All articles by Vidya Sagar Maddela
Vidya Sagar Maddela
Pfizer secures EC approval for Hympavzi to treat Haemophilia A/B
Hympavzi is the first once-weekly subcutaneous treatment approved in the EU, for people with severe haemophilia B and the first to be administered via a pre-filled pen or syringe for people with severe haemophilia A or B
Bayer to develop and market Cytokinetics’ aficamten in Japan
Bayer will obtain rights to Cytokinetics’ aficamten in Japan, in exchange for around €70m in upfront and near-term payments, up to €490m in commercial milestone payments, along with tiered royalties on future sales
Sangamo gets FDA IND approval for ST-503 to treat neuropathic pain
ST-503 is an investigational epigenetic regulator intended to treat intractable pain due to idiopathic small fibre neuropathy (iSFN), a type of peripheral neuropathy, which leverages an adeno-associated virus (AAV) vector
Cardiovascular Researchers Dramatically Reduce Size and Severity of Stroke Using Antidiabetic Drug in Preclinical Models
Huntington Medical Research Institutes (HMRI) is a pioneer in scientific research with a 70-year track record of groundbreaking discoveries that have changed the world — from seatbelts to lifesaving diagnostic technology like the MRI
Aclaris to license Biosion’s two biologics assets for up to $940m
Aclaris will pay more than $40m in upfront payment, license fees and compensation for certain development costs, and up to $900m in regulatory and sales milestone payments, along with tiered royalties
Alkeus gets FDA Rare Paediatric Disease and Fast Track designations for gildeuretinol
The FDA Rare Paediatric Disease and Fast Track designations underscore significant unmet needs in Stargardt disease, which causes severe vision impairment in children and young adults, due to a defective ABCA4 protein
Vaderis Receives FDA Fast Track Designation for VAD044 for the Treatment of Hereditary Hemorrhagic Telangiectasia
HHT, an Orphan Disease, is the second most common inherited bleeding disorder in the world frequently causing severe disease burden, reduced life expectancy and impaired Quality of Life
Merck secures global licence of LaNova’s LM-299 for up to $3.2bn
Merck has been granted an exclusive licence to manufacture and commercialise LM-299 worldwide, in exchange for an upfront payment of $588m and additional milestone payments totalling up to $2.7bn
Azurity secures FDA nod for Danziten to treat chronic myeloid leukaemia
Danziten is a re-engineered formulation of Swiss drugmaker Novartis’ Tasigna (nilotinib), indicated for adults with Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) after prior therapy
BioNTech to acquire Chinese cancer drugmaker Biotheus for $800m
The acquisition will expand BioNTech’s footprint in China, with a local research and development hub that supports clinical trials, advanced biologics manufacturing facility, and add more than 300 Biotheus employees