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Pharmaceutical
Shares of US ophthalmic drug developer Ocuphire Pharma were lifted 7.6% to $3.53 this morning, as the company updated on the development of its lead product candidate. 13 February 2023
Biotechnology
At the start of last week, US pharma major Bristol Myers Squibb pulled out of a licensing collaboration with Dragonfly Therapeutics on the development of the latter’s cancer drug candidate DF6002. UK pharma major GSK gained US Food and Drug Administration for its immune-oncology drug Jemperli for the treatment of endometrial cancer and an FDA advisory committee voted in favor of a clinical trial testing the drug in rectal cancer. There were a number of financial results releases, among which Anglo-Swedish drugmaker AstraZeneca posted fourth-quarter and full-year 2022 figures claiming that long-term investment in R&D is paying off. Also, the USA’s AbbVie announced financials on Thursday, with full-year guidance that warned its best-selling drug Humira will now be facing biosimilar competition in the USA. 12 February 2023
Biotechnology
The US Food and Drug Administration (FDA) has verbally informed US biotech Blueprint Medicines that it has placed a partial clinical hold on the Phase I/II VELA trial of BLU-222 due to visual adverse events (AEs) observed in a limited number of patients, the company announced on Friday, with the news pushing the firm’s shares down 7.9% to $40.80 pre-market. 11 February 2023
Biotechnology
Given the spate of non-conversions of accelerated approvals by the US regulator, there was good news yesterday for UK pharma major GSK regarding Jemperli (dostarlimab-gxly), as the company’s ambition is for the drug to become the backbone of its ongoing immuno-oncology-based R&D program. 10 February 2023
Biotechnology
US pairing Biogen and Sage Therapeutics have announced that the US Food and Drug Administration (FDA) has accepted the filing of a New Drug Application (NDA) for zuranolone in the treatment of major depressive disorder (MDD) and postpartum depression (PPD). 6 February 2023
Biotechnology
Genetic medicines company 4D Molecular Therapeutics has announced that its Fabry disease gene therapy program has been placed on clinical hold by the US Food and Drug Administration (FDA). 6 February 2023
Biotechnology
The US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) to expand the use of Takhzyro (lanadelumab-flyo) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in pediatric patients aged two to 6 February 2023
Biosimilars
Sandoz, the generics and biosimilars business unit of Swiss pharma giant Novartis that is soon to be spun out, today announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for proposed biosimilar denosumab. 6 February 2023
Biotechnology
Gilead Sciences’ shares closed up 3.8% at $84.50 on Friday, after the US biotech major revealed a new US regulatory approval for one of its core growth drivers in the cancer setting. 4 February 2023
Pharmaceutical
Having twice previously declined to approve two other products in the class, the US Food and Drug Administration has now granted marketing authorization for UK pharma major GSK’s Jesduvroq (daprodustat) tablets as the first oral treatment for anemia (decreased number of red blood cells) caused by chronic kidney disease in adults on dialysis. 3 February 2023
Generics
Mumbai, India-based generic drugmaker Lupin Limited revealed that it has received tentative approval from Food and Drug Administration (FDA), under the US President’s Emergency Plan for AIDS Relief (PEPFAR), for its New Drug Application for dolutegravir, emtricitabine and tenofovir alafenamide (DETAF) tablets. 1 February 2023
Biosimilars
Biologic products have revolutionized the treatment options for many diseases and typically carry favorable benefit–risk profiles compared with small molecule drugs. 31 January 2023
Biotechnology
Last Monday Japanese pharma giant Takeda announced a licensing deal with China’s Hutchmed for rights to the latter’s colorectal cancer drug Elunate (fruquintinib). On the research front, US pharma giant Merck & Co released new clinical data for its mega-blockbuster cancer drug Keytruda in two therapy settings – one positive and one missing its endpoint. Also, Ocuphire released top-line Phase II data on its diabetic retinopathy candidate APX3330 that failed to meet the primary endpoint of the study. There was also positive news for Merck &Co, with the US Food and Drug Administration granting a new indication for Keytruda as adjuvant treatment in lung cancer. 29 January 2023
Pharmaceutical
The US Food and Drug Administration (FDA) has granted accelerated approval to Jaypirca (pirtobrutinib) for relapsed or refractory mantle cell lymphoma (MCL) - a rare blood disorder - after at least two lines of systemic therapy, including a BTK inhibitor. 28 January 2023
Pharmaceutical
The US Food and Drug Administration (FDA) on Friday announced the approval of the investigational oral selective estrogen receptor degrader (SERD) Orserdu (elacestrant) for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. 28 January 2023
Biotechnology
On Thursday, the US Food and Drug Administration’s (FDA) Vaccine and Related Biological Products Advisory Committee (VRBPAC) met to discuss future vaccination regimens addressing COVID-19. 27 January 2023
Biotechnology
Yesterday the US Food and Drug Administration (FDA) granted yet another approval for Merck & Co’s mega blockbuster checkpoint blocker Keytruda (pembrolizumab, this time for adjuvant treatment following resection and platinum-based chemotherapy for stage IB (T2a ≥4 cm), II, or IIIA non-small cell lung cancer (NSCLC). 27 January 2023
Biotechnology
The US Food and Drug Administration (FDA) has approved the expanded indication for Enjaymo (sutimlimab-jome), the first and only treatment of hemolysis in adults with cold agglutinin disease (CAD), to include patients with or without a history of transfusions. 27 January 2023
Biotechnology
The US Food and Drug Administration yesterday revised the Emergency Use Authorization (EUA) for Evusheld (tixagevimab co-packaged with cilgavimab) to limit its use to when the combined frequency of non-susceptible SARS-CoV-2 variants nationally is less than or equal to 90%. 27 January 2023
Pharmaceutical
Pharma industry analyst GlobalData has highlighted the strength of data supporting a submission from US biotech Intercept Pharmaceuticals in non-alcoholic steatohepatitis (NASH). 26 January 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 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
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
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
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 US Food and Drug Administration (FDA) yesterday approved Abrysvo (respiratory syncytial virus vaccine). 23 October 2024
Biotechnology
Shares in Sangamo Therapeutics surged around 40% on Tuesday, following the announcement that the US Food and Drug Administration has granted the company a faster path to approval for its gene therapy ST-920 (isaralgagene civaparvovec) for Fabry disease. 23 October 2024
Pharmaceutical
Shares of Swedish drugmaker Camurus fell almost 10% to 588.50 kroner yesterday after it revealed that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the new drug application (NDA) for CAM2029 (octreotide) extended-release injection for the treatment of patients with acromegaly. 23 October 2024
Biosimilars
Iceland-based Alvotech and the US unit of Israel’s of Teva Pharmaceutical Industries today revealed that that the US Food and Drug Administration (FDA) has approved Selarsdi (ustekinumab-aekn) in a new presentation 22 October 2024
Biotechnology
Biotech firm Gilead Sciences has announced plans to voluntarily withdraw the US accelerated approval for Trodelvy (sacituzumab govitecan-hziy) for the treatment of adults with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor. 21 October 2024
Biotechnology
The US Food and Drug Administration has approved Vyloy (zolbetuximab-clzb), a claudin 18.2 (CLDN18.2)-directed cytolytic antibody, with fluoropyrimidine and platinum-containing chemotherapy, from Japanese drug major Astellas Pharma. 19 October 2024
Biotechnology
The US Food and Drug Administration (FDA) has placed a partial clinical hold on the two-stage, open-label, randomized Phase III trial, PRESERVE-003 (NCT05671510). 18 October 2024
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