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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
Pharmaceutical
USA-based Intercept Pharmaceuticals has won conditional marketing authorization from the European Commission for its liver disease drug Ocaliva (obeticholic acid). 14 December 2016
Pharmaceutical
Swissmedic has published amendments to regulations for drug manufacturers when highlighting changes to manuscripts of medicinal product information relating to their products. 14 December 2016
Pharmaceutical
The European Commission has granted marketing authorization for Rekovelle (follitropin delta), a human recombinant follicle stimulating hormone (human rFSH), following a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in October. 14 December 2016
Pharmaceutical
The UK regulator has ruled on breaches of the Association of British Pharmaceutical Industry code of conduct by five separate pharma companies. 13 December 2016
Pharmaceutical
The Russian Federal Antimonopoly Service (FAS) has designed a mechanism for the withdrawal of licenses on the production of drugs in Russia from their rightful owners, according to Igor Artemyev, head of the FAS. 13 December 2016
Pharmaceutical
The US Food and Drug Administration has approved Synjardy XR (empagliflozin and metformin hydrochloride extended-release) tablets for adults with type 2 diabetes. 13 December 2016
Pharmaceutical
As a result of an updated review, the US Food and Drug Administration has concluded that use of the type 2 diabetes medicine pioglitazone may be linked to an increased risk of bladder cancer. 13 December 2016
Biosimilars
South Korea’s Celltrion Healthcare welcomes the publication of the latest position paper from the European Crohn’s and Colitis Organization (ECCO) on the use of biosimilars for inflammatory bowel disease (IBD). 12 December 2016
Pharmaceutical
Rather like Kite’s registrational Zuma-1 trial of KTE-C19 in lymphoma, Novartis’ Eliana study has generated a fileable response rate. In the case of the Swiss firm’s rival CAR-T therapy, CTL019, this is in childhood leukemia patients, says EP Vantage, the editorial arm of the Evaluate group. 10 December 2016
Biotechnology
The US Food and Drug Administration has accepted the first Biologics License Application (BLA) for durvalumab, a PD-L1 human monoclonal antibody (MAb), and granted priority review status with a Prescription Drug User Fee Act (PDUFA) set for the second quarter of 2017. 10 December 2016
Biotechnology
The European Commission has granted an additional indication for Lucentis (ranibizumab) to treat patients with visual impairment due to choroidal neovascularization (CNV) associated with causes other than neovascular age-related macular degeneration (nAMD), or secondary to pathologic myopia (PM). 9 December 2016
Pharmaceutical
A wide-ranging bill promising to fund biomedical research, establish a council to speed up the discovery, development, and delivery of innovative medicines and advance precision medicine, has been passed in the US Senate. 8 December 2016
Biotechnology
Following a positive recommendation in October from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), the European Commission (EC) has now granted conditional marketing authorization for Venclyxto (venetoclax) monotherapy. 8 December 2016
Biotechnology
The European Medicines Agency has accepted for review the Marketing Authorization Application (MAA) for Dupixent (dupilumab) for the treatment of adults with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy. 8 December 2016
Biotechnology
Breakthrough immunotherapy Opdivo (nivolumab) has been approved in the European Union for the treatment of classical Hodgkin lymphoma (cHL), a rare and often-aggressive blood cancer. 7 December 2016
Biotechnology
US clinical-stage biotech Sage Therapeutics was trading 7% higher after Tuesday’s trading at $55.68 following news from its development plan for its SAGE-547 program in postpartum depression (PPD). 7 December 2016
Biotechnology
The US Food and Drug Administration has approved Avastin (bevacizumab) for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer. 7 December 2016
Pharmaceutical
Over the past half-century, the prescription medication industry has witnessed phenomenal growth. To combat sharp increments in drug costs during the 1970s, states deployed laws and developed guidance material with the help of the Food and Drug Administration, writes Dr Nicola Davies in her monthly exclusive FDA Blog for The Pharma Letter. 7 December 2016
Pharmaceutical
Changes in the way that NHS England commissions specialized treatments have been called for by a charity working to improve the lives of patients and families affected by genetic conditions. 6 December 2016
Pharmaceutical
Global drugmakers operating their plants in Russia have criticized the latest state initiative to introduce new restrictions on the participation of foreign drug manufacturers in tenders for the public procurement of drugs for state needs, reports The Pharma Letter’s local correspondent. 6 December 2016
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