Regulatory approval Archives

News and Trends 14 Jul 2021

EMA Market Approval Rate for Small Biotechs Skyrocketed Last Year

The success rate for small biotechs applying for regulatory approval from the EMA has risen by over 100% since 2016, which analysts partly attribute to increased access to sophisticated technology and funding. According to a recent announcement from the EMA, the regulator greenlit a whopping 89% of applications for marketing authorization for new medicines from […]

July 14, 2021 - 3 minutesmins - By Victor Kotsev

News and Trends 17 Jun 2021

FDA Approval of Biogen’s Drug Boosts European Alzheimer’s Space

The FDA shocked many life sciences observers by greenlighting Biogen’s treatment candidate for Alzheimer’s last week. Yet, for much of the Alzheimer’s disease community on both sides of the Atlantic, the decision also brings cautious hope. Controversy recently erupted when the FDA conditionally granted accelerated approval to Biogen’s aducanumab, making it the first approved treatment […]

June 17, 2021 - 6 minutesmins - By Victor Kotsev

News and Trends 20 May 2021

EU Approves Edible Insects for Humans but Roadblocks Remain

Europe is seeing a surge of interest in edible insect farming after an EU vote earlier this month greenlit the first insect-derived food product for human consumption. But insect protein pioneers still face other obstacles such as restrictions on what insects can be fed. The approval went to dried yellow mealworm developed by French-based biotech […]

May 20, 2021 - 6 minutesmins - By Anita Chakraverty

News and Trends 11 May 2021

ADC Approval Buoys Spirits in Cancer Treatment Space

The FDA recently approved an antibody-drug conjugate drug from ADC Therapeutics as a treatment for blood cancer. This has given a major confidence boost to other European companies in the field as the deal mill picks up speed. Last month, ADC Therapeutics in Switzerland broke into the mainstream when its lead candidate Zynlonta received FDA […]

May 11, 2021 - 7 minutesmins - By Jonathan Smith

multiple sclerosis novartis roche ema approval

News and Trends 27 Apr 2021

EMA Approvals for Multiple Sclerosis Highlight Treatment Shortfalls

While the EU saw rapid-fire approvals in the multiple sclerosis space last month, the innovations centered mostly on improving existing approaches. Which areas of multiple sclerosis treatment need more options? At the end of March, the EMA made key decisions on three treatments for multiple sclerosis (MS), a chronic neurodegenerative disease affecting 2.5 million people […]

April 27, 2021 - 6 minutesmins - By Jonathan Smith

cardiovascular disease amarin vascepa vazkepa

News and Trends 21 Apr 2021

Vazkepa Gets EMA Nod for Cardiovascular Disease, But Hurdles Remain

Last month’s EU approval of Vazkepa — a treatment derived from fish oil and branded as Vascepa in the US — has added much-needed ammunition to the arsenal of doctors battling cardiovascular disease. Yet other similar treatments are returning lukewarm results and the possibility of approvals being withdrawn hangs in the air. Icosapent ethyl, a […]

April 21, 2021 - 5 minutesmins - By Victor Kotsev

Industrial plant sustainability bioeconomy

News and Trends 18 Feb 2021

Cannabinoids in Focus after GW Pharmaceuticals Snapped up for €6B

This month’s €6B acquisition of the UK heavyweight GW Pharmaceuticals by Jazz Pharmaceuticals has been hailed as a major validation of the medical cannabinoid industry. The deal is the largest to date in the medical cannabinoid field. Jazz’s offer valued GW’s shares nearly 50% higher than their previous day’s close. The acquisition is expected to […]

February 18, 2021 - 6 minutesmins - By Victor Kotsev

mRNA DNA race Covid 19 vaccine BioNTech Pfizer

News and Trends 22 Dec 2020

EMA Greenlights BioNTech and Pfizer mRNA Vaccine for Covid-19

BioNTech and Pfizer’s Covid-19 vaccine, made from messenger RNA, has become the first of its kind to be approved by the EMA. The EMA has granted conditional approval to Comirnaty, a vaccine against Covid-19 developed by BioNTech and Pfizer. The approval comes weeks after the UK became the first country in the world to approve […]

December 22, 2020 - 5 minutesmins - By Jonathan Smith

Cultured meat Europe cellular agriculture

News and Trends 14 Dec 2020

Will Europe Follow Singapore in Approving Cultured Meat?

Singapore is the first country to grant approval to meat grown from animal cells, known as cultured meat. Will European countries follow suit? Eat Just is a San Francisco-based company that sells plant-based alternatives to eggs and other animal products. The firm made headlines last week when it got regulatory approval to market cultured chicken […]

December 14, 2020 - 5 minutesmins - By Kostas Vavitsas

In Depth 4 Nov 2020

The Return of Gene Therapy

Gene therapy is a hot area in the biotech industry right now, with many treatments in development and a number of recent approvals. However, the path has not always been a smooth one. Gene therapy has been one of the biggest success stories of the 21st century. Genetic diseases were once seen as incurable, etched […]

November 4, 2020 - 8 minutesmins - By Farhan Mitha

News and Trends 30 Oct 2020

Bayer’s AskBio Acquisition Strong Statement For Gene Therapy in Europe

This week, German big pharma Bayer announced a €3.5B takeover of Asklepios BioPharmaceutical, a well known US gene therapy specialist. This is only one of many examples of the funding windfall experienced by the gene therapy field in 2020. Despite the difficulties posed by the Covid-19 pandemic, 2020 has been a good year for gene […]

October 30, 2020 - 6 minutesmins - By Helen Albert

Expert Advice 14 Oct 2020

Everything You Need to Know About Biotech Business Models

What’s my business model? Who do I partner with? How do I scale up? These are typical strategic questions a young biotech will regularly face. The business model of a biotech company can determine its long-term trajectory to success. In this article, we’ll focus on a typical ‘platform’ biotech company in the biopharma sector whose […]

October 14, 2020 - 6 minutesmins - By External Contributor

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

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Regulatory approval

EMA Market Approval Rate for Small Biotechs Skyrocketed Last Year

FDA Approval of Biogen’s Drug Boosts European Alzheimer’s Space

EU Approves Edible Insects for Humans but Roadblocks Remain

ADC Approval Buoys Spirits in Cancer Treatment Space

EMA Approvals for Multiple Sclerosis Highlight Treatment Shortfalls

Vazkepa Gets EMA Nod for Cardiovascular Disease, But Hurdles Remain

Cannabinoids in Focus after GW Pharmaceuticals Snapped up for €6B

EMA Greenlights BioNTech and Pfizer mRNA Vaccine for Covid-19

Will Europe Follow Singapore in Approving Cultured Meat?

The Return of Gene Therapy

Bayer’s AskBio Acquisition Strong Statement For Gene Therapy in Europe

Everything You Need to Know About Biotech Business Models

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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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