Japan’s Eisai has launched the Parkinson’s disease treatment Equfina (safinamide) in South Korea. It is the first launch of Equfina in the Asian region outside of Japan. 1 February 2021
The European Commission has reversed its decision to trigger an emergency provision in the Brexit deal to control COVID-19 vaccine exports from the European Union that was announced on Friday
. 31 January 2021
The European regulator has released a safety update on BioNTech and Pfizer’s COVID-19 vaccine, Comirnaty, concluding that real-world data from vaccinations is consistent with the known safety profile of the vaccine, with no new side effects to report. 29 January 2021
The Serum Institute of India (SII), the world's biggest vaccine maker, has applied to authorities to conduct a small domestic trial of Novavax’ COVID-19 vaccine, NVX-CoV2373, which was found to be 89.3% effective in a UK trial. 29 January 2021
Sandoz, the generic and biosimilar medicines unit of Novartis, announced the US launch of generic icatibant injection pre-filled syringe to treat acute attacks of rare disease hereditary angioedema (HAE) in adults 18 years and older, making it available immediately for US patients. 29 January 2021
US biotech NeuBase Therapeutics has announced its acquisition of the infrastructure, programs and intellectual property for several peptide-nucleic acid scaffolds from Vera Therapeutics, formerly known as TruCode Gene Repair. 28 January 2021
Seattle-based Lumen Bioscience has announced the launch of a project costing up to $14.5 million funded by CARB-X to develop an oral monoclonal antibody cocktail to prevent serious diarrheal diseases. 27 January 2021
The Australian medicines regulator, the Therapeutic Goods Administration (TGA), has approved BioNTech and Pfizer’s COVID-19 vaccine, Comirnaty (BNT162b2). 25 January 2021
Samsung Bioepis, Korea’s joint venture between Samsung Biologics and Biogen that has become a leader in the global biosimilars market, has opened its new headquarters. 25 January 2021
Shares of Adamis Pharmaceuticals leapt a massive 41% to $1.79 on Friday, after the company announced that its Symjepi (epinephrine) Injection products are now available to members of the Walgreens Prescription Savings Club program. 25 January 2021
On Friday, the US Food and Drug Administration approved yet another indication for Bristol Myers Squibb’s blockbuster immuno-oncology drug Opdivo (nivolumab), this time in combination with Exelixis’ Cabometyx (cabozantinib), as first-line treatment for patients with advanced renal cell carcinoma (RCC). 23 January 2021
The US affiliate of Italian family-owned drugmaker Chiesi has announced the appointment of Jason Beyer as VP and head of neonatology and cystic fibrosis, and Jay Meyer as VP and head of the cardiovascular hospital business unit. 22 January 2021
Russia’s homegrown coronavirus vaccine, Sputnik V, has won approval in Hungary and the UAE, under emergency use authorization procedures. 21 January 2021
The European Medicines Agency (EMA) has published an overview of its key recommendations in 2020 on the authorization and safety monitoring of medicines for human use. 21 January 2021
The Russian Direct Investment Fund (RDIF) confirms that the Scientific Review was held yesterday between its COVID-19 vaccine Sputnik V and European Medicines Agency (EMA) scientific teams. 20 January 2021
A new company focused on immunological and inflammatory diseases, dubbed Vera Therapeutics, has launched with $80 million in series C financing led by Abingworth LLP. 19 January 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