Blog
RSS FeedPosted by Michael Wonder on 28 Apr 2020
The race for coronavirus vaccines: a graphical guide
28 April 2020 - Eight ways in which scientists hope to provide immunity to SARS-CoV-2. ...
Posted by Michael Wonder on 28 Apr 2020
FDA approves Merck’s Keytruda (pembrolizumab) for use at an additional recommended dose of 400 mg every six weeks for all approved adult indications
28 April 2020 - Merck today announced that the U.S. FDA has approved an additional recommended dosage of 400 mg every ...
Posted by Michael Wonder on 28 Apr 2020
A new FDA fast track designation for Zambon
28 April 2020 - The designation is for L‑CsA‑i for the treatment of bronchiolitis obliterans syndrome, developed by Breath Therapeutics, a ...
Posted by Michael Wonder on 28 Apr 2020
In race for a coronavirus vaccine, an Oxford group leaps ahead
27 April 2020 - As scientists at the Jenner Institute prepare for mass clinical trials, new tests show their vaccine to ...
Posted by Michael Wonder on 27 Apr 2020
Vaccine could potentially be available later this year, coalition says
27 April 2020 - Group head hopes to deliver shots sooner than 12-18 months. ...
Posted by Michael Wonder on 27 Apr 2020
Neurocrine Biosciences announces FDA approval of once daily Ongentys (opicapone) as an add-on treatment for patients with Parkinson's disease experiencing "off" episodes
27 April 2020 - Neurocrine Biosciences plans to make Ongentys available to patients later this year. ...
Posted by Michael Wonder on 27 Apr 2020
Lokelma US label updated to include dosing guidance for the treatment of hyperkalaemia in patients with end-stage renal disease on haemodialysis
27 April 2020 - Label update is based on data from Phase IIIb DIALIZE trial ...
Posted by Michael Wonder on 27 Apr 2020
Takeda announces U.S. FDA breakthrough therapy designation for mobocertinib (TAK-788) for the treatment of NSCLC patients with EGFR exon 20 insertion mutations
27 April 2020 - Designation represents positive progress for a unique patient population in need of targeted therapy options. ...
Posted by Michael Wonder on 27 Apr 2020
CytoDyn submits completed biologics license application to the FDA for leronlimab as a combination therapy for highly treatment experienced HIV patients
27 April 2020 - During the FDA’s review period, the Company will dedicate all resources to ensure availability of leronlimab for ...
Posted by Michael Wonder on 27 Apr 2020
Ousting vaccine chief ‘is going to set us back,’ former FDA head says
26 April 2020 - Scott Gottlieb says Rick Bright’s departure is likely to be counterproductive. ...
Posted by Michael Wonder on 27 Apr 2020
America needs to win the coronavirus vaccine race
26 April 2020 - Other countries might not be quick to share. Time to speed up trials and ramp up manufacturing ...
Posted by Michael Wonder on 27 Apr 2020
Prescriptions surged as Trump praised drugs in coronavirus fight
25 April 2020 - Prescriptions for two antimalarial drugs jumped by 46 times the average when the president promoted them on ...
Posted by Michael Wonder on 26 Apr 2020
Janssen announces submission of two applications to U.S. FDA seeking approval of Simponi Aria (golimumab) for the treatment of polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis
24 April 2020 - Submissions demonstrate Janssen’s commitment to developing new options for young patients. ...
Posted by Michael Wonder on 25 Apr 2020
FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems
24 April 2020 - Close supervision is strongly recommended. ...
Posted by Michael Wonder on 25 Apr 2020
CSL's blood payments in US under the microscope
25 April 2020 - CSL has been forced to defend the way it runs its blood plasma collection business in ...