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Biotechnology
Research news last week included US biotech releasing early data for its FT819 in the treatment of systemic lupus erythematosus (SLE), which sent the firm’s shares leaping as much as 70%. Also, Netherlands-based NewAmsterdam Pharma announced positive data on its obicetrapib and ezetimibe combination in cardiovascular disease. On the regulatory front, Dutch firm argenX and China’s Zai Lab gained approval from the Chinese medicines regulator for their Vyvgart Hytrulo in chronic inflammatory demyelinating polyneuropathy (CIDP) care. Meantime, USA-based Kura Oncology signed a collaboration with Japan’s Kyowa Kirin on the development of ziftomenib for myeloid leukemia (ALS). 24 November 2024
Biotechnology
Japanese drugmaker Chugai, which is majority owned by Roche, On Friday revealed that Zenyaku Kogyo has obtained regulatory approval from the Ministry of Health, Labor and Welfare (MHLW), for an additional dosage and administration of an anti-CD20 monoclonal antibody Rituxan (rituximab) intravenous injection 100mg and 500mg, which is co-marketed by both companies, for chronic idiopathic thrombocytopenic purpura (ITP) in children. 23 November 2024
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
Pharmaceutical
The NDA Group, a regulatory, drug development and medical device consultancy, has released findings from the eighth annual comparison of drug approvals in the European Union (EU) and the USA. 31 March 2021
Biotechnology
Germany has again updated its guidance on the use of Vaxzevria, after new reports related to a rare kind of blood clotting occurring in people who had previously received the vaccine. 31 March 2021
Pharmaceutical
The European Commission has granted conditional marketing authorization for Nexpovio (selinexor), a first-in-class, oral selective inhibitor of nuclear Export (SINE) medicine, in combination with dexamethasone. 31 March 2021
Biotechnology
The US Food and Drug Administration has issued a Complete Response Letter (CRL) regarding Merck & Co’s supplemental Biologics License Application (sBLA) seeking approval for Keytruda, for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC). 30 March 2021
Biotechnology
Swiss pharma giant Roche has seen its spinal muscular atrophy (SMA) drug Evrysdi (risdiplam) follow up its US approval by getting the green light from the European Commission (EC). 30 March 2021
Biotechnology
Danish cancer specialist Genmab has announced the granting of European approval to its development partner, Novartis, for Kesimpta (ofatumumab). 30 March 2021
Biotechnology
Incyte has won European approval for Pemazyre (pemigatinib), as a second-line option for certain people with locally advanced or metastatic bile duct cancer. 30 March 2021
Pharmaceutical
The Delhi High Court in India has set out three major directives with regard to patients suffering from rare diseases. 29 March 2021
Biotechnology
US drugmaker Bristol Myers Squibb has announced that the European Medicines Agency (EMA) has validated its type II variation application for Opdivo (nivolumab) for the adjuvant treatment of patients with surgically resected, high-risk muscle-invasive urothelial carcinoma. 29 March 2021
Biotechnology
Shares of Netherlands-based gene therapy company uniQure were up more than 9% at $32.00 in pre-market US trading, as the company revealed new evidence regarding a safety scare related to its hemophilia B gene therapy. 29 March 2021
Pharmaceutical
A statement from the European pharma industry criticizes progress on a new proposal for making health technology assessments more efficient in the region. 29 March 2021
Biotechnology
The US Food and Drug Administration on Friday approved Abecma (idecabtagene vicleucel; ide-cel), a first-in-class B-cell maturation antigen (BCMA)-directed genetically-modified autologous T-cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma. 29 March 2021
Biotechnology
Among last week’s notable news, AstraZeneca released long-waited data from the US Phase III trial of its COVID-1 vaccine, AZD1222, which pave the way for US regulatory approval and restore confidence in Europe, but this was not without further controversy. Roche and Regeneron Pharmaceuticals reported strong Phase III data for their REGN-COV2 antibody cocktail for hospitalized COVID-19 patients. Pfizer and Eli Lilly suffered a setback on their osteoarthritis pain drug tanezumab, with a negative Food and Drug Administration advisory committee vote. Dutch rare diseases firm ProQR Therapeutics announced encouraging early-stage results for its QR-421a in Usher syndrome, a rare blindness disorder. 28 March 2021
Biotechnology
UK pharma major GlaxoSmithKline and Vir Biotechnology have submitted an application to the US Food and Drug Administration requesting Emergency Use Authorization (EUA) for VIR-7831 (GSK4182136), an investigational dual-action SARS-CoV-2 monoclonal antibody for the treatment of adults and adolescents with mild-to-moderate COVID-19 who are at risk for progression to hospitalization or death. 27 March 2021
Pharmaceutical
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended five novel medicines for approval at its March 2021 meeting. A final decision on the approval by the European Commission is usually issues in about two-three months. 27 March 2021
Pharmaceutical
Following its March meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced recommendations for the extension of indications on six already approved drugs. 27 March 2021
Biotechnology
Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved Breyanzi (lisocabtagene maraleucel: liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy for the treatment of patients with relapsed or refractory (R/R) large B-cell lymphoma and R/R follicular lymphoma. 26 March 2021
Pharmaceutical
Japan’s leading drugmaker Takeda says that the European Medicines Agency (EMA) has accepted the company’s filing packages for its dengue vaccine candidate (TAK-003) which is being investigated for the prevention of dengue due to any dengue virus serotype in individuals ages four to 60. 26 March 2021
Biotechnology
With the Europe Union struggling to deliver COVID-19 vaccines into the arms of its people, and the European Commission at war with the UK and its main vaccine supplier - AstraZeneca, the European Medicines Agency today revealed that its human medicines committee (CHMP) has adopted several important recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the EU. 26 March 2021
Pharmaceutical
A new US indication has been approved for Myrbetriq (mirabegron extended-release tablets) and Myrbetriq Granules (mirabegron for extended-release oral suspension) to treat neurogenic detrusor overactivity (NDO) in children ages three years and older. 26 March 2021
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