3 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.
National Health Service (NHS) England has given approval to allow eligible patients access to Roche’s Ocrevus (ocrelizumab) subcutaneous injection for people with relapsing multiple sclerosis and primary progressive multiple sclerosis. 12 July 2024
India's Zydus Lifesciences has been barred by the Delhi High Court from selling its breast cancer drug, Sigrima, a biosimilar version of Roche's pertuzumab (brand name Perjeta). 12 July 2024
The clinical trial landscape for chronic lymphocytic leukemia (CLL) shows a robust global effort to advance treatment options and understand the disease, according to a report. 12 July 2024
Shares of Texas, USA-based protein expert Salarius Pharmaceuticals fell more than 20% to $2.28 by close of trading on Thursday after the Food and Drug Administration (FDA) placed a study of the clinical-stage biopharmaceutical company's lead drug candidate on partial clinical hold. 12 July 2024
The Russian drugmaker Geropharm has demanded a compulsory license from Denmark’s Novo Nordisk to produce a generic of Ozempic (semaglutide), which is a drug used for diabetes and the active ingredient is marketed as Wegovy for weight loss, reports The Pharma Letter’s local correspondent. 12 July 2024
GlaxoSmithKline Trading, the distribution division of the British pharma major GSK, has filed a complaint to the Russian anti-trust regulator FAS on the recent auction for state procurements of GSK’s anti-HIV drug Tivicay (dolutegravir). 12 July 2024
As part of an ongoing organizational restructuring effort, Swiss pharma giant Novartis (NOVN: VX) will reportedly close an R&D site in San Diego, USA, leading to job losses. 12 July 2024
Efforts to end US business deals with certain foreign biotechs considered threats are gaining traction again, with House Speaker Mike Johnson stating his intention to hold a vote on the BIOSECURE act this year. 11 July 2024
Henry Pelish has continued his rise up the ranks at Nuvalent, a Boston-based biopharma focused on creating precisely targeted therapies for clinically proven kinase targets in cancer. 11 July 2024
The US Food and Drug Administration (FDA) has granted Fast Track designation for AB-1005, which is being developed for moderate Parkinson’s disease by German pharma major Bayer gene therapy subsidiary Asklepios BioPharmaceutical (AskBio). 11 July 2024
French drugmaker Ipsen has entered into an exclusive global licensing agreement for FS001, an antibody-drug conjugate (ADC) with first-in-class potential, from China-based Foreseen Biotechnology. 11 July 2024
German drug discovery and development company Evotec has entered into a multi-year master research collaboration and option and license agreement with US pharma giant Pfizer. 11 July 2024
Shares of US pharma giant Pfizer were up more than 3% at $29.25 pre-market, as the company announced progress in its attempt to play a role in the fast-growing obesity sector. 11 July 2024
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
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Company Spotlight
A pre-clinical stage biopharmaceutical group developing new medicines and treatments to treat blood and autoimmune disease and to bring the curative power of bone marrow transplantation to a greater number of patients suffering from otherwise incurable life-threatening diseases.