Real-world evidence and real-world data The use of real-world evidence (RWE) to support regulatory and reimbursement decision-making received increasing attention over the past decades. The US FDA provides a definition of RWE as “the clinical evidence about the usage and potential benefits and risks of a medical product”1. RWE can be used across the entire…
AbbVie and Janssen receive positive CHMP opinions for novel cancer therapies
The European Medicines Agency (EMA) could soon change the face of cancer treatment with its potential approval of two novel bispecific antibodies, epcoritamab and talquetamab. The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting conditional marketing authorization for two novel cancer therapies — AbbVie’s epcoritamab and Janssen’s talquetamab. Epcoritamab for relapsed/refractory…
The ‘Iron man suit’ for QA Managers: Quality management software taps power of ChatGPT
Gone are the days when Microsoft’s animated paperclip, Clippy, popped up on your screen with helpful — and sometimes annoying — tips and tricks for your Word document. Now, the Israeli eQMS compliance provider Dot Compliance has launched what it hails as an industry-first electronic Quality Management System (eQMS) for life sciences with a prominent…
Oncopeptides’ Pepaxti wins positive opinion from CHMP for multiple myeloma patients
Oncopeptides AB (Nasdaq Stockholm:ONCO) has won a unanimous positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for Pepaxti (melphalan flufenamide) in the EU. The European Commission will make a final decision on the drug candidate in the next 60 days. An approval would make the drug available…
Valneva aims to salvage COVID-19 vaccine deal with EU
French vaccine company Valneva SE (Nasdaq:VALN; Euronext Paris:VLA) is hoping to change the European Commission’s (EC) mind after regulators notified the firm that they intend to terminate an Advance Purchase Agreement (APA) for its inactivated whole-virus COVID-19 vaccine candidate VLA2001. VALN shares fell 15% to $20.00. In February, Valneva announced that it expected authorization for…
Biogen gives up seeking European approval for aducanumab
After winning FDA approval for the controversial Alzheimer’s drug Aduhelm (aducanumab) in June 2021, Biogen (Nasdaq:BIIB) has encountered a string of setbacks. Most recently, the company has decided to yank its applications for market approval after the European Medicines Agency (EMA) recommended the refusal of the marketing authorization for Aduhelm in December 2021. At that…
Valneva anticipates EMA nod for its COVID-19 vaccine candidate in April
French vaccine company Valneva SE (Nasdaq:VALN; Euronext Paris:VLA) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has sent the company a “small set” of questions related to its VLA2001 COVID-19 vaccine candidate. The firm announced on February 25 that CHMP had sent the company a…
Sanofi and GSK aim to commercialize COVID-19 vaccine
In the U.S., Moderna (NASDAQ:MRNA) and Pfizer (NYSE:PFE) continue to dominate the COVID-19 landscape while demand for Johnson & Johnson’s (NYSE:JNJ) vaccine remains limited. Now, Sanofi (NASDAQ:SNY) and GSK (NYSE:GSK) are preparing to get into the game by preparing their regulatory submissions for their COVID-19 vaccine. The companies are currently communicating with the FDA and…
EMA gives thumbs down to Biogen’s Alzheimer’s drug aducanumab
Biogen (NSDQ:BIIB) and Eisai Co., Ltd. (Tokyo, Japan) have announced that the European Medicines Agency (EMA) has given its marketing authorization application for Aduhelm (aducanumab) a “negative trend vote.” The Committee for Medicinal Products for Human Use (CHMP) with the EMA will likely adopt a formal opinion on the application during meetings scheduled for December…
Tightening regulations in Japan drive PMDA compliance with integrated pharmacovigilance ecosystems
Pharmaceutical regulations in Japan are continuously expanding and updating to improve the safety of pharmaceutical drugs. Throughout history, the detection and understanding of harmful side effects of pharmaceutical drugs have led to new enhancements of regulations to allow regulatory agencies to find adverse events more effectively. In turn, this has led to stricter regulations. Likewise,…
AbbVie wins CHMP positive opinion to use Skyrizi as an active psoriatic arthritis treatment
AbbVie (NYSE:ABBV) announced that the interleukin-23 antagonist Skyrizi (risankizumab) had received backing from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to treat active psoriatic arthritis. The committee recommended the drug for adults with active psoriatic arthritis who have had an inadequate response or who have been intolerant to one…
Pfizer and BioNTech seek EMA nod for younger adolescents
After announcing that its vaccine was 100% efficacious in a Phase 3 trial involving adolescents aged 12 to 15, Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) are seeking authorization from the European Medicines Agency (EMA) to distribute the vaccine to that age group. BioNTech’s CEO, Uğur Şahin, estimated that the vaccine would be available to early adolescents in 27 European countries…