STAT

JUNE 16, 2023

If donanemab’s similar results hold up to scrutiny (the data are limited to a press release , they’ll be presented in full at the Alzheimer’s Association International Conference in July and in a forthcoming paper), it will likely enjoy the same decision. It’s beneficial. Full approval is almost a certainty.

Drug Pricing 291

Drug Pricing 291

Express Pharma

NOVEMBER 28, 2024

However, winning in the Indian market requires a strategically thought-out India-specific strategy that accounts for the market nuances such as non-uniform payer coverage of specialty drugs, pricing schedules and varying levels of healthcare infrastructure.

Pharmaceutical Companies 105

Pharmaceutical Companies Pharmaceutical Companies Drug Pricing 105

STAT

DECEMBER 6, 2023

The news about anti-obesity drugs keeps getting better. In November, data presented at the American Heart Association meeting added cardiovascular benefit to value in combating obesity and diabetes.

Diabetes 269

Diabetes Drug Pricing 269

Safe Biologics

JULY 13, 2023

On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) hosted a webinar entitled MEDICARE DRUG PRICE NEGOTIATIONS: Impact on Healthcare Development and Patient Access to Medicines which focused on unintended consequences for patient access that may result from the implementation of the Inflation Reduction Act (IRA).

Drug Pricing 130

Drug Pricing Biosimilars Drug Development 130

FDA Law Blog: Biosimilars

APRIL 7, 2025

In a year of major change and outstanding questions, growing scrutiny on patent protection and drug pricing, and uncertainty around global price control measures and the Inflation Reduction Act, understanding the implications of new leadership and emerging mandates is critical. Hyman, Phelps & McNamara, P.C.s

Drug Pricing 59

Drug Pricing 59

pharmaphorum

JANUARY 16, 2023

Two top pharma companies have exited the UK’s voluntary medicines pricing agreement in protest at what the industry has said is a “punitive” system of revenue clawbacks, casting doubt on the future of the scheme in its present form.

Drug Pricing 69

Drug Pricing 69

NY Times

DECEMBER 6, 2021

President Biden presented a key provision from his Build Back Better bill that would take steps to combat the high costs of prescription drugs.

Drug Pricing 53

Drug Pricing 53

Drug Channels

OCTOBER 12, 2020

Informa Connect-CBI’s 6th Edition Drug Pricing Transparency Congress. November 16-17, 2020 | Virtual Event www.informaconnect.com/drug-pricing-transparency. Drug Channels Readers: View the complete agenda and register today. Be sure to use your exclusive promo DRUG30 to save $300 *.

Drug Pricing 40

Drug Pricing 40

Safe Biologics

JANUARY 10, 2023

In December, ASBM recorded the seventh and final module in its biosimilar Continuing Education (CE) Course on Biosimilars, presented with the Ohio State University College of Pharmacy. The latest module is entitled “PBMs and Payer Practices” and is presented by ASBM’s Immediate Past Chair Madelaine Feldman, MD, FACR.

Biosimilars 100

Biosimilars Drug Pricing 100

Drug Channels

MARCH 18, 2024

Informa Connect’s Life Sciences Pricing & Contracting USA May 21-23, 2024 | New Orleans Drug Channels readers save 10% with code 24DRCH10* Whether your daily focus is on Medicaid, Government Pricing, 340B, Drug Price Transparency, Commercial Contracting or Chargebacks , we have you covered!

Drug Pricing 98

Drug Pricing 98

Pharmaceutical Technology

JANUARY 31, 2023

The US omnibus bill passed in late December 2022 will give the agency greater powers to regulate accelerated approval drugs, while the Inflation Reduction Act’s lowering of drug prices will create an uncertain environment for drug developers, he said. That’s up to… all of us in aggregate.

Drug Pricing 52

Drug Pricing Biosimilars Drug Development 52

Pharma in Brief

FEBRUARY 16, 2024

The Patented Medicine Prices Review Board ( PMPRB or Board ) has released a “What We Learned” Report (the Report ), marking the next step along the path to new Guidelines. which was commissioned to facilitate consultation with stakeholders and report on the presentations and discussions.

Drug Pricing 52

Drug Pricing 52

Safe Biologics

SEPTEMBER 12, 2023

ASBM & GaBI Webinar on Medicare Price Negotiation Examines Impact on Innovation, Patient Access On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) hosted a webinar entitled MEDICARE DRUG PRICE NEGOTIATIONS: Impact on Healthcare Development and Patient Access to Medicines. Spiegel’s segment here.

