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Orphan status in Europe for lymphoma drug Zynlonta
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
The 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
Lumakras – 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
Trade 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
The 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
A 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
Congress 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”
In 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
As Moderna announces it has submitted COVID-19 vaccine booster data, the FDA advisory committee of outside experts will convene in two weeks’ time
‘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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Moving timesContinuity and stability are vital when it comes to the EMA's relocation when it leaves London
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SMC gives green light for Amgen’s KyprolisThe committee also gives verdict on three other products
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FDA nod for Janssen schizophrenia treatment Invega HafyeraThe phase 3 study results showed that 92% of patients were relapse-free after 12 months
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UK’s NICE recommends anti-cholesterol Leqvio for high-risk patientsThe approval for the Novartis drug by the NHS gatekeeper could save 30,000 lives over 10 years
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Merck’s anti-COVID drug molnupiravir moves to phase 3 for preventionThe MOVe-AHEAD trial will test whether the drug prevents infection in those living in the same household as someone with confirmed COVID-19
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FDA’s director and deputy director of its Office of Vaccines Research & Review resignThe departure of director Marion Gruber and deputy director Philip Krause is unexpected
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Boehringer Ingelheim/Lilly’s empagliflozin is first drug to show clear benefit in heart failureResults presented at the European Society of Cardiology Congress from the phase 3 trial demonstrated a 27% drop in hospitalisation risk
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Tecentriq withdrawn in hard-to-treat breast cancer in USA post-marketing study failed to show benefit for patients with triple-negative breast cancer taking Tecentriq and chemotherapy
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Merck’s Keytruda gains two more approvals in Japan
New approvals in breast and colorectal cancer take the number of indication for the immunotherapy mega-blockbuster to 15 in Japan
Latest regulatory appointments
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EFPIA confirms first and second vice-presidentsNovo Nordisk CEO Lars Fruergaard Jørgensen appointed first vice-president and Servier president Olivier Laureau confirmed as second vice-president
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EFPIA appoints Hubertus von Baumbach as presidentVon Baumbach will serve as president of the EFPIA for the next two years
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ABPI appoints industry veteran Richard Torbett as new chief executiveTorbett initially joined the pharma association in March 2016
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Professor Carole Longson moves from NICE to the ABPIShe joins the UK pharma body as its chief scientific officer
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MedTech Europe appoints new board of directors
Chair of the board Michelle Brennan is among those newly elected
COVID-19 Updates and Daily News
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- Embattled Biogen talks up Aduhelm
- First oral antiviral drug for COVID-19 reviewed by Health Canada
- David Hunt launches independent agency The Considered
- FDA’s director and deputy director of its Office of Vaccines Research & Review resign
- One dose of AZ’s COVID-19 vaccine ‘highly effective’ against severe disease from variants
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