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.
Asklepios BioPharmaceutical (AskBio), a gene therapy company wholly-owned and independently operated as a subsidiary of Bayer, has announced a new strategic collaboration with Belief BioMed (BBM) to explore the potential for new gene therapies. 25 September 2024
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
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
The UK’s National Institute for Health and Care Excellence (NICE) has recommended abemaciclib in combination with endocrine therapy, within its marketing authorization, as an option for adjuvant treatment of hormone receptor-positive, HER2-negative, node-positive early breast cancer in adults whose disease is at high risk of recurrence, defined as pathological tumor involvement in: 17 June 2022
The Swiss parliament has failed to finance the government's plan to buy COVID-19 vaccines in 2023, forcing the cabinet to try to renegotiate contracts with Moderna and Pfizer/BioNTech’s for millions of doses of their vaccines, according to a report from Reuters. 17 June 2022
Iceland-based global pureplay biosimilars developer and manufacturer Alvotech announced that its ordinary shares and warrants will begin trading on the Nasdaq Stock Market on Thursday, June 16, under the new ticker symbols “ALVO” and “ALVOW”, respectively. 16 June 2022
UK drugmaker GSK has welcomed the decision from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to grant Innovation Passport designation to two of its oncology medicines. 16 June 2022
Recordati Rare Diseases, a US biopharma that forms part of the wider Italian group, has presented multiple positive data sets on Isturisa (osilodrostat) at the annual ENDO 2022 meeting in Atlanta, Georgia. 16 June 2022
US biotech Checkpoint Therapeutics today announced positive interim efficacy results from its registration-enabling clinical trial evaluating its anti-PD-L1 antibody, cosibelimab, in patients with locally advanced cutaneous squamous cell carcinoma (cSCC) who are not candidates for curative surgery or radiation. 16 June 2022
Swiss drugmaker Roche has announced the results of a trial run in collaboration with Banner Alzheimer’s Institute, the University of Antioquia in Colombia and the National Institute on Aging. 16 June 2022
Aqemia, a next-gen French pharmatech company leveraging artificial intelligence and quantum physics announced, today that it has entered a new research collaboration with pharma major Sanofi. 16 June 2022
Nuplazid (pimavanserin), which is approved for the treatment of Parkinson’s disease psychosis, could struggle to gain a new nod in Alzheimer’s after agency briefing notes revealed doubts over the developer’s submission. 16 June 2022
Following Tuesday’s scientific recommendation to approve Moderna’s coronavirus vaccine for older children, a panel of experts yesterday endorsed the jab for children as young as six months old. 16 June 2022
US biotech company Exelixis and Sweden’s BioInvent have entered into an option and license agreement focused on the identification and development of novel antibodies for use in immune-oncology (I-O) therapeutics. 16 June 2022
Danish CNS specialist Lundbeck announced that the results from the DELIVER study have been recognized for their importance for the scientific and medical community. The results from the clinical study with Vyepti (eptinezumab) were accepted for publication in the prestigious journal Lancet Neurology, one of the most cited medical journals within neurology. 16 June 2022
India's Central Drugs Standard Control Organization's (CDSCO) oncology/hematology Subject Expert Committee, which advises the drug regulator, has asked the local subsidiary of Swiss pharma giant Roche to submit the efficacy results of its Phase III trial on Tecentriq (atezolizumab), an anti-cancer drug. 16 June 2022
LifeArc and the UK Dementia Research Institute (UK DRI) have today launched a new partnership to accelerate development of new diagnostic tests, treatments, and devices from scientific research discoveries to benefit people with dementia, which around 900,000 people in the UK are living with. 16 June 2022
Japanese drugmaker Shionogi has signed an agreement with the National Health Service (NHS) to begin an innovative subscription payment model reimbursement of cefiderocol in England. 15 June 2022
Germany’s MorphoSys has entered into an equity participation agreement and license agreements to allow US biotech Human Immunology Biosciences (HIBio) to develop and commercialize MorphoSys’ felzartamab, an anti-CD38 antibody, and MOR210, an anti-C5aR1 antibody. 15 June 2022
Shares of Japanese drug major Shionogi closed down 5.6% at 6,493 yen today, despite revealing what it described as a “landmark” collaboration for access to its antibiotic cefiderocol, which is marketed under the trade name Fetroja. 15 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.