Pharma Rep Focus

Merck’s Keytruda regimen gains positive EMA CHMP opinion

Pharmaceutical Technology

FEBRUARY 26, 2024

Merck's KEYTRUDA has received a positive opinion from the EMA CHMP for use in combination with chemotherapy for non-small cell lung cancer.

Nuance, Paige Launch Network to Speed Up Second Opinions in Pathology

MedCity News

NOVEMBER 27, 2023

.” Paige’s digital pathology tools will be embedded into PowerShare, Nuance’s nationwide image sharing network with the goal of connecting more pathology labs to expert second opinions.

Networking

Networking Consulting Healthcare Healthcare

How Transcarent Is Expanding Access to Expert Second Opinions

MedCity News

JANUARY 17, 2023

Transcarent recently announced a partnership with The Clinic by Cleveland Clinic, which provides second opinions from medical specialists via video visits. Now Transcarent members can access The Clinic’s services as a benefit, which means they won’t face any out-of-pocket costs in most cases.

Medical

Vitiligo treatment gets positive CHMP opinion

European Pharmaceutical Review

FEBRUARY 24, 2023

The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of ruxolitinib cream (Opzelura ) for non-segmental vitiligo with facial involvement in people over 12 years old. News : @EMA_News has issued a positive opinion for an Incyte-discovered therapy for patients with #vitiligo.

Food and Drug Administration

Food and Drug Administration Medicine Medical Food

How ZoomInfo Helps Overcome the Top Pain Points of Inside Sales

Advertiser: ZoomInfo

With more access to user reviews, analyst opinion, and industry research, decision-makers are more informed than ever while navigating what is now known as the “buyer’s journey.”. Recent digital transformation has shifted the B2B landscape by ushering in the era of buyer empowerment.

Sales

Eculizumab biosimilar gets positive CHMP opinion

European Pharmaceutical Review

APRIL 6, 2023

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for EPYSQLI , a biosimilar referencing Soliris (eculizumab), also known as SB12. The post Eculizumab biosimilar gets positive CHMP opinion appeared first on European Pharmaceutical Review.

Medicine

Medicine Patients Pharmaceutical Marketing

An Evolving ‘Opinion’ Landscape: New Paths—and Synergies—for Pharma KOLs & DOLs

PharmExec

OCTOBER 13, 2023

Industry experts discuss the relationship between digital and traditional (key) opinion leaders and how companies are adjusting their strategies to harness the unique brand engagement benefits each role can provide in driving better patient outcomes.

Pharma

Pharma Patients

Bristol Myers’ Abecma wins FDA nod in earlier multiple myeloma with updated boxed warning on secondary cancer

Fierce Pharma

APRIL 5, 2024

After a short period of doubt, the FDA has followed the opinion of its advisers and moved Bristol Myers Squibb’s CAR-T therapy Abecma into the earlier treatment of multiple myeloma.

FDA

CHMP provides positive opinion for BMS’s Reblozyl

Pharmaceutical Technology

FEBRUARY 23, 2024

The positive opinion is based on findings from the Phase III COMMANDS trial which met its primary endpoint.

CHMP provides positive opinion for Merck’s Keytruda

Pharmaceutical Technology

NOVEMBER 13, 2023

The EMA CHMP provided a positive opinion for granting approval to Merck’s Keytruda combination therapy to treat biliary tract cancer.

Judge Pan Releases Antitrust Publishing Case Opinion

Copyright Clearance Center

NOVEMBER 11, 2022

The post Judge Pan Releases Antitrust Publishing Case Opinion appeared first on Copyright Clearance Center.

Citrate-free HCF of adalimumab biosimilar gets positive opinion

European Pharmaceutical Review

JANUARY 30, 2023

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has adopted a positive opinion for a citrate-free high concentration formulation (HCF) of its biosimilar Hyrimoz ® (adalimumab).

