Thursday, September 12, 2024

FDA Shutting Down Fentanyl Access Program for Cancer Patients

(9/12, Pat Anson, Pain News Network) ...In a notice published on the FDA website for its Transmucosal Immediate-Release Fentanyl Medicines (TIRF) access program, the agency said that all fentanyl-based medications "will be discontinued" on September 30...The FDA's decision to end TIRF-REMS apparently came after Teva Pharmaceuticals notified the agency in August that it was discontinuing production of Actiq, a fentanyl lozenge, and Fentora, a fentanyl buccal tablet...Opioid litigation and the cost of defending itself in court may have influenced Teva's decision to discontinue TIRF medication... Full

High Doses of Adderall Increase Risk of Psychosis Fivefold, McLean Study Finds

(9/12, Jonathan Saltzman, The Boston Globe) ...High doses of Adderall, the widely prescribed drug for attention deficit hyperactivity disorder, were associated with more than a fivefold increased risk for a first-time episode of psychosis or mania, according to a study released Thursday by McLean Hospital...Teva Pharmaceutical Industries Ltd., one of the biggest manufacturers of the generic form of Adderall, declined to comment on the study... Sub. Req’d

High Doses of ADHD Drugs Linked to a Greater Risk of Psychosis

(9/12, Akshay Syal, M.D., NBC News) ...The drugs include Adderall, Vyvanse and generic amphetamines, such as dextroamphetamine...In a statement to NBC News, a spokesperson for Takeda Pharmaceuticals, the maker of Vyvanse, said, "Takeda believes it is important for patients to take our medicines in accordance with U.S. Food and Drug Administration (FDA)-approved labeling guidance and in consultation with their prescribing health care provider."... Full

Sandoz Is ‘Not Aiming To Be A Leader' In US Small-Molecule Generics

(9/12, David Wallace, Generics Bulletin) ...In a frank acknowledgement of Sandoz's position in the US small-molecule generics market, the company's North America president Keren Haruvi has indicated that the firm is "not looking to be a leader in the generics space" and is still suffering from a lack of investment made in its pipeline during the period several years ago when it was looking to sell the oral solids business... Global Sub. Full

'I've Built this Business to Last, Not for Sale', Says Biocon's Kiran Mazumdar-Shaw On Sellout Rumours

(9/12, Shereen Bhan, CNBC TV 18) ...Kiran Mazumdar-Shaw, Executive Chairperson of Biocon, has firmly dismissed rumours that the company is selling out, stressing her commitment to growing Biocon Biologics as an independent entity. However, the Biocon Chairperson revealed that the company has been exploring equity investment options as part of its strategy to reduce debt levels. This follows Biocon's strong focus on efficiency, growth in the biosimilars sector, and upcoming expansion plans... Full

Hikma Bolsters Injectables With Completion Of Xellia Deal

(9/11, David Wallace, Generics Bulletin) ...Hikma has set out expected enhancements to its injectables business, following the completion of its recent agreement to acquire a bundle of US finished-dose assets from Xellia Pharmaceuticals following clearance under applicable US antitrust laws... Global Sub. Full

Amneal Secures Fourth 505(b)(2) Injectable Approval Of 2024 With Bortezomib

(9/11, Adam Zamecnik, Generics Bulletin) ...The US Food and Drug Administration has approved Amneal Pharmaceuticals' and Shilpa Medicare's new formulation of the anti-cancer drug Velcade (bortezomib), paving the way for the launch of the first ready-to-use subcutaneous formulation of bortezomib in the second quarter of 2025. Marketed under the name Boruzu, the drug functions as a proteasome inhibitor used in the treatment of multiple myeloma and mantle cell lymphoma... Global Sub. Full

J&J Expands Tremfya into IBD with New FDA Approval

(9/11, Max Bayer, Endpoints News) ...The FDA has approved Johnson & Johnson's IL-23 blocker Tremfya to treat ulcerative colitis, a boost to the pharma's hopes that the drug will serve as a worthy follow-up to the blockbuster Stelara. Wednesday's label expansion is the first time Tremfya has been given the go-ahead to treat a form of inflammatory bowel disease. Already approved for plaque psoriasis and psoriatic arthritis, it's also been submitted to US regulators as a treatment for Crohn's disease, among other indications... Full

ANI And Alimera Merger Moves Ahead Following Fleeting Legal Wrangle

(9/11, Dean Rudge, Generics Bulletin) ...ANI Pharmaceuticals and Alimera Sciences say they will close their previously agreed $380m+ merger before the market opens on September 16,, with the announcement coming just 24 hours after eye-disease specialist Alimera disclosed that it was suing ANI to compel completion of the deal... Global Sub. Full

Eli Lilly Invests $1.8 Billion in Ireland Sites to Scale Up Alzheimer's, Obesity Drug Production

(9/12