Pharma & Biotech Pricing, Policy & Regulation
Pharmaceutical
The share prices of Pfizer, GSK, Novavax and other vaccine companies were all markedly lower on Friday. This was not due to the publication of disappointing research results in the sphere, or an ominous stance taken by a major regulator on a key filing, but rather a political development that could spell trouble for the vaccines field as a whole. 15 November 2024
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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
article
The UK government has reappointed BioIndustry Association (BIA) chairman Daniel Mahony as its Life Sciences Investment Envoy. 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
Biotechnology
The UK’s health technology assessor the Institute for Health and Clinical Excellence (NICE) says that talks with the makers of Enhertu have ended without agreement, meaning guidance that does not recommend Enhertu for advanced breast cancer will remain unchanged. 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
Biotechnology
Germany’s Lindis Biotech, a specialist in multi-specific antibody platforms, has announced an exclusive licensing agreement with Pharmanovia, for the commercialization of Korjuny (catumaxomab). 19 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
New research published by the European Federation of Pharmaceutical Industries and Associations (EFPIA) provides in-depth analysis of the economic footprint of the pharmaceutical industry in Europe, across member states and compares Europe to other regions of the world. 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
Pharmaceutical
Johnson & Johnson says it has “grave concern” for the availability of future innovative mental health treatments in England, following a decision by National Institute for Health and Care Excellence (NICE) to not re-appraise Spravato (esketamine nasal spray) for treatment-resistant depression in England 13 June 2024
Pharmaceutical
AstraZeneca’s Farxiga (dapagliflozin) has received approval from the US Food and Drug Administration to improve glycemic control in children with type-2 diabetes (T2D). 13 June 2024
Biotechnology
The US Food and Drug Administration (FDA) yesterday granted traditional approval for US pharma major Eli Lilly’s Retevmo (selpercatinib). 13 June 2024
Pharmaceutical
The US Centers for Medicare & Medicaid Services’ (CMS) Office of the Actuary has released projections of National Health Expenditures (NHE) and health insurance enrollment for the years 2023-2032. 13 June 2024
Pharmaceutical
US Senator Bernie Sanders, chairman of the Senate Committee on Health, Education, Labor and Pensions (HELP), has announced that members will vote next week on whether to subpoena Doug Langa, senior vice president, head of North America operations and president of Novo Nordisk. 12 June 2024
Pharmaceutical
The Association of the British Pharmaceutical Industry (ABPI) has had its say on the upcoming UK election for a second time this week. 12 June 2024
Pharmaceutical
Russia is sharply cutting centralized state purchases of anti-HIV drugs due to the problems with funding and the reduction of supplies to Russia by global drugmakers, reports The Pharma Letter’s local correspondent. 12 June 2024
Biotechnology
The Center for Drug Evaluations of the National Medical Products Administration (NMPA) in China has accepted the biologics license application (BLA) for zanidatamab for second-line treatment of HER2-positive biliary tract cancer (BTC). 11 June 2024
Biotechnology
The US Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee yesterday unanimously voted that donanemab shows clinical benefit for the treatment of early Alzheimer’s disease. 11 June 2024
Pharmaceutical
Genfit, a biopharmaceutical company focused on rare liver diseases, has announced that it has received an Accelerated Approval for Iqirvo (elafibranor). 11 June 2024
Pharmaceutical
The US Food and Drug Administration issued a Federal Register Notice announcing the Emerging Drug Safety Technology Meeting (EDSTM) program, which will be administered through the Center for Drug Evaluation and Research’s (CDER) newly established Emerging Drug Safety Technology Program (EDSTP). 11 June 2024
Pharmaceutical
The Association of the British Pharmaceutical Industry (ABPI) has issued a challenge to the UK’s political parties ahead of next month’s election. 10 June 2024
Pharmaceutical
Calico Life Sciences, a biotech company specializing in aging and age-related diseases, has had its candidate fosigotifator accepted into the US Food and Drug Administration’s Support for Clinical Trials Advancing Rare Disease Therapeutics (START) Pilot Program. 10 June 2024
Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Bimzelx (bimekizumab) for the treatment of active moderate to severe hidradenitis suppurativa (HS) in adults with an inadequate response to conventional systemic HS therapy. 10 June 2024
Pharmaceutical
British pharma major AstraZeneca's bid to broaden the label for Tagrisso (osimertinib) will be considered under the Priority Review scheme. 10 June 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved the recent supplemental New Drug Application (sNDA), submitted by Spanish dermatology focused drugmaker Almirall, to expand the use area for its drug Klisyri (tirbanibulin) to up to 100 cm. 10 June 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved UK pharma major GSK’s Arexvy (respiratory syncytial virus [RSV] vaccine, adjuvanted) for the prevention of RSV lower respiratory tract disease (LRTD) in adults 50 through 59 years of age who are at increased risk. 10 June 2024
Biotechnology
Swiss pharma giant Roche (ROG: SIX) has announced that the European Commission (EC) has approved Alecensa (alectinib) monotherapy, as adjuvant treatment following tumor resection for adults with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) at high risk of recurrence. 10 June 2024
Pharmaceutical
In a blog post, the general counsel of European trade group EFPIA - the European Federation of Pharmaceutical Industries and Associations - has argued for effective incentives to be included in the EU general pharmaceutical legislation. 10 June 2024
Biosimilars
As the BIOSECURE Act progresses through the US legislative process, the US pharmaceutical industry finds itself at a crossroads. 10 June 2024
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