Regulation
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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
Biotechnology
The European Commission (EC) has approved Sanofi’s Xenpozyme (olipudase alfa) as the first and only enzyme replacement therapy to treat non-central nervous system (CNS) manifestations of acid sphingomyelinase deficiency (ASMD) in pediatric and adult patients with ASMD type A/B or ASMD type B. 28 June 2022
Biotechnology
The US Food and Drug Administration (FDA) has placed a partial clinical hold on US biotech firm Nuvation Bio’s Phase I dose escalation study of NUV-422 in solid tumors, including high grade glioma, HR+/HER2- advanced breast cancer and metastatic castration resistant prostate cancer. 28 June 2022
Biotechnology
The European Commission (EC) has approved its CAR-T cell therapy Yescarta (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy. 28 June 2022
Pharmaceutical
Shares in Spero Therapeutics were down by nearly 9% in pre-market trading on Tuesday. 28 June 2022
Pharmaceutical
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has started a review of data to extend the use of the smallpox vaccine Imvanex to include protecting people from monkeypox disease. 28 June 2022
Biotechnology
The European Commission has granted marketing authorization for Nexviadyme (avalglucosidase alfa), an enzyme replacement therapy (ERT) for the long-term treatment of both late-onset and infantile-onset Pompe disease, a rare, progressive and debilitating muscle disorder, from French pharma major Sanofi. 28 June 2022
Biotechnology
Family-owned Italian drugmaker Menarini Group and USA-based Radius Health have announced that Menarini, with support from Radius, has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for elacestrant in patients with ER+/HER2- advanced or metastatic breast cancer. 27 June 2022
Biotechnology
Leading PARP blocker Lynparza (olaparib) looks set to secure a new marketing authorization in Europe, after a positive scientific opinion. 27 June 2022
Pharmaceutical
Breakups can be messy, but 18 months after the UK formally left the European Union, the newly-empowered Medicines and Healthcare products Regulatory Agency (MHRA) is determined to stay strong. 26 June 2022
Pharmaceutical
Regulatory news last week included a US Food and Drug Administration (FDA) advisory panel voting against approval of Acadia Pharmaceuticals’ Nuplazid for the treatment of Alzheimer’s associated with psychosis (ADP). Also, the FDA put a surprise clinical hold on a trial of Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) drug candidate SRP-5051 (vesleteplirsen). Among important research news, AstraZeneca and partner Ionis Pharmaceuticals announced positive results from a Phase III trial evaluating their rare disease candidate eplontersen. Meantime, Enanata Pharmaceuticals has filed a patent infringement suit against Pfizer relating to the latter’s highly successful COVID-10 antiviral Paxlovid. Troubled Belgian biotech Galapagos last Wednesday announced not one, but two acquisitions – CellPoint and AboundBio – aiming to expand into CAR-T therapeutics. 26 June 2022
Biosimilars
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorization of its bevacizumab biosimilar referencing Avastin, Vegzelma (CT-P16), from South Korea-headquartered Celltrion Healthcare. 25 June 2022
Biotechnology
The European Medicines Agency’s human medicines committee (CHMP) recommended seven novel medicines for approval at its June 2022 meeting, including the first gene therapy for hemophilia A. 24 June 2022
Pharmaceutical
The US Food and Drug Administration (FDA) has unveiled an Action Plan for Rare Neurodegenerative Diseases including Amyotrophic Lateral Sclerosis (ALS). 24 June 2022
Biotechnology
Merck & Co today announced that the European Commission (EC) has approved Keytruda (pembrolizumab) Merck’s mega-blockbuster anti-PD-1 therapy, as monotherapy for the adjuvant treatment of adults and adolescents aged 12 years and older with stage IIB or IIC melanoma and who have undergone complete resection. 24 June 2022
Biotechnology
Shares of Sarepta Therapeutics dropped almost 9% to $65.39 in after-hours trading yesterday, after the company said the US Food and Drug Administration put a clinical hold on SRP-5051 (vesleteplirsen), a treatment for patients with Duchenne muscular dystrophy (DMD). 24 June 2022
Pharmaceutical
Late comers to coronavirus vaccine development, pharma majors France’s Sanofi and the UK’s GSK have announced positive data from their vaccine trial which evaluated an adjuvanted bivalent D614 and Beta (B.1.351) vaccine candidate. 24 June 2022
Biotechnology
Shares of German biotech BioNTech closed up almost 7% at $132.29 yesterday, after the company – which burst on the scene with its hugely successful COVID-19 vaccine Comirnaty – announced a important development for its wider portfolio. 24 June 2022
Pharmaceutical
Drug repurposing involves the use of existing drugs for new indications.1 Repurposed drugs include not only previously approved drugs but also clinically failed and investigational drugs.2 24 June 2022
Biotechnology
The European Medicines Agency (EMA) has recommended granting a marketing authorization for COVID-19 Vaccine (inactivated, adjuvanted) Valneva, developed by developed by French company Valneva, for use in the primary vaccination of people from 18 to 50 years of age. 23 June 2022
Biotechnology
Swiss pharma giant Novartis has received an Accelerated Approval in the USA for its combination BRAF/MEK inhibitor therapy, for certain biomarker-defined tumors. 23 June 2022
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