Latest Pharma and Biotech News
Biotechnology
15 October 2024 Danish CNS specialist Lundbeck today revealed that it has reached to acquire Longboard Pharmaceuticals.
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Pharmaceutical
Spanish dermatology specialist Almirall (BME: ALM) has announced the successful completion of the decentralized regulatory procedure in Europe for efinaconazole. 15 October 2024
Pharmaceutical
French biopharma company Inventiva has announced financing of immediately 94.1 million euros ($103 million) and up to 348 million euros, subject to satisfaction of specified conditions. 15 October 2024
Biotechnology
Antibody-drug conjugates (ADCs) represent a transformative class of cancer therapy that combine the targeting ability of antibodies with the cell-killing potential of cytotoxic drugs. 15 October 2024
Biosimilars
Celltrion today announced two-year results of subcutaneous infliximab (CT-P13 SC) dose escalation therapy at United European Gastroenterology (UEG) Week 2024 in Vienna, Austria. 15 October 2024
Pharmaceutical
Canada-based biotech Sernova (TSX: SVA) has announced key new appointments to its executive leadership team. 15 October 2024
Biotechnology
Danish CNS specialist Lundbeck today revealed that it has reached to acquire Longboard Pharmaceuticals. 15 October 2024
Biotechnology
At last month’s European Academy of Dermatology and Venereology (EADV) congress in Amsterdam, Novartis presented new early and long-term Phase III data for remibrutinib in chronic spontaneous urticaria (CSU). 14 October 2024
Biotechnology
GSK released positive headline results from two Phase III clinical trials, ANCHOR-1 and ANCHOR-2. 14 October 2024
Biotechnology
A recent study published in The New England Journal of Medicine has detailed seven cases of blood cancer in patients treated with the gene therapy Skysona (elivaldogene autotemcel). 14 October 2024
Biotechnology
UK pharma major AstraZeneca and Japanese drugmaker Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has won conditional approval in China. 14 October 2024
Biotechnology
French biotech Innate Pharma has appointed Jonathan Dickinson as its new chief executive (CEO) and chairman of the executive board, effective November 1, 2024. 14 October 2024
Biotechnology
The US Food and Drug Administration (FDA) on Friday approved US pharma giant Pfizer’s Hympavzi (marstacimab-hncq). 14 October 2024
Biotechnology
Roche has presented positive two-year data from the ongoing RAINBOWFISH study assessing the efficacy and safety of Evrysdi (risdiplam) in children with spinal muscular atrophy (SMA) who were treated pre-symptomatically as infants before six weeks of age. 14 October 2024
Pharmaceutical
India's Central Drugs Standard Control Organization (CDSCO) has provided a favorable recommendation for its novel antibiotic Miqnaf (nafithromycin) discovered and developed for the treatment of community-acquired bacterial pneumonia (CABP) in adults. 14 October 2024
Biotechnology
Stealth BioTherapeutics has received a favorable vote from a US Food and Drug Administration advisory committee regarding its lead product, elamipretide. 14 October 2024
Biotechnology
Turnstone Biologics has announced a major restructuring of its operations, cutting its workforce by approximately 60%. 14 October 2024
Biotechnology
Boston, USA-based Upstream Bio, a biotech developing treatments for inflammatory diseases, with an initial focus on severe respiratory disorders, has made an impressive start to life as a public-listed company.00000 14 October 2024
Pharmaceutical
The Danish Medicines Council (Medicinrådet), responsible for evaluating and recommending new treatments for Denmark’s healthcare system, is facing a significant increase in processing times. 14 October 2024
Biotechnology
Shares of French biotech Transgene tumbled 13.5% to 1.01 euros by late morning after it announced that its randomized Phase II study to evaluate TG4001 in combination with avelumab versus avelumab alone in patients with recurrent or metastatic HPV16-positive cervical and anogenital tumors has not met the primary objective of the study (improvement in progression-free survival). 14 October 2024
Biotechnology
The US Food and Drug Administration (FDA) has approved a 2mL pre-filled syringe and pre-filled autoinjector, each containing 320mg of Belgian drugmaker UCB’s Bimzelx (bimekizumab-bkzx), to treat psoriasis. 14 October 2024
