2023, FDA, Prospecting and Sales

Phase 3 lung cancer fail dents prospects of Ipsen, Servier’s Onivyde

pharmaphorum

AUGUST 3, 2022

Immunotherapies and combination therapies have dramatically improved the prospects for newly-diagnosed SCLC patients, but despite these advances, many rapidly relapse due to the aggressive nature of the disease. million) in sales for the product in the first six months of this year, a rise of 30% at constant exchange rates.

Prospecting

Prospecting FDA Sales Patients

iHealthScreen Inc. Announces FDA 510K Submission for iPredict™ AMD tool

Legacy MEDSearch

MAY 24, 2023

iHealthScreen conducted a prospective trial in the general population to prospectively assess the product’s accuracy, sensitivity and specificity. These prospective study results were initially presented at the Annual Meeting of the American Academy of Ophthalmology (AAO) and selected for Panel Discussion as outstanding work.

FDA

FDA Prospecting Recruitment Healthcare

Trial sets up earlier use of J&J’s Carvykti in myeloma

pharmaphorum

JANUARY 29, 2023

One of the Johnson & Johnson’s top clinical trial readouts for 2023 just generated results, which bode very well for the future prospects of multiple myeloma CAR-T Carvykti. Legend said last week that Carvykti made $55 million in the fourth quarter. BMS is due to report fourth quarter results on 2 February.

Sales

Sales Prospecting Patients Manufacturing

CSL closes on EU approval for haemophilia B gene therapy

pharmaphorum

DECEMBER 16, 2022

The positive opinion for etranacogene dezaparvovec – which was approved as Hemgenix by the FDA last month – raises the prospect of the first one-time therapy in the EU for the bleeding disorder, which affects around 1 in 50,000 of the population, according to the European Haemophilia Network (EUHANET).

Medicine

Medicine Prospecting Networking Marketing

Watch These 4 Large Drug Stocks Amid the Booming Industry

Contrarian Sales Techniques

DECEMBER 14, 2022

The acquisition activity of large pharmaceutical companies is also a result of the lackluster sales of older drugs, the government's scrutiny of the pricing of drugs, and the emergence of new tech firms such as Google and Apple. The US Food and Drug Administration (FDA) has approved Wegovy, which is a 2.4-mg It has gained 12.0%

Food and Drug Administration

Food and Drug Administration Pharmaceutical Sales Medicine

Centinel Spine® Completes Enrollment in First-of-its-Kind 2-Level IDE Trial Evaluating prodisc® C Match-the-Disc™ Cervical TDR System

Legacy MEDSearch

JUNE 16, 2023

The prospective, randomized clinical trial is designed to evaluate the safety and effectiveness of the pro disc C Vivo and pro disc C SK system by comparing it with an approved TDR product as a control for 2-level indications, making it the first and only of its kind with two investigational devices and a TDR control.

Food and Drug Administration

Food and Drug Administration Recruitment Safety Medical

Building Your Brand In Medical Device Sales With Pat Kothe

Evolve Your Success

APRIL 11, 2023

Building your brand in medical device sales requires experience, strategic insights, and a relentless pursuit of excellence. With 40 years of medical device sales experience, Pat discusses how to build a successful medical device sales business. He also touches on the sales funnel, the art of hiring, and more.

Sales

Sales Medical Medical sales Media

BlackSwan Vascular Wins FDA Premarket Approval of Innovative New Treatment for Peripheral Arterial Hemorrhages

Legacy MEDSearch

APRIL 21, 2023

a privately held company that is developing innovative therapies in endovascular embolization, is pleased to announce it has received FDA Premarket Approval (PMA) of its Lava® Liquid Embolic System (Lava® LES) for treatment of peripheral arterial hemorrhage. Bay Area-based BlackSwan Vascular, Inc.,

FDA

FDA Safety Recruitment Prospecting

New FDA Clearance Makes Eyenuk the First Company with Multiple Cameras for Autonomous AI Detection of Diabetic Retinopathy

