Adial Pharmaceuticals’ CEO Cary Claiborne discussed with Generics Bulletin how repurposing antinausea drug ondansetron and genetically targeting patients with specific biomarkers can address the unmet need in the current treatment of addiction.
Unleashing a trio of major announcements, Formycon has indicated a gloomy outlook for US Stelara biosimilar pricing; revealed plans to pause commercialization of its Sandoz-partnered US Cimerli rival to Lucentis amid discounting from rivals; and set out ambitious plans to win FDA approval for its proposed Keytruda biosimilar without any Phase III data.
In its latest draft standard contract for 2025/26, the National Health Service in England has proposed enhanced prescribing requirements “in recognition of the increasing importance of biosimilars in the provision of biological medicines.”
A US tariff on imports from China raises the spectre of similar action against India, but Aurobindo, the largest generics company in the US by prescriptions dispensed, assures it has alternatives in place. While trials for an opthalmology biosimilar are delayed, supply of other biosimilars to Europe is set to begin in Q2 FY26.
Momentum is building around the European Commission’s race to propose a Critical Medicines Act, which aims to tackle drug shortages and create a better framework for establishing manufacturing facilities of essential medicines in the EU.
Discussing a new report highlighting the lack of US biosimilar competition on the cards for the majority of biologics losing exclusivity in the next ten years, the AAM’s Access! 2025 conference heard that the “sobering” findings should act as a “wake-up call for stakeholders.”
Trump’s former FDA commissioner sees ‘nothing good’ coming from negotiating a new user fee agreement in the ‘current political environment.’
At a lively AAM Access! conference in Florida this week, the latest actions taken by Donald Trump ranked high on the agenda. But as well as acknowledging the negative effects of potential tariffs, the AAM’s president and CEO John Murphy also suggested that the advent of the second Trump administration could offer an opportunity for the generics and biosimilars sector to make its voice heard on proposed market reforms.
The Association for Accessible Medicines has urged the Trump administration not to impose proposed tariffs on the off-patent drug sector to avoid drug shortages and additional costs for manufacturers.
Adial Pharmaceuticals’ CEO Cary Claiborne discussed with Generics Bulletin how repurposing antinausea drug ondansetron and genetically targeting patients with specific biomarkers can address the unmet need in the current treatment of addiction.
Recently-appointed president of Medicines for Europe Stephan Eder speaks to Generics Bulletin about the off-patent association’s priorities to secure a sustainable operating environment for the generics, biosimilars and value-added medicines sector in Europe.
In an exclusive interview with Generics Bulletin, Aspargo Labs CEO Michael Demurjian discusses the importance of reformulated liquid oral suspension drugs, while outlining plans to launch a smart device that connects patients and doctors.
At the J.P. Morgan Healthcare Conference in San Francisco, Teva has provided a timeline for its much-talked-about long-acting injectable olanzapine candidate, after wrapping up a Phase III clinical trial with data that the firm believes will give it a major advantage over its competitors.
A month after Vanda failed to win a trade secrets case against the US FDA corresponding to generic approvals for its brands Hetlioz and Fanapt, the originator has again fallen, this time to the agency and Teva in the alleged unlawful approval of the Israeli firm’s generic Hetlioz product.
Teva will have to wait until the end of the next decade to launch its proposed generic version of Axsome Therapeutics’ Auvelity treatment for MDD.
While the UK Court of Appeal’s decision in Merck Serono v Comptroller-General will be unwelcome by innovators, it provides much-needed certainty for companies seeking – or seeking to invalidate – supplementary protection certificates based on marketing authorizations for new uses of known active ingredients.
Reporting global Entresto sales of more than $7.8bn in 2024, Novartis spoke to investors on the latest legal dynamics for its best-selling product as the threat of US generic competition from MSN Laboratories continues to loom.