Food and Drug Administration

Food and Drug Administration Medicine Food Safety

In talc defense, Johnson & Johnson sues 4 doctors over their 'junk litigation opinions'

Fierce Pharma

JULY 14, 2023

As Johnson & Johnson awaits a decision on its second attempt to resolve talc lawsuits through a bankruptcy ploy, the company is attempting another legal tactic to free itself from those liabili | As Johnson & Johnson awaits a decision on its second attempt to resolve talc lawsuits through a bankruptcy ploy, the company is attempting another (..)

Doctors

Mirati’s lung cancer treatment gains EMA CHMP’s positive opinion

Pharmaceutical Technology

NOVEMBER 13, 2023

Mirati Therapeutics has obtained EMA CHMP's positive opinion for Krazati to treat KRASG12C-mutated non-small cell lung cancer.

Why you need Key Opinion Leaders?

Medical Device Success

JUNE 5, 2017

Key Opinion Leaders (KOLs) can be a very powerful component of the marketing plan for medical device companies of all sizes. At large pharma and medical device companies, there are entire departments devoted to the management of Key Opinion Leaders. The post Why you need Key Opinion Leaders? Reading time: 2 – 3 minutes.

Medical

Medical Marketing Management Doctors

EMA Committee Issues Positive Opinion on Sandoz’ Biosimilar Trastuzumab

PharmaTech

SEPTEMBER 18, 2023

The EMA’s Committee for Medicinal Products for Human Use has given a positive opinion on Sandoz’ biosimilar trastuzumab for breast and gastric cancer.

Medicine

Travere's Filspari, J&J's Carvykti win support from CHMP in blitz of positive recommendations

Fierce Pharma

FEBRUARY 23, 2024

A narrow miss in a confirmatory trial has | Along with host of other positive recommendations, European drug regulators rendered a positive opinion on Travere's Filspari for full approval in Berger’s disease.

GSK’s daprodustat obtains positive opinion from EMA CHMP

Pharma Leaders

JUNE 27, 2023

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has provided a positive opinion recommending authorisation of GlaxoSmithKline’s (GSK) daprodustat for symptomatic anaemia linked to chronic kidney disease (CKD).

Food and Drug Administration

Food and Drug Administration Medicine Food Safety

EMA CHMP issues positive opinion for AstraZeneca’s Soliris

Pharmaceutical Technology

JUNE 27, 2023

The EMA CHMP has issued a positive opinion recommending marketing authorisation for expanded use of AstraZeneca’s Soliris (eculizumab).

Marketing

EMA Gives Positive Opinion on Two of Janssen’s Bispecific Antibodies

PharmaTech

JULY 27, 2023

Janssen has received a positive opinion from the EMA for two novel bispecific antibodies, TALVEY (talquetamab) and TECVAYLI (teclistamab), which the company is developing to treat blood cancer.

EMA CHMP provides positive opinion for ViiV’s cabotegravir

Pharmaceutical Technology

JULY 25, 2023

The EMA CHMP has provided a positive opinion recommending grant of marketing authorisation to ViiV Healthcare’s cabotegravir.

Marketing

Physician Opinions on Burnout in 2022 – Report

InCrowd

JANUARY 24, 2023

The post Physician Opinions on Burnout in 2022 – Report appeared first on InCrowd. In November of 2022, InCrowd surveyed 500 US physicians to track burnout. Download the full report to learn more about this research.

Physicians

Physician Opinions on Burnout in 2022 – Blog

InCrowd

JANUARY 24, 2023

Contact us at support@incrowdnow.com The post Physician Opinions on Burnout in 2022 – Blog appeared first on InCrowd. If you’d like to learn more about this research, download the full report. Are you a healthcare professional interested in sharing your experience in a guest writing piece?

Physicians

Physicians Management Healthcare Healthcare

Marinus Pharmaceuticals gets positive opinion for ZTALMY from CHMP

Pharma Leaders

MAY 29, 2023

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of Marinus Pharmaceuticals’ ZTALMY (ganaxolone) oral suspension. This recommendation by the CHMP will be reviewed now by the European Commission (EC).

