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
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
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
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
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
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
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
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
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
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
Achilles Therapeutics has raised £53 million ($70 million) in a Series C financing round, with OrbiMed, Boxer Capital of Tavistock Group, and other healthcare-focused institutional investors joining existing investors. 19 November 2020
US biotech Five Prime Therapeutics has announced the pricing of an underwritten public offering of 7,200,000 shares of its common stock at a price to the public of $21.00 per share. 17 November 2020
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
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
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
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
Privately-held Ferring Pharmaceuticals has announced the opening of a global manufacturing hub in Finland for the drug substance of its intravesical non-replicating gene therapy Adstiladrin (nadofaragene firadenovec-vncg). 3 October 2024
Shares of UK drug developer Hemogenyx Pharmaceuticals rose as much as 9% and closed up 5.9% at 1.70 pence yesterday on the news of a further investment from Prevail Partners. 3 October 2024
UK-based biotech Resolution Therapeutics has announced the completion of a £63.5 million ($76.8 million) series B financing round led by Syncona. 3 October 2024
The BioIndustry Association (BIA), in collaboration with the Centre for Process Innovation (CPI), has published a new report on the UK’s mRNA sector. 2 October 2024
Aspen Neuroscience, a private biotechnology company specializing in autologous cell therapies, has announced the opening of a major new facility near its headquarters in San Diego. 2 October 2024
Privately-held UK biotech Curve Therapeutics today announced the further strengthening of its leadership team with the appointments of Andre Hoekema as chairman of the board and Cora Griffin as head of business development. 2 October 2024
NK:IO, a London startup developing a cell therapy for treating solid tumors, has announced the appointment of a permant chief executive and the finalization of a seed funding round. 2 October 2024