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Pharmaceutical
German family-owned pharma major Boehringer Ingelheim’s attempt to block the Medicare Drug Price Negotiation Program was rejected by a federal judge. 5 July 2024
Pharmaceutical
Mochida Pharmaceutical announced that it has submitted a New Drug Application to the China National Medical Products Administration (NMPA) for Epadel S (MND-21), a highly purified eicosapentaenoic acid (EPA). 4 July 2024
Biosimilars
Korean company Samsung Biologics has signed a production agreement with an unidentified large US pharma corporation worth more than $1.06 billion. 3 July 2024
Biotechnology
Californian biotech Alumis has raised $250 million in a downsized initial public offering with a concurrent private placement. 1 July 2024
Pharmaceutical
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has concluded its review of Intercept Pharmaceuticals’ Ocaliva (obeticholic acid) and has recommended that the medicine’s marketing authorization be revoked 29 June 2024
Biotechnology
Boston-based biotech firm Ginkgo Bioworks has announced significant workforce reductions as part of its ongoing restructuring efforts. 28 June 2024
Biotechnology
PolTREG, a Polish biotech developing cell therapies for autoimmune diseases, has announced that its polyclonal Treg cell therapy PTG-007 demonstrated significant insulin secretion restoration in early-onset type-1 diabetes (T1D) patients, as well as a longer period of disease remission compared to a control group receiving standard-of-care. 24 June 2024
Generics
The US affiliate of Teva Pharmaceutical Industries announced today the launch of an authorized generic of Victoza (liraglutide injection 1.8mg), in the USA. 24 June 2024
Pharmaceutical
Amendments to the Therapeutic Goods Regulations 1990 (Schedule 5, item 6 have been made .... 24 June 2024
Pharmaceutical
US drugmaker Lexicon Pharmaceuticals today announced that, following multiple interactions with and recent feedback from the US Food and Drug Administration (FDA), it has resubmitted its New Drug Application (NDA) for sotagliflozin as an adjunct to insulin therapy for glycemic control in people with type 1 diabetes and chronic kidney disease (CKD). 21 June 2024
Biotechnology
Indian drugmaker Cipla announced that its wholly-owned subsidiary in the UK, Cipla (EU) Limited, will invest an additional 3 million euros ($3.2 million) in Ethris GmbH, a German firm delivering mRNAs directly to the respiratory system. 19 June 2024
Biotechnology
Dutch autoimmune diseases specialist Argenx announced that results from the Phase II ALPHA study of efgartigimod in post-COVID-19-mediated postural orthostatic tachycardia syndrome (PC-POTS) show that treated patients had no clinically meaningful improvement compared to placebo on the total Malmö POTS symptom (MaPS) score and COMPASS31. 17 June 2024
Biosimilars
The proposed US BIOSECURE Act was this week left out of the House Rules Committee’s final list of amendments to be voted on for inclusion in the NDAA, an agreement that specifies the budget and spending for the US Department of Defense. 15 June 2024
Pharmaceutical
The USA’s Biomedical Advanced Research and Development Authority (BARDA) has announced up to $500 million in Project NextGen funding to plan and execute multiple Phase IIb clinical trials evaluating novel vaccines administered as a nasal spray or as a pill to protect against symptomatic COVID-19. 15 June 2024
Pharmaceutical
Pfizer chief executive Albert Bourla said the pharma giant is pausing big acquisitions after spending $43 billion last year on buying Seagen, according to a Bloomberg report. 12 June 2024
Biotechnology
The US Food and Drug Administration (FDA) has accepted Eisai’s supplemental Biologics License Application (sBLA) for monthly Leqembi (lecanemab-irmb) intravenous (IV) maintenance dosing. 10 June 2024
Biotechnology
The European Medicines Agency (EMA) has approved a Type II variation to the Summary of Product Characteristics (SmPC) for its approved Chimeric Antigen Receptor (CAR) T-cell therapies, Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel) from Gilead Sciences’ Kite subsidiary. 6 June 2024
Biotechnology
Netherlands-based gene therapy company uniQure announced that the US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for its AMT-130 gene therapy in development for Huntington’s disease. 3 June 2024
Pharmaceutical
German family-owned pharma major Boehringer Ingelheim’s new program to cap out-of-pocket costs at $35 per month for eligible patients for the company’s inhalers is now available. 1 June 2024
Biotechnology
Today, Japanese pharma major Astellas announced the US Food and Drug Administration (FDA) has acknowledged the company’s resubmission of the Biologics License Application (BLA) for zolbetuximab. 31 May 2024
Biotechnology
Dutch gene therapy company uniQure (Nasdaq: QURE) announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to AMT-130, sending the firm’s shares leaping more than 38% to $13.00 by close of trading on Thursday. 18 April 2025
Pharmaceutical
US President Donald Trump issued an executive order on April 15 listing several potential policy changes aimed at lowering US drug prices.
