Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2011-12-20 | telmisartan - amlodipine | Boehringer Ingelheim (Germany) | essential hypertension in adults |
Submission of a Market Application in the EU |
2017-07-26 | catumaxomab | Fresenius Biotech (Germany), now Neovii Biotech (Switzerland) | malignant ascites | Withdrawal of a market application in the EU |
2014-01-08 | NVA237 (glycopyrronium bromide) | Novartis (Switzerland) | once-daily treatment for chronic obstructive pulmonary disease (COPD) |
Submission of a Market Application in the US |
2011-12-20 | erlotinib | Roche (Switzerland) | first-line monotherapy in people with locally advanced or metastatic NSCLC with EGFR (epidermal growth factor receptor) activating mutations |
Granting of a Market Authorisation in the USA |
2011-12-20 | Trophos (France) | Granting of a patent | ||
2011-12-20 | Abbott (USA) | Identification of anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) patients | ||
2017-09-14 | rivaroxaban | Bayer Healthcare (Germany) |
|
Granting of a Market Authorisation in the EU |
2012-04-26 | denosumab | Amgen (USA) | reduction of the risk of developing bone metastases in men with castrate-resistant prostate cancer (extension of indication) | Refusal of a Market Authorisation in the US |
2011-12-20 | abiraterone acetate | J&J (USA) |
|
Granting of a Market Authorisation in the EU |
2011-12-20 | Gene therapy program for the treatment of hemophilia B | Amsterdam Molecular Therapeutics (The Netherlands) | hemophilia B |
|
2011-12-21 | Alteplase, rt-PA | Boehringer Ingelheim (Germany) | thrombolytic treatment of acute ischaemic stroke up to 4.5 hours of onset of stroke symptoms and after prior exclusion of intracranial haemorrhage | |
2011-12-27 | nalmefene | Lundbeck (Denmark) | alcohol dependence |
Product launch |
2013-08-29 | teriflunomide | Genzyme (USA - MA), a Sanofi company (France) | relapsing remitting multiple sclerosis (RRMS) |
Granting of a Market Authorisation in the EU |
2012-03-02 | rivaroxaban | Bayer Healthcare (Germany) Janssen Research & Development (J&J - USA) | secondary prevention after an acute coronary syndrome (ACS) | Refusal of a Market Authorisation in the US |
2011-12-28 | AstraZeneca (UK) Dynavax (USA) | asthma | ||
2011-09-21 | cardiotrophin-1 | Digna Biotech (Spain) | acute liver failure |
Granting of the orphan status in the US |
2012-01-01 | Disitertide (P144) | Digna Biotech (Spain) | Systemic sclerosis | |
2015-10-12 | ceftobiprole | Basilea Pharmaceutica (Switzerland) | severe community-acquired and hospital-acquired pneumonia |
Granting of a Market Authorisation in the EU |
2015-01-22 | lisdexamfetamine dimesylate | Shire (UK-USA) | Attention-Deficit Hyperactivity Disorder (ADHD) |
Granting of a Market Authorisation in the EU |
2014-10-21 | resminostat | 4SC (Germany) | hepatocellular carcinoma |
Granting of a patent |
© 2024 Biopharmanalyses - Powered by Samacom+