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RSS FeedPosted by Michael Wonder on 10 Apr 2020
Update on EU actions to support availability of medicines during COVID-19 pandemic
10 April 2020 - The continued availability of medicines is one of the most important priorities for EU authorities that are ...
Posted by Michael Wonder on 10 Apr 2020
EicOsis EC5026 granted fast track designation by FDA for neuropathic pain
9 April 2020 - EicOsis LLC, a pharmaceutical startup developing a new class of oral non-narcotic analgesics based on inhibition of ...
Posted by Michael Wonder on 10 Apr 2020
Ensuring access to medications in the US during the COVID-19 pandemic
9 April 2020 - The coronavirus disease 2019 (COVID-19) pandemic continues to rapidly evolve. ...
Posted by Michael Wonder on 09 Apr 2020
Merck and Pfizer receive US FDA breakthrough therapy designation and submit application for Bavencio for first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma
9 April 2020 - Breakthrough therapy designation and submission based on positive Phase III JAVELIN Bladder 100 study results. ...
Posted by Michael Wonder on 09 Apr 2020
EMA establishes task force to take quick and coordinated regulatory action related to COVID-19 medicines
9 April 2020 - As part of its health threat plan activated to fight COVID-19, the EMA has finalised and ...
Posted by Michael Wonder on 09 Apr 2020
Global regulators stress need for robust evidence on COVID-19 treatments
9 April 2020 - International regulators have published a report today highlighting their considerations on the development of potential COVID-19 ...
Posted by Michael Wonder on 09 Apr 2020
Bayer launches pre-filled syringe to administer eye medication Eylea in Europe
8 April 2020 - The European Medicines Agency has granted approval for the new Eylea (aflibercept) injection pre-filled syringe. ...
Posted by Michael Wonder on 09 Apr 2020
Liquidia announces FDA acceptance of new drug application for LIQ861 (treprostinil) inhalation powder for the treatment of pulmonary arterial hypertension
8 April 2020 - Liquidia Technologies today announced that the US FDA accepted for review the Company’s new drug application seeking ...
Posted by Michael Wonder on 08 Apr 2020
U.S. FDA approves Braftovi (encorafenib) in combination with cetuximab for the treatment of BRAF V600E mutant metastatic colorectal cancer after prior therapy
8 April 2020 - Braftovi plus cetuximab is the first and only FDA approved targeted regimen specifically for adults with previously ...
Posted by Michael Wonder on 08 Apr 2020
Pharmaceutical profits and public health are not incompatible
8 April 2020 - We need the capital and creativity of the private sector to take on the coronavirus. ...
Posted by Michael Wonder on 08 Apr 2020
Cows come home for CSL in COVID-19 vaccine battle
8 April 2020 - It sounds like a pitch for a sci-fi thriller — using genetically modified cows to fight ...
Posted by Michael Wonder on 08 Apr 2020
FDA approves first generic of a commonly used albuterol/salbutamol inhaler to treat and prevent bronchospasm
8 April 2020 - The U.S. FDA today approved the first generic of Proventil HFA (albuterol sulphate/salbutamol sulphate) metered dose inhaler, ...
Posted by Michael Wonder on 08 Apr 2020
Acceleron receives FDA breakthrough therapy designation for sotatercept in pulmonary arterial hypertension
8 April 2020 - Sotatercept granted first FDA breakthrough therapy designation in pulmonary arterial hypertension since the Agency established the designation ...
Posted by Michael Wonder on 08 Apr 2020
Bristol Myers Squibb announces acceptance of U.S. and EU regulatory filings for Opdivo (nivolumab) plus Yervoy (ipilimumab) combined with limited chemotherapy in first-line lung cancer
8 April 2020 - Submissions based on results from Phase 3 CheckMate-9LA trial. ...
Posted by Michael Wonder on 08 Apr 2020
Esperion Announces European Commission approval of the Nustendi (bempedoic acid and ezetimibe) tablet for the treatment of hypercholesterolaemia and mixed dyslipidaemia
6 April 2020 - First non-statin, LDL-C lowering combination medicine ever approved in Europe. ...