Category: EMA

  • Biogen pulls EU application for Alzheimer’s drug Aduhelm

    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 clear the current data for the drug is not sufficient to get it past the EMA’s Committee for Medicinal Products for Human Use (CHMP). The decision does not come as […]

  • EU says not enough evidence to warrant fourth COVID jabs

    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 (ECDC) and EMA’s COVID-19 task force (ETF). The official word from the EU authorities is that for now a fourth dose of Pfizer/BioNTech’s Comirnaty  or Moderna’s SpikeVax – the preferred […]

  • EMA sets out proposals to reform EU’s clinical trials framework

    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 order to position the bloc as an international “focal point” for clinical research. The broad strokes of the proposals are laid out in a document entitled Accelerating Clinical Trials in […]

  • Biogen’s Alzheimer’s drug Aduhelm is rejected by EU advisors

    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 for the drug. The companies had already indicated that the CHMP looked likely to turn down their marketing application for Aduhelm (aducanumab), but the decision nevertheless is a heavy blow, […]

  • CHMP minded to turn down Alzheimer’s drug Aduhelm, says Biogen

    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 discussion next month. The CHMP had a “negative trend vote” on the drug at a meeting last week which included an “oral explanation” of Aduhelm (aducanumab), which was approved in […]

  • EMA starts review of Enhertu for HER2+ gastric cancer

    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 approved the new indication for antibody-drug conjugate Enhertu (trastuzumab deruxtecan) will add to its first EU approval in advanced HER2-positive breast cancer after two or more HER2-targeted therapies. Around one […]

  • Incyte Reports EMA’s Validation of MAA for Ruxolitinib Cream to Treat Vitiligo

    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 600+ patients aged ≥12yrs. with vitiligo The therapy demonstrated improvements in facial & total body repigmentation @ 24wks. of treatment, patients treated with ruxolitinib cream did not report site reactions […]

  • EU starts review of Merck’s oral COVID drug molnupiravir

    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. Molnupiravir is already filed for approval in the US and Canada – where Merck is known as MSD – amid hopes that the drug could be used to protect vulnerable […]

  • EU backs broader use of Comirnaty as COVID booster than US

    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 more, but says EU member states must decide for themselves whether to make a third dose available to their citizens. The regulator’s human medicines committee (CHMP) said that a third […]

  • EMA looks at booster data for Pfizer/BioNTech COVID-19 jab

    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 given six months after the first course to people aged 16 and over. The EMA’s CHMP human medicines committee will carry out an accelerated review of the application, which comes […]

  • COVID-19: Celltrion’s therapeutic option

    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 Celltrion’s R&D unit, to learn more. Celltrion’s COVID-19 therapeutic, CT-P59, is a monoclonal antibody (mAb) with activity against COVID-19. It was identified as a potential treatment through the screening of […]

  • EMA starts review of latecomer GSK/Sanofi COVID-19 vaccine

    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 vaccine – now dubbed Vidprevtyn – is based on a recombinant protein antigen developed by Sanofi’s vaccines unit Sanofi Pasteur, and also includes an immune-boosting adjuvant developed by GSK […]

  • EMA finds possible link between mRNA COVID jabs and myocarditis

    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 heart inflammation.  According to the EMA’s pharmacovigilance risk assessment committee (PRAC), labelling for Pfizer/BioNTech’s Comirnaty and Moderna’s Spikevax should be updated to reflect “very rare cases” of myocarditis and pericarditis […]

  • J&J must ditch 60m COVID jabs made at US plant, but 10m are okay, says FDA

    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 jettisoned, according to an FDA update. The problems at the plant run by contract manufacturer Emergent BioSolutions first emerged a few weeks ago, after an FDA inspection uncovered a string […]

  • How will NICE fare in a post-Brexit world?

