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Biotechnology
An antibody-drug conjugate (ADC) from AstraZeneca and Daiichi Sankyo has secured approval in China. 24 February 2023
Biotechnology
At its February meeting, the European Medicines Agency’s human medicines committee CHMP recommended approval of eight novel medicines, one of which is a biosimilar. 24 February 2023
Biotechnology
The US Food and Drug Administration (FDA) has approved Altuviiio (efanesoctocog alfa), a high-sustained factor VIII replacement therapy. 24 February 2023
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for Pfizer’s respiratory syncytial virus (RSV) vaccine candidate. 22 February 2023
Biotechnology
UK pharma major AstraZeneca today revealed that Imfinzi (durvalumab) and Imjudo (tremelimumab) immunotherapy combinations have been approved in the European Union (EU) for the treatment of advanced liver and lung cancers. 22 February 2023
Biotechnology
Shanghai Junshi Biosciences has announced positive results from a randomized, double-blind, placebo-controlled, multicenter Phase III clinical study (TORCHLIGHT Study, NCT04085276) examining the company’s product toripalimab in combination with paclitaxel for injection (albumin-bound) in patients with an initial diagnosis of stage IV or recurrent/metastatic triple-negative breast cancer. 22 February 2023
Pharmaceutical
Global specialist HIV company ViiV Healthcare, which is majority owned by GSK, has been granted marketing authorization by the European Medicines Agency (EMA) for Triumeq PD. 22 February 2023
Pharmaceutical
USA-based Akebia Therapeutics said yesterday that it has received a second interim response from the US Food and Drug Administration (FDA) to its formal dispute resolution request regarding the Complete Response Letter (CRL) for vadadustat received in March 2022, with the news sending the firm’s plunging 25.5% to $0.65. 22 February 2023
Biotechnology
Authorization has been granted by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for a new version of the Moderna’s ‘bivalent’ COVID-19 vaccine. 21 February 2023
Pharmaceutical
Japanese drugmaker Astellas closed Monday’s trading 2% lower following some news on fezolinetant, its investigational agent for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. 21 February 2023
Pharmaceutical
Karyopharm Therapeutics and privately-held Italian drugmaker Menarini Group today announced that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted full Marketing Authorization for Nexpovio (selinexor) in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. 21 February 2023
Biotechnology
The European Commission has granted conditional marketing authorization (CMA) for Hemgenix (etranacogene dezaparvovec), the first and only one-time gene therapy for the treatment of severe and moderately severe hemophilia B (congenital Factor IX deficiency) in adults without a history of Factor IX inhibitors. 21 February 2023
Biotechnology
Netherland-based biotech Azafaros today announced its progress in ongoing interactions with health authorities regarding its lead asset, AZ-3102. 20 February 2023
Biotechnology
Australian medicines regulator the Therapeutic Goods Administration (TGA) has granted provisional approval to US messenger RNA (mRNA) specialist Moderna’s bivalent COVID-19 vaccine: elasomeran and davesomeran (Spikevax bivalent original/Omicron BA.4-5) for use as a booster dose in individuals aged 12 years and older. 20 February 2023
Biotechnology
A recent survey by SVB Securities’ MEDAcorp unit of 48 urologists and medical oncologists suggests that Seagen and Astellas’ Padcev (enfortumab vedotin-ejfv) +/- Merck & Co’s Keytruda (pembrolizumab) may rapidly displace platinum chemo +/- Merck KGaA’s Bavencio (avelumab) maintenance as the frontline standard of care over the next three years. 20 February 2023
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval for Travere Therapeutics’ Filspari (sparsentan) to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g. 20 February 2023
Biotechnology
The US Food and Drug Administration (FDA) on Friday approved retinal disease specialist Apellis Pharmaceuticals' drug for geographic atrophy secondary to age-related macular degeneration (AMD) after pushing back its planned decision by three months to review more data. 18 February 2023
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Austedo XR (deutetrabenazine) extended-release tablets, a new once-daily formulation indicated in adults for tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD). 18 February 2023
Pharmaceutical
Long approved in Europe, family-owned Italian drugmaker Chiesi Farmaceutici has now received marketing authorization for its Lamzede (velmanase alfa-tycv) in the USA. 17 February 2023
Pharmaceutical
US pharma giant Pfizer on Thursday said a Phase III study combining its breast-cancer drug Talzenna (talazoparib), with its prostate-cancer drug Xtandi (enzalutamide) showed a 37% reduction in the risk of disease progression or death in men with metastatic castration-resistant prostate cancer (mCRPC). 17 February 2023
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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