Lundabolag beviljas särläkemedelsstatus i USA

Bioteknikbolaget Cantargias läkemedel CAN10 för behandling av systemisk skleros har nu beviljats status som särläkemedel i USA.

Heidi Stensmyren is eager for new challenges in the biotech industry

Heidi Stensmyren has served as President of the Swedish Medical Association, held a managerial position at Karolinska University Hospital and is now Medical Director at a biotech company. “I’m curious and like to have influence, so I’ve often chosen management roles,” she says.

Here are the pharmaceutical companies best prepared for AI

How well prepared are pharmaceutical companies in the field of artificial intelligence? That is what a new analysis has tried to evaluate.

CROs in drug development: "We use our expertise to speed up the process

Consultancy firms have become an increasingly important part of drug development. “It’s a trend and a business model that works, and we see no indication that it will change,” says Helena Lüning of the industry organisation ASCRO.

Uppsala-based company wins important patent dispute – but the decision is subject to appeal

A US district court has ruled in favour of Orexo in a dispute over the patent protecting the Swedish company’s drug Zubsolv, developed for treating patients with opioid addiction. However, the opposing party, the Indian company Sun, is not giving up and has filed an appeal.

Nytt centrum för avancerade terapiläkemedel vid Lunds universitet

Lunds universitet inrättar nu ett utvecklingscentrum för avancerade terapier (ATMP). Centrumet får namnet LU-ATMP och skapas i syfte att omvandla medicinsk forskning till terapier för patienter.

Gothenburg-based company acquired by Norwegian diagnostics group

Gentian Diagnostics acquires Gothenburg-based Getica.

Certifiering tar Mendus cancerkandidat framåt: "Ökar värdet"

Immunterapibolaget Mendus har beviljats så kallad ATMP-certifiering av den europeiska läkemedelsmyndigheten EMA för sin ledande läkemedelskandidat vididencel.

Novo Nordisk invests billions in expanding its production capacity

Danish pharmaceutical company Novo Nordisk is making a major investment to develop and expand its production facility in Hillerød, north of Copenhagen. DKK 15.9 billion, equivalent to almost SEK 25 billion, is being invested over six years.

Nanexa develops depot formulation of the diabetes and obesity drug Saxenda

Uppsala-based company Nanexa has signed an agreement with a German contract research company to start a clinical study with a monthly depot of liraglutide. The drug is currently approved for the treatment of diabetes and obesity.

Rapid developments in AI – “All stakeholders are struggling to understand it”

Artificial intelligence is being discussed more and more, and developments in the field are moving rapidly. As the Swedish Medical Products Agency testifies, keeping up with developments is not easy.

Swedish and Ukrainian Medical Product Agencies sign an agreement

The Directors-General of the Swedish and Ukrainian Medical Products Agencies have signed a cooperation agreement.

New report: Fewer PhDs in life sciences

A new report from Vinnova suggests that competency returns in the life science sector are declining.

Confidence in childhood vaccines is in decline worldwide

Since the pandemic, confidence in vaccinating children has plummeted. In a new report, UNICEF urges world leaders to act before the situation worsens. In 52 out of 55 countries surveyed, public perception of the importance of vaccinating children has declined.

Pfizer’s record year – topped the $100 billion mark

In 2022 Pfizer, as the first pharmaceutical company in history, reached an annual revenue of more than 100 billion dollars, thereby surpassing Johnson & Johnson as the industry’s top selling business.

New diagnostic rules raise concerns

In a panel discussion, several voices from academia and the industry expressed concerns about the transition to the new regulatory framework for in-vitro diagnostics (IVDR). They argue that it may create significant differences between regions, and patients may be affected.

“I am driven by the desire to develop a product that can be sold worldwide”

Ranked number one in the world by the WHO in diarrhoea research and soon in phase III studies for its vaccine candidate – Scandinavian Biopharma is rushing forward in the pursuit of the world’s first ETEC vaccine. Meet the company’s CEO Björn Sjöstrand.

”Jag drivs av att ta fram en produkt som kan säljas i hela världen”

Rankade som nummer ett i världen av WHO inom diarréforskning och snart i fas III-studier för sin vaccinkandidat – Scandinavian Biopharma rusar fram i jakten på världens första ETEC-vaccin. Möt företagets vd Björn Sjöstrand.

“An entire industry is about to be wiped out”

According to Jennie Ekbeck, CEO of Umeå Biotech Incubators, Sweden risks not having any small diagnostic companies left in five years.

The government proposes fines for pharmaceutical companies that fail to notify drug shortages in time

According to a compilation from the Swedish Medicines Agency, the number of residually notified medicines increased by 54 % in Sweden last year compared to the previous year. In a bill presented by the government a number of proposals are put forward to counteract the problem.

”Vi måste säkerställa att alla medborgare får tillgång till nya behandlingar”

Idag är behandlingar som gavs för två år sedan redan obsoleta och inget tyder på att vi nått en platå vad gäller nya terapier. Det anser Läkemedelsverkets generaldirektör Björn Eriksson som talar på den pågående konferensen Framtidens Hälso & Sjukvård.

"Unclear proposal from the EU Commission on how to solve the MDR challenges"

Even before the EU regulation on medical devices (MDR) came into force, medical technology companies and doctors were concerned that it would endanger the availability of medical devices in the EU. Unfortunately, the fears have come true.

“Everyone is screaming for talent”

Attracting talent is one of the life science industry’s major future challenges, which was one of the conclusions of the panel discussion that ended the New Horizons in Biologics & Bioprocessing conference on 15 December.

Astra Zeneca nådde inte mål i lungcancerstudie