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The US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) yesterday voted 21 to 0, with one abstention, to recommend that the FDA grant Emergency Use Authorization (EUA) for the Novavax COVID-19 vaccine (NVX-CoV2373) for individuals aged 18 years and over. 8 June 2022
Pharmaceutical
Florida-based Veru, a biopharma developing novel medicines for COVID-19 and other viral and acute respiratory distress syndrome (ARDS)-related diseases and for the management of breast and prostate cancers, was trading 15% higher an hour after New York trading began on Tuesday. 7 June 2022
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Priorix (Measles, Mumps and Rubella Vaccine, Live) for active immunization for the prevention of measles, mumps and rubella (MMR) in individuals 12 months of age and older, developed by UK pharma major GSK. 7 June 2022
Pharmaceutical
US biotech Amylyx Pharmaceuticals saw its shares leap 25% to $12.24 in early trading Friday after the US Food and Drug Administration extended the review timeline for its amyotrophic lateral sclerosis treatment. 6 June 2022
Biotechnology
Shares of US biotech TG Therapeutics were down more than 9% at $4.35 by mid-afternoon today, after it announced that the US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date to December 28, 2022, for the Biologics License Application (BLA) for ublituximab as a treatment for patients with relapsing forms of multiple sclerosis (RMS). 1 June 2022
Biotechnology
Swedish Orphan Biovitrum (Sobi) and French pharma major Sanofi have been awarded Breakthrough Therapy designation in the USA, for efanesoctocog alfa (BIVV001). 1 June 2022
Pharmaceutical
Pherecydes Pharma has been granted AAC Early Access Program approval by France’s Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) for its anti-Staphylococcus aureus (S. aureus) phages. 31 May 2022
Biotechnology
The US Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) to treat adults with prurigo nodularis, a chronic inflammatory skin disease that causes extreme itch and skin lesions. 31 May 2022
Biotechnology
Two new approvals for Opdivo (nivolumab)-based regimens in esophageal squamous cell carcinoma (ESCC) will bring meaningful competition for the leading checkpoint blocker, Keytruda (pembrolizumab). 31 May 2022
Pharmaceutical
A US label extension for oral spinal muscular atrophy (SMA) drug Evrysdi (risdiplam) will help its developers make further inroads in what is an increasingly competitive therapeutic area. 31 May 2022
Biosimilars
US drugmaker Amneal has announced that the US Food and Drug Administration (FDA) has approved the company’s Biologics License Application (BLA) for pegfilgrastim-pbbk, a biosimilar referencing Neulasta. 30 May 2022
Pharmaceutical
Previews of planned presentations at the important ASCO oncology meeting starting on June 2 dominated news last week, but we still saw important research results in other therapeutic sectors. Among these, Pfizer released data on its ulcerative colitis candidate etrasimod, boasting a potential best-in-class profile. US drugmaker Biohaven Pharmaceutical announced that its troriluzole did not reach statistical significance in a Phase III study of spinocerbellar ataxia. Also, Iovance Biotherapeutics released new data on its melanoma candidate lifileucel, which the biotech touted as being positive, but investors did not agree, with the stock falling more than 50%. On the regulatory front, Avadel Pharmaceuticals hit a setback in its application for US Food and Drug Administration (FDA) approval of its investigational narcolepsy drug FT218, with the agency seeking patent claim clarification with respect to final labelling. 29 May 2022
Biotechnology
The US Food and Drug Administration has granted accelerated approval for Kymriah (tisagenlecleucel) for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy, said Swiss pharma giant Novartis. 28 May 2022
Biotechnology
The race to meet sudden, stratospheric demand for new anti-obesity meds is hotting up, but Novo Nordisk CEO Lars Fruergaard Jørgensen takes a collegiate approach. 26 May 2022
Biotechnology
Japanese drugmaker Chugai Pharmaceutical announced that it launched anti VEGF/anti Ang-2 bispecific antibody Vabysmo Intravitreal Injection 120 g/mL (faricimab [genetical recombination]) for the treatment of age-related macular degeneration associated with subfoveal choroidal neovascularization and diabetic macular edema (DME). 26 May 2022
Biotechnology
Roche has won approval from the European Commission (EC) for the use of Polivy (polatuzumab vedotin) in combination with MabThera (rituximab) plus cyclophosphamide, doxorubicin, and prednisone (R-CHP) for adults with untreated diffuse large B-cell lymphoma (DLBCL). 26 May 2022
Biotechnology
Following a European Medicines Agency recommendation in March, the European Commission has now granted formal approval for Carvykti (ciltacabtagene autoleucel, or cilta-cel), from Johnson & Johnson’s subsidiary Janssen. 26 May 2022
Biotechnology
Antios Therapeutics has been given the cold shoulder by erstwhile development partner Assembly Biosciences, after a clinical hold was placed on its hepatitis B program. 26 May 2022
Pharmaceutical
French privately-held drugmaker Servier has announced that the US Food and Drug Administration (FDA) approved Tibsovo (ivosidenib tablets) in combination with azacitidine for the treatment of patients with newly diagnosed IDH1-mutated acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. 26 May 2022
Biotechnology
Merck & Co’s blockbuster drug Keytruda (pembrolizumab) has been approved by the European Commission alongside chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery for adults with locally advanced or early-stage triple-negative breast cancer (TNBC) at high risk of recurrence. 25 May 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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