    NICE has a global reputation as a pioneering HTA – but is that influence at risk now that the UK has left the EU? Experts from ICON give us their views on the past, present and future of NICE’s standing on the world stage. This article appears in our digital magazine, Deep Dive: Market Access […]

  • EU starts rolling review of GSK’s antibody for COVID-19

    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 type cleared for early use in the EU.  Sotrovimab (VIR-7831) – also known as GSK4182136 – is being assessed as a treatment for patients with SARS-CoV-2 infection aged 12 and […]

  • Calliditas eyes 2022 approval in EU for rare kidney disease drug Nefecon

    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 getting the green light for an accelerated review by the EMA.  The Swedish biotech is planning to file Nefecon for approval in the second quarter to the EU regulator, which […]

  • EMA starts review of GSK/Vir COVID-19 antibody

    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 type cleared for early use in the EU.  The monoclonal antibody – also known as GSK4182136 – is being evaluated for the treatment of people with mild or moderate COVID-19 […]

  • UK will offer under-30s alternative to AZ’s COVID jab

    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 to rare blood clots.  Updated figures from the Medicines and Healthcare products Regulatory Agency (MHRA) reveal 79 people experienced blood clots after receiving a dose of Vaxzevria (AZD1222), with 19 […]

  • Paediatric trial of AZ COVID jab ‘halted as a precaution’

    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 clotting is investigated by the UK drugs regulator.  Around 300 volunteers have been enrolled into the trial, but investigators have decided to pause dosing with the Oxford/AZ vaccine while they […]

  • CHMP backs Celltrion’s regdanvimab antibody for COVID-19

    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 at its March meeting.  Regdanvimab (CT-P59) – which is currently under a rolling review at the EMA – can be used for the treatment of COVID-19 in adults who don’t […]

  • Takeda Reports EMA’s Acceptance of TAK-003 for the Prevention of Dengue

    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 prevent dengue fever of any severity and due to any of the four dengue virus serotypes The trial met its 1EPs showed overall vaccine efficacy against VCD @12 mos. follow-up […]

  • States halting AZ jab a ‘disaster’ for EU’s COVID vaccination programme

    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 response to the pandemic in Europe.  Germany, France, Italy and Spain are among the member states that have announced a suspension of dosing with AZD1222 in the last 24 hours […]

  • J&J’s COVID-19 shot backed for emergency use in EU

    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 – after a review by its human medicines committee.  The CHMP has concluded that the Ad26.COV2.S vaccine can be used in people aged over 18, saying that “the data on the […]

  • EU regulators probe safety of AstraZeneca vaccine batch after blood clot reports

    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 use as a precaution following reports of blood clots. Initial findings showed no issue with the shots suspended by Austrian authorities after a person was diagnosed with severe blood clotting […]

  • EMA backs emergency use of Lilly’s COVID antibodies

    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, clearing the way for use in EU member states. The CHMP says bamlanivimab (LY-CoV555) can be given alone or administered together with etesevimab (LY-CoV016) to treat at-risk patients aged 12 […]

  • EMA starts rolling review of Sputnik V COVID vaccine

    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 the shot.  “EMA will assess Sputnik V’s compliance with the usual EU standards for effectiveness, safety and quality. While EMA cannot predict the overall timelines, it should take less time […]

  • Insights+ Key Biosimilars Events of January 2021

    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 alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a “reference […]

  • EMA approves AZ’s COVID-19 vaccine – including for over-65s

    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 it shouldn’t be used in elderly people. The conditional marketing authorisation makes AZD1222 the third coronavirus vaccine to be approved for EU use after the Pfizer/BioNTech and Moderna shots, and […]

  • Sobi gets EU nod for Doptelet in rare blood disorder ITP

    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 drug. Doptelet (avatrombopag) – an oral thrombopoietin receptor agonist – has been cleared to boost depleted levels of platelets in the blood of patients with ITP, an autoimmune clotting disorder […]

  • EMA says AstraZeneca’s COVID-19 shot could be approved on 29 January

    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 UK, and could give it the go-ahead later this month. The filing for conditional marketing approval is scheduled for review by the EMA’s CHMP human medicine committee at a meeting […]

  • EMA will use Panalgo software for real-world data analytics

    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 to streamline its public health efforts. IHD – or Instant Health Data – will be used by the EMA to carry out data analyses and examine medicinal product utilisation, answer […]

  • Elsevier to Work with Heel for Mechanism-based Drug Action Discovery

    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, have recently completed a series of research projects with a focus on improving exploratory preclinical studies. “We at Heel are pioneers in the field of systems research and have a […]

