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RSS FeedPosted 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 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
Glaucoma drug Vyzulta, psoriasis remedy Skilarence win insurance benefit
28 January 2022 - The government granted health insurance benefits for Bausch Health Korea’s glaucoma treatment Vyzulta (latanoprostene bunod) and ...
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
Recommendations made by the PBAC – December 2021 intracycle meeting
28 January 2022 - Recommendations made by the PBAC in December 2021 relating to the listing of drugs on the PBS ...
Posted by Michael Wonder on 28 Jan 2022
'I feel like I'm drowning': thousands with cystic fibrosis wait to hear if 'life-saving' drug will be listed on PBS
27 January 2022 - Matt Dickinson was struggling to breathe when his mother rushed him to an Adelaide hospital earlier ...
Posted by Michael Wonder on 28 Jan 2022
Australians deserve fast access to the latest medicines, vaccines and treatments
28 January 2022 - Medicines Australia recommends the Australian Government delivers a plan to shorten the time that patients wait ...
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
The certainty of uncertainty in health technology assessment
26 January 2022 - History is replete with stories of poor decisions—catastrophes that leaders might have averted, and great opportunities that ...
Posted by Michael Wonder on 27 Jan 2022
Positive Early Access to Medicines Scheme (EAMS) scientific opinion awarded to GBT’s voxelotor for the treatment of haemolytic anaemia due to sickle cell disease
27 January 2022 - Global Blood Therapeutics today announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has awarded ...
Posted by Michael Wonder on 27 Jan 2022
Shortage of prescription infant formula worries parents
28 January 2022 - A shortage of prescription infant formula has parents worried about how they will feed their babies. ...
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). ...