Fierce Pharma

MARCH 10, 2023

FDA calls expert hearing for Intercept’s high-profile NASH application for Ocaliva aliu Fri, 03/10/2023 - 10:49

FDA 104

FDA 104

ISPE

MAY 10, 2023

CoP Leader Profiles: Terry Jacobs Trudy Patterson Wed, 05/10/2023 - 11:21 InTouch May / June 2023 CoP Leader Profiles: Terry Jacobs Marcy Sanford 1 May 2023 Terry Jacobs is Chair of the Oral Solid Dosage (OSD) Community of Practice (CoP) Steering Committee. CoP profiles NA NA

Dosage 52

Dosage Pharmaceutical Companies Pharmaceutical Companies 52

Pharmacy Times

OCTOBER 27, 2023

Adverse event profiles of several approved CDK4/6 inhibitors are discussed.

65

65

Pharmacy Times

AUGUST 22, 2023

Zydus Pharmaceuticals (USA) Inc, has come a long way since its first commercial launch in August 2005.

123

123

ISPE

JULY 7, 2023

CoP Leader Profiles: Christian Wölbeling Trudy Patterson Fri, 07/07/2023 - 12:16 InTouch July / August 2023 CoP Leader Profiles: Christian Wölbeling Marcy Sanford 1 July 2023 Christian Wölbeling has been a member of ISPE for 25 years. A founding member and current Chair of ISPE’s Pharma 4.0™

Documentation 52

Documentation Pharmaceutical Companies Pharmaceutical Companies 52

Fierce Pharma

MAY 23, 2023

Amid high-profile injectable launch, Novo Nordisk scores with its pill version of obesity drug Wegovy kdunleavy Tue, 05/23/2023 - 10:34

92

92

ISPE

MAY 10, 2023

CoP Leader Profiles: Roujian “RJ” Zhang Trudy Patterson Wed, 05/10/2023 - 11:37 InTouch May / June 2023 CoP Leader Profiles: Roujian “RJ” Zhang Marcy Sanford 1 May 2023 Roujian “RJ” Zhang is Chair of ISPE’s new Quality Control (QC)/Analytical Community of Practice (CoP) Steering Committee. CoP profiles NA NA

Method Validation 52

Method Validation FDA 52

ISPE

MARCH 8, 2023

Introducing CoP Leader Profiles: Rachel Owen Trudy Patterson Wed, 03/08/2023 - 09:46 InTouch March / April 2023 Introducing CoP Leader Profiles: Rachel Owen Marcy Sanford 1 March 2023 With this issue, Pharmaceutical Engineering ® launches a new feature in P+E: profiles of Communities of Practice (CoP) leaders. CoP profiles

Controlled Substances 52

Controlled Substances 52

ISPE

JULY 7, 2023

CoP Leader Profiles: Heather Watson Trudy Patterson Fri, 07/07/2023 - 12:01 InTouch July / August 2023 CoP Leader Profiles: Heather Watson Marcy Sanford 1 July 2023 Heather Watson has been a member of ISPE for 22 years.

Communication 52

Communication 52

Fierce Pharma

DECEMBER 1, 2022

Eli Lilly dumps Innovent's PD-1 after FDA rebuff, nixing high-profile Chinese cancer drug. Thu, 12/01/2022 - 15:03.

FDA 100

FDA 100

Fierce Pharma

FEBRUARY 7, 2023

Despite high-profile media coverage, FDA balks at GSK's 'unprecedented' Jemperli proposal in rectal cancer aliu Tue, 02/07/2023 - 17:07

FDA 79

FDA 79

Pharmacy Times

APRIL 15, 2024

Bristol Myers Squibb will also present findings on apixaban (Eliquis) at the American College of Cardiology Annual Scientific Session and Expo.

65

65

Fierce Pharma

FEBRUARY 13, 2023

Pfizer, AZ, Lilly and more support Sanofi in high-profile Amgen patent fight fkansteiner Mon, 02/13/2023 - 11:21 Big Pharma divided?

82

82

Pharmacy Times

MAY 15, 2023

Investigators of the phase 2 study also found a comparable reactogenicity to the individual influenza and COVID-19 vaccines from Novavax or authorized vaccine comparators.

Vaccines 139

Vaccines 139

Fierce Pharma

JANUARY 9, 2023

Bristol Myers Squibb, Pfizer turned away from SCOTUS in high-profile cases. Mon, 01/09/2023 - 11:48.

70

70

Fierce Pharma

FEBRUARY 2, 2024

Mark your calendars, oncology drug and CAR-T therapy developers. Mark your calendars, oncology drug and CAR-T therapy developers. The FDA has decided on a date for a highly anticipated advisory committee meeting for Bristol Myers' Abecma and J&J's Carvykti.

FDA 120

FDA 120

Fierce Healthcare

NOVEMBER 9, 2023

Financial struggles at Bright Health Group and Friday Health Plans have raised concerns about how well the Affordable Care Act's (ACA's) risk adjustment program is working, especially whether it's | Financial struggles at Bright Health Group and Friday Health Plans have raised concerns about how well the Affordable Care Act's risk (..)