Biosimilars 130

Biosimilars Drug Pricing Drug Development 130

Safe Biologics

JULY 20, 2023

REGISTER NOW: July 26th ASBM/GaBI Webinar on IRA Medicare Price Negotiation On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) will host the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA). REGISTER HERE. View the agenda.

Biosimilars 130

Biosimilars Drug Pricing Drug Development 130

Safe Biologics

JULY 20, 2023

REGISTER NOW: July 26th ASBM/GaBI Webinar on IRA Medicare Price Negotiation On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) will host the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA). REGISTER HERE. View the agenda.

Biosimilars 130

Biosimilars Drug Pricing Drug Development 130

Drug Channels

OCTOBER 19, 2021

The 340B Drug Pricing Program’s explosive growth plays a crucial role in the economics of the health system specialty pharmacy channel. P.S. I'll be presenting my "State of Specialty Pharmacy 2021," live and in-person at next week's Asembia Specialty Pharmacy Summit. See below for data and details.

Specialty Pharmacies 96

Specialty Pharmacies Hospitals Drug Pricing 96

Safe Biologics

JULY 13, 2023

REGISTER NOW: July 26th ASBM/GaBI Webinar on IRA Medicare Price Negotiation On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) will host the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA). REGISTER HERE.

Drug Pricing 100

Drug Pricing Biosimilars 100

Safe Biologics

JULY 13, 2023

REGISTER NOW: July 26th ASBM/GaBI Webinar on IRA Medicare Price Negotiation On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) will host the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA). REGISTER HERE.

Drug Pricing 100

Drug Pricing Biosimilars 100

Safe Biologics

NOVEMBER 12, 2023

ASBM to Present at World Drug Safety Congress Americas 2023 On October 19th, ASBM Advisory Board Chair Philip Schneider will present at the World Drug Safety Congress Americas 2023 in Boston, Massachusetts. Read the new FDA’ Guidance here. Submit comments on the guidance here.

Biosimilars 130

Biosimilars Drug Pricing Packaging Labelling 130

Putting Patients First Blog

SEPTEMBER 3, 2024

Overall, while the NHC appreciates CMS’ intent to streamline the data submission process and make it more accessible, we encourage ongoing dialogue and adjustments to ensure that the process remains patient-centered, efficient, and capable of capturing the full spectrum of information necessary to inform meaningful drug price negotiations.

Drug Pricing 52

Drug Pricing Insurance Coverage and Processing Labelling Communication 52

FDA Law Blog: Biosimilars

SEPTEMBER 15, 2023

On September 18-20, Informa Connect will hold its annual #MDRPSummit in Chicago (and via livestream) to discuss the complex, ever-evolving laws and regulations in the government pricing and price reporting space. A complete agenda is available here. Hyman, Phelps & McNamara, P.C.’s

Drug Pricing 64

Drug Pricing 64

Drug Channels

OCTOBER 7, 2024

Other expert and thought leaders from within the industry are slated to present deep dive sessions, workshops and panels that will answer your most pressing questions: What are the latest legislative updates and proposed federal bills impacting PBM operations? What are the most effective strategies for spread pricing and reimbursement models?

Drug Pricing 97

Drug Pricing Biosimilars 97

Big Molecule Watch

FEBRUARY 12, 2024

Today, the district court for the Western District of Texas granted the government’s motion to dismiss the lawsuit brought by PhRMA and other organizations challenging the Drug Price Negotiation Program of the Inflation Reduction Act. Becerra et al.

Drug Pricing 69

Drug Pricing 69

pharmaphorum

DECEMBER 7, 2022

Having recently assessed the relationship between drug price and prevalence of non-oncology rare diseases, CRA’s Life Sciences Practice team explores in greater depth the situation for these orphan drugs in France in this final article of a three-part series. Influence of ATUc programme on drug pricing.

Drug Pricing 105

Drug Pricing Drug Development 105

Safe Biologics

DECEMBER 6, 2023

Learn about ASBM’s recent educational activities surrounding IRA Medicare drug price negotiation, interchangeable biosimilars, and other key policy issues affecting patient access to medicines. McKibbin will continue in his current clinical duties at University of Pittsburgh Medical Center Altoona, PA.

Biosimilars 130

Biosimilars Packaging Labelling Drug Development 130

Drug Channels

SEPTEMBER 20, 2021

Drug Channels readers will save 10% off when they use code 21DRCH10 and register prior to October 20th.*.

