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Pharmaceutical
Draft EU regulatory proposals have been described by the leading European trade body as “sabotage” of the industry. We consider the fallout with Maarten Meulenbelt, partner and expert on EU regulatory affairs at Sidley Austin. 31 March 2023
Biotechnology
Two years after the US regulator concluded it was necessary to increase label warnings on safety for certain JAK inhibitors, the European Medicines Agency has followed suit. 31 March 2023
Biotechnology
Chinese biopharma Hutchmed today revealed that it completed the rolling submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for fruquintinib, its highly selective and potent oral inhibitor of VEGFR-1, -2 and -3, for the treatment of refractory metastatic colorectal cancer (CRC). 31 March 2023
Biotechnology
The US Food and Drug Administration (FDA) has lifted a partial clinical hold on the Phase I/II VELA trial of BLU-222, said the drugs developer, Blueprint Medicines, sending the US biotech’s shares up 4% to $42.57. 30 March 2023
Biotechnology
A short delay to bluebird bio’s US regulatory submission for lovo-cel (lovotibeglogene autotemcel) appears to have spooked investors, with shares in the company falling by a quarter. 30 March 2023
Biotechnology
New Jersey, USA-based cancer giant Merck has converted a conditional nod for its checkpoint blocker, Keytruda (pembrolizumab), into regular approval. 30 March 2023
Biotechnology
The European Commission (EC) has approved Libtayo (cemiplimab) in combination with platinum-based chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with ≥1% PD-L1 expression, US biotech firm Regeneron revealed today. 29 March 2023
Biotechnology
Bristol Myers Squibb’s Sotyktu (deucravacitinib) is continuing to vindicate the company’s decision to favor the drug’s development over Otezla (apremilast). 28 March 2023
Biotechnology
Health Canada has scored a regulatory first, granting approval to Roche’s new blood cancer med, Columvi (glofitamab). 28 March 2023
Biotechnology
Shares of USA/Israel-based biotech BrainStorm Cell Therapeutics rose as much as 13% yesterday on more positive news from the US regulator, which in February issued a refusal-to-file (RTF) letter regarding the submission for its cell therapy NurOwn (autologous MSC-NTF cells). 28 March 2023
Biotechnology
Netherlands-based iOnctura today announced that the innovative medicine designation, the Innovation Passport, has been awarded for roginolisib, a potential treatment for metastatic uveal melanoma by the UK’s Medicines & Healthcare products Regulatory Agency (MHRA). 28 March 2023
Biotechnology
Having gained US approval with much fanfare in December 2022 and in Europe in February this year, Hemgenix (etranacogene dezaparvovec), from Australian biotech CSL Limited, has now received regulatory clearance in the UK 27 March 2023
Biotechnology
Germany’s Merck KGaA has regained exclusive worldwide rights to develop, manufacture, and commercialize its checkpoint blocker Bavencio (avelumab). 27 March 2023
Pharmaceutical
Shares of Incyte fell 2.8% to $70.23 on Friday, after the US Food and Drug Administration (FDA) unexpectedly rejected an extended-release version of its blockbuster drug, Jakafi (ruxolitinib). 27 March 2023
Biotechnology
The US Food and Drug Administration (FDA) has approved Joenja (leniolisib) for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older, Dutch biotech firm Pharming announced late Friday. 25 March 2023
Biotechnology
Japanese drugmaker Chugai Pharmaceutical announced that its in-house developed Enspryng [satralizumab (genetical recombination)] has received forerunner designation for the expected indication of myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) and autoimmune encephalitis (AIE) from the Ministry of Health, Labor and Welfare (MHLW). 24 March 2023
Biotechnology
US biotech Biogen is focusing on the positives after a US Food and Drug Administration (FDA) advisory committee (AdCom) meeting on tofersen, an investigational product for the treatment of superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). 23 March 2023
Pharmaceutical
Cidara Therapeutics saw its shares fall 10% to $1.71 in after-hours trading yesterday, despite receiving a regulatory approval for a new drug. 23 March 2023
