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But new competition to both products could come soon from Alnylam Pharmaceuticals, now set to receive an FDA decision in this indication by late March. The post FDA Nod for BridgeBio Brings New Competition to Blockbuster Pfizer Cardio Drug appeared first on MedCity News.
Eli Lilly’s Kisunla is now FDA approved for treating patients in the early stages of Alzheimer’s disease. The post Eli Lilly Alzheimer’s Drug Lands FDA Approval, Introducing Competition to Eisai’s Leqembi appeared first on MedCity News.
The FDA decision for Travere Therapeutics’ Filspari also expands its addressable patient population. The post Full FDA Approval of Travere’s Kidney Drug Stiffens Competition With Novartis, Calliditas appeared first on MedCity News.
Eli Lilly drug Ebglyss is now FDA-approved for atopic dermatitis, an inflammatory skin disorder also known as eczema. The post New Eli Lilly Eczema Drug Brings Competition and Dosing Edge Versus Sanofi, LEO Pharma Meds appeared first on MedCity News. The biologic drug came from Lilly’s $1.1 billion acquisition of Dermira in 2020.
The FDA approved Roche’s Columvi as a third-line treatment for a type of blood cancer called diffuse large B-cell lymphoma. This new Roche drug will compete against Epkinly, AbbVie’s recently approved DLBCL drug.
If Ionis can commercialize this drug, competition would include products from Takeda Pharmaceutical and BioCryst Pharmaceuticals. In its Phase 3 test, Ionis Pharmaceuticals drug donidalorsen reduced the frequency of swelling attacks caused by the rare disease hereditary angioedema.
FDA approval of Sanofi hemophilia A drug Altuviiio provides patients with a therapeutic option that lasts longer than most other products available, including one already marketed by the French pharma giant. Altuviiio also gives Sanofi a way to better compete against blockbuster Roche drug Hemlibra.
Amgen’s Lumakras became the first FDA-approved drug that addresses the elusive KRAS mutation, but Mirati believes its newly approved therapy, Krazati, could be better. The small molecule’s features include the ability to penetrate into the brain, where it can address cancer that has spread to the central nervous system.
FDA approval of Ascendis Pharma’s Yorvipath is just in time for patients with hypoparathyroidism as Takeda Pharmaceutical will soon stop making the only drug therapy for the rare disorder. But competition could come from others, including an AstraZeneca peptide in late-stage development.
Autolus' Aucatzyl has become the first CAR-T approved by the FDA without a REMS mandate. Watch out, Gilead and Novartis: there's a new CAR-T in town. And the company is ready to hit the ground running, facing Gilead and Novartis as its competitors.
A drug developed by Protalix BioTherapeutics and Chiesi Group is now FDA approved for treating Fabry disease, a rare inherited metabolic disorder. The drug, Elfabrio, is an enzyme replacement therapy.
Shield could also face new competition from other liquid biopsy companies. The post With FDA Nod for Colorectal Cancer Screening, How Much Market Share Can Guardant’s Blood Test Get? appeared first on MedCity News.
Pfizer’s Litfulo is the first treatment approved for treating adolescents with severe alopecia areata. The drug’s approval also covers adults, were it will compete against Eli Lilly’s Olumiant.
Alnylam Pharmaceuticals drug Onpattro, an FDA-approved treatment for nerve pain caused by hereditary transthyretin amyloidosis, now has Phase 3 data showing it can also help the much larger group of patients suffering heart problems from the rare protein disease.
The FDA approved TheracosBio’s Brenzavvy as a treatment for type 2 diabetes. But before it won a regulatory nod for controlling blood glucose in adults, it was approved at a different dose (with flavor) as a veterinary product.
The Federal Trade Commission says more than 100 patents from 10 biopharma companies are improperly listed in the FDA’s official publication of approved products. Such listings delay generic competition, which reduces consumer choice and keeps prices high, the regulator said.
After years of using the patent system to delay competition from a rival company and then exhausting that ploy early this year, Jazz Pharmaceuticals is taking a new route—suing the FDA.
The company has received a complete response letter (CRL) from the FDA for a proposed update to the labelling for Izervay (avacincaptad pegol) that sought to include the results of the phase 3 GATHER2 trial and improve the drug's competitive profile against rival Syfovre (pegcetacoplan) from Apellis.
More than two years after an initial FDA approval in melanoma, Bristol Myers Squibb is moving its PD-1/LAG-3 combo Opdualag into registrational testing in one of the most important oncology disease | More than two years after an initial FDA approval in melanoma, Bristol Myers Squibb is moving its PD-1/LAG-3 combo Opdualag into registrational testing (..)
Ionis Pharmaceuticals is looking ahead to a Phase 3 study for an antisense medicine it is developing to treat Angelman syndrome, a rare neurodevelopmental disorder with no FDA-approved therapies. Its main competition is an Ultragenyx Pharmaceutical drug set to begin pivotal testing later this year.
FDA is asking artificial intelligence teams to develop a digital endpoint tool to study freezing of gait, a symptom of Parkinson’s that can have a serious impact on patients.
With Regeneron’s treatment delayed, AbbVie is expanding its T-cell engager competition against Roche in blood cancer with a new FDA approval. With Regeneron's treatment delayed, AbbVie is expanding its T-cell engager competition against Roche in blood cancer with a new FDA approval.
Even as Biogen weighs strategic options for its biosimilars unit, the group is celebrating an industry first. | The exact launch timing of the biosimilar remains unclear, but Roche said it expects competition to kick off in the second half of 2023.
