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Orphan status in Europe for lymphoma drug Zynlonta

European Commission HQ.jpg

The ADC Therapeutics antibody-drug conjugate is licensed to treat patients with a common form of non-Hodgkin lymphoma.

Valneva shares fall as UK cancels COVID-19 vaccine order

LondonThe UK government has cancelled a supply agreement for French vaccine maker Valneva’s COVID candidate VLA2001 over an alleged breach of obligations.

Green light for Amgen’s KRAS inhibitor in the UK

Amgen flagLumakras – known as Lumykras in the UK – will be available to 600 lung cancer patients in England through an early access scheme.

Future of MHRA uncertain amid Brexit-fuelled shake up

LondonTrade unions and regulatory experts warn that budget and staff cuts may lead to drug approval delays or the UK regulator simply rubber-stamping EMA decisions

FDA pauses BioMarin gene therapy trial

BiomarinThe study for BMN 307 in genetic disease phenylketonuria will be paused while malignancies in mice are explored

Pfizer starts RSV trial ahead of winter season

Pfizer new logo 2021A vaccine against the common respiratory syncytial virus could be available soon, as Pfizer joins GSK and J&J in launching phase 3 trials

Congress “concerned by apparent anomalies” around FDA’s approval of Aduhelm

FDA newCongress demands more information from the FDA on its controversial approval of Biogen’s Alzheimer’s drug and its dealings with the company.

New data advances AstraZeneca’s “revolution in oncology”

AZ NEWIn a busy few weeks for AstraZeneca, the company will present data on 14 approved and potential drugs in lung and breast cancer

FDA experts to evaluate Pfizer-BioNTech COVID-19 booster

FDA newAs Moderna announces it has submitted COVID-19 vaccine booster data, the FDA advisory committee of outside experts will convene in two weeks’ time

Brexit‘Post-Brexit landscape for EU-wide IP Rights: The Story So Far’

Brexit means pharma must review its intellectual property rights across Europe

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