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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
Biotechnology
San Francisco, USA-based inflammatory disease biotech Third Harmonic Bio saw its shares rocket almost 40% to $5.09 as the company revealed an orderly exit plan. 15 April 2025
Pharmaceutical
New research from consultancy Vital Transformation has shown the effects of US policy the Inflation Reduction Act’s (IRA) drug pricing provisions on biopharmaceutical investment, research and development (R&D). 15 April 2025
Pharmaceutical
US pharma major Bristol Myers Squibb yesterday disclosed that its Phase III ODYSSEY-HCM trial of Camzyos (mavacamten) did not meet its primary endpoints for treating non-obstructive hypertrophic cardiomyopathy (nHCM). 15 April 2025
Biotechnology
French pharma major Sanofi has shared new progress from its mid- to late-stage respiratory pipeline. 15 April 2025
Biosimilars
The US Food and Drug Administration (FDA) has designated Yuflyma (adalimumab-aaty) as an interchangeable biosimilar to AbbVie’s mega blockbuster drug Humira (adalimumab), to treat eight conditions, including Crohn's disease and ulcerative colitis. 15 April 2025
Biotechnology
German family-owned drug major Boehringer Ingelheim and Cue Biopharma have announced a strategic research collaboration and license agreement to develop and commercialize Cue Biopharma’s CUE-501 product candidate, a differentiated B cell depletion therapy for autoimmune diseases. 15 April 2025
Biotechnology
Spanish biotech Reveal Genomics has formed a strategic partnership with oncology firm Ona Therapeutics to support the clinical development of ONA-255, a novel antibody-drug conjugate designed to target therapy-resistant tumor cells in advanced solid cancers. 15 April 2025
Biotechnology
The atopic dermatitis (AD) treatment landscape is witnessing intensified competition with several novel therapies nearing market entry. While biologics like dupilumab have already transformed care, emerging drug classes such as OX40 inhibitors are showing promise in clinical trials. 15 April 2025
Pharmaceutical
US gastrointestinal (GI) and rare diseases specialist Ironwood Pharmaceuticals was trading 34% lower early Monday. 14 April 2025
Pharmaceutical
Japan’s RaQualia Pharma has announced the termination of the license agreement regarding a retinoic acid receptor agonist (tamibarotene/TM-411/SY-1425, between the USA’s Syros Pharmaceuticals and TMRC Co, a consolidated subsidiary of RaQualia. 14 April 2025
Generics
A Texan drug compounder cannot rely on federal law to avoid a lawsuit over copycat sales of a rheumatoid arthritis treatment, clearing the way for Zyla Life Sciences to pursue claims under state competition laws. 14 April 2025
Biotechnology
US sequencing firm PacBio is cutting jobs and reducing spending across its business as it braces for the financial impact of new global tariffs and growing uncertainty around federal research funding. 14 April 2025
Biosimilars
Shares of California-based Coherus BioSciences (Nasdaq: CHRS) rose more than 5% to $0.88 in pre-market activity today as it completed a transformative transaction. 14 April 2025
Pharmaceutical
US pharma giant Pfizer has announced that it is discontinuing development of danuglipron (PF-06882961), an oral glucagon-like peptide-1 (GLP-1) receptor agonist, which was being investigated for chronic weight management. 14 April 2025
Biotechnology
Dutch rare diseases biotech firm ProQR Therapeutics today announced the appointment of Dr Cristina Lopez Lopez as chief medical officer (CMO). 14 April 2025
Pharmaceutical
The Dutch Healthcare Authority (NZa) has published a report entitled From patent to competition – Analysis of expenditure and use of seven expensive medicines in hospital treatments. 14 April 2025
Biotechnology
The European Commission has approved Columvi (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified who are ineligible for autologous stem cell transplant (ASCT), Swiss pharma giant Roche announced this morning. 14 April 2025
Pharmaceutical
Japanese biotech Prism BioLab has entered a strategic partnership with AI drug discovery company Elix to accelerate the development of small molecule therapies for difficult-to-treat diseases. 14 April 2025
Biotechnology
Shares in US biotech Novavax fell more than 20% before the weekend, following remarks from health and human services secretary Robert F Kennedy Jr, who questioned the scientific basis of the company’s COVID-19 vaccine in a televised interview. 14 April 2025
Biotechnology
UCB, Belgium’s largest pharma company, has announced findings from a collection of real-world evidence studies to reaffirm the effectiveness and clinical impact of romosozumab, the only dual-acting osteoporosis treatment that increases bone formation and decreases bone resorption, around the world. 14 April 2025
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