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Biotechnology
US mRNA specialist biotech Moderna says that it has completed its submission to the US Food and Drug Administration (FDA) for emergency use authorization for its BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.222. 24 August 2022
Biotechnology
Japanese drugmaker Chugai Pharmaceutical today announced receipt of approval from the Ministry of Health, Labor and Welfare (MHLW) for the anticancer agent/antimicrotubule binding anti-CD79b monoclonal antibody Polivy intravenous infusion (polatuzumab vedotin (genetical recombination) for an additional indication of treatment of patients with previously untreated diffuse large B-cell lymphoma (DLBCL). 24 August 2022
Pharmaceutical
Japanese pharma major Takeda announced the company’s dengue vaccine, Qdenga (dengue tetravalent vaccine [live, attenuated]; formerly known as TAK-003), was approved by the Indonesia National Agency for Drug and Food Control, Badan Pengawas Obat dan Makanan (BPOM), for the prevention of dengue disease caused by any serotype in individuals six years to 45 years of age. 23 August 2022
Pharmaceutical
Shares of Clinical stage US biotech Minerva Neurosciences were up more than 5% at $4.35 pre-market, after it said it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for roluperidone for the treatment of negative symptoms in patients with schizophrenia. 23 August 2022
Biotechnology
Pharvaris, a Switzerland-based clinical-stage company, today announced that the US Food and Drug Administration (FDA) verbally informed Pharvaris that, based on its review of non-clinical data, the agency is placing a clinical hold on the clinical trials of PHA121 in the USA under two Pharvaris Investigational New Drug (IND) applications for the treatment of HAE. 23 August 2022
Pharmaceutical
CSL Vifor and Travere Therapeutics today announced that the European Medicines Agency (EMA) has accepted for review the Conditional Marketing Authorization (CMA) application for sparsentan for the treatment of IgAN, a rare kidney disorder and a leading cause of end-stage kidney disease (ESKD). 22 August 2022
Pharmaceutical
The European medicines regulator has started reviewing a submission from Japanese drugmaker Otsuka Pharmaceutical for its acute myeloid leukemia (AML) therapy ASTX727. 22 August 2022
Biotechnology
Following in the steps of US mRNA biotech Moderna, which last week gained a first regulator approval for its bivalent vaccine, now BioNTech and Pfizer say they have completed their submission to the US Food and Drug Administration (FDA) today requesting an Emergency Use Authorization of a 30µg booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years and older. 22 August 2022
Pharmaceutical
A regulatory submission from British firm Mundipharma, for the invasive candidiasis (IC) candidate rezafungin, has been accepted for review by the European Medicines Agency. 22 August 2022
Pharmaceutical
US central nervous system specialist Axsome Therapeutics saw its shares close up more than 40% at $59.55 on Friday, after it revealed that the US Food and Drug Administration (FDA) has approved its Auvelity (dextromethorphan HBr-bupropion HCl) extended-release tablets for the treatment of major depressive disorder (MDD) in adults. 22 August 2022
Biotechnology
US biotech major Gilead Sciences today announced that the European Commission (EC) has granted marketing authorization for Sunlenca (lenacapavir) injection and tablets for the treatment of HIV infection, in combination with other antiretroviral(s), in adults with multi-drug resistant HIV infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen. 22 August 2022
Generics
A US federal court on Friday ordered an Illinois company to stop manufacturing and distributing drugs alleged to be adulterated in violation of the Federal Food, Drug, and Cosmetic Act (FDCA). 22 August 2022
Biotechnology
Major research news last week was mixed, with the USA’s Gilead Sciences last Monday releasing positive Phase III data for its Trodelvy in HR+/HER2 metastatic cancer, while France’s Sanofi released disappointing Phase III trial results with its SERD candidate amcenestrant and saying it would discontinue the development program. On the deal-making front, US pharma Merck & Co entered into a collaboration with biotech Orna Therapeutics on the development of multiple vaccines and therapies, paying an upfront $150 million plus pledging milestone and royalties of up to $3.5 billion. Also of note, the US Food and Drug Administration (FDA) last week approved bluebird bio’s beta thalassemia drug Zynteglo, making it the first cell-based gene therapy for this condition. 21 August 2022
Biotechnology
Japanese drugmaker Kyowa Kirin said on Friday that the European Commission (EC) has approved Crysvita (burosumab) for the treatment of FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors (PMTs) that cannot be curatively resected or localized in children and adolescents aged 1 to 17 years and in adults. 20 August 2022
Pharmaceutical
The European Medicines Agency’s (EMA) Emergency Task Force (EFT) has reviewed data on the monkeypox vaccine Imvanex used as an intradermal injection. 20 August 2022
Biotechnology
Swedish blood disease specialist Oncopeptides has won European approval for its multiple myeloma therapy Pepaxti (melphalan flufenamide). 19 August 2022
Biotechnology
Shares in oncology company Curis rose by around 15% on Thursday, after the US Food and Drug Administration lifted a partial clinical hold on the Phase I/II TakeAim Lymphoma trial. 19 August 2022
Pharmaceutical
Today, privately-held Italian pharmaceutical and diagnostics company Menarini, and wholly-owned US subsidiary Stemline Therapeutics, announced the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for elacestrant, an investigational oral selective estrogen receptor degrader (SERD) for patients with ER+/HER2- advanced or metastatic breast cancer. 19 August 2022
Biosimilars
South Korea-based Celltrion Healthcare announced today that the European Commission (EC) has approved Vegzelma (CT-P16), a biosimilar bevacizumab referencing Roche’s European Union-approved Avastin, for the treatment of metastatic breast cancer, non-small cell lung cancer, advanced and/or metastatic renal cell cancer, metastatic carcinoma of the colon or rectum, ovarian cancer and cervical cancer. 19 August 2022
Pharmaceutical
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has started a review of a conditional marketing authorization application for Skycovion, a vaccine for protecting against COVID-19. 19 August 2022
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
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
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