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The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has concluded a hurried preliminary review of a signal of blood clots in people vaccinated with COVID-19 Vaccine AstraZeneca. 18 March 2021
Biotechnology
The US Food and Drug Administration has extended the review period for the supplemental New Drug Application (sNDA) for Rinvoq (upadacitinib) in the treatment of adult patients with active psoriatic arthritis. 17 March 2021
Biotechnology
The European Commission (EC) has approved an expanded label for Keytruda (pembrolizumab) as monotherapy for adults and children aged three years and older with relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option. 17 March 2021
Biotechnology
In a filing with the US Securities and Exchange Commission (SEC), bluebird bio has announced the departure of its chief medical officer, David Davidson. 17 March 2021
Pharmaceutical
The US Federal Trade Commission (FTC) and its counterpart competition enforcement agencies in the USA, European Union, the UK and Canada, are launching a working group to update their approach to analyzing the effects of pharmaceutical mergers. 17 March 2021
Biotechnology
The regenerative medicine and advanced therapies sector raised a record $19.9 billion in funding in 2020, fueling the broader biotech sector and driving a rapidly advancing pipeline of potentially transformative therapies, according to the Alliance for Regenerative Medicine’s (ARM) 2020 Annual Report released today. 16 March 2021
Biotechnology
As of lunchtime on Tuesday, 11 European countries had halted the rollout of COVID-19 Vaccine AstraZeneca after a number of cases of blood clots. 16 March 2021
Pharmaceutical
Since the start of the fight against the COVID-19 pandemic, the Russian Direct Investment Fund has been in favor of active coordination with all partners, including from Europe, and open to negotiations, said the organization’s chief executive Kirill Dmitriev today. 15 March 2021
Biosimilars
As India's Biocon Biologics partners pharma giants Novartis and Pfizer to enhance access to life-saving cancer drugs for patients, especially in Sub-Saharan and Asian regions, several Indian drug majors are ponying up to ensure easy access to top cancer drugs, reports The Pharma Letter’s India correspondent. 15 March 2021
Pharmaceutical
Stockholm’s Calliditas Therapeutics has completed its US regulatory submission for Nefecon (budesonide), an oral treatment for primary IgA Nephropathy (IgAN). 15 March 2021
Biotechnology
Last week, news related to COVID-19 included US pharma giant Merck & Co and biotech partner Ridgeback Biotherapeutics releasing encouraging mid-stage data on molnupiravir, their antiviral treatment. Producing negative news, CytoDyn reported Phase III data on its COVID-10 candidate Vyrologix (lerontimab) in COVID-19. Elsewhere, US biotech bluebird bio released new analyses relating to LentiGlobin in cell therapy programs that the US Food and Drug Administration put on clinical hold due to a possible link with a case of acute myeloid leukemia (AML). Also of note, after a long wait, AVEO Oncology last Wednesday finally gained FDA approval for its bladder cancer drug Fotivda (tivozanib). 14 March 2021
Biotechnology
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has begun a safety review of Zynteglo (betibeglogene autotemcel), a gene therapy authorized to treat the rare blood condition beta thalassaemia. 12 March 2021
Biotechnology
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) is doing all it can to stay on top of safety monitoring and messaging around COVID-19 Vaccine AstraZeneca. 12 March 2021
Biotechnology
Takeda Pharmaceutical has submitted a New Drug Application (NDA) to the Ministry of Health, Labor and Welfare (MHLW) in Japan for Takhzyro (lanadelumab) subcutaneous injection, a monoclonal antibody therapy for prophylaxis against attacks of hereditary angioedema (HAE). 12 March 2021
Biotechnology
Marking the fourth vaccine to be recommended for the prevention of the novel coronavirus by the European Medicines Agency, the EMA today revealed it has recommended granting a conditional marketing authorization for COVID-19 Vaccine Janssen in people from 18 years of age. 11 March 2021
Pharmaceutical
Health authorities in European Union (EU) countries have intervened amid concerns around the safety of the AstraZeneca COVID-19 vaccine. 11 March 2021
Biotechnology
Japanese drug major Astellas Pharma says it has submitted New Drug Application (NDA) to Japan's Ministry of Health, Labor and Welfare (MHLW) for enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer that has progressed after anti-cancer medication. 11 March 2021
Biotechnology
After several US setbacks affecting the firm’s lead product, AVEO Oncology late Wednesday finally received US Food and Drug Administration approval for Fotivda (tivozanib) as a treatment of adults with relapsed or refractory advanced renal cell carcinoma who have received two or more prior systemic therapies. 11 March 2021
Pharmaceutical
Cloud revenue management solutions provider Model N has announced findings from its 2021 State of Revenue Report, which examines current issues around revenue execution and management in the healthcare sector. 11 March 2021
Biotechnology
Shares of US biotech bluebird bio gained 13% pre-market today and were still up 8.8% at $32.70 by mid-morning after it announced encouraging analyses of its gene therapy program that was linked with a serious adverse event. 10 March 2021
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
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