NOVARTIS

Novartis v. Hetero USA Inc. (2024 WL 3757086) involves a Hatch-Waxman patent infringement action over Entresto®. The court found the ’659 patent invalid for lack of written description, denying Novartis’s injunction request pending appeal. Judge Andrews was skeptical of Novartis’s claims of irreparable harm, noting that MSN’s launch should not be blamed for other generic drug makers’ actions or Novartis’s business decisions. The court granted a temporary stay for Novartis to seek relief from the Federal Circuit.

Bruce Albala, a key figure in Alzheimer's disease drug development, passed away during his 40th wedding anniversary in Greece. Known for his work on β-secretase inhibitors, Albala led Eisai's BACE program, guiding elenbecestat through Phase 3 trials. Despite elenbecestat's limited success, Albala's pragmatic approach and advocacy for safer BACE inhibitor doses were highly regarded. He transitioned to academia in 2019, focusing on improving AD clinical trial efficiency.

FDA considers removing oral phenylephrine from OTC guidelines due to lack of efficacy, not safety concerns. Public comments invited until May 7, 2025, before final decision. Phenylephrine is in many nasal decongestants like Sudafed and Mucinex. FDA's proposal does not affect nasal spray decongestants.

Experts discuss tirzepatide's safety and benefits after a UK death linked to the drug, highlighting the need for high-quality trials and the importance of the 'yellow card scheme' for reporting side effects.

Alcon adopted Veeva Vault in 2019 for clinical data management, reporting, and regulatory compliance. The platform has enabled Alcon to deliver databases quickly, with 35% of its portfolio getting databases in four weeks or less. Customer feedback indicates satisfaction, with 45% of data entered on the same day as the visit date.

The Immunomodulators market is projected to grow from $248M in 2023 to $364.7M by 2030, driven by rising autoimmune diseases, advancements in biologics, and personalized medicine. Immunomodulators are crucial for treating immune-mediated diseases, with technological advancements expanding treatment options. The market segments include immunosuppressants, immunostimulants, and biologics, with biologics leading growth. Key regions like the U.S. and China show significant growth potential.

SEC recommends market authorisation for Dr Reddy's Siponimod tablets (0.25 mg, 1 mg, 2 mg) for secondary progressive multiple sclerosis (SPMS), with conditions including phase IV clinical trials and CYP2C9 Genotype determination.

Ionis Pharmaceuticals (IONS) reported a narrower-than-expected Q3 2024 loss of 95 cents per share, with total revenues of $134 million, beating estimates. The company's shares have declined 22.9% YTD. Ionis receives royalties from Biogen for Spinraza and co-markets Qalsody with Biogen. Wainua, co-marketed with AstraZeneca, was approved in the U.S. and the UK, generating $30 million in milestone payments. Commercial revenues were $76 million, missing estimates. Ionis maintained its 2024 financial guidance, expecting total revenues over $575 million and an adjusted operating loss of less than $475 million.

Chemists at Emory University and Caltech synthesized a complex natural molecule, cylindrocyclophane A, using a revolutionary C-H functionalization strategy, marking a significant advancement in organic synthesis. This method transforms inert C-H bonds into reactive sites, enabling the creation of intricate organic compounds from low-cost materials. The synthesis involved 10 C-H functionalization steps, showcasing the potential of this approach in drug development and materials science.

In 2024, smaller deals have dominated pharma M&A, with no single deal surpassing $5 billion. Despite this, M&A remains crucial for refilling pipelines and supporting smaller biotechs. Notable deals include Vertex's $4.9 billion acquisition of Alpine Immune Sciences, Eli Lilly's $3.2 billion acquisition of Morphic, and Gilead's $4.3 billion purchase of CymaBay. Oncology and neuroscience have seen significant activity, with Novartis and AstraZeneca leading in oncology, and Bristol Myers Squibb and Lundbeck in neuroscience.