AZ, Merck get EU nod for Lynparza as adjuvant breast cancer therapy
The European Commission has cleared AstraZeneca and Merck & Co’s Lynparza as an adjuvant or neoadjuvant treatment for breast cancer, extending its lead over would-be […]
The European Commission has cleared AstraZeneca and Merck & Co’s Lynparza as an adjuvant or neoadjuvant treatment for breast cancer, extending its lead over would-be […]
AstraZeneca and Daiichi Sankyo have claimed approval in the EU for Enhertu as a second-line therapy for HER2-positive metastatic breast cancer, moving the drug up […]
AbbVie has submitted its oral CGRP inhibitor atogepant for prevention of both episodic and chronic migraine in the EU as it tries to catch up […]
Sanofi has claimed approval in the EU for Xenpozyme as a treatment for acid sphingomyelinase deficiency (ASMD) – which becomes the first and only treatment […]
The EMA’s human medicines advisory committee has recommended that BioMarin Pharmaceutical’s haemophilia A gene therapy Roctavian be approved in the EU, removing one of the […]
Johnson & Johnson and Legend Biotech will arrive at next week’s ASCO congress with a new EU approval for multiple myeloma CAR-T Carvykti. The European […]
PTC Therapeutic’s Upstaza gene therapy for patients with genetic disorder AADC deficiency has been recommended for approval in the EU, setting up another test of […]
UK scientists are being denied from joining the €95 billion Horizon research funding programme as a dispute over the trade border in Northern Ireland gets […]
Idorsia has become the first drugmaker in the EU to claim approval for a drug for chronic insomnia in the dual orexin receptor antagonist class, […]
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 […]
Pharmaceutical companies have said they will try to carve months off the time between approval and launch for new medicines in Europe, and reduce disparities […]
Immunocore now has approval on both side of the Atlantic for Kimmtrak – the first cancer therapeutic based on T cell receptor (TCR) technology – […]
A new treatment for adults with insomnia disorder has been recommended for use in Europe, giving hope to people whose lives are blighted by the […]
Bayer has claimed EU approval for Kerendia, its new drug for chronic kidney disease (CKD) in people with type 2 diabetes, as the company tries […]
Global Blood Therapeutics’ run of positive regulatory news for its oral sickle cell disease treatment Oxbryta has continued with an approval for the drug in […]
lupusAstraZeneca’s Saphnelo has become the first new drug to be approved to treat the autoimmune disease systemic lupus erythematosus (SLE) in the EU for more […]
Merck & Co has passed another milestone in its drive to move PD-1 inhibitor Keytruda earlier in the treatment pathway for cancer, with the European […]
We have seen a boom in biotech initial public offerings over the last two years, but many of Europe’s offerings have migrated to the United […]
Already scrambling to refile its obeticholic acid (OCA) drug for non-alcoholic steatohepatitis (NASH) after the FDA rejected it last year, Intercept Pharma was hoping for […]
Roche and Blueprint Medicines have opened a second front in their rivalry with Eli Lilly in RET-mutated cancers, after getting approval for Gavreto from the […]
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 […]
Shares in France’s Valneva leaped after it got an EU order to supply 60 million doses of its COVID-19 vaccine VLA2001 over the next two […]
Companies looking to replicate a drug’s EU market success in the US will face significant hurdles unless they are fully aware of the ever-changing national […]
Shots: The opinion was based on the P-III KEEPsAKE-1 & 2 studies evaluate Skyrizi (150mg, SC) vs PBO in adults with active PsA who had […]
Shots: Coave to receive $11.7M up front & equity investment, ~ $76.5M as clinical development, regulatory & commercial milestones along with royalties on net sales […]
Shots: The approval is based on the P-III trial that evaluates Ultomiris (q4w/q8w) vs Soliris in children & adolescents aged ≤18yrs. with PNH The interim […]
Incyte and MorphoSys’ antibody therapy tafasitamab has been approved in Europe, promising to provide a more convenient alternative to expensive and cumbersome CAR-T therapies for […]
The FDA may be reluctant to trust JAK inhibitors, but the European Commission is more willing, and has just handed a first-in-class approval in atopic […]
UCB has been bringing up the rear in the IL-17 inhibitor category with bimekizumab, but now has EU approval for the drug and thinks it […]
The EU regulator has approved FibroGen and Astellas Evrenzo for adults with anaemia caused by chronic kidney disease (CKD), just days after the FDA turned […]
AstraZeneca’s Forxiga has become the first SGLT2 inhibitor to be approved in Europe for use in people with chronic kidney disease, extending its lead over […]
Shots: Marinus to receive ~$30M up front & is eligible to receive ~$115M in R&D reimbursement milestone on achievement of clinical & commercialization milestones along […]
Bristol-Myers Squibb is in a battle with Merck & Co for position in the upper gastrointestinal cancer immunotherapy market, and has just reinforced its position […]
Bluebird bio has its first approval for Skysona (formerly Lenti-D), its gene therapy for children with the rare disease cerebral adrenoleukodystrophy (CALD), after getting the […]
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. […]
Digital health thought leader Mark Tarby, BrightInsight vice president of regulatory and quality management systems, shared his take on what the EU MDR means for […]
Shots: Under Dzuveo agreement, AcelRx to receive ~$55M as an up front and commercial milestones in addition to 35% to 45% revenue share on net […]
The European Commission has given competition clearance to the $39 billion acquisition of Alexion by AstraZeneca, leaving the UK as the last remaining obstacle to […]
