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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Biotechnology
German cancer specialist Immatics has announced the pricing of its $150 million public offering, with Jefferies, BofA Securities, and Leerink acting as joint book runners. 11 October 2024
Biotechnology
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer and BioNTech's latest COVID-19 vaccine, Comirnaty (KP.2). 11 October 2024
Biotechnology
US vaccine company Gritstone bio has filed for bankruptcy. 10 October 2024
Biotechnology
In what Astella Pharma calls “a landmark decision for advanced bladder cancer patients,” the Japanese drugmaker gained approval in the UK for its treatment regimen. 10 October 2024
Pharmaceutical
Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly. 10 October 2024
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
All news
Biotechnology
US clinical-stage genetic meds company MeiraGTx Holdings has released positive top-line data from its clinical bridging study of AAV-GAD for the treatment of Parkinson’s disease, MGT-GAD-025. 15 October 2024
Pharmaceutical
Johnson & Johnson has reported revenue of $22.5 billion for the third quarter of 2024, a 5.2% increase year-over-year. 15 October 2024
Pharmaceutical
Novartis has discontinued an early Phase II trial of LTP001 in idiopathic pulmonary fibrosis (IPF). The company confirmed that the decision was not related to safety, with no issues emerging in the study. 15 October 2024
Biotechnology
Eli Lilly has released new data demonstrating more patients with moderately to severely active Crohn's disease treated with mirikizumab – Johnson & Johnson’s (NYSE: JNJ) Stelara -achieved histologic response at Week 52 compared to ustekinumab, regardless of prior biologic experience. 15 October 2024
Pharmaceutical
US pharma major Eli Lilly has announced plans to invest around 1.5 billion yuan ($206 million) into expanding its manufacturing facility in Suzhou, China. 15 October 2024
Biotechnology
In Hong Kong, Akeso Biopharma has successfully raised $250 million through a share placement, marking its second major fundraising effort of 2024. 15 October 2024
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
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