The UK’s Medicines and Health Regulatory Agency (MHRA) has approved the combination of Opdivo (nivolumab) plus Yervoy (ipilimumab) for first-line treatment of unresectable malignant pleural mesothelioma. 6 August 2021
Korean company GC Pharma and Japan’s Tottori University have announced a worldwide licensing and collaboration agreement for the orally administrable chaperone drug of GM1 gangliosidosis (GM1). 2 August 2021
Pfizer has raised the price of Comirnaty, its COVID-19 vaccine, by more than a quarter and Moderna by more than a tenth in the latest EU supply contracts, the Financial Times reported today. 2 August 2021
The US Food and Drug Administration has updated the Emergency Use Authorization (EUA) for the investigational COVID-19 antibody cocktail REGEN-COV (casirivimab and imdevimab). 31 July 2021
The US Food and Drug Administration (FDA) has published a revision to its Manual of Policies and Procedures (MAPP), Generic Drug Labeling Revisions Under Section 505(j)(10) of the Federal Food, Drug, and Cosmetic (FD&C) Act. 27 July 2021
Bayer today announced Prof Dr Dominik Ruettinger as the new head of research and early development for oncology at its Pharmaceuticals Division, effective October 1, 2021. 26 July 2021
AgeX Therapeutics closed 7.3% higher at $1.50 on Friday, after the US biotech said that its previously-announced merger with privately-held peer LyGenesis has been called off. 24 July 2021
Novo Holdings has co-led a $55 million series A financing round funding Hemab, a company focused on next generation therapeutics for serious bleeding and thrombosis disorders. 22 July 2021
Spain’s largest drugmaker Almirall says it has received approval from the European Commission for Klisyri (tirbanibulin) for the topical treatment of actinic keratosis (AK) on the face or scalp in adults. 21 July 2021
Japanese drugmaker Kyowa Kirin says that its Crysvita (burosumab) has been approved for the option of self-administration in the European Union (EU) for the treatment of X-linked hypophosphatemia (XLH), a rare metabolic bone disease that impacts children and adults. 20 July 2021
Chicago-based specialty drug company Xeris Pharmaceuticals has agreed a deal with Tetris Pharma for the commercialization of Ogluo (glucagon) in Europe. 20 July 2021
Portuguese drugmaker BIAL and Slovenia-based Medis Pharmaceutical Company have entered into an exclusive partnership on two central nervous system drugs. 19 July 2021
Germany’s Merck KGaA has entered into a contract manufacturing agreement with Universal Corporation, Kenya, a subsidiary of India’s Strides Pharma Science, for the large-scale production of a new pediatric medication, once it has been registered. 15 July 2021
The Centers for Medicare and Medicaid Services (CMS) has begun the formal process to determine whether and to what extent Aduhelm (aducanumab) will be covered through Medicare. 13 July 2021
Global law firm Hogan Lovells said today it has secured an important victory before the Commercial Court of London, UK, for its client Acerus, a Canadian-based specialty pharmaceuticals company, against Recipharm Limited. 12 July 2021
Vor Biopharma, a cell therapy company pioneering engineered hematopoietic stem cell (eHSC) therapies combined with targeted therapies for the treatment of cancer, today announced a collaboration with Janssen Biotech, a unit of US healthcare giant Johnson & Johnson. 9 July 2021
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