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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
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
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
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
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
The price of cystic fibrosis drugs is still too high
27 January 2022 - The Swedish Dental and Pharmaceutical Benefits Agency, TLV, has decided that Kaftrio and Kalydeco for cystic fibrosis ...
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 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 25 Jan 2022
Oncopeptides withdraws withdrawal of first marketed drug
24 January 2022 - Swedish pharmaceutical company Oncopeptides announced that it has contacted the U.S FDA and rescinded its 22 ...
Posted by Michael Wonder on 25 Jan 2022
Bimzelx (bimekizumab) approved in Japan for the Treatment of plaque psoriasis, generalised pustular psoriasis and psoriatic erythroderma
24 January 2022 - The third approval for bimekizumab worldwide reinforces UCB’s commitment to bring new treatment options to the global ...
Posted by Michael Wonder on 25 Jan 2022
Vyepti (eptinezumab) approved by the EU Commission for the preventive treatment of migraine in adults
24 January 2022 - Vyepti is the first intravenous treatment approved for migraine prevention in Europe. ...
Posted by Michael Wonder on 24 Jan 2022
FDA approves Nucala (mepolizumab) 40 mg pre-filled syringe for children with severe eosinophilic asthma
24 January 2022 - This approval allows for at home administration in patients 6-11 years old with severe eosinophilic asthma. ...
Posted by Michael Wonder on 24 Jan 2022
Health Canada approves Ipsen’s Sohonos (palovarotene) as the first approved treatment for fibrodysplasia ossificans progressiva
24 January 2022 - Ipsen today announced the Health Canada approval of Sohonos (palovarotene), an oral selective retinoic-acid receptor gamma agonist ...
Posted by Michael Wonder on 24 Jan 2022
Chugai’s Actemra approved for additional indication of SARS-CoV-2 pneumonia in Japan
21 January 2022 - The approval is based on the results of several clinical studies in hospitalised patients with COVID-19. ...