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Biotechnology
Following the negative results of the COAST Phase III trial announced on 24 March, Australia-based Opthea announced has updated on its clinical program, including the termination of COAST (Combination of OPT-302 with Aflibercept Study) and accelerated top-line results from its second Phase III trial ShORe (Study of OPT-302 in combination with Ranibizumab) in patients with wet AMD. 31 March 2025
Pharmaceutical
The Center for Biologics Evaluation and Research (CBER), part of the US Food and Drug Administration, saw its top vaccine official pushed out of the post on Friday, according to people familiar with the matter, according to a Wall Street report. 29 March 2025
Pharmaceutical
Novo Nordisk’s two-year suspension from the Association of the British Pharmaceutical Industry (ABPI) for serious breaches of the ABPI Code of Practice has come to an end. 17 March 2025
Pharmaceutical
Israel-based radiopharma company Isotopia has launched Isoprotrace in Germany, supported by distribution partner DSD Pharma. 10 March 2025
Biosimilars
Japanese drugmaker Kyowa Kirin and Swiss generics and biosimilars giant Sandoz have won approval for the partial change of their rituximab biosimilar for the treatment of refractory nephrotic syndrome (frequently relapsing or steroid-dependent). 7 March 2025
Biotechnology
Swiss pharma giant Roche has announced the launch of the Roche Genentech Innovation Center Boston, USA, at Harvard’s Enterprise Research Campus in Allston which will further strengthen the long-standing partnership in areas such as disease biology, engineering, and artificial intelligence / machine learning. 7 March 2025
Biotechnology
US cell and gene therapy specialist Mustang Bio has announced the exit of the lease for its manufacturing facility in Worcester, Massachusetts, and concurrent divestment of certain fixed assets including furniture and equipment to an AbbVie unit for $1.0 million. 3 March 2025
Biotechnology
US health officials are reportedly reexamining a $590 million agreement awarded to Moderna for the development of its bird flu vaccine, according to sources cited by Bloomberg. The review is part of a broader government effort to scrutinize spending on mRNA-based vaccines, the technology behind Moderna’s COVID-19 shot. 28 February 2025
Pharmaceutical
Concerns over the vaccine scepticism of the new US Department of Health and Human Services (HHS) Secretary are only increasing as Robert F Kennedy Jr (RFK Jr) settles in to his new role. 27 February 2025
Pharmaceutical
Rare disease-focused biopharma Zevra Therapeutics has agreed to sell its Rare Pediatric Disease Priority Review Voucher (PRV) to an undisclosed buyer for $150 million. 27 February 2025
Biotechnology
Further to the announcement on January 2, 2025 on the potential combination of UK-listed Poolbeg Pharma and Austria’s HOOKIPA Pharma, the board of Poolbeg announced that it was informed yesterday that HOOKIPA has terminated discussions on the proposed combination of the two companies. 21 February 2025
Biotechnology
Reacting to press reports, Germany’s Merck KGaA has confirmed it is in advanced discussions with SpringWorks Therapeutics with the aim of acquiring the US biotechnology company. 11 February 2025
Biotechnology
Kite, a Gilead Sciences company, will share four posters that add to the growing body of evidence to support the clinical use of its chimeric antigen receptor (CAR) T-cell therapy portfolio, at the 7th European CAR T-cell Meeting, 6-8 February 2025, Strasbourg, France. 8 February 2025
Pharmaceutical
US Senate lawmakers on Tuesday morning voted to advance Robert F Kennedy Jr's nomination to lead the US Department of Health and Human Services (HHS). 4 February 2025
Biotechnology
Japan’s Eisai and US partner Biogen have announced today update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab (trade name Leqembi) as a treatment for early mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD) in the European Union. 3 February 2025
Pharmaceutical
UK pharma major AstraZeneca has scrapped its plans to invest £450 million in expanding ($559 million) to expand its vaccine plant in Speke, Liverpool, blaming a reduction in government support. 1 February 2025
Pharmaceutical
Evaxion Biotech has priced a public offering, seeking to raise $10.8 million before expenses, with closing anticipated tomorrow. 30 January 2025
Pharmaceutical
hVIVO, a fast-growing early-stage German contract research organization (CRO) has acquired two clinical research units from Clinical Research Services (CRS), in Mannheim and Kiel, Germany, for a total of 10 million euros ($10.5 million). 29 January 2025
Biosimilars
Swiss generic and biosimilar medicines firm Sandoz today announced it has filed an antitrust lawsuit in the USA against Amgen for extending and entrenching the dominant market position of its blockbuster medicine, Enbrel (etanercept), first approved by the US Food and Drug Administration (FDA) in 1998. 14 April 2025
