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
Spanish dermatology specialist Almirall has entered into a licensing and research collaboration with Inserm Transfert, the private subsidiary of the French National Institute of Health and Medical Research (Inserm), to advance treatment options for vitiligo. 18 May 2022
Extending its leadership in coronavirus vaccines, New York’s Pfizer has widened its emergency authorization for Comirnaty in 5-11 year olds, to include a booster dose. 18 May 2022
US ultra-rare disease specialist Ultragenyx Pharmaceutical and gene and cell therapy company Abeona Therapeutics have announced an exclusive license agreement for AAV gene therapy ABO-102 (now UX111) for the treatment of Sanfilippo syndrome type A (MPS IIIA). 18 May 2022
Aprea Therapeutics saw its shares tank almost 30% to $0.68, after it revealed it has completed the acquisition of the privately-held USA-based biotechnology company Atrin Pharmaceuticals. 18 May 2022
The UK Medicines and Healthcare Regulatory Agency (MHRA) decision to grant a licence for Ongavia, a biosimilar to Lucentis (ranibizumab), said the product’s developer, Israeli generics giant Teva Pharmaceutical Industries. 18 May 2022
Indian pharmaceutical companies are concerned about the increase in warning letters and OAIs (official action indicated) from the US Food and Drug Administration, which could potentially delay product launches and can push up regulatory uncertainty and compliance costs. As the number of US FDA inspections increases, so does the number of good manufacturing practices ( 17 May 2022
Japanese drugmaker Kyowa Kirin has decided to build a new active pharmaceutical ingredient (API) manufacturing building (HB7 Building) at its Takasaki plant that is responsible for manufacturing biopharmaceuticals. 17 May 2022
French specialty vaccine company Valneva yesterday announced that it has received a notice from the European Commission (EC) of intent to terminate the advance purchase agreement (APA) for Valneva’s inactivated whole-virus COVID-19 vaccine candidate VLA2001. 17 May 2022
US pharma major AbbVie has announced an exclusive worldwide license option agreement with clinical-stage biotech Cugene for CUG252, a potential best-in-class Treg-selective interleukin (IL)-2 mutein, as well as other novel IL-2 muteins, for the potential treatment of autoimmune and inflammatory diseases. 17 May 2022
Today, abemaciclib becomes the first successful addition in England to adjuvant endocrine therapy for early breast cancer patients in nearly two decades, following the Medicines and Healthcare products Regulatory Agency (MHRA) approval. 17 May 2022
US biotech major Gilead Sciences yesterday announced the US Food and Drug Administration (FDA) has lifted the clinical hold placed on the company’s Investigational New Drug Application (IND) to evaluate injectable lenacapavir for HIV treatment and HIV pre-exposure prophylaxis (PrEP). 17 May 2022
Industry commentator GlobalData has presented an analysis outlining what it describes as an explosion of research in immuno-neurology over the last decade. 17 May 2022
USA-based clinical-stage biotech Elicio Therapeutics has entered into a clinical supply agreement with Regeneron Pharmaceuticals to evaluate the safety and efficacy of Elicio’s lead asset, ELI-002, an investigational KRAS-targeted cancer vaccine, in combination with Regeneron’s Libtayo (cemiplimab). 17 May 2022
Building on a licensing deal with AstraZeneca, British biotech RQ Biotechnolgoy has announced its launch, with a focus on developing antibody treatments and preventive therapies. 17 May 2022
Privately-held Icelandic biosimilars developer Alvotech Holdings has announced positive top-line results from a pharmacokinetic (PK) study for AVT04, its proposed biosimilar to Stelara (ustekinumab). 17 May 2022
Alzheimer’s disease (AD) is a progressive fatal neurological disorder and the most common cause of dementia primarily affecting the elderly population, with AD-associated dementia accounting for two-thirds of dementia cases in Japan. 17 May 2022
UK pharma major GlaxoSmithKline has presented data suggesting favorable long-term efficacy with single inhaler triple therapy (SITT) Trelegy (fluticasone furoate/ umeclidinium/vilanterol) Ellipta, compared to alternative triple therapies. 16 May 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.