  • Daiichi Sankyo, AZ close on EU approval of Enhertu for breast cancer

    Daiichi Sankyo and AstraZeneca could be just weeks away from an EU approval for their antibody-drug conjugate (ADC) for breast cancer – Enhertu – which is tipped to become a multibillion-dollar blockbuster. At its meeting last week, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of Enhertu (trastuzumab deruxtecan) for patients […]

  • Cyberattack targets EMA, hacks COVID-19 vaccine data

    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, the EU regulator confirmed its security had been breached and said it had launched an investigation with law enforcement, but would not be providing any additional information while that probe […]

  • BioNTech and Pfizer Report CMA Submission of BNT162b2 to EMA for COVID-19

    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 The submitted data showed a 95% efficacy rate, efficacy was consistent across age, gender, race, and ethnicity demographics, with an observed efficacy in adults aged ≥65yrs. of >94%, favorable tolerability […]

  • Vertex gets EU okay to treat younger cystic fibrosis patients

    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 specific gene mutations. The regulator has given a green light to use of Symkevi (tezacaftor/ivacaftor) with Vertex’ Kalydeco (ivacaftor) in patients ages six years and older who have two copies […]

  • Bio-Thera Reports MAA Submission to EMA for BAT1706 a Proposed Biosimilar to Avastin

    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 Member States, Iceland, Norway, and Liechtenstein The submission of the MAA for BAT1706 marks it as the first ex-China MAA/ BLA submission. The BLA of the biosimilar for metastatic carcinoma […]

  • Guido Rasi steps down, handing the running of EMA to Emer Cooke

    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 becoming the first women in the role. Rasi’s second five-year term came to an end on Friday (13 November), with his second stint dominated by the move of the EMA […]

  • Trials and tribulations in Biogen’s Alzheimer’s drug reviews

    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 behind the drug is strong enough to support approval. The EMA has just kicked off its review of the anti-amyloid therapy, following in the footsteps of the FDA in the […]

  • FDA sets April verdict for Pfizer’s “underestimated” atopic dermatitis drug

    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 Bourla believes hasn’t been given the credit it is due by Wall Street analysts. The US regulator has started a priority review of abrocitinib for mediate to severe atopic dermatitis […]

  • Kite cues up first EMA okay for mantle cell lymphoma CAR-T

    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 therapy for mantle cell lymphoma. The EMA’s human drugs advisory committee recommended approval of Tecartus (brexucabtagene autoleucel; formerly KTE-X19) for relapsed or refractory MCL setting up a formal approval by […]

  • Novartis’ big bet on inclisiran nears fruition, as CHMP backs drug

    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 is now a step closer to getting a return on its investment. Inclisiran – now give the trade name Leqvio – has been recommended for approval by the CHMP as […]

  • Race for COVID-19 vaccine hots up as EMA begins review of BioNTech/Pfizer jab

    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 with a rival from AstraZeneca and Oxford University. The announcement comes just days after the regulator said its CHMP scientific committee had begun to look at the first batch of […]

  • EMA starts rapid review of Bluebird’s gene therapy for rare disease CALD

    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 the EMA started an accelerated review. If approved, Lenti-D (elivaldogene autotemcel or eli-cel) could transform the prospects of people with CALD, the most severe form of the neurodegenerative disease ALD […]

  • PTC Reports the EMA’s Acceptance of MAA for Evrysdi (risdiplam) to Treat SMA

    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 of Evrysdi (risdiplam) in symptomatic infants with type 1 SMA aged 2-7mos. and in people with types 2/3 SMA aged 2-25 yrs/ respectively The submission also includes data from JEWELFISH […]

  • Insights+ Key Biosimilars Events of July 2020

    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 alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a “reference […]

  • Sanofi faces possible manslaughter charges in epilepsy drug probe

    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 babies whose mothers took the drug. Depakine was found to carry a high risk of birth defects if taken by pregnant women. Sanofi, which denies wrongdoing and says it warned […]

  • How Are Regulatory Agencies Reacting to the Use of Real-World Evidence?

    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 development process, continuing on into post-market surveillance. With drug developers and other researchers becoming more interested in using RWD and the RWE that results from analyzing it, regulatory agencies have […]