pharmaphorum

OCTOBER 4, 2022

AstraZeneca and Merck & Co’s Lynparza has been the undisputed market leader in the PARP inhibitor category for some years, but would-be competitors continue to chip away at its market share. The post PARP rivals close in on AZ and Merck’s market leading Lynparza appeared first on.

Leads 52

Leads Marketing FDA Patients 52

MedCity News

SEPTEMBER 30, 2022

An Amylyx Pharmaceuticals drug developed to slow the progression of amyotrophic lateral sclerosis is now approved, making it just the third FDA-approved treatment for the disease. Amylyx will market its new product under the name “Relyvrio.”.

FDA 75

FDA Leads Pharmaceutical Marketing 75

World of DTC Marketing

OCTOBER 21, 2021

The FDA’s “accelerated approval” program expedites the evaluation process for new treatments so that patients can have access to them sooner. Between 2011 and 2018, cumulative spending on 44 FDA-approved oral targeted therapy drugs was $3.5 appeared first on World of DTC Marketing.com.

FDA 234

FDA Insurance Prescription Medicine 234

Legacy MEDSearch

APRIL 11, 2023

Food and Drug Administration (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. Moximed is based in Fremont, California.

Marketing 96

Marketing FDA Food and Drug Administration Specialization 96

European Pharmaceutical Review

AUGUST 11, 2023

The European Commission has revoked the conditional marketing authorisation (MA) for Novartis’ sickle cell medicine crizanlizumab in the European Union (EU) and EEA. Conditional marketing authorisation is a pragmatic tool for the fast-track approval of a medicine that fulfils an unmet medical need.

Marketing 82

Marketing Food and Drug Administration Medicine FDA 82

Pharmaceutical Technology

FEBRUARY 10, 2023

4D Molecular Therapeutics (4DMT), the California-based biotechnology company focused on developing gene therapies for rare and large market diseases, has had the FDA place a clinical hold onto its Fabry disease (FD) gene therapy program (4D-310).

FDA 105

FDA Leads Competition Marketing 105

Pharmaceutical Technology

FEBRUARY 22, 2024

United has commenced litigation with the FDA to combat Liquidia’s Yutrepia encroaching on the market for its leading drug Tyvaso.

FDA 52

FDA Leads Marketing 52

pharmaphorum

NOVEMBER 23, 2022

The Japanese pharma said it has filed for approval of TAK-003 with the FDA for the prevention of dengue disease caused by any dengue virus serotype in individuals aged four through 60. Dengue fever is unusual in that a first infection is rarely serious, but a second can lead to much more serious disease. billion in peak sales.

FDA 117

FDA Marketing Leads Safety 117

Pharmaceutical Technology

APRIL 3, 2023

The European Commission (EC) has granted marketing authorisation for Sandoz’s biosimilar Hyrimoz (adalimumab) citrate-free high-concentration formulation (HCF). With eight marketed biosimilars, Sandoz is offering the broadest biosimilar portfolio and is the leading biosimilars company in Europe, with more than two decades of experience.

Marketing 105

Marketing Food and Drug Administration Medicine Food 105

Pharmaceutical Technology

JUNE 19, 2023

UK-based pharmaceutical giant GSK has announced that the US Food and Drug Administration (FDA) has extended the review period of its new drug application (NDA) for the rare bone cancer drug momelotinib by three months. Novartis and Incyte Corp’s Jakafi was the first FDA-approved drug for the treatment of myelofibrosis in November 2011.

Food and Drug Administration 98

Food and Drug Administration FDA Prescription Food 98

European Pharmaceutical Review

AUGUST 21, 2023

For 20 of the leading biopharmaceutical companies, the second quarter (Q2) of 2023 has brought an aggregate market capitalisation growth of 2.3 Q2 2023 biopharma market capitalisation results Eli Lilly “Eli Lilly witnessed the largest market capitalisation growth of 36.1 trillion in the Q1 of 2023 to $3.56

Biopharma 80

Biopharma Marketing Sales Medicine 80

Legacy MEDSearch

APRIL 6, 2023

announced that it has received FDA 510(k) clearance for CardioSTAT, an ambulatory, continuous ECG monitoring solution that relies on a wire free, single-use recorder. The FDA clearance opens the door to the world’s largest medical device market. Icentia Inc., “This approval marks a key milestone for our company.