Pharmaceutical
US pharma major AbbVie closed down almost 2% at $153.67 yesterday, after it revealed a regulatory setback for its investigational Parkinson’s treatment. 23 March 2023
Biotechnology
Delaware, USA-based firm Incyte has secured approval in the USA for its checkpoint blocker Zynyz (retifanlimab-dlwr). 23 March 2023
Biotechnology
Zhongshan-based biopharma company Akeso will await the verdict of the Chinese medicines regulator on a penpulimab-based combo therapy. 22 November 2024
Pharmaceutical
The nomination of Robert F Kennedy Jr — known as RFK Jr — for the role of US Secretary of the Department of Health and Human Services (HHS) President-elect Donald Trump sent shares in vaccine companies sharply downwards. 22 November 2024
Biotechnology
British pharma major AstraZeneca is facing challenges in its bid to secure full approval for its anticoagulant reversal therapy, Andexxa (andexanet alfa), in the USA. 22 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval of Ziihera (zanidatamab-hrii) 50mg/mL for injection for intravenous use, say the drug’s developer, Jazz Pharmaceuticals. 21 November 2024
Biotechnology
Astellas Pharma has been hit by bad news from the US Food and Drug Administration, which will not currently approve the firm’s request to supplement the label for Izervay (avacincaptad pegol). 21 November 2024
Biotechnology
The European Commission (EC) has granted marketing authorization for Hympavzi (marstacimab), from US pharma giant Pfizer. 20 November 2024
Pharmaceutical
Ascentage Pharma will see its investigational BCL-2 selective inhibitor, lisaftoclax, assessed under China’s Priority Review scheme. 20 November 2024
Pharmaceutical
Anthony Harnden has been appointed as the new chair of the UK’s Medicine and Healthcare products Regulatory Agency (MHRA). 20 November 2024
Pharmaceutical
Australia’s Therapeutic Goods Administration (TGA) yesterday warned that health professionals and consumers are advised that the oral antihistamine promethazine hydrochloride, sold as Phenergan and other generic brands, should not be used in children under six years of age. 20 November 2024
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Monday approved the medicine Filspari (sparsentan) from Vifor France to treat primary immunoglobulin A nephropathy (IgAN). 19 November 2024
Biosimilars
Following US approval in May this year, South Korea’s Samsung Bioepis and US biotech Biogen have now won approval from the European Commission (EC) for their Opuviz 40mg/mL solution for injection in a vial, a biosimilar referencing Regeneron and Bayer’s Eylea (aflibercept). 18 November 2024
Biotechnology
Shanghai-based Junshi Biosciences has received UK regulatory approval for Loqtorzi (toripalimab) in nasopharyngeal carcinoma (NPC) and esophageal squamous cell carcinoma (ESCC). 18 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental Biologics License Application (sBLA) for Dupixent(dupilumab), Regeneron and partner Sanofi revealed late Friday. 18 November 2024
Pharmaceutical
The Danish government’s newly-unveiled health reform has been praised for tackling chronic disease care and health inequalities while driving health innovation. 18 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Syndax Pharmaceuticals’ Revuforj (revumenib). 18 November 2024
Pharmaceutical
Johnson & Johnson has taken legal action to defend a contentious rebate initiative, filing a lawsuit in the US District Court for the District of Columbia. 15 November 2024
Biotechnology
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved an updated version of Novavax’s Nuvaxovid jab targeting the latest subvariant. 15 November 2024
Biotechnology
The European Medicines Agency’s (EMA) human medicines committee (CHMP) made a number of recommendations at its November meeting, notable among which was a reversal of a previous rejection of Alzheimer’s drug Leqembi (lecanemab). 15 November 2024
Biotechnology
Oxford, UK-based rare respiratory diseases focused AlveoGene today revealed it has been granted a Rare Pediatric Disease designation (RPDD) by the US Food and Drug Administration (FDA) for AVG-002, its novel, inhaled gene therapy for lethal neonatal surfactant protein B (SP-B) deficiency. 15 November 2024
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