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How Can Pharma Companies Simplify the Five-Phase Drug Development Process? Infiniti’s Experts Highlight the Need for Product Research Solutions

The increasing competition of the pharmaceutical industry has encouraged companies to invest in innovation and drug development. However, the drug development process is challenging, and without appropriate guidance, developers can face various roadblocks. What is the solution? Infiniti’s product research solutions enable companies to identify, evaluate, and strategize for potential roadblocks through the process. Additionally, our product research experts provide drug developers with crucial insights regarding target customers, regulatory requirements, and competitors’ strategies through the process. This further provides companies with a strategic advantage and enables them to successfully develop and launch a new drug and monitor their success efficiently. To leverage Infiniti’s product research solutions for comprehensive insights regarding the drug development process and an effective strategy, request a free proposal.

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Five Phases of the Drug Development Process (Graphic: Business Wire)

With constant technological and pharmaceutical advancements, the pharmaceutical industry is continually becoming more competitive and challenging. Pharmaceutical companies need to focus on innovation and stay ahead of the curve to acquire and maintain market share successfully. Therefore, many pharma companies and researchers have shifted focus on drug development. The drug development process is long drawn and includes multiple phases. It is a five-phase process in the United States and acquiring regulatory approval from the Food and Drug Administration (FDA) is extremely challenging. Therefore, Infiniti’s experts decided to simplify the five-phase drug development process and discuss the value of product research solutions during every stage of the process in their recent article.

Gain comprehensive insights into the five phases of the drug development process and the value of product research solutions by reading the complete article here.

“Although the drug development process becomes easier with more available resources, workforce, and a better understanding of the regulatory requirements, many major pharma companies may still struggle to complete the process without experts’ guidance,” says a pharmaceutical industry expert at Infiniti Research.

Infiniti’s product research experts discussed the following five phases of the drug development process:

  • Discovery and development of a particular compound that elicits a desirable effect on the druggable target for any disease and developing a drug candidate

  • Preclinical research involves testing of the drug candidate on an animal species with similar genetic makeup as humans and gaining an understanding of the dosage and toxicity levels

  • Designing a clinical trial, developing a protocol, and submitting an IND application is part of the third phase of the drug development process

  • The relevant information procured from the preclinical and clinical research is submitted to the FDA for review, and it is either approved, delayed, or referred to an advisory committee for further review

  • The fifth phase involves surveillance of the drug after it has been approved, manufactured, and marketed. This aims to analyze the long-term efficacy and safety of the drug and involves various inspections by FDA representatives

To learn how Infiniti Research helps pharma companies strategize for each phase efficiently, and overcome potential bottlenecks with product research

Diamond Pharma Services Supports GenSight Biologics in Submitting Its First Marketing Authorisation Application, for Ocular Gene Therapy LUMEVOQ

  • Diamond Pharma Services has provided EU regulatory, pharmacovigilance, quality and compliance support to GenSight, leading to the Marketing Authorisation Application for LUMEVOQ

  • LUMEVOQ is a gene therapy to treat vision loss due to the rare, mitochondrial genetic disease, Leber Hereditary Optic Neuropathy

Diamond Pharma Services (“Diamond”), a leading technical services and regulatory affairs consulting group, has announced that it provided EU regulatory, pharmacovigilance, quality and compliance support to GenSight Biologics (“GenSight”), including the preparation, authoring support, agency communication and submission of GenSight’s first Marketing Authorisation Application to the European Medicines Agency (EMA), for its novel ocular gene therapy LUMEVOQ®. The EMA decision is expected in H2 2021.

LUMEVOQ (Lenadogene nolparvovec) is a gene therapy to treat vision loss due to the rare, mitochondrial genetic disease, Leber Hereditary Optic Neuropathy (LHON) caused by mutation in the ND4 mitochondrial gene. LHON mainly affects young males, and the ND4 mutation results in the worst visual outcomes, with most patients becoming legally blind. There is a high unmet medical need for LHON patients, of which there are 800-1200 in the EU and the US annually.

