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Biotechnology
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) is doing all it can to stay on top of safety monitoring and messaging around COVID-19 Vaccine AstraZeneca. 12 March 2021
Biotechnology
Takeda Pharmaceutical has submitted a New Drug Application (NDA) to the Ministry of Health, Labor and Welfare (MHLW) in Japan for Takhzyro (lanadelumab) subcutaneous injection, a monoclonal antibody therapy for prophylaxis against attacks of hereditary angioedema (HAE). 12 March 2021
Biotechnology
Marking the fourth vaccine to be recommended for the prevention of the novel coronavirus by the European Medicines Agency, the EMA today revealed it has recommended granting a conditional marketing authorization for COVID-19 Vaccine Janssen in people from 18 years of age. 11 March 2021
Pharmaceutical
Health authorities in European Union (EU) countries have intervened amid concerns around the safety of the AstraZeneca COVID-19 vaccine. 11 March 2021
Biotechnology
Japanese drug major Astellas Pharma says it has submitted New Drug Application (NDA) to Japan's Ministry of Health, Labor and Welfare (MHLW) for enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer that has progressed after anti-cancer medication. 11 March 2021
Biotechnology
After several US setbacks affecting the firm’s lead product, AVEO Oncology late Wednesday finally received US Food and Drug Administration approval for Fotivda (tivozanib) as a treatment of adults with relapsed or refractory advanced renal cell carcinoma who have received two or more prior systemic therapies. 11 March 2021
Pharmaceutical
Cloud revenue management solutions provider Model N has announced findings from its 2021 State of Revenue Report, which examines current issues around revenue execution and management in the healthcare sector. 11 March 2021
Biotechnology
Shares of US biotech bluebird bio gained 13% pre-market today and were still up 8.8% at $32.70 by mid-morning after it announced encouraging analyses of its gene therapy program that was linked with a serious adverse event. 10 March 2021
Pharmaceutical
The US Government Accountability Office (GAO) has called on the US Food and Drug Administration (FDA) to address a backlog in inspections that has been worsened by the pandemic. 10 March 2021
Biotechnology
Shares of US gene therapy company Rocket Pharmaceuticals were up more than 9% at $53.14 in early afternoon trading on Tuesday, after the company revealed that the Food and Drug Administration has granted Regenerative Medicine Advanced Therapy (RMAT) designation to RP-L201, its investigational gene therapy for the treatment of leukocyte adhesion deficiency-I (LAD-I). 10 March 2021
Biotechnology
US biotech Soleno Therapeutics has provided an update following recent interactions with the US Food and Drug Administration regarding the development of once-daily DCCR (diazoxide choline) extended-release tablets for the treatment of Prader-Willi Syndrome (PWS). 9 March 2021
Pharmaceutical
Stumbling 7% before the closing bell on Monday, shares in San Diego’s Acadia Pharmaceuticals fell a further 38% in after-hours trading, following a regulatory setback. 9 March 2021
Biotechnology
Clarivate today announced the launch of its annual "Drugs to Watch" list, identifying drugs entering the market or launching key indications in 2021 which are predicted to achieve blockbuster status by 2025. 9 March 2021
Generics
The Russian pharmaceutical industry remains heavily dependent on imports of active pharmaceutical ingredients (APIs), despite efforts that have been made by the state to reduce import dependence in recent years, according to recent statements by representatives of some leading Russian pharmaceutical producers and analysts, reports The Pharma Letter’s local correspondent. 8 March 2021
Biotechnology
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion for bamlanivimab alone and bamlanivimab administered together with etesevimab for the treatment of COVID-19 patients. 8 March 2021
Biotechnology
A third pharma major in as many weeks has voluntarily withdrawn from an immuno-oncology indication, as the US regulator toughens its stance towards Accelerated Approvals. 8 March 2021
Pharmaceutical
Swiss drugmaker Vifor Pharma and Cara Therapeutics today announced that the US Food and Drug Administration has accepted and granted Priority Review for the New Drug Application (NDA) for Korsuva (difelikefalin) solution for injection for the treatment of moderate-to-severe pruritus in hemodialysis patients. 8 March 2021
Biotechnology
Two sets of research results attracted attention last week. US biotech Amgen and UK pharma major AstraZeneca last Monday released positive Phase III results for their tezepelumab, which could change the way asthma is treated. Also, last Wednesday, US Pharma major Eli Lilly and partner Incyte announced encouraging Ph III data on their JAK inhibitor Olumiant for alopecia areata, an autoimmune disease that causes hair loss. On Tuesday, G1 Therapeutics announced the start of the rollout with partner, Germany’s Boehringer Ingelheim, of their new drug Cosela (trilaciclib) as a treatment for chemotherapy-induced myelosuppression. Amgen again hit the headlines last week, announcing that it is buying Five Prime – and its lead candidate bemarituzumab – for $1.9 billion. 7 March 2021
Biotechnology
Shares of US biotech major Gilead Sciences closed up 2.2% at $64.62 on Friday, after its Kite subsidiary announced that the US Food and Drug Administration has granted accelerated approval to Yescarta (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. 6 March 2021
Pharmaceutical
USA-based FibroGen and its partner, AstraZeneca, have revealed that the Cardiovascular and Renal Drugs Advisory Committee of the US Food and Drug Administration will hold an advisory committee (AdCom) meeting to review the new drug application for roxadustat in the USA 5 March 2021
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
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
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