As the European Commission (EC) comes to the end of a multi-year process for revising the general pharmaceutical legislation framework, drugmakers are urging lawmakers to prioritize research. 21 November 2022
The US Food and Drug Administration yesterday approved a new Monday-Wednesday-Friday dosing regimen for Jazz Pharmaceuticals' Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn), with the news edging the drugmaker’s shares up 1.4% to $147.18. 19 November 2022
India’s Sun Pharmaceutical Industries today announced that the US Food and Drug Administration (FDA) has approved Sezaby (phenobarbital sodium powder for injection) for the treatment of neonatal seizures. 18 November 2022
A new drug discovery company in California has launched with $78 million in a series A financing led by SR One, a16z Bio + Health and Norwest Venture Partners. 18 November 2022
The British medicines regulator has granted marketing authorization to Upstaza (eladocagene exuparvovec), a one-time gene replacement therapy developed by PTC Therapeutics. 17 November 2022
Privately-held German drugmaker Boehringer Ingelheim has welcomed the updated 2023 Global Initiative for Chronic Obstructive Lung Disease (GOLD) Report. 17 November 2022
Shares of Everest Medicines leapt more than 19% to HK$12.22 today, as it announced that its New Drug Application (NDA) for Nefecon for the treatment of primary immunoglobulin A nephropathy (IgAN) has been accepted by China’s National Medical Products Administration 15 November 2022
A Dutch company with a novel business model, Avanzanite Bioscience, is looking to expand patient access to medicines for rare diseases in Europe. 15 November 2022
Belgian biopharma UCB has announced that the US Food and Drug Administration has accepted for review a New Drug Application for zilucoplan. 14 November 2022
Industry analyst PharmaVentures have releases a new white paper examining the market landscape and key success factors for biosimilars. 14 November 2022
The chief executive of Bristol Myers Squibb has warned that the US pharmaceutical company could divert investment away from the UK because of the expansion of a levy designed to limit the National Health System (NHS) medicines bill, told the Financial Times. 14 November 2022
Via its local subsidiary, Germany’s BioNTech has agreed to acquire Novartis’ (NOVN: VX) GMP-certified manufacturing facilities in Singapore. 14 November 2022
The US Food and Drug Administration (FDA) has approved Adcetris (brentuximab vedotin) for the treatment of pediatric patients two years and older with previously untreated high risk classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide. 11 November 2022
Bristol Myers Squibb has opened its Cruiserath Biologics site in Dublin, Ireland, 125-acre facility with approval from US and EU regulators, costing $1 billion to develop. 11 November 2022
UK pharma major AstraZeneca says its rare diseases business Alexion is expanding its presence in Asia, announcing the availability in China of Soliris (eculizumab). 11 November 2022
In a draft decision, the UK’s reimbursement agency has opted not to recommend funding for Lynparza (olaparib) for women with early-stage, high-risk breast cancer. 10 November 2022
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Cosentyx (secukinumab), alone or in combination with methotrexate (MTX), in two types of juvenile idiopathic arthritis (JIA). 9 November 2022
Shanghai Yingli Pharmaceutical announced that linperlisib, trade name因他瑞®, a novel phosphoinositide 3-kinase delta (PI3Kδ) inhibitor, has been approved by the National Medical Products Administration (NMPA) of China for the treatment of relapsed/refractory follicular lymphoma (R/R FL) in patients who have received two or more prior systemic therapies. 9 November 2022
Merck & Co’s 15-strain Streptococcus vaccine, Vaxneuvance, has won UK approval for use in infants as young as six months, adding to the existing nod for adults. 9 November 2022
With the aim of strengthening its presence in these markets and its leadership in Europe in medical dermatology, Spain’s leading drugmaker Almirall has opened new affiliates in the Czech Republic and Slovakia. 8 November 2022
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
Abivax ABVX) today announced the results of an interim efficacy and safety analysis of an open-label maintenance (OLM) study that enrolled patients with ulcerative colitis (UC). 3 October 2024