24 September 2024 Japan’s Daiichi Sankyo and Anglo-Swedish pharma major AstraZeneca were trading lower on Tuesday after announcing topline results from the TROPION-Breast01 study.
Italian biotech Genespire—which is developing off-the-shelf gene therapies for pediatric patients affected by genetic diseases—has announced the closing of a 46.6 million euros ($52 million) Series B financing. 25 September 2024
US biotech 2seventy bio and partner Bristol Myers Squibb today revealed that they will discontinue enrollment in its ongoing Phase III KarMMa-9 study. 25 September 2024
Amgen yesterday revealed that Tepezza (teprotumumab [genetical recombination]) has been approved for the treatment of active or high clinical activity score (CAS) thyroid eye disease (TED) in Japan. 25 September 2024
Eli Lilly's Kisunla has been approved in Japan for early symptomatic Alzheimer's disease, following its US approval in July 2024. Administered via IV infusion, it targets patients with mild cognitive impairment and dementia linked to amyloid pathology. Kisunla aims to slow cognitive and functional decline in AD patients 25 September 2024
Belgian drugmaker UCB (Euronext: UCB) has announced the presentation of new four-year data in patients with moderate to severe plaque psoriasis treated with bimekizumab, the company’s IL-17A and IL-17F inhibitor that is marketed as Bimzelx. 25 September 2024
Healthcare plan provider Centivo has raised $75 million in equity and debt financing to support its goal of offering affordable care to employees and their families. 25 September 2024
President Biden has said the USA will commit at least $500 million to support African countries in battling the ongoing mpox outbreak in Central and Eastern Africa. 25 September 2024
People affected Niemann-Pick disease, a rare and fatal genetic disorder, have waited a lifetime for an effective medicine. Now, in the space of a week, the US regulator has approved two. 25 September 2024
Rare disease firm bluebird bio has announced a company-wide restructuring aimed at cutting costs by 20% and achieving quarterly cash flow break-even by the second half of 2025. 25 September 2024
Wave Life Sciences has announced positive interim data from the ongoing Phase II FORWARD-53 study of WVE-N531, which is an exon skipping oligonucleotide being investigated in boys with Duchenne muscular dystrophy (DMD) who are amenable to exon 53 skipping. 25 September 2024
USA-based Generate:Biomedicines (Generate) today announced a multi-target collaboration with Swiss pharm giant Novartis to discover and develop protein therapeutics across multiple disease areas. 24 September 2024
The Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved Otsuka’s (TYO: 4578) Lupkynis (voclosporin) for the treatment of lupus nephritis (LN), an inflammation of the kidneys caused by systemic lupus erythematosus (SLE), an autoimmune disease 24 September 2024
CSL Vifor today announced that Japan’s Ministry of Health and Labor Welfare (MHLW) has granted its partner, Zeria Pharmaceutical marketing authorization approval for Veltassa (patiromer). 24 September 2024
The Pharmaceutical Research and Manufacturers of America (PhRMA) is continuing its legal challenge against the US government’s drug pricing reforms. 24 September 2024
BioAtla has granted an exclusive global license to Context Therapeutics for BA3362, a T cell-engaging antibody targeting solid tumors. 24 September 2024
Japan’s Daiichi Sankyo and Anglo-Swedish pharma major AstraZeneca were trading lower on Tuesday after announcing topline results from the TROPION-Breast01 study. 24 September 2024
Japanese drugmaker Taiho Pharmaceutical today announced it has obtained manufacturing and marketing approval from Japan’s Ministry of Health, Labor and Welfare (MHLW) for the oral heat shock protein (HSP) 90 inhibitor Jeselhy (pimitespib; development code: TAS-116), 40mg tablets for the indication of gastrointestinal stromal tumor (GIST) that has progressed after chemotherapy. 20 June 2022
A subsidiary of Japan-based Kyorin Holdings has signed a joint development and license agreement with cell-based medicine company CellGenTech over the latter firm’s genetically modified human adipocytes (GMAC) in Fabry disease. 20 June 2022
Nature Medicine has published final results from the Phase III SPR1NT trial of Zolgensma (onasemnogene abeparvovec) in spinal muscular atrophy (SMA). 20 June 2022
Swiss drugmaker Basilea Pharmaceutica has announced that the sales of the antifungal Cresemba (isavuconazole) by its license partner Pfizer in the Asia Pacific region, exceeded the threshold triggering the first sales milestone payment for this region of $1.25 million. 20 June 2022
In a filing with the US Securities and Exchange Commission, Clovis Oncology has revealed it will voluntarily withdraw part of the label for its PARP blocker Rubraca (rucaparib). 20 June 2022
