Blog
RSS FeedPosted by Michael Wonder on 08 Mar 2021
Viatris and Kindeva Drug Delivery announce FDA tentative approval of the first abbreviated new drug application generic version of Symbicort (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol
8 March 2021 - Milestone reinforces Viatris' commitment to complex products and innovative solutions to help increase patient access ...
Posted by Michael Wonder on 08 Mar 2021
BioMarin announces FDA regenerative medicine advanced therapy designation granted to valoctocogene roxaparvovec, investigational gene therapy for haemophilia A
8 March 2021 - RMAT designation granted by FDA during bleeding disorders awareness month. ...
Posted by Michael Wonder on 08 Mar 2021
Genentech provides update on Tecentriq U.S. indication in prior-platinum treated metastatic bladder cancer
7 March 2021 - Genentech today announced that the company is voluntarily withdrawing the U.S. indication for Tecentriq (atezolizumab) in prior-platinum ...
Posted by Michael Wonder on 08 Mar 2021
Cara Therapeutics and Vifor Pharma announce U.S. FDA acceptance and priority review of NDA for Korsuva injection in haemodialysis patients with moderate to severe pruritus
8 March 2021 - FDA has set Prescription Drug User Fee Act target action date of 23 August 2021. ...
Posted by Michael Wonder on 07 Mar 2021
Canada authorises one-shot COVID-19 vaccine from Johnson & Johnson
5 March 2021 - The first one-shot COVID-19 vaccine from Johnson & Johnson has been authorized by Health Canada, making ...
Posted by Michael Wonder on 06 Mar 2021
U.S. FDA approves Yescarta for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy
5 March 2021 - Yescarta is the first CAR T-cell therapy approved for indolent follicular lymphoma; approval marks the third ...
Posted by Michael Wonder on 06 Mar 2021
Genentech’s Actemra becomes the first biologic therapy approved by the FDA for slowing the rate of decline in pulmonary function in adults with systemic sclerosis associated interstitial lung disease, a rare, debilitating condition
4 March 2021 - The U.S. FDA previously granted priority review designation to Actemra for the treatment of systemic sclerosis-associated ...
Posted by Michael Wonder on 05 Mar 2021
Idorsia submits European marketing authorisation application for daridorexant for the treatment of adult patients with insomnia
3 March 2021 - The application includes robust data from the Phase 3 registration program, which demonstrated efficacy of daridorexant ...
Posted by Michael Wonder on 05 Mar 2021
New legislation to support medicine substitutions
5 March 2021 - New legislation has been passed to allow pharmacists to substitute a different medicine when a patient's ...
Posted by Michael Wonder on 05 Mar 2021
TGA adopts Access Consortium guidance for fast-tracking authorisations of modified COVID-19 vaccines for variant
5 March 2021 - TGA has adopted guidance developed by the Access Consortium - a coalition of regulatory authorities from ...
Posted by Michael Wonder on 04 Mar 2021
Blueprint Medicines announces EMA validation of type II variation marketing authorisation application for Ayvakyt (avapritinib) for the treatment of advanced systemic mastocytosis
3 March 2021 - Blueprint Medicines today announced that the EMA has validated the company's type II variation marketing authorisation application ...
Posted by Michael Wonder on 04 Mar 2021
Junshi Biosciences and Coherus BioSciences announce initiation of rolling submission of BLA for toripalimab to the U.S. FDA for the treatment of nasopharyngeal carcinoma
3 March 2021 - BLA submitted with FDA’s breakthrough therapy designation. ...
Posted by Michael Wonder on 04 Mar 2021
FDA approves Accu-Joint hemi implant, a hemi-arthroplasty metatarsal head or phalangeal base implant for the metatarsophalangeal joint
2 March 2021 - The Accu-Joint is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in ...
Posted by Michael Wonder on 04 Mar 2021
FDA releases a new plan to bring its data skills up to speed
4 March 2021 - When Ram Iyer started his new job at the Food and Drug Administration in 2020, he ...
Posted by Michael Wonder on 04 Mar 2021
FDA accepts Dupixent (dupilumab) for review in children with moderate to severe asthma
4 March 2021 - Submission supported by data demonstrating Dupixent significantly reduced severe asthma attacks and is the only biologic to ...