This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
Eisai and Biogen have received approval for their antibody Leqembi (lecanemab-irmb) , 100mg/mL injection for intravenous use, from the US Food and Drug Administration (FDA) under the Accelerated Approval Pathway to treat Alzheimer’s disease (AD). The regulatory approval is based on the data obtained from the Phase II trial.
The approval was based on findings from the international, randomised, open-label Phase III DESTINY-Breast04 clinicaltrial. Furthermore, Enhertu’s safety profile was in line with prior clinicaltrials without any new safety concerns detected. Enhertu-treated subjects had a median overall survival (OS) of 23.4
The regulatory agency carried out the review of the Biologics License Application (BLA) for the therapy under the Priority Review approach. bluebird bio was granted a rare paediatric priority review voucher following approval. thalassemia.
Related: FDAApproves New Use for Ozempic to Reduce the Risks of Kidney Disease Maze stands out in the biotech space with its Compass platform, which analyzes genetic data to identify disease-linked variants. To further expand its research, Maze has entered several strategic partnerships and licensing agreements.
Semglee was approved under the FDA’s 351(k) pathway, a biologics license application process. It ensures that the bio similarity is based on animal studies, clinicaltrials, and analytical studies.
While a rumoured takeover by Merck & Co has yet to materialise, Seagen is getting on with its own business development, including a just-agreed licensing deal for a cancer immunotherapy developed by Dutch biotech Lava Therapeutics. The biotech said earlier it planned to seek FDAapproval to start clinicaltrials towards the end of 2022.
MediWound, a biopharmaceutical company focused on biotherapeutic solutions for tissue repair and regeneration, announced that the US Food and Drug Administration (FDA) approved their orphan biological product NexoBrid (anacaulase-bcdb) for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns.
Efficacy of Cyfendus The FDAapproval of the Cyfendus anthrax vaccine is grounded in a series of studies supported by the US government and carried out by Emergent. Additionally, 533 participants received at least one dose of the comparator-licensed anthrax vaccine, BioThrax (Anthrax Vaccine Adsorbed). Overall, 66.3
The therapy is indicated for endometrial cancer that has progressed during, or following, prior treatment with a platinum-based chemotherapy, and in women with dMMR tumors as determined by an FDA-approved test. The immunotherapy received approval as a monotherapy based on GSK’s Biologics License Application (BLA).
Eli Lilly’s Olumiant (baricitinib) has won US Food and Drug Administration (FDA) approval as the first systemic treatment for severe alopecia areata (AA), an autoimmune disorder that leads to patchy baldness. The Olumiant approval is therefore a big win as it helps fulfill a significant unmet need in the area.
In March, Horizon received FDA priority review for its supplemental Biologics License Application (sBLA) for the expanded labelling of Krystexxa. XTALKS WEBINAR: Beyond the EHR: ClinicalTrials in the Age of Abundant Data. There were no new safety signals reported in the trial.
Sling Therapeutics has positive topline results from its Phase IIb/III LIDS clinicaltrial evaluating its oral small-molecule therapy linsitinib for the treatment of thyroid eye disease (TED). Sling Therapeutics in-licensed linsitinib from Astellas Pharma at the time of its launch as a company in 2022.
Cidara Therapeutics announced the receipt of a $20m milestone payment from Melinta Therapeutics following the US Food and Drug Administration (FDA) approval of its antifungal treatment Rezzayo. In July 2022, Cidara gave Melinta US licensing rights for rezafungin following submission to the FDA.
Related: Arrowhead Pharmas New Rare Disease Campaign for FCS Highlights Importance of Lowering Triglycerides The FDAsapproval of Crenessity was based on two randomized, double-blind, placebo-controlled trials in 182 adults and 103 children with classic CAH. billion in revenue by 2024.
According to the deal, Horizon will provide the funding to develop the therapy until the conclusion of its two Phase II clinicaltrials. Under the agreement, Horizon will hold an option for the acquisition of the ADX-914 programme, which is exercisable through a period after concluding the Phase II trials.
Brexafemme is claimed to be the only oral antifungal to receive approval from the US Food and Drug Administration (FDA) to treat VVC, as well as reducing RVVC incidence. Ibrexafungerp is currently being evaluated in Phase III clinicaltrials to treat invasive candidiasis (IC), a life-threatening fungal infection.
Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely.
Akili already has the first and only FDA cleared video game-based digital therapeutic (DTx) for children with attention-deficit hyperactivity disorder (ADHD), but is looking to add to its range via a licensing deal with Australia’s TALi Digital. .
Approval of the Month: Repurposed Transplant Drug Approved Based Only on Real-World Evidence. In July, Astellas Pharma US received FDAapproval for the use of Prograf (tacrolimus) capsules, injection, and oral suspension for the prevention of lung transplant rejection.
. “Rolontis,” a treatment for neutropenia that had its technology licensed out to Spectrum Pharmaceuticals, Inc. and “Oraxol,” which was licensed out to Athenex, Inc. FDAapproval this year. Belvarafenib (HM95573, solid tumor) , which was licensed to Genentech, Inc.,
U.S.
According to pre-clinical findings, a booster dose of this vaccine elicited a robust neutralising antibody response against the variants Omicron BA.1, A clinicaltrial of the vaccine to assess its safety, tolerability and immunogenicity in people aged 12 years and above is anticipated to commence this month.
In this episode, Ayesha discussed a new COVID-19 test technology that Innova Medical Group, world leader in at-home COVID-19 tests, has reached a licensing deal for with the University of Birmingham where the technology was developed. AstraZeneca’s Enhertu Gets FDAApproved as First Therapy for HER2-Low Breast Cancer.
It is estimated that Rett syndrome affects 6,000 to 9,000 patients in the US, with a diagnosed population of approximately 4,500 patients, according to a press release from Acadia announcing Daybue’s approval. However, in animal studies, trofinetide has been shown to increase dendritic branching and synaptic plasticity signals.
With a list price of $3 million and a recent accelerated US Food and Drug Administration (FDA) approval, bluebird bio’s gene therapy Skysona (elivaldogene autotemcel, eli-cel), has officially become the world’s most expensive drug. Gene Therapy Zynteglo Wins Landmark FDAApproval for Beta Thalassemia.
(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to expand the approval of COMIRNATY® (COVID-19 Vaccine, mRNA) to include individuals ages 12 through 15 years.
FDAApproves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. It’s very exciting to see this treatment go from being an experimental therapy used at my daughter’s bedside to now being FDAapproved. The FDA granted approval under the accelerated approval regulation. NEW YORK, Nov.
Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S. Following today’s FDAapproval, the U.S. in 1-15 year olds and 98.7-100%
Like with small molecules, clinicaltrials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. A 351(K) application must include information explaining that the biosimilarity is completely based on the data related to animal studies, clinical studies, and analytical studies.
While allogeneic hematopoietic stem cell transplants (HSCT) provide long-term benefit to a subset of AML patients, other cell therapy modalities such as natural killer (NK) cells or chimeric antigen receptor (CAR)-T cells have failed to show conclusive benefit in late-stage clinicaltrials.
A Potential New Treatment for Atopic Dermatitis Biopharma company Almirall recently announced the publication of positive Phase III data from two clinical studies, ADvocate1 and ADvocate2 , that evaluated lebrikizumab as a monotherapy in adult and adolescent patients with atopic dermatitis. Dupixent inhibits signaling of both IL-4 and IL-13.
Spectrum filed for accelerated approval of poziotinib as a second-line treatment for patients with HER2 exon 20 insertion-mutated, non-small cell lung cancer (NSCLC), but the FDA was unconvinced by the phase 2 data presented in support of the drug.
We will now rapidly move to initiate our Phase 2 trial of Berubicin for adults with GBM and expect to begin enrolling patients in the first quarter of next year,” commented John Climaco , CEO of CNS Pharmaceuticals. and 2 trials planned by our sublicensee WPD in Poland.
Three patients from the phase 1/2 trial – two aged under six at the time of treatment and one aged 13 – showed improvements in skills like cognition, expressive language and fine motor skill acquisition than would be expected if untreated. The post Regenxbio expands MPS I gene therapy trial after first look at data appeared first on.
Steven Joffe from the University of Pennsylvania’s Perelman School of Medicine found that the FDAapproved 99% of all expanded access requests for almost 9,000 investigational drugs. To apply for Expanded Access: The patient consults with their licensed physician to make sure they have exhausted all other treatment options.
At its second attempt, Novartis has won FDAapproval for its cholesterol lowering drug inclisiran, which can reduce levels with just two injections a year. Novartis added inclisiran to its pipeline after buying The Medicines Company – which had licensed the drug from Alnylam – for $9.7 It has a long way to go.
The FDA also issued a Rare Pediatric Disease Priority Review Voucher (PRV) to Ipsen that can be used for subsequent drug applications that would not qualify for a priority review. The FDAapproval of Sohonos is a breakthrough for the US FOP community,” said Howard Mayer, head of R&D at Ipsen, in the company’s news release.
Related: After 18 Years, FDAApproves Malaria Prevention Drug. It is the world’s first and only licensed malaria vaccine and also the first licensed for use against a human parasitic disease of any kind. Currently, the only other viable malaria vaccine, known as RTS,S/AS01 (Mosquirix), has a demonstrated efficacy of 55.8
Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1] Haematologica.
This has been borne out in a Phase 2 clinicaltrial, which demonstrated evidence that prophylactic administration of Quercis’ investigational drug reduced levels of key markers of coagulation, without observed VTE or major bleeding events 2. ZUG, Switzerland , Jan. Chief Medical Officer of Quercis Pharma.
Fast Track designation is well-timed, as we anticipate starting our Phase 2 clinicaltrial in hospitalized COVID-19 patients this month, and should help bring Brilacidin to patients faster in these dire times.”. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A.
Phase III BRIDGE open-label, switch-over clinicaltrial met key objectives for safety and efficacy.
” In May 2020 , Protalix and Chiesi Global Rare Diseases announced the submission of a Biologics License Application (BLA) to the U.S. Protalix has licensed to Pfizer Inc.
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking expanded approval of STELARA® (ustekinumab) to treat pediatric patients ages 5 years and older with juvenile psoriatic arthritis (jPsA).
This is because it has been nearly two decades since a drug was last approved for Alzheimer’s disease. However, despite the welcome news, there are some within the scientific community that remain aducanumab skeptics owing to conflicting results from previous clinicaltrials.
The results of the Phase II trial in patients with IgA nephropathy have been encouraging, and we look forward to completion of the Phase III trial and submission of the Biological Licensing Application (BLA) to the US FDA and other global regulatory authorities,” said Brian J. How Does Sibeprenlimab Work? “The
We organize all of the trending information in your field so you don't have to. Join 21,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content