The Treasury Department announced a deal with G-7 allies that will exclude US companies from some taxes imposed by other countries in exchange for removing the Section 899 “revenge tax” proposal from President Donald Trump’s tax bill.
“OECD Pillar 2 taxes will not apply to U.S. companies, and we will work cooperatively to implement this agreement across the OECD-G20 Inclusive Framework in coming weeks and months,” Treasury Secretary Scott Bessent said on social media Thursday.
Adial Pharmaceuticals, Inc. (NASDAQ:ADIL), a micro-cap pharmaceutical company with a market capitalization of $3.62 million, has secured manufacturing agreements with Thermo Fisher Scientific and Cambrex to produce its investigational alcohol use disorder treatment AD04, the company announced Wednesday.
The agreements cover production of AD04 (0.33 mg ondansetron tablets) for upcoming clinical trials and the planned New Drug Application submission to the U.S. Food and Drug Administration. Demonstration batches required before registration and clinical batches have already been completed. With its current ratio of 1.99,
Thermo Fisher will serve as the Contract Development and Manufacturing Organization for the drug product, while Cambrex will supply the ondansetron active pharmaceutical ingredient under an FDA-approved Drug Master File.
"These agreements with Thermo Fisher and Cambrex are another key component in our planning for the upcoming conduct of the AD04 clinical trial program and to meet our requirements for the FDA," said Cary Claiborne, President and CEO of Adial Pharmaceuticals.
The collaboration includes manufacturing for clinical supplies and preparation of Chemistry, Manufacturing, and Controls documentation required for FDA submission.
AD04 is Adial’s genetically targeted, serotonin-3 receptor antagonist being developed for Alcohol Use Disorder in heavy drinking patients. The company recently completed its ONWARD pivotal Phase 3 clinical trial, which showed promising results in reducing drinking with no overt safety concerns.
Novartis entered into a four-year partnership with Flagship Pioneering’s ProFound Therapeutics to discover and develop novel protein therapies for cardiovascular conditions.
The deal, announced Thursday, has Novartis promising $25 million in upfront and near-term milestone payments and will be on the hook for downstream milestones worth $750 million per target. ProFound will also be entitled to tiered royalties. The companies did not disclose how many targets they plan on going after, nor did they identify which specific indications they will focus on.
Proteins are at the center of the ProFound partnership. The companies will leverage the startup’s ProFoundry platform, which looks for novel drug targets within the human proteome, the collection of all human proteins, aided by computational and predictive AI models to accelerate the process.
Fiona Marshall, president of biomedical research at Novartis, said in a statement on Tuesday that through the ProFound collaboration, the pharma aims to “explore under-researched biology, uncover new mechanisms, and translate pioneering science into life-changing treatments.”
With Thursday’s announcement, ProFound joins fellow Flagship startup Generate:Biomedicines, which inked a pact with Novartis in September 2024. The AI-focused deal involved a $65 million upfront commitment and carries the potential for hefty performance-based milestones, giving the arrangement an overall value of up to $1 billion. Generate will leverage its generative capabilities to discover and develop protein therapeutics for Novartis to study in the clinic.
Novartis already has a strong presence in the cardiovascular space with its heart failure drug Entresto, which in 2024 surged 31% year-on-year to bring in more than $7.8 billion. Despite its double-digit growth, however, Entresto is currently under threat from generic competitors, which Novartis is trying hard to block.
Beyond Entresto, Novartis also has the siRNA therapeutic Leqvio, approved in 2021 to lower cholesterol in patients with clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia. In August last year, the pharma released Phase III data showing that Leqvio could strongly lower levels of low-density lipoprotein cholesterol in patients who were at low or moderate risk of developing ASCVD, potentially opening up avenues for label expansion.
In February, Novartis dropped $925 million upfront and pledged up to $2.15 billion in regulatory and sales milestones to acquire Anthos Therapeutics and its blood thinner abelacimab. The investigational antibody targets Factor XI, a key clotting protein. In 2019, Novartis helped launch Anthos alongside Blackstone Life Sciences, in the process offloading abelacimab to the startup.
The pharma is now studying abelacimab in three Phase III studies, including one in atrial fibrillation and two in cancer-associated thrombosis.
The Advisory Committee on Immunization Practices (ACIP), made up of members recently hand-selected by Health and Human Services Secretary Robert F. Kennedy Jr., voted 5-1 on Thursday to recommend against flu vaccines containing the preservative thimerosal.
One committee member, Vicky Pebsworth, abstained on each vote.
A few moments before, the CDC's vaccine advisory committee voted 6-0 to recommend all Americans aged 6 months and older receive an annual influenza vaccine.
