patients case-study-mhra-and-astrazeneca 
pharmaphorum
MARCH 18, 2021
EMA’s safety committee (PRAC) concludes that the benefits of the #COVID19Vaccine AstraZeneca still outweigh its risks despite possible link to rare blood clots associated with low levels of blood platelets. Read more: [link] pic.twitter.com/0NO8kh5a48. — EU Medicines Agency (@EMA_News) March 18, 2021. Investigations still ongoing.
pharmaphorum
JANUARY 29, 2021
The shot is the first to show efficacy against the new variant found in the UK which accounted for around half of cases in the phase 3 study. Novavax said that the MHRA began a rolling review of the vaccine in mid-January, adding that it will share further trial results and data as soon as they become available.
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pharmaphorum
JULY 15, 2021
The UK drugs regulator has backed Merck KGaA’s MET inhibitor for the treatment of some patients with non-small cell lung cancer under the early access to medicines scheme (EAMS). The results showed that tumour shrinkage of at least 30% was seen in 45% of patients treated with the drug.
The Pharma Data
SEPTEMBER 14, 2020
After sparking a wave of concern through industry and mainstream media with the news it had halted international studies investigating its COVID-19 vaccine on 6 September, AstraZeneca has now announced that clinical trial operations conducted alongside its partners at the University of Oxford are now back in full swing.
pharmaphorum
DECEMBER 5, 2022
It has been announced today that Novartis’ Pluvicto (lutetium vipivotide tetraxetan) has shown statistically significant and clinically meaningful radiographic progression-free survival benefit in patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC).
Delveinsight
FEBRUARY 18, 2021
Bluebird suspends gene therapy trials after two sickle cell patients develop cancer. During the pause, bluebird will assess whether the BB305 lentiviral vector is linked to AML and MDS cases. Bluebird also lately realized a case of MDS in a participant in the phase 1/2 clinical trial.
The Pharma Data
MARCH 25, 2022
AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been recommended for marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.
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