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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 UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved the medicine sugemalimab (trade name Eqjubi) to treat adult patients with a type of cancer called non-small cell lung cancer (NSCLC ). 31 October 2024
Biotechnology
The US Food and Drug Administration’s Antimicrobial Drugs Advisory Committee (AMDAC) voted by 16 to 2 to recommend approval of Descovy (emtricitabine 200mg and tenofovir alafenamide 25mg tablets; F/TAF) for the proposed indication of pre-exposure prophylaxis (PrEP) in men and transgender women (TGW) who have sex with men. 8 August 2019
Biotechnology
Takeda has submitted a New Drug Application (NDA) in Japan for a subcutaneous (SC) formulation of Entyvio (vedolizumab) as a maintenance therapy for moderately to severely active ulcerative colitis (UC). 8 August 2019
Biotechnology
Rhythm Pharmaceuticals has announced positive top-line results from two pivotal, Phase III clinical trials evaluating setmelanotide, the company’s melanocortin-4 receptor (MC4R) agonist, for the treatment of pro-opiomelanocortin (POMC) and leptin receptor (LEPR) deficiency obesities. 8 August 2019
Pharmaceutical
Edavarone, from Mitsubishi Tanabe Pharma, has been approved in China as an intravenous treatment for amyotrophic lateral sclerosis (ALS). 7 August 2019
Biotechnology
Following US Food and Drug Administration approval of gene therapy Zolgensma (onasemnogene abeparvovec-xxxx) on May 24, the agency said on Tuesday that, on June 28, it was informed by AveXis, the product’s manufacturer and developer, about a data manipulation issue that impacts the accuracy of certain data from product testing performed in animals submitted in the biologics license application (BLA) and reviewed by the FDA. 7 August 2019
Biotechnology
Pharma major Sanofi announced European Union (EU) approval for an extension of the marketing authorization for Dupixent (dupilumab) to include adolescents 12 to 17 years of age with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy. 6 August 2019
Biotechnology
Provention Bio has revealed that the US Food and Drug Administration has granted coveted Breakthrough Therapy designation (BTD) to teplizumab (PRV-031) for the prevention or delay of clinical type 1 diabetes (T1D) in individuals at-risk of developing the disease. 5 August 2019
Pharmaceutical
The AstraZeneca type two diabetes drug Foxiga (dapagliflozin) has had its label updated for the European Union to include positive cardiovascular (CV) outcomes and renal data from the Phase III DECLARE-TIMI 58 trial. 5 August 2019
Biotechnology
Late on Friday, the US Food and Drug Administration announced it has granted approval to Turalio (pexidartinib) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with surgery. 3 August 2019
Pharmaceutical
Amid fears that the UK’s departure from the European Union (EU) will likely be disruptive to trade, the British government has said it will provide funding to “accelerate preparations at the border, support business readiness and ensure the supply of critical medicines.” 2 August 2019
Generics
Ireland-headquartered drugmaker Endo International has applauded the US District Court for the District of Columbia's ruling supporting the Food and Drug Administration's (FDA) view that vasopressin cannot be used for compounding by outsourcing facilities. 2 August 2019
Biotechnology
The European Commission has granted marketing authorization for Maviret (glecaprevir/pibrentasvir) to shorten once-daily treatment duration from 12 to eight weeks in treatment-naïve, compensated cirrhotic, chronic hepatitis C (HCV) patients with genotype (GT)1, 2, 4, 5, and 6 infection. 2 August 2019
Biotechnology
In Japan, a new filing for marketing approval for the monoclonal antibody tildrakizumab-asmn has been lodged, for the treatment of moderate-to-severe psoriasis and psoriatic arthritis. 2 August 2019
Pharmaceutical
Ahmedabad-based Zydus Cadila has reported positive top-line results from a Phase III trial of Lipaglyn (saroglitazar) for treating type 2 diabetes. The therapy has been approved in India to treat diabetes-related conditions since 2013. 2 August 2019
Biotechnology
Ireland-incorporated Horizon Therapeutics yesterday announced the availability of an expanded access program for its investigational medicine teprotumumab. 2 August 2019
Biotechnology
UK and USA-based clinical-stage biotech Orchard Therapeutics has received a Regenerative Medicine Advanced Therapy (RMAT) designation for OTL-103, a gene therapy for the treatment of Wiskott-Aldrich Syndrome (WAS). 1 August 2019
Pharmaceutical
A European Commission (EC) approval means that GlaxoSmithKline’s Nucala (mepolizumab) is the only monthly anti-IL5 biologic approved in Europe that people with severe eosinophilic asthma can take at home, after a healthcare professional decides it is appropriate. 1 August 2019
Biotechnology
The US Food and Drug Administration has granted Breakthrough Therapy designation (BTD) for investigational agent bempegaldesleukin (NKTR-214), from Nektar Therapeutics, in combination with Bristol-Myers Squibb's Opdivo (nivolumab) for the treatment of patients with previously untreated unresectable or metastatic melanoma. 1 August 2019
Biotechnology
Hotly-tipped Hong Kong-based biotech Chi-Med has said it expects to file for a new cancer drug this year, the second after its approved therapy Elunate (fruquintinib). 31 July 2019
Pharmaceutical
The US Department of Health and Human Services (HHS) and the country’s Food and Drug Administration (FDA) have announced a plan to import certain prescription drugs in order to lower prices for patients. 31 July 2019
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