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RSS FeedPosted by Michael Wonder on 25 Mar 2022
Ipsen receives positive CHMP opinion for Cabometyx in radioactive iodine-refractory differentiated thyroid cancer
25 March 2022 - Recommendation based on data from the COSMIC-311 Phase 3 trial, in which Cabometyx (cabozantinib) demonstrated a 78% ...
Posted by Michael Wonder on 25 Mar 2022
Novartis receives positive CHMP opinion for Kymriah CAR-T cell therapy for adult patients with relapsed or refractory follicular lymphoma in Europe
25 March 2022 - CHMP opinion based on Phase 2 global ELARA trial demonstrating high response rates in heavily pretreated patients; ...
Posted by Michael Wonder on 25 Mar 2022
CHMP recommends EU approval of Roche’s Polivy combination for people with previously untreated diffuse large B-cell lymphoma
25 March 2022 - Recommendation is based on pivotal data from the Phase 3 POLARIX trial. ...
Posted by Michael Wonder on 25 Mar 2022
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) plus chemotherapy, with or without bevacizumab, as treatment for patients with persistent, recurrent or metastatic cervical cancer whose tumours express PD-L1 (CPS ≥1)
25 March 2022 - Opinion granted based on positive results from Phase 3 KEYNOTE-826 trial. ...
Posted by Michael Wonder on 25 Mar 2022
Novartis receives positive CHMP opinion for Jakavi to treat acute and chronic graft versus host disease
25 March 2022 - CHMP opinion based on Phase 3 REACH2 and REACH3 trials that showed Jakavi improved response rates and ...
Posted by Michael Wonder on 25 Mar 2022
New gene therapy to treat adult patients with multiple myeloma
25 March 2022 - EMA has recommended a conditional marketing authorisation in the European Union for Carvykti (ciltacabtagene autoleucel) for the ...
Posted by Michael Wonder on 25 Mar 2022
ATAGI statement on recommendations on a winter booster dose of COVID-19 vaccine
25 March 2022 - ATAGI recommends an additional booster dose of COVID-19 vaccine to increase vaccine protection before winter for ...
Posted by Michael Wonder on 24 Mar 2022
Leaked TRIPS proposal misguided about improving global COVID-19 vaccination rates
24 March 2022 - The leaked proposal on the waiver on intellectual property rights for COVID-19 vaccines is misguided and ...
Posted by Michael Wonder on 24 Mar 2022
Pressured by patients, FDA reviews ALS drug with modest data
25 March 2022 - The FDA meets next week to review a closely watched drug for ALS, or Lou Gehrig’s ...
Posted by Michael Wonder on 24 Mar 2022
Evusheld long-acting antibody combination recommended for approval in the EU for the pre-exposure prophylaxis of COVID-19
24 March 2022 - Recommendation based on Phase 3 PROVENT trial showing a significant reduction in the risk of developing ...
Posted by Michael Wonder on 24 Mar 2022
Fresenius Kabi announces FDA approval of SMOFlipid lipid injectable emulsion for paediatric patients requiring parenteral nutrition
24 March 2022 - First and only four-oil lipid injectable emulsion indicated for paediatric parenteral nutrition, including term and preterm neonates. ...
Posted by Michael Wonder on 24 Mar 2022
U.S. FDA approves streamlined process for initiating HIV therapy with Cabenuva (cabotegravir and rilpivirine), the first and only complete long-acting injectable HIV treatment
24 March 2022 - Adults living with HIV now have an option to start injectable regimen without the need for ...
Posted by Michael Wonder on 24 Mar 2022
Pfizer granted FDA breakthrough therapy designation for respiratory syncytial virus vaccine candidate for the prevention of RSV in older adults
24 March 2022 - Pfizer today announced that its respiratory syncytial virus vaccine candidate, PF-06928316 or RSVpreF, received breakthrough therapy ...
Posted by Michael Wonder on 24 Mar 2022
Fennec Pharmaceuticals resubmits new drug application to the U.S. FDA for Pedmark
24 March 2022 - Fennec Pharmaceuticals today announced the resubmission of its new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 24 Mar 2022
Lilly announces complete response letter for sintilimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of people with non-squamous non-small cell lung cancer
24 March 2022 - Eli Lilly today announced that the U.S. FDA has issued a complete response letter (CRL) for ...