Featured Stories

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.

EU Group Facilitates Switching Multinational Trials To CTR
Revisions to the updated EU guideline on transitioning multinational trials to the Clinical Trials Regulation are said to be “solution oriented.”

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.
Taking The Medicare Pricing Law To Court
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.’
Stealth Defense: Medicare, IRS Implementation May Weaken Pharma’s Arguments Against IRA
Court Could Pause Medicare Drug Price Negotiation Process Following First Hearing In IRA Litigation
IRA Litigation Landscape: Where The Cases Are And Where They Are Headed
Litigation Against Medicare Price Negotiation Gains Four Potential New Plaintiffs
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Keeping Track: Rybrevant Goes RTOR, Two-Part Review For Dasiglucagon, And CRL For Ultomiris
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

Global Pharma Guidance Tracker – August 2023
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
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Multimedia

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.

Lantidra’s First-Cycle Complete Response Letter Centered On Inspection And Product Quality Issues
Although the CRL delayed the cell therapy’s approval by almost two years, additional CMC-related testing requested by the FDA ultimately came to be seen as a good thing by sponsor CellTrans because it provided assurance of product consistency.

IRA Litigation Landscape: Where The Cases Are And Where They Are Headed
Pink Sheet infographic details the district court judges and circuit courts that will be deciding the cases brought by industry against the IRA, breaking down the Democrat and Republican appointees as well as the arguments in each suit.

ANDA Submissions Lagging As FY 2023 Nears Its End
Generic drug sponsors are on pace to submit the second-fewest number of ANDAs in a fiscal year in the history of GDUFA.
Regional Comparisons

Swiss New Drug Approval Times On A Par With EMA, But Longer Than US FDA
The median approval time for new drugs in Switzerland lengthened in 2022, mainly because of applications filed during the peak of the COVID-19 pandemic, says the country’s regulator.

How Do Japan’s Clinical Trial eConsent Rules Compare With The EU And US?
A newly-translated guidance document from Japan’s drug and device regulator outlines the points that clinical trial sponsors should consider when using electronic methods to collect informed consent from participants.

Rare Diseases: European Market Access ‘Better Organized’ Than US, Says Rhythm
Rhythm is working with country-level authorities and centers of excellence in Europe to gain reimbursement and access for its obesity treatment Imcivree.

Different, But Not Poles Apart: Running Decentralized Clinical Trials In EU & US
This second segment of a two-part article on a regional comparison of EU and US approaches to decentralized clinical trials highlights the differences between the two regions relating to the more practical aspects of setting up and running such studies.
Recent Stories
EU Orphan Drug Law Reform Will See Innovation Drop By 12%, Industry Warns
The European Commission’s proposals to overhaul the EU pharma legislation, which will see some orphan drug incentives cut, would cause a “significant dip in innovation,” according to number crunching from pharma industry association EFPIA.
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.
US FDA's Cavazzoni Criticizes Plant Shutdown That Triggered Serious Cisplatin Shortage
Director of the FDA’s center for drugs slams firm for failing to reach out before suspending operations in the wake of an inspection that raised serious data integrity concerns. Instead, firms should be alerting the agency as soon as they realize there could be shortages.
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.
EU CHMP Opinions And MAA Updates
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
Dissent In Parliament As Commission Claims EU Pharma Revision Will Improve Competitiveness and Access
Proposals on regulatory data protection and transferable exclusivity vouchers to encourage antimicrobial R&D have received mixed reactions from the parliament’s rapporteurs for the draft legislation.
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.
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.
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.
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.
Additional Analyses Help Idorsia Secure English Funding For Chronic Insomnia Drug Quviviq
Quviviq is to become the first dual orexin receptor antagonist available on the National Health Service. Just over 20,000 people in England could receive treatment with the drug in its first year, says the health technology assessment institute, NICE.
Tackling AMR: OECD Says Greater Investment Needed In Later-Stage Drug R&D
Governments should increase financial resources for novel antimicrobial drug candidates in the later stages of development and tackle shortages of existing, underused antibiotics to combat antimicrobial resistance, says a new report from the OECD.
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