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.
AstraZeneca (LSE: AZN) announced robust financial results for the second quarter of 2024, with a 13% increase in total revenue to $12.94 billion, driven by a strong performance across its key therapeutic areas. 25 July 2024
The US Food and Drug Administration (FDA) has issued a Federal Register notice, “Biosimilar Product Development Guidance; Establishment of a Public Docket; Request for Information and Comments.” 25 July 2024
The Indian government has announced a full exemption from customs duties on three cancer medications: trastuzumab deruxtecan, osimertinib and durvalumab. 24 July 2024
Positive top-line results from the Phase III AFFINE study (NCT04370054) evaluating giroctocogene fitelparvovec, an investigational gene therapy for the treatment of adults with moderately severe to severe hemophilia A, were released today by US pharma giant Pfizer. 24 July 2024
Sage Therapeutics’ shares plunged nearly 22% to $10.25 in pre-market activity, as it announced disappointing top-line results from the Phase II KINETIC 2 dose-range study of the oral investigational drug SAGE-324 (BIIB124) as a potential treatment in essential tremor (ET). 24 July 2024
A report has been presented by the House Committee on Oversight and Accountability entitled The Role of Pharmacy Benefit Managers (PBMs) in Prescription Drug Markets. 24 July 2024
US pharma giant Merck & Co has released positive top-line results from its Phase IIb/III clinical trial (MK-1654-004) evaluating clesrovimab (MK-1654), 24 July 2024
The US medicines regulator has issued a warning letter to Indian contract development and manufacturing organization (CDMO) Brassica Pharma for severe data integrity violations at its manufacturing facility in Thane. 24 July 2024
Former executives at Johnson & Johnson (NYSE: JNJ) have teamed up to launch a new biotech company, Third Arc Bio, with significant backing from investors. 24 July 2024
Australian radiopharma developer Telix Pharmaceuticals Limited has launched an offering of A$600 million ($405 million) of convertible notes due 2029. 24 July 2024
The US Food and Drug Administration (FDA) announced it has approved Millicent’s Femlyv (norethindrone acetate and ethinyl estradiol), the first orally disintegrating tablet approved for the prevention of pregnancy. 24 July 2024
Brenig Therapeutics, a neurology-focused drug development company using an AI-based discovery platform, has closed a $65 million series A financing. 24 July 2024
Tuesday was not a good day for shareholders in US biopharma Cellectar Biosciences—a US biopharma focused on the discovery, development and commercialization of drugs for the treatment of cancer. 23 July 2024
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has today approved a new indication for Wegovy (semaglutide) to reduce the risk of overweight and obese adults suffering serious heart problems or strokes. 23 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.