Drug Pricing 93

Drug Pricing 93

Big Molecule Watch

AUGUST 25, 2023

The Inflation Reduction Act’s Medicare Drug Price Negotiation Program will kick off next week. There are reports that the White House may announce the list of selected drugs even before that deadline, on Tuesday, August 29 th. Before the IRA, the government could not set prices for any drugs covered by Medicare.

Drug Pricing 40

Drug Pricing Biosimilars Insurance Coverage and Processing Labelling 40

European Pharmaceutical Review

JANUARY 18, 2024

Market projections Leading treatments in the insomnia treatment market “The loss of patent exclusivity will allow cheaper generic versions of the DORAs to enter the [insomnia treatment] market” The company emphasised that at present, the US represents the largest insomnia market, with 81.9

Drug Pricing 98

Drug Pricing Biosimilars Compounding 98

Drug Channels

AUGUST 21, 2020

As regular readers know, I believe the 340B Drug Pricing Program needs to evolve into a more transparent, properly regulated program. I’ll be joining Jeremy during this webinar for an interactive presentation, discussion, and Q&A. This webinar will take place on September 11, 2020 (12:00 p.m. to 1:00 p.m.

Drug Pricing 52

Drug Pricing 52

Digital Pharmacist

MARCH 19, 2024

From sweeping federal legislation aimed at reigning in costs to the unexpected maneuvers of drug manufacturers, the effects of these changes reverberate throughout the healthcare system. The Dynamics of Increasing Drug Prices The escalation of drug prices is a multifaceted issue, with various factors contributing to its rise.

Drug Pricing 52

Drug Pricing Diabetes Pharmaceutical Companies Pharmaceutical Companies 52

Drug Channels

MARCH 28, 2022

Drug Channels readers will save 10% off when they use code 22DRCH10 and register prior to April 29, 2022.*. The 2022 format includes 3 days of in-person programming, plus a virtual offering of select sessions and recorded presentations available on-demand for 10 business days.

Drug Pricing 75

Drug Pricing 75

Pharmaceutical Technology

JANUARY 16, 2023

The topic of inflation overlaps with drug pricing strategy themes. Policymakers are attempting to respond to inflation crises by introducing new frameworks on the regulation of drug prices. Similar echoes are heard in Europe, where pressure to curb price growth will stay a priority.

Drug Pricing 64

Drug Pricing Pharmaceutical Companies Pharmaceutical Companies Biosimilars 64

Drug Channels

JULY 29, 2024

You’ll benefit from three days of learning, education and networking, and will return to the office having mastered regulatory guidelines to deliver compliant government pricing and reporting programs. OIG Address - The Office of the Inspector General reviews recent OIG evaluations involving prescription drug pricing, payment and coverage.

Drug Pricing 52

Drug Pricing 52

Safe Biologics

JANUARY 1, 2023

ASBM Adds Module on PBM Practices to OSU College of Pharmacy Biosimilars Course In December, ASBM recorded the seventh and final module in its biosimilar Continuing Education (CE) Course on Biosimilars, presented with the Ohio State University College of Pharmacy. In this module Dr. Feldman explains unique features of the U.S.

Biosimilars 100

Biosimilars Drug Pricing 100

Drug Channels

APRIL 19, 2021

Join the compliance community for dynamic discussions on the top risk areas for specialty pharmaceutical companies, including speaker programs, patient support programs, charitable donations, specialty pharmacy relationships, patient advocacy group interactions, mergers and acquisitions, medical affairs activities, drug pricing, transparency and more! (..)

Specialty Pharmacies 40

Specialty Pharmacies Drug Pricing Pharmaceutical Companies Pharmaceutical Companies 40

Pulses

JANUARY 9, 2024

When learning new processes and information that are unfamiliar to the learner, having too many new ideas present can inhibit learning. Sweller proposed that cognitive load can be reduced by decreasing the number of unknowns present, therefore increasing learning capacity.

Drug Pricing 64

Drug Pricing Communication 64

Big Molecule Watch

SEPTEMBER 9, 2024

The IRA instructed HHS select certain “high priced” Medicare-covered drugs for inclusion in the first year of the Program. We are also be monitoring pending legal challenges to the IRA and tracking updates on the IRA Litigation Tracker, which are available on our IRA webpage.

Drug Pricing 49

Drug Pricing 49