10 October 2024 Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly.
Kees Melief, chief scientific officer of ISA Pharmaceuticals, provides an Expert View on why therapeutic cancer vaccines will be a success following many years of being out of favor. 3 September 2021
Shares in Forte Biosciences plummeted 81.6% to $5.25 pre-market today, after it revealed late Thursday that top-line data from its Phase II clinical trial of FB-401 for the treatment of atopic dermatitis failed to meet statistical significance. 3 September 2021
Shares of Swedish Orphan Biovitrum, also known as Sobi, jumped as much as 23.6% to 235 Swedish kronor early today, after the company revealed it has received a takeover bid. 3 September 2021
Ultomiris (ravulizumab) has now been approved in the European Union for expanded use to include children (with a body weight of 10 kg or above) and adolescents with paroxysmal nocturnal hemoglobinuria (PNH). 3 September 2021
Portugal’s largest drugmaker BIAL has agreed with Sunovion Pharmaceuticals to buy the rights to commercialize apomorphine sublingual film in the European Union (EU), the European Economic Area (EEA) and the UK. 2 September 2021
Swedish biotech pairing Alligator Bioscience and Scandion Oncology have concluded a research collaboration, describing its outcome as positive. 2 September 2021
A US Food and Drug Administration (FDA) review of a large clinical trial has led the agency to conclude that JAK inhibitors lead to an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death. 2 September 2021
Ardena, a Belgian pharmaceutical ctract development and manufacturing Organization (CDMO), says it has acquired Idifarma, a Spain-based contract manufacturer of niche and highly potent generic and innovative drugs. 2 September 2021
Precision BioSciences and UK biotech Tiziana Life Sciences have entered an exclusive license agreement to explore Tiziana's foralumab, a fully human anti-CD3 monoclonal antibody (MAb), as an agent to induce tolerance of allogeneic CAR T-cells to potentially improve the clinical outcome of CAR-T cell therapy. 2 September 2021
Japan’s largest drugmaker Takeda Pharmaceutical today revealed that the Phase III PANTHER (Pevonedistat-3001) study did not achieve pre-defined statistical significance for the primary endpoint of event-free survival (EFS). 2 September 2021
Brukinsa (zanubrutinib) has received approval from the US Food and Drug Administration (FDA) for the treatment of adult patients with Waldenström’s macroglobulinemia (WM). 2 September 2021
The US Food and Drug Administration (FDA) has approved long-acting atypical antipsychotic Invega Hafyera (six-month paliperidone palmitate), the first-and-only twice-yearly injectable for the treatment of schizophrenia in adults. 2 September 2021
Research from industry analyst GlobalData underscores the dominance of two players in the cystic fibrosis (CF) space - Vertex Pharmaceuticals and AbbVie. 2 September 2021
Another coronavirus vaccine is moving towards the finishing line, as South Korean firm SK Bioscience announced the initiation of Phase III tests for its candidate, GBP510. 1 September 2021
GlaxoSmithKline has launched its shingles vaccine, Shingrix (zoster vaccine recombinant), in the UK. The vaccine will be available to purchase from pharmacies and private healthcare practices, as well as through a national immunization program for people in their seventies. 1 September 2021
Merck & Co has announced a label update for Keytruda (pembrolizumab), the US pharma giant’s blockbuster anti-PD-1 therapy, for its indication in first-line advanced urothelial carcinoma (bladder cancer) in the USA. 1 September 2021
All signs point to an M&A boom in late 2021 and throughout 2022. In this episode, Lance Minor, principal and national co-leader of the life sciences practice at BDO, provides valuable insight into current and emerging trends in the biotech investing landscape. 1 September 2021
Danish dermatology specialist Leo Pharma has revealed plans to cut 200 jobs, marking the company’s fourth workforce reduction since 2022. 11 October 2024
Swiss generic and biosimilar medicines major Sandoz today announced that it has launched a generic paclitaxel formulation in the USA, the first generic to its reference medicine to be approved by the US Food and Drug Administration (FDA). 11 October 2024
California-based AI company Suki has raised $70 million in new funding to accelerate the growth of its AI-powered voice solutions in healthcare. 11 October 2024
Pfizer is to present initial findings from its CULTIVATE study of its sphingosine-1-phosphate (S1P) receptor modulator Velsipity (etrasimod) in Crohn’s disease (CD) at United European Gastroenterology Week 2024. 11 October 2024
Two US units of Israel’s Teva Pharmaceutical Industries have agreed to pay $450 million to resolve two matters that allege Teva violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA), the US Department of Justice (DoJ) announced yesterday. 11 October 2024
Switzerland-based KeyBioscience and US pharma major Eli Lilly have agreed to extend their collaboration on the development of dual amylin calcitonin receptor agonists (DACRA), a new class of potential treatments for obesity and related disorders. 11 October 2024
Booster Therapeutics, a biotechnology company pioneering a new class of proteasome activator medicines to treat neurodegenerative and other diseases, has launched with the support of a $15 million financing. 11 October 2024
South Korea’s Samsung Bioepis has released its Fourth Quarter 2024 Biosimilar Market Report, marking the seventh-edition of the Quarterly Biosimilar Market Report in the United States. 11 October 2024
German cancer specialist Immatics has announced the pricing of its $150 million public offering, with Jefferies, BofA Securities, and Leerink acting as joint book runners. 11 October 2024
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer and BioNTech's latest COVID-19 vaccine, Comirnaty (KP.2). 11 October 2024
In what Astella Pharma calls “a landmark decision for advanced bladder cancer patients,” the Japanese drugmaker gained approval in the UK for its treatment regimen. 10 October 2024
Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly. 10 October 2024
Pfizer released positive top line results from the final prespecified overall survival (OS) analysis of the TALAPRO-2 study of Talzenna (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with Xtandi (enzalutamide). 10 October 2024
Nanoscope Therapeutics says that, following a productive FDA meeting with the US Food and Drug Administration (FDA) for its clinical program evaluating MCO-010 for the treatment of retinitis pigmentosa (RP), the company will commence with submission of a Biologics License Application (BLA) in the first quarter of 2025. 10 October 2024
US healthcare giant Johnson & Johnson’s Tecvayli (teclistamab) has been recommended by the National Institute for Health and Care Excellence (NICE) as a first-line option to treat myeloma in England and Wales. 10 October 2024
Cancer start-up Black Diamond Therapeutics has announced a significant restructuring as part of its plan to focus resources on its lead drug, BDTX-1535. 10 October 2024