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This week, were celebrating a significant milestone: the release of our 200th episode of the Xtalks LifeScience Podcast ! We’re excited to continue our journey by bringing you more in-depth conversations with industry leaders, highlighting the innovations and trends that shape the future of lifesciences.
Lifescience podcasts have emerged as an invaluable tool for building connections with audiences in the digital era. Furthermore, we’ll explore the unique advertising opportunities that this platform offers, positioning brands at the forefront of the lifescience industry. The result?
This liquid formulation of metronidazole is the sole FDA-approved liquid option, offering a groundbreaking prescribing alternative for patients encountering difficulties in swallowing or facing taste-related obstacles. With a 24-month shelf life and no need for refrigeration, Likmez provides a convenient option for patients.
In this week’s Xtalks LifeScience podcast episode, Ayesha and the team spoke with the co-founders and co-CEOs of Amylyx, Joshua Cohen and Justin Klee, and Amylyx’s General Manager of Canada Chris Aiello, about the recent FDAapproval of the company’s ALS drug Relyvrio.
In July 2021, the agency approved the first interchangeable biosimilar product, Semglee (insulin glargine-yfgn) for the treatment of diabetes. The FDAapproved the supplemental Biologics License Application (sBLA) for Cyltezo as the first interchangeable biosimilar with Humira.
In 2023, there were significant advancements and notable trends in the lifesciences. Xtalks compiled a list of its top lifescience news and trends of 2023, which provided readers with the latest developments, information and expert insights across lifescience industries, including pharma, biotech and medical device.
Register for this free webinar to learn about the value of real-world data as a critical business tool to guide brand strategy and find the right patients for best outcomes. Live and On-Demand: Tuesday, February 7, 2023, at 12pm JST/Japan (8:30am IST/India). The CAPELLA Clinical Trial Evaluated the Antiviral Activity of Sunlenca.
Amneal Pharmaceuticals and Shilpa Medicare have announced US Food and Drug Administration (FDA) approval of Boruzu, a ready-to-use formulation of bortezomib for subcutaneous or intravenous (IV) administration.
Prescription digital medicine company Akili Interactive is set to launch a digital campaign for its FDA-approved video game for the treatment of attention deficit hyperactivity disorder (ADHD). The video game is called EndeavorRx and is the first and only FDA-backed therapy delivered through a video game experience.
From Bristol-Myers Squibbs monumental acquisition of Celgene to Pfizers recent purchase of Seagen, these deals illustrate the strategies and ambitions driving innovation in lifesciences. Following the merger, Actavis rebranded itself as Allergan, leveraging the strong recognition of Allergans brand.
“We are thrilled with the FDA’sapproval of Letybo. This is a huge achievement for Hugel as we focus on becoming a top aesthetics brand in the US,” said James Hartman, president of Hugel America in the news release. “As 134 How Does Letybo Work?
In the dynamic landscape of oncology therapeutics, understanding the trends and performances of leading drugs is crucial for stakeholders across the healthcare and lifesciences sectors. The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research.
The US Food and Drug Administration (FDA) has granted approval to Azurity Pharmaceuticals’ liquid version of its epilepsy drug zonisamide (100 mg/5 mL; brand name Zonisade) as an adjunct therapy for the treatment of partial seizures in adults and pediatric patients 16 years of age and older with epilepsy.
Register for this free webinar to learn about the value of imaging data as a real-world data source, and the power of linking it with clinical data stored in electronic health records (EHRs) to inform research across the drug and device lifecycle for lifesciences. The NDA FDAapproval is a milestone for the Thea Group.
In 1970, the FDAapproved ketamine as an anesthetic. In March 2019, the American regulator approved esketamine , an enantiomer of ketamine, for use in treatment-resistant depression as a nasal spray. Fox Foundation gave Sanacora a $2 million grant to study the drug’s use for depression in patients with Parkinson’s disease.
Why it sold so well: Botox is FDA-approved for the treatment of chronic migraines and that is currently the only chronic condition for which it has received approval. It is a biologic drug available exclusively as a brand-name medication, with no generic or biosimilar forms available. billion in the US and $4.1
Cabenuva was actually expected to win FDAapproval towards the end of 2019; however, manufacturing issues garnered rejection from the FDA at the time. Since then, Cabenuva received its first global approval in Canada in March 2020, followed by authorization in the EU in December under two separate brand names.
In October 2022, Xtalks celebrated two decades of bringing diverse stakeholders in the lifescience industry together through first holding physical events, then soon after, hosting exclusively online events. Just last year, the FDAapproved a one-time gene therapy treatment for hemophilia B priced at $3.5
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 FDAapprovals for the use of their B-cell maturation antigen (BCMA)-targeting CAR T-cell therapies as earlier line treatment options for multiple myeloma.
Allergan Aesthetics, an AbbVie company renowned for its development of leading aesthetics brands and products, recently announced the US Food and Drug Administration (FDA) approved their ground-breaking hyaluronic acid product, SkinVive by Juvéderm, for achieving remarkable skin smoothness.
On December 16, 2022, AbbVie announced in a press release that the US Food and Drug Administration (FDA) approved Vraylar as an adjunctive therapy to antidepressants for the treatment of MDD in adults. This approval positions Vraylar as the first and only dopamine and serotonin partial agonist for the most common forms of depression.
