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The nomination of Robert F Kennedy Jr — known as RFK Jr — for the role of US Secretary of the Department of Health and Human Services (HHS) President-elect Donald Trump sent shares in vaccine companies sharply downwards. 22 November 2024
Biotechnology
British pharma major AstraZeneca is facing challenges in its bid to secure full approval for its anticoagulant reversal therapy, Andexxa (andexanet alfa), in the USA. 22 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval of Ziihera (zanidatamab-hrii) 50mg/mL for injection for intravenous use, say the drug’s developer, Jazz Pharmaceuticals. 21 November 2024
Biotechnology
Astellas Pharma has been hit by bad news from the US Food and Drug Administration, which will not currently approve the firm’s request to supplement the label for Izervay (avacincaptad pegol). 21 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental Biologics License Application (sBLA) for Dupixent(dupilumab), Regeneron and partner Sanofi revealed late Friday. 18 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Syndax Pharmaceuticals’ Revuforj (revumenib). 18 November 2024
Biotechnology
Oxford, UK-based rare respiratory diseases focused AlveoGene today revealed it has been granted a Rare Pediatric Disease designation (RPDD) by the US Food and Drug Administration (FDA) for AVG-002, its novel, inhaled gene therapy for lethal neonatal surfactant protein B (SP-B) deficiency. 15 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval of PTC Therapeutics’ gene therapy for the treatment of AADC (aromatic L-amino acid decarboxylase) deficiency, making it the first-ever gene therapy approved in the USA that is directly administered to the brain. 14 November 2024
Biotechnology
Shares of US genetic meds company MeiraGTx Holdings were up 7% at $7.12 in early trading after it announced important developments along with its third-quarter 2024 financials, reporting a $0.54 per share loss. 13 November 2024
Pharmaceutical
Intercept Pharmaceuticals, now wholly owned subsidiary of Italy’s Alfasigma, today revealed that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) that addresses the supplemental New Drug Application (sNDA) for Ocaliva (obeticholic acid, OCA) seeking full approval for the treatment of indicated patients with primary biliary cholangitis (PBC) – a rare, progressive disease that disproportionally affects women. 12 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has removed the clinical hold on the Investigational New Drug (IND) application for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates, US vaccines developer Novavax revealed yesterday. 12 November 2024
Biotechnology
RAPT Therapeutics has announced the termination of its zelnecirnon program following regulatory concerns around safety. 12 November 2024
Biotechnology
On November 8, the US Food and Drug Administration approved Aucatzyl (obecabtagene autoleucel; obe-cel) from US biopharma Autolus Therapeutics' 11 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program, according to Sarah Wicks and James Valentine at US law firm Hyman, Phelps & McNamara. 11 November 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 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
Japan’s largest drugmaker Takeda Pharmaceutical is issuing a US recall for all doses of Natpara (parathyroid hormone) for Injection (25mcg, 50mcg, 75mcg, and 100mcg), 6 September 2019
Pharmaceutical
Cancer drugs currently account for 27% of all new drug approvals in the USA since 2010, a dramatic increase from the 4% share of the 1980s, according to a newly-completed analysis. 6 September 2019
Biotechnology
Shares of US biotech firm Magenta Therapeutics edged up more than 2% to $9.97, after it announced that the US Food and Drug Administration granted Regenerative Medicine Advance Therapy (RMAT) designation for MGTA-456, a one-time cell therapy for the treatment of multiple inherited metabolic disorders. 5 September 2019
Pharmaceutical
Two positive developments for Puma Biotechnology this week have lifted hopes for the potential of the firm’s sole product, the breast cancer therapy Nerlynx (neratinib). 5 September 2019
Pharmaceutical
Californian cardiorenal disease specialist Ardelyx announced positive results from the Phase III AMPLIFY study on Tuesday, sending shares in the firm up over 70%. 4 September 2019
Generics
Mylan might have to wait a while before launching, but that has not stopped investor excitement at the tentative US approval of its generic of Eli Lilly’s (NYSE: LLY) Alimta (pemetrexed). 30 August 2019
Biotechnology
A trio of hepatitis C regimens has been linked to cases of worsening function or failure of the liver. 29 August 2019
Biotechnology
The US Food and Drug Administration has granted Breakthrough Therapy designation for nirogacestat, an oral, selective, small molecule, gamma-secretase inhibitor, for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis, says USA-based biopharma firm SpringWorks Therapeutics. 29 August 2019
Pharmaceutical
Shares in Kyowa Hakko Kirin closed 3% up on Wednesday with news of the US Food and Drug Administration’s (FDA) approval of Nourianz (istradefylline) tablets as an add-on treatment to levodopa/carbidopa for Parkinson’s disease (PD). 28 August 2019
Biotechnology
US pharma major Eli Lilly saw its shares close up 2.07% at $111.78 yesterday, after it revealed that the US regulator had cleared its interleukin (IL)-17A-targeting antibody Taltz (ixekizumab) for a third indication. 27 August 2019
Biotechnology
Specialty pharma company US WorldMeds has had its supplemental Biologics License Application (sBLA) approved for Myobloc (rimabotulinumtoxinB) injection for the treatment of chronic sialorrhea in adults. 27 August 2019
Pharmaceutical
The US Food and Drug Administration yesterday announcing the availability of a draft guidance for industry titled, “Male Breast Cancer: Developing Drugs for Treatment." 27 August 2019
Pharmaceutical
On the regulatory front last week, there was a major setback for Sarepta Therapeutics on Monday, after the US Food and Drug Administration issued a complete response letter (CRL) for its Duchenne muscular dystrophy candidate Vyondys 53 (golodirsen). On a positive note, there was FDA approval for the TB Alliance’s pretomanid treatment-resistant tuberculosis (TB). Research news included that the NEPTUNE trial of AstraZeneca’s Imfinzi and tremelimumab had once again failed in lung cancer. 25 August 2019
Pharmaceutical
US ophthalmology specialist Clearside Biomedical was 44% down after an hour’s trading on Thursday. 22 August 2019
Biotechnology
The US Food and Drug Administration has accepted the New Drug Application (NDA) for zanubrutinib for priority review for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. 22 August 2019
Pharmaceutical
Privately-owned US drugmaker Alvogen has obtained marketing approval for Qsymia (phentermine and topiramate extended-release) from the South Korea Ministry of Food and Drug Safety (MFDS) in partnership with Vivus. 22 August 2019
Biotechnology
Eiger BioPharmaceuticals says that the US Food and Drug Administration has granted Breakthrough Therapy designation for peginterferon lambda (Lambda) for the treatment of hepatitis delta virus (HDV) infection. 22 August 2019
Biotechnology
The US Food and Drug Administration (FDA) has accepted Vertex Pharmaceuticals’ New Drug Application (NDA) for a triple therapy combination in cystic fibrosis (CF), and granted priority review to the submission. 20 August 2019
Biotechnology
The US Food and Drug Administration has seen enough from PharmaMar to accept a filing for an accelerated approval for lurbinectedin monotherapy as a treatment second-line small cell lung cancer. 20 August 2019
Pharmaceutical
The US Food and Drug Administration on Monday approved Xenleta (lefamulin) to treat adults with community-acquired bacterial pneumonia, in both oral and intravenous formulations. 20 August 2019
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