Legacy MEDSearch

JUNE 22, 2023

Food and Drug Administration (FDA) clearance to use the Topcon NW400 retinal camera with its EyeArt AI system to automatically detect diabetic retinopathy (DR), adding to the already-cleared usage with Canon CR-2 AF and Canon CR-2 Plus AF cameras. ” This latest FDA clearance for the EyeArt v2.2.0 sensitivity and 91.1%

FDA

FDA Food and Drug Administration Recruitment Marketing

Clinical Study Results of the BlueWind System for Patients with Overactive Bladder Featured at the 2023 AUA Annual Meeting

Legacy MEDSearch

MAY 1, 2023

The results were featured in the late-breaking session ( LBA01-05 ) at the American Urological Association (AUA) 2023 Annual Meeting in Chicago on Sunday, April 30 th. Results from the trial are under review by the FDA. We continue to work with the FDA and look forward to introducing this innovative solution to physicians and patients.”

Patients

Patients Medical Safety Recruitment

Russia’s focus on domestic pharma production could shield it from sanctions’ effects

Pharmaceutical Technology

JULY 4, 2022

Compared with other emerging pharmaceutical markets (such as India and China, covered in previous Emerging Market Outsourcing Reports), Russian facilities lack many US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals, meaning Russian manufacturing is more focused on the domestic market.

Pharma

Pharma Food and Drug Administration Manufacturing Medicine

Illegal online pharmacies gain traction as regulators lag behind

Pharmaceutical Technology

MAY 26, 2023

The FDA has flagged this issue as pharmacies selling prescription drugs illegally have proliferated over the years. The US Food and Drug Administration (FDA commissioner Dr. Robert Califf says, “The illegal sale of prescription drug stimulants online puts Americans at risk and contributes to potential abuse, misuse, and overdose.”

Food and Drug Administration

Food and Drug Administration Prescription FDA Medical

Intercept receives orphan drug designation for liver disease combo therapy

Pharmaceutical Technology

MAY 17, 2023

The US Food and Drug Administration (FDA) has awarded an orphan drug designation to Intercept Pharmaceuticals’ fixed-dose combination of obeticholic acid and bezafibrate for the treatment of primary biliary cholangitis. Data from the analyses will be used for a potential end-of-Phase II study meeting with the FDA. billion in 2029.

Food and Drug Administration

Food and Drug Administration FDA Pharmaceutical Prospecting

Exforge antitrust settlement caps Novartis’ year of legal disputes

Pharmaceutical Technology

JANUARY 6, 2023

Last year, Novartis began with a win in January, as the US Court of Appeals affirmed the validity of Gilenya’s patent, allowing the company to sue a competitor generics company for filing for FDA approval for its Gilenya generic. In a press release, the company said a generic launch would damage sales in FY 2023 by $300,000.

Pharmaceutical

Pharmaceutical Doctors Healthcare Provider Prescription

Pharma Rep Focus

Phase 3 lung cancer fail dents prospects of Ipsen, Servier’s Onivyde

iHealthScreen Inc. Announces FDA 510K Submission for iPredict™ AMD tool

Trending Sources

Trial sets up earlier use of J&J’s Carvykti in myeloma

CSL closes on EU approval for haemophilia B gene therapy

Watch These 4 Large Drug Stocks Amid the Booming Industry

Centinel Spine® Completes Enrollment in First-of-its-Kind 2-Level IDE Trial Evaluating prodisc® C Match-the-Disc™ Cervical TDR System

Building Your Brand In Medical Device Sales With Pat Kothe

BlackSwan Vascular Wins FDA Premarket Approval of Innovative New Treatment for Peripheral Arterial Hemorrhages

New FDA Clearance Makes Eyenuk the First Company with Multiple Cameras for Autonomous AI Detection of Diabetic Retinopathy

Clinical Study Results of the BlueWind System for Patients with Overactive Bladder Featured at the 2023 AUA Annual Meeting

Russia’s focus on domestic pharma production could shield it from sanctions’ effects

Illegal online pharmacies gain traction as regulators lag behind

Intercept receives orphan drug designation for liver disease combo therapy

Exforge antitrust settlement caps Novartis’ year of legal disputes

Stay Connected