Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2016-03-16 | monoclonal antibody targeting interferon gamma | Novimmune (Switzerland) | hemophagocytic lymphohistiocytosis (HLH) |
Granting of the Breakthrough Therapy status |
2007-11-29 | human recombinant interferon-beta 1a | Faron Pharmaceuticals (Finland) | acute lung injury (ALI) acute respiratory distress syndrome (ARDS) |
Granting of a patent |
2016-04-01 | pandemic influenza vaccine (H5N1) (live attenuated, nasal) | MedImmune (USA - global biologics arm of AstraZeneca (UK) | prophylaxis against influenza in an officially declared pandemic situation in children and adolescents |
Positive opinion for the granting of a Market Authorisation in the EU |
2016-04-01 | sacubitril/valsartan | Novartis (Switzerland) | symptomatic chronic heart failure with reduced ejection fraction |
Positive opinion for the granting of a Market Authorisation in the EU |
2015-11-12 | ledipasvir/sofosbuvir fixed-dose combination | Gilead Sciences (USA -CA) | patients with genotype 4, 5 and 6 chronic hepatitis C virus (HCV) infection and in patients co-infected with HIV | Granting of a Market Authorisation in the US |
2016-08-22 | emtricitabine 200mg/tenofovir disoproxil fumarate 300mg | Gilead Sciences (USA - CA) | reduction of the risk of sexually acquired HIV-1 infection among uninfected adults at high risk |
Granting of a Market Authorisation in the EU |
2015-07-01 | bioassay service platform | Domainex (UK) | Product launch | |
2016-07-28 | NY-ESO-1 specific T cells | Adaptimmune Therapeutics (UK) | synovial sarcoma |
Granting of a patent |
2016-12-12 | dusquetide | Soligenix (USA - NJ) | oral mucositis | Granting of a patent |
2014-12-17 | blood based test for early detection of pancreatic cancer | Immunovia (Sweden) | pancreatic cancer |
Product launch |
2013-06-07 | N-[2,6-bis(1-methylethyl)phenyl]-N’-[[1-[4-(dimethylamino) phenyl]cyclopentyl]methyl]urea, hydrochloride salt | Atterocor (USA - MI) | adrenocortical carcinoma |
Granting of the orphan status in the EU |
2018-09-14 | ibalizumab | TaiMed Biologics (Taiwan) Theratechnologies (Canada) |
|
Acceptation for review of a NDA |
2016-02-10 | guanfacine hydrochloride prolonged release tablets | Shire (UK - USA) Shionogi (Japan) | attention deficit hyperactivity disorder (ADHD) | Submission of an NDA |
2016-10-07 | faster-acting insulin aspart | Novo Nordisk (Denmark) | type 1 and type 2 diabetes |
Negative opinion for the granting of a Market Authorisation in the US |
2017-06-02 | nonacog beta pegol | Novo Nordisk (Denmark) | hemophilia B | Granting of a Market Authorisation in the EU |
2016-04-28 | lutetium (177 Lu) chloride | ITG Isotope Technologies Garching GmbH (Germany) | radiolabelling of carrier molecules |
Positive opinion for the granting of a Market Authorisation in the EU |
2016-04-28 | pancreas powder | Aptalis Pharma, now part of Pfizer (USA - NY) | pancreatic enzyme replacement treatment in exocrine pancreatic insufficiency due to cystic fibrosis or other conditions (e.g. chronic pancreatitis, post pancreatectomy or pancreatic cancer) |
Positive opinion for the granting of a Market Authorisation in the EU |
2016-06-01 | fixed dose combination of rilprivirine, emtricitabine and tenofovir alafenamide available as 25 mg/200 mg/25 mg film-coated tablets | Gilead Sciences (USA - CA) | HIV-1 infection | Granting of a Market Authorisation in the EU |
2018-02-14 | opicapone | Bial-Portela (Portugal) Neurocrine Biosciences (USA - CA) | adjunctive therapy in adult patients with Parkinson’s disease and motor fluctuations | Submission of a Market Application in the US |
2016-04-28 | chlorhexidine | GSK (UK) | prophylaxis of omphalitis (infection of the umbilical cord) in newborn infants |
Positive opinion for the granting of a Market Authorisation in the EU |
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