Related: Veozah (Fezolinetant) Is a New Type of Drug for Menopausal Hot Flashes Lead Investigator Dr. Genevieve Neal-Perry Discusses New Trial Data for Astellas’ Menopause Drug Fezolinetant (Veozah) – Xtalks LifeScience Podcast Ep. Bayer is preparing to file for FDAapproval based on strong Phase III data it shared last month.
is one of the largest global medtech companies with diverse segments ranging from lifescience solutions to specialty diagnostics, analytical instruments and laboratory products and services. Danaher (Overall Rank 435) Danaher operates in three key areas: Biotechnology, LifeSciences and Diagnostics.
The US Food and Drug Administration (FDA) has approved Bristol Myers Squibb’s (BMS) Cobenfy (xanomeline and trospium chloride), formerly KarXT, for the treatment of schizophrenia, the first new class of drug for the disorder to hit the market in over four decades.
However, the company last aired the ad on May 2, 2022, the same day they announced the US Food and Drug Administration (FDA) approval of Quviviq. Quviviq is an FDA-approved prescription medicine that helps treat insomnia in adults, with a low risk of dependence and side effects. billion during the same period.
In the first half of 2023, pharmaceutical drugs accounted for half of the most viewed new brands by TV ad impressions, according to an iSpot.tv The drug took off quickly after its approval given the growing popularity of GLP-1 agonists like rival Novo Nordisk’s Ozempic for the treatment of diabetes and off-label use for weight loss.
Some include Mind Medicine, Compass Pathways and Champignon Brands. Mind Medicine has multiple FDA-approved trials that are ongoing in multiple jurisdictions and geographies, along with drug developments efforts that include substances such as psilocybin, LSD, MDMA, DMT and their Ibogaine derivative, 18-MC. Champignon Brands.
Compounded GLP-1 medications, created by specialized pharmacies under a special US Food and Drug Administration (FDA) allowance due to ongoing shortage, have become increasingly popular for weight loss. In May, Eli Lilly reached a settlement with one of the medical spas.
The first line of treatment for invasive candidiasis is a subset of antifungal medications called echinocandins, which includes caspofungin (brand name Cancidas), the drug that rezafungin was compared with in clinical trials. For example, Scynexis Inc.
For healthcare professionals and stakeholders in the lifesciences sector, understanding the top-performing cardiovascular drugs is not just about recognizing their financial success. Marketing in both cardiac and hematological indications has contributed to its success, which continues to grow in emerging markets globally.
Related: Non-Stimulant ADHD Drugs: Qelbree Versus Strattera According to the FDA, generics “work in the same way and provide the same clinical benefit and risks as their brand-name counterparts.” The entry of Vyvanse generics into the market will certainly be welcomed by patients as generics are cheaper than the branded version.
Novartis is investing $200 million into expanding its Indianapolis, Indiana, site for in-house production of radioisotopes and constructing a brand new one in Carlsbad, California. The facilities are part of the company’s plans to expand its manufacturing and supply chain capabilities.
The settlement requires Totality to take several specific corrective actions, which include refraining from making any statements that suggest the spa’s products are genuine, FDA-approved Lilly products, and stopping the use of Eli Lilly branding in promoting any of the products.
The exact cost of Vevye has not been publicly disclosed; however, it is estimated that the price of Vevye may be in the range of similar cyclosporine ophthalmic emulsions, such as brand-name Restasis that carries a list price of $645.63 One such approved medication is Miebo , an ophthalmic solution developed by Bausch + Lomb and Novaliq.
In the dynamic landscape of oncology therapeutics, understanding the trends and performances of leading drugs is crucial for stakeholders across the healthcare and lifesciences sectors. The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research.
The company said it cannot “validate the safety or effectiveness of products claiming to contain tirzepatide that are not our own branded product.” Since the compounded versions of Mounjaro are not FDAapproved, Lilly said they may expose patients to potentially serious health risks.
AstraZeneca has unveiled plans to build a brand new manufacturing facility at a site in Ireland operated by its recent acquisition Alexion, providing employment for around 100 workers including scientists and engineers. “This significant investment will ensure the AstraZeneca supply network is fit for the future.”
Skip created a virtual classroom to test children with ADHD and is now working with a company that collects data with this application to support the path to FDAapproval. Pharma can also utilise VR technology to aid in their research, such as testing new medications for children with ADHD. About the author .
Related: Cyltezo Becomes First FDA-Approved Interchangeable Humira Biosimilar. Biosimilars are less expensive than their reference products because of lower R&D costs and a shorter and cheaper path to approval due to reduced clinical trial requirements.
Exact Sciences and long-time colon cancer screening advocate and award-winning journalist Katie Couric have teamed up for Colon Cancer Awareness Month this March in a TV ad for the company’s at-home screening test Cologuard. The ad is part of Exact Sciences’ “Mission to Screen” campaign that was launched this week.
Novartis’s latest attempt to block the US Food and Drug Administration’s (FDA) approval of a generic version of its blockbuster heart failure drug, Entresto (sacubitril/valsartan), has been shot down by a federal court. Novartis plans to continue its legal battle.
BioRad Laboratories Lifescience research and diagnostics giant BioRad announced a 5% workforce reduction over 350 employees with the most significant cuts at its Hercules headquarters, along with additional layoffs at its Pleasanton and Richmond locations.
The life expectancy after symptoms develop is around two to five years. Relyvrio’s FDAapproval was seen as controversial from the get-go as it was based on data from a small Phase II trial that showed a modest slowing of disease progression in patients who received the drug.
The US Food and Drug Administration (FDA) has approved Iwilfin (eflornithine) to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have had at least a partial response to previous multiagent, multimodality therapy including anti-GD2 immunotherapy.
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