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Pharmaceutical
Pfizer released positive top line results from the final prespecified overall survival (OS) analysis of the TALAPRO-2 study of Talzenna (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with Xtandi (enzalutamide). 10 October 2024
Biotechnology
Nanoscope Therapeutics says that, following a productive FDA meeting with the US Food and Drug Administration (FDA) for its clinical program evaluating MCO-010 for the treatment of retinitis pigmentosa (RP), the company will commence with submission of a Biologics License Application (BLA) in the first quarter of 2025. 10 October 2024
Biotechnology
US healthcare giant Johnson & Johnson’s Tecvayli (teclistamab) has been recommended by the National Institute for Health and Care Excellence (NICE) as a first-line option to treat myeloma in England and Wales. 10 October 2024
Pharmaceutical
Cancer start-up Black Diamond Therapeutics has announced a significant restructuring as part of its plan to focus resources on its lead drug, BDTX-1535. 10 October 2024
Biosimilars
The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Applications for AVT03, a proposed biosimilar candidate to the Prolia and Xgeva (denosumab), submitted by Germany’s STADA Arzneimittel. 10 October 2024
Pharmaceutical
Beijing’s InnoCare Pharma has announced encouraging Phase II results for its novel TYK2 inhibitor, ICP-488, aimed at treating moderate-to-severe plaque psoriasis. 10 October 2024
Biotechnology
China’s Quantum Pharmaceuticals has announced a significant licensing agreement between its biologics-focused subsidiary, Ailux Biologics, and Johnson & Johnson. 10 October 2024
Biotechnology
USA-based Kezar Life Sciences announced this week that it was pausing its Phase IIb PALIZADE trial evaluating zetomipzomib in lupus nephritis (LN) following the deaths of four patients. 10 October 2024
Biotechnology
Advances in gene editing, such as the FDA approval of Vertex Pharmaceuticals’ Casgevy (exagamglogene autotemcel) in December 2023 for the treatment of beta thalassemia and sickle cell disease, have fueled significant interest in innovative epigenetic drugs. 10 October 2024
Pharmaceutical
GSK has reached a settlement with 10 plaintiff firms, resolving 93% of the Zantac (ranitidine) product liability cases it faced in state courts across the USA. 10 October 2024
Biotechnology
Gene therapy start-up GEMMA Biotherapeutics (GEMMABio) has announced a significant partnership with Brazil's Fiocruz, a key supplier for the Brazilian Ministry of Health. 10 October 2024
Biotechnology
Japanese drugmaker Ono Pharmaceutical has entered into a license agreement with South Korea’s LigaChem Biosciences. 10 October 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for Part 1 of the New Drug Application (NDA) for dasiglucagon. 10 October 2024
Generics
CMS released a Request for Information (RFI) and a sample list of prescription drugs that the agency preliminarily intends to include under the proposed Medicare $2 Drug List Model. 10 October 2024
Biotechnology
California’s Arda Therapeutics, a biotech focused on targeted cell depletion therapies for chronic diseases, has announced the successful completion of a $43 million Series A financing round. 9 October 2024
Biotechnology
Biogen revealed that felzartamab, an investigational anti-CD38 monoclonal antibody, has received Breakthrough Therapy designation. 9 October 2024
Biotechnology
German pharma major Bayer has announced the opening of its new life science incubator, Bayer Co.Lab Shanghai. 9 October 2024
Biotechnology
Purespring Therapeutics, a gene therapy company focused on transforming the treatment of kidney diseases, has raised £80 million ($105 million) in a Series B financing. 9 October 2024
Pharmaceutical
Sage Therapeutics’ share price fell 11% to $6 in pre-market activity on Tuesday, after it announced disappointing top-line results from LIGHTWAVE. 9 October 2024
Biotechnology
German family-owned pharma major Boehringer Ingelheim and USA-based Circle Pharma (have entered into a research collaboration and license agreement with the shared goal to develop a first-in-class cyclin inhibitor that can halt the growth of cancer cells potentially offering hope to those living with hard-to-treat cancers. 9 October 2024
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