Responding to the announcement, Morningstar’s healthcare equity research director Karen Andersen gave her views on why this matters. 18 April 2025
Biotechnology
The US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Eylea HD (aflibercept) Injection 8mg, submitted by US biotech Regeneron Pharmaceuticals. 18 April 2025
Biotechnology
Australian clinical-stage biotech Neurizon Therapeutics, which is advancing innovative treatments for neurodegenerative diseases, has significantly strengthened its executive management team with three key appointments. 18 April 2025
Pharmaceutical
US biopharma company Galmed Pharmaceuticals has entered into a research collaboration with Virginia Commonwealth University to investigate its lead candidate Aramchol (arachidyl amido cholanoic acid) as a potential solution to drug resistance in gastrointestinal cancers. 17 April 2025
Biotechnology
BigHat Biosciences, a Californian biotech with a machine learning (ML)-guided antibody discovery and development platform, has announced a strategic collaboration with US pharma major Eli Lilly. 17 April 2025
Biotechnology
US cancer drug developer Werewolf Therapeutics today announced the appointment of Steven Bloom as chief business officer (CBOP. 17 April 2025
Pharmaceutical
Wall Street watched in awe as Eli Lilly made rampant gains in early trading Thursday. 17 April 2025
Biotechnology
Swiss pharma major Novartis has discontinued development of its experimental treatment QUC398 for knee osteoarthritis, ending hopes for a new therapy in the anti-ADAMTS-5 class. 17 April 2025
Pharmaceutical
Florida biopharma Ligand Pharmaceuticals subsidiary Pelthos Therapeutics is to merge with Channel Therapeutics, a developer of non-opioid pain treatments. 17 April 2025
Pharmaceutical
India’s Venus Remedies has secured Qualified Infectious Disease Product designation from the United States Food and Drug Administration for its investigational antibiotic VRP-034, a next-generation formulation of polymyxin B designed to reduce kidney toxicity. 17 April 2025
Biosimilars
Indian drugmaker Biocon subsidiary Biocon Biologics has announced a settlement and license agreement with the USA’s Regeneron that clears the way to commercialize Yesafili (aflibercept-jbvf), an interchangeable biosimilar aflibercept, in the USA. 17 April 2025
Biotechnology
Germany’s Evotec has unveiled a new strategy, and provided 2025 guidance—bolstered by strong results from the fourth-quarter of 2024. 17 April 2025
Biotechnology
Japanese drugmaker Chugai Pharmaceutical announced that results from the Phase III clinical trial (NIHONBASHI study) of anti-VEGF/anti-Ang-2 bispecific antibody Vabysmo (faricimab) intravitreal injection 120mg/mL, for angioid streaks associated with neovascularization were presented at the 129th Annual Meeting of the Japanese Ophthalmological Society on April 17. 17 April 2025
Pharmaceutical
Switzerland-based Addex Therapeutics, a biopharma developing a portfolio of novel small molecule allosteric modulators for neurological disorders, has announced an update on its Phase II asset, ADX71149. 17 April 2025
Biotechnology
US gene therapy company bluebird bio announced that after three weeks of engagement, including a timeline extension, Ayrmid Pharma has not submitted a binding proposal to acquire bluebird and has not obtained necessary financing. 17 April 2025
Pharmaceutical
The US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has voted to expand its recommendation for the use of respiratory syncytial virus (RSV) vaccines approved for adults 50-59 years of age at increased risk of RSV-associated lower respiratory tract disease (LRTD). 17 April 2025
Pharmaceutical
US biotech Wayfinder Biosciences has entered a research collaboration with Japanese drugmaker Daiichi Sankyo to develop small molecule therapies targeting RNA in neurodegenerative diseases. 16 April 2025
Biosimilars
China’s Chime Biologics has formed a strategic partnership with European biosimilars specialist Polpharma Biologics to support the end-to-end development and manufacture of a biosimilar product targeting the global market. 16 April 2025
Biotechnology
US biotech Myeloid Therapeutics has restructured its operations to concentrate on two cancer programs already in the clinic, a move that has resulted in staff reductions and an uncertain future for its early-stage research work. 16 April 2025
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