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Biotechnology
The US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Sarclisa (isatuximab) alongside bortezomib, lenalidomide and dexamethasone (VRd) for transplant-ineligible newly diagnosed multiple myeloma (NDMM). 28 May 2024
Pharmaceutical
Russia has registered a new domestic drug, fluorothiazinone, which is intended for the treatment of bacterial infections caused by microorganisms resistant to antibiotics, reports The Pharma Letter’s local correspondent. 28 May 2024
Biotechnology
UK pharma major AstraZeneca’s chief executive Sir Pascal Soriot outlined ambitious plans to increase revenue by nearly 75% to $80 billion by 2030. On the research front, US healthcare giant Johnson & Johnson released positive new data on its Tremfya in the treatment of ulcerative colitis (UC), and US biotech Tango Therapeutics announced that it is discontinuing development of its investigational cancer drug TNG348 due to toxicity. Also of note, the US Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation for Cartesian Therapeutics’ myasthenia gravis candidate Descartes-8. 26 May 2024
Pharmaceutical
Following the release of an American Society of Clinical Oncology (ASCO) abstract on Thursday, Verastem Oncology’s shares were up 50% in aftermarket trading. 25 May 2024
Biosimilars
The European Commission (EC) has approved Omlyclo (CT-P39), an omalizumab biosimilar referencing Xolair. 24 May 2024
Pharmaceutical
The European Commission (EC) has approved the label update of both Nilemdo (bempedoic acid) and Nustendi (bempedoic acid / ezetimibe fixed-dose combination (FDC)), as treatments for hypercholesterolaemia (high levels of cholesterol) and to reduce the risk of adverse cardiovascular events. 24 May 2024
Generics
On Thursday, the US Food and Drug Administration’s (FDA0 Center for Drug Evaluation and Research published its fiscal year 2023 (FY23) Generic Drug User Fee Amendments (GDUFA) Science and Research Report. 24 May 2024
Biosimilars
The European Commission has presented European Union (EU) guidance on public procurement of medicines which is critical to improve the security of supply for patients and health systems. 24 May 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for Descartes-08. 22 May 2024
Biosimilars
Swiss generic and biosimilar medicines company Sandoz today announced that the European Commission (EC) has granted marketing authorization for Wyost (denosumab) and Jubbonti (denosumab), the first and only biosimilar versions of reference medicines Xgeva and Prolia in Europe. 22 May 2024
Biotechnology
A partial clinical hold affecting progress at Larimar Therapeutics has been lifted by the US Food and Drug Administration. 22 May 2024
Biotechnology
A new subcutaneous version of the checkpoint blocker Opdivo (nivolumab) could be approved earlier than expected, after the US regulator brought forward the date for a decision. 22 May 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for inavolisib. 21 May 2024
Biotechnology
The European Commission (EC) has decided not to adopt the European Medicines Agency’ human medicines committee CHMP's negative opinion of January 24, 2024 on the annual renewal of the conditional marketing authorization of Translarna (ataluren) and has returned the opinion to the CHMP for re-evaluation. 21 May 2024
Biosimilars
On Monday, the US Food and Drug Administration (FDA) approved Biocon’s Yesafili (aflibercept-jbvf) and Samsung Bioepis and Biogen’s Opuviz (aflibercept-yszy) as the first interchangeable biosimilars referencing Regeneron’s Eylea (aflibercept). 21 May 2024
Biotechnology
The US Food and Drug Administration (FDA) announced the final withdrawal of the approval of BridgeBio Pharma Truseltiq (infigratinib) for previously treated, unresectable locally advanced or metastatic cholangiocarcinoma. 20 May 2024
Pharmaceutical
Ireland is attracting fewer clinical trials than some European countries with similar populations and economic performances, according to a report by the Irish Pharmaceutical Healthcare Association (IPHA), which represents the research-based biopharmaceutical industry. 20 May 2024
Biotechnology
Shares of HLB Pharma plunged almost 30% to 67,100 won on Friday to their daily price floors, as the US Food and Drug Administration (FDA) rejected a new drug approval for rivoceranib, the Korean firm’s liver cancer treatment, according to a Korea Times report. 18 May 2024
Biotechnology
The US Food and Drug Administration has approved Imdelltra (tarlatamab-dlle) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. 17 May 2024
Pharmaceutical
Japanese drugmaker Ono Pharmaceutical has received supplemental approvals for the BRAF inhibitor Braftovi (encorafenib), and the MEK inhibitor Mektovi (binimetinib), when used in combination, in Japan for two new indications. 17 May 2024
Biotechnology
Moderna today received approval from the European Commission (EC) for its mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. 23 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
Biotechnology
Updated versions of the leading vaccines for coronavirus have been approved by the US Food and Drug Administration. 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
China's National Medical Products Administration (NMPA) has approved domestic biopharma firm Innovent Biologics’ Dupert (fulzerasib) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring KRAS G12C mutation who have received at least one systemic therapy. 22 August 2024
Biotechnology
Leqembi (lecanemab) has been granted a marketing authorization by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). 22 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
Generics
Swipha, a leading Nigerian pharmaceutical manufacturer, has received prequalification from the World Health Organization (WHO) for its sulfadoxine-pyrimethamine (SP) drug. 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
Pharmaceutical
Germany's pharmaceutical sector is on high alert for potential drug shortages, following China’s recent intensification of its espionage laws. 21 August 2024
Biotechnology
GSK (LSE: GSK) has received Breakthrough Therapy designation from the US Food and Drug Administration for GSK'227, an investigational B7-H3-targeted antibody-drug conjugate (ADC). 20 August 2024
Biotechnology
AstraZeneca (LSE: AZN) has announced that Fasenra (benralizumab) has picked up a new approval from China's National Medical Products Administration (NMPA). 20 August 2024
Biotechnology
The US Food and Drug Administration (FDA) has approved Lazcluze (lazertinib) in combination with Rybrevant (amivantamab-vmjw), from Janssen Biotech, for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC). 20 August 2024
Biotechnology
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has approved Padcev (enfortumab vedotin) for the treatment of adult patients with locally advanced or metastatic urothelial cancer. 20 August 2024
Biotechnology
The European Commission (EC) has granted conditional marketing authorization for Tepkinly (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. 20 August 2024
Biotechnology
BioNTech (Nasdaq: BNTX) and MediLink Therapeutics have resumed recruitment for their Phase I trial of BNT326/YL202, following the US Food and Drug Administration's decision to lift a partial clinical hold. 19 August 2024
Biotechnology
Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE: AZN) have announced regulatory advancements for Enhertu (trastuzumab deruxtecan), in the treatment of certain people with brease cancer. 19 August 2024
Biotechnology
The UK’s National Health Service (NHS) got off to a good start with the introduction of cell and gene therapies but it must do more to get ready for the arrival of the advanced therapies of the future, according to a new report for the Association of the British Pharmaceutical Industry (ABPI). 19 August 2024
Biotechnology
Last week’s research news included US biotech Avidity Biosciences releasing strong early-stage trial results for its Duchenne muscular dystrophy (DMD) candidate delpacibart zotadirsen (AOC 1044). On the regulatory front, the US Food and Drug Administration (FDA) approved Ascendis Pharma’s hypoparathyroidism drug Yorvipath. The FDA also granted approval for Gilead Sciences’ seladelpar, now trade-named Livdelzi, for the treatment of the rare liver disease PCB. Also of significant importance, the US Centers for Medicare and Medicaid Services (CMS) last week selected 10 drugs for the first cycle of negotiations for pricing under the Inflation Reduction Act (IRA). 18 August 2024
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