Blog
RSS FeedPosted by Michael Wonder on 03 Mar 2020
FDA grants breakthrough therapy designation for Genentech’s Esbriet (pirfenidone) in unclassifiable interstitial lung disease
2 March 2020 - There are currently no FDA approved treatments for unclassifiable ILD, a debilitating, severe respiratory condition. ...
Posted by Michael Wonder on 03 Mar 2020
Sebela Pharmaceuticals announces FDA approval of Pizensy for oral solution for the treatment of chronic idiopathic constipation in adults
2 March 2020 - Sebela seeks partner to commercialise in the U.S. ...
Posted by Michael Wonder on 03 Mar 2020
'Get it done. We need it': Trump's coronavirus message to big pharma
3 March 2020 - President Donald Trump sought to show his personal engagement in the fight against coronavirus, meeting with ...
Posted by Michael Wonder on 03 Mar 2020
Mallinckrodt initiates rolling submission of new drug application to the U.S. FDA for terlipressin for the treatment of patients with hepatorenal syndrome type 1
2 March 2020 - Terlipressin would be the first FDA-approved treatment option in the United States for patients with HRS-1 if ...
Posted by Michael Wonder on 03 Mar 2020
Extended-release drugs could be costing U.S. health care system billions
1 March 2020 - If doctors prescribed short-acting medications that must be taken twice a day instead of once-a-day extended-release ...
Posted by Michael Wonder on 03 Mar 2020
KemPharm submits KP415 NDA to the FDA for the treatment of ADHD
2 March 2020 - If approved, KemPharm believes that KP415 may address several unmet needs, including earlier onset of action ...
Posted by Michael Wonder on 02 Mar 2020
FDA accepts MorphoSys' biologics license application and grants priority review for tafasitamab and lenalidomide for the treatment of relapsed/refractory DLBCL
2 March 2020 - MorphoSys announced today that the U.S. FDA accepted filing of MorphoSys' biologics license application and granted priority ...
Posted by Michael Wonder on 02 Mar 2020
FDA approves new therapy for patients with previously treated multiple myeloma
2 March 2020 - Today, the U.S. FDA approved Sarclisa (isatuximab-irfc), in combination with pomalidomide and dexamethasone, for the treatment of ...
Posted by Michael Wonder on 02 Mar 2020
U.S. FDA accepts regulatory submission for tanezumab, a potential first-in-class treatment for patients with chronic pain due to moderate-to-severe osteoarthritis
2 February 2020 - Pfizer and Eli Lilly today announced that the U.S. FDA accepted for review a Biologics License Application ...
Posted by Michael Wonder on 29 Feb 2020
FDA grants breakthrough therapy designation for Debiopharm's novel chemo-radio sensititiser Debio 1143 for front-line treatment of head & neck cancer
27 February 2020 - The FDA decision was based on the compelling magnitude of the clinically phase II findings in combination ...
Posted by Michael Wonder on 29 Feb 2020
FDA approves first generic of Daraprim
28 February 2020 - Agency continues to support competition in generic drugs, increasing patient access to more affordable medicines. ...
Posted by Michael Wonder on 28 Feb 2020
Acacia Pharma announces US approval of Barhemsys (amisulpride) for the treatment and prevention of PONV
27 February 2020 - Barhemsys is the first and only antiemetic to be approved for the rescue treatment of PONV ...
Posted by Michael Wonder on 28 Feb 2020
Biohaven's Nurtec ODT (rimegapant) receives FDA approval for the acute treatment of migraine in adults
27 February 2020 - First and only calcitonin gene-related peptide receptor antagonist available in a fast-acting orally disintegrating tablet. ...
Posted by Michael Wonder on 28 Feb 2020
Tessa Therapeutics announces U.S. FDA regenerative medicine advanced therapy designation granted to its CD30 CAR-T cell therapy for the treatment of relapsed or refractory CD30-positive classical Hodgkin lymphoma
27 February 2020 - RMAT designation follows positive proof-of-concept data from two independent Phase I/II clinical studies conducted by Baylor College ...
Posted by Michael Wonder on 28 Feb 2020
When can intermediate outcomes be used as surrogate outcomes?
27 February 2020 - Randomised clinical trials have a long history of success in many medical arenas. ...