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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
Chugai Pharmaceutical says it has filed a new drug application with the Ministry of Health, Labor and Welfare (MHLW) for risdiplam, an oral survival motor neuron-2 (SMN2) splicing modifier, for the treatment of spinal muscular atrophy (SMA). 16 October 2020
Biotechnology
The US Food and Drug Administration (FDA) has approved an expanded label for Keytruda (pembrolizumab), Merck & Co’s anti-PD-1 therapy, as monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin's lymphoma (cHL). 15 October 2020
Biotechnology
Health Canada has approved Luxturna (voretigene neparvovec), a one-time gene therapy for the treatment of adult and pediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells. 15 October 2020
Biotechnology
On Wednesday, the US Food and Drug Administration approved Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn; REGN-EB3), a mixture of three monoclonal antibodies, as the first FDA-cleared treatment for Zaire ebolavirus (Ebola virus) infection. 15 October 2020
Biotechnology
The European Medicines Agency has confirmed that mRNA-1273, a vaccine candidate against COVID-19, is eligible for submission of an application for a European Union Marketing Authorization under the Agency’s centralized procedure, said the vaccine’s developer. 14 October 2020
Pharmaceutical
The European Medicines Agency’s (EMA) initiative to implement exceptional transparency measures that are targeting regulatory activities for the assessment and approval of medicines and vaccines for COVID-19 has been praised by two trade groups representing the pharmaceutical industry. 14 October 2020
Pharmaceutical
Shares of Harmony Biosciences were up more than 6% at $37.24 mid-morning today, after it announced that the US Food and Drug Administration has approved Wakix (pitolisant) for the treatment of cataplexy in adult patients with narcolepsy. 14 October 2020
Pharmaceutical
The joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, appointed by the US Food and Drug Administration returned a positive vote on Alkermes’ ALKS-3831 (olanzapine/samidorphan). 13 October 2020
Biotechnology
Australia’s Therapeutic Goods Administration (TGA), part of the Department of Health, has granted a provisional determination for UK drug major to AstraZeneca in relation to its COVID-19 vaccine, ChAd0x1-S [recombinant]/AZD1222. 12 October 2020
Biotechnology
As US President Donald Trump puts his weight behind Eli Lilly and Regeneron Pharmaceuticals’ bid for US Food and Drug Administration Emergency Use Authorization (EUA) for their respective COVID-19 monoclonal antibody (MAb) therapies, pharma writers for the investigative team at GlobalData assess the situation. 12 October 2020
Biotechnology
Last week’s notable news included Bristol Myers Squibb making a further push into the cardiovascular arena with a $13.1 billion bid for MyoKardia and its drug mavacamten. Australia’s Mesoblast suffered a setback with the US Food and Drug Administration issuing a complete response letter (CRL) on its graft versus host disease candidate Ryoncil. Coronavirus was never out of sight, with the European Medicines Agency using its emergency program of rolling reviews for two COVID-10 vaccines: AstraZeneca’s AZD1222 and also Pfizer and BioNTech’s BNT-162b2. Also, despite warnings from the Trump administration, the FDA last week issued guidelines on the submission and review of COVID-19 vaccine that contain provisions that would prevent any such products being cleared before the November 3 presidential elections. On the research front, Axovant Gene Therapies released new Phase II data on its Parkinson’s disease candidate AXO-Lenti-PD that investors did not view as positive as the company. 11 October 2020
Biotechnology
The US Food and Drug Administration (FDA) has granted a rare pediatric disease designation to Italfarmaco Group’s givinostat for the treatment of Duchenne muscular dystrophy (DMD), which allows it an expedited review process. 9 October 2020
Biotechnology
Despite the coronavirus pandemic causing chaos on a global scale throughout much of 2020, the US Food a d Drug Administration has strived to limit the impact on much-needed, novel drug approvals. 9 October 2020
Biosimilars
Halpryza (rituximab injection), a recombinant human/murine chimeric monoclonal antibody drug co-developed by Chinese biopharma firm Innovent Biologics and US pharma major Eli Lilly, has been officially approved by the National Medical Products Administration (NMPA) of China for patients with diffuse large b cell lymphoma (DLBCL), follicular lymphoma (FL), and chronic lymphocytic leukemia (CLL) in China. 9 October 2020
Biotechnology
Subsequent to discussions with regulatory authorities, Regeneron Pharmaceuticals says it has submitted a request to the US Food and Drug Administration for an Emergency Use Authorization (EUA) for its REGN-COV2 investigational antibody combination for the treatment of COVID-19. 8 October 2020
Biotechnology
The US Food and Drug Administration over the last couple of day has issued two coveted Rare Pediatric Disease designations (RPDD). 8 October 2020
Pharmaceutical
On Tuesday, the US Food and Drug Administration issued guidance with recommendations for vaccine sponsors regarding the scientific data and information that would support the issuance of an emergency use authorization (EUA) for an investigational vaccine intended to prevent COVID-19. 7 October 2020
Pharmaceutical
Shares of Acacia Pharma closed up 4.5% at 2.22 euros today, as the UK company revealed that the US Drug Enforcement Administration (DEA) has designated its procedural sedative Byfavo (remimazolam injection) as a Schedule IV medicine. 6 October 2020
Biotechnology
Less than a week after the European Medicines Agency (EMA) started the first ‘rolling review’ of a COVID-19 vaccine, the regulator has begun another. 6 October 2020
Biosimilars
South Korea’s Samsung Bioepis and Biogen today announced that the European Medicines Agency (EMA) has accepted for review its Marketing Authorization Application for SB11, a proposed biosimilar referencing Lucentis (ranibizumab). 6 October 2020
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