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
The Russian government may postpone the introduction of controversial practice of mandatory labeling of drugs on the domestic pharmaceutical market (which is scheduled to come into force on January 1, 2020) for at least six months, according to recent statements of some senior state officials and members of the Russian Parliament (State Duma), reports The Pharma Letter’s local correspondent. 19 November 2019
Pharmaceutical
The European Medicines Agency (EMA) is now in possession of the keys to its new permanent headquarters in Amsterdam. 18 November 2019
Biotechnology
Israeli drugmaker Protalix BioTherapeutics closed 40% up on Monday amid good news for pegunigalsidase alfa, the Fabry disease candidate that it is advancing alongside its development and commercialization partner, Chiesi Farmaceutici. 18 November 2019
Pharmaceutical
Swiss drugmaker Novartis has released positive data from new subgroup analyses of the Phase III PARAGON-HF study of Entresto (sacubitril/valsartan). 18 November 2019
Biotechnology
The US Food and Drug Administration on Friday approved Adakveo (crizanlizumab-tmca), a treatment to reduce the frequency of vaso-occlusive crisis – a common and painful complication of sickle cell disease that occurs when blood circulation is obstructed by sickled red blood cells – for patients aged 16 years and older. 18 November 2019
Pharmaceutical
Regulatory decisions featured heavily in last week’s news, with Celgene and partner Acceleron scoring a first US Food and Drug Administration approval for Reblozyl, a treatment for beta-thalassemia, a rare hematological disorder. On the negative side, Solid Biosciences was hit by a clinical hold on its Duchenne drug candidate, SGT-001. And, on Thursday, China’s BeiGene received its first US regulatory approval, with the FDA clearing its mantle cell lymphoma drug Brukinsa (zanubrutinib) for marketing. Meantime, on the research front, Swiss pharma giant Roche reported positive results with its spinal muscular atrophy candidate risdiplam. Also, following positive data from a Phase III trial of bardoxolone, Reata Pharmaceuticals said it would file for approval of the drug for kidney damage reversal. 17 November 2019
Pharmaceutical
At its November 11-14 meetings, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended five novel medicines for marketing approval. 16 November 2019
Pharmaceutical
A little over five years ago, British drugmaker GlaxoSmithKline was riding high, following multiple years of strong sales and related year-on-year share price gains. 15 November 2019
Pharmaceutical
The European Commission (EC) has approved Qtrilmet (metformin hydrochloride, saxagliptin and dapagliflozin) modified-release tablets to improve glycemic control in adults with type-2 diabetes (T2D), says Cambridge, UK-based AstraZeneca 15 November 2019
Biotechnology
On Thursday, the US Food and Drug Administration granted accelerated approval to Brukinsa (zanubrutinib) capsules for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. 15 November 2019
Pharmaceutical
A key scientific panel of the US medicines regulator has voted unanimously in favor of granting a label expansion for Amarin’s Vascepa (icosapent ethyl). 15 November 2019
Pharmaceutical
As discussed in last month’s column, The FDA’s take on Medical Innovation, the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) strives to support the innovation and development of novel drugs and biological products. 1 15 November 2019
Biotechnology
An antibiotic from Japanese drugmaker Shionogi has been approved by the US Food and Drug Administration, sending shares in the Osaka-based firm up around 1.5% on Friday. 15 November 2019
Pharmaceutical
The US regulator has granted Priority Review status for an application to market the MEK 1/2 inhibitor selumetinib as a potential new medicine for certain rare neurological conditions. 14 November 2019
Pharmaceutical
The US Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) advises against marketing authorization of a low dose SGLT2 inhibitor, voting 14 to 2 that the benefits of empagliflozin 2.5mg do not outweigh the risks to support approval as an adjunct to insulin for adults with type 1 diabetes, citing a lack of adequate data to support evidence for safety and efficacy. 14 November 2019
Generics
The US Food and Drug Administration has sent a warning letter to Netherlands-incorporated drugmaker Mylan over procedures at an Indian manufacturing facility. 14 November 2019
Biotechnology
Actelion Pharmaceuticals has decided to voluntarily withdraw the European and other health authority filings still under review to extend the indication of Opsumit (macitentan) to include the treatment of adults with inoperable chronic thromboembolic pulmonary hypertension (CTEPH). 13 November 2019
Pharmaceutical
Shares in heart specialist Amarin were boosted by over 25% on Tuesday, following positive results for Vascepa (icosapent ethyl) and the release of FDA briefing notes in advance of Thursday’s Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. 12 November 2019
Biotechnology
The US Food and Drug Administration has granted Breakthrough Therapy designation for mavorixafor (X4P-001) for the treatment of adult patients with WHIM (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis) syndrome, a rare, inherited, primary immunodeficiency disease caused by genetic mutations in the CXCR4 receptor gene. 12 November 2019
Pharmaceutical
US pharma giant Merck has revealed that the European Commission has granted a conditional marketing authorization to Ervebo for active immunization of individuals 18 years of age or older to protect against Ebola Virus Disease (EVD) caused by Zaire Ebola virus. 12 November 2019
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