Lenalidomide

Belantamab mafodotin's comeback, FDA approvals for subcutaneous daratumumab-hyaluronidase and expanded CAR T-cell products, and isatuximab-based quadruplet emerging as new standard for transplant-ineligible newly diagnosed multiple myeloma patients.

Zydus Lifesciences plans to acquire commercial assets via M&A or licensing for a specialty portfolio, including potential US launch of liver therapy saroglitazar. The company aims to diversify into medical devices, expand diagnostics and nutrition businesses, and build a specialty play in the US, particularly in orphan and rare diseases. Zydus also targets Europe for M&A, focusing on profitable growth and innovation in unmet medical needs, including orphan and rare diseases. The company is bullish on biologics and globalizing its biosimilars portfolio, with a new facility set to commission in 2025. Zydus received WHO approval for a typhoid conjugate vaccine and expects significant supply orders from UNICEF. The company remains committed to the US market despite potential pricing pressures and political changes.

EMA’s CHMP recommends Sanofi’s Sarclisa with VRd for newly diagnosed MM in transplant-ineligible patients, based on Phase III IMROZ trial results. Sarclisa, approved in over 50 countries for relapsed or refractory MM, shows no new safety concerns when combined with VRd. Sanofi aims to establish a new standard-of-care in the EU.

Bristol-Myers Squibb (BMY) benefits from biopharma market growth and rival AbbVie's trial setback, with BMY stock up 10.5%. CMO Samit Hirawat's $100,000 insider purchase adds confidence. BMY leads in oncology and offers a 4.39% dividend yield. Q3 earnings beat estimates, driven by Eliquis and Opdivo, with FDA approval for Cobenfy in schizophrenia. Analysts have a 'Hold' consensus on BMY stock.

Dr Reddy's Labs reported highest-ever Q2 revenue of Rs 8,016 crore, but net profit dropped 15% to Rs 1,255 crore due to acquisition costs and impairment charges. Brokerages remain neutral, citing lack of strong drug pipeline and elevated SG&A costs. Dr Reddy's plans to launch biosimilar Abatacept by 2027 and capture GLP-1 and peptides’ opportunity, but faces skepticism from Citi and Jefferies.

The FDA's approval of luspatercept for first-line treatment of anemia in lower-risk MDS patients without prior ESA use expands treatment options, emphasizing efficacy and QOL. Jorge Cortes highlights the need to balance these factors, noting luspatercept's significant impact on QOL compared to ESAs. The ultimate goal is to improve symptoms and QOL, though MDS remains incurable, with ongoing research focusing on altering the disease's natural history.

USPTO's Drug Patent and Exclusivity Study debunks false narratives about pharmaceutical patents, revealing that none of the 25 high-value medicines studied had more than 18 years of exclusivity, countering accusations of patent manipulation.

Cipla's Q2 earnings on Oct 29 expected to show 5% net profit growth to Rs 1,215 crore and 5% revenue growth to Rs 6,996 crore, with EBITDA margin around 26%. US sales growth forecast at 3% to $235 million, domestic sales likely high single-digit growth. Margin growth expected to remain capped due to lack of high-margin drug launches in the US.

Johnson & Johnson seeks EU approval for D-VRd combo, including subcutaneous Darzalex, for newly diagnosed multiple myeloma patients. The therapy, already approved in the U.S. for transplant-eligible patients, aims to improve frontline treatment outcomes. Based on Phase 3 CEPHEUS trial data, D-VRd showed a 43% reduction in death or disease progression and 60% of patients had no detectable cancer cells.

AURIGA study shows daratumumab plus lenalidomide significantly improves MRD-negative conversion rates (50.5% vs 18.8%) in newly diagnosed myeloma patients post-ASCT, with benefits across all risk subgroups.