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.

Vaccines 105

Vaccines Immunization 105

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.

Vaccines 105

Vaccines 105

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.

Chemotherapy 81

Chemotherapy FDA 81

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).

Chemotherapy 58

Chemotherapy Compounding Labelling FDA 58

PharmaShots

MARCH 23, 2023

haemophilia A without factor VIII inhibitors with no new safety signals, patients experienced no bleeds/no spontaneous bleeds/no joint bleeds were 66.7%/81.9%/88.9%, haemophilia A without factor VIII inhibitors with no new safety signals, patients experienced no bleeds/no spontaneous bleeds/no joint bleeds were 66.7%/81.9%/88.9%,

Labelling 40

Labelling FDA 40

ISPE

SEPTEMBER 8, 2023

It is incumbent for industry to modernize manufacturing processes to improve efficiency and increase confidence in quality assurance for the benefit of patients while introducing novel technology and modalities as the science advances. The survey launched in April 2023 and is still open !

FDA 52

FDA Dosage Documentation Communication 52

pharmaphorum

AUGUST 20, 2021

AstraZeneca’s AZD7442 has shown that it can prevent COVID-19 infection when given to healthy patients – the first time this has been demonstrated by a long-acting antibody-based drug. There were 25 cases of COVID-19 overall in the study, with no cases of severe COVID-19 coronavirus-related deaths in subjects treated with AZD7442.

Hospitals 52

Hospitals Vaccines 52