Blog
RSS FeedPosted by Michael Wonder on 13 Apr 2020
How a premier U.S. drug company became a virus ‘super spreader'
12 April 2020 - Biogen employees unwittingly spread the coronavirus from Massachusetts to Indiana, Tennessee and North Carolina. ...
Posted by Michael Wonder on 10 Apr 2020
FDA approves first therapy for children with debilitating and disfiguring rare disease
10 April 2020 - Today, the U.S. FDA approved Koselugo (selumetinib) for the treatment of paediatric patients, 2 years of age ...
Posted by Michael Wonder on 10 Apr 2020
This tiny federal agency was built to respond to a crisis like coronavirus. Now that it’s here, is BARDA ready?
6 April 2020 - It seems like an agency tailor-made for a crisis like the coronavirus pandemic. ...
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
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
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
Genentech provides regulatory update on risdiplam for the treatment of spinal muscular atrophy
7 April 2020 - U.S. FDA extends review time for risdiplam following agreed submission of additional data, including SUNFISH Part 2. ...
Posted by Michael Wonder on 08 Apr 2020
Alnylam completes rolling submission of new drug application to the U.S. FDA and submits marketing authorisation application to the EMA for lumasiran for the treatment of primary hyperoxaluria type 1
7 April 2020 - Lumasiran is the first potential therapeutic to demonstrate substantial reduction in urinary oxalate excretion. ...
Posted by Michael Wonder on 08 Apr 2020
Agenus receives fast track designation for balstilimab in advanced cervical cancer
7 April 2020 - Agenus today announced that the U.S. FDA has granted Agenus fast track designation for investigation of balstilimab ...