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

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

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

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 FDA Approval Trials Clinical Development 54

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 Vaccination Vaccine Genetics 147

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 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

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

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

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

AUGUST 15, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson announced yesterday that the US Food and Drug Administration (FDA) has granted marketing authorization for its combination treatment Akeega for metastatic castration-resistant prostate cancer (mCRPC) with BRCA1/2 mutations.

FDA Approval 52

FDA Approval Gene Hormones Licensing 52

The Pharma Data

JULY 12, 2021

“With our longstanding expertise in innovative science in the cardiovascular space, today’s approval of finerenone marks an important milestone in Bayer’s commitment to improving the lives of patients with kidney and cardiovascular diseases.”. FDA has approved finerenone for marketing authorization in the U.S.

FDA Approval 52

FDA Approval Cardiology Medicine Trials 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.

Vaccination 103

Vaccination Vaccine Sales Clinical Development 103

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

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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Production Marketing Development Pharmacy 98

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 96

Trials Clinical Trials Clinical Trials FDA Approval 96

The Pharma Data

OCTOBER 14, 2020

WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. WAKIX received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019.

FDA Approval 52

FDA Approval Hormones Production Drugs 52

Roots Analysis

MARCH 9, 2023

In recent years, several drugs targeting rare kidney disorders have received the FDA approval; therapies in the current pipeline are being developed to target ~15 disease indications. The below figure presents the distribution of drugs indicated for rare kidney disorder, based on their phase of development.

Drugs 52

Drugs FDA Approval Marketing Development 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 97

Gene Therapy Gene Trials Protein 97

XTalks

NOVEMBER 9, 2023

Eli Lilly is now fully armed on the GLP-1 front as it’s finally received US Food and Drug Administration (FDA) approval for Zepbound (tirzepatide), its obesity version of Mounjaro. The FDA approved Zepbound for chronic weight management in adults with obesity. Ozempic was approved in 2017 and Wegovy in 2021.

FDA Approval 59

FDA Approval Manufacturing Drugs Pharmacy 59

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

Roots Analysis

DECEMBER 18, 2023

Entry of the First Peptide Receptor Radionuclide Therapy into the Market Advanced Accelerator Applications (now part of Novartis), Oncopeptides, Endocytes, and Alnylam Pharmaceuticals were pioneers in adopting this innovative concept. Pluvicto® received the FDA approval in March 2022 and the EMA approval in December 2022.

Drugs 40

Drugs FDA Approval Antibody Development 40

The Pharma Data

MARCH 28, 2022

The FDA approval is based on the results from the SUSTAIN FORTE trial. We are pleased with the FDA approval for a higher 2.0 mg dose of Ozempic ® , which further supports our purpose of driving change in diabetes care” said Martin Lange, executive vice president, Development at Novo Nordisk. Ozempic ® 2.0

FDA Approval 52

FDA Approval Trials Clinical Trials Clinical Trials 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

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 62

FDA Approval Marketing Drugs Clinical Development 62

Drug Discovery World

NOVEMBER 23, 2023

As part of CALYX, Minoryx is conducting an extensive pre-screening MRI-based campaign aimed at identifying eligible adult X-linked Adrenoleukodystrophy (X-ALD) patients with cALD. In June 2023, the US Food and Drug Administration (FDA) approved CALYX’s trial of leriglitazone to treat adult male X-ALD patients with cALD.

Trials 52

Trials Clinical Trials Clinical Trials FDA Approval 52

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

APRIL 9, 2021

Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories said in a statement that the data marked the first time an anti-PD-1 therapy showed potential adjuvant treatment for patients with RCC.

FDA Approval 57

FDA Approval Trials Clinical Development Drugs 57

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 70

Drugs Sales FDA Approval Marketing 70

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

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

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.

Development 40

Development Drugs Trials FDA Approval 40

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 87

FDA Approval Drugs Trials Clinical Trials 87

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 80

Marketing Gene Silencing Gene Drugs 80