Pharmaceutical

Pharmaceutical Medicine Safety Patients

EMA seeks public opinion on AI in drug development

European Pharmaceutical Review

JULY 21, 2023

Digital transformation to drive biomanufacturing market The post EMA seeks public opinion on AI in drug development appeared first on European Pharmaceutical Review.

Food and Drug Administration

Food and Drug Administration Medicine Ethics Consulting

Novo Nordisk closes in on EU approval for its once-weekly insulin Awiqli

Fierce Pharma

MARCH 22, 2024

It was one of several opinions handed down by the CHMP. . | With a positive recommendation from Europe’s Committee for Medicinal Products for Human Use (CHMP), Novo has come a step closer to bringing its revolutionary Awiqli (once weekly basal insulin icodec) to the market.

Medicine

Medicine Sales Marketing

Gilead Sciences’ Trodelvy secures positive opinion from EMA’s CHMP

Pharmaceutical Technology

JUNE 26, 2023

Gilead Sciences has received positive opinion from the EMA's CHMP for its Trodelvy (sacituzumab govitecan) to treat breast cancer.

Amicus’ Opfolda wins positive CHMP opinion in Pompe Disease

Pharmaceutical Technology

APRIL 27, 2023

Amicus Therapeutics announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Opfolda (miglustat) intended for treatment of Pompe Disease. A decision from the European Commission (EC) is expected in Q3 2023. A decision from the European Commission (EC) is expected in Q3 2023.

Food and Drug Administration

Food and Drug Administration Food Marketing Medicine

Epcoritamab gains positive opinion from CHMP for lymphoma therapy

Pharmaceutical Technology

JULY 24, 2023

AbbVie has received a positive opinion from the CHMP of EMA for epcoritamab to treat adults with R/R DLBCL.

Influencer Marketing, Digital Opinion Leaders

PharmExec

MARCH 25, 2024

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

Marketing

Novartis gets positive opinion from CHMP for Cosentyx in adult HS

Pharmaceutical Technology

APRIL 27, 2023

Novartis has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on Cosentyx (secukinumab) for use in adults with active moderate to severe hidradenitis suppurativa (HS), a painful and persistent inflammatory skin disease.

Food and Drug Administration

Food and Drug Administration Medicine Food Safety

Amicus gets positive CHMP opinion for Opfolda to treat late-onset Pompe disease

Pharma Leaders

APRIL 27, 2023

Amicus Therapeutics has received positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for Opfolda (miglustat) to treat late-onset Pompe disease (LOPD). The CHMP’s positive opinion was based on the clinical data obtained from the Phase III PROPEL pivotal study.

Medicine

Medicine Patients

Takeda dengue vaccine receives positive CHMP opinion

pharmaphorum

OCTOBER 17, 2022

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion of Takeda GmbH’s live, attenuated dengue tetravalent vaccine, Qdenga ( TAK-003 ). The post Takeda dengue vaccine receives positive CHMP opinion appeared first on. billion in sales over the course of several years.

Medicine

Medicine Safety Marketing Sales

Novavax receives positive opinion from CHMP for full MA of Covid vaccine

Pharmaceutical Technology

MAY 29, 2023

Novavax has received positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for full marketing authorisation (MA) of its Covid vaccine, Nuvaxovid (NVX-CoV2373) , in the European Union (EU).

Safety

Safety Medicine Marketing

Digital Opinion Leader deep-dive: the sharer

PharmaVoice

JULY 18, 2022

Learn about Digital Opinion Leaders who curate tailored content experiences and provide value to their followers.

GSK scraps plan to launch oral anemia drug in EU, ceases further expansion efforts

Fierce Pharma

JULY 26, 2023

Despite a positive opinion from local drug reviewers, GSK has decided not to bring its FDA-approved oral anemia drug daprodustat to Europe—or any additional countries for that matter.

FDA

Janssen Receives Positive Opinion for AKEEGA Plus Prednisone or Prednisolone

PharmaTech

MARCH 8, 2023

Janssen has received a positive opinion from EMA for AKEEGA plus prednisone or prednisolone for the treatment of BRCA1/2 gene-mutated metastatic castration resistant prostate cancer.