Regulation
Refine Search
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
Pharmaceutical
On Tuesday, the US Food and Drug Administration approved Inqovi (decitabine and cedazuridine; ASTX727) tablets for treatment of adult patients with myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML). 8 July 2020
Pharmaceutical
The global remote patient monitoring (RPM) market is advancing at a significant rate across the entire healthcare industry, notes Dr Nicola Davies in her exclusive column for the Pharma Letter. This has most recently been driven by the COVID-19 pandemic1 and the US Food and Drug Administration’s guidance for the expanded use of certain approved RPM devices during this period.2 8 July 2020
Generics
The stringent regulatory vigilance by the US Food and Drug Administration is expected to continue with an increase in the number of inspections and re-inspection of Indian pharma facilities to clear the overall backlog. 7 July 2020
Pharmaceutical
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have developed a joint strategy for the next five years that has been released for a two-month public consultation. 7 July 2020
Pharmaceutical
The European Commission (EC) has approved Enerzair Breezhaler (indacaterol acetate/glycopyrronium bromide/mometasone furoate) for maintenance of asthma not adequately controlled with a combination of a long acting beta2 agonist (LABA) and a high-dose of an inhaled corticosteroid (ICS) following one or more exacerbations in the previous year. 7 July 2020
Pharmaceutical
Endo International has been granted US Food and Drug Administration approval for Qwo (collagenase clostridium histolyticum-aaes), a treatment for cellulite. 7 July 2020
Biotechnology
Swiss oncology-focused drug discovery firm ADC Therapeutics today announced that the US Food and Drug Administration has lifted the partial clinical hold on the pivotal Phase II clinical trial of camidanlumab tesirine (Cami, formerly ADCT-301) in patients with relapsed or refractory Hodgkin lymphoma (HL). 6 July 2020
Biosimilars
French pharma major Sanofi announced on Friday that its Insulin aspart Sanofi (insulin aspart 100 Units/mL) has received European Union marketing authorization, and will provide another treatment option for adults, adolescents and children aged one year and older who have diabetes. 6 July 2020
Pharmaceutical
Last week saw Gilead Sciences’ chief executive outline pricing for developed countries for its remdesivir in the treatment of COVID-19, and the US Food and Drug Administration issue new clinical guidelines for drugmakers developing vaccines for the novel coronavirus. Heron Therapeutics had a major disappointment last Monday, when the FDA issued a complete response letter (CRL) regarding its post-operative pain candidate HTX-011. Intercept Pharmaceuticals also received a CRL the same day for its non-alcoholic steatohepatitis (NASH) candidate. There was better news for Akero Therapeutics, which presented encouraging new data on its NASH candidate AKR-001. 5 July 2020
Pharmaceutical
The European Commission has granted conditional marketing authorization for Veklury (remdesivir) as a treatment for SARS-CoV-2 infection, the virus that causes COVID-19, US biotech Gilead Sciences announced, 3 July 2020
Pharmaceutical
The European Commission (EC) has approved the extension of the indication of Invokana (canagliflozin) to include renal outcome data from the CREDENCE trial. 3 July 2020
Biotechnology
The specialist HIV company ViiV Healthcare, which is majority owned by GlaxoSmithKline, has announced that the US Food and Drug Administration (FDA) has approved Rukobia (fostemsavir), 600 mg extended-release tablets. 3 July 2020
Biotechnology
CSL Behring has announced that the European Medicines Agency (EMA) has approved the new Summary of Product Characteristics, which includes information about new, extended dosing options, for Idelvion (coagulation Factor IX [recombinant], albumin fusion protein; albutrepenonacog alfa). 3 July 2020
Pharmaceutical
The US Food and Drug Administration has approved Byfavo (remimazolam) for injection for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less, marking the second approval for UK-based Acacia Pharma. 3 July 2020
Biotechnology
The US Food and Drug Administration has approved a randomized, double-blind, placebo-controlled Phase III clinical trial protocol to evaluate the safety and efficacy of intravenous siltuximab plus standard of care in hospitalized patients with COVID-19 associated acute respiratory distress syndrome (ARDS). 2 July 2020
Pharmaceutical
On Monday, the European Commission adopted the decision granting marketing authorizations to Janssen, a Johnson & Johnson (NYSE: NJ) company, for a vaccine against Ebola. 2 July 2020
Pharmaceutical
The US Food and Drug Administration (FDA) has delivered a clear message alongside its provision of guidance for those developing COVID-19 vaccines for the ultimate purpose of licensure. 1 July 2020
Biotechnology
Germany’s Merck KGaA and US drug giant Pfizer have received US approval to market Bavencio (avelumab) for the maintenance treatment of locally-advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. 1 July 2020
Pharmaceutical
As of today (July 1, 2020 in Australia, advertisers of medicines will no longer be required to seek pre-approval from sector regulator, the Therapeutic Goods Administration (TGA) for advertisements of therapeutic goods in mainstream media. 1 July 2020
Biotechnology
Intercept Pharmaceuticals has received a complete response letter from the Food and Drug Administration regarding its New Drug Application (NDA) for obeticholic acid (OCA) for the treatment of fibrosis due to non-alcoholic steatohepatitis (NASH). 30 June 2020
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Today's issue
Company Spotlight
A US biotech company dedicated to creating oral drugs with an emphasis on indications in virology and immunology.
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze