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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
Important new data for the antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan-hziy) have been outlined ahead of their presentation at the annual meeting of the European Society of Medical Oncology (ESMO 22). 5 September 2022
Pharmaceutical
UK pharma major AstraZeneca says its Forxiga (dapagliflozin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, has been approved in China to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease (ESKD), cardiovascular (CV) death and hospitalization for heart failure (hHF) in adults with chronic kidney disease (CKD) at risk of progression with and without type-2 diabetes (T2D). 5 September 2022
Biotechnology
Important research news last week included Germany’s Bayer and US drug major Bristol Myers Squibb releasing new data at the European Society of Oncology (ESC) on their asundexian and milvexian, respectively. On the M&A front, last Tuesday Diurnal said it has agreed to an acquisition by US neurology specialist Neurocrine Biosciences, then on Thursday, Danish diabetes care giant Novo Nordisk announced a $1.1 billion deal to acquire Forma Therapeutics and its sickle cell disease drug candidate etavopivat. Also of note, Denmark’s Ascendis Pharma last week said it has filed for US Food and Drug Administration (FDA) approval for its hypoparathyroidism candidate TransCon PTH. 4 September 2022
Biotechnology
The US Food and Drug Administration (FDA) on Friday approved Imfinzi (durvalumab) in combination with gemcitabine and cisplatin for adult patients with locally advanced or metastatic biliary tract cancer (BTC). 3 September 2022
Pharmaceutical
The US Food and Drug Administration (FDA) has approved an update to the label of Bayer’s (BAYN: DE) Kerendia (finerenone), a nonsteroidal mineralocorticoid receptor antagonist. 2 September 2022
Biotechnology
The US Food and Drug Administration (FDA) this week approved both the Pfizer and BioNTech, and the Moderna omicron-specific booster against COVID-19. The European Medicines Agency (EMA) also recommended such approvals. 2 September 2022
Biotechnology
The US Food and Drug Administration (FDA) has approved Spevigo (spesolimab-sbzo), the first approved treatment option for generalized pustular psoriasis s (GPP) flares in adults, developed by German family-owned pharma major Boehringer Ingelheim. 2 September 2022
Pharmaceutical
Shares of US drugmaker Amneal Pharmaceuticals closed down 7.7% at $2.17 yesterday, after it announced submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for IPX203, a novel, oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules for the treatment of Parkinson’s disease (PD). 1 September 2022
Biotechnology
The US Food and Drug Administration (FDA) has approved French pharma major Sanofi’s Xenpozyme (olipudase alfa-rpcp) for the treatment of non-central nervous system (non-CNS) manifestations of the rare disease acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients. 1 September 2022
Biotechnology
Danish biotech firm Ascendis Pharma saw its shares gain 2.6% to $ 2.22 late-morning, as it moved a step closer to bringing second commercial product to market. 31 August 2022
Biotechnology
Outlook Therapeutics, a biopharmaceutical company working to develop and launch the first approved ophthalmic formulation of bevacizumab for use in retinal indications, has announced it has re-submitted its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for ONS-5010. 30 August 2022
Biotechnology
AstraZeneca's (LSE: AZN) Evusheld (tixagevimab and cilgavimab, formerly AZD7442), a long-acting antibody combination, has been approved in Japan for both prevention (pre-exposure prophylaxis) and treatment of symptomatic disease caused by SARS-CoV-2 infection. 30 August 2022
Biotechnology
The European Commission (EC) has approved Scemblix (asciminib) for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP), previously treated with two or more tyrosine kinase inhibitors (TKIs). 30 August 2022
Pharmaceutical
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published the 2022-2026 workplan of the initiative Accelerating Clinical Trials in the EU (ACT EU). 30 August 2022
Biotechnology
The US Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for efanesoctocog alfa (BIVV001) for the treatment of hemophilia A, a rare and life-threatening bleeding disorder. The target action date for the FDA decision is February 28, 2023. 30 August 2022
Biosimilars
Israeli generics giant Teva Pharmaceutical Industries announced that the European Commission (EC) has granted a Marketing Authorization for Ranivisio/FYB201 (ranibizumab), a biosimilar of the ophthalmology treatment Lucentis across all five indications in adults for which Lucentis is authorized. 29 August 2022
Biotechnology
Delaware, USA-based Incyte has announced that the US Food and Drug Administration (FDA) has approved Pemazyre (pemigatinib), a selective fibroblast growth factor receptor (FGFR) inhibitor, to treat adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement. 26 August 2022
Biotechnology
The UK’s Medicines and Healthcare Regulatory Agency (MHRA) has approved Sunlenca (lenacapavir) injection and tablets, in combination with other antiretrovirals, in adults with multi-drug resistant HIV infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen. 26 August 2022
Biotechnology
Nuvaxovid, the COVID-19 vaccine developed by US vaccines specialist Novavax (Nasdaq: NVAX), has today been granted an extension to its existing UK approval, for 12- to 17-year-olds. This extension has been authorized by the Medicines and Healthcare products Regulatory Agency (MHRA). 26 August 2022
Biotechnology
Franco-American biopharma Erytech Pharma lost 20% of its market value on Thursday. 26 August 2022
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