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Pharmaceutical
The US Food and Drug Administration (FDA) has approved Teva Pharmaceutical's Austedo XR (deutetrabenazine), as a one pill, once-daily treatment option, now with four new tablet strengths (30, 36, 42, 48 mg) indicated in adults for tardive dyskinesia (TD) and Huntington’s disease (HD) chorea. 30 May 2024
Pharmaceutical
Helsinn and Angelini Pharma have renewed their distribution and licence agreement for Aulin (nimesulide) and Mesulid (nimesulide). 28 May 2024
Biotechnology
South Korea’s Ministry of Food and Drug Safety (MFDS) has approved the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody Leqembi (lecanemab) for treatment in adult patients with mild cognitive impairment due to Alzheimer’s disease (AD) or mild AD (early AD). 28 May 2024
Pharmaceutical
Negotiators of a proposed World Health Organization (WHO) pandemic accord have been unable to reach consensus ahead of a self-imposed deadline of next week’s World Health Assembly. 25 May 2024
Pharmaceutical
Russia is experiencing a boom in demand and sales of antidepressants these days, according to recent statements by representatives of some leading local pharmacies and analysts. 21 May 2024
Pharmaceutical
A Delaware, USA, federal jury on Friday said that AstraZeneca should pay $107.5 million in royalty damages for infringing a Pfizer-brand cancer treatment patent, with its cancer drug Tagrisso (osimertinib), according to IP Law360. 20 May 2024
Biotechnology
USA-based Moderna has won a case at the European Patent Office (EPO) in its dispute with Pfizer and BioNTech over its Covid-19 vaccine, in a boost for the mRNA-vaccine maker in its ongoing legal fight to recoup pandemic profits from its rivals. 18 May 2024
Pharmaceutical
This week, the US Centers for Medicare & Medicaid Services (CMS) announced it would hold off on a provision to rule RIN 0938-AU28 that would have required pharmaceutical manufacturers to stack discounts and rebates to report a best price for the Medicaid drug rebate program. 17 May 2024
Biotechnology
While marking up 23 bills yesterday, the House Energy & Commerce Committee’s (E&C) Health Subcommittee approved H.R. 7384 to extend the PPRV program, which incentivizes R&D by giving vouchers to expedite review of pediatric rare disease drugs. 17 May 2024
Biotechnology
A Californian company working on allogeneic CAR T products has raised approximately $110 million through a stock offering. 16 May 2024
Pharmaceutical
Danish diabetes and obesity giant Novo Nordisk is planning to test whether its weight loss drugs, including semaglutide, marketed as Wegovy, can impact alcohol use in patients with liver disease, according to Bloomberg. 15 May 2024
Pharmaceutical
Japanese drugmaker Eisai today announced it has received approval in China for the additional indication of its in-house discovered antiepileptic drug (AED) Fycompa (perampanel hydrate) for adjunctive treatment of primary generalized tonic-clonic seizures in patients with epilepsy aged 12 years and older. 13 May 2024
Biotechnology
The US Food and Drug Administration (FDA) has notified Moderna that, due to administrative constraints, the agency does not expect to complete its review of the Biologics License Application (BLA) for mRNA-1345 by May 12. 10 May 2024
Biotechnology
Swiss company ADC Therapeutics has announced a $105 million underwritten offering of common shares and pre-funded warrants. 7 May 2024
Pharmaceutical
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has now approved Pfizer’s Oxbryta (voxelotor) to be recommended for use on the National Health Service NHS to treat people with hemolytic anemia caused by sickle cell disease (SCD). 6 May 2024
Biotechnology
AstraZeneca on Monday announced the successful completion of an equity investment with France-based Cellectis, a clinical-stage biotechnology company. 6 May 2024
Pharmaceutical
Subsidies for Danish drugmaker giant Novo Nordisk’s diabetes drug Ozempic (semaglutide) will be restricted in its home country due to rising public spending on the blockbuster diabetes medicine, which is increasingly being used as a weight-loss treatment, according to a report from Bloomberg. 2 May 2024
Pharmaceutical
As of May 1, Johnson & Johnson is updating its brand and uniting both its two business segments under the Johnson & Johnson brand name in the UK. 1 May 2024
Generics
Danish specialty pharma company Xellia Pharmaceuticals, which is owned by Novo Holdings, today revealed that the US Court has vacated the Modified Consent Decree imposed on Xellia’s Cleveland, Ohio, USA facility in 2016. 29 April 2024
Pharmaceutical
US antivirals specialist Gilead Sciences announced that the US Food and Drug Administration (FDA) approved an updated label with additional data reinforcing the safety and efficacy profile of Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets, B/F/TAF) to treat pregnant people with HIV-1 (PWH) with suppressed viral loads. 27 April 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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