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Pharmaceutical
The US Food and Drug Administration approved French privately-held drug major Servier’s vorasidenib, now trade named Voranigo, an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor, for certain types of brain tumors. 7 August 2024
Biotechnology
The US subsidiary of Swiss family-owned protein specialist Octapharma today revealed that the US Food and Drug Administration (FDA) has expanded the approval of fibryga, fibrinogen (human) lyophilized powder for reconstitution, for fibrinogen replacement in bleeding patients with acquired fibrinogen deficiency (AFD). 6 August 2024
Biotechnology
Actinium Pharmaceuticals’ shares closed down 60% yesterday and fell a further 10% to $2.23 in after-hours trading, when the company announced a regulatory setback for its Iead candidate. 6 August 2024
Biosimilars
The Biosimilars Council—part of the USA’s Association for Accessible Medicine (AAM) representing companies developing off-patent medicines—has provided an update on its activities on the regulatory, legislative and educational fronts. 5 August 2024
Pharmaceutical
US rare disease drug focussed company Zevra Therapeutics saw its shares rise nearly 43% to $9.00 in after-hours trading on Friday as it announced a positive development for its arimoclomol. 5 August 2024
Biotechnology
The US Food and Drug Administration (FDA) yesterday approved Jemperli (dostarlimab-gxly), from UK pharm major GSK. 2 August 2024
Biotechnology
Adaptimmune Therapeutics (Nasdaq: ADAP) has received Accelerated Approval from the US Food and Drug Administration (FDA) for Tecelra (afamitresgene autoleucel). 2 August 2024
Biotechnology
The US Food and Drug Administration (FDA) has approved a new indication for Darzalex Faspro, (daratumumab and hyaluronidase-fih) from US healthcare giant Johnson & Johnson. 31 July 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) submission for suzetrigine (VX-548). 31 July 2024
Pharmaceutical
Shares in North Carolina, USA-based vTv Therapeutics (Nasdaq: VTVT) have fallen over a quarter after the firm announced a clinical hold on its diabetes program. 30 July 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has given its approval to Alpha Cognition’s oral therapeutic, Zunveyl (benzgalantamine), for the treatment of Alzheimer's disease (AD). 30 July 2024
Pharmaceutical
Spanish drugmaker Grifols, one of the world’s leading producers of plasma-derived medicines, has announced that the US Food and Drug Administration (FDA) has approved an expanded label for Xembify, the company’s 20% subcutaneous immunoglobulin (SCIg), to include treatment-naïve patients with primary humoral immunodeficiencies (PI). 29 July 2024
Pharmaceutical
The US Food and Drug Administration’s (FDA) Office of New Drugs (OND), part of the Center for Drug Evaluation and Research (CDER), plays a pivotal role in advancing public health by facilitating access to novel, effective and safe drugs that address unmet clinical needs. 29 July 2024
Pharmaceutical
The US Food and Drug Administration (FDA) had approved its Leqselvi (deuruxolitinib) 8mg tablets for the treatment of adults with severe 29 July 2024
Pharmaceutical
Viking Therapeutics plans to advance its experimental weight loss injection into a late-stage trial earlier than expected. 26 July 2024
Biotechnology
An advisory panel of the US Food and Drug Administration has questioned the design of a trial for AstraZeneca’s (LSE: AZN) Imfinzi (durvalumab), while confirming that it met the primary efficacy goal. 26 July 2024
Biotechnology
Californian drugmaker BioMarin Pharmaceutical (Nasdaq: BMRN) has announced that the US Food and Drug Administration has approved a label expansion for Brineura (cerliponase alfa). 25 July 2024
Biosimilars
The US Food and Drug Administration (FDA) has issued a Federal Register notice, “Biosimilar Product Development Guidance; Establishment of a Public Docket; Request for Information and Comments.” 25 July 2024
Pharmaceutical
The US medicines regulator has issued a warning letter to Indian contract development and manufacturing organization (CDMO) Brassica Pharma for severe data integrity violations at its manufacturing facility in Thane. 24 July 2024
Pharmaceutical
The US Food and Drug Administration (FDA) announced it has approved Millicent’s Femlyv (norethindrone acetate and ethinyl estradiol), the first orally disintegrating tablet approved for the prevention of pregnancy. 24 July 2024
Pharmaceutical
On Thursday, the US Food and Drug Administration released a Drug Safety Communication warning that Veozah (fezolinetant), which is used to treat hot flashes due to menopause, can cause rare but serious liver injury. 13 September 2024
Biotechnology
The US Food and Drug Administration (FDA) has approved Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), the first and only PD-(L)1 inhibitor for subcutaneous (SC) injection for patients in the USA, Swiss pharma giant Roche subsidiary Genentech announced yesterday. 13 September 2024
Biotechnology
The US Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC). 12 September 2024
Pharmaceutical
