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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
Pharmaceutical
The American Gastroenterological Association (AGA) has recently released a major update to its clinical guideline for the pharmacological management of moderate-to-severe ulcerative colitis (UC). 2 April 2025
Pharmaceutical
Plenty of money changed hands in pharma M&A during March, with the biggest deal a $6.7 billion merger between Mallinckrodt Pharmaceuticals and Endo, after the pair emerged from bankruptcy processes linked to liabilities over the US opioid crisis. 2 April 2025
Pharmaceutical
Boehringer Ingelheim, now Germany's largest pharma company, today reported a currency-adjusted 6.1% gain in full-year 2024 revenues, buoyed by its diabetes and lung drugs. 2 April 2025
Pharmaceutical
Freed from their former obligations to remain loyal to agency and state, a number of high-profile figures from the US Food and Drug Administration (FDA) have sounded the alarm about its direction of travel under Robert Francis Kennedy Jr (RFK Jr), the new Secretary of Health and Human Services. 2 April 2025
Biotechnology
US healthcare giant Johnson & Johnson’s venture capital arm has made its first investment in South Korea, leading a $20 million series B financing round for Prazer Therapeutics, a biotech focused on targeted protein degradation. 2 April 2025
Pharmaceutical
French drugmaker Sanofi has appointed Chris Corsico as its new global head of development, according to an internal company communication obtained by The Pharma Letter. 2 April 2025
Pharmaceutical
Danish biotech Gubra saw its share gains more than 8% to 448.00 kroner, after it announced positive results from the single ascending dose (SAD) Phase I clinical trial with the long-acting amylin analogue GUBamy (GUB014295). 2 April 2025
Pharmaceutical
UK-based clinical-stage biopharmaceutical company Cerevance has announced top-line results from the Phase II ASCEND trial of solengepras as an investigational monotherapy in patients with early, untreated Parkinson’s disease, that failed to meet the primary endpoint of the study. 2 April 2025
Biosimilars
The European Medicines Agency (EMA) announced it is exploring improvements to the development and evaluation of biosimilar medicines, while upholding strict European Union (EU) safety standards. 2 April 2025
Pharmaceutical
Japanese drugmaker Sumitomo Pharma said yesterday that it is divesting its Asian business to major Japanese trading house Marubeni for roughly 72 billion yen ($480 million) in a deal that forms part of its post-Latuda (lurasidone) turnaround efforts. 2 April 2025
Pharmaceutical
The European Medicines Agency (EMA) has granted Priority Medicine (PRIME) designation to radiprodil, an investigational, potent negative allosteric modulator selectively targeting the N-methyl-D-aspartate receptor subtype 2B (NR2B or GluN2B), for the treatment of GRIN-related neurodevelopmental disorder (NDD), from neurodevelopmental disorders company GRIN Therapeutics. 2 April 2025
Biotechnology
French biotech Transgene has named Simone Steiner as its new chief technical officer, in a move aimed at advancing the development and production of its virus-based immunotherapies. 2 April 2025
Pharmaceutical
Privately-held German radiopharmaceutical company Isotope Technologies Munich (ITM) has announced the appointment of Celine Wilke as chief medical officer (CMO), taking over from interim CMO Heike Oberwittler. 1 April 2025
Biotechnology
Family-controlled Spanish pharma company Esteve has signed a license and supply agreement with Eton Pharmaceuticals for global rights to Increlex (mecasermin), except for USA, paying an upfront of 4 million euros ($4.3million). 1 April 2025
Biotechnology
US biotech AIRNA has raised $155 million in series B funding to advance its lead RNA-editing therapy into human trials and expand its pipeline of genetic medicines targeting both rare and common diseases. 1 April 2025
Biotechnology
Olga Uspenskaya-Cado has been named chief medical officer (CMO) of VectorY Therapeutics, a privately-held Dutch biotech advancing vectorized antibody therapies for neurodegenerative diseases. 1 April 2025
Pharmaceutical
US drug developer Palatin Technologies announced that its BMT-801 Phase II obesity co-administration study met its primary endpoint and was highly statistically significant. 1 April 2025
Pharmaceutical
UK-based AI-first development company Isomorphic Labs revealed that it has raised $600 Million in its first external funding round. 1 April 2025
Pharmaceutical
Nuage Therapeutics, a Barcelona-based firm specializing in precision therapies for cancer, has appointed Stuart Hughes as chief executive and Vanessa Malier as chair of the board. Mr Hughes succeeds founding CEO Judit Anido, who will assist during the leadership transition. 1 April 2025
Biotechnology
US oncology biotech Inspirna is winding down after a decade of operations, according to a LinkedIn post from chief executive Usman Azam. 1 April 2025
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