Shares of Everest Medicines shot up 10% to HK$17.38 today, after it announced today that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has recommended Priority Review for the New Drug Application (NDA) of Nefecon, a new oral formulation of budesonide, for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of rapid disease progression. 30 December 2022
Japanese drugmaker Kyowa Kirin announced that Mitomycin C agent (mitomycin 2mg for ophthalmic topical use), licensed from India’s Intas Pharmaceuticals has been approved by Ministry of Health, Labor and Welfare (MHLW) for an adjunct to open glaucoma surgery in Japan. 29 December 2022
SpringWorks Therapeutics has completed the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for nirogacestat, an investigational gamma secretase inhibitor. 28 December 2022
Denmark’s LEO Pharma has won approval in Japan for Adtralza (tralokinumab) subcutaneous injection, for adults with atopic dermatitis in the second-line setting. 23 December 2022
Eli Lilly and ProQR Therapeutics have expanded their licensing and collaboration agreement focused on the discovery, development and commercialization of new genetic medicines. 22 December 2022
Japan-based Sosei Group, a leader in G protein-coupled receptor (GPCR) focused structure-based drug design (SBDD) and development, has been notified by US pharma giant Pfizer that the first subject in a Phase II clinical trial has been dosed with Pfizer’s candidate PF-07081532. 21 December 2022
AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) has picked up a new approval in Europe, as a monotherapy in gastric cancer. 19 December 2022
The US Food and Drug Administration (FDA) has lifted its partial clinical hold for patients under the age of 18 in studies evaluating lovotibeglogene autotemcel (lovo-cel) for sickle cell disease (SCD) by US biotech bluebird bio, whose shares were down 8.5% at $6.96 despite the positive development. 19 December 2022
The US Food and Drug Administration (FDA) on Friday approved AbbVie’s Vraylar (cariprazine) as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults. 19 December 2022
Hyderabad, India-based Biological E Limited (BE) says that its 14-valent paediatric pneumococcal conjugate vaccine (investigational pneumococcal polysaccharide conjugate vaccine PCV14) against S. pneumoniae infection has received approval from the Drugs Controller General of India (DCGI) for manufacture and commercialization in India. 17 December 2022
German biotech Evotec today said it has achieved further significant progress within its neuroscience collaboration with Bristol Myers Squibb. 16 December 2022
UK-based STORM Therapeutics, a clinical biotech discovering and developing small molecule therapies targeting RNA modifying enzymes for oncology and other diseases, has announced the successful completion of a $30 million Series B financing round. 14 December 2022
Japanese drugmaker Chugai Pharmaceuticals, which is majority-owned by Roche, says that the Intellectual Property High Court has rendered judgment to dismiss the plaintiff’s appeal filed on June 9, 2022, regarding generic drugs to an osteoporosis agent, active vitamin D3 derivative Edirol (eldecalcitol) Capsule 0.5µg/0.75µg. 14 December 2022
Today, Denmark-based companies Novozymes and Chr Hansen announced they have entered into an agreement to create a leading global biosolutions partner through a statutory merger of the two companies. 12 December 2022
The USA’s Institute for Clinical and Economic Review (ICER) has published its latest report on Unsupported Price Increases (UPI) of prescription drugs in the United States. 9 December 2022
Cell and gene therapy solutions provider Polyplus has acquired Xpress Biologics, a contract manufacturing and development organization (CDMO), with the goal of expanding its offering. 9 December 2022
Japanese pharma major Takeda has received a positive reimbursement decision from the UK’s health technology assessor, the National Institute for Health and Care Excellence (NICE). 9 December 2022
Icelandic firm Alvotech and Germany’s STADA are launching their Humira (adalimumab) biosimilar Hukyndra (adalimumab) in several European countries. 7 December 2022
The European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for review of US biotech major Biogen’s tofersen, an investigational drug for the treatment of superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). 5 December 2022
Trevi Therapeutics has announced significant milestones in its clinical programs for Haduvio (nalbuphine), an investigational therapy aimed at treating chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC). 4 October 2024
Italian pharma major Recordati saw its shares rise more than 5% to 52.00 euros in early trading, as it announced a deal to expand its portfolio of marketed rare disease medicines. 4 October 2024
Paris-based asset manager Kurma Partners has raised 140 million euros ($154 million), successfully completing the first closing of Biofund IV 4 October 2024
The European Medicines Agency’s pharmacovigilance committee, PRAC, has started a review of medicines containing finasteride and dutasteride following concerns regarding suicidal ideation (suicidal thoughts) and behaviors. 4 October 2024
Opioid Use Disorder (OUD) is a chronic neurological disorder that is described as the consequences associated with repeated, compulsive use of opioid drugs and prolonged self-administration of opioid drugs. 4 October 2024
Proposals from the National Health Service (NHS) England have been set out for a phased launch of Eli Lilly’s obesity injection Mounjaro/Zepbound (tirzepatide) at the start of a consultation. 4 October 2024
Aspire Pharma, a UK-based niche generics business, has announced the acquisition of all assets from Canute Pharma, further expanding its product range. 4 October 2024
Bristol Myers Squibb has received a new approval from the US Food and Drug Administration for its blockbuster checkpoint blocker, Opdivo (nivolumab). 4 October 2024
Singapore’s Agency for Science, Technology and Research (A*STAR) and US biotech incubator Flagship Pioneering have agree to collaborate on advancing health and sustainability outcomes in Singapore and the broader Asia Pacific region. 4 October 2024
The US Food and Drug Administration (FDA) has removed the partial clinical hold on delpacibart etedesiran (del-desiran/AOC 1001), an investigational treatment designed to address the root cause of myotonic dystrophy type 1 (DM1), under development by US biotech Avidity Biosciences . 4 October 2024
F2G’s September $100m funding round provides the company with crucial funds to
renavigate approval of its lead drug, olorofim. The substantial financing also
highlights the paucity of novel antifungal products in the clinic. 3 October 2024
The US Food and Drug Administration (FDA) has granted the Gilead Sciences subsidiary Kite a Regenerative Medicine Advanced Therapy Designation (RMAT) for Yescarta (axicabtagene ciloleucel) for adults with newly-diagnosed, high-risk large B-cell lymphoma (LBCL). 3 October 2024
The US Food and Drug Administration (FDA) has determined the shortage of tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been resolved. 3 October 2024
Israel’s Teva Pharmaceutical Industries and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, have announced a global licensing deal for the development of an anti PD-1 oncology biosimilar candidate. 3 October 2024
Caliway Biopharmaceuticals has successfully completed its initial public offering, raising NT$6.4 billion ($206 million), the largest IPO in Taiwan's biotech industry to date. 3 October 2024
Kedrion Biopharma has finalized an agreement with Germany-based Biotest for the long-term commercialization and distribution of Yimmugo (immune globulin) in the USA. 3 October 2024
US clinical-stage biotech Arcus Biosciences has entered into a clinical trial collaboration with AstraZeneca on renal cancer treatments. 3 October 2024
PeptiDream says that its wholly-owned PDRadiopharma subsidiary has entered into a strategic partnership with French nuclear medicines firm Curium. 3 October 2024
Abivax ABVX) today announced the results of an interim efficacy and safety analysis of an open-label maintenance (OLM) study that enrolled patients with ulcerative colitis (UC). 3 October 2024