UCB Gets FDA Approval for Generalized Myasthenia Gravis
UCB’s Rystiggo (rozanolixizumab-noli), a treatment for two subtypes of generalized myasthenia gravis (gMG), has been approved by the US Food and Drug Administration (FDA). Muscle weakness episodes in the rare autoimmune disease is caused by antibodies that cling to proteins at the connection site between nerves and muscles. Rystiggo, an antibody-based treatment, reduces circulating antibodies and reduces symptoms.
FDA Grants Roche Accelerated Approval for Lymphoma Therapeutics
The US Food and Drug Administration (FDA) has granted Roche accelerated approval for Columvi, its antibody-based therapeutics for two aggressive forms of lymphoma. Results from a phase 1/2 study found the drug provided durable remission for over half of patients and a complete response for 43%, with 66% continuing to respond for 9 months or longer.
FDA Grants Full Approval of Amgen’s Supplemental Biologics License Application for Leukemia Treatment
Amgen’s supplemental biologics license application (sBLA) for its leukemia treatment Blincyto has received full approval by the US Food and Drug Administration (FDA). The move comes based on new data from two phase 3 trials, upgrading the treatment’s accelerated approval to a full approval in the treatment of CD19-positive B-cell precursor acute lymphoblastic leukaemia (B-ALL).
Patients Regularly Switch Between Psoriasis Biologics
A recent real-world data study published in the Journal of Dermatological Treatment finds that patients with psoriasis change up their biologic therapeutics. Claims data from nearly 8,000 patients taken revealed that, on average, 14.4% of patients changed biologics within 12 months of the study’s two year period, while over a quarter swapped by 24 months.
NICE Issues Final Draft Guidance Recommending Tezspire for Severe Asthma
The UK’s National Institute for Health and Care Excellence (NICE) released a final draft guidance recommending the use of Amgen and Astrazeneca’s Tezspire in maintenance treatment for some patients with severe asthma. The biologic is the only one of its kind, targeting an important asthma-related inflammatory protein.
Twist Biosciences Unveils Factory It Says Could Make Biologic Prices Competitive
Twist Biosciences, a biotech specializing in DNA synthesis, has revealed details of its new, state-of-the-art facilities the company says may drive competitive pricing in nucleic acid biologics. The facility, set in Oregon, US, is equipped with four DNA manufacturing devices and has room to grow, up to a total of 12. In addition, the upgrades will help speed production in other ways.
Whitepaper: Early Product Characterization Mitigates Risks in Biologics Development
Product characterization has become much more complicated with the increased focus on biologics. Despite this, it is an essential part of the drug development process that can no longer be standardized. Learn more about product characterization and how to implement effective strategies In a new whitepaper by BioReliance.
US Drug Launch Prices Higher Than Ever in 2022
A Reuters analysis has found that US launch prices for new drugs are approaching record highs. The study found this year’s median annual price of 13 drugs recently approved by the Food and Drug Administration (FDA) for chronic conditions is $257,000, with seven other drugs reaching the $200,000+ range. The report comes as the Democrat’s signature Inflation Reduction Act is signed into law, which would let Medicare negotiate the prices of a small number of expensive drugs.
Podcast: Live Biologics & the Microbiome with 4D Pharma’s Duncan Peyton
Live biotherapeutics are key early-stage clinical candidates of 4D Pharma, building on increasing knowledge of the microbiome. In the latest [...]
FDA and Industry Set Priorities Through Prescription Drug User Fee Act (PDUFA) Reauthorization
The FDA first began the Prescription Drug User Fee Act (PDUFA) reauthorization process in July. Now the agency has released [...]
The Importance of RWE in FDA Approvals
RWE is now helping the U.S. Food and Drug Administration (FDA) to approve more drugs than ever. In 2019, RWE [...]
Report: Biosimilars Drive Down Prices of Biologics
A recent study published in JAMA Network Open suggests biologics filgrastim, pegfilgrastim, infliximab and insulin glargine all saw their prices [...]
