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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
Pharmaceutical
The accelerated approval pathway (AAP), which was first introduced by the US Food and Drug Administration (FDA) in 1992 to tackle the HIV epidemic, enables expedited development and approval of new therapies for serious diseases that lack efficient treatment options.1,2 26 August 2022
Pharmaceutical
Texas, USA-based clinical-stage biopharma Savara says that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) granted Promising Innovative Medicine (PIM) designation to molgramostim for the treatment of aPAP, a rare lung disease with no approved pharmaceutical treatments. 26 August 2022
Biotechnology
US biotech BioMarin Pharmaceutical yesterday announced that the European Commission (EC) has granted conditional marketing authorization (CMA) to Roctavian (valoctocogene roxaparvovec) gene therapy for the treatment of severe hemophilia A (congenital Factor VIII deficiency) in adult patients without a history of Factor VIII inhibitors and without detectable antibodies to adeno-associated virus serotype 5 (AAV5). 25 August 2022
Biotechnology
On August 24, the US Food and Drug Administration announced it has approved Pharmacyclics application for Imbruvica (ibrutinib) for pediatric patients ≥ 1 year of age with chronic graft versus host disease (cGVHD) after failure of 1 or more lines of systemic therapy. Formulations include capsules, tablets, and oral suspension. 25 August 2022
Biotechnology
UK pharma major AstraZeneca this morning announced that it has received marketing approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for three of its pharmaceutical products, sending the firm’s shares edging up 1.3% to 11,497.12 pence. 25 August 2022
Biotechnology
US healthcare giant Johnson & Johnson subsidiary Janssen today revealed that the European Commission (EC) has granted conditional marketing authorization (CMA) of Tecvayli (teclistamab) as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM). 24 August 2022
Biotechnology
Very young children can benefit from a high level of immunity to the novel coronavirus after receiving the Comirnaty vaccine, new research shows. 24 August 2022
Biotechnology
US cancer-focused biotech Foghorn Therapeutics saw its shares plummet 25% to $11.00 by close of trading yesterday, after it announced that the US Food and Drug Administration (FDA) has placed a full clinical hold on the Phase I dose escalation study of FHD-286. 24 August 2022
Biotechnology
US mRNA specialist biotech Moderna says that it has completed its submission to the US Food and Drug Administration (FDA) for emergency use authorization for its BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.222. 24 August 2022
Biotechnology
Japanese drugmaker Chugai Pharmaceutical today announced receipt of approval from the Ministry of Health, Labor and Welfare (MHLW) for the anticancer agent/antimicrotubule binding anti-CD79b monoclonal antibody Polivy intravenous infusion (polatuzumab vedotin (genetical recombination) for an additional indication of treatment of patients with previously untreated diffuse large B-cell lymphoma (DLBCL). 24 August 2022
Pharmaceutical
Japanese pharma major Takeda announced the company’s dengue vaccine, Qdenga (dengue tetravalent vaccine [live, attenuated]; formerly known as TAK-003), was approved by the Indonesia National Agency for Drug and Food Control, Badan Pengawas Obat dan Makanan (BPOM), for the prevention of dengue disease caused by any serotype in individuals six years to 45 years of age. 23 August 2022
Pharmaceutical
Shares of Clinical stage US biotech Minerva Neurosciences were up more than 5% at $4.35 pre-market, after it said it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for roluperidone for the treatment of negative symptoms in patients with schizophrenia. 23 August 2022
Biotechnology
Pharvaris, a Switzerland-based clinical-stage company, today announced that the US Food and Drug Administration (FDA) verbally informed Pharvaris that, based on its review of non-clinical data, the agency is placing a clinical hold on the clinical trials of PHA121 in the USA under two Pharvaris Investigational New Drug (IND) applications for the treatment of HAE. 23 August 2022
Pharmaceutical
CSL Vifor and Travere Therapeutics today announced that the European Medicines Agency (EMA) has accepted for review the Conditional Marketing Authorization (CMA) application for sparsentan for the treatment of IgAN, a rare kidney disorder and a leading cause of end-stage kidney disease (ESKD). 22 August 2022
Pharmaceutical
The European medicines regulator has started reviewing a submission from Japanese drugmaker Otsuka Pharmaceutical for its acute myeloid leukemia (AML) therapy ASTX727. 22 August 2022
Biotechnology
Following in the steps of US mRNA biotech Moderna, which last week gained a first regulator approval for its bivalent vaccine, now BioNTech and Pfizer say they have completed their submission to the US Food and Drug Administration (FDA) today requesting an Emergency Use Authorization of a 30µg booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years and older. 22 August 2022
Pharmaceutical
A regulatory submission from British firm Mundipharma, for the invasive candidiasis (IC) candidate rezafungin, has been accepted for review by the European Medicines Agency. 22 August 2022
Pharmaceutical
US central nervous system specialist Axsome Therapeutics saw its shares close up more than 40% at $59.55 on Friday, after it revealed that the US Food and Drug Administration (FDA) has approved its Auvelity (dextromethorphan HBr-bupropion HCl) extended-release tablets for the treatment of major depressive disorder (MDD) in adults. 22 August 2022
Biotechnology
US biotech major Gilead Sciences today announced that the European Commission (EC) has granted marketing authorization for Sunlenca (lenacapavir) injection and tablets for the treatment of HIV infection, in combination with other antiretroviral(s), in adults with multi-drug resistant HIV infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen. 22 August 2022
Generics
A US federal court on Friday ordered an Illinois company to stop manufacturing and distributing drugs alleged to be adulterated in violation of the Federal Food, Drug, and Cosmetic Act (FDCA). 22 August 2022
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