination of several years of clinical development and a hefty investment in three large-scale clinical trials.

Drugs 122

Drugs Trials Insulin FDA Approval 122

pharmaphorum

OCTOBER 2, 2020

COMP360 is a crystalline formulation of psilocybin in phase 2b clinical development in patients who have not responded to standard therapy for depression. Compass has a patented synthetic version of psilocybin, the active ingredient in magic mushrooms, and raised around $127.5 million with its IPO shortly after the announcement.

Medicine 122

Medicine Life Science FDA Approval Development 122

The Pharma Data

JULY 8, 2021

With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.

Clinical Trials 52

Clinical Trials Clinical Trials FDA Approval Trials 52

XTalks

NOVEMBER 28, 2023

The biosimilar industry today is marked by rapid advancements, regulatory evolution and growing market acceptance. Featuring Ilsun Hong, VP and Product Evaluation Team Leader, and Thomas Newcomer, VP and Head of US Market Access at Samsung Bioepis, the discussion revolves around key developments, challenges and future trends in biosimilars.

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