Regulation
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Biotechnology
The developers of the newly-approved hemophilia A therapy Altuviiio (efanesoctocog alfa) have announced positive results from the Phase III XTEND-Kids trial. 2 March 2023
Generics
In 2022, generic drugs remained a significant public health priority for the US Food and Drug Administration (FDA), the agency announced yesterday, along with publishing its 2022 Office of Generic Drugs (OGD) Annual Report. 2 March 2023
Pharmaceutical
Texan biopharma Reata Pharmaceuticals opened trading more than 180% higher on Wednesday. 1 March 2023
Pharmaceutical
The European Commission has granted marketing authorization for Nubeqa (darolutamide) alongside androgen deprivation therapy in combination with docetaxel, to treat metastatic hormone-sensitive prostate cancer (mHSPC). 1 March 2023
Biotechnology
The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) yesterday voted that available data is adequate to support the safety and effectiveness of the respiratory syncytial virus (RSV) bivalent vaccine candidate PF-06928316 or RSVpreF, from US pharma giant Pfizer. 1 March 2023
Pharmaceutical
New York-based central nervous system (CNS) specialist Axsome Therapeutics has hit a regulatory snag in the development of AXS-05 (dextromethorphan/bupropion). 28 February 2023
Biotechnology
The Biologics License Application (BLA) for Leqembi (lecanemab), an investigational anti-amyloid beta (Aβ) protofibril antibody, has been designated for Priority Review by the National Medical Products Administration (NMPA) in China. 28 February 2023
Pharmaceutical
Even as the US Food and Drug Administration’s (FDA) director of drug quality Carmelo Rosa recently emphasized the need for Indian pharmaceutical companies to continually strive to manufacture drugs of the highest quality, both domestically and internationally, the Indian government has gone into overdrive to ensure that the impeccable standards of its regulatory mechanisms can be maintained over the long-term, reports The Pharma Letter’s India correspondent. 27 February 2023
Biotechnology
US rare diseases specialist Fulcrum Therapeutics lost more than half of its stock market value on Friday. 27 February 2023
Pharmaceutical
Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved the oral androgen receptor inhibitor (ARi) darolutamide plus ADT in combination with docetaxel in the indication of metastatic prostate cancer. 27 February 2023
Pharmaceutical
The European Medicines Agency’s human medicines committee, the CHMP, on Friday recommended the refusal of a marketing authorization for US pharma giant Merck & Co’s Lagevrio (molnupiravir) for the treatment of COVID-19 in adults. 27 February 2023
Biotechnology
Last week’s important regulatory news included the US Food and Drug Administration (FDA) approving Travere Therapeutics’ Filspari for the reduction of proteinuria in adults with primary IgAN. Among research news, Actinium Pharmaceuticals released positive Phase III data on its myeloid leukemia candidate Iomab-12. On the M&A front, troubled US drug developer Jounce Therapeutics found a ‘white knight’, entering a reverse merger with the UK’s Redx Pharma. Deal-making saw AstraZeneca sign a licensing agreement with China-based KYM Biosciences for CMG901, a potential gastric cancer treatment to expand its own portfolio. Also, having already forked out around $1 billion in upfront and milestone payments, Swiss pharma giant Roche terminated its agreement with US biotech Blueprint Medicines on the cancer drug Gavreto. 26 February 2023
Biotechnology
An antibody-drug conjugate (ADC) from AstraZeneca and Daiichi Sankyo has secured approval in China. 24 February 2023
Biotechnology
At its February meeting, the European Medicines Agency’s human medicines committee CHMP recommended approval of eight novel medicines, one of which is a biosimilar. 24 February 2023
Biotechnology
The US Food and Drug Administration (FDA) has approved Altuviiio (efanesoctocog alfa), a high-sustained factor VIII replacement therapy. 24 February 2023
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for Pfizer’s respiratory syncytial virus (RSV) vaccine candidate. 22 February 2023
Biotechnology
UK pharma major AstraZeneca today revealed that Imfinzi (durvalumab) and Imjudo (tremelimumab) immunotherapy combinations have been approved in the European Union (EU) for the treatment of advanced liver and lung cancers. 22 February 2023
Biotechnology
Shanghai Junshi Biosciences has announced positive results from a randomized, double-blind, placebo-controlled, multicenter Phase III clinical study (TORCHLIGHT Study, NCT04085276) examining the company’s product toripalimab in combination with paclitaxel for injection (albumin-bound) in patients with an initial diagnosis of stage IV or recurrent/metastatic triple-negative breast cancer. 22 February 2023
Pharmaceutical
Global specialist HIV company ViiV Healthcare, which is majority owned by GSK, has been granted marketing authorization by the European Medicines Agency (EMA) for Triumeq PD. 22 February 2023
Pharmaceutical
USA-based Akebia Therapeutics said yesterday that it has received a second interim response from the US Food and Drug Administration (FDA) to its formal dispute resolution request regarding the Complete Response Letter (CRL) for vadadustat received in March 2022, with the news sending the firm’s plunging 25.5% to $0.65. 22 February 2023
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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