8 October 2024 UK-based AviadoBio, a LifeArc Ventures portfolio company, and Astellas Pharma today announced an exclusive option and license agreement for AVB-101.
Today, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) – the expert committee that evaluates the value of medicines in in the country – published advice recommending Australia’s discount rate could be lowered between 3.5% - 4% to bring the country closer to other recommended international standards. This is down from the current 5%. 18 November 2022
The US Food and Drug Administration late yesterday approved Tzield (teplizumab-mzwv) injection to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients eight years and older who currently have stage 2 type 1 diabetes. 18 November 2022
The US Food and Drug Administration has approved the second interchangeable biosimilar insulin product to Lantus (insulin glargine), Eli Lilly’s Rezvoglar (insulin glargine-aglr). 17 November 2022
The European Commission today granted marketing authorization for Sino-American biotech BeiGene’s Brukinsa (zanubrutinib) for the treatment of adult patients with treatment-naïve or relapsed/refractory chronic lymphocytic leukemia (CLL), one of the most common types of leukemia in adults. 17 November 2022
Japanese drug major Takeda today revealed that the Phase III PhALLCON trial of Iclusig (ponatinib) for adult patients with newly-diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) met its primary efficacy endpoint in the frontline setting. 17 November 2022
French specialty vaccine company Valneva today announced the appointment of Dipal Patel as chief commercial officer (CCO) and management board member. 17 November 2022
The unexpected news of a positive Food and Drug Administration advisory committee vote yesterday sent US cardiorenal-focussed drugmaker Ardelyx’ shares surging 84.4% to $2.25 in pre-market trading this morning. 17 November 2022
Research from industry analyst GlobalData has identified challenges in the development of new CAR-T cell therapies for chronic lymphocytic leukemia (CLL). 17 November 2022
Japanese drug major Astellas Pharma today announced positive top-line results from the Phase III SPOTLIGHT clinical trial evaluating the efficacy and safety of zolbetuximab in combination with mFOLFOX6 (a combination regimen that includes oxaliplatin, leucovorin and fluorouracil). 17 November 2022
Germany’s Merck KGaA has announced an investment of more than 290 million euros ($302 million) in its biosafety testing capacity at Rockville, Maryland, USA. 16 November 2022
Due to the high-risk nature of drugs being developed for neurology diseases, most product launches in the recent history of Parkinson’s disease have been the result of strategic partnerships for marketing and sales, with few exceptions. 16 November 2022
Marking a second M&A deal this year, USA-based gene therapy company Kriya Therapeutics today announced the acquisition of a privately held biotechnology company Redpin Therapeutics, which is developing regulatable gene therapies for intractable diseases of the nervous system. 16 November 2022
Bonum Therapeutics, a biopharma using allosteric regulation to create conditionally active and less toxic medicines, has announced a $93 million Series A financing. 16 November 2022
Access to therapies used to treat major chronic diseases remains particularly limited in Central and Eastern Europe (CEE). Off patent medicines are often the first opportunity for patients to access the essential medicines they need, says Medicines for Europe, the trade body representing bakers of biosimilar and generic drugs. 16 November 2022
In a draft recommendation, the UK’s reimbursement agency has found in favor of three COVID-19 treatments, while sidelining several others. 16 November 2022
Cambridge, UK-based Napp Pharmaceuticals today announced that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted a marketing authorization application for rezafungin, a novel echinocandin in clinical development for the treatment of invasive candidiasis in adult patients. 16 November 2022
Positive top-line results from a trial in atopic dermatitis (AD) lifted shares in Californian biotech Arcutis Biotherapeutics around 4% on Tuesday. 16 November 2022
California’s Arda Therapeutics, a biotech focused on targeted cell depletion therapies for chronic diseases, has announced the successful completion of a $43 million Series A financing round. 9 October 2024
Purespring Therapeutics, a gene therapy company focused on transforming the treatment of kidney diseases, has raised £80 million ($105 million) in a Series B financing. 9 October 2024
Sage Therapeutics’ share price fell 11% to $6 in pre-market activity on Tuesday, after it announced disappointing top-line results from LIGHTWAVE. 9 October 2024
German family-owned pharma major Boehringer Ingelheim and USA-based Circle Pharma (have entered into a research collaboration and license agreement with the shared goal to develop a first-in-class cyclin inhibitor that can halt the growth of cancer cells potentially offering hope to those living with hard-to-treat cancers. 9 October 2024
Bayer has entered into a collaboration with MOMA Therapeutics to develop a small molecule oncology program using the latter’s proprietary KNOMATIC platform. 9 October 2024
The UK has launched a new Regulatory Innovation Office (RIO), with the goal of accelerating new technologies, particularly in sectors like biotech and healthcare, by reducing regulatory barriers. 9 October 2024
Calluna Pharma, a biotech focused on treating inflammatory and fibrotic diseases, has appointed Mark Gaffney as its new chief executive. 9 October 2024
Some two-and-a-half years after buying the Novo Holdings portfolio company ReViral and its respiratory syncytial virus (RSV) candidate sisunatovir in a deal worth up to $525 million, US pharma giant Pfizer may have signalled an early end to the pricey project. 9 October 2024
US pharma major Bristol Myers Squibb’s recent approval from the US Food and Drug Administration (FDA) for Cobenfy (xanomeline and trospium chloride) for the treatment of adults with schizophrenia is a win for the company. 9 October 2024
Cambridge, USA-based City Therapeutics has announced its launch with a vision to lead the future of RNA interference (RNAi)-based medicine. 9 October 2024
Zephyrm Bioscience, a Cayman Islands-based biotech, has filed for an initial public offering (IPO) in Hong Kong, seeking to raise additional capital to advance its cell therapy pipeline. 9 October 2024
Privately-held UK biotech Curve Therapeutics has announced the appointment of Rab Prinjha as chief research and development (R&D) officer. 9 October 2024
Genor Biopharma has announced plans for a significant merger with Edding Group, marking one of the first reverse takeovers involving a Hong Kong-listed biopharma company. 8 October 2024
UK-based AviadoBio, a LifeArc Ventures portfolio company, and Astellas Pharma today announced an exclusive option and license agreement for AVB-101. 8 October 2024
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Company Spotlight
A clinical-stage biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role.