.jpg)
The future looked bright for one of Novo Nordisk’s experimental combinations in a recent phase II trial. However, strict regulations now force the Danish drug group to reconsider phase III development.
After years with focus on conventional clinical trials, the Trial Nation project extends its scope and now aims to attract a broader variety of clinical studies to Denmark and Danish hospitals.
Combinations of at least two different drugs have become an important element of Novo Nordisk's future plans within obesity, fatty liver disease and diabetes. One combination in particular looks set to become a top product, says chief science officer.
Biogen has requested priority review for Alzheimer's disease therapy aducanumab, which could speed the medication's path to market.
Danish pharmaceutical company Xellia Pharmaceuticals has signed a distribution agreement with Indian Caplin Point Laboratories that allows Xellia to commercialize five generic drugs in the US.
Swedish biotech firm Hansa Biopharma signs million-dollar deal with US-based gene therapy company Sarepta. The deal ensures Hansa Biopharma gets USD 10 million and milestone payments of up to USD 397.5 million.
European Union officials held talks with Gilead Sciences executives on Monday in a bid to hammer out a deal to secure its antiviral drug remdesivir to combat the coronavirus.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommends conditional approval of Hansa Biopharma's main asset Idefirix in EU. The Swedish biotech firm expects to launch the drug by approximately fourth quarter of 2020.
Thomas Wejs Møller, who for the next two years will head the EU network Competent Authorities for Medical Devices, CAMD, would like to use the new pharma regulations to give the entire area a major boost.
Biotech company Oncology Venture divests two of its drug candidates to Norwegian CRO. The deal includes milestone payments that could surpass USD 30 million as well as potential sales royalties. CFO is pleased.
Experienced biotech leader Martin Bonde leaves Danish Novo Seeds' consultancy firm Biorigin to become CEO of a Swiss cancer company, where Novo Seeds is also a major investor. "I just had to accept," he says.
Varct Diagnostics, which is developing a method to detect cancer from a single blood sample, has received DKK 15 million from the Innovation Fund Denmark, to be spent on fully developing the method and validating it for humans next year. The goal is to license the technology to a major international diagnostics firm, and talks are ongoing, says CEO.
During an extraordinary meeting Thursday, the European Medicines Agency, EMA, nominated Irish Emer Cooke to head the agency once the current executive director steps down on Nov. 1 after ten years in office.
Thursday, two candidates face their perhaps most important exam to date, when they have to convince the European Medicines Agency that they should be the agency's new executive director. DMA's director general, Thomas Senderovitz, sits on the board of the EMA and he provides and insight into the process before, during and after.
German pharmaceutical group Merck is the latest company among several to join the Danish Trial Nation organization, which aims to increase the number of clinical trials conducted in Denmark.
Finland's Nordic Healthcare Group has acquired Danish firm Health Innovation Institute, which advises life science companies on things like digital innovation within health care. A major advantage, says the latter's CEO.
Kammeradvokaten, legal counsel to the Danish government, accuses CEO of Danish organization Statens Serum Institut, Mads Melbye, and EVP of research Peter Lawætz Andersen of "gross breach of the rules about disqualification" as well as several other issues.
Novo Nordisk now expects to submit its candidate semaglutide for approval against obesity around the turn of the year. Meanwhile, the company's chief research officer maintains significant weight loss target for the company's obesity candidate AM833.
Cirqle Biomedical has received millions from the EU and the USA's NIH for the development of a contraceptive for women without hormones and side effects. Clinical trials are starting soon, and the goal is to enter the market in 2025.
New questions from members of the Danish Medicines Council about the effect of Biogen's muscle-wasting treatment Spinraza have caused the decision over whether the treatment should be offered to a wider group to be delayed.
Four years after the launch of Enstilar, a psoriasis treatment, Leo Pharma hopes to give the product a significant lift with data for a new treatment concept using the medicine.
Biotech company Scandion Oncology expands its board of directors, adding Bo Rode Hansen, who left an executive position at Roche in 2018 to become chief science officer and since CEO of a US start-up in Boston.
Scandion Oncology and 2curex will get DKK 6 million (USD 905,000) from the EU to optimize the treatment of breast cancer with Scandion's drug candidate.
Julie Enevold Brooker is Janssen's first country director in Denmark for decades, and has been hired to transform the pharmaceutical giant's nordic and regional focus, instead making the company an expert on the Danish healthcare system before the company launches a number of crucial new products.
Allergy group ALK has secured the rights to sell a treatment for middle ear infections to specialists in the US. The deal is the latest addition to ALK's USA strategy, where close relationships to prescribing doctors play a central role.
