Drug Channels

SEPTEMBER 19, 2023

To help you prepare, I share fresh insights from a new survey of PBMs’ plan sponsor clients. A plan sponsor can feel satisfied with its larger PBM’s transparency, while remaining blissfully unaware of how its PBM actually earns money. Can plan sponsors get some satisfaction? I outline some of these novel profit sources below.

82

82

PharmExec

AUGUST 24, 2023

In this Q&A, Matt Smith, Vice President Research Site Development, Slope discusses the competition pharma companies and trial sponsors face when trying to become a sponsor of choice and build trust with sites and patients.

52

52

Pharmafile

JANUARY 17, 2023

Thermo Fisher Scientific has announced that it has become a founding sponsor of Momentum Labs in Alachua, Florida, US. The company has taken on this role in an attempt to support emerging biotechnology companies, and Momentum Labs aims to work as a collaborative laboratory and office space for a variety of expanding biotechs in the region.

Communication 97

Communication 97

Outsourcing Pharma

JULY 4, 2023

Clerkenwell Health, a specialist clinical research organisation (CRO) focused on supporting clients with the design and delivery of psychedelic-assisted therapy trials, is sponsoring the upcoming Psych Symposium 2023 on Thursday 6 July in London.

96

96

Safe Biologics

NOVEMBER 12, 2023

On November 6, 2023, the Centers for Medicare and Medicaid Services (CMS) announced a proposed Rule that would permit Medicare Part D plan sponsors to substitute non-interchangeable biosimilars in place of the biologic medicines now used to treat many chronic conditions such as rheumatoid arthritis, Crohn’s disease and cancer.

Biosimilars 113

Biosimilars 113

Pharmaceutical Technology

OCTOBER 24, 2023

A panel discussion at a Copenhagen conference saw representatives from sponsor organisations sharing their hopes for CROs to take ownership when trials go wrong.

52

52

FDA Law Blog: Biosimilars

SEPTEMBER 10, 2023

Even though an IND is not required, this guidance is intended to provide recommendations for sponsors to follow for using RWE from such studies for regulatory decision-making. The guidance describes steps sponsors should take to evaluate the study’s feasibility for such purposes.

Documentation 108

Documentation Vaccines Drug Development 108

Pharmaceutical Technology

OCTOBER 24, 2023

Sponsors are being urged to compensate participants in oncological clinical trials, as well as make in-person visits to contract research organisations to keep exploratory studies from slowing down.

52

52

Pharmaceutical Technology

AUGUST 16, 2022

Large (market cap $10–100bn) and mega-cap (market cap >$100bn) sponsors also require contract manufacturers and packagers with specialist injectable capabilities in the case of cell and gene therapies, as shown in the report titled Contract Injectable Packaging Trends in the Bio/Pharma Industry (August 2022).

Packaging 64

Packaging Vaccines 64

Drug Channels

APRIL 2, 2024

Nonetheless, CVS Pharmacy’s cost-plus model has some notable shortcomings for plan sponsors and is far less “disruptive” than the company would like us to believe. As I explain, a shift to cost-based pharmacy reimbursement could stabilize CVS Health’s retail business by improving its dispensing profits.

Documentation 63

Documentation 63

PharmaTech

OCTOBER 11, 2023

The relationship you build with your executive sponsor (ES) is the most critical relationship you will build with your CDMO partner and will serve as the foundation for long-term commercial success.

40

40

Outsourcing Pharma

JANUARY 24, 2024

Elisa Cascade is chief product officer at Advarra, a business that says it aims to advance the way clinical research is conducted by bringing life sciences companies, CROs, research sites, investigators, and academia together at the intersection of safety, technology, and collaboration.

105

105

Pharma and Life Sciences Blog

NOVEMBER 15, 2023

From Vision to Victory: The Executive Sponsor's Journey to Program Success - Fred Johnson, BCBSA; Matt Stewart and Bianca Lieb, RiseNow Dnyanesh Wed, 11/15/2023 - 17:40 Video Thumbnail Image Video URL [link] Innovate Year 2023

52

52

STAT

NOVEMBER 14, 2023

“If you go and look at the number of people who go on pharma-sponsored trials, it’s just this commitment and this increase.” Industry-sponsored trials increased 43% from 2006 to 2014, while newly registered NIH-funded trials decreased 24% over the same period.

363

363

Outsourcing Pharma

SEPTEMBER 15, 2022

Australian CRO Avance Clinical has expanded in North America by acquiring C3 Research Associates, positioning it to continue supporting sponsors as they move into later-phase studies that need US sites.

52

52

pharmaphorum

JULY 26, 2021

Why sponsor? *Be Here’s what last year’s overall sponsors PRECISIONeffect had to say about their experience; “Like most people we were really disappointed when the live event was moved to virtual. Well done to all at the PM society for an excellent event and we look forward to sponsoring next year’s event!”.

Communication 52

Communication 52

Drug Channels

DECEMBER 6, 2023

Nonetheless, CVS Pharmacy’s cost-plus model has some notable shortcomings for plan sponsors and is far less “disruptive” than the company would like us to believe. As I explain, a shift to cost-based pharmacy reimbursement could stabilize CVS Health’s retail business by improving its dispensing profits.

Documentation 67

Documentation 67

BioPharma Dive

JULY 3, 2023

What is the GDPR and why does it matter to your life sciences company. iliomad Health Data can help you maintain GDPR compliance.

