Due to fraudulent clinical trials from a contract research organization, the EMA’s expert committee, the CHMP, is now suspending marketing approval authorizations for around 100 generic drugs on the market.
The German Minister for Health has revealed that the German state has ordered vaccines from Bavarian Nordic, as the country reports 5 cases of monkeypox.
Drug-resistant bacteria kill hundreds of thousands of people every year, and national regulatory forces across the world are now coming together to ensure a uniform approach to clinical trials for antibiotics.
Morten Søgaard is leaving Pfizer to join Astellas, where he will be in charge of 100 employees. Going from one of the world largest pharmaceutical firms to a considerably smaller one will be a challenge, he says.
International antibiotic alliance Carb-X has received commitments of up to USD 370m to accelerate the development of new antibiotics to combat a future shortage. The news is welcomed by several players on the AMR field.
Former executive vice president of Novo Nordisk, US, Jesper Høiland has decided to step down from his role as global chief commercial officer at Ascendis Pharma.
The US-based company behind glucose-monitoring systems could become a giant on the diabetes device market following a rumored acquisition of Insulet, a maker of insulin pumps.
CEO Paul Chaplin reports that Bavarian is making more doses of its vaccine against monkeypox due to the recent outbreak.
Bavarian, which signed a supply contract with an unnamed European country last week, reports it is in dialog with several countries, some yet to be affected, concerning the firm’s monkeypox vaccine.
Almirall is launching psoriasis cream Wynzora in Denmark. The treatment has been inlicensed from Danish firm MC2 Therapeutics, where the CEO says ”it is a special feeling” to see Wynzora launched in its home country.
Jorge Alderete, ALK’s president in North America, is leaving the firm after 23 years. He will be replaced by Hans Lindeberg, ALK’s current head of the Nordic region.
Over the course of three days, Bavarian Nordic has seen its share price increase by around DKK 100 (USD 14.3).
As the firm concludes operational activities following a sale of the business to Kempharm, Oprhazyme has halved its board of directors. The firm’s chair will also step down following its AGM in June.
The discovery of monkeypox in several countries has led to share price increases at a number of companies with smallpox vaccines or treatments in their portfolios, including Bavarian Nordic.
During this month’s meeting of the CHMP, the EMA’s expert committee, a total of nine new drugs have been recommended while six drugs have had indication extensions accepted. Two treatments have been rejected.
During its May meeting, the Danish Medicines Councils has rejected breast cancer drug Piqray, which is developed by Novartis, and has partly reversed a prior rejection of acute myeloid leukemia (AML) treatment Xospata, developed by Astellas Pharma.
Carsten Hellmann, the chief executive of allergy firm ALK-Abelló, has sold company shares for almost DKK 11m (USD 1.5m).
After a challenging period, Novo Nordisk can once again supply fast-acting insulin product Novorapid, Dagens Pharma reports.
In a phase III study of dasiglucagon, biotech firm Zealand Pharma has met its endpoint, reducing the need for children under 12 months with the rare disorder to undergo intensive hospital treatment by 55%.
A new dermatological alliance between Spanish skin health firm Almirall and German-listed Evotec aims to discover new drugs for the treatment of skin diseases including cancers and eczema.
On Thursday, as more monkeypox cases emerge across Europe, Bavarian Nordic has announced a supply contract with an undisclosed European country for its vaccine Imvanex.
Research collaborations with China, including those in the life science sector, are being put under the microscope as defense authorities express concerns about Chinese espionage in Europe.
Sunday’s sales agreement between US-based Kempharm and Orphazyme will be decided on May 30, when the company’s creditors meet to vote on the proposal.
Co-Founder and former CSO of Orphazyme Thomas Kirkegaard Jensen and Bo Rode Hansen, CEO of Scandion Oncology, are both involved in another secret venture backed by Novo Holdings.
Allan Flyvbjerg, CEO of Steno Diabetes Center in Copenhagen, says Eli Lilly’s tirzepatide has proved itself a fierce challenger to Novo Nordisk’s newest generation of diabetes drugs.
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