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.
Germany’s Merck KGaA says that its biopharmaceutical division - Merck Serono - is well on track with the implementation of the group’s “Fit for 2018” transformation and growth program. 18 September 2014
New research from Decision Resources Group has found that only a small proportion of patients with Crohn's disease/ulcerative colitis (CD/UC) eligible for biologic therapy currently receive a biologic. 18 September 2014
The rheumatoid arthritis (RA) disease-modifying antirheumatic drug market will increase from $14 billion in 2013 to over $18.2 billion in 2023 in the USA, France, Germany, Italy, Spain, the UK and Japan, new research has forecast. 17 September 2014
Biosimilars stand to represent a major opportunity for cost saving across Europe as long as it becomes a sustainable market, according to a report from GfK MarketAccess on behalf of the European Biosimilars Group, a sector of the European Generic medicines Association. 15 September 2014
The US Generic Pharmaceutical Association (GPhA) last week released a report showing that generic drugs saved the USA’s health system $239 billion in 2013, a 14% increase over cost savings achieved in 2012, and the largest annual savings to date. 15 September 2014
The European Commission granted marketing authorization for US drug major Eli Lilly and family-owned German pharma company Boehringer Ingelheim’s insulin glargine product, indicated to treat diabetes in adults, adolescents and children aged two years and above. 10 September 2014
The market for psoriatic arthritis (PsA) therapies will grow nearly 66%, increasing to $3.7 billion in 2023, owing to the continued uptake of premium-price biologics and novel therapies that are expected to launch during the 2013 to 2023 forecast period. 10 September 2014
South Korea’s Green Cross says that the country’s Ministry of Food and Drug Safety has granted marketing authorization for Neulapeg (pegteograstim), a treatment for abnormally low level of neutrophils in patient undergoing chemotherapy. 28 August 2014
The General Superintendent of the Brazilian Antitrust Agency (CADE) approved the agreement between the Brazilian Company for Pharmaceutical Biotechnology (Bionovis), Ares Trading AS (Merck) and Germany’s Merck KGaA, reports Juliane Carvalho on Brazil Pharma News. 28 August 2014
Several Chinese large-scale pharmaceutical enterprises have devoted themselves to research and development of monoclonal antibody agents, which have achieved results in 2013, according to a new report, titled Research on China Monoclonal Antibody (McAB) Industry, 2014, added to the offering of researchandmarkets.com. 28 August 2014
Physicians across six different specialties expect that they will base prescribing decisions for biosimilars on the robustness and number of clinical trials that a biosimilar has gone through, according to Decision Resources Group. 28 August 2014
Japanese drug major Daiichi Sankyo says it has started the Phase III trial of CHS-0214, an investigational etanercept biosimilar, in rheumatoid arthritis (the RApsody trial) in Japan. 20 August 2014
The US Food and Drug Administration yesterday granted tentative approval for Basaglar (insulin glargine injection), which is indicated to improve glycemic control in adults with type 2 diabetes and in combination with mealtime insulin in adults and pediatric patients with type 1 diabetes. 19 August 2014
South Korean biopharmaceutical firm Celltrion says it has completed the filing procedure to obtain US Food and Drug Administration approval for Remsima, its biosimilar infliximab, the active ingredient of US health care giant Johnson & Johnson’s blockbuster anti-inflammatory drug Remicade. 13 August 2014
A coalition of institutional investors who have over $430 billion in assets has commended Amgen and Novartis for supporting a set of investor principles to guide corporate boards on policy and oversight responsibilities related to biosimilar activities. 12 August 2014
Indian generic drugmaker Lupin has entered into a strategic distribution agreement with LG Life Sciences (South Korea) to launch insulin glargine, a novel insulin analogue under the brand name Basugine. 11 August 2014
The US Food and Drug Administration has announced the availability of a draft guidance for industry titled “Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act.” 11 August 2014
US Senators Lamar Alexander (Republican, Tennessee) and Orrin Hatch (Rep, Utah) have led colleagues in calling on the Obama administration to release guidance documents on biosimilar drug approvals. 6 August 2014
Switzerland-based Harlan Laboratories, a privately held provider of general and specialty toxicology services through its contract research services (CRS) business, is prepared to meet the global demand for development programs in novel biologics and biosimilars. 31 July 2014
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
The Biosimilars Council, alongside the Association for Accessible Medicines (AAM), released its 2024 US Generic & Biosimilar Medicines Savings Report. 6 September 2024
Biosimilar-focused biopharmaceutical company and contract development and manufacturing organization (CDMO) Tanvex BioPharma has named Stephen Lam its new chief executive (CEO). 5 September 2024
Biocon Biologics has signed a settlement and license agreement with Johnson & Johnson that clears the way to commercialize its Bmab 1200, a proposed biosimilar to Stelara (ustekinumab), in Europe, the UK, Canada, and Japan. 3 September 2024
Regeneron Pharmaceuticals has filed a lawsuit against Sandoz, alleging that its biosimilar to Eylea (aflibercept) infringes certain patents. 29 August 2024
Celltrion’s US subsidiary has signed an agreement with pharmacy benefit managers (PBMs) Cigna Healthcare, and Express Scripts that will help expand patient access to Zymfentra (infliximab-dyyb). 29 August 2024
Drug development consultancy Certara has published a report on the Inflation Reduction Act’s (IRA) impact on oncology biosimilar uptake. 29 August 2024
South Korea’s Celltrion yesterday announced the European Commission (EC) approval for the use of SteQeyma (CT-P43), an ustekinumab biosimilar referencing Stelara, for the treatment of multiple chronic inflammatory diseases. 27 August 2024
The USA’s Federal Trade Commission (FTC) said yesterday that it has submitted a comment supporting the Food and Drug Administration’s (FDA) draft guidance regarding interchangeable biosimilar drugs. 23 August 2024
The US subsidiary of South Korea’s Celltrion announced its US Food and Drug Administration (FDA)-approved biosimilar adalimumab-aaty has been added to the Costco member prescription program. 14 August 2024
The US Food and Drug Administration (FDA) has approved Enzeevu (aflibercept-abzv) 2mg vial kit and pre-filled syringe for intravitreal injection, developed by Swiss biosimilars company Sandoz. 12 August 2024
The Biosimilars Council—part of the USA’s Association for Accessible Medicine (AAM) representing companies developing off-patent medicines—has provided an update on its activities on the regulatory, legislative and educational fronts. 5 August 2024
Chinese biotech Bio-Thera Solutions (SHSE: 688177) has picked up European Medicines Agency approval for BAT1706, a biosimilar referencing Avastin (bevacizumab). 1 August 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
Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products. 23 July 2024
The US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) submitted by South Korea’s Samsung Bioepis for Epysqli (eculizumab-aagh) as a biosimilar to Soliris (eculizumab). 22 July 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.