Regulatory approval Archives

News and Trends 31 Aug 2022

Emactuzumab designated as an orphan medicinal product for TGCT in Europe

SynOx Therapeutics Limited says its novel monoclonal antibody, emactuzumab, in development for the treatment of tenosynovial giant cell tumor (TGCT) and other diseases, has been designated as an orphan medicinal product for both localized and diffuse types of the disease by the European Medicines Agency (EMA). No systemic treatments have been approved for TGCT in […]

August 31, 2022 - 4 minutesmins - By Jim Cornall

News and Trends 24 Aug 2022

Northwest Biotherapeutics’ pediatric investigation plan approved by MHRA

Northwest Biotherapeutics, a biotech company developing DCVax personalized immune therapies for solid tumor cancers, has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for its pediatric investigation plan (PIP). The development, regulatory review and regulatory approval of a PIP is a pre-requisite for application for approval of a new medicine for […]

August 24, 2022 - 3 minutesmins - By Jim Cornall

News and Trends 22 Aug 2022

Drug to treat rare kidney disease to be reviewed by EMA

The European Medicines Agency (EMA) has agreed to review a conditional marketing authorization (CMA) application for a drug to treat a rare kidney disorder. The news was announced today (August 21) by CSL Vifor and Travere Therapeutics Inc, and, if approved, the companies say sparsentan will address a significant unmet need in treating IgA nephropathy […]

August 22, 2022 - 3 minutesmins - By Liza Laws

News and Trends 19 Aug 2022

Aeglea BioTherapeutics’ arginine 1 deficiency treatment gets EMA ok

Aeglea BioTherapeutics, Inc. says its marketing authorization application (MAA) for pegzilarginase for the treatment of arginase 1 deficiency (ARG1-D) has been validated by the European Medicines Agency (EMA). The MAA was submitted by Immedica Pharma AB, Aeglea’s commercialization partner in Europe and the Middle East. Pegzilarginase is a novel, recombinant human arginase 1 enzyme that […]

August 19, 2022 - 3 minutesmins - By Jim Cornall

News and Trends 28 Jul 2022

Biogen’s New Drug Application for first treatment of rare form of neurological disease accepted by FDA

A drug to target a rare genetic form of a neurological disease that affects the nerve cells, leading to the loss of everyday functions, could be the first of its kind available if approved. The US Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) from Massachusetts-based Biogen Inc. for tofersen, an […]

July 28, 2022 - 4 minutesmins - By Liza Laws

geneuro multiple sclerosis neuron viral dna

News and Trends 18 Jul 2022

First-ever Marketing Authorization Application for biosimilar targeting MS filed

An international biotech, with headquarters in Amsterdam, has announced that the European Medicines Agency (EMA) has accepted the first-ever Marketing Authorization Application (MAA) for its biosimilar product. Polpharma Biologics, which is dedicated to the development of biosimilars, announced on Friday (July 15) that natalizumab, similar to Tysabri, which treats multiple sclerosis, has been accepted as […]

July 18, 2022 - 3 minutesmins - By Liza Laws

News and Trends 27 Jun 2022

Covid vaccine granted marketing authorization in Europe

Specialty vaccine company, Valneva, has been given marketing authorization in Europe for its inactivated whole-virus COVID-19 vaccine VLA2001. This is a turnaround from the company’s situation in May of this year when the stock price was knocked down by 20% when gaining traction in the EU was proving to be a struggle. Despite authorization from […]

June 27, 2022 - 3 minutesmins - By Liza Laws

News and Trends 20 Apr 2022

Valneva’s Covid-19 Vaccine Reaches UK Market with EU In Sights

A Covid-19 vaccine developed by the French company Valneva has received the green light from the UK’s drug regulator. The EMA, meanwhile, is proving harder to convince. The UK’s relationship with the French vaccine developer Valneva has run hot and cold over the past two years. In 2020, the UK government invested in Valneva’s manufacturing […]

April 20, 2022 - 4 minutesmins - By Jonathan Smith

Cultured meat Europe cellular agriculture

In Depth 13 Apr 2022

Cultured Meat Is Coming Soon: Here’s What You Need to Know

Cultured meat promises to change the way we eat and help solve some of the big problems of a crowded planet. When will it be on our plate and how will this technology impact the world? In a couple of years, your food might be served with meat that has been grown from animal cells […]

April 13, 2022 - 12 minutesmins - By Clara Rodríguez Fernández

Best in Biotech 22 Dec 2021

The Biggest European Biotech News of 2021

In spite of the challenges posed by the Covid-19 pandemic, the European biotech industry has emerged stronger than ever this year. These were the key moments for the sector in 2021. The year 2021 has seen skyrocketing fortunes for many European biotech players. Investment firms, for instance, raised far more funding than in 2020, which […]

December 22, 2021 - 10 minutesmins - By Jonathan Smith

argenx efgartigimod treatment autoimmune disease myasthenia gravis

News and Trends 21 Dec 2021

Argenx’s Potential Blockbuster Gets FDA Nod for Autoimmune Disease

US regulators have approved the first-in-class drug efgartigimod for the treatment of the rare muscle disease generalized myasthenia gravis, opening up its developer argenx to billion-dollar revenues. Efgartigimod, to be marketed as Vyvgart, is an antibody fragment drug for use in adults with generalized myasthenia gravis. The FDA’s decision represents the first successful drug approval […]

December 21, 2021 - 4 minutesmins - By Anita Chakraverty

growth hormone deficiency ascendis pharma

News and Trends 1 Sep 2021

Slow-Release Jab for Child Growth Hormone Deficiency Gets FDA Nod

The FDA has given the green light to Danish company Ascendis Pharma for the first slow-release formulation that provides a weekly alternative to daily injections for children with growth hormone deficiency. For decades, patients with growth hormone deficiency have required tedious daily hormone injections to stave off the effects of the rare condition, including slow […]

September 1, 2021 - 5 minutesmins - By Jonathan Smith

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Regulatory approval

Emactuzumab designated as an orphan medicinal product for TGCT in Europe

Northwest Biotherapeutics’ pediatric investigation plan approved by MHRA

Drug to treat rare kidney disease to be reviewed by EMA

Aeglea BioTherapeutics’ arginine 1 deficiency treatment gets EMA ok

Biogen’s New Drug Application for first treatment of rare form of neurological disease accepted by FDA

First-ever Marketing Authorization Application for biosimilar targeting MS filed

Covid vaccine granted marketing authorization in Europe

Valneva’s Covid-19 Vaccine Reaches UK Market with EU In Sights

Cultured Meat Is Coming Soon: Here’s What You Need to Know

The Biggest European Biotech News of 2021

Argenx’s Potential Blockbuster Gets FDA Nod for Autoimmune Disease

Slow-Release Jab for Child Growth Hormone Deficiency Gets FDA Nod

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Webinar: Organoids in cancer research - Paving the way for faster drug development across cancer indications

10 biotech companies leading the way in Denmark

Webinar: Advancements in antimalarial drug discovery and development

Six psychedelic drug companies aiming to revolutionize mental health treatment

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

Webinar: Organoids in cancer research - Paving the way for faster drug development across cancer indications

10 biotech companies leading the way in Denmark

Webinar: Advancements in antimalarial drug discovery and development

Six psychedelic drug companies aiming to revolutionize mental health treatment

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

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