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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.
The way ahead for HEOR in biopharma should be built on increasing C-suite visibility and understanding of the value contribution that HEOR makes and demonstrating that a failure to invest in HEOR puts companies at a competitive disadvantage, especially in the face of rising regulatory and payer expectations for evidence.
The post The New Radiopharma Competition Requires Unprecedented Medical Logistics appeared first on MedCity News. As the innovative, multi-billion dollar industry expands rapidly, pharma companies must consider how to deliver and differentiate.
The post Eli Lilly Alzheimer’s Drug Lands FDA Approval, Introducing Competition to Eisai’s Leqembi appeared first on MedCity News. In addition to slowing cognitive decline and disease progression, clinical trial results showed that amyloid beta plaques were reduced to the point where some patients could stop taking the infused therapy.
The big three insulin manufacturers have cut prices across their product lineups, but potential competition from other biosimilar insulins is still in earlier stages of development. Insulin prices have long been a pain point for diabetics.
The post Full FDA Approval of Travere’s Kidney Drug Stiffens Competition With Novartis, Calliditas appeared first on MedCity News. The full approval comes nearly a year after the Travere drug narrowly missed the main goal of its confirmatory study.
The post New Eli Lilly Eczema Drug Brings Competition and Dosing Edge Versus Sanofi, LEO Pharma Meds 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 biologic drug came from Lilly’s $1.1 billion acquisition of Dermira in 2020.
These platforms need to replace traditional data management methods and workflows for biopharma companies and contract development and manufacturing organizations that seek competitive advantages. Cloud-based data management solutions help the industry meet its business and compliance challenges.
However, the Phase 2 results showed only “clinically meaningful” improvement in resolving liver fibrosis, a key measure of the drug’s potential competitiveness in a crowded field of contenders. Eli Lilly reported 74% of patients treated with tirzepatide achieved resolution of metabolic dysfunction-associated steatohepatitis, or MASH.
The results could help Lilly differentiate its product from Novo Nordisk’s in the increasingly competitive market of obesity medications. Eli Lilly obesity drug Zepbound led to 47% greater relative weight loss compared to Wegovy in a head-to-head clinical trial.
The agency said Illumina’s proposed remedies are insufficient and the tie-up is likely to reduce competition in the R&D and commercialization of new cancer tests. The Federal Trade Commission has ordered Illumina to divest Grail, the liquid biopsy company it acquired for more than $7 billion.
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.
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.
While investors hoped for greater weight loss, some analysts say less burdensome monthly dosing of MariTide could make it competitive against weekly injectable weight drugs Zepbound and Wegovy. Amgen’s experimental obesity drug, MariTide, led to an average 20% reduction in weight in a Phase 2 clinical trial.
The move means Sanofi is out of the competitive chase to develop a so-called “oral SERD” therapy for patients with a certain type of breast cancer. Sanofi breast cancer drug amcenestrant has failed in a Phase 3 clinical trial, leading the pharmaceutical giant to discontinue all clinical development of the small molecule.
MiRecule, winner in the biopharma track of MedCity News’s Pitch Perfect startup competition, is now pursuing a Series A round of financing. RNA therapies developer miRecule is partnered with Sanofi on the development of a treatment for facioscapulohumeral muscular dystrophy, or FSHD.
New recommendations to boost the competitiveness in UK biopharma and Medtech sectors have been published by Imperial College London. The ‘Sectoral Systems of Innovation and the UK’s Competitiveness’ reports assess the value-added per capita of each sector and how they compare internationally.
As the biopharma space gets more competitive and the days of blockbuster drugs seem further in the rearview, biopharma companies are investing in digital to find new and innovative ways to differentiate themselves.
Cytokinetics drug aficamten met the main goal of a pivotal test in obstructive hypertrophic cardiomyopathy. If approved, the daily pill would compete against a Bristol Myers Squibb drug projected to become a blockbuster seller.
The biopharma company will be required to seek prior approval before acquiring related products. to address the potential competitive harm Amgen’s $27.8 We believe the government can protect competition while enhancing the value of biotech M&A activity,” John Delacourt, Deputy General Counsel for BIO declared.
The competition saw 23 healthcare startups across biopharma, medical devices, and health tech geared for consumers/employers as well as payers/providers pitch their business plans to teams of investor judges.
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.
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.
The restructuring of cardiovascular drugmaker Amarin means the layoff of about 30% of staff. Sales of Vascepa, the company’s only commercialized product, have suffered as generic versions gain traction in the market.
After last year saw the rise of popular obesity treatments, biopharma's interest in the field only appears to only be growing. With Novo Nordisk and Eli Lilly dominating the obesity field, Amgen's CEO Robert Bradway knows a new offering will have to offer a unique benefit.
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.
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.
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.
Authors: | Gain the competitive edge with accurate probability of success assessments to uncover undervalued companies and early-stage assets for acquisitions.
A study published in Drug Discovery Today found that although outsourcing of biopharma R&D offers productivity benefits, near-term gains can be offset by slower innovation over the long term. Examples of this include certain clinical developments, which can benefit from competition between pharmaceutical firms.
They also think Walgreens’ move could lead to greater competition, consolidation and innovation within the broader pharmacy industry. Experts think that this move could yield several strategic benefits, given the higher profit margins associated with specialty medications compared to traditional drugs. appeared first on MedCity News.
Industry observers note that most of these drugs are older products facing generic competition soon, so greater industry impact will come as the program expands to more drugs in years to come. The first 10 drugs selected for Medicare price negotiations now have new prices set to take effect in 2026.
The antibody’s target puts it in competition with drugs from AstraZeneca, Pfizer, and Sanofi. Blackstone Life Sciences startup Uniquity Bio emerged from stealth with an in-licensed drug candidate that could treat a wide range of immunology and inflammation indications.
While pharmaceutical companies continue to raise list prices year-over-year, we work behind the scenes to fight the trend by driving competition, negotiating with drugmakers and incentivizing the use of less expensive medicines that deliver the same clinical value.
Neurocrine Biosciences is paying $175 million up front for rights to a preclinical Voyager Therapeutics gene therapy that could put the biotech in competition with Eli Lilly among other companies. Voyager could earn up to $1.5 billion in milestone payments.
A new report by the Association of the British Pharmaceutical Industry (ABPI) has identified the UK biopharma industry is increasingly seeking talent with artificial intelligence (AI) and data skills to maintain competitiveness as digital technology continues to drive innovation. This has spiked from 27 in 2019 to 225 in 2022.
Generic competition has eroded sales of multiple sclerosis drug Ampyra, marketed as Fampyra outside the U.S. Biogen told Acorda Therapeutics that it’s terminating its ex-U.S. rights to Fampyra in order to focus on other priorities, which include expanding beyond MS.
But competition could come from others, including an AstraZeneca peptide in late-stage development. 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.
Its main competition is an Ultragenyx Pharmaceutical drug set to begin pivotal testing later this year. 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.
Sanofi submitted the first unsolicited offer to acquire Horizon Therapeutics, but Amgen ultimately won what became a competitive bidding process. Amgen says Horizon’s drug lineup complements its own portfolio of autoimmune and inflammatory disorder products. .
Preliminary weight loss and safety data for Structure Therapeutics’ drug candidate suggest it’s competitive with other oral GLP-1 targeting contenders from big pharma companies.
The most advanced program has results from a Phase 2 test in China suggesting it could be competitive with other medications that target the GLP-1 and GIP receptors to trigger weight loss. Kailera Therapeutics licensed its portfolio of metabolic disorder drugs from Hengrui.
A Federal Trade Commission complaint alleges the deal amounts to a monopoly player taking out its competition. Sanofi, which markets the two primary treatments for Pompe disease, was trying to add a third one by licensing rights to a Maze Therapeutics drug candidate with a different therapeutic approach.
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