European Pharmaceutical Review

NOVEMBER 25, 2022

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

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Legacy MEDSearch

NOVEMBER 3, 2023

Food and Drug Administration (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.

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Pharmaceutical Technology

APRIL 4, 2023

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.

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European Pharmaceutical Review

JANUARY 10, 2023

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.

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Legacy MEDSearch

OCTOBER 18, 2023

Food and Drug Administration (FDA) 510(k) clearance for the company’s FreedomFlow Orbital Atherectomy Peripheral Platform. Food and Drug Administration (FDA) 510(k) Clearance for its FreedomFlow® Orbital Atherectomy Peripheral Platform Press Release by: Cardio Flow, Inc. Cardio Flow, Inc. , Announces U.S.

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MedCity News

JUNE 12, 2023

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 & Drug Administration (FDA) clearance, and provided solid clinical study evidence.

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Pharmaceutical Technology

AUGUST 17, 2008

Nicola Boyes: The FDA has come under criticism recently for extreme delays in approving new drugs for the market, is the criticism valid and if so how are the delays impacting on the US pharmaceutical industry at present? This higher threshold, although not explicit, would also be expected to slow drug approvals.

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Evolve Your Success

FEBRUARY 7, 2023

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.

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Pharmaceutical Technology

APRIL 3, 2023

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.

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World of DTC Marketing

JUNE 22, 2021

Milton Friedman A newly approved drug to treat Alzheimer’s disease is expected to become a multibillion-dollar expense for Medicare. By one projection, spending on the drug for Medicare patients could end up being higher than the budgets for the Environmental Protection Agency or NASA. (New Milton Friedman.

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Legacy MEDSearch

OCTOBER 25, 2022

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 Drug Administration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System.

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Pharmaceutical Technology

JUNE 20, 2023

The investigational drug candidate vamorolone has a mode of action based on binding to the same receptor as glucocorticoids while changing its downstream activity. In the US and Europe, the drug has received orphan drug status to treat Duchenne muscular dystrophy (DMD).

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Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (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.

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Pharmaceutical Technology

MARCH 15, 2023

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 Drug Administration (FDA).

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Pharmaceutical Technology

APRIL 17, 2023

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 Drug Administration (FDA).

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Pharmaceutical Technology

NOVEMBER 11, 2022

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 Drug Administration (FDA) approved the company’s Imjudo (tremelimumab) plus Imfinzi (durvalumab) for treating adults with unresectable hepatocellular carcinoma.

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Infuse Medical

JANUARY 9, 2020

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. Medical device products require approval by the Food and Drug Administration (FDA) before they go to market.

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European Pharmaceutical Review

NOVEMBER 2, 2023

The US Food and Drug Administration ( FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). US sales of Stelara totalled $6.4 He added that the approval of Wezlana “could have a meaningful impact for patients managing their disease.”

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Pharmaceutical Technology

JANUARY 31, 2023

The gene therapy received Orphan Drug and Fast Track designations from the US Food and Drug Administration (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.

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European Pharmaceutical Review

AUGUST 4, 2023

There are at present, nine US Food and Drug Administration (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.

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Rep-Lite

SEPTEMBER 21, 2024

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!

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Pharmaceutical Technology

JULY 20, 2022

On 6 July, in an effort to accelerate access, the US Food and Drug Administration (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.

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Pharmaceutical Technology

FEBRUARY 14, 2023

Precision oncology firm Corbus Pharmaceuticals and CSPC Megalith Biopharmaceutical have entered an exclusive licensing agreement for the latter’s new clinical stage antibody drug conjugate (ADC), CRB-701 (SYS6002). upfront payment and eligible for royalties on net sales. CSPC Megalith is a subsidiary of CSPC Pharmaceutical Group.

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European Pharmaceutical Review

AUGUST 10, 2022

It was approved by the US Food and Drug Administration in October 2021 as an adjunctive treatment for adult patients with severe active ANCA-associated vasculitis, specifically granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) (the two main forms of ANCA-associated vasculitis), in combination with standard therapy.

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Legacy MEDSearch

FEBRUARY 13, 2023

Food and Drug Administration (FDA) 510(k) clearance and launch of the company’s upgraded AI-powered software. Hyperfine, Inc., the groundbreaking medical device company that created the Swoop® system, the world’s first FDA-cleared portable magnetic resonance imaging (MRI) device for imaging of the brain, today announced the U.S.

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Legacy MEDSearch

JANUARY 3, 2023

Food and Drug Administration for its Respiratory Health point of care test. Over the past 17 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs. About Visby Medical.

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Pharmaceutical Technology

JUNE 21, 2023

In the past year, Hemgenix has been granted approval by the US Food and Drug Administration (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.

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Legacy MEDSearch

JUNE 7, 2022

Food and Drug Administration (FDA) clearance for the company’s FreedomFlow® Peripheral Guidewire. Scott Kraus, Vice President of Sales & Market for Cardio Flow, commented, “Cardio Flow is encouraged by the initial feedback from Dr. Mustapha, who is a recognized leader in the treatment of PAD and critical limb ischemia (CLI).

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Pharmaceutical Technology

JULY 29, 2022

In preparation for this, drug manufacturing will begin later this year and will be outsourced to external contract manufacturing organisations (CMOs). The most common marketed drugs in this space aim to address the hyperammonaemia caused by the defective genes in this disorder. David Bumcrot PhD, CSO, CAMP4 Therapeutics.

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Legacy MEDSearch

DECEMBER 12, 2022

IRRAS markets and sells its comprehensive, innovative IRRAflow and Hummingbird ICP Monitoring product lines to hospitals worldwide through its direct sales organization in the United States and select European countries as well as an international network of distribution partners.

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Pharma Leaders

JUNE 28, 2023

The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Regeneron Pharmaceuticals for its Biologics License Application (BLA) for aflibercept 8mg to treat wet diabetic macular oedema (DME), age-related macular degeneration (wAMD) and diabetic retinopathy (DR).

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Food and Drug Administration FDA Safety Food 52

Legacy MEDSearch

AUGUST 8, 2022

MicroPort Navibot has received 510(K) clearance from the Food and Drug Administration (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.

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Legacy MEDSearch

SEPTEMBER 27, 2022

Food and Drug Administration (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. Our clients include both blue-chip companies and innovative startups within the MedTech space.

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European Pharmaceutical Review

FEBRUARY 22, 2023

Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. When the balloon reaches a sufficient pressure, this pushes the dissolvable needle into the intestinal wall, delivering the drug payload.”

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Legacy MEDSearch

SEPTEMBER 16, 2022

Food and Drug Administration (FDA) has cleared its Tasso+ lancet as a Class II medical device. Over the past 17 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs.

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Medical FDA Food and Drug Administration Recruitment 97

Legacy MEDSearch

JANUARY 19, 2023

Food and Drug Administration (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.

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Pharmaceutical Technology

SEPTEMBER 2, 2022

The rate of drug approvals could be on the rise. In a recent report, GlobalData revealed that the US Food and Drug Administration (FDA) approved 122 new drug applications (NDAs) and biologic license applications (BLAs) in 2021. De-risking drug launch. This figure represents a 2.4% Insourcing vs outsourcing.

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