Sandoz Group AG

US drug shortages decreased to 277 in Sept 2024, with 50% lasting 2+ years. Key shortages include ADHD meds, pain treatments, chemotherapy drugs, insulin, and diabetes/weight loss meds. IV fluids added due to Hurricane Helene impacting Baxter's production.

The future of a sustainable biosimilars market in the US hinges on strategic legislative reforms, improved education for stakeholders, and a robust reimbursement framework, according to a panel of industry leaders at the GRx+Biosims 2024 conference. Biosimilars have saved $36 billion in 2023 and delivered nearly 3 billion days of patient therapy without clinically significant differences from originator biologics. The discussion highlighted the need for expanding biosimilars across therapeutic areas, streamlining approval processes, and educating the public. The panel also emphasized the importance of a balanced reimbursement model and the role of pharmacy benefit managers (PBMs) in biosimilar uptake. The Inflation Reduction Act's implications were also discussed, with concerns about its potential to limit biosimilar competitiveness unless paired with sustainable reimbursement. The session concluded with a call for collaborative action to ensure biosimilars' accessibility and sustainability.

JPMorgan maintains Overweight rating on CIPLA:IN stock with a target of INR 1,600.00, following the Goa plant's VAI classification by the US FDA. This positive development could expedite the launch of gAbraxane, anticipated to contribute 2-3% to CIPLA's core earnings by FY2026-2027.

Cipla Ltd. shares rose 10% after USFDA granted VAI status to its Goa facility, enabling the launch of Abraxane, a $700 million market cancer drug.

Cipla Ltd. shares surged 10% after USFDA classified its Goa facility as 'Voluntary Action Indicated', enabling key niche launches like the Abraxane generic. Citi expects potential $24-$48 million sales in FY26-27, with a 'buy' recommendation and price target of ₹1,830.

The FDA accepted a BLA for HLX14, a biosimilar of denosumab, based on comparative quality and clinical studies. HLX14 met primary endpoints in a phase 3 trial, showing efficacy and safety in osteoporosis treatment. In March 2024, the FDA approved two denosumab biosimilars from Sandoz, marking the first approvals for biosimilars of Prolia and Xgeva.

Swiss National Bank mulls interest rate cuts; Novartis gains FDA approval for leukemia drug Scemblix; UBS posts $1.4 billion Q3 profit. These developments reflect shifting financial strategies and innovation balancing economic stability.

Keytruda, a cancer drug, achieved $25 billion in global sales, treating 40 cancers in the US and 17 in India. Its mechanism activates the immune system to fight cancer cells, categorized as immunotherapy. Despite high costs, it has shown remarkable results in some cases, prompting Indian drugmakers to develop affordable biosimilars as patents expire.

Federal Circuit denies Regeneron's request for injunction pending appeal against Amgen's biosimilar aflibercept launch, expediting the case for January 2025 oral arguments.