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Intarcia’s Implantable GLP-1 Gets Unanimous No Vote But Lots Of New Trial Design Advice

US FDA advisory panel feels there could be a place for Intarcia’s exenatide drug-device combo – if the company is willing to put in the work.

Advisory Committees Drug Safety

NASH Drug Development: Experts Argue The Case For Noninvasive Tests As Surrogate Endpoints For Approval

However, FDA officials appear skeptical that imaging-based and circulating biomarkers are ready for prime time when it comes to supporting accelerated approval of drugs for noncirrhotic nonalcoholic steatohepatitis.

Drug Approval Standards Research & Development

FDA Change In Bioequivalence Requirements Leads To Downgrade Of Accord’s Generic Tacrolimus

After agency tightened bioequivalence testing recommendations for tacrolimus products post approval, studies found Accord’s generic version of Prograf may deliver higher concentrations, leading agency to downgrade its therapeutic equivalence rating. No problems were found with five other tacrolimus ANDAs.

Generic Drugs Post Market Regulation & Studies

As New Tech Emerges For Early Research, FDA Chief Scientist Says Diversity Must Start In Preclinical Development

In a Pink Sheet interview Chief Scientist Bumpus discusses need to move diversity conversation up further in the pipeline. Better ‘organs on a chip’ should help.

Leadership Diversity & Inclusion

Pilot Phase Of Operation Warp Speed For Rare Diseases Beginning Soon

US FDA’s biologics center intends to ask for volunteers to help demonstrate the concept, modeled on the COVID vaccine effort, which includes speedier communication with sponsors to expedite development of products for rare diseases.

Gene Therapy Rare Diseases

Platform Technology Designation A Gene Therapy Opportunity, OTP Director Verdun Says

The new designation could streamline development of multiple products that use the same backbone, said Nicole Verdun, director of the US FDA’s Office of Therapeutic Products.

Gene Therapy Research & Development

PBM Reforms: House Hearing Suggests Bipartisan Consensus On Legislative Policies Has Limits

There was lots of criticism of pharmacy benefit managers (and a fair amount of pharmaceutical manufacturers) at the oversight hearing. However, Democrats may be more cautious about preserving the benefits PBMs provide versus the downsides in developing reforms.

Reimbursement Market Access

Delivery Device Continues To Be Intarcia’s Downfall Ahead Of FDA Panel On Nonapproval of Implantable GLP-1

CDER reviewers don’t buy that safety concerns with exenatide implant ITCA 650 are in line with the risks labeled for already approved GLP-1 agonists for type 2 diabetes – even other formulations of the same drug – potentially due to unique considerations associated with Intarcia’s delivery method.

United States Advisory Committees

Drug Promotion: Growth In Digital Marketing Warrants New Oversight Approaches, Experts Say

Panelists at a recent Duke-Margolis meeting cite growing use of native ads and patient influencers, as well as the limited attention given to presentation of risk information, in calling for a re-examination of how pharmaceutical promotion on digital platforms is regulated.

Advertising, Marketing & Sales Ad Campaigns

A Caveated Boost For Me-Toos And PBMs In New Net Price Competition Study

PBMs are able to leverage brand-to-brand competition across a variety of drug classes to lower costs, but that achievement and the presence of me-too drugs is more complicated than what might on its surface look like a clear win for the US health system.

Pricing Debate Reimbursement

The $4 Million NDA: US FDA User Fees After 30 Years

The cost of filing a New Drug Application with the US FDA has pushed above the $4 million mark. That is a remarkable rate of increase from the original $100,000 fee set in 1992 – but it does buy a lot more.

User Fees Drug Review

Are Fees The New Rebates? PhRMA Highlights Shifts In PBM Practices As House Tees Up Reform Vote

Pharmacy benefit managers are increasingly making money off new types of fees tied to list prices, drug industry lobby says, highlighting importance of delinking all PBM compensation from the cost of medicines. Most Congressional proposals in play do not include delinkage provision.

Pricing Debate Reimbursement

Real-World Data Or Studies Of Competitor Drugs Can Serve As Confirmatory Evidence For US FDA

Draft guidance describes seven types of confirmatory evidence that can be used with one adequate and well-controlled clinical study to demonstrate substantial evidence of effectiveness, including evidence from expanded access, real-world data, and studies of other drugs in the same class.

Guidance Documents Drug Approval Standards

From Interchangeability To Invisibility: FDA Wipes Designation From Biosimilar Labels

Amid continuing stakeholder confusion over the meaning and significance of the US FDA’s interchangeability designation for biosimilars, the agency has now recommended omitting altogether details of interchangeability from biosimilar labels.

Biosimilars Regulation

Lantidra Chronology: 19 Years From IND Submission To Approval For The Cellular Therapy

Pink Sheet’s Drug Review Profile looks at the timeline behind the development and FDA review of CellTrans’ treatment for type 1 diabetes.

Drug Review Profile Regenerative Medicine

Medicare Drug Pricing In Court: Judge Praises ‘Zealous Advocacy’ Of Attorneys In First Hearing On IRA

DOJ and Chamber of Commerce attorneys argue over whether Chamber has standing to sue and whether AbbVie has suffered harm meriting a preliminary injunction to halt the program. With Medicare’s Oct. 2 deadline looming, Judge Newman said he would issue a decision ‘as quickly as we can.’

Legal Issues Medicare
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