The FDA have rejected an application for marketing authorization for Orphazyme's main drug candidate, arimoclomol, as a treatment for metabolic disease Niemann Pick C. The authority wants more data.
The FDA rejection of Orphazyme's drug candidate in its main indication will trigger major cuts at the biotech firm, but CEO Christophe Bourdon has no comment on where they will be implemented and how hard the US organization will be hit.
Friday's disappointing rejection letter from the US FDA is affecting Orphazyme's guidance for 2021. Now, the biotech firm forecasts an operating deficit of DKK 670-700m, up from DKK 100-150m.
Biotech heavyweight Bo Jesper Hansen is very disappointed over the FDA rejection of Orphazyme's only drug candidate.
The US health department aims to have a hearing on publishing the regulatory framework for selling hearing aids over the course of the year.
The European Medicines Agency is reluctant to implement the 50 percent efficacy threshold for covid-19 vaccines.
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Investing in diagnostics is complicated, even for Novo Holdings – but due to the potential in the industry, the company is hungry for more acquisitions, after completing its largest-ever investment in a diagnostics company on Tuesday.
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Medtech group Olympus is very satisfied with its new advisor Lars Marcher, who is the former CEO of its competitor, Ambu. He will help Olympus develop a new 10-year strategy.
Global action must be taken in the battle against Alzheimer's according to Biogen's Japanese collaborative partner Eisai, following the US pharmaceutical company's recent drug approval in the US.
According to VP for Investor Relations & Communications Rolf Sass Sørensen, the Danish pharmaceutical company came close to landing its first partial production contract for covid-19 vaccines on Danish soil.
At Tuesday's general assembly, Sonova appointed Gregory Behar and Roland Diggelmann to the company board.
After three years of work, Utlity Therapeutics is almost ready to apply to the FDA for approval for one of its two antibiotics.
Sunstone Life Science Ventures is not selling its Orphazyme shares because of the upcoming crucial FDA ruling, general partner Sten Verland tells MedWatch.
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Japanese medtech company Olympus has hired the former long-time Ambu executive Lars Marcher as a new advisor to the firm, which recently launched a portfolio of single-use bronchoscopes which could give Ambu a run for their money.
In May, the hearing aid company company Demant advanced in the public US sales channel Veterans Affairs, while GN Hearing retreated for the sixth month in a row.
Demant's market share of the public US sales channel VA rose to 14.74 percent in May compared to 9.21 percent the month before, which a DNB analyst calls a strong development.
The research-based collaboration will evaluate Lumen Bioscience's technology platform with the aim of creating oral medicines for obesity and other metabolic diseases.
The European Council wishes to reinforce EU preparedness for potential future health emergencies. The Danish Association of the Pharmaceutical Industry supports this idea.
The USD 1.8bn price does not reflect the value of Emisphere, according to former Emisphere shareholders, who have sued MHR Fund Management.
The Welsh diagnostics company BBI Group will soon be in Danish hands, as Novo Holdings has taken over majority ownership of the firm.
Following three investments via the newly-established Singapore office, Novo Holdings is poised to expand its Asian venture to China, where it hopes to open an office before the end of the year.
Genmab’s US partner Janssen has presented new data on the effect of the cancer drug Darzalex.
New data from trial involving a drug treating severe depression disappoints the stock market, and biotech company Sage Therapeutics faces share price decline.
The US authority has said yes to a meeting with Enochian Biosciences to discuss a potential start to clinical trials of the company's HIV treatment. The biotech company is also looking to raise funds.
Associate Director, Biostatistics - Genmab Clinical Business Process Manager - Genmab 
Associate Director, PV/GCP Quality Assurance - Y-mAbs Therapeutics 
Principal Formulation Scientist, Oral Formulation Research - Novo Nordisk 
Chemist responsible for validation and qualification for Laboratory Automation Development Associate Medical Director, Translational Medicine - Y-mAbs Therapeutics 
Regulatory affairs life cycle specialist Principal Biostatistician - ALK 
Employee for regulatory department Radiochemist in CMC Development - Y-mAbs Therapeutics 
Senior Clinical Development Scientist/Physician - Lundbeck Clinical Trial Manager - Genmab Clinical Supply Manager/Specialist - Lundbeck 
(Senior) Regulatory Science Specialist - IWA Consulting Formulation Specialist, Oral Formulation Research - Novo Nordisk Senior Contract Manager - Genmab 
Analytical Coordinator (Senior scientist) – Permanent position, Symphogen Chief Physician - Clinical Innovation Centre, Novo Nordisk Senior Formulation Scientist, Oral Formulation Research - Novo Nordisk Drug Safety Advisor - ALK Project Assistant, Translational medicine - Y-mAbs Therapeutics Senior Manager, IT QA - Genmab 
eTMF Manager - Klifo Clinical Supply Coordinator - Klifo Associate Formulation Scientist, Oral Formulation Research - Novo Nordisk 
