New Products
Big pharma once again fails to dominate the top 20 expected best sellers from products due for launch this year. Small-to-medium pharma account for nearly half the list, while Vertex has two products in the top five.
The FDA approved Vimkunya on 14 February as the first vaccine for preventing chikungunya in adolescents as well as adults.
Kostaive is the first self-amplifying mRNA COVID-19 vaccine to receive approval from the European Commission and could provide serious competition to Pfizer/BioNTech's Comirnaty and Moderna's Spikevax.
Pfizer has been unable to take a big slice of the meningococcal vaccine market with Penbraya and now GSK looks set to consolidate its lead with its new 5-in-1 vaccine.
The Swedish company is celebrating approval for the first treatment for MCT8 deficiency
After coming up blank with its in-house oncology efforts, the German conglomerate is mulling a deal to acquire the US specialist company which has just managed a new drug approval for mirdametinib.
A manufacturing inspection issue may have put paid to J&J getting a rapid approval for its subcutaneous version of Rybrevant in the US, but a positive opinion from the CHMP plus an expanded EU approval for the IV version are two recent boosts to a franchise taking aim at Tagrisso’s crown.
Novartis enjoyed exceptional growth in 2024, and its US leader, Victor Bulto, puts that down to greater R&D and commercial co-ordination paying off with drugs such as Kisqali in early breast cancer.
The drug maker won US FDA approval for the pain reliever in moderate to severe acute pain, but it has plans to expand into chronic pain as well.
Cancer retained its crown as 37 novel drugs were approved for pan-EU marketing last year; treatments for blood disorders followed closely behind in what was another slow year at the European Medicines Agency.
The FDA green light for Datroway in breast cancer marks the first for a TROP2-directed antibody-drug conjugate and is a relief for partners AstraZeneca and Daiichi Sankyo after multiple filing mis-steps in its lung cancer indication.
Big pharma is under pressure to find the next big thing, and new launches bring high hopes. But focusing on the number of new drugs approved each year may mislead on the sector’s success if profitability and significant sales elude a majority.
Throughout 2024, Chinese firms as sole sponsors initiated a total of seven global Phase III trials that including US sites. BeiGene, Genfleet and InnoCare are expected to add four similar studies this year.
Just a handful of big pharma approvals of 2024 are tipped to be multi-billion dollar blockbusters. Even though it is still early days for these drugs, the pull of M&A is looking increasingly strong for big pharma as more smaller firms go it alone.
The year’s new drugs included the first drug approved for non-alcoholic steatohepatitis (NASH) and two drugs for primary biliary cholangitis (PBC).
Vertex hopes to convert CF patients to new combo Alyftrek from Trikafta with once-daily dosing. Approved on 20 December, the new triplet has longer patent protection and 7% higher US pricing.
The antisense oligonucleotide specialist is ready to launch its rare disease therapy Tryngolza but could face competition from a more potent rival by mid-2025.
The cell therapy won approval for pediatric steroid-refractory acute graft versus host disease after two complete response letters over the last four years.
Nemluvio is the first IL-31 inhibitor approved by the US FDA for atopic dermatitis and will compete with Sanofi/Regeneron’s Dupixent and other, newer IL-13 inhibitors.
China’s fresh approval of a sublingual form of Simcere's edaravone/dexborneol brain cytoprotective agent for acute ischemic stroke is paving the way for an international Phase III study in this indication.