2024 has been a year of breakthroughs. Scientists developed the first graphene-based semiconductor, generative AI took center stage, and NASA launched its Europa Clipper spacecraft to explore Jupiter’s moon to determine its astrobiological potential.
Meanwhile, pharma had its own standout moments. FDA approvals like Iovance’s Amtagvi, the first T-cell therapy for solid tumors, and BMS’ Cobenfy, the first antipsychotic targeting cholinergic receptors for schizophrenia, marked a new era of therapeutic approaches.
Here’s a look at the biggest moments in pharma this year.
Biggest pharma M&A deals
Novo’s $16.5 billion Catalent acquisition
In February, Novo Holdings, the parent company of Novo Nordisk, announced its acquisition of Catalent for $16.5 billion in cash. As part of this deal, Novo Nordisk also bought three Catalent fill-finish sites for $11 billion to boost production of its popular weight loss drugs like Ozempic and Wegovy.
BMS’ $14 billion acquisition of Karuna Therapeutics
Finalized in March, this deal gave Bristol Myers Squibb ownership of KarXT, a novel antipsychotic drug approved later in the year. This acquisition adds a key psychiatric treatment to BMS’s pipeline, with significant financial implications as the transaction is expected to reduce the company’s 2024 earnings by about $0.30 per share due to financing costs.
J&J’s $13.1 billion Shockwave deal
In April, Johnson & Johnson completed its $13.1 billion acquisition of Shockwave Medical, a company known for its intravascular lithotripsy (IVL) technology used to treat calcified arterial lesions. This acquisition program supports its rollout and ensures accessibility and strengthens J&J’s position in cardiovascular intervention, expanding into calcified coronary artery disease (CAD) and peripheral artery disease (PAD) segments.
AbbVie’s $8.7 billion acquisition of Cerevel Therapeutics
AbbVie finalized its acquisition of Cerevel Therapeutics in August, adding promising clinical-stage assets to its neuroscience portfolio. This includes treatments for schizophrenia and Parkinson’s, such as emraclidine and tavapadon, which are in advanced clinical trials. This deal helps AbbVie strengthen its presence in the neuropsychiatric treatment space.
Most anticipated drug approvals
Eli Lilly’s donanemab
Approved in July, Eli Lilly’s donanemab targets beta-amyloid plaques to slow early Alzheimer’s progression. Initially rejected for accelerated approval in 2023, it gained traditional approval after phase 3 trials showed significant cognitive decline reduction.
BMS’ KarXT
In September, Bristol Myers Squibb’s Cobenfy (xanomeline and trospium chloride) became the first antipsychotic targeting cholinergic receptors for schizophrenia, moving away from dopamine-targeting drugs. Trials showed significant symptom reduction but warned of side effects like urinary retention and liver issues.
Amtagvi for solid tumors
In February, the FDA granted accelerated approval to Iovance’s Amtagvi (lifileucel), the first T-cell therapy for solid tumors and for advanced melanoma post-anti-PD-1 therapy. This one-time immunotherapy uses T-cells to attack cancer and is indicated for adults with unresectable or metastatic melanoma who have already undergone PD-1 and BRAF inhibitor treatments.
Pfizer’s gene therapy for hemophilia B
In April, Pfizer’s Beqvez was approved as a one-time gene therapy for moderate to severe hemophilia B, reducing the need for frequent factor IX infusions. Priced at $3.5 million per treatment, Pfizer also launched a program to support its rollout and ensure accessibility.
Best-selling drugs of 2024
Keytruda: Merck’s cancer immunotherapy is set to dominate the market, with projected 2024 sales of $30 billion. The drug continues to grow thanks to expanded indications across various cancers, solidifying its place as one of the top-selling therapies globally.
Ozempic: Novo Nordisk’s GLP-1 receptor agonist for diabetes and weight loss is expected to hit $14 billion in sales this year. Its popularity has soared due to its effectiveness in weight management, creating a booming market demand beyond diabetes treatment.
Eliquis: Co-marketed by BMS and Pfizer, this anticoagulant is projected to bring in $11 billion in 2024. It remains a key treatment for stroke prevention and blood clot management, especially in patients with atrial fibrillation.
Dupixent: Regeneron and Sanofi’s blockbuster anti-inflammatory drug is expected to reach $13 billion in sales this year. Originally approved for eczema, Dupixent has expanded into treatments for asthma, eosinophilic esophagitis, and other inflammatory conditions, driving its market growth.
Worst regulatory letdowns
Rocket’s rare disease gene therapy
In June, Rocket’s gene therapy for leukocyte adhesion deficiency (LAD-I) was delayed after the FDA issued a complete response letter requesting additional manufacturing data. This setback came after a three-month review extension.
Daiichi Sankyo and Merck’s lung cancer ADC
In June, the FDA issued a CRL for their lung cancer therapy, patritumab deruxtecan, due to manufacturing issues at a third-party facility. Despite the safety and efficacy of the drug, approval was stalled.
Lykos PTSD treatment
Lykos Therapeutics received a CRL from the FDA in June for its midomafetamine capsules for PTSD. The agency recommended further phase 3 trials to assess safety and efficacy, following concerns raised during an FDA Advisory Committee meeting.
Vanda gastroparesis drug
The FDA rejected Vanda Pharmaceuticals’ application for tradipitant in September, citing insufficient evidence for approval. Despite data from placebo-controlled studies and real-world evidence, the FDA requested further studies, which Vanda argued aren’t necessary. The company also intends to submit a new application for tradipitant to treat motion sickness later this year.
