Latest Pharma and Biotech News
Pharmaceutical
25 November 2024 In what could be construed to be India's quest for pharmaceutical supremacy, a clarion call has been made for the country to set its indigenous standards.
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Biotechnology
Clinical-stage US CAR-T therapies developer Poseida Therapeutics saw its shares skyrocket 227% to $9.36 pre-market today, on the news of a proposed takeover by Swiss pharma giant Roche. 26 November 2024
Pharmaceutical
Shares in US biotech major Amgen were 11% lower early on Tuesday. 26 November 2024
Biotechnology
Replimune, a clinical-stage biotech focused on oncolytic immunotherapies, has announced plans to raise $125 million through a public offering. 26 November 2024
Biotechnology
Chinese gene therapy firm Kanglin Biotechnology has completed a $20 million series A financing round, with the money earmarked for KL003, an innovative treatment for blood disorders. 26 November 2024
Biotechnology
BRL Medicine, a Shanghai-based biotechnology company specializing in cell and gene therapies, has raised nearly 200 million yuan ($27 million) in a series B+ round led by CSPC Fund. 26 November 2024
Biotechnology
Italian oncology focused biotech Nerviano Medical Sciences yesterday announced that it has successfully negotiated with Germany’s Merck KGaA to buy back the full world-wide rights of NMS 293 (also known as NMS-03305293). 26 November 2024
Biotechnology
South African-Australian private equity firm LeapFrog Investments has announced the close of its fourth fund (Fund IV), with commitments and designated co-investments totalling $1.02 billion. 26 November 2024
Biotechnology
Pyxis Oncology has announced encouraging preliminary data from a Phase I trial of PYX-201, its lead antibody-drug conjugate (ADC), in solid tumors. 26 November 2024
Biotechnology
The Phase III SKYSCRAPER-01 trial has missed its primary endpoint, Swiss cancer giant Roche has reported. 26 November 2024
Pharmaceutical
Spanish HIV focused immunotherapies company AELIX Therapeutics, a spin-off of IrisCaixa, has announced the acquisition of its investigational assets related to the HTI therapeutic HIV vaccine by US antiviral specialist Gilead Sciences. 26 November 2024
Biotechnology
US biopharma Biohaven has provided an update regarding the taldefgrobep alfa development programs in spinal muscular atrophy (SMA) and obesity. 25 November 2024
Biotechnology
Cassava Sciences, a US biotech developing a novel, investigational treatment for Alzheimer’s disease (AD) dementia, was trading 83% lower at midday on Thursday. 25 November 2024
Pharmaceutical
Positive top-line results from the Phase III ZENITH study evaluating Winrevair (sotatercept-csrk) in adults with pulmonary arterial hypertension (PAH, WHO Group 1) functional class (FC) III or IV at high risk of mortality, were released today by US pharma giant Merck & Co. 25 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for belantamab mafodotin in combinations with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]) for multiple myeloma patients who have received at least one prior line of therapy. 25 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Imkeldi (imatinib) oral solution, the first oral liquid form of imatinib to treat certain forms of leukemia and other cancers, from privately-held US-Ireland-based pharmaceutical company Shorla Oncology. 25 November 2024
Pharmaceutical
Specialist pre-clinical contract research organization (CRO) and ion channel screening company Metrion Biosciences has announced the appointment of Lee Patterson as its new chief executive. 25 November 2024
Pharmaceutical
Levothyroxine, a widely prescribed treatment for hypothyroidism, may contribute to bone loss in older adults, according to new research presented at the Radiological Society of North America’s (RSNA) annual meeting. 25 November 2024
Biotechnology
Danish biotech Adcendo today announced the successful closing of an oversubscribed $135 million Series B financing round. 25 November 2024
Biotechnology
StemCyte, a subsidiary of StemCyte International, has secured approval from the US Food and Drug Administration for Regenecyte, a cord blood-derived stem cell therapy. 25 November 2024
Biotechnology
A patient in Neurogene’s ongoing Phase I/II trial for Rett syndrome—who was dosed on November 5 with 3E15 vg of NGN-401—has now died from a treatment-related serious adverse event (SAE). 25 November 2024
All news
Pharmaceutical
