US synthetic biology company Primordial Genetics has announced the launch of its proprietary RNA polymerases to advance safe, viable mRNA-based vaccines and therapeutics. 23 February 2023
Japan’s Ono Pharmaceutical has received Taiwan approval for Opdivo (nivolumab) as a neoadjuvant therapy combined with two platinum-based chemo drugs for resectable non-small cell lung cancer (NSCLC) free of EGFR or ALK mutations. 23 February 2023
UK-based Pharmanovia has expanded its neurology portfolio by acquiring certain rights to Sunosi (solriamfetol) from Axsome Therapeutics. 22 February 2023
The US subsidiary of Swiss biotech firm Octapharma has submitted a Biologics License Application Supplement (sBLA) to the US Food and Drug Administration (FDA) to expand the approval of wilate. 21 February 2023
Spanish drugmaker PharmaMar has announced it is closing the Phase III Neptuno trial with plitidepsin for the treatment of COVID-19 in hospitalized patients. 20 February 2023
French clinical-stage biotech Abivax today announced the appointment of Dr Sheldon Sloan as new chief medical officer, effective on March 1, 2023. 17 February 2023
The US Food and Drug Administration yesterday published a funding opportunity announcement (FOA) for fiscal year 2023 to support research projects that enhance biosimilar and interchangeable biological product development and regulatory science. 17 February 2023
In 2022, the European Medicines Agency (EMA) recommended 89 medicines for marketing authorization. Of these, 40 had a new active substance which had never been authorized in the European Union (EU) before. 16 February 2023
UK clinical-stage biotech Cerevance today announced an expansion of its Series B funding round with the addition of $51 million, bringing the total Series B financing to $116 million. 13 February 2023
British oncology and central nervous system (CNS) specialist Astex Pharmaceuticals has inked a new collaboration deal with Cardiff University’s Medicines Discovery Institute (MDI). 13 February 2023
Swiss pharma giant Roche’s US biotech subsidiary Genentech on Friday announced the construction of a new biologics manufacturing facility at its Oceanside, California, campus, marking the occasion with a ground-breaking ceremony. 13 February 2023
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of medicines containing pseudoephedrine following concerns about the risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), conditions affecting blood vessels in the brain. 10 February 2023
The US Food and Drug Administration (FDA) has approved Eylea (aflibercept) as the first pharmacologic treatment for preterm infants with retinopathy of prematurity (ROP), a leading cause of childhood blindness worldwide, says US biotech Regeneron, which out-licensed the drug to German pharma major Bayer. 10 February 2023
Indian drugmaker Lupin Limited says it has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application for glycopyrrolate Injection USP, a generic equivalent of Robinul Injection, 0.2mg/mL of Hikma Pharmaceuticals. 9 February 2023
A new biotech startup, LAmAb Biologics, has been founded with the goal of creating a first-in-class antibody in allergic rhinitis, otherwise known as hay fever. 9 February 2023
Swiss rare disease company Santhera Pharmaceuticals has secured a final reimbursement agreement with the French authorities for its Leber's hereditary optic neuropathy (LHON) therapy Raxone (idebenone). 8 February 2023
The British medicines regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA), has granted marketing authorization for Takeda’s dengue vaccine Qdenga. 8 February 2023
The Hellenic Association of Pharmaceutical Companies (SfEE) has announced that representatives of patient associations, the medical, academic and scientific community, and the pharma sector submitted to the Prime Minister and the Minister for Health their joint proposals to pursue the national dialogue on the creation of a modern and effective National Action Plan against Caner. 6 February 2023
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