US healthcare giant Johnson & Johnson subsidiary Janssen has received approval from Health Canada for Darzalex has approved (daratumumab) in combination with bortezomib, thalidomide and dexamethasone (VTd) for the treatment of patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT). 22 December 2020
US pharma giant Pfizer has signed an agreement with Russian drugmaker Pharmstandard on the production of four of its anti-cancer drugs at the facilities of the Russian company in the Ufa region. 22 December 2020
Novavax has appointed Rick Crowley to a newly-created position of chief operations officer, with responsibility for quality, manufacturing, supply chain and regulatory affairs. 22 December 2020
Biogen has won European approval for a new intramuscular (IM) injection route of administration for Plegridy (peginterferon beta-1a) in relapsing-remitting multiple sclerosis (MS). 21 December 2020
The Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, today announced that Sputnik V, the Russian vaccine against coronavirus, has been registered by the Ministry of Health of the Republic of Belarus, which becomes the first foreign country to officially register the vaccine. 21 December 2020
The UK is planning to roll out a fast-track drug approval process, following the end of the transition period which has seen the country bound by the European regulatory process. 21 December 2020
In what was largely expected following a unanimous vote from an advisory panel on Thursday, the US Food and Drug Administration’s on Friday authorized the emergency use of mRNA-1273, Moderna’s vaccine against COVID-19 in individuals 18 years of age or older. 19 December 2020
Japanese drugmaker Daiichi Sankyo has announced the achievement of the primary endpoint of a Phase III study of mirogabalin for central neuropathic pain after spinal cord injury. 18 December 2020
Chippenham, UK-based Vectura Group has secured an $11 million milestone payment, after its partner Hikma Pharmaceuticals launched a generic version of GlaxoSmithKline’s Advair Diskus (fluticasone propionate/salmeterol) in the USA. 18 December 2020
Japan’s Chugai Pharmaceutical has won Chinese approval for Edirol (eldecalcitol), an active vitamin D3 derivative, as a therapeutic drug for osteoporosis. 18 December 2020
Taiwan biotech Lumosa Therapeutics has received approval for its new drug application (NDA) for its extended-release injectable pain reliever Naldebain (dinalbuphine sebacate) from Singapore’s Health Science Agency (HSA). 18 December 2020
BioNTech and Shanghai Fosun Pharmaceutical have agreed to supply China with an initial 100 million doses of their BNT162 mRNA-based vaccine candidate against COVID-19. 17 December 2020
An outcomes-based deal between Germany’s Boehringer Ingelheim and American insurer Highmark has resulted in a 20% cost of care saving, the firms said. 16 December 2020
University of Birmingham spinout Revitope Oncology has received a $10 million investment from China’s Junshi Biosciences, in exchange for 9.9% of the company. 16 December 2020
Mumbai, India-based Cipla has settled a patent litigation for a generic blood cancer medicine with innovator Celgene, which is now a wholly owned subsidiary of Bristol Myers Squibb. 15 December 2020
The production of drugs in Russia for 10 months of the current year grew to 399.1 billion roubles ($5.4 billion), which is 17% higher than in the same period in 2019, according to a recent report from the Russian pharma analytics agency RNC Pharma. 15 December 2020
Danish vaccine specialist MinervaX has raised 47 million euros ($57 million) in a series B financing round, featuring new investors such as Sanofi Ventures and Wellington Partners, as well as existing backers like the Novo Holdings REPAIR Impact Fund. 15 December 2020
The China National Medical Products Administration (NMPA) has approved and issued a Product license for Chinese firm Sinovac Biotech’s 23-Valent pneumococcal polysaccharide (PPV) Vaccine to prevent the infection by streptococcus pneumonia in adults and children aged two years old and above. 14 December 2020
The Trump Administration, through the US Department of Health and Human Services (HHS) and Department of Defense (DoD), will purchase an additional 100 million doses of the COVID-19 vaccine candidate, called mRNA-1273, from Moderna. 12 December 2020
The European Commission said on Friday it is negotiating intensely to build a diversified portfolio of COVID-19 vaccines at fair prices. 12 December 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