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In pharma, growth depends on new products with hefty price tags when over 80% of voters want lower costs for their prescription drugs. They relied so much on a new drug that they tried to market a product with bad science behind it. The pharma industry is a giant behemoth that needs new drugs to survive and grow.
EndoStim , a medical device company developing and commercializing a first-in-class implantable neurostimulation treatment for drug refractory gastroesophageal reflux disease (GERD), announced that the U.S. Food and DrugAdministration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System.
In this episode, Samuel Adeyinka interviews Marc Toth , who shares his entrepreneurial journey in the cardiovascular medical device sales industry. We are corporate with $150 million in sales for corporate but I’ve been here since the beginning. The foods are put on the trays, then go up to the person who has a diabetic diet.
In part two of our interview with Antra Boyd and Karen DiMarco, we get more of their perspective of the medical sales industry, specifically the role they believe a medical sales rep plays and its importance to their role as nurses. To listen to the first part, check it out at The Medical Sales Podcast. Sales can be pushy.
AcelRx Pharmaceuticals has announced the sale of its drug DSUVIA (sufentanil sublingual tablet) to Alora Pharmaceuticals. With this agreement, AcelRx will be able to take part in the long-term value expected to be created by Alora as they expand the commercialisation of the drug approved by the Food and DrugAdministration (FDA).
The success of chimeric antigen receptor T-cells (CAR-T) in blood cancers has led to the US Food and DrugAdministration's (FDA) approval of six products with a pipeline of cell therapies that numbers in the thousands. The total market for cell therapies in oncology is projected to exceed $37bn worldwide by 2028.
The gene therapy received Orphan Drug and Fast Track designations from the US Food and DrugAdministration (FDA). The regulator has also cleared the investigational new drug (IND) application for APB-102. Furthermore, the Phase I/II clinical study of APB-102 is expected to commence in the second half of this year.
Food & DrugAdministration (FDA) for its smaller-diameter CurvaFix® IM Implant indicated for fixation of fractures of the pelvis. Often, conservative treatment leads to lengthy hospitalizations, high nursing home admittance, and a high one-year mortality rate. Food & DrugAdministration (FDA).
A strong medical sales team is essential for success in the healthcare industry. These teams not only drive product sales but also build lasting relationships with healthcare professionals, helping deliver innovative medical solutions to those who need them most. Let Us Build You A Medical Sales Machine Today!
the leading provider of convenient, clinical-grade blood collection solutions, announced that the U.S. Food and DrugAdministration (FDA) has cleared its Tasso+ lancet as a Class II medical device. Tasso, Inc., About Tasso. Our clients include both blue-chip companies and innovative startups within the MedTech space.
Food and DrugAdministration for commercial use in the United States. Director of Global Sales and Marketing of NeuroLogica. Trauma/ER: The BodyTom 64’s unique combination of internal lead shielding and battery operation allows any standard trauma bay to be transformed into an advanced CT imaging suite.
In the past year, Hemgenix has been granted approval by the US Food and DrugAdministration (FDA) and has received conditional marketing authorisation from the European Commission (EC) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). Haemophilia B is a rare condition.
MicroPort Navibot has received 510(K) clearance from the Food and DrugAdministration (FDA) in the United States for the SkyWalker System, the company’s first robot-assisted platform for orthopedic applications. Our clients include both blue-chip companies and innovative startups within the MedTech space.
The Role of Certified Pharmaceutical Representatives in the Shifting Sales Landscape The US Bureau of Labor Statistics (BLS) projects the number of jobs for pharmaceutical sales representatives will grow by four percent by 2031, adding approximately 170,000 new job openings per year over this decade.
In preparation for this, drug manufacturing will begin later this year and will be outsourced to external contract manufacturing organisations (CMOs). This leads to hyperammonaemia, which causes symptoms such as vomiting, mental confusion, and lethargy. A nitrogen-binding drug, its global sales were $292m in 2021, as per GlobalData.
Of the 175 new drugs approved by the US Food and DrugAdministration (FDA) between 2016 and 2019, most were biologics. Of the 175 new drugs approved by the US Food and DrugAdministration (FDA) between 2016 and 2019, most were biologics.
Utilizing the Halo cloud-based platform allowed HeartBeam to meet its schedule for FDA submission of the HeartBeam AIMI software for acute care settings that provides a 3D vector electrogram (VECG) comparison of baseline and symptomatic 12-lead ECG to more accurately identify a heart attack.
Tyber Medical LLC, the global, leading private-label medical device provider for major orthopedic trauma, extremity, and spine companies, has been awarded a U.S. Food and DrugAdministration (FDA) 510(k) clearance for its new NiTy+ One-Shot Staple Fixation System.
Under its terms, Pharming has paid a $10m milestone payment to Novartis for the first commercial sale of Joenja. In March 2023, Joenja secured approval from the US Food and DrugAdministration (FDA) to treat the targeted patients. Both genes are important for the body’s development and for the functioning of immune cells.
HemoSonics, LLC , a leading medical device company delivering individualized diagnostic solutions for Patient Blood Management (PBM), announced that it has received 510(k) market clearance from the U.S. Food and DrugAdministration (FDA) for the Quantra Hemostasis System with QStat Cartridge.
Food and DrugAdministration has approved the company’s fourth-generation rechargeable sacral neuromodulation system. The Axonics R20 neurostimulator utilizes the same small 5cc form factor as the Axonics R15 and is paired with the same tined lead and intuitive patient remote control. Axonics, Inc.,
It received approval from the US Food and DrugAdministration in October 2018. EyePoint Pharmaceuticals will also receive potential royalties on the combined net sales of Iluvien and Yutiq in the US from 2025 to 2028.
