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novartis avexis zolgensma fda data manipulation

News and Trends 2 Apr 2020

Update: FDA Imposes No Penalties for Novartis Data Manipulation Scandal

Update (02/04/2020): The FDA has concluded an investigation into a data manipulation scandal surrounding the approval of Novartis’ gene therapy Zolgensma, and has decided against sanctions. The FDA launched an investigation into the manipulated data surrounding the gene therapy application last year, and recently reported that the investigated data violations didn’t meet the threshold for […]

April 2, 2020 - 3 minutesmins - By Jonathan Smith

News and Trends 2 Apr 2020

Swiss and German Team to Develop Inhaled mRNA Coronavirus Treatment

The Swiss antibody specialist Neurimmune and the German RNA biotech Ethris are collaborating to develop inhaled messenger RNA (mRNA) antibodies that can treat the catastrophic respiratory effects of coronavirus disease, also known as Covid-19. The therapeutic mRNA would be delivered directly into the lungs of symptomatic patients via nebulizers with nanoparticle aerosols. The mRNA could […]

April 2, 2020 - 3 minutesmins - By Anita Chakraverty

News and Trends 31 Mar 2020

Ipsen Resumes Phase III Testing for Rare Disease Drug and Abandons Pediatric Trial

The French pharmaceutical company Ipsen has restarted the dosing of its treatment for a rare bone disease in a phase III trial after obtaining questionable interim results. At the same time, the company has terminated a phase II trial of the same drug in pediatric patients with a different bone disorder following a partial clinical […]

March 31, 2020 - 4 minutesmins - By Karen O’Hanlon Cohrt

News and Trends 31 Mar 2020

Swiss Biopharma Launches Second Cancer Antibody Deal with Japanese Pharma Giant

The Japanese heavyweight Ono Pharmaceutical has recruited Numab Therapeutics for a second time to co-develop a multi-specific antibody cancer treatment in a deal worth up to €246M (CHF 260M). The announcement follows a two-year collaboration between Ono and Numab announced in March 2017. Under the new agreement, which includes upfront and milestone payments, Ono has […]

March 31, 2020 - 3 minutesmins - By David Kirk

News and Trends 31 Mar 2020

Update: AM-Pharma Increases Acute Kidney Injury Phase III Funds to €163M

Update (31/03/2020): AM-Pharma has raised an extra €47M on top of an existing €116M equity round to fund an upcoming phase III trial of a treatment for acute kidney injury. The money will help the Dutch biotech to prepare for its upcoming phase III trial of a protein drug for acute kidney injury, which is […]

March 31, 2020 - 3 minutesmins - By Jonathan Smith

In Depth 30 Mar 2020

Could mRNA Vaccines Fulfill Their Potential Against Coronavirus?

The first vaccine against coronavirus disease could one day be made of mRNA. How is mRNA showing promise against the pandemic, and what could it signify for the mRNA field? The global number of coronavirus disease (Covid-19) cases has passed 600,000 and is threatening to bring healthcare systems worldwide to their knees. To control the […]

March 30, 2020 - 7 minutesmins - By Jonathan Smith

Best in Biotech 30 Mar 2020

10 Unusual Applications of CRISPR Gene Editing

CRISPR has been all over the news in the past couple of years, and with reason. This gene editing tool is making gene editing easier and faster than ever, and the possibilities it has opened up go well beyond human health. You might have heard of the tremendous potential CRISPR could have in treating disease. […]

March 30, 2020 - 8 minutesmins - By Clara Rodríguez Fernández

News and Trends 27 Mar 2020

Evox Therapeutics Receives up to €800M from Takeda To Tackle Rare Diseases

The Japanese pharmaceutical company Takeda has struck a deal worth up to €803M with UK biotech Evox Therapeutics to develop rare disease treatments delivered to cells via nanocapsules called exosomes. As part of the deal, Evox will use its proprietary technology platform to modify and load RNA and protein drugs into exosomes and target the […]

March 27, 2020 - 3 minutesmins - By Laura Cowen

valo therapeutics oxford finland cancer immunotherapy

Startup Scout 27 Mar 2020

This Startup is Making a Cancer Vaccine out of Viruses

Valo Therapeutics is operating both in the UK and Finland to develop a cancer vaccine based on a virus designed to kill tumors. Mission: To combine two different immunotherapy techniques — oncolytic viruses and cancer vaccines — into one treatment for solid tumors. Immunotherapy has transformed the cancer treatment landscape, offering therapies such as checkpoint […]

March 27, 2020 - 4 minutesmins - By Jonathan Smith

News and Trends 26 Mar 2020

Silence Therapeutics to Work with AstraZeneca in RNAi Deal Worth up to €3.6B

AstraZeneca is recruiting RNAi specialist Silence Therapeutics to develop treatments for cardiovascular, renal, metabolic, and respiratory diseases. RNA interference, or RNAi, is a relatively new field of medicine in which therapeutic small interfering (si)RNA molecules — known as siRNA molecules — can selectively block genes and thus inhibit the production of disease-causing proteins. John Strafford, […]

March 26, 2020 - 3 minutesmins - By Laura Cowen

News and Trends 26 Mar 2020

Novacyt Launches Two-Hour Coronavirus Test After FDA Approval

The French clinical diagnostics specialist Novacyt has announced FDA authorization for its fast and easily transportable test for the coronavirus disease COVID-19. The company is also rolling out the kit this week via manufacturing and distribution partnerships across Europe. The test received an Emergency Use Authorization from the FDA, which means it can only be […]

March 26, 2020 - 3 minutesmins - By External Contributor

News and Trends 25 Mar 2020

DBV Technologies’ Peanut Allergy Treatment Hits FDA Setback

French biotech DBV Technologies’ bid for the US approval of a skin patch to treat nut allergies could be delayed as the FDA requested more information on the patch’s efficacy. Specifically, the FDA requested more information on patch-site adhesion – critical to the patch working effectively – as well as its long-term efficacy. According to […]

March 25, 2020 - 3 minutesmins - By External Contributor

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Illuminating biotech in the City of Light: Inside Paris’s thriving ecosystem

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Update: FDA Imposes No Penalties for Novartis Data Manipulation Scandal

Swiss and German Team to Develop Inhaled mRNA Coronavirus Treatment

Ipsen Resumes Phase III Testing for Rare Disease Drug and Abandons Pediatric Trial

Swiss Biopharma Launches Second Cancer Antibody Deal with Japanese Pharma Giant

Update: AM-Pharma Increases Acute Kidney Injury Phase III Funds to €163M

Could mRNA Vaccines Fulfill Their Potential Against Coronavirus?

10 Unusual Applications of CRISPR Gene Editing

Evox Therapeutics Receives up to €800M from Takeda To Tackle Rare Diseases

This Startup is Making a Cancer Vaccine out of Viruses

Silence Therapeutics to Work with AstraZeneca in RNAi Deal Worth up to €3.6B

Novacyt Launches Two-Hour Coronavirus Test After FDA Approval

DBV Technologies’ Peanut Allergy Treatment Hits FDA Setback

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Illuminating biotech in the City of Light: Inside Paris’s thriving ecosystem

ASCO 2025: key highlights in cancer therapeutics

New report: Artificial intelligence and the future of antibody discovery

Stem cell therapy: a potential cure for hearing loss?

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

Illuminating biotech in the City of Light: Inside Paris’s thriving ecosystem

ASCO 2025: key highlights in cancer therapeutics

New report: Artificial intelligence and the future of antibody discovery

Stem cell therapy: a potential cure for hearing loss?

Connect with decision-makers and researchers worldwide for collaborative opportunities

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Advertise with us

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