This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
billion on Thursday for allegedly delaying its Breyanzi cancer drug to avoid payments to shareholders of the former Celgene Corp, which the drugmaker bought in 2019. Food and DrugAdministration approval for the non-Hodgkin lymphoma drug by a Dec. The post BMS: Delayed new drug to avoid paying billions?
Biogen will partner with Roche on the development, and potential sale of a promising cancer drug the Swiss pharma is advancing for several types of lymphoma, announcing Tuesday it’s exercised an option to share rights to the treatment. Food and DrugAdministration on Biogen Inc.’s
Food and DrugAdministration (FDA) has approved the EMPAVELI Injector (enFuse ® ) for the subcutaneous delivery of EMPAVELI ® (pegcetacoplan), which is commercialized in the United States by Apellis Pharmaceuticals, Inc. “Enable’s purpose is to redefine drug delivery for the benefit of patients. .
It seems that pharma is only interested in drugs that have the potential to sell hundreds of millions as opposed to small products that may only sell to a limited audience. A study in 2020 estimated that the median cost of getting a new drug into the market was $985 million, and the average price was $1.3 5 drugs) ranged from $765.9
Bringing the very first prescription digital therapeutic (PDT) to market in 2017, Pear Therapeutics went above and beyond to follow suggested regulatory guidelines, obtained Food & DrugAdministration (FDA) clearance, and provided solid clinical study evidence.
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.
The Luye Pharma drug demonstrated comparable bioavailability with Johnson and Johnson’s Invega Sustenna ® at steady state in a clinical trial ( NCT04922593 ). If successful, the drug is forecasted to reach sales of $63.5 GlobalData’s report showed LY03010 is expected to launch in the US in 2024. million in 2031, representing 0.6
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.
On April 3, Janssen Pharmaceutical Companies of Johnson & Johnson announced the availability of an additional 240mg strength tablet for its prostate cancer drug ERLEADA (apalutamide) in the United States. Previously, the drug was only available as a 60mg tablet – four of the which would need to be daily. billion in 2021.
Clarivate Plc has released its Drugs to Watch 2023 report — among 70 of the drugs highlighted, including potential blockbuster drugs, the majority were revealed to be personalised medicines. The report offers predictive analysis of drugs entering the market or launching key indications in 2023.
The US Food and DrugAdministration ( FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). US sales of Stelara totalled $6.4 The post FDA approves first Stelara biosimilar, Wezlana appeared first on European Pharmaceutical Review.
Food and DrugAdministration (FDA). ” Please visit the link below to learn more about POLARIS AR and STELLAR Knee, and to connect with a sales or POLARIS AR team representative: [link] ABOUT POLARIS AR POLARIS AR is a Miami based startup whose mission is to develop a new class of Mixed Reality surgical technology.
Food and DrugAdministration (FDA) 510(k) clearance for the company’s FreedomFlow Orbital Atherectomy Peripheral Platform. Food and DrugAdministration (FDA) 510(k) Clearance for its FreedomFlow® Orbital Atherectomy Peripheral Platform Press Release by: Cardio Flow, Inc. Cardio Flow, Inc. ,
Food & DrugAdministration (FDA) for its smaller-diameter CurvaFix® IM Implant indicated for fixation of fractures of the pelvis. Food & DrugAdministration (FDA). CurvaFix, Inc., The company is focusing on Fragility Fractures of the Pelvis and high-impact pelvic fractures.
The US Food and DrugAdministration (FDA) has approved AbbVie’s Rinvoq (upadacitinib) for patients with Crohn’s disease who do not respond to TNF blockers, a common immune suppressant treatment for the condition. Clinical response was observed after just two weeks in some cases.
BioNTech has signed exclusive licence and collaboration agreements with Duality Biologics (DualityBio) for the development of two antibody-drug conjugate (ADC) assets for solid tumours. The agreements also include the manufacturing and commercialisation of the two assets, including DB-1303 and DB-1311, across the globe.
Food and DrugAdministration (FDA) 510(k) clearance for its CellFX System, expanding the indication for use to include the treatment of sebaceous hyperplasia in patients with Fitzpatrick skin types I-III. These treatment tips broaden the portfolio of previously available 1.5mm, 2.5mm and 5.0mm treatment tip sizes.
According to a market report by GlobalData, expanding generic drug competition and a drop in demand for COVID-19 vaccines and therapies have lowered the aggregate market capitalisation of the global top 20 biopharmaceutical companies by 9.1 billion in Q3 from its eye disease drug Eylea. percent from $3.45 trillion in Q2 2022 to $3.14
Food and DrugAdministration (FDA) has cleared its Tasso+ lancet as a Class II medical device. This action is part of the FDA’s ongoing effort to ensure the safe and effective use of blood lancets in the home and health care settings. Tasso, Inc., For more information, please visit www.tassoinc.com.
US-based development-stage biopharmaceutical firm Satsuma Pharmaceuticals is developing STS101, a unique nasal powder formulation of the anti-migraine drug dihydroergotamine mesylate, for the treatment of acute migraine. In March 2023, Satsuma submitted a new drug application for STS101 to the US Food and DrugAdministration (FDA).
Food and DrugAdministration (FDA). “FDA clearance is a significant milestone towards the commercialization of Polso CONNECT and towards creating a new model in chronic care management,” said ChroniSense Medical CEO, Bridget Ross. “FDA clearance is an important validation of our technology.
This most recent FDA 510(k) clearance extends the system’s previous FDA clearances and permits the activation of software functionality that connects to the patient’s bedside monitor and openly transmits treatment information to the central nursing station. For more information, please visit www.irras.com. Are you hiring?
The US Food and DrugAdministration (FDA) has granted final approval to India-based Zydus Lifesciences ‘ 500mg azithromycin tablets for the treatment of bacterial infections. Zydus will manufacture the drug at its formulation facility in Moraiya, Ahmedabad, in the Indian state of Gujarat.
Food and DrugAdministration for commercial use in the United States. Director of Global Sales and Marketing of NeuroLogica. BodyTom 64 is designed and manufactured to comply with the FDA Quality System Regulations and ISO 13485:2016 requirements and is in conformance with global regulatory harmonized standards.
In the world of medical device marketing and sales, executing a well thought through product launch provides a huge opportunity to gain market share, grow your clientele, and increase your revenue. Plan Ahead Before FDA Approval. With an unpredictable FDA timeline, the launch date could come sooner than you think.
Food and DrugAdministration (FDA) 510(k) clearance of the BiWaze ® Clear System. See Full Press Release at the Source: ABM RESPIRATORY CARE ANNOUNCES THE FDA CLEARANCE OF THE BIWAZE CLEAR SYSTEM. For more information visit, www.abmrc.com. . Press Release by: ABM Respiratory Care. Are you hiring?
Food and DrugAdministration (FDA) clearance for the company’s FreedomFlow® Peripheral Guidewire. Announces FDA Clearance for FreedomFlow® Peripheral Guidewire, plus First Commercial Case Completed in U.S. Cardio Flow, Inc., For further information, visit www.acvcenters.com. Press Release by: Cardio Flow, Inc.
Food and DrugAdministration (FDA) 510(k) clearance for its new NiTy+ One-Shot Staple Fixation System. Tyber Medical is committed to providing rapid access to FDA-cleared and CE-marked private label, orthopedic device technology that advance patient care and healing outcomes. About Tyber Medical LLC.
Food and DrugAdministration for its Respiratory Health point of care test. See Full Press Release at the Source: Visby Medical Receives FDA Emergency Use Authorization for Respiratory Health Test for use in CLIA waived settings. About Visby Medical. For more information, visit www.visby.com. Are you hiring?
Food and DrugAdministration (FDA) 510(k) clearance for the Flex-Thread Ulna Intramedullary (IM) Nail System. Conventus Flower Orthopedics, an innovation-driven medical technology company, announced they have received U.S. Our clients include both blue-chip companies and innovative startups within the MedTech space.
Food and DrugAdministration has approved the company’s fourth-generation rechargeable sacral neuromodulation system. The post Axonics Receives FDA Approval for Fourth-Generation Rechargeable Sacral Neuromodulation System appeared first on Legacy MedSearch | Medical Device Recruiters. Axonics, Inc., Are you hiring?
a commercial-stage healthcare business dedicated to neonatal intensive care and the acute care hospital community, announced FDA approval of the newest generation of its tankless inhaled nitric oxide (iNO) delivery system. . Food and DrugAdministration (FDA). VERO Biotech Inc., VERO Biotech Inc. Are you hiring?
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. and Europe. Are you hiring?
Food and DrugAdministration (FDA) for 510(k) clearance. If FDA clearance is obtained, the ALICE device production line will be extended for Low-Rate Initial Production (LWRIP), which is an important operational stage in developing infrastructure to support serial manufacturing, quality control and shipping.
For the quarter ending on 30 September 2022, product sales were reported at $10.59bn from $9.7bn in Q3 last year, indicating a growth of 9%. In October, the US Food and DrugAdministration (FDA) approved the company’s Imjudo (tremelimumab) plus Imfinzi (durvalumab) for treating adults with unresectable hepatocellular carcinoma.
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).
Food and DrugAdministration (FDA) for the Quantra Hemostasis System with QStat Cartridge. The FDA clearance of the QStat Cartridge expands the Quantra System’s indications for use to include trauma, and liver transplantation procedures. market today. Press Release by: HemoSonics, LLC. Are you hiring?
There are at present, nine US Food and DrugAdministration (FDA)-approved agents, GlobalData stated. Worldwide sales for Humira peaked at $21.2 This has developed following numerous adalimumab biosimilar offerings being brought to market. billion in 2022, a product that was launched in 2002.
Food and DrugAdministration (FDA) 510(k) clearance and launch of a next-generation RhinAer® stylus. See Full Press Release at the Source: Aerin Medical Receives FDA Clearance of Next-Generation RhinAer® Stylus for Treatment of Patients with Chronic Rhinitis. Aerin Medical Inc., Press Release by: Aerin Medical.
The sale of an illegally imported supplement being marketed as a weight-gain enhancer has been associated with cases of dizziness, cognitive impairment, and sedation, according to the US Food and DrugAdministration (FDA).
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. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
Food and DrugAdministration (FDA) 510(k) clearance of the LOBO-7 and LOBO-9 Vascular Occluders, the latest addition to the company’s LOBO ® Vascular Occlusion System. LOBO-3 and LOBO-5, both previously FDA cleared, are intended for use in 1.5 Okami Medical Inc., ” About Okami Medical, Inc.
On 6 July, in an effort to accelerate access, the US Food and DrugAdministration (FDA) allowed pharmacists to also begin prescribing the drug to eligible individuals with Covid-19. The pharmacist can then review their medical history to make sure there are no concerns of drug-drug interactions with Paxlovid.
Food and DrugAdministration (FDA) granted marketing authorization of the MISHA Knee System, an implantable shock absorber (ISA) for the knee. Also, we recognize the dedicated reviewers at FDA for completing their thorough benefit-risk assessment of our breakthrough technology. Are you hiring?
We organize all of the trending information in your field so you don't have to. Join 8,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content