Insurance 110

Insurance 110

Fierce Pharma

APRIL 19, 2024

CSL Vifor has proposed to launch a campaign that would undo the potentially misleading messages it sent about the safe | CSL Vifor has proposed to launch a campaign that would undo the potentially misleading messages it sent about the safety of a rival product, the European Commission (EC) said.

58

58

Pharmacy Times

NOVEMBER 13, 2023

Bonaca also notes that pharmacists can play a key role in educating patients and clinicians about the appropriate use and dosing of antithrombotic drugs for vascular protection.

111

111

Fierce Pharma

AUGUST 24, 2023

After the “extreme disappointment” of vadadustat’s anemia snub in March 2022—plus a partnership gone awry and a formal dispute with the FDA—Akebia Therapeutics has dusted itself off and readied for | After the “extreme disappointment” of vadadustat’s anemia snub in March 2022—plus a partnership gone awry and a formal dispute with the FDA—Akebia Therapeutics (..)

FDA 76

FDA 76

Pharmacy Times

NOVEMBER 29, 2022

Derazantinib is an investigational oral inhibitor of FGFR1, FGFR2, and FGFR3 in patients with locally advanced or metastatic intrahepatic cholangiocarcinoma.

123

123

Fierce Pharma

JANUARY 25, 2024

Three months after launching an investigation into the risk of patients developing secondary T-cell cancers after receiving a CAR-T drug, the FDA has shared more information on the cases it has see | Three months after launching an investigation into the risk of secondary T-cell cancers after treatment with a CAR-T medicine, the FDA has shared more (..)

FDA 102

FDA 102

BioPharm

APRIL 18, 2024

Webinar Date/Time: Tue, May 21, 2024 11:00 AM EDT

52

52

Pharmacy Times

JULY 18, 2023

Neither of the 2 current standards of care offers patients a cure.

120

120

Fierce Healthcare

MARCH 1, 2024

Payers, providers and pharmacies are scrambling to keep up after a high-profile cyberattack against a UnitedHealth Group subsidiary took down critical systems. Payers, providers and pharmacies are scrambling to keep up after a high-profile cyberattack against a UnitedHealth Group subsidiary took down critical systems.

132

132

Outsourcing Pharma

OCTOBER 20, 2023

Matteo Lai was part of a panel at DPharm in Boston this year, it was called working together to accelerate the adoption of digital biomarkers in clinical trials.

78

78

ISPE

OCTOBER 28, 2022

Communities of Practice Profiles: Shaping the Future of the Combination Products Industry. Communities of Practice Profiles: Shaping the Future of the Combination Products Industry. Trudy Patterson. Fri, 10/28/2022 - 09:05. November / December 2022. Marcy Sanford. 1 November 2022.

FDA 52

FDA 52

Drug Topics

DECEMBER 13, 2023

Understanding the adverse event profile of bispecific antibodies can aid treatment selection and improve patient outcomes.

200

200

PharmExec

SEPTEMBER 11, 2023

Pharm Exec’s latest selections of notable biopharma brand launches—some with novel preemptive approaches—highlight products that are paving uncharted paths across a diverse disease landscape.

59

59

pharmaphorum

MAY 17, 2021

The plans to float on the London Stock Exchange’s Alternative Investment Market (AIM) will raise the company’s profile, widen shareholder base and improve the chances of finding and expanding commercial partnerships. The post Arecor hopes London stock market float will raise profile of insulin products appeared first on.

Hospitals 52

Hospitals Vaccines 52

Pharmaceutical Technology

DECEMBER 19, 2023

Super pollutants like black carbon found their way onto the agenda of COP28, which hosted the annual conference's first 'Health Day'

52

52

Pharmacy Times

NOVEMBER 3, 2022

UC Davis cancer researchers hope new technology will help diagnose and treat melanoma more successfully.

65

65

pharmaphorum

DECEMBER 10, 2020

The post OVID Health appoints high-profile leaders as senior counsel appeared first on. In the past year the agency has achieved six-figure growth and launched the Patient Partnership Index , an initiative that aims to help create better partnerships between the pharma industry and patient communities.

Communication 52

Communication Immunization Vaccines 52

Pharmacy Times

JANUARY 10, 2023

The biopsy test is the first companion diagnostic approved for entrectinib for individuals who do not have an available tissue sample.

FDA 73

FDA 73

Pharmacy Times

MARCH 18, 2024

The authors note that understanding the DNA methylation profile in leukemia can help predict whether or not a patient will respond to treatment.

123

123

Fierce Healthcare

SEPTEMBER 1, 2023

Welcome to this week's Chutes & Ladders, our roundup of hirings, firings and retirings throughout the industry.

58

58

Pharmaceutical Technology

MAY 19, 2023

The US Supreme Court has unanimously voted in favour of Sanofi and Regeneron in a years-long legal feud with Amgen over the potential patent infringement surrounding the companies’ anti-cholesterol drugs. This marks a milestone in the dispute nearly a decade after the first lawsuit filed by Amgen against the two companies.

FDA 59

FDA 59