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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 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.
Eli Lilly’s Kisunla is now FDA approved for treating patients in the early stages of Alzheimer’s disease. 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 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 reported 74% of patients treated with tirzepatide achieved resolution of metabolic dysfunction-associated steatohepatitis, or MASH. 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.
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.
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.
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.
As professionals with more than a half-century between us working in biopharma and diagnostics marketing and communications from the corporate (Ayaz Malik) and agency (Sandra Stahl) sides, we believe nurturing multigenerational teams is an especially powerful yet underutilized strategy for our industry.
Embarking on the journey from product development to market success in the biopharma industry is no small feat. The landscape is highly competitive with new prescription medications launching worldwide each year. However, this journey is fraught with challenges as revealed by an in-depth analysis.
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.
Biopharma blockbusters in the last 10 years show a disturbing trend. As a top 10 biopharma company leader shared with us, “Real blockbusters are gone. For biopharma, success in this space will require integrated models that are significantly different than what has been used with historic medicines. In oncology, it’s 47% less.
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.
Together, these groups compile vast amounts of data, including rich information on patient populations, target customers, and the competitive landscape. Historically, competitive and market analysis data has been stored in spreadsheets. Truly understanding the competitive landscape and market environment.
Over the past 15 years, more than 60% of asset growth among the top 30 biopharma companies came from acquisitions. The pace of innovation in biopharma has rocketed over the last two years, with vaccines, new antivirals, and therapies delivered at an unprecedented pace.
Guardant Health’s Shield, a liquid biopsy that screens for colorectal cancer by analyzing a patient blood sample, will compete against stool-based tests already established in the market. Shield could also face new competition from other liquid biopsy companies.
Mirati Therapeutics is the subject of takeover speculation in the biopharma sector once again, as it waits for the FDA’s decision on its KRAS inhibitor adagrasib in non-small cell lung cancer (NSCLC). Response rates above 50% in PD-1 high/intermediate patients with no liver tox surprises could set up for a potential acquisition.”
Continuing advancements within this field deliver new hope to doctors and patients, transforming disease outcomes for previously incurable indications. The quality grade is even more important in many novel therapeutic modalities because the specialty enzymes often form an integral part of the product and are closer to the patient.
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.
billion buyout of Principia Biopharma has run into trouble, after the FDA placed it on partial clinical hold while a safety signal is investigated. One of the main assets of Sanofi’s $3.7 The hold on dosing applies to subjects in the trials who have received the drug for less than 60 days.
Now, as the President of Accord BioPharma , the U.S. PM360: From your time at Roche when you were dealing with biosimilars as potential competition to now leading the launch of biosimilars at Accord and Intas, how have you seen the marketplace for biosimilars evolve over that time? Look, competition is healthy.
The Italian biopharma said it had decided to press ahead with the new study after assessing results from 100 patients with TRS in open-label studies who received the glutamate modulator drug as an add-on to their current therapy for more than six months. in the evenamide group.
From connecting with patients by interactive ads to dabbling into cross-platform integration, here is what our specialists had to say. What are new and effective ways of engaging patients who are now using streaming services? Biopharma marketers are following their audiences and investment in this channel continues to increase.
With 2024 on the horizon, many in the biopharma space are taking stock of 2023 and what the current environment means for their potential success next year. This allows for a complementary portfolio fit without the kind of competitive overlap that comes under regulatory scrutiny from the FTC.
In fact, for the past five years, the number of treated patients with cancer has seen an average annual increase of 5% globally (1). Increased competition and evolving standard of care New competitors are entering the market at a rapid pace, and competition is intensifying. However, with rapid growth comes growing pains.
Food and Drug Administration advisory committee’s narrow 8-6 vote in favor of recommending accelerated approval for a first-in-class gene transfer therapy was welcomed by Duchenne muscular dystrophy (DMD) patients and caregivers. Most patients must use a wheelchair by the time they are in their teens.
On the other hand, the author explained that these challenges are anticipated to be addressed through advances in technology, industry effort on implementation of standardisation and increased competition in the market. Could centrifugal bioreactor accelerate cell-therapy manufacturing?
