Puma Biotechnology has presented final overall survival (OS) data from the Phase III ExteNET trial testing neratinib in HER2-positive early stage breast cancer. 11 December 2020
The United Arab Emirates’ (UAE) health ministry says an interim analysis of in-country phase-three clinical trials of Chinese-made Sinopharm’s COVID-19 vaccine has 86% efficacy against the infection, according to a report by the Aljazeera state news agency. 9 December 2020
Swiss firms RetinAI Medical and Novartis are to collaborate in the use of artificial intelligence tools for the development of ophthalmology and digital health products. 8 December 2020
The Danish Maritime and Commercial High Court has ruled that Novo Nordisk's publication of the press release of September 19, 2019: "Tresiba showed an overall lower risk of hypoglycemia and significantly lower HbA1c when compared to insulin glargine U300 in people with type 2 diabetes" was in violation of the Danish Marketing Practices Act and the Danish Medicines Act. 7 December 2020
In an op-ed for The Dispatch, Johns Hopkins Professor Marty Makary slammed the US Food and Drug Administration for "holding up COVID-19 vaccine approval" and dubbed the agency's progress "Operation Turtle Speed." 7 December 2020
Sweden’s Orexo has licensed the UK’s Accord Healthcare to commercialize the opioid use disorder (OUD) medicine Zubsolv (buprenorphine/naloxone) in Europe. 7 December 2020
Novo Nordisk announced on Saturday that the US Food and Drug Administration approved an updated label for Saxenda (liraglutide) injection 3mg for use in the treatment of obesity in adolescents (12–17 years) with a body weight above 60 kg and an initial body mass index (BMI) corresponding to 30 kg/m2 or greater for adults, as an adjunct to a reduced-calorie diet and increased physical activity. 5 December 2020
Age-related disease specialist BioAge Labs has raised $90 million in a series C financing round co-led by Andreessen Horowitz and including new investors Kaiser Foundation Hospitals, AARP Foundation and Phi-X Capital. 4 December 2020
BioNTech and Pfizer announced today that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a temporary authorization for emergency use for their COVID-19 vaccine BNT162b2. 2 December 2020
The European Medicines Agency today revealed it has received an application for conditional marketing (CMA) for a COVID-19 mRNA vaccine from Moderna. 1 December 2020
BioNTech and Pfizer today said they have submitted a formal Application for Conditional Marketing Authorization (CMA) to the European Medicines Agency (EMA) for their mRNA vaccine candidate, BNT162b2, against COVID-19. 1 December 2020
Swiss oncology and rare disease specialist Helsinn Group has inked a Chinese license and distribution deal with Kyowa Kirin for Valchlor (chlormethine). 1 December 2020
Moderna has agreed to supply an extra two million doses of its COVID-19 vaccine to the UK, beginning in March 2021, bringing the total to seven million doses. 30 November 2020
Chugai Pharmaceutical has filed a patent infringement lawsuit against Nissan Chemical Corporation, in relation to Edirol (eldecalcitol). 27 November 2020
Taipei, Taiwan-based biotech PharmaEngine has signed an exclusive, worldwide licensing agreement with British counterpart Sentinel Oncology to gain rights to the latter's checkpoint kinase1 inhibitor SOL578, which has the potential to treat tumors. 27 November 2020
Randomized, controlled trials are the gold standard for evaluating the safety and effectiveness of drugs, said the US Food and Drug Administration yesterday, in a defense of its recent approval of a COVID-19 treatment, the efficacy of which has been questioned by the World Health Organization (WHO). 26 November 2020
The European Society for Radiotherapy and Oncology (ESTRO) and the ESTRO Cancer Foundation (ECF) have announced the launch of a new research initiative to explore challenges to the uptake of radiotherapy for lung cancer patients in Europe. 25 November 2020
In a novel approach to raise interest in research that it does not intend to pursue itself, Japanese drug major Astellas Pharma has launched a “Contact for Potential Acquisition of Astellas’ R&D programs” section on its corporate website. 25 November 2020
Health Canada has approved the new drug submission (NDS) for Tavalisse (fostamatinib disodium hexahydrate) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to other treatments. 23 November 2020
The US Food and Drug Administration say it has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on December 10 to discuss the request for emergency use authorization (EUA) of a COVID-19 vaccine, dubbed BNT162b2, from Pfizer in partnership with BioNTech that was filed on Friday. 21 November 2020
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