EMA pilot will see if clinical trial data should be digested ‘raw’
A pilot study has been launched by the EMA to see whether it is helpful for regulators to look at the ‘raw data’ from clinical […]
A pilot study has been launched by the EMA to see whether it is helpful for regulators to look at the ‘raw data’ from clinical […]
The FDA approves new cancer treatments in half the time of the EMA – but does faster mean better? And how can regulators balance timely […]
Biogen has given up on seeking approval for its Alzheimer’s disease therapy Aduhelm in the EU, saying that discussions with EU regulators had made it […]
It is too early to consider widespread use of a second COVID-19 vaccine booster dose, according to the European Centre for Disease Prevention and Control […]
The European Commission, EMA and national regulators within the EU have launched an initiative to change the way clinical trials are designed and run in […]
The EMA’s human medicines committee has said it cannot approve Biogen and Eisai’s Alzheimer’s disease therapy Aduhelm, saying it was unconvinced by the data submitted […]
Biogen and Eisai have said that the EMA’s human medicines committee looks unlikely recommended approval of their Alzheimer’s drug Aduhelm when it comes up for […]
The EMA has started its review of AstraZeneca and Daiichi Sankyo’s Enhertu for a second indication, as a second-line treatment for HER2-positive gastric cancer. If […]
Shots: The MAA is based on the P-II LOTIS-2 study evaluating Zynlonta (CD19-directed ADC) in 145 patients with r/r DLBCL following two or more prior […]
Shots: The submissions are based on the P-II ELARA trial evaluates the efficacy and safety of Kymriah in adult patients with r/r FL after at […]
Shots: The MAA is based on the P-III TRuE-V clinical program that consists of 2 P-III studies ie., TRuE-V1 & V2 evaluating ruxolitinib cream in […]
The EMA has started a rolling review of Merck & Co and Ridgeback Biotherapeutics’ much-anticipated oral antiviral molnupiravir as a treatment for COVID-19 in adults. […]
Shots: The submission is based on the P-III MOVe-OUT trial that evaluates molnupiravir (800mg, bid) in non-hospitalized adult patients with COVID-19 At the interim analysis, […]
Shots: The US FDA has accepted the sBLA and EMA has validated the type-II variation application for Beovu (brolucizumab, 6mg) for the treatment of DME. […]
The EMA has given the go-ahead to the use of Pfizer and BioNTech’s COVID-19 vaccine Comirnaty as a booster for all people aged 18 or […]
Shots: The MAA was based on the efficacy & safety results from the P-II/III RELATIVITY-047 trial that evaluates the fixed-dose combination of relatlimab (160mg) + […]
The EU regulator has started to review a marketing application filed by Pfizer and BioNTech for a third, booster dose of their Comirnaty COVID-19 vaccine […]
Shots: The MAA is based on the P-III ADAPT trial evaluating the safety and efficacy of efgartigimod vs PBO in a ratio (1:1) in 167 […]
Shots: The MAA is based on the ongoing P-II/III CAPELLA study evaluates the antiviral activity of lenacapavir (PO, SC, every 6mos.) in combination with other […]
Shots: The applications are based on P-III CheckMate -648 trial evaluates Opdivo (3 mg/kg, q2w) + Yervoy (1 mg/kg, q6w up to 24mos.) or Opdivo […]
In just over a year, Celltrion Healthcare says it has identified and delivered a potential treatment for COVID-19. pharmaphorum spoke to Kwon Ki-sung, Head of […]
The EMA has kicked off a rolling review of a COVID-19 vaccine from Sanofi and GlaxoSmithKline, which started a 35,000-patient phase 3 trial in May. […]
The EU medicines regulator has said that there is some evidence to suggest a possible link between mRNA-based vaccines for COVID-19 and rare cases of […]
The failings at a Baltimore, US factory making Johnson & Johnson’s COVID-19 vaccine mean that millions of doses of the shot will have to be […]
NICE has a global reputation as a pioneering HTA – but is that influence at risk now that the UK has left the EU? Experts […]
The EMA has begun a rolling review of a COVID-19 antibody developed by GlaxoSmithKline and Vir BioTech which could become the fourth drug of its […]
Shots: The application is based on P-Ib/II CARTITUDE-1 study evaluating cilta-cel in adults with r/r MM who have received at least prior 3L therapies across […]
Shots: The company has submitted MAA for Omburtamab to EMA for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma The company continues to […]
Calliditas Therapeutics is on course to launch its first product, Nefecon for rare disease primary IgA nephropathy (IgAN), in the first half of 2022 after […]
The EMA has started reviewing the emergency use application for GlaxoSmithKline and Vir Biotech’s COVID-19 antibody VIR-7831, which could become the fourth drug of its […]
The UK drugs regulator has said people aged under 30 should be offered an alternative to the AstraZeneca COVID-19 vaccine, because of evidence linking it […]
Oxford University has suspended a clinical trial of its AstraZeneca-partnered COVID-19 vaccine in children and adolescents while a possible link to rare cases of blood […]
The EU looks set to approve emergency use of a third antibody therapy for COVID-19 after its human medicines committee backed use of Celltrion’s regdanvimab […]
Shots: The MAA is based on the P-III EV-301 trial which involves assessing Enfortumab Vedotin vs CT in ~ 600 patients with LA/m-UC, prior treated […]
Shots: The submission is based on a P-III TIDES trial assessing TAK-003 (0.5ml, SC) vs PBO in 20,000+ healthy children & adolescents aged 4-16yrs. to […]
The decision by around a dozen EU countries to suspend dosing with AstraZeneca’s COVID-19 vaccine is facing criticism, amid fears that it could undermine the […]
