Business
ARM’s Cell and Gene Meeting on the Mesa offered optimism that a biopharma financial market recovery is under way, but cell and gene therapies still are seen as risky investments.
Sales of Johnson & Johnson’s Stelara declined 6.6% in the third quarter as the first biosimilars launched in Europe and US sales were softer than expected.
Emerging Company Profile: The Maryland-based biotech is working on a functional cure for type 1 diabetes that is similar to Vertex’s VX-880 – but with some key differences.
The US major is investing over $360m in new money into the UK but the country has being losing its lustre as an appealing place to invest since Brexit and needs to offer more to multinationals.
New product launches come with great expectations, which are sometimes unrealistic. This can lead to disappointment. Lately, market access restrictions are exacerbating sales challenges.
In this week's podcast edition of Five Must-Know Things: making cell and gene therapies more accessible; Roche’s obesity plans; BIOSECURE and Indian firms; IPOs begin to recover; and Nxera looks to the future.
Big pharma executives at ARM’s Cell and Gene Meeting on the Mesa shared some of the practical challenges of bringing one-time treatments to market in hemophilia, cancer and beyond.
Impressed by the data to date on bexicaserin for epileptic encephalopathies syndromes, the Danish drugmaker hopes the drug, through the acquisition of Longboard, will become a cornerstone of its new neuro-rare disease franchise.
The US FDA approved the drug for hemophilia A and B, and while it may struggle to compete in hemophilia A against Roche’s Hemlibra, it has a big convenience advantage in hemophilia B.
Public Company Edition: Upstream grossed $255m and CAMP4 raised $75m in October’s first initial public offerings. In follow-on offerings, Crinetics and Scholar Rock brought in $500m and $300m, respectively. Also, Turnstone cut 60% of its workforce and Gritstone filed for bankruptcy.
Data from Evaluate show that biopharma venture capital investment fell from $7.95bn in Q2 to $6.59bn in Q3, but both outpaced every quarter in 2023 as the financial market recovery continues.
The Swiss company is aiming to regain its innovator status and expand its offering across all breast cancer settings. Approval of Itovebi is just the start.
The French major and partner Denali's attempts to validate RIPK1 as a promising target have once again foundered as oditrasertib comes up short in a multiple sclerosis trial months after a failure in amyotrophic lateral sclerosis.
Recent major developments in the Korean biotech sector include Orum Therapeutics’ IPO plan and HLB’s US resubmission for the approval of rivoceranib in combination with camrelizumab for first-line liver cancer.
The TCR therapy showed strong efficacy and durability in patients with previously treated melanoma. A Phase III pivotal trial is due to start in December.
The biopharma industry posted 22 mergers and acquisitions during the third quarter, according to Evaluate, for a total of $8.2bn. Those tallies marked a second consecutive quarter of decline.
An overall survival benefit for patients in TALAPRO-2 could pave the way for a broader label for the combination in metastatic prostate cancer.
The payout will bring GSK closer to resolving lawsuits which have occupied it for years – though investors are now likely to focus on new product growth concerns at the UK firm.
With more advanced therapies gaining approval, companies at ARM’s Cell and Gene Meeting on the Mesa considered hurdles to making their products more broadly available and developing them for larger indications.
The company is developing the drug as a way to reduce injection burden for wet AMD patients and plans to meet with the US FDA early next year to discuss Phase IIb topline results.