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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
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 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
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 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
Former bowel cancer patient calls for NZ to fund drug she says saved her life
26 January 2022 - A woman with bowel cancer who was told she may have two years to live says ...
Posted by Michael Wonder on 26 Jan 2022
Incyte provides update on parsaclisib and MCLA-145
25 January 2022 - Incyte today announced updates regarding the clinical development of parsaclisib, the Company’s next-generation oral inhibitor of ...
Posted by Michael Wonder on 25 Jan 2022
Senhwa’s pidnarulex receives US FDA fast track designation for the treatment of solid tumours with BRCA1/2, PALB2 and other HR gene mutations
24 January 2022 - Senhwa Biosciences announced today that the US FDA has granted fast track designation for Pidnarulex, a first ...
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 24 Jan 2022
Breast cancer patients in Scotland are set to receive tumour blasting wonder drug that starts working in weeks - sparking hopes of a wider rollout for NHS patients across the rest of the UK
23 January 2022 - A breast cancer drug that can melt away tumours in weeks has been given the green ...
Posted by Michael Wonder on 24 Jan 2022
People with chronic myeloid leukaemia granted early access to Novartis’ investigational treatment
24 January 2022 - The Medicine and Healthcare products Regulatory Agency grants positive scientific opinion on use of asciminib as 3rd-line ...
Posted by Michael Wonder on 20 Jan 2022
Immunotherapy with blinatumomab improves the chances of survival in very rare childhood blood cancer
20 January 2022 - The Federal Joint Committee (G-BA) today classified the additional benefit of the active ingredient blinatumomab as significant ...
Posted by Michael Wonder on 20 Jan 2022
Lumakras (sotorasib) receives approval in Japan for patients with KRAS G12C mutated advanced non-small cell lung cancer
20 January 2022 - Approval based on pivotal CodeBreaK 100 data demonstrating durable responses and a favourable benefit-risk profile with Lumakras. ...
Posted by Michael Wonder on 20 Jan 2022
Bristol Myers Squibb receives approval for Abecma (idecabtagene vicleucel), the first CAR T therapy approved for the treatment of multiple myeloma in Japan
20 January 2022 - Bristol-Myers Squibb today announced that Japan’s Ministry of Health, Labour and Welfare has approved Abecma (idecabtagene ...