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

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

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

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.

Manufacturing 130

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

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.

Vaccination 97

Vaccination Vaccine FDA Approval Development 97

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

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

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

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

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

Pharmaceutical Technology

APRIL 17, 2023

In December 2021, the US Food and Drug Administration (FDA) approved argenx’s Vyvgart for the treatment of myasthenia gravis in December 2021, marking the company’s first approval. Vyvgart is also the first FDA-approved neonatal Fc receptor (FcRN) antagonist. Please check your email to download the Report.

Antibody 130

Antibody Engineer FDA Approval Development 130

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.

Production 98

Production Marketing Development Pharmacy 98

pharmaphorum

NOVEMBER 19, 2020

Novartis/Genentech’s eye drug Lucentis could be the next big blockbuster to face competition from cheaper biosimilars after its US patent expired this year – and Samsung Bioepis and Biogen are closing in after the FDA accepted a filing for their cut-price rival.

FDA Approval 64

FDA Approval Marketing Drugs Clinical Development 64

XTalks

JANUARY 6, 2021

However, there was a pause in developments in this field after psychedelic research was banned in the late 1960s. Nevertheless , in recent analyses, the psychedelic drug market in North America is expected to grow with a CAGR of 15.8 Other Psychedelic Drug Developers. Johnson & Johnson and Field Trip Health.

Drugs 97

Drugs Clinical Trials Clinical Trials Medicine 97

pharmaphorum

DECEMBER 21, 2021

BeiGene was also the developer of Novartis’ PD-1 inhibitor tislelizumab , which was filed for FDA approval in September as a second-line treatment for oesophageal cancer. BeiGene will also promote some Novartis cancer drugs in China, helping to firm up Novartis’ presence in the country’s sizeable cancer market.

Drugs 98

Drugs Antibody Pharma Companies Development 98

The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.

Licensing 52

Licensing Licensing Vaccination Vaccine 52

XTalks

JULY 31, 2024

Leqselvi is the second oral drug approved for severe alopecia areata after Pfizer’s Litfulo (ritlecitinib) last year. Related: Pfizer’s Newly Approved Litfulo to Take on Eli Lilly’s Olumiant in Growing Alopecia Market So, what is alopecia areata?

Immune Response 105

Immune Response Dermatology Clinical Trials Clinical Trials 105

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.

Drugs 72

Drugs Sales FDA Approval Marketing 72

The Pharma Data

SEPTEMBER 29, 2020

The FDA approval is based on data from a clinical development programme that included positive results from a pivotal phase 3 study. HES is a rare and under-diagnosed disorder which is characterised by persistent and market overproduction of eosinophils, a type of white blood cell.

FDA Approval 52

FDA Approval Clinical Development Marketing Development 52

pharmaphorum

NOVEMBER 10, 2021

The agreement includes a sizeable $500 million upfront payment, reflecting that Nurtec ODT (rimegepant) is already FDA-approved for treating acute migraine with and without aura in adults, and for prevention of episodic migraine in patients who suffer less than 15 headache days per month.

Licensing 52

Licensing Licensing Drugs Sales 52

pharmaphorum

JANUARY 30, 2022

The FDA has approved Roche’s much-anticipated faricimab for two major causes of blindness, setting up a market clash with Bayer and Regeneron’s market leading drug Eylea. Analysts at GlobalData think that faricimab and another Roche-developed product will be the main derivers of the market in the coming years.

Drugs 52

Drugs Marketing Sales FDA Approval 52

Pharmaceutical Technology

APRIL 5, 2023

More than a decade after the first patient was treated with a CAR-T therapy, six therapies relying on the same principles have been approved by the US Food and Drug Administration (FDA) and marketed to thousands of patients. It will be six years since the US FDA approval of Kymriah in August this year.

Gene Therapy 147

Gene Therapy Gene Engineer Production 147

pharmaphorum

AUGUST 31, 2022

It is actually the control formulation used in clinical development of its original product MED2005, which contained glyceryl trinitrate as an active ingredient. However, “the USA remains the largest market opportunity globally for ED treatments,” said Futura’s chief executive, James Barder.

Drugs 52

Drugs FDA Approval Production Marketing 52

XTalks

JUNE 20, 2023

Columvi is Roche’s second CD20xCD3 T-cell engager to enter the market after the company’s Lunsumio was first approved as a third-line therapy for follicular lymphoma in December 2022. As part of the accelerated approval, Roche will have to conduct confirmatory trials for Columvi.

Antibody 98

Antibody Trials Drugs FDA Approval 98

XTalks

AUGUST 9, 2023

According to information shared by brain health disorders-focused biotech Sage in a press release announcing Zurzuvae’s FDA approval, approximately half of all PPD cases may go undiagnosed without appropriate screening. The companies were banking on an approval in the MDD indication to make up a large chunk of Zurzuvae’s market share.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Trials 52

Delveinsight

AUGUST 21, 2020

Interstitial Cystitis market comprises robust pipeline therapies in late and mid-stage development, which are expected to be launched shortly, such as KRP-116D (Kyorin Pharmaceutical), Certolizumab pegol/ Cimzia (UCB Pharma), LP-08 (Lipella Pharmaceuticals), GRT6010 (Grünenthal), ASP6294 (Astellas Pharma), and SI-722 (Seikagaku Corporation).

Drugs 52

Drugs Marketing Trials Production 52