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
Following a European Medicines Agency recommendation in March, the European Commission has now granted formal approval for Carvykti (ciltacabtagene autoleucel, or cilta-cel), from Johnson & Johnson’s subsidiary Janssen. 26 May 2022
Indiana, USA-based drugmaker Eli Lilly is making a major investment in its home state, with a $2.1 billion project to expand its manufacturing footprint. 26 May 2022
Antios Therapeutics has been given the cold shoulder by erstwhile development partner Assembly Biosciences, after a clinical hold was placed on its hepatitis B program. 26 May 2022
French privately-held drugmaker Servier has announced that the US Food and Drug Administration (FDA) approved Tibsovo (ivosidenib tablets) in combination with azacitidine for the treatment of patients with newly diagnosed IDH1-mutated acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. 26 May 2022
Belgium-based biotech Galapagos has exercised its option to in-license novel drug targets for inflammatory bowel disease (IBD) discovered by Scipher Medicine’s Spectra platform. 26 May 2022
An exclusive licensing agreement has been agreed by SunRock Biopharma, a Spanish company that is developing a portfolio of innovative bispecific antibodies to treat incurable cancer, and UK-based oncology-focused drug development firm, Ellipses Pharma. 25 May 2022
Israel-based Teva Pharmaceutical Industries and US biotech AbbVie's Allergan unit reached a settlement worth $161.5 million to resolve claims the companies fueled an opioid epidemic in West Virginia. 25 May 2022
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has published a positive Final Appraisal Determination recommending Libtayo (cemiplimab). 25 May 2022
The world’s leading cancer conference kicks off in Chicago on Friday June 3, and for many industry participants, it will be the first time they have attended a medical meeting in person since the pandemic started over two years ago. 25 May 2022
Merck & Co’s blockbuster drug Keytruda (pembrolizumab) has been approved by the European Commission alongside chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery for adults with locally advanced or early-stage triple-negative breast cancer (TNBC) at high risk of recurrence. 25 May 2022
California, USA-based biotech Nymox Pharmaceutical saw its shares plunge as much as 64% yesterday, after it said it has received a Refusal to File (RTF) letter from the Food and Drug Administration on regarding the company's New Drug Application (NDA) for fexapotide triflutate, its candidate for the treatment of benign hyperplasia (BPH). 25 May 2022
China-based R&D service provider for the pharmaceutical and biotech industries Pharmaron Beijing has entered into a definitive asset purchase agreement to acquire the Coventry active pharmaceutical ingredients (API) manufacturing site in the USA from Noramco. 25 May 2022
US pharma major Eli Lilly closed more than 1% higher on Tuesday after announcing impressive results on mirikizumab in ulcerative colitis (UC) at Digestive Disease Week (DDW) 2022. 25 May 2022
An Expert View from Robert Wessman, chairman and CEO at global pharmaceutical company Alvogen, and founder and chairman at biopharma specialist, Alvotech. 25 May 2022
US pharma giant Pfizer has announced detailed results from two pivotal studies that make up the ELEVATE UC Phase III registrational program evaluating etrasimod, a once-daily, oral, selective sphingosine 1-phosphate (S1P) receptor modulator for the treatment of moderately-to-severely active ulcerative colitis (UC). 25 May 2022
The US Food and Drug Administration has accepted for priority review the Biologics License Application (BLA) submitted by CSL Behring, a subsidiary of Australia’s CSL Limited, for etranacogene dezaparvovec, an investigational gene therapy for the treatment of adults with hemophilia B. 25 May 2022
Positive results for nirogacestat would appear to validate Pfizer’s strategy of spinning out assets that fall outside of its strategic focus. 25 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.