Blog
RSS FeedPosted by Michael Wonder on 16 Mar 2022
Rinvoq (upadacitinib) receives FDA approval for the treatment of adults with moderately to severely active ulcerative colitis
16 March 2022 - In clinical trials, Rinvoq (upadacitinib) achieved the primary endpoints of clinical remission (per modified Mayo Score) at ...
Posted by Michael Wonder on 16 Mar 2022
Consequences of lack of funding for efforts to combat COVID-19 if Congress does not act
15 March 2022 - The U.S. has made tremendous progress in our fight against COVID-19. ...
Posted by Michael Wonder on 16 Mar 2022
FDA drafts guidance on genome editing, CAR T cell therapies
16 March 2022 - The U.S. FDA has issued two draft guidances addressing the development of human gene therapy products that ...
Posted by Michael Wonder on 16 Mar 2022
Pfizer and BioNTech submit for U.S. emergency use authorisation of an additional booster dose of their COVID-19 vaccine for older adults
15 March 2022 - Submission based on real-world safety and efficacy data from Israel. ...
Posted by Michael Wonder on 16 Mar 2022
Europe begins reviewing application for AstraZeneca COVID drug
15 March 2022 - Europe's drug regulator said on Tuesday it had begun reviewing AstraZeneca's application for antibody based COVID-19 therapy, ...
Posted by Michael Wonder on 15 Mar 2022
FDA approves first generic of Symbicort to treat asthma and COPD
15 March 2022 - Agency supports development of complex generic drug-device combination product to improve competition and access to more affordable ...
Posted by Michael Wonder on 15 Mar 2022
Myrtelle receives FDA fast track, rare paediatric disease, and orphan drug designations for its proprietary gene therapy for the treatment of Canavan disease
15 March 2022 - Myrtelle today announced that the U.S. FDA has granted fast track, rare paediatric disease and orphan ...
Posted by Michael Wonder on 15 Mar 2022
Drug industry says EMA’s PRIME scheme useful but could be improved
14 March 2022 - Eligibility criteria for admission to the EMA's priority medicines (PRIME) scheme are too strict to facilitate ...
Posted by Michael Wonder on 15 Mar 2022
Single dose Kozenis (tafenoquine) approved for children with Plasmodium vivax malaria by Australian Therapeutic Goods Administration
14 March 2022 - Novel paediatric relapse prevention treatment marks a major contribution towards malaria elimination efforts. ...
Posted by Michael Wonder on 15 Mar 2022
Collider bias
14 March 2022 - Bias is a systematic, non-random error in the estimation of a treatment effect or the effect of ...
Posted by Michael Wonder on 14 Mar 2022
Incyte announces U.S. FDA has extended the supplemental new drug application review period for ruxolitinib cream (Opzelura) for the treatment of vitiligo
14 March 2022 - Incyte announced today that the U.S. FDA has extended the review period for the supplemental new ...
Posted by Michael Wonder on 14 Mar 2022
Corium receives FDA approval of Adlarity (donepezil transdermal system) for treatment of patients with Alzheimer's disease
14 March 2022 - First and only once weekly patch for convenient, well-tolerated delivery of most used drug for treatment of ...
Posted by Michael Wonder on 14 Mar 2022
Phathom Pharmaceuticals submits vonoprazan NDA to FDA for the treatment of erosive oesophagitis
14 March 2022 - Phathom Pharmaceuticals announced today that it has submitted a new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 14 Mar 2022
Update on US regulatory review of Fasenra in chronic rhinosinusitis with nasal polyps
14 March 2022 - The US FDA has issued a complete response letter regarding the supplemental biologics license application for ...
Posted by Michael Wonder on 12 Mar 2022
Antengene announces Xpovio approved by the TGA in Australia for the treatment of relapsed and/or refractory multiple myeloma and triple class-refractory multiple myeloma
10 March 2022 - Xpovio is the first of a new class of SINE (selective inhibitor of nuclear export) medicines. ...