Food and DrugAdministration (FDA). ChroniSense Medical, a portfolio company of Rainbow Medical, is continuing its clinical development in collaboration with leading hospitals, partners, and expert practitioners in the U.S., ChroniSense Medical Ltd. and globally.
Food and DrugAdministration (FDA) has granted an Investigational Device Exemption (IDE) to advance the company’s PATCH Clinical Study, a multi-center, single-arm, pivotal study evaluating the safety and effectiveness of the Vivasure PerQseal ® Closure Device System. For more information, please visit www.vivasuremedical.com.
The biotechnology and drug sectors performed well in the second half of 2022 after struggling in the first six months. Despite the uncertainty surrounding the global economy, the drug and biotechnology sectors have continued to perform well in the second half of 2022. This can lead to significant losses for large companies.
Oyster Point Pharma introduced Tyrvaya, a nasal spray approved by the Food and DrugAdministration (FDA) to treat dry eye disease, in November last year. These acquisitions could possibly add a minimum of $1bn in sales of Viatris by 2028. Famy Life Sciences has an ophthalmology portfolio that complements Viatris.
Food and DrugAdministration (FDA) for 510(k) clearance. The ALICE device is being contract manufactured by an end-to-end solution provider that offers New Product Introduction (NPI) services to mass production capabilities for leading medical electronic device companies. and Israel.
As part of our Drugs to Watch series, our team of oncology experts pored over thousands of abstracts for presentations at this year’s just-concluded American Society of Clinical Oncology (ASCO) Annual Meeting. This signifies the growth potential of marketed drugs in established marketplaces and the complexity of oncology treatment paradigms.
on meeting specific near-term regulatory, approval and initial commercial sale milestones. A New Drug Application (NDA) for olutasidenib filed by Forma was accepted by the US Food and DrugAdministration (FDA), and a regulatory decision is anticipated on 15 February next year. and tiered royalty payments.
Activ Surgical is on the leading edge when it comes to enhancing surgical vision and significantly reducing unintended medical errors, and I am confident that ActivSight will improve surgical outcomes.”. Activ Surgical received 501(k)-clearance for ActivSight by the Food and DrugAdministration (FDA) in the United States in 2021.
Celltrion USA has received approval from the US Food and DrugAdministration (FDA) for Humira (adalimumab) biosimilar, Yuflyma (adalimumab-aaty) , for multiple indications. It will be offered to patients in prefilled syringe and autoinjector administration options.
Food and DrugAdministration (FDA) 510(k) clearance to aid in the early detection of sepsis for the approximately 30 million adult patients with signs and symptoms of infection who present to US emergency departments (ED) each year. For updates, follow Cytovale on LinkedIn and Twitter.
Roche has acquired the worldwide rights to develop and commercialise Chinese biotechnology company Zion Pharma’s lead programme, ZN-A-1041. The company will also be eligible for additional payments of up to $610m after achieving specified development, regulatory and sales-based milestones, and for tiered royalties on sales.
Ayvakit has received the US Food and DrugAdministration (FDA) approval to treat advanced systemic mastocytosis in adults. The partnership with Royalty Pharma monetises royalty payments obtainable from net sales of Gavreto by Roche outside of the US, excluding Greater China.
Before marketing the device, a pre-market submission and approval are required by Food and DrugAdministration FDA. That may frequently lead your team to race to complete all necessary tasks before the product’s debut. Meanwhile, you can prepare promotions, train sales personnel, and handle other jobs.
Food and DrugAdministration (FDA) has granted the coveted Breakthrough Device Designation for its LifeGel Absorbable Surgical Hemostat. Medcura, Inc., a medical device company dedicated to transformatively improving the management of surgical bleeding, announces that the U.S.
CBMG will receive $245m in an upfront payment and will also be entitled to potential development, regulatory filing, commercialisation and sales milestones along with tiered royalty payments on net trade sales. The regulator has also granted orphan drug designation for the therapy to treat follicular lymphoma (FL).
In September 2021, Bristol Myers Squibb in-licensed the first programme, EVT8683, after the successful filing of an investigative new drug (IND) application with the Food and DrugAdministration (FDA). This programme has now proceeded into a Phase I clinical trial.
Additionally, for WVE-006, GSK will make development and launch milestone payments of up to $225m to Wave, which is also eligible to get up to $300m in milestone payments based on sales. Wave will conduct all preclinical research for the programmes of both companies until investigational new drug (IND)-facilitating studies. .
In 2019, Daiichi Sankyo entered a global development and commercialisation agreement with AstraZeneca for Daiichi Sankyo’s lead antibody-drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), in a deal worth $6.9bn. GlobalData estimates that global annual sales for datopotamab deruxtecan in the NSCLC setting will exceed $500m in 2028.
a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, today announced a New Drug Application (NDA) for its LUMISIGHT Optical Imaging Agent has been submitted to the U.S. Food and DrugAdministration (FDA). Lumicell, Inc., Are you hiring?
Food and DrugAdministration (FDA) granted marketing authorization of the MISHA Knee System, an implantable shock absorber (ISA) for the knee. Knee OA develops when the joint’s natural shock absorbers, cartilage and meniscus, no longer cushion the joint from daily activities, leading to chronic pain and activity limitation.
Depending on their business model, life sciences companies typically use Salesforce Sales Cloud, Health Cloud, or Service Cloud as their primary CRM. Life Sciences Cloud also drives compliance with various regulatory agencies, such as the US Food and DrugAdministration. What is Life Sciences Cloud?
The frequency of administration associated with a therapy is a critical factor that companies in this space focus on to fine-tune their chances of success in the wAMD market. Lower frequency of administration represents a significant alleviation of treatment burden and lower cost of treatment compared with standard of care.
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