Pharmaceutical
New regulations for running clinical trials in the UK have now been signed into law, the Medicines & Healthcare products Regulatory Agency (MHRA) announced on Friday. 14 April 2025
Pharmaceutical
According to the country’s trade group LIF, Sweden must be a driving force in the European Union (EU) to ensure that pharmaceuticals continue to be exempt from tariffs and that a negotiated solution with the US must be reached. 14 April 2025
Pharmaceutical
Deal-making news last week included US drug developer KalVista Pharma signing a licensing agreement with Kaken Pharma to market its investigational hereditary angioedema (HAE) drug sebetralstat in Japan. US biotech firm Cartesian Therapeutics released positive Phase IIb data on its Descartes-08 in myasthenia gravis. The US Appeal Court gave a favorable ruling on Indian drugmaker Sun pharmaceuticals’ alopecia drug Leqselvi. Also of note, the US Food and Drug Administration (FDA) last week approved Bristol Meyers Squibb’s checkpoint therapy Opdivo plus Yervoy. 13 April 2025
Biotechnology
US mRNA specialist Moderna has announced that the German Standing Committee on Vaccination (STIKO) has issued a recommendation for mRESVIA, the company’s RSV vaccine available in a pre-filled syringe (PFS). 11 April 2025
Pharmaceutical
Speculation about the US Administration’s views on the Pharmaceutical Benefits Scheme (PBS) has reconfirmed the sanctity of the PBS as the cornerstone of Australia’s healthcare system, the domestic pharma trade group stressed. 11 April 2025
Biotechnology
Johnson & Johnson has announced new data from an analysis modelling long-term progression free survival (PFS) in transplant eligible (TE) and transplant ineligible (TIE) newly diagnosed multiple myeloma (NDMM) patients given Darzalex (daratumumab)-subcutaneous (SC) therapy alongside bortezomib, lenalidomide and dexamethasone (VRd). 11 April 2025
Biotechnology
US biotech giant Amgen today announced a significant breakthrough with its global Phase III DeLLphi-304 clinical trial evaluating Imdelltra (tarlatamab-dlle). 11 April 2025
Pharmaceutical
The obesity drug market has experienced a seismic shift in recent years, with Novo Nordisk's Wegovy (semaglutide) and Eli Lilly's Mounjaro (tirzepatide) revolutionizing the way the condition is treated. 11 April 2025
Pharmaceutical
Indian drugmaker Sun Pharmaceutical shares were buzzing in trade on the last trading day of the week to April 11, rising as much as 5%. 11 April 2025
Pharmaceutical
The US Centers for Medicare & Medicaid Services (CMS) has announced action intended to preserve the core mission of the Medicaid program against a wider backdrop of wider cost-cutting under the regime of President Donald Trump. 11 April 2025
Pharmaceutical
US biopharma company Palatin Technologies is at risk of being removed from the NYSE American exchange after failing to meet minimum stockholders' equity requirements. 11 April 2025
Biotechnology
US biotech Oncolytics Biotech has entered into a funding agreement with institutional investor Alumni Capital, providing access to up to $20 million in equity financing over the next 15 months. 11 April 2025
Pharmaceutical
The UK’s National Institute for Health and Care Excellence (NICE) has recommended AstraZeneca’s Truqap (capivasertib) with fulvestrant as an option for around 1,100 adults with hormone receptor (HR)-positive HER2-negative breast cancer that has certain genetic mutations and has spread. 11 April 2025
Biotechnology
Australian biotech Opthea is cutting around two-thirds of its workforce, as the company moves to curb spending following the collapse of its lead program for age-related macular degeneration (AMD). 11 April 2025
Pharmaceutical
Swiss pharma giant Novartis has announced a planned $23 billion investment over five years in US-based infrastructure, ensuring all key Novartis medicines for US patients will be made in the USA. 11 April 2025
Pharmaceutical
US biotech Imbria Pharmaceuticals has raised $57.5 million in a series B financing round to fund a new mid-stage trial of its only pipeline drug, ninerafaxstat, for a form of heart muscle disease with limited treatment options. 11 April 2025
Biotechnology
Late Thursday, the US Food and Drug Administration revealed it is taking a ground-breaking step to advance public health by replacing animal testing in the development of monoclonal antibody (MAb) therapies and other drugs with more effective, human-relevant methods. 11 April 2025
Biotechnology
US biotech Atossa Therapeutics has entered into a research collaboration with China-backed Nona Biosciences, aiming to identify next-generation antibody therapies for breast cancer using Nona’s proprietary platform technology. 10 April 2025
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