Headquartered in Paris, France, GenSight is a biopharma company focused on developing and commercialising innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders. Diamond has provided GenSight with regulatory, pharmacovigilance, quality and compliance support for LUMEVOQ leading up to the MAA assessment.

Maureen Graham, Managing Director, Regulatory, Diamond Pharma Services, said: “We are pleased GenSight Biologics chose to work with our team of experts at Diamond to provide European Regulatory, Pharmacovigilance, Quality and Compliance support for LUMEVOQ, its first MAA submission, and the first for a gene therapy treating a mitochondrial disease. It has been a personal ambition of mine to have the opportunity to work on a gene therapy within the ophthalmic arena, and GenSight has allowed Diamond that opportunity and that privilege.

This submission adds to Diamond’s broad experience in providing support to companies developing advanced therapy medicinal products (ATMPs), which includes over 50 programmes at various stages of development, and two MAA approvals – Glybera® and Yescarta®.”

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Katie Odgaard
Zyme Communications
Tel: +44 7787 502 947
E-mail: [email protected]

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Jeffries Says Sanofi Is ‘Most Compelling’ European Pharma Stock

– By Barry Cohen

Here’s a switch: Analysts are predicting sales for a Sanofi (NASDAQ:SNY) blockbuster drug that exceeds the company’s forecast.

Jefferies analysts wrote Dupixent revenue is likely to peak at $12.5 billion, according to an article in FiercePharma. That’s about 8% higher than Sanofi CEO Paul Hudson has set for the medication.

Dupixent is the first biologic medication approved by the Food and Drug Administration for adults and children aged six years and up with moderate to severe atopic dermatitis for whom topical treatments have not worked or are not advised.

Atopic is the most common type of eczema, affecting more than 9.6 million children and about 16.5 million adults in the United States, according to the National Eczema Association. It’s a chronic condition that can come and go for years or throughout life and can overlap with other types of eczema. The condition triggers inflammation that damages the skin barrier, leaving it dry and prone to itching and rashes.

As of the second quarter, Dupixent sales have been running at about $1 billion every three months. Jeffries thinks that number could double by 2028 as the patient population for atopic dermatitis expands and the drug makes inroads into treatment for asthma and several additional indications.

Other companies have eczema drugs in testing, but it appears they will present little challenge to Dupixent because of their side effects. One is abrocitinib from Pfizer Inc. (NYSE:PFE), the other is Rinvoq from AbbVie Inc.(NYSE:ABBV).

Jeffries Says Sanofi Is 'Most Compelling' European Pharma Stock
Jeffries Says Sanofi Is ‘Most Compelling’ European Pharma Stock

In addition to making Dupixent Sanofi’s key growth driver, Hudson, a year into his tenure at the company’s helm, has launched a program to cut about $2.5 billion in costs by 2022. He’s also focusing the company’s research and development so it yields drugs that are “first-in-class” or “best-in-class.” To supplement in-house research, Sanofi has been busy scouting for outside help. It recently closed a $3.7 billion acquisition of Principia Biopharma. According to the terms of the deal, the Paris-based company gets drugs to treat conditions such as multiple sclerosis, immunological and inflammatory diseases.

Jeffries analysts acknowledge Sanofi is much more than Dupixent, pointing to the company’s flu vaccines, robust pipeline and cost-cutting initiatives. In a bit of high praise, Jeffries said that from an investment perspective, Sanofi is the “most compelling” among large European pharma companies.

Sanofi is also engaged in the fight against Covid-19. The company recently began a phase 1/2 clinical trial of the vaccine it is developing in conjunction with GlaxoSmithKline (NYSE:GSK). The company said it anticipates results will be available in December, and if the shot passes muster, Sanofi could ask for regulatory approval in the first half of 2021.

Sanofi currently trades just below $50, It’s year-to-date range is $37.62 to $55. Its dividend yields nearly 3.4%. According to CNN Money, the 19 analysts offering 12-month price forecasts have a median target of $62.62, with a high estimate of $68.99 and a low estimate of $50.27. They rate Sanofi