Intercept Pharmaceuticals’ Ocaliva (obeticholic acid) will come under the microscope when the US Food and Drug Administration’s (FDA) Gastrointestinal Drugs Advisory Committee meets on Friday. 12 September 2024
Generics
The US Food and Drug Administration (FDA) yesterday announced revised final guidance for industry entitled, “ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA.” 12 September 2024
Biotechnology
Cartesian Therapeutics today announced that the US Food and Drug Administration (FDA) has granted Rare Pediatric Disease designation to Descartes-08 for the treatment of juvenile dermatomyositis (JDM). 9 September 2024
Biotechnology
ProKidney announced strategic updates to its Phase III program for rilparencel, an investigational treatment to potentially preserve kidney function in patients with type 2 diabetes and advanced chronic kidney disease (CKD). 9 September 2024
Pharmaceutical
Last week’s research news included French pharma major Sanofi releasing mixed Phase III results for it tolebrutinib in progressive multiple sclerosis. Also of note, US vaccine developer Vaxcyte announced strong early-stage trial results for its VAX-31 in pneumococcal disease. On the regulatory front, US drugmaker Travere Therapeutics gained full approval from the US Food and Drug Administration (FDA) for its kidney disease drug Filspari. US cancer drug developer IN8bio announced a prioritization of its R&D pipeline to focus on INB-100 in acute myeloid leukemia, along with a workforce cutback. 8 September 2024
Pharmaceutical
San Diego, USA-based Travere Therapeutics saw its shares close up more than 8% at $10.75 yesterday on positive news form the US regulator. 6 September 2024
Pharmaceutical
Shares in US biopharma Axsome Therapeutics, a biopharmaceutical company developing and delivering novel therapies for the management of CNS disorders, closed 7% higher on Wednesday. 5 September 2024
Pharmaceutical
Regulatory news last week included European Commission approval for Swiss drugmaker Basilea’s antibacterial Cresemba, triggering a milestone payment from partner Pfizer. On the research front, Neurocrine Biosciences released mixed results from a Phase II study of its NBI-1117568 as a treatment for schizophrenia. Also, Alnylam Pharmaceuticals reported new Phase III data on its vutrisiran in cardiomyopathy. Swiss pharma giant Novartis inked collaboration with Lindy Bioscience aiming to turn biologic drugs into at home injectables, US major Eli Lilly launched a single vial formulation of its fast selling obesity drug Zepbound at a price discount of around 50% compared with other GLP-1 medicines. 1 September 2024
Biotechnology
Emergent BioSolutions’ shares were up 16.44% at $10.37 pre-market on news of US regulatory clearance of its mpox vaccine. 30 August 2024
Biotechnology
Johnson & Johnson said yesterday that it has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) seeking the first approval of nipocalimab. 30 August 2024
Biotechnology
The US Food and Drug Administration on Monday revised the Emergency Use Authorization (EUA) for Invivyd’s Pemgarda (pemivibart) to limit its use to when the combined national frequency of variants with substantially reduced susceptibility to Pemgarda is less than or equal to 90%. 27 August 2024
Pharmaceutical
Last week’s research news featured a new study from Eli Lilly, showing tirzepatide – the active ingredient of its diabetes drug Mounjaro and obesity treatment Zepbound – can delay the onset of diabetes. On the financial reporting front, Denmark’s Lundbeck released strong first-half results and raised its full year guidance. A new company – Borealis Biosciences – emerged from stealth last week, with funding from Novartis and Versant Ventures. Also of note, US biotech major Regeneron had a setback, when the Food and Drug Administration (FDA) issued a complete response letter (CRL) regarding the biologics license application (BLA) for its multiple myeloma candidate linvoseltamab. 25 August 2024
Biotechnology
The US Food and Drug Administration (FDA) has scheduled a public meeting of key scientific advisors to discuss the use of predictive biomarkers for immune checkpoint inhibitors. 23 August 2024
Biosimilars
The USA’s Federal Trade Commission (FTC) said yesterday that it has submitted a comment supporting the Food and Drug Administration’s (FDA) draft guidance regarding interchangeable biosimilar drugs. 23 August 2024
Pharmaceutical
Liquidia Corporation announced Thursday that it has filed litigation in the US District Court of the District of Columbia (Case No. 1:24-cv-02428) that challenges the recent decision by the US Food and Drug Administration (FDA) to grant three-year new clinical investigation (NCI) exclusivity to Tyvaso (treprostinil) DPI.9.6. 23 August 2024
Biotechnology
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the biologics license application (BLA) for linvoseltamab.. 21 August 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has granted tentative approval of Liquidia Corp’s Yutrepia (treprostinil) inhalation powder to treat adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). 21 August 2024
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