The EU’s medicines regulator has recommended granting conditional approval to a fourth COVID-19 vaccine – a single-dose shot from Johnson & Johnson’s Janssen unit – […]
European safety regulators have launched an investigation into the safety of a batch of the Oxford University/AstraZeneca COVID-19 vaccine, as countries including Denmark suspended its […]
The EMA’s human medicines committee has said two Eli Lilly antibodies are effective in people with COVID-19 who are at risk of developing severe disease, […]
With EU countries breaking ranks in order to get access to the Russian Sputnik V COVID-19 vaccine, the EMA has started a rolling review of […]
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective […]
Shots: The MAA submission is based on a P-Ib/II CARTITUDE-1 study assessing the safety and efficacy of cilta-cel in adults with r/r MM. The company […]
The EMA has approved AstraZeneca’s COVID-19 vaccine for use in the EU in all adults aged over 18, despite assertions in Germany this week that […]
Sweden’s Sobi has secured EU approval for Doptelet in primary chronic immune thrombocytopenia (ITP), an indication that the company expects to accelerate sales of the […]
Shots: The PRIME designation is based on two Phase I/II studies in R/R cHL conducted at Baylor College of Medicine and the University of North […]
Shots: The approval is based on P1093 & ODYSSEY (Penta20) studies assessing safety, tolerability & dose-finding of Tivicay (5mg) in pediatric patients aged 4wks.-18yrs. while […]
The European medicines Agency (EMA) said this morning it has received a marketing application from AstraZeneca for its COVID-19 vaccine, already rolling out in the […]
Six months after rebranding from BHE, Panalgo has won a contract to supply the European Medicines Agency (EMA) with its IHD data analytics platform, pledging […]
Elsevier, the data analytics business specialized in science and health, and Heel, a pharmaceutical company specialized in developing and manufacturing medicines made from natural ingredients, […]
Shots: The submission is based on SUSTAIN FORTE trial assessing Ozempic (2.0mg, qw) vs Ozempic (1.0mg) in 961 people with T2D in need of treatment […]
Shots: The EMA Submission is based on P-l CHRYSALIS study to evaluate the safety and efficacy of Amivantamab as a monotherapy and in combination with […]
Daiichi Sankyo and AstraZeneca could be just weeks away from an EU approval for their antibody-drug conjugate (ADC) for breast cancer – Enhertu – which […]
The European Medicines Agency (EMA) says it suffered a cyberattack, with documents relating to a Pfizer and BioNTech’s COVID-19 vaccine accessed. In a terse statement, […]
Shots: The companies have submitted CMA to the EMA for BNT162b2, against COVID-19. The submission completes the rolling review process initiated on Oct 6, 2020 […]
A new EMA approval has expanded the use of Vertex Pharma’s exon-skipping cystic fibrosis therapy Symkevi to children as young as six if they have […]
Shots: The company has submitted an MAAA for BAT1706 to EMA. Bio-Thera seeks a commercial license for all approved indications of bevacizumab in the EU […]
Shots: The US FDA has accepted the BLA of AVT02 for review and is expected to decide on the filing in Sept’2021 while the EMA […]
EMA executive director Guido Rasi has ended his second term at the helm of the EU medicines regulator, with Emer Cooke taking the wheel and […]
Shots: The MAA submitted to the EMA and the NDA to the US is based on P-III FIDELIO-DKD study assessing finerenone (10/20mg, qd) + SOC […]
Regulatory reviews of Biogen’s Alzheimer’s drug aducanumab are now ongoing on both sides of the Atlantic, but debate is still ongoing about whether the data […]
Pfizer could be just a few months away from getting FDA approval for its JAK1 inhibitor abrocitinib in atopic dermatitis, a drug that CEO Albert […]
Gilead Sciences’ Kite Pharma unit is closing on approval of its second European approval for a CAR-T for cancer, after the CHMP backed its Tecartus […]
Novartis’ near-$10 billion takeover of The Medicines Company last year was focused mainly on one asset – cholesterol-lowering drug inclisiran – and the Swiss pharma […]
Shots: The Rolling Submission is based on the preliminary results from pre-clinical and early clinical studies in adults, which shows that BNT162b2 triggers the production […]
The European Medicines Agency has begun a second “rolling review” of a potential coronavirus vaccine jointly developed by BioNTech and Pfizer, setting up a race […]
Bluebird bio could be just a few months away from approval of its gene therapy for rare disease cerebral adrenoleukodystrophy (CALD) in the EU, after […]
Shots: The US FDA and EMA has received ODD to Galecto’s GB0139 for the treatment of IPF. GB0139 showed significant reduction of YKL-40 biomarker in […]
Shots: The MAA submission is based on dose-finding Part 1 and confirmatory Part 2 of the FIREFISH and SUNFISH studies evaluating the efficacy and safety […]
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective […]
Shots: The P-IIIb C-OPTIMISE study assessing Cimzia (200mg, q2w with a loading dose of 400mg @ 0, 2 & 4wks.) vs PBO during 48wks. open-label […]
Sanofi has been placed under formal investigation in France for possible charges including manslaughter relating to the epilepsy drug Depakine, following the deaths of four […]
Shots: The MAA is based on P-III study assessing the efficacy and safety of vosoritide, further supported by the long-term safety and efficacy from the […]
As we have discussed here previously, real-world data (RWD) and real-world evidence (RWE) offer many potential benefits in every stage of the drug discovery and […]
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