A court in Belgium has ordered AstraZeneca to deliver additional doses of its COVID-19 vaccine to EU member states by 27 September, although far fewer […]
Capacity to supply Moderna’s COVID-19 vaccine in Europe could be swelled by round 300 million doses a year, following an agreement to set up a […]
Shots: The approval is based on P-III ADAURA trial assessing Tagrisso (80mg, qd, PO) vs PBO in 682 patients with stage IB, II, IIIA EGFRm […]
Lawyers for the European Commission asked a court in Brussels today to fine AstraZeneca millions of euros for its “obvious” failure to meet the terms […]
Shots: The P-III TIDES study involves assessing two doses of TAK-003 (0.5mL, SC on day 1 & 90) vs PBO to prevent laboratory-confirmed symptomatic dengue […]
US biotech bluebird bio has had a challenging time in the last few months, so a recommendation for EU approval of its gene therapy for […]
Shots: The recommendation is based P-III ADAURA trial assessing Tagrisso (80mg, qd, PO) vs PBO in 682 patients with stage IB, II, IIIA EGFRm NSCLC […]
Shots: EMA’s CHMP has recommended conditional marketing authorization of Selumetinib in the EU. The recommendation is based on the results from the P-I/II SPRINT Stratum […]
Roche’s Enspryng has been recommended for approval in the EU for treating neuromyelitis optica spectrum disorder (NMOSD), extending the treatment options for people with the […]
Shots: The CHMP has recommended the approval of Opdivo (nivolumab) + Yervoy (ipilimumab) as 1L treatment for unresectable MPM and is based P-III CheckMate -743 […]
GW Pharmaceuticals’ Epidyolex has been approved in the EU for a third epilepsy indication, giving a boost for the company ahead of its $7.2 billion […]
The EU has continued a refocus of its COVID-19 vaccination drive on mRNA shots, ordering another 100 million doses of Pfizer and BioNTech’s Comirnaty shot. […]
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 […]
More than 5,000 collaborative studies were thwarted by GDPR rules in 2019 – but is there a way to protect sensitive data while still allowing […]
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 […]
The UK Government and EU Commission trumpeted their Brexit trade deal, struck at the end of December, as ‘comprehensive’, the ‘biggest yet’. But a closer […]
Boris Johnson’s sense of humour seems to have got him into trouble again, at the most delicate of times. The Prime Minister reportedly told Conservative […]
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 – […]
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 […]
Shots: The approval is based on pivotal P-II DESTINY-Breast01 study involves assessing of Enhertu (5.4 mg/kg) in 184 patients as a monothx. for patients with […]
Shots: Imfinzi has been approved in the EU and the UK for an additional dosing option (1500mg, fd, q4w) in LA, unresectable NSCLC in adults […]
Louis van de Wiel, Vice President, Site Head EU Manufacturing, Kite, a Gilead Company, reveals the complexity that sits behind the process of individualised cell […]
The post-Brexit trade deal agreed on Christmas Eve has been overwhelmingly backed by the UK parliament, providing some degree of stability – but also plenty […]
Roche has secured EU approval for Phesgo, a fixed-dose combination of its breast cancer drugs Herceptin and Perjeta that is easier and cheaper to administer […]
Shots: AstraZeneca’s Imfinzi durvalumab (1500mg, fd, q4w) is recommended for approval in the EU for an additional dosing option in the approved indication of LA, […]
Shots: The recommendation is based on a P-II DESTINY-Breast01 study assessing trastuzumab deruxtecan in patients with HER2 positive unresectable/ m-BC prior treated with trastuzumab emtansine […]
The UK and EU have reached an agreement on border checks for Northern Ireland that should guarantee that trade in medicines and food continues without […]
COVID-19 is proving to be the perfect storm in terms of the supply of pharmaceutical products. But learning how to overcome the challenges of 2020 […]
Shots: The companies sign an agreement with the EC to supply 200M doses of BNT162b2 mRNA-based vaccine candidate against SARS-CoV-2 to EU member states, with […]
Shots: J&J has resumed recruitment, enrolment, and vaccination in all studies of its COVID-19 vaccine across the EU, after a temporary pause. Trials in the […]
Shots: The approval is based on a biomarker subgroup analysis of P-III PAOLA-1 study assessing Lynparza + bevacizumab vs bevacizumab alone as 1L maintenance treatment in […]
Shots: The approval is based on P-III DAPA-HF study involves assessing of Forxiga (10mg) + SOC vs PBO +SOC in 4744 patients with heart failure […]
Shots: The approval is based on PRIMA study assessing Zejula (300mg qd), later amended to incorporate an individualised starting dose of Zejula (200 mg or […]
Shots: The CHMP’s positive opinion is based on P-III ETHOS & KRONOS studies, which are a part of AstraZeneca’s P-III ATHENA program assessing Trixeo Aerosphere […]
Shots: EC has approved an advance purchase agreement in which the Janssen will supply 200 M doses of thw COVID-19 vaccine candidate to EU member […]
The European Commission has taken its advance orders for potential COVID-19 vaccines to more than 1.1 billion, after signing a supply deal for up to […]
Google has reportedly pledged not to use Fitbit’s user data for its advertising business. With the deadline quickly approaching, is it enough that European regulators […]
Alnylam’s European head of market access and GM of mid-size markets, Anant Murthy, shares his perspective on how a US biotech can adapt to the […]
The European data strategy aims to construct common data spaces for all, create a single EU market for data, and catalyze a dynamic data economy. […]
At the beginning of 2020, the European Commission introduced a “European strategy for data.” The document proposes to bolster and advance the data economy in […]
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