Marie Gårdmark: Potential step change – EU regulators get to play with data

A new pilot from EMA is starting in September to assess wether the analysis of 'raw data' by regulatory authorities improves the evaluation of marketing approval for new medicines. Marie Grådmark writes in a column that she is looking forward...

BioArctic moves forward with its candidate for Parkinson’s

BioArctic announces positive early phase study results for its drug candidate for Parkinson’s disease.

Lonza

Samuel Lagercrantz: The government’s performance in healthcare and life sciences so far

Since the change of government in Sweden, developments in the healthcare sector have shown promising signs, but the outlook in life sciences is less promising, ...

Setback for pharmaceutical companies in the Zantac case

A Delaware judge has ruled in favour of allowing expert witnesses to testify in a case involving the now-cancelled drug Zantac and its potential carcinogenicity.

New rules for diagnostic products, but who will certify them? “An extreme shortage area”

In less than two weeks, new and stricter EU rules will enter into force for thousands of products used in important diagnoses of, among other things, cancer and...

Marie Gårdmark: New incentives for orphan products on its way

"Let’s hope that the learnings from development of new therapies for rare diseases will spill over to more common conditions, orphan products paving the wave fo...

AZ gets approval for drug targeting rare disease – it may reduce cortisone dependence

AstraZeneca’s drug Fasenra gets an expanded indication in the EU and is now approved as a treatment for the rare autoimmune disease known as Churg-Strauss syndrome.

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Mercodia AB

Studie: Taurin gav längre livslängd för djur

Möss, ormar och apor som fick aminosyran taurin under en längre tid uppvisade mindre åldersrelaterade tecken än kontrollgrupper, enligt en studie.

Clinigen Clinical Supplies Management GmbH

He saved lives with his theories – was ostracised and ended up in a mental hospital

Hungarian doctor Ignaz Semmelweis (1818-1865) undoubtedly possessed plenty of persistence, diligence and sound reasoning skills – but he was hardly blessed with...

Yxan går hos läkemedelsjätte – över 2 000 jobb ska bort

Bristol Myers Squibb planerar stora neddragningar. Omkring 2 200 av bolagets anställda väntas få gå när läkemedelsjätten ska skära i kostnaderna.

Collaboration for a simpler production of gene therapies launched

A collaboration between universities and companies aims at providing better production methods for the development of gene therapies. The initiative is led by J...

Affibody AB

Aurevia

Marie Gårdmark: Finally, it’s time for a revision of the EU pharma legislation

A challenge for the EU Commission is to deliver a new framework that will also take care of another “pillar” of the pharmaceutical strategy, namely, to ensure that new medicines will be available for all citizens in Europe, writes Marie Gårdmark...

Sobis samarbete med Sanofi ger skörd – läkemedel mot hemofili godkänt i USA

Svenska särläkemedelsbolaget Sobi har fått ett nytt läkemedel mot hemofili A godkänt i USA. I EU väntas en ansökan om godkännande lämnas in senare i år.

Investments worth 40 billion in the Öresund region – “A huge investment wave”

A new report reveals that medical companies in the Oresund region are investing like never before.

QPS Netherlands B.V

RegSmart Life Science AB

LINK Medical Research

Isofol Medical: "Inte befogat bedriva nya studier i egen regi"

Efter bakslaget i augusti då varken de primära eller sekundära effektmåtten uppnåddes i Agent-studien, meddelar nu Isofol Medical att det utifrån bolagets finan...