UK clinical-stage Zura Bio Limited, founded in January this year, and JATT Acquisition Corp, a publicly-traded US special purpose acquisition company (SPAC) formed for the purpose of acquiring or merging with one or more businesses, have entered into a definitive business combination agreement. 20 June 2022
Over the years, cell therapy has become an essential treatment method for many incurable diseases, illnesses and injuries such as cancers, autoimmune diseases, spinal cord injuries, and neurological conditions. 20 June 2022
The continuous depreciation of the forint, the pandemic, and then the war in Ukraine has seriously endangered safe access to modern medicinal treatments, which is now exacerbated by the disproportionate and high special tax increase that may lead to unforeseen consequences, says the Hungarian pharma trade group Association of Innovative Pharmaceutical Manufacturers (AIPM). 20 June 2022
At its June 16, 2022, meeting in Amsterdam, the European Medicines Agency's (EMA) management board, among other items, heard an update about the implementation of the new EU regulation that reinforces EMA’s role in crisis preparedness and management for medicinal products and medical devices. 20 June 2022
Among significant news last week, US biotech Alnylam Pharmaceutical on Monday revealed that the Food and Drug Administration has approved its rare disease drug Amvuttra (vutrisiran). Japan’s Shionogi entered into a landmark collaboration to expand global access to its antibiotic cefiderocol. Swiss pharma giant Roche last Wednesday released new data on its Alzheimer’s disease candidate crenezumab that once again proved a failure. Also, rumors surfaced on Friday that US biotech Seagen is in talks with US pharma giant Merck & Co about a possible acquisition of the company with which it already has research collaborations. 19 June 2022
The US Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) meeting to discuss the case for approval of pimavanserin for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP) resulted in a decisive negative vote of 9 to 3, noting that the evidence presented does not support a conclusion that pimavanserin is effective for the treatment of hallucinations and delusions in the ADP population. 18 June 2022
As the COVID-19 pandemic has prompted multinational pharma corporations to adopt a ‘China Plus One’ strategy, Indian government officials are urging domestic players to take advantage of the opportunity to become a viable alternative to China. 18 June 2022
Market research firm Graphical Research has released an analysis indicating that the global biodefense market size is set to grow significantly through to 2028. 17 June 2022
Cardio-renal diseases specialist Renibus Therapeutics has announced positive interim data from its lead clinical candidate, RBT-1, from its randomized, placebo-controlled Phase II trial. 17 June 2022
US clinical-stage biotech Scholar Rock today announced new data from the Phase II TOPAZ trial extension period evaluating patient outcomes after 24-months of treatment, which support sustained and continued improvement with apitegromab (SRK-015) for non-ambulatory patients with Types 2 and 3 SMA receiving a spinal muscular atrophy (SMN) therapy. 17 June 2022
World Trade Organization (WTO) members unveiled a new package of trade accords late Thursday following a marathon negotiating session in Geneva, Switzerland, headlined by deals to create flexible intellectual property rules covering COVID-19 vaccines, as well as other trade issues such as global fishing subsidies. 17 June 2022
Switzerland-headquartered biotech Addex Therapeutics today announced that it has terminated the Phase IIb/III study evaluating dipraglurant as a potential treatment for dyskinesia associated with Parkinson’s disease (PD-LID) due to the slow recruitment of patients. 17 June 2022
Shares in Akero Therapeutics ended the day up over a fifth on Thursday, after the firm announced a deal with Pfizer, including a $25 million equity investment. 17 June 2022
The US Food and Drug Administration (FDA) has approved a supplemental indication for Imcivree (setmelanotide) injection for chronic weight management in adult and pediatric patients aged six years and older with obesity due to Bardet-Biedl Syndrome (BBS). 17 June 2022
Pharma can boast a major role in improving the quality of life of patients with diseases such as breast cancer and rheumatoid arthritis in Latin America, writes The Pharma Letter’s local correspondent. 17 June 2022
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Company Spotlight
Capricor Therapeutics is a clinical-stage biotechnology company focused on the discovery, development, and commercialization of first-in-class biological therapeutics for the treatment of rare disorders.