Blog
RSS FeedPosted by Michael Wonder on 29 Jan 2022
Bristol Myers Squibb receives positive CHMP opinion for CAR T cell therapy Breyanzi (lisocabtagene maraleucel) for relapsed or refractory DLBCL, PMBCL and FL3B
28 January 2022 - Recommendation for approval based on results from TRANSCEND NHL 001, the largest pivotal trial of patients ...
Posted by Michael Wonder on 28 Jan 2022
Updates on Olumiant (baricitinib) FDA review for atopic dermatitis
28 January 2022 - Eli Lilly and Incyte today announced updates on the Phase 3 development program for Olumiant (baricitinib) in ...
Posted by Michael Wonder on 28 Jan 2022
Regeneron and Sanofi provide regulatory update on Libtayo (cemiplimab-rwlc) in advanced cervical cancer
28 January 2022 - Regeneron Pharmaceuticals and Sanofi today announced the voluntary withdrawal of the supplemental biologics license application for Libtayo ...
Posted by Michael Wonder on 28 Jan 2022
Highlights from CHMP 24-27 January meeting
28 January 2022 - EMA’s CHMP recommended seven medicines for approval at its January 2022 meeting. ...
Posted by Michael Wonder on 28 Jan 2022
Pfizer's COVID-19 vaccine (Comirnaty) provisionally approved for use as a booster in individuals aged 16-17 years old
28 January 2022 - The Therapeutic Goods Administration has provisionally approved the Pfizer COVID-19 vaccine, Comirnaty for use as a ...
Posted by Michael Wonder on 27 Jan 2022
Moderna aims to deliver Omicron COVID-19 vaccine by September
27 January 2022 - A COVID-19 booster shot, targeted specifically at the Omicron variant, is expected to be delivered by ...
Posted by Michael Wonder on 27 Jan 2022
FDA enforces ClinicalTrials.gov results posting requirements, including threats of financial penalty
27 January 2022 - Clinical trials requiring registration on ClinicalTrials.gov generally must have results submitted no later than one year after ...
Posted by Michael Wonder on 27 Jan 2022
FDA grants breakthrough therapy designation for Dizal Pharmaceutical's DZD9008 in patients with locally advanced or metastatic non-small cell lung cancer harbouring EGFR Exon 20 insertion
27 January 2022 - Breakthrough therapy designation further demonstrates excellent clinical profile of DZD9008 (sunvozertinib). ...
Posted by Michael Wonder on 27 Jan 2022
TGA approves Tepmetko for patients with non-small-cell lung cancer
27 January 2022 - Tepotinib (Tepmetko) has provisional approval in Australia for the treatment of adult patients with locally advanced or ...
Posted by Michael Wonder on 27 Jan 2022
COVID-19: EMA recommends conditional marketing authorisation for Paxlovid
27 January 2022 - The EMA’s CHMP has recommended granting a conditional marketing authorisation for the oral antiviral medicine Paxlovid ...
Posted by Michael Wonder on 27 Jan 2022
Lantern Pharma receives rare paediatric disease and orphan drug designations for LP-184 for the treatment of atypical teratoid rhabdoid tumour
24 January 2022 - Lantern Pharma today announced that the U.S. FDA has granted both rare paediatric disease designation and orphan ...
Posted by Michael Wonder on 27 Jan 2022
COVID-19 vaccine weekly safety report (27 January 2022)
27 January 2022 - To 23 January 2022, the TGA has received 431 reports which have been assessed as likely to ...
Posted by Michael Wonder on 26 Jan 2022
Pfizer pushes to intervene in lawsuit seeking COVID vaccine information from FDA
27 January 2022 - Pfizer wants to intervene in a Texas federal lawsuit seeking information from the U.S. FDA used ...
Posted by Michael Wonder on 26 Jan 2022
Immunocore announces FDA approval of Kimmtrak (tebentafusp-tebn) for the treatment of unresectable or metastatic uveal melanoma
26 January 2022 - Kimmtrak is the first T cell receptor therapeutic to receive regulatory approval. ...
Posted by Michael Wonder on 26 Jan 2022
Catalyst Biosciences receives rare paediatric disease designation for CB 4332 for the treatment of CFI deficiency
25 January 2022 - Catalyst Biosciences today announced the U.S. FDA has granted rare paediatric disease designation for CB 4332 for ...