As Roche comes under competitive pressure on its breast cancer business, the Swiss company hopes a new drug will add a 2-billion-Swiss-francs luster to the once high-flying portfolio. |
But increased competition is on the horizon. Sodium oxybate — which in the late 1980s was marketed to bodybuilders and then became known as GHB and criminally used as a date rape drug — has been sold under the brand name Xyrem after gaining FDA approval in 2002. Competition starts to heat up. Classic treatment options.
With a new FDA nod, BeiGene has filled the follicular lymphoma approval gap for BTK inhibitors. BeiGene has filled the follicular lymphoma gap for BTK inhibitors with an FDA approval for Brukinsa about a year after AbbVie and Johnson & Johnson's Imbruvica stumbled in a phase 3 trial.
Tremfya will enter the UC space as J&J’s older Stelara, which is approved to treat both forms of IBD, nears biosimilar competition and Inflation Reduction Act-mandated price concessions. Johnson & Johnson already has a major presence in the crowded inflammatory bowel disease (IBD) space with its popular Stelara.
According to the pre-IND meeting with the US Food and Drug Administration (FDA), Luye Pharma plans to submit the New Drug Application (NDA) for LY03010 to the FDA through the 505(b)(2) pathway. The post Promising schizophrenia drug faces tough competition appeared first on European Pharmaceutical Review.
Amgen’s 2022 market report has detailed how competition has driven savings across healthcare, estimating that a considerable number of biologics will be in competition with biosimilars in five to 10 years. A rise in savings per quarter was recognised in this year’s data. Seven more are expected to be launched in 2023.
It’s often stated – mostly without reference to data – that the environment for innovative launches is more competitive now than it ever has been. Continued competitive intensity. The first in class launches barely have time to establish before they face competition, and then the competition keeps on coming.
With its blockbuster eye drug Eylea, Regeneron is already juggling between a recent FDA rejection and new competition. With its blockbuster eye drug Eylea, Regeneron is already juggling between a recent FDA rejection and new competition. Meanwhile, biosimilar players are also eying a piece of the pie.
While the first-mover advantage is often critical in the realm of drug launches, Eli Lilly is often happy to split the pie with its peers. While the first-mover advantage is often critical in the realm of drug launches, Eli Lilly is often happy to split the pie with its peers.
With Eylea biosimilar competition creeping in and Roches Vabsymo jockeying for market share in key indications, Regeneron is racing to carve out a new market for the high-dose version of its block | High-dose Eylea demonstrated non-inferiority to the original version of the drug in patients with macular edema following retinal vein occlusion, an indication (..)
The US Food and Drug Administration (FDA) has approved Rykindo ® (risperidone) for extended-release injectable suspension. Clinical trials of the FDA approved Rykindo ®. So, Rykindo ® will have to contend with the competition of other antipsychotic LAIs as treatments for psychosis disorders.
The FDA needs to study what people do when they see a DTC ad. Drug pricing is done by internal teams who look at what the market will bear and the competitive landscape. The FDA, in its wisdom, has never studied what patients actually do when they see a DTC TV ad. DTC ads raise awareness around health conditions.
Regulatory Restrictions on Keyword Use Pharmaceutical ads must comply with regulations from organizations like the FDA (U.S.) , MHRA (UK) , and EMA (EU). Competition for High-Value Keywords Branded drug names and general medical terms attract intense competition. Optimizing PPC Campaigns for Compliance and ROI 1.
4D Molecular Therapeutics (4DMT), the California-based biotechnology company focused on developing gene therapies for rare and large market diseases, has had the FDA place a clinical hold onto its Fabry disease (FD) gene therapy program (4D-310).
J&J's Rybrevant/Lazcluze combination is cleared by FDA for first-line EGFR+ NSCLC, giving AstraZeneca's top-seller Tagrisso its first direct competition
SUMMARY: The FDA is coming under intense pressure to approve Biogen’s Alzheimer’s drug, but Aaron S. Since that time, Biogen’s MS drugs have faced intense competition as MS patients continue to vent on social media that the Biogen drug has nasty side effects. Washington Post.
The US Food and Drug Administration ( FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). Sustainable biosimilar competition in Europe: can it be achieved? The post FDA approves first Stelara biosimilar, Wezlana appeared first on European Pharmaceutical Review.
The US Food and Drug Administration (FDA) has accepted AstraZeneca’s new drug application (NDA) for the combination of capivasertib and FASLODEX (fulvestrant), and granted it priority review. We look forward to working with the FDA to bring this potential first-in-class AKT inhibitor to patients as quickly as possible.”
That’s good news for Bristol Myers Squibb, which has secured a few more competition-free months for its aging leukemia blockbuster Sprycel. . | With Xspray Pharma and Eversana’s cancer med hitting a regulatory setback, a launch in the second half of 2023 now looks unlikely.
The first US Food and Drug Administration (FDA)-approved biosimilar has been authorised to treat multiple sclerosis. Haruvi added that Tyruko has the potential to extend the reach of natalizumab treatment for these patients and “fuel innovation through competition in the market”. Approval of Tyruko has been granted to Sandoz Inc.
While Trodelvy is expected to be the first ADC approved in the HR+/HER2-negative breast cancer setting, Daiichi / AstraZeneca’s Enhertu (trastuzumab deruxtecan) received US Food and Drug Administration (FDA) approval just last month for patients with HER2-low expressing breast cancers.
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