I recently sat down with Erica Taylor, PhD, Vice President and Chief Marketing Officer at Genentech, to talk about the future of biopharma marketing and creating more meaningful content. Now, due to the highly competitive environment, the process is truncated to 12-18 months. Marketing is key to adding that layer of storytelling.
Investors in 2022 appeared confident that the continued transformation of drug research and development protocols and the overall life sciences industry will not only include digital health solutions, but will even depend on them for data collection, analysis, patient engagement, and even their therapeutic properties.
The Biosimilars Forum has hailed 2022 as a watershed year that could create a more competitive U.S. Clarivate research indicates biosimilar competition will drive down prices and relative market share of HUMIRA ® in the U.S. By end of year, as many as ten adalimumab biosimilars could be on the U.S. from 91% in 2023 to 36% by 2031.
The increasing adoption of technologies promoting safety, efficacy and reduced production costs has been a persistent trend that will continue to benefit the industry and help to treat a broader patient population. These challenges predominantly surround scalability, stability, regulatory compliance and access to patients.
Biopharma should pay special attention to this. The human interaction deficit is on average more pronounced in patients living with serious health conditions. As we plan our patient engagement strategies for the coming years, in-person interactions must be central to our vision. Trust Patient engagement is about building trust.
In-licensing and acquisitions are fast tracks for pharmaceutical companies to access groundbreaking technologies and assets that will drive the next generation of transformative patient treatments. Dealmaking is not a trivial process.
While the global biopharma industry retains its huge dependence on the U.S. This should, at least in theory, make them an appealing target for biopharma companies looking to expand beyond the hugely competitive markets of the U.S., market, emerging markets present great opportunities for biotech and pharmaceutical companies.
For the approximately 10% of biopharma candidates that actually manage to make it to clinical trials, many fail to achieve enough revenue once they reach the market to justify the R&D effort. In fact, one-third of drugs launched over a recent 10-year period fell short of sales expectations.
Embracing a mindset shift to pave the way for effective engagement models In an incredibly competitive market, field teams now must work harder than ever to stand out. Beyond selling alone, the industry needs to make a concerted shift towards patient-centric engagement, which is a key facet of success for field teams.
Clarivate oncology experts share major takeaways from ESMO and their expected impact on the treatment landscape and patients. Introduced earlier in the treatment paradigm, Keytruda could substantially reduce risk of recurrence in high-risk early-stage melanoma patients. Context: In August 2021, Merck & Co. in the placebo group.
Before that, she was the head of omnichannel strategy at Ionis Pharma and held senior digital roles at various healthcare and biopharma companies. Throughout her career, Zara has leveraged human-centered innovation to empower people and to realize her commitment to improve healthcare access for patients with unmet needs.
Nonetheless, some stakeholders remain concerned with this new approach given the complexity of biological medicines and the need for patients to be treated individually and have called for further discussions with regulators and all stakeholders. What are the concerns about the interchangeability of biosimilars?
May 9, 2023 Since the Orphan Drug Act was passed in 1983, the number of products being researched and approved for rare and orphan diseases has increased dramatically, offering hope and life-saving treatments for the millions of patients affected by these often under-served conditions.
Doubling down on strategic therapeutic areas Pharma once again finds itself having to narrow its sights on partnerships that deliver the next blockbuster and enable differentiation from the competition—all while navigating increasing regulatory scrutiny and shifting patient and payer expectations.
In this issue, we take a closer look on the importance of patient education to Healthcare Professionals and navigating the challenges that arise. ABIGAIL MALLON Chief Patient Experience Officer, VMS BioMarketing Physician burnout is on the rise. The second to increase in patient-oriented communication and support for physicians.
Based on this, the AI assistant could also suggest next steps, like sharing clinical evidence aligned with Dr. Smiths patients, a comparative study related to competitive products Dr. Smith has prescribed, or follow-up material to a webinar Dr. Smith attended. The result? References 1. Veeva Pulse Field Trends Report, 2023 2.
One of the critical factors determining the success of a clinical trial is the selection of appropriate clinical sites that have evidenced access to specific patient populations. Patient recruitment accounts for 32% of all trial costs and patient drop out averages 18%, according to Deloitte figures. Food and Drug Administration.
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