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Biotechnology
In late 2023, Vertex Pharmaceuticals and CRISPR Therapeutics’ made history by gaining the first FDA approval for a CRISPR-based drug, Casgevy (exagamglogene autotemcel) for the treatment of sickle cell disease with vaso-occlusive crisis. 6 February 2024
Pharmaceutical
UK pharma major GSK’s Arexvy (respiratory syncytial virus vaccine, adjuvanted) is currently undergoing regulatory review with the potential of being approved in Europe for use in adults aged between 50 and 59 who are at an increased risk for respiratory syncytial virus (RSV) infection. 5 February 2024
Biotechnology
Adaptimmune Therapeutics saw its shares leap almost 10% by close of trading Wednesday and a further 5.2% to $1.01 in after-hours trading as it announced a regulator development for its cell therapy. 1 February 2024
Biosimilars
The US Food and Drug Administration (FDA) yesterday released the Revised Biosimilar User Fee Amendment (BsUFA) Research Roadmap to provide updated information about the biosimilar regulatory science research pilot program research priorities. 1 February 2024
Pharmaceutical
All ongoing clinical trials in the European Union (EU) must be transitioned to the Clinical Trials Information System (CTIS) by January 31, 2025. 31 January 2024
Pharmaceutical
Private company Defender Pharmaceuticals has had its submission for a new motion sickness treatment rejected by the US Food and Drug Administration. 31 January 2024
Biotechnology
UK pharma major GSK today announced that its Omjjara (momelotinib) has now been granted Marketing Authorization (MA) in Great Britain by the Medicines and Healthcare products Regulatory Agency (MHRA), following approval by the European Commission earlier this week. 31 January 2024
Pharmaceutical
Indian drugmaker Orchid Pharma's antibiotic drug Exblifep (cefepime/enmetazobactam) has received approval from the European Medicines Agency (EMA), leading to a 20% surge in the company's stock. 30 January 2024
Biotechnology
Britain’s medicines regulator has approved a novel antibiotic developed by Cidara Therapeutics, a biotechnology company based in San Diego, California. 30 January 2024
article
Following on from its recent approval of Hyqvia (immune globulin) in Europe, Japanese pharma major Takeda has picked up a US approval for another CIDP product. 30 January 2024
Pharmaceutical
Having first authorized US pharma giant Pfizer’s (NYSE: PFE) Paxlovid (nirmatrelvir and ritonavir) for emergency use, the US Food and Drug Administration (FDA) is now making another amendment. 30 January 2024
Pharmaceutical
Takeda has secured European approval for Hyqvia (immune globulin) as maintenance therapy for people with chronic inflammatory demyelinating polyneuropathy (CIDP). 29 January 2024
Biotechnology
The European Commission (EC) has granted marketing authorization for Omjjara (momelotinib), a once-a-day, oral JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor. 29 January 2024
Biotechnology
The US supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) has been accepted and granted Priority Review for patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+) solid tumors who have received prior treatment or who have no satisfactory alternative treatment options. 29 January 2024
Biosimilars
The US subsidiary of South Korea’s Celltrion is the latest to file for US approval of a biosimilar version of Swiss pharma giant Roche’s Actemra (tocilizumab). 29 January 2024
Pharmaceutical
Swedish pharma trade body Lif has welcomed a decision from authorities regarding the reimbursement model for innovative antibiotics. 29 January 2024
Biotechnology
New clinical trial data last week saw the shares of USA-based Gilead Sciences fall significantly as the company released disappointing Phase III results on its Trodelvy for lung cancer. Meanwhile, Ionis Pharma announced positive Phase III data on its donidalorsen for the treatment of hereditary angioedema (HAE). On the regulatory front, Legend Biotech announced in a Stock Exchange filing that the US Food and Drug Administration (FDA) is planning to convene an advisory committee meeting to review its cell therapy Carvykti, which is being developed with Johnson & Johnson. Also of note, Dutch firm LAVA Therapeutics attracted positive investor support, with its shares rising 43%, following the news of a research collaboration with US pharma giant Merck & Co to trial its prostate cancer candidate LAVA-1207 in combination with Keytruda. 28 January 2024
Biotechnology
The US Food and Drug Administration has approved Dupixent (dupilumab) for the treatment of children with eosinophilic esophagitis. 26 January 2024
Biotechnology
New information from senior executives at the US Food and Drug Administration casts light on its recent decision to apply a black box warning to certain CAR-T cell therapies. 26 January 2024
Pharmaceutical
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended two novel medicines for approval at its January 2024 meeting, but rejected two others. 26 January 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
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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