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
Danish diabetes care giant Novo Nordisk today announced positive headline results from the main phases of ONWARDS 1 (52 weeks) and ONWARDS 6 (26 weeks) Phase IIIa trials with once-weekly insulin icodec, edging the firm’s shares up 1.35 to 779.9 kroner. 3 June 2022
US biotech major Gilead Sciences has announced that Stacey Ma will join the company as executive vice president, pharmaceutical development and manufacturing, and will become a member of the company’s senior leadership team, reporting to chairman and chief executive, Daniel O’Day. 3 June 2022
Japanese drug major Astellas Pharma’s subsidiary Xyphos Biosciences and Cambridge, Massachusetts-based GO Therapeutics have entered into a strategic research collaboration and license agreement to develop novel immuno-oncology therapeutics. 2 June 2022
Immatics Biotechnologies saw its American-traded shares rise just a modest 3.2% to $7.79 this morning, despite signing a multi-billion-dollar deal, albeit heavily back-loaded. 2 June 2022
Shares of Canada-based clinical-stage precision cancer drugs developer Repare Therapeutics were up 27.5% at $11.16 pre-market today, on the news of a worldwide license and collaboration agreement with Swiss pharma giant Roche for the development and commercialization of camonsertib (also known as RP-3500). 2 June 2022
China-based CNS drug developer SciNeuro Pharmaceuticals yesterday announced the execution of an exclusive, worldwide license and option agreement with UK pharma major GlaxoSmithKline. 2 June 2022
TauRx Pharmaceuticals, a company that claims to be the global leader in tau-based research in Alzheimer’s disease, has announced the unblinding of initial data from completion of the randomized portion of its pivotal Phase III trial, LUCIDITY. 1 June 2022
Belgian biotech Galapagos has announced that the UK's National Institute of Health and Clinical Excellence (NICE) has recommended the use of Jyseleca (filgotinib) for the treatment of adults with moderately to severely active ulcerative colitis (UC) when other treatments have not been successful. 1 June 2022
Sage Therapeutics rose as much as 10% to $34.81 after, along with partner Biogen, it announced that the Phase III SKYLARK Study of zuranolone, an investigational oral drug being evaluated in women with postpartum depression (PPD), met its primary and all key secondary endpoints. 1 June 2022
Shares of US biotech TG Therapeutics were down more than 9% at $4.35 by mid-afternoon today, after it announced that the US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date to December 28, 2022, for the Biologics License Application (BLA) for ublituximab as a treatment for patients with relapsing forms of multiple sclerosis (RMS). 1 June 2022
Investment in artificial intelligence (AI) is on the increase in the pharma industry due to its capacity to drive efficiencies and innovation. 1 June 2022
US pharma major Bristol-Myers Squibb has become the first foreign pharmaceutical manufacturer that has decided to leave Russia due to the ongoing military conflict and associated with the sanctions imposed on Russia. 1 June 2022
Swedish Orphan Biovitrum (Sobi) and French pharma major Sanofi have been awarded Breakthrough Therapy designation in the USA, for efanesoctocog alfa (BIVV001). 1 June 2022
With media and politicians calling attention to the problem of rising drug prices, it’s important to remember one fact: Generic and biosimilars represent the only segment of health care in the USA that consistently reduces costs, noted the USA’s Association for Accessible Medicines (AAM). 1 June 2022
Korean biosimilar company Samsung Bioepis is presenting new data on its copy of Humira (adalimumab), which is branded as Imraldi and Hadlima and also referred to as SB5, at the Annual European Congress of Rheumatology (EULAR 2022). 1 June 2022
US biotech Biohaven Pharmaceutical migraine nasal spray zavegepant is set to generate annual sales of $206.8 million in the USA following the potential approval of its new drug application (NDA), which was received by the Food and Drug Administration (FDA) last week. 1 June 2022
In a letter to shareholders, Takeda Pharmaceutical chief executive Christophe Weber has explained that drug manufacturers may be forced to cut prices in the near term. 1 June 2022
Global drugmakers and their Russian partners are losing their positions in the Russian market for anti-cancer drugs due to expiration of patent protection for a number of their drugs and their replacement by Russian-made generics, reports The Pharma Letter’s local correspondent. 1 June 2022
The USA’s Federal Trade Commission and the Department of Justice, Antitrust Division, will host a two-day virtual workshop to explore new approaches to enforcing the antitrust laws in the pharmaceutical industry. 1 June 2022
Bruised by its failure to enter the superlatively lucrative market for coronavirus shots, British drug developer GlaxoSmithKline is to spend billions boosting its vaccines business. 31 May 2022
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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.