Poolbeg Pharma has announced the strategic expansion of POLB 001, an innovative targeted therapy which blocks the p38 MAP kinase, into oncology. 16 January 2023
The US subsidiary of Indian generics major Zydus Lifesciences (formerly known as Cadila Healthcare) has received tentative approval from the US Food and Drug Administration (FDA) to market levomilnacipran extended-release capsules, 20mg, 40mg, 80mg and 120mg. 16 January 2023
The US Food and Drug Administration (FDA) says sit has signed the Agreement on Mutual Recognition between the Swiss Confederation and the United States of America Relating to Pharmaceutical Good Manufacturing Practice. 14 January 2023
Japanese drugmaker Kaken Pharmaceutical has announced a partnership with Axcelead Drug Discovery Partners to speed up novel drug discovery. 12 January 2023
London-listed drug formulation specialist Arecor Therapeutics has reached a key milestone in the development of the ready-to-use injectable AT307, triggering a payment from partner Hikma Pharmaceuticals. 12 January 2023
Airsupra (albuterol/budesonide) has been approved in the USA for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older. 11 January 2023
USA-based Alto Neuroscience has reported results from its Phase IIa study of ALTO-100, demonstrating clear evidence of efficacy and favorable safety in patients with major depressive disorder (MDD). 11 January 2023
Autoimmune disease specialist EVOQ Therapeutics has appointed David Giljohann as chief executive, replacing co-founder William Brinkerhoff, who has served as CEO since the company was established in 2016. 10 January 2023
The US regulator has accepted a new drug application (NDA) for vamorolone, submitted by Santhera Pharmaceuticals and ReveraGen BioPharma, with a decision expected by October 26. 9 January 2023
Metabolic and digestive disease specialist HighTide Therapeutics has raised $107 million in a series C financing led by China’s TCM Healthcare Fund, with money also from Yuexiu Fund and Yuthai Fund. 6 January 2023
Taipei, Taiwan-based biotech PharmaEssentia is expecting a regulatory nod in Japan, as soon as by June, for Besremi (ropeginterferon alpha-2b), for the treatment of the rare blood cancer polycythemia vera. 6 January 2023
US biotech major Biogen says that Dr Priya Singhal, currently head of global safety and regulatory sciences and interim head of research and development (R&D), has been promoted to the post of executive vice president, head of development. 5 January 2023
A milestone payment has been triggered in an ongoing collaboration between Cambridge, UK-based drug discovery firm PhoreMost and Germany’s Boehringer Ingelheim. 5 January 2023
Rare disease company Fulcrum Therapeutics has reappointed its founding chief executive Robert Gould to the top job, on an interim basis. 4 January 2023
Danish clinical-stage biotech NMD Pharma today announced that Mike Heffernan has been appointed as chairman of the board of directors, succeeding Patrick Vink, who has served as chairman since 2015. 3 January 2023
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted a supplemental biologics license application (sBLA) submitted by BeiGene for tislelizumab in patients with first-line unresectable or metastatic hepatocellular carcinoma (HCC). 1 January 2023
Denmark’s Novo Nordisk last week announced that the US Food and Drug Administration (FDA) has approved a new indication for Wegovy (semaglutide) injection 2.4mg, making it the first-and-only prescription anti-obesity medicine for teens with once-weekly dosing. 31 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