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Biotechnology
CNS-focused biotech company Cerevance has announced an initial closing of its series B-1 extension financing round that will add $47 million to the $51 million previously raised, bringing the total series B-1 raise to $98 million. 26 April 2024
Pharmaceutical
Australian medicines regulator the Therapeutic Goods Administration (TGA) has published updated acceptable intake (AI) information for nitrosamine impurities in medicines consistent with recent EMA updated information- external site. 26 April 2024
Biotechnology
German pharma and life science company Merck KGaA today revealed it is investing more than 300 million euros ($320 million) in a new research center at its global headquarters in Darmstadt, Germany. 25 April 2024
Pharmaceutical
With peptides, oligos and peptide conjugates continuing to attract drug developer interest and industry capacity in short supply, China’s WuXi AppTec says its Changzhou site has been approved by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). 19 April 2024
Pharmaceutical
Japanese drugmaker Eisai has announced that the injection formulation of its in-house discovered antiepileptic drug (AED) Fycompa (perampanel hydrate) for intravenous (IV) infusion has been launched in Japan. 17 April 2024
Biotechnology
UK pharma major GSK says that the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for its 5-in-1 meningococcal ABCWY (MenABCWY) vaccine candidate. 16 April 2024
Pharmaceutical
Japanese pharma major Shionogi has received approval of a supplemental New Drug Application (sNDA) for Xofluza (baloxavir marboxil) for the treatment and post-exposure prophylaxis for influenza virus infection for pediatrics aged 5 to 15 April 2024
Biotechnology
The UK subsidiary of Japanese pharma major Takeda has received approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) for lanadelumab (trademarked Takhzyro) for the routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged two years to less than 12. 11 April 2024
Biotechnology
UK pharma major AstraZeneca today revealed that Fasenra (benralizumab) is now approved by the US Food and Drug Administration (FDA) for add-on maintenance treatment for patients with severe asthma aged six to 11 with an eosinophilic phenotype. 11 April 2024
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today approved the medicine Nulibry (fosdenopterin) to treat the genetic disease Molybdenum Cofactor Deficiency (MoCD) Type A. 9 April 2024
Pharmaceutical
French pharma major Sanofi today announced the UK launch of Verorab (Sanofi Inactivated Rabies Vaccine) an inactivated rabies vaccine indicated for pre-exposure and post-exposure prophylaxis of rabies in all age groups. 5 April 2024
Pharmaceutical
Japan’s Asahi Kasei Pharma has concluded an agreement with Swedish Orphan Biovitrum Japan Co regarding exclusive distribution rights in Japan for the additional indication of idiopathic thrombocytopenic purpura (immune thrombocytopenia) for Doptelet (avatrombopag maleate), a thrombopoietin receptor agonist. 2 April 2024
Pharmaceutical
Earlier this week Merck & Co gained much awaited approval from the Food and Drug Administration for its pulmonary arterial hypertension (PAH) treatment Winrevair (sotatercept-csrk) injection. 30 March 2024
Pharmaceutical
Germany’s Merck KGaA says it has expanded its M Lab Collaboration Center in Shanghai, the company’s largest in its global network of 10 interconnected labs. 29 March 2024
Pharmaceutical
Eisai today announced that it has entered into an agreement to divest its Japanese rights for vertigo and equilibrium disturbance treatment Merislon (betahistine mesilate) and muscle relaxant Myonal (eperisone hydrochloride) to fellow Japan based Kaken Pharmaceutical. 29 March 2024
Pharmaceutical
Swedish company InDex Pharmaceuticals have announced the departure of chief executive (CEO) Jenny Sundqvist and chief financial officer and deputy CEO Johan Giléus. 27 March 2024
Biotechnology
In a stock exchange filing yesterday, German biotech BioNTech said that, as previously disclosed, the company was in discussions with the USA’s National Institutes of Health (NIH) concerning royalties and other amounts allegedly owed on sales of the company's Pfizer partnered COVID-19 vaccine, Comirnaty. 26 March 2024
Pharmaceutical
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) today announced the new Quantitative Medicine (QM) Center of Excellence (CoE). 25 March 2024
Generics
Swiss generic and biosimilar medicines maker Sandoz today opened a new production facility in Kundl, Austria, to serve more patients with affordable life-saving drugs produced entirely in Europe. 21 March 2024
Pharmaceutical
Pfizer intends to sell around 630 million Haleon ordinary shares, taking its interest down to 22.6% from 32%. 19 March 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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