Food and Drug Administration 98

Food and Drug Administration Food FDA Recruitment 98

Pharmaceutical Technology

APRIL 18, 2023

IntelGenx Corp announced that the US Food and Drug Administration (FDA) has approved the company’s Rizafilm VersaFilm new drug application (NDA) for the treatment of acute migraine. Rizafilm, the US market name for Rizaport outside of the US, is administered via an oral soluble film.

Food and Drug Administration 98

Food and Drug Administration FDA Food Manufacturing 98

pharmaphorum

JANUARY 4, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson have submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA), seeking approval of talquetamab for the treatment of patients with relapsed or refractory multiple myeloma (RRMM). This reduces the timeframe for the MAA to be reviewed.

Marketing 78

Marketing Medicine FDA Patients 78

Pharmaceutical Technology

MARCH 20, 2023

The race for a first-to-market therapy in non-alcoholic steatohepatitis (NASH) has been a marathon, with many companies facing numerous setbacks and failures. The FDA accepted Intercept’s resubmitted NDA on 19 January 2023 and set a PDUFA of 22 June 2023.

Marketing 52

Marketing FDA Leads Safety 52

Pharmaceutical Technology

SEPTEMBER 6, 2022

The US Food and Drug Administration (FDA) has awarded Orphan Drug Designation (ODD) to Avacta Group’s lead pre|CISION drug candidate, AVA6000, to treat soft tissue sarcoma. By 2024, doxorubicin is anticipated to have a market size of $1.38bn and is extensively utilised as a part of the standard of care in various types of cancers. .

Food and Drug Administration 98

Food and Drug Administration FDA Safety Food 98

Legacy MEDSearch

DECEMBER 5, 2022

WISE Srl, a medical device company developing next-generation implantable electrodes for neuromonitoring, neuromodulation and brain-machine interfacing (BMI), announced the FDA clearance of its WISE Cortical Strip (WCS®) , a single use medical device intended to be used on the brain surface for Intra Operative Neurophysiological Monitoring (IONM).

FDA 98

FDA Recruitment Leads Medical 98

European Pharmaceutical Review

JANUARY 3, 2023

A marketing authorisation application (MAA) has been submitted by The Janssen Pharmaceutical Companies of Johnson & Johnson to the European Medicines Agency (EMA) for approval of talquetamab, a bispecific t-cell engager antibody for the treatment of patients with relapsed or refractory multiple myeloma (RRMM).

Marketing 79

Marketing Food and Drug Administration Medicine Food 79

Pharmaceutical Technology

APRIL 4, 2023

The FDA has seen a record surge in review designations being awarded over the last two years for Alzheimer’s indications, with 12 review designations being awarded to drugs between 2020 and 2022. Between 2020 and 2021, the number of designations increased by 600%, with seven designations being awarded by the FDA in 2021. ©GlobalData.

FDA 98

FDA Specialization Leads Marketing 98

Legacy MEDSearch

MARCH 13, 2023

Food and Drug Administration (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. The PATCH pivotal study will enroll up to 188 patients across the U.S.

Medical 98

Medical FDA Food and Drug Administration Recruitment 98

Pharmaceutical Technology

JUNE 21, 2023

AGEPHA Pharma has received approval from the US Food and Drug Administration (FDA) for LODOCO (colchicine, 0.5 We are dedicated to addressing heart disease, the leading cause of death, by ensuring all patients have access to LODOCO.” mg tablet) to treat cardiovascular disease.

Food and Drug Administration 98

Food and Drug Administration FDA Prescription Food 98

Pharmaceutical Technology

JULY 12, 2022

The success of chimeric antigen receptor T-cells (CAR-T) in blood cancers has led to the US Food and Drug Administration'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.

Leads 52

Leads Food and Drug Administration Marketing Sales 52

Legacy MEDSearch

NOVEMBER 15, 2022

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 Drug Administration (FDA) 510(k) clearance for its new NiTy+ One-Shot Staple Fixation System. Press Release by: Tyber Medical.

Medical 98

Medical FDA Food and Drug Administration Engineering 98

World of DTC Marketing

DECEMBER 2, 2021

GOOD MORNING: The FDA is taking a scientific approach to evaluating direct-to-consumer (DTC) drug advertising, focusing on measuring consumer perceptions of the information presented in ads. ” So, are we supposed to believe that better images in DTC ads lead to patients asking for an Rx? ” Uh…no.

