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Biotechnology
Belgian clinical-stage biotech Celyad Oncology, which is focused on the discovery and development of chimeric antigen receptor T cell (CAR-T) therapies for cancer, yesterday announced that the US Food and Drug Administration (FDA) has lifted the clinical hold on the CYAD-101-002 (KEYNOTE-B79) Phase Ib trial after the company made changes to the eligibility criteria for the trial. 2 August 2022
Biotechnology
US healthcare giant Johnson & Johnson’s Janssen subsidiary today announced that the US Food and Drug Administration (FDA) has approved Stelara (ustekinumab) for the treatment of pediatric patients six years of age and older with active psoriatic arthritis (PsA). 1 August 2022
Generics
The US Food and Drug Administration’s (FDA) Office of Generic Drugs has published its first progress report on the activities and accomplishments of the Global Generic Drug Affairs program’s Generic Drug Cluster. 1 August 2022
Biotechnology
US precision genetic medicine for rare diseases developer Sarepta Therapeutics said on Friday that it intends to submit a Biologics License Application (BLA) seeking accelerated approval for SRP-9001 (delandistrogene moxeparvovec) to treat ambulant individuals with Duchenne muscular dystrophy. 1 August 2022
Biotechnology
Regulatory events featured in last week’s news, first with US biotech major Biogen announcing that the US Food and Drug Administration (FDA) has accepted its new drug application (NDA) for tofersen, a potential treatment for amyotrophic latera sclerosis (ALS), for priority review. Also, Swiss women’s health specialist ObsEva suffered a setback, as the FDA said it is seeking additional data on its NDA for linzagolix for uterine fibroids. On the M&A front, Dutch firm NewAmsterdam Pharma last week announced a merger with special purpose acquisition company (SPAC) Frazier Lifesciences. There was good news for US mRNA specialist Moderna on Friday, when it announced receiving a new contract from the US government for its COVID-19 booster jab, mRNA-1273.222, worth $1.74 billion. 31 July 2022
Pharmaceutical
The US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Zoryve (roflumilast) cream 0.3% for the treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age or older. 30 July 2022
Biotechnology
AbbVie has announced that the European Commission has approved Rinvoq as an oral therapy for the treatment of active non-radiographic axial spondyloarthritis in adults with objective signs of inflammation, as indicated by elevated C-reactive protein and/or magnetic resonance imaging. 29 July 2022
Pharmaceutical
US pharma company Acer Therapeutics and its Switzerland-based collaboration partner Relief Therapeutics are confident that their New Drug Application (NDA) for ACER-001 (sodium phenylbutyrate) is back on track. 29 July 2022
Biotechnology
Hot on the heels of European Union authorization for the same indication, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Rinvoq (upadacitinib), from US drugmaker AbbVie, for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. 28 July 2022
Pharmaceutical
Shares of Switzerland-based ObsEva fell as much as 80% yesterday, after the women’s health therapy developer revealed it has hit a stumbling block in the US approval of its linzagolix for uterine fibroids. 28 July 2022
Pharmaceutical
Cidara Therapeutics’ shares closed up 11.6% at $0.76 yesterday, when it announced that it has entered into a license agreement with Melinta Therapeutics under which Cidara has granted Melinta an exclusive license to commercialize rezafungin in the USA. 28 July 2022
Pharmaceutical
The European Medicines Agency’s (EMA) Emergency Task Force (ETF) has started a review of data on the use of sabizabulin for treating COVID-19. 27 July 2022
Pharmaceutical
Combination therapies comprise two or more different types of medical products, including drugs, devices, and biological products.1 These individual components of combination therapies are called constituent parts, which might be physically or chemically combined and produced as a single entity (single entity combination product), packaged together as one unit (co-packaged combination product), or distributed separately (cross-labeled combination product).2 27 July 2022
Pharmaceutical
The US Food and Drug Administration (FDA) today announced the availability of a final guidance for industry entitled General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products. 27 July 2022
Pharmaceutical
The European Medicines Agency (EMA) has initiated a series of actions to respond to the ongoing monkeypox outbreak, which has been escalated by the World Health Organization (WHO) to a Public Health Emergency of International Concern (PHEIC) on July 23. 27 July 2022
Pharmaceutical
Russia plans to take additional measures to speed registration of new drugs in the domestic market – in a move, that will allow the country to avoid a potential shortage caused by sanctions and their consequences, reports The Pharma Letter’s local correspondent. 27 July 2022
Biotechnology
AbbVie's Rinvoq (upadacitinib) has been approved by the European Commission for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. 26 July 2022
Biotechnology
The US Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for tofersen, an investigational drug for superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). 26 July 2022
Biotechnology
Enhertu (trastuzumab deruxtecan) has been granted priority review in a new indication in the USA following results from the DESTINY-Breast04 Phase III trial showing that it is the first HER2-directed therapy to demonstrate a survival benefit in patients with HER2-low metastatic breast cancer. 26 July 2022
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted British marketing authorization for Global Blood Therapeutics’ Oxbryta (voxelotor) for the treatment of hemolytic anemia due to sickle cell disease (SCD) in eligible adult and pediatric patients aged 12 years and older as monotherapy or in combination with hydroxycarbamide (hydroxyurea). 26 July 2022
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
Novartis late yesterday revealed that Scemblix (asciminib) was granted accelerated approval by the US Food and Drug Administration (FDA) for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). 30 October 2024
Pharmaceutical
Privately-held US drugmaker Protega Pharmaceuticals says that the US Food and Drug Administration (FDA) has approved Roxybond (oxycodone hydrochloride) immediate-release (IR) CII 10mg tablet for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. 29 October 2024
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