Announcing a range of cost-cutting measures, the chief executive of Swiss biotech Idorsia has said it will take “longer than originally planned” for Quviviq (daridorexant) to become a commercial success. 21 July 2023
Pharmaceutical
Following the success of the European Medicines Agency’s OPEN initiative in dealing with vaccines and treatments regulation during the height of the COVID19 pandemic, the EMA has now expanded the scope of the scheme to a wider range of medicines. 21 July 2023
Pharmaceutical
The Indian government is to make 'Schedule M' compulsory for medium, small, and micro enterprises (MSMEs) involved in drug manufacturing, to help in quality assurance and also reduce compliance burden in the pharmaceutical sector. 20 July 2023
Biotechnology
Swiss vaccine company LimmaTech Biologics has in-licensed technology from GSK to continue development and commercialization of a quadrivalent shigellosis vaccine candidate. 20 July 2023
Pharmaceutical
Johnson & Johnson has increased its 2023 sales and earnings estimates for a second consecutive quarter. 20 July 2023
Pharmaceutical
The US Federal Trade Commission and the Department of Justice have released a draft update of the Merger Guidelines, which describe and guide the agencies’ review of mergers and acquisitions to determine compliance with federal antitrust laws. 20 July 2023
Pharmaceutical
Not surprisingly given the negative opinion from the European Medicines Agency’s (EMA) human medicines committee (CHMP), the European Commission has followed guidance and has not granted marketing authorization for palovarotene, an investigational treatment for fibrodysplasia ossificans progressiva (FOP). 20 July 2023
Pharmaceutical
US healthcare conglomerate Johnson & Johnson and Japanese drugmaker Astellas have joined a growing list of companies and groups that are suing the US government over its Medicare price-setting policies. 20 July 2023
Biosimilars
Sandoz, the global generic and biosimilar medicines of Swiss pharma giant Novartis, today announced an investment of around $90 million at its site in Ljubljana, Slovenia, to establish a dedicated Sandoz Biopharma Development Center by 2026. 20 July 2023
Pharmaceutical
The Sosei Group Corporation has acquired Swiss biotech Idorsia’s pharma business in Japan and Asia Pacific, excluding China. 20 July 2023
Biotechnology
New data from Merck & Co will help push its flagship immunotherapy Keytruda (pembrolizumab) into earlier lines of treatment in cervical cancer. 20 July 2023
Biotechnology
The Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy designation (BTD) for the combination of fruquintinib and sintilimab (a PD-1 antibody). 20 July 2023
Pharmaceutical
Negotiations over the future of drug pricing in the UK are off to a rocky start, as the UK government seeks to sustain the high rebate rates in the current statutory regime. 20 July 2023
Biotechnology
Boston, USA-based biotech start-up Jnana Therapeutics has appointed Dr George Vratsanos as its chief medical officer and head of research and development. 20 July 2023
Generics
Prices for imported active pharmaceutical ingredients (APIs) are rising again in Russia after the decline in 2022. This year the growth is equivalent to by 40%-100% year-on-year due to the devaluation of the rouble and the need to use intermediaries for these procurements, reports The Pharma Letter’s local correspondent. 20 July 2023
Pharmaceutical
A new analysis of clinical research into selinexor suggests it could be an effective maintenance therapy for certain people with endometrial cancer. 19 July 2023
Pharmaceutical
Leading Russian patient communities have once again called on the state to increase public procurements of HIV drugs – in a move to prevent the risks of a shortage of antiretroviral (ARV) drugs in the second half of 2023, reports The Pharma Letter’s local correspondent. 19 July 2023
Pharmaceutical
A finger prick blood test shows promise in the ability to detect Alzheimer’s disease, according to research reported for the first time today at the Alzheimer’s Association International Conference (AAIC) 2023. 19 July 2023
Pharmaceutical
Zambon, a privately-owned Italian pharmaceutical company, has announced results from the Phase III PROMIS-I and PROMIS-II studies. 19 July 2023
Pharmaceutical
Brighton, UK-based infectious disease specialist Destiny Pharma today announced that Chris Tovey will join the company as chief executive (CEO) on September 1, 2023. 19 July 2023
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