98

98

Pharma Mirror

JUNE 8, 2022

The post Novotech Sponsors Endpoints ASCO 2022 Expert Panel on Accelerating Oncology Clinical Trials in China appeared first on Pharma Mirror Magazine. According to the Endpoints ASCO session: “China and the US are the world’s largest oncology research destinations, and the.

52

52

Express Pharma

JULY 31, 2023

As part of its ongoing 100 th anniversary celebrations, Novo Nordisk A/S is sponsoring an Indian delegation of 10 school students- five girls and five boys- to be part of its global Future Scientists Summer Camp to be organised in Copenhagen, Denmark in August 2023.

52

52

STAT

FEBRUARY 23, 2024

Today, we discuss how the FDA is holding firm in how it handles non-compliant trial sponsors and investigators, how PhRMA is rebuilding its ranks, and offer up a fabulous podcast. Want to stay on top of the science and politics driving biotech today?    Sign up  to get our biotech newsletter in your inbox.

Drug Pricing 239

Drug Pricing Drug Development 239

STAT

MAY 11, 2023

AbbVie has filed a lawsuit against a behind-the-scenes company that helps health plan sponsors take advantage of the assistance programs created by drug companies to provide specialty medicines to patients for free.

246

246

Drug Channels

MARCH 1, 2024

Today’s guest post comes from Era Prakash, Vice President of Product Management at Cencora. Era contends that workflow integration can help biopharma companies address challenges that limit provider utilization of patient support programs. She also outlines three major challenges related to the provider workflow technology market.

52

52

STAT

MAY 8, 2024

The qualification means that FDA has determined in advance that sponsors can use the feature as a secondary endpoint in clinical trials without having to do additional work.

235

235

STAT

DECEMBER 15, 2023

Also, the FDA has a new registry of trial sponsors and investigators who didn’t finish their paperwork.   Sign up  to get our biotech newsletter in your inbox. Turns out Jay Bradner is moving from academia and Novartis to serve as Amgen’s new CSO. Have a nice weekend! Read the rest…

Drug Pricing 257

Drug Pricing Drug Development 257

STAT

SEPTEMBER 21, 2023

But this lawsuit is novel by also going after a private equity sponsor that it believes hatched the entire alleged scheme — and could serve as a warning to other private equity deals, which have flooded the health care industry. Normally, the FTC sues the company that it believes has violated antitrust law. Read the rest…

Hospitals 363

Hospitals 363

STAT

MARCH 22, 2023

In the face of rising drug prices, health plan sponsors have quietly used a clever, but questionable tactic over the past few years to deflect costs. And now, some pharmaceutical companies are pushing back. Continue to STAT+ to read the full story…

Drug Pricing 245

Drug Pricing Pharmaceutical Companies Pharmaceutical Companies 245

Big Molecule Watch

AUGUST 16, 2023

In August 2023, the Food and Drug Administration issued two draft guidance, both related to the development of biosimilar products, entitled “ Formal Meetings between the FDA and Sponsors or Applicants of BsUFA Products ” and “ Classification Categories for Certain Supplements under BsUFA III ”, respectively.

Biosimilars 52

Biosimilars 52

STAT

JANUARY 4, 2024

Pfizer, whose departure STAT reported first , was listed on BIO’s website as a sponsor at one of the group’s highest levels. UCB, headquartered in Belgium, decided not to renew its BIO membership after a routine evaluation of its engagement in trade associations, said company spokesperson Erica Puntel.

277

277

STAT

SEPTEMBER 26, 2022

Regulators in half a dozen European countries are now taking steps to enforce requirements that clinical trial sponsors make study results public, although three other countries have so far taken little to no action, a new analysis finds.

Drug Development 264

Drug Development 264

STAT

NOVEMBER 30, 2023

“How clinical AI is changing radiology for good,” Philips promised to share in a sponsored session.

247

247

STAT

FEBRUARY 7, 2024

House committee passed a bipartisan bill to ban drug middlemen from charging fees based on drug list prices — the first in a raft of efforts to reform pharmacy benefit managers that would ban the practice in at least some of the employer-sponsored insurance marke t, STAT tells us. The bill, sponsored by Rep.

Diabetes 265

Diabetes 265

STAT

FEBRUARY 6, 2024

WASHINGTON — A House panel passed a bipartisan bill to ban drug middlemen from charging fees based on drug list prices — the first in Congress’ raft of PBM reform efforts that would actually ban the practice in at least some of the employer-sponsored insurance market. The bill, by Rep.

296

296

STAT

FEBRUARY 29, 2024

Called Atlas, the platform is designed so that a trial sponsor can research what tools are available to measure things like physical activity or sleep for many commonly studied diseases. CEO Andy Coravos said that robust intelligence can help developers move more quickly and avoid mistakes that require costly changes to trial protocols.

Pharmaceutical Companies 342

Pharmaceutical Companies Pharmaceutical Companies Drug Development 342

STAT

FEBRUARY 22, 2024

Food and Drug Administration told an advocacy group that it is not planning to take a tougher stance against wayward clinical trial sponsors and investigators that fail to register studies or report results, a central issue in the ongoing debate over greater transparency into clinical research.

341

341

Outsourcing Pharma

SEPTEMBER 28, 2023

A partnership has been formed between Phesi and Krsytelis, born out of a need to address the lack of diversity in clinical trials.

96

96

Outsourcing Pharma

NOVEMBER 17, 2021

According to data released by the company, the majority of study professionals plan to run agile or hybrid trials over the course of the next 12 months.

97

97