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Biotechnology
RAPT Therapeutics has announced the termination of its zelnecirnon program following regulatory concerns around safety. 12 November 2024
Biotechnology
On November 8, the US Food and Drug Administration approved Aucatzyl (obecabtagene autoleucel; obe-cel) from US biopharma Autolus Therapeutics' 11 November 2024
Pharmaceutical
Li Li, Commissioner of China's National Medical Products Administration (NMPA), and Mette Aaboe Hansen, interim director general of Danish Medicines Agency, have signed a letter of intent to promote bilateral cooperation in regulation of drugs and medical devices. 11 November 2024
Pharmaceutical
Shanghai-based Dizal has made a submission to the US Food and Drug Administration, seeking approval for sunvozertinib. 8 November 2024
Biotechnology
US mRNA specialist Moderna today announced Health Canada has approved mRESVIA (respiratory syncytial virus mRNA vaccine) for active immunization for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults 60 years of age and older. 8 November 2024
Biotechnology
US healthcare giant Johnson & Johnson today revealed it has submitted applications with the US Food and drug Administration (FDA) and European Medicines Agency (EMA) to expand the approved indications for its Darzalex (daratumumab) subcutaneous (SC) formulation for the treatment of high-risk smouldering multiple myeloma (SMM). 8 November 2024
Biotechnology
Asklepios BioPharmaceutical (AskBio) today announced that AB-1003 (also known as LION-101) has received rare pediatric disease designation and orphan-drug designation from the US Food and Drug Administration (FDA) for the treatment of limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). 7 November 2024
Pharmaceutical
USA-based Acadia Pharmaceuticals has entered into a definitive asset purchase agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $150 million upon the closing of the transaction. 6 November 2024
Biotechnology
GSK’s Arexvy (RSV vaccine) has received an expanded approval in Canada to prevent lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults aged 50-59 who are at increased risk. 6 November 2024
Biotechnology
French pharma major Sanofi’s Dupixent (dupilumab), which notched up sales of 3.5 billion euros ($3.8 billion) in third-quarter 2024, +23.8% year-on-year, has picked up yet another indication in collaboration with Regeneron. 6 November 2024
article
The US Food and Drug Administration (FDA) has announced approval of a modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) 6 November 2024
Pharmaceutical
European regulators will decide by December 6 whether Novo Holdings, the controlling shareholder of Danish pharma giant Novo Nordisk, can finalize its $16.5 billion acquisition of contract drug manufacturer Catalent. 5 November 2024
Pharmaceutical
Photocure, a Norway-based bladder cancer-focused company, has announced that Jiangsu Yahong Meditech, the parent company of its partner Asieris Pharmaceuticals, has received marketing authorization for Hexvix (hexaminolevulinate) in China. 5 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for donidalorsen, an investigational RNA-targeted medicine for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older, under development by Ionis Pharmaceuticals. 4 November 2024
Pharmaceutical
Disc Medicine today announced a successful End of Phase 2 with the US Food and Drug Administration (FDA) supporting the regulatory path forward, including potential for accelerated approval, for bitopertin in erythropoietic protoporphyria (EPP). 4 November 2024
Pharmaceutical
On Friday, the US Food and Drug Administration published the FDA Voices: “FDA Takes Exciting Steps Toward Establishing the Rare Disease Innovation Hub,” by Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research (CDER) and Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER). 4 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted a Rare Pediatric disease designation for BPM31510T, an investigational treatment for epidermolysis (EB) from BPGbio. 4 November 2024
Pharmaceutical
US pharma major AbbVie last week proposed $1.4 billion acquisition of US CNS drug developer Aliada Therapeutics. Last week saw a bunch of third quarter 2024 financials results, among which were Elil Lilly, AbbVie and Merck & Co. Also of note, Lexicon’s type I diabetes drug Zynquista faced a Food and Drug Administration (FDA) advisory committee review that resulted in largely negative vote against recommendation. 3 November 2024
Pharmaceutical
Texas-based biopharma Lexicon Pharmaceuticals was trading nearly 36% lower on Friday morning. 1 November 2024
Generics
Medicines for Europe has launched a study of market barriers faced by European generics and biosimilar pharmaceutical companies operating in 11 key third-country markets. 31 October 2024
Biotechnology
The National Institute for Health and Care Excellence (NICE) has published a Final Appraisal Determination (FAD) recommending that Zinbryta (daclizumab) be made available on the UK’s National Health Service (NHS) for adult patients living with relapsing-remitting multiple sclerosis (RRMS). 15 March 2017
Pharmaceutical
The UK’s National Institute for Health and Clinical Excellence (NICE), in collaboration with NHS England, has decided to propose a dynamic upper-limit for costs per quality adjusted life year (QALY) above which they will not recommend funding for highly specialized technologies (HST) treatments. 15 March 2017
Biotechnology
The US Food and Drug Administration has extended the action date for the supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab), an anti-PD-1 therapy, for previously treated patients with advanced microsatellite instability-high (MSI-H) cancer. 15 March 2017
Generics
Indian drug major Sun Pharmaceutical Industries said yesterday that the US Food and Drug Administration will lift the Import Alert imposed on the Mohali (Punjab) manufacturing facility and remove the facility from the Official Action Initiated (OAI) status. 15 March 2017
Biotechnology
US drugmaker AbbVie has announced that priority review has been granted by the Japanese Ministry of Health, Labor and Welfare (MHLW) for its investigational, pan-genotypic, ribavirin-free regimen of glecaprevir/pibrentasvir (G/P) for the treatment of all major genotypes of the chronic hepatitis C virus (HCV). 14 March 2017
Pharmaceutical
A quartet of companies have been named and shamed for breaching the Association of the British Pharmaceutical Industry’s (ABPI) code of practice. 14 March 2017
Pharmaceutical
The National Health Service in England has provided interim guidance, recommending that Humira (adalimumab) be routinely commissioned for adults with severe refractory uveitis. 14 March 2017
Pharmaceutical
Sanofi says it is disappointed about the provisional recommendation by the England and Wales medicines cost-effectiveness regulator for one of its drugs. 14 March 2017
Biotechnology
The National Institute for Health and Clinical Excellence (NICE) has today published new draft guidance recommending that the manufacturer of Opdivo (nivolumab) provides more information on its drug's effectiveness for treating classical Hodgkin lymphoma. 14 March 2017
Biotechnology
French pharma major Sanofi has received a positive scientific opinion under the UK’s Early Access to Medicines Scheme (EAMS) for the investigational dermatitis medicine dupilumab. 14 March 2017
Biotechnology
The US Food and Drug Administration has approved Kisqali (ribociclib, formerly known as LEE011) in combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer. 14 March 2017
Pharmaceutical
Rare diseases are characterized by the US Food and Drug Administration (FDA) as those conditions that affect less than 200,000 people in the American population. While 200,000 may seem a large number, it is obviously characteristic of rare diseases to be…well, rare, says Dr Nicola Davies in her regular exclusive contribution to The Pharma Letter. 14 March 2017
Pharmaceutical
"Thank God it's Gottlieb" was one analyst’s reaction to the news that President Trump was to pick industry veteran and former FDA deputy commissioner Scott Gottlieb to lead the agency. 13 March 2017
Pharmaceutical
The UK’s Medicines and Healthcare Products Regulatory Agency – in coordination with 14 other European regulatory agencies – has approved a new Decapeptyl (triptorelin pamoate) indication for pre-menopausal women with early-stage breast cancer. 13 March 2017
Biotechnology
Shares in Radius Health have fallen 5% on the news that the US Food and Drug Administration needs more time to review the company’s New Drug Application (NDA) for abaloparatide. 13 March 2017
Pharmaceutical
At its March meeting, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded a safety review and started a new one for which there will be a public hearing. 13 March 2017
Pharmaceutical
Political news regarding healthcare and repeal of Obamacare with a planned replacement took a back seat last week, as the issue continued to be debated but with no outcome as yet. And in the UK, there were no developments on Brexit, though the Prime Minister is expected to push the Brexit button this week, which will start the ‘divorce’ negotiations. Pharma company focus included AbbVie and its Humira, Vertex and Concert Pharma, TG Therapeutics and Kite. 12 March 2017
Pharmaceutical
How to improve the availability of high quality, safe and effective medicines to patients in countries beyond Europe and how to make better use of existing tools? 10 March 2017
Pharmaceutical
Cancer treatments are not being trialled in children because of outdated European regulations which are in urgent need of reform, say cancer experts in the UK. 10 March 2017
Pharmaceutical
UK-based pharmaceutical services firm Clinigen will market Fycompa (perampanel) in South Africa, after regulators there gave the anti-epileptic medicine the green light. 10 March 2017
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