Food and Drug Administration 185

Food and Drug Administration Side effects FDA Prescription 185

Pharmaceutical Technology

DECEMBER 6, 2022

The three leading Alzheimer’s disease (AD) drugs currently in development are all monoclonal antibodies—donanemab by Eli Lilly , lecanemab by Eisai and Biogen , and gantenerumab by Roche. The post Monoclonal antibodies challenge marketed small-molecule Alzheimer’s dominance appeared first on Pharmaceutical Technology.

Marketing 59

Marketing Leads Pharmaceutical FDA 59

Legacy MEDSearch

SEPTEMBER 16, 2022

the leading provider of convenient, clinical-grade blood collection solutions, announced that the U.S. Food and Drug Administration (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.

Medical 97

Medical FDA Food and Drug Administration Recruitment 97

Legacy MEDSearch

DECEMBER 8, 2022

Food and Drug Administration (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. and globally.

FDA 97

FDA Patients Food and Drug Administration Medical 97

Legacy MEDSearch

DECEMBER 1, 2022

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 Drug Administration (FDA) for the Quantra Hemostasis System with QStat Cartridge. market today. market today.

FDA 95

FDA Food and Drug Administration Recruitment Medical 95

European Pharmaceutical Review

MARCH 8, 2023

Now working as a woman in pharma, Dr Ekaterina Malievskaia highlighted her female inspirations in the industry, two of which have held leading roles at Bristol Myers Squibb and the US Food and Drug Administration (FDA). Click here to read EPR’s previous ‘ Women Inspiring Pharma’ series.

Leads 52

Leads Pharma Food and Drug Administration Medicine 52

European Pharmaceutical Review

FEBRUARY 21, 2023

SYFOVRE (pegcetacoplan injection) is the first and only treatment approved by the US Food and Drug Administration (FDA) for geographic atrophy (GA), a leading cause of blindness. A marketing authorisation application (MAA) is under review by the European Medicines Agency (EMA) with a regulatory decision expected in early 2024.

FDA 83

FDA Food and Drug Administration Food Leads 83

Legacy MEDSearch

NOVEMBER 28, 2022

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. See Full Press Release at the Source: NeuroLogica Announces FDA 510(k) Clearance of BodyTom® 64.

FDA 92

FDA Food and Drug Administration Electronics Recruitment 92

World of DTC Marketing

MARCH 23, 2022

Accelerated Approval was developed in 1992 in response to the HIV/AIDS crisis and has led to expedited drug and biologic approvals in several disease areas across the FDA. Of course, they should, but in the end, it’s going to come down to trust in their doctor and the FDA. Do patients care?

Patients 200

Patients FDA Doctors Physicians 200

Pharmaceutical Technology

FEBRUARY 14, 2023

In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Key innovation: Leading companies in nanoparticles for drug delivery. Bristol-Myers Squibb is the leading patent filer in nanoparticles for drug delivery.

Leads 59

Leads Pharmaceutical Transportation FDA 59

pharmaphorum

JUNE 24, 2022

The FDA has ordered a clinical hold on Sarepta’s SRP-5051 (vesleteplirsen) drug candidate after one patient in the study developed very low levels of magnesium, a condition known as hypomagnesaemia, that can lead to muscle weakness and tremors, seizures, and irregular heart rhythms.

FDA 70

FDA Safety Recruitment Leads 70

Pharmaceutical Technology

MARCH 27, 2023

Food and Drug Administration (FDA) for Lifileucel. The BLA submission for lifileucel, a leading drug candidate of the company, is a step toward in making TIL therapy an option for patients who have progressed following prior treatments. “Our Our preparations for commercialization remain on track to support a launch later this year.

Food and Drug Administration 52

Food and Drug Administration FDA Food Medicine 52

pharmaphorum

NOVEMBER 9, 2022

ADC Therapeutics has said it will not seek accelerated approval of its Hodgkin lymphoma drug camidanlumab tesirine (cami) based on phase 2 results, as the FDA will not review it unless a confirmatory trial is already “well underway and fully enrolled.”.

FDA 57

FDA Prospecting Marketing Safety 57

pharmaphorum

DECEMBER 16, 2022

The Japanese pharma says it will now start talking to regulatory authorities around the world about potential marketing applications for zolbetuximab as a first-line treatment for patients with locally advanced unresectable or metastatic gastric and gastro-oesophageal (GEJ) cancer. Claudin 18.2 cancers appeared first on.

Leads 57

Leads Biopharma Prospecting Patients 57