The end of the beginning: Lilly execs eye top spot in burgeoning Alzheimer's market after Kisunla's FDA approval
Fierce Pharma
JULY 11, 2024
Alzheimer’s disease marketing at Eli Lilly, said during a recent interview.
US FDA approves Daiichi Sankyo-AstraZeneca’s Enhertu for lung cancer
Pharmaceutical Technology
AUGUST 12, 2022
A specifically engineered HER2-directed antibody drug conjugate (ADC), Enhertu is being co-developed and co-marketed by Daiichi Sankyo along with AstraZeneca. Enhertu is claimed to be the first HER2-directed therapy to receive approval for treating HER2 mutant metastatic NSCLC patients. “We In the trial, 1.9%
FDA Approval 
264
264 Join 32,000+
Insiders
Sign Up for our Newsletter
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
FDA approves Biotests’s plasma-derived treatment for immunodeficiencies
BioPharma Reporter
JUNE 20, 2024
Biotest, a subsidiary of Grifols, has received FDA approval for Yimmugo, a treatment for primary antibody deficiency syndromes (PID)
FDA Approval 52
52 
Three trends in the antibody-drug conjugate (ADC) market
Drug Discovery World
JUNE 1, 2023
Antibody-drug conjugates (ADCs) are biopharmaceutical products in which a monoclonal antibody (mAB) is linked to a small molecule drug with a stable linker 1. A Nature publication confirmed that there are currently 12 FDA-approved ADCs on the market, and nine of these secured FDA approval in the past six years 2.
Antibody 98
98 
Seagen, Genmab win speedy FDA approval for cervical cancer drug
Bio Pharma Dive
SEPTEMBER 21, 2021
Tivdak, a type of drug known as an antibody-drug conjugate, is the fourth approved medicine for Seagen and its third to reach market since December 2019.
FDA Approval 279
279 
Roche follows AbbVie with FDA approval for dual-targeting lymphoma drug
Bio Pharma Dive
JUNE 16, 2023
The approval of Columvi adds another “bispecific antibody” to the market, highlighting the fast research progress for drugs that target two proteins rather than one.
FDA Approval 171
171 
AstraZeneca-Daiichi Sankyo’s Enhertu gets US FDA approval for breast cancer
Pharmaceutical Technology
AUGUST 8, 2022
With the approval for this indication, AstraZeneca is entitled to make a milestone payment of $200m to Daiichi Sankyo under a partnership deal signed in 2019. A HER2-directed antibody-drug conjugate (ADC), Enhertu is co-developed and marketed by AstraZeneca and Daiichi Sankyo.
FDA Approval 264
264 
Celltrion’s Yuflyma receives US FDA approval for multiple conditions
Pharmaceutical Technology
MAY 25, 2023
It is already the first proposed high-concentration (100mg/mL), low-volume and citrate-free adalimumab biosimilar in the world to receive marketing authorisation from the European Commission. Yuflyma is a recombinant fully human anti–tumour necrosis factor α (anti-TNFα) monoclonal antibody.
FDA Approval 130
130 
Lilly’s Ulcerative Colitis Therapy Mirikizumab Finally Snags FDA Approval
BioSpace
OCTOBER 26, 2023
Following an FDA rejection and a previous discontinuation in psoriasis, Eli Lilly’s anti-IL-23 antibody has finally won an approval in ulcerative colitis, joining a crowded inflammatory bowel disease market.
FDA Approval 120
120 
Roche, AbbVie to Compete for Lymphoma Market Share with New BsAbs
BioSpace
JUNE 15, 2023
With Roche’s FDA approval on Thursday, both companies' bispecific antibodies will hit the market this summer for relapsed or refractory diffuse large B-cell lymphoma.
Marketing 85
85 
Therapeutic antibody potential in 2024
Drug Discovery World
MAY 1, 2024
DDW’s Megan Thomas speaks to industry experts and thought leaders about the potential for therapeutic antibodies in 2024. Many of the best-selling drugs in 2023 were monoclonal antibody (mAB) therapies, including Keytruda (pembrolizumab), Humira (adalimumab), and Dupixent (dupilumab) 1.
Antibody 59
59 
Ogsiveo Receives FDA Approval as First Therapy for Desmoid Tumors
XTalks
NOVEMBER 30, 2023
Pfizer spinout SpringWorks Therapeutics’ Ogsiveo (nirogacestat) has received US Food and Drug Administration (FDA) approval for the treatment of desmoid tumors, an ultra-rare subtype of non-cancerous soft tissue sarcomas that can cause severe pain and disfigurement.
FDA Approval 101
101 
2024 predictions: Experts comment on monoclonal antibodies
Drug Discovery World
MARCH 12, 2024
Here, experts weigh in on the future of monoclonal antibodies (mAbs). Amanda Halford, President Bioprocess, Cytiva “In 2024, the emphasis will remain on novel mAbs, specifically antibody drug conjugates. Innovations include next-generation antibodies with improved efficacy and reduced side effects.
Antibody 81
81 
Cyltezo Becomes First FDA-Approved Interchangeable Humira Biosimilar
XTalks
OCTOBER 22, 2021
Boehringer Ingelheim’s Cyltezo has become the second interchangeable biosimilar approved by the FDA, and the first approved interchangeable monoclonal antibody. In July 2021, the agency approved the first interchangeable biosimilar product, Semglee (insulin glargine-yfgn) for the treatment of diabetes.
FDA Approval 98
98 
Market cap growth surges for over half of the top biopharmaceutical companies in 2022
Pharmaceutical Technology
FEBRUARY 8, 2023
The top 20 companies in the global biopharma industry saw 5.4%* aggregate market capitalization from $3.43 Pfizer maintained its third-place position in the market in 2022, reporting a market capitalization of $287.6 witnessed the biggest market capitalization growth of 45.3% trillion to $3.61 billion on Dec 31, 2022.
Marketing 195
195 
J&J goes after another FDA approval for a cancer bispecific
pharmaphorum
DECEMBER 30, 2021
Johnson & Johnson’s much-touted crop of bispecific antibodies for cancer generated its first commercial product in May, and the drugmaker has now filed for FDA approval of a second candidate. “We look forward to working with the FDA in their review of our teclistamab submission.”
FDA Approval 121
121 
Can an antibody therapy prevent fentanyl overdoses?
Drug Discovery World
FEBRUARY 15, 2024
DDW Editor Reece Armstrong speaks to Tracy M Woody , President and Chief Executive Officer of Cessation Therapeutics, about the company’s goal to develop an antibody therapy to prevent fentanyl overdoses. As it stands, there are no FDA-approved products designed to prevent a fentanyl overdose.
Antibody 59
59 
The regulatory round-up: Five important FDA approvals
Drug Discovery World
JULY 20, 2023
The US Food and Drug Administration (FDA) has granted marketing authorisations to several new therapeutics over the last month that will have a significant impact on areas of unmet need and the evolution of future treatments.
FDA Approval 40
40 
Which diseases are poised to benefit from therapeutic antibody development
Drug Discovery World
NOVEMBER 14, 2023
DDW’s Megan Thomas looks at how different diseases will benefit from the success of therapeutic antibodies. Cancer Monoclonal antibodies (mAbs) are a type of targeted drug therapy, and as such are often used to treat cancer. This is not only made clear by the fact that the global cancer mAbs market size was valued at $55.6
Antibody 59
59 
ImmunityBio’s Cancer Immunotherapy Anktiva Wins FDA Approval, Boasting a “Triangular Offense”
XTalks
APRIL 24, 2024
ImmunityBio’s Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) along with the Bacillus Calmette-Guérin (BCG) vaccine has won US Food and Drug Administration (FDA) approval for the treatment of non-muscle invasive bladder cancer (NMIBC). The company is planning to launch Anktiva commercially in the US by mid-May.
FDA Approval 52
52 
Downturn for top biopharma companies Q3 market cap as Covid-19 vaccine demand falls
Pharmaceutical Technology
DECEMBER 20, 2022
The top 20 global biopharmaceutical companies exhibited a downward trend in aggregate market capitalisation by 9.1% This downturn in market cap was attributed to a decline in the demand for Covid-19 vaccines and therapies. Bayer recorded a negative market capitalization growth of 22.3% trillion in Q2 2022 to $3.14
Marketing 130
130 
Treatment options for Crohn’s disease expand after Rinvoq approval
Pharmaceutical Technology
MAY 19, 2023
The US Food and Drug Administration (FDA) has approved AbbVie’s Rinvoq (upadacitinib) for patients with Crohn’s disease who do not respond to TNF blockers, a common immune suppressant treatment for the condition. Data from two Phase III studies, U-EXCEED and U-EXCEL, involving 857 patients was used to support the approval.
FDA Approval 264
264 
Cell therapies in AML inch closer to market while facing challenges
Pharmaceutical Technology
JANUARY 19, 2023
Acute myeloid leukemia (AML) is part of a market of blood malignancies that commercial cell therapies have not managed to penetrate yet. However, it is possible to target CD33 in the clinic, as evidenced by the FDA approval of Pfizer’s anti-CD33 antibody-drug conjugate Mylotarg (gemtuzumab ozogamicin) in 2000.
Marketing 130
130 
STAT+: Immunogen wins FDA approval for targeted medicine to treat advanced ovarian cancer
STAT News
NOVEMBER 14, 2022
The Food and Drug Administration on Monday approved a new treatment for patients with advanced ovarian cancer — an antibody that delivers a targeted dose of chemotherapy directly to cancer cells. market in more than seven years, and the first approval of a wholly owned medicine in Immunogen’s 41-year history.
Medicine 98
98 
Brukinsa (zanubrutinib) Gets FDA Approval for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
XTalks
JANUARY 26, 2023
This is the fourth US FDA approval that BeiGene has received for Brukinsa since 2019. This includes a greater focus on digital campaigns and diversifying marketing campaigns with race and ethnicity insights.
FDA Approval 97
97 
J&J’s Carvykti and BMS’ Abecma Win FDA Approvals for Earlier Use in Multiple Myeloma
XTalks
APRIL 11, 2024
After backing from the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) last month, Johnson and Johnson (J&J) and Bristol Myers Squibb (BMS) scored FDA approvals for the use of their B-cell maturation antigen (BCMA)-targeting CAR T-cell therapies as earlier line treatment options for multiple myeloma.
FDA Approval 52
52 
Failed trial nixes another FDA approval, this time for BMS’ Istodax
pharmaphorum
AUGUST 4, 2021
Bristol-Myers Squibb’s HDAC inhibitor Istodax has been on the US market for a decade as a treatment for peripheral T-cell lymphoma (PTCL), but will now be withdrawn from sale after a failed phase 3 trial. The post Failed trial nixes another FDA approval, this time for BMS’ Istodax appeared first on.
FDA Approval 98
98 
FDA grants accelerated approval for ImmunoGen’s ovarian cancer ADC
Pharmaceutical Technology
NOVEMBER 14, 2022
The US Food and Drug Administration (FDA) has granted accelerated approval for ImmunoGen’s Elahere (mirvetuximab soravtansine-gynx) to treat adults with folate receptor alpha (FR?)-positive, binding antibody, a cell-surface protein which is greatly expressed in ovarian cancer, as well as the maytansinoid payload DM4.
FDA Approval 246
246 
MHRA fast tracks ADvantage’s immunomodulator for Alzheimer’s disease
Pharmaceutical Technology
APRIL 6, 2023
The designation, under the regulator’s Innovative Licensing and Access Pathway (ILAP), will fast-track a potential route to market for AD04 by providing collaborative opportunities with UK institutes like the National Institute for Health and Care Excellence (NICE).
FDA Approval 264
264 
Roche Reintroduces Susvimo Wet AMD Eye Implant After Recall
XTalks
JULY 11, 2024
Susvimo, a refillable eye implant, received US Food and Drug Administration (FDA) approval in 2021, but its initial rollout faced challenges due to septum dislodgement cases that prompted Roche to issue a voluntary market recall in October 2022. Merck is also looking to tread into the eye disease market.
FDA Approval 104
104 
Future of Bispecific Antibody: Exploring the Rise in Approvals
Roots Analysis
OCTOBER 4, 2023
Bispecific antibodies are a type of antibody that can bind to two different targets at the same time. I, recently, worked on a market research report, titled Bispecific Antibodies Market , 2023-2035. In fact, six bispecific antibodies have been approved in 2022. during the period 2023-2035.
Antibody 40
40 
Flash FDA approval sends ChemoCentryx spiralling upwards
pharmaphorum
OCTOBER 10, 2021
ChemoCentryx has claimed FDA approval for its avacopan drug for a rare autoimmune disease, becoming the first orally-active drug that targets the complement C5 receptor. The post Flash FDA approval sends ChemoCentryx spiralling upwards appeared first on.
FDA Approval 52
52 
Janssen makes EMA marketing application for talquetamab for RRMM
pharmaphorum
JANUARY 4, 2023
The Janssen Pharmaceutical Companies of Johnson & Johnson have submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA), seeking approval of talquetamab for the treatment of patients with relapsed or refractory multiple myeloma (RRMM). This reduces the timeframe for the MAA to be reviewed.
Marketing 81
81 
Provention and Sanofi enter deal to launch teplizumab for type 1 diabetes
Pharmaceutical Technology
OCTOBER 7, 2022
Additionally, the company granted Sanofi an exclusive right of first negotiation (ROFN) to attain international rights to market teplizumab for T1D indications for a one-time payment of $20m. An anti-CD3 monoclonal antibody, teplizumab is in the developmental stage to delay T1D.
FDA Approval 299
299 
FDA approval to Keytruda and Lenvima; FibroGen’s Roxadustat; Pfizer’s TICOVAC; Ipsen’s Palovarotene; Jazz Pharma’s Xywav; Seagen-RemeGen’s Cancer Medicine
Delveinsight
AUGUST 17, 2021
FDA’s Green Flag to Keytruda and Lenvima combination by Merck and Eisai for Advanced renal cell carcinoma (RCC). The FDA approved the combination of Keytruda and Lenvima produced by Merck and Eisai, as a first-line treatment of adult patients with advanced renal cell carcinoma (RCC). Global President, Vaccines, Pfizer.
FDA Approval 98
98 
J&J files lung cancer bispecific amivantamab for FDA approval
pharmaphorum
DECEMBER 4, 2020
Johnson & Johnson has filed its bispecific antibody amivantamab to the FDA, hoping to muscle into the big market for drugs that are used to treat EGFR-positive non-small cell lung cancer (NSCLC). The post J&J files lung cancer bispecific amivantamab for FDA approval appeared first on.
FDA Approval 68
68 
Biohaven Eyes FDA Approval for Second Migraine Drug Zavegepant After Promising Trial Results
XTalks
DECEMBER 10, 2021
Zavegepant is an antibody drug that prevents binding of the calcitonin gene-related peptide (CGRP) to the CGRP receptor. CGRP receptor antagonists are a new class of antibody drugs used for migraine treatment. The pain relief effects were sustained for up to 48 hours.
FDA Approval 98
98 
FDA approves AZ’s anifromulab, ending 10-year lupus drug drought
pharmaphorum
AUGUST 2, 2021
AstraZeneca has completed the resurrection of its anifrolumab drug for systemic lupus erythematosus (SLE) after claiming FDA approval for the drug as an add-on therapy for adults with the autoimmune disease. The post FDA approves AZ’s anifromulab, ending 10-year lupus drug drought appeared first on.
FDA Approval 52
52 
AbbVie’s Rinvoq and Pfizer’s Cibinqo Win FDA Approvals as Eczema Treatments, Bringing Competition to Sanofi’s Dupixent
XTalks
JANUARY 21, 2022
For AbbVie’s Rinvoq, the FDA approval is an expansion of its approval for the treatment of rheumatoid arthritis and psoriatic arthritis. On the other hand, this is the first US approval for Cibinqo. Dupixent has been a market hit since it was first approved by the FDA in 2017.
FDA Approval 98
98 
Roche takes on Alexion as FDA approves satralizumab in NMOSD
pharmaphorum
AUGUST 17, 2020
The big Swiss pharma had been hoping for approva l in patients regardless of whether they have anti-aquaporin-4 (AQP4) antibodies. But so far Roche has not produced enough data in the broader patient group and the FDA has instead approved Enspryng in patients producing the AQP4 antibodies.
FDA Approval 59
59 
FoundationOne Liquid CDx Is a New Companion Diagnostic for Metastatic Colorectal Cancer
XTalks
JUNE 16, 2023
Foundation Medicine recently announced that the US Food and Drug Administration (FDA) approved FoundationOne Liquid CDx to serve as a companion diagnostic for identifying metastatic colorectal cancer patients with BRAF V600E alterations, suitable for treatment with Pfizer’s Braftovi (encorafenib) with cetuximab.
FDA Approval 97
97 
FDA approves under-pressure GSK’s Jemperli for endometrial cancer
pharmaphorum
APRIL 23, 2021
The FDA has approved GlaxoSmithKline’s Jemperli (dostarlimab) immunotherapy, a drug acquired through its $5.1 With Jemperli , a PD-1 class drug, GSK is a latecomer to the immunotherapy party with a host of other competitors already on the market in various cancers.
FDA Approval 52
52 
Lunsumio Gets FDA Accelerated Approval as Third Line Treatment for Follicular Lymphoma
XTalks
JANUARY 9, 2023
The US Food and Drug Administration (FDA) granted Roche’s Lunsumio (mosunetuzumab) an accelerated approval near the end of 2022 for the treatment of adult patients with relapsed or refractory follicular lymphoma. It was approved in the EU for the same indication in June last year.
FDA Approval 98
98 
An increasing impact of BCMA-targeting biologics in multiple myeloma
Pharmaceutical Technology
SEPTEMBER 2, 2022
Multiple myeloma (MM) therapeutics comprise a multi-billion dollar market, among the most valuable in oncology. lenalidomide) + a steroid ± an anti-CD38 antibody. The first anti-BCMA product to enter the R/R market was GlaxoSmithKline’s antibody-drug conjugate (ADC) Blenrep (belantamab mafodotin-blmf), gaining FDA approval in 2020.
Antibody 147
147 
Let's personalize your content