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COVID-19 Pfizer/BioNTech booster approved by FDA and CDC
The plan to offer Americans a third, booster shot of the Pfizer/BioNTech COVID-19 vaccine has finally been waved through by the FDA and CDC
FDA approves Seagen/Genmab’s antibody-drug conjugate Tivdak for women with advanced cervical cancer
The drug has been granted accelerated approval, and the companies have also released positive data on first-line treatment
New data for Tecentriq in early-stage lung cancer
Roche’s PD-L1 blocker reduced the risk of disease recurrence and death for patients with stage 2-3a non-small cell lung cancer following surgery
Strong five-year survival data for Kisqali in breast cancer
Novartis’ Kisqali plus letrozole offers more than a year survival benefit for postmenopausal women with HR+/HER2 advanced breast cancer
Biogen’s Vumerity recommended by CHMP in MS
A thumbs up for Vumerity in the EU could ease the way for Biogen’s follow-up to Tecfidera in multiple sclerosis
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
‘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 pauses BioMarin gene therapy trial The study for BMN 307 in genetic disease phenylketonuria will be paused while malignancies in mice are explored
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Pfizer starts RSV trial ahead of winter seasonA vaccine against the common respiratory syncytial virus could be available soon, as Pfizer joins GSK and J&J in launching phase 3 trials
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Congress “concerned by apparent anomalies” around FDA’s approval of AduhelmCongress demands more information from the FDA on its controversial approval of Biogen’s Alzheimer’s drug and its dealings with the company.
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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
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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
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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
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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- FDA approves Seagen/Genmab’s antibody-drug conjugate Tivdak for women with advanced cervical cancer
- Gilead’s Veklury (remdesivir) cuts risk of severe COVID-19 by 87%
- One dose of AZ’s COVID-19 vaccine ‘highly effective’ against severe disease from variants
- AstraZeneca’s Imfinzi provides sustained survival benefit for lung cancer patients
- First oral antiviral drug for COVID-19 reviewed by Health Canada
- EU “still interested” in Valneva COVID vaccine despite UK snub
- Our mission: helping patients in areas of unmet medical need
- Novo Nordisk settles US insulin pricing dispute for $100m
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- Lynparza significantly delays disease progression as first-line treatment in prostate cancer
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- Oxford PharmaGenesis wins Communiqué Medical Affairs Agency of the Year award at Communiqué 2021
- China backs use of Roche’s Actemra for coronavirus
- Future of MHRA uncertain amid Brexit-fuelled shake up
- Nicky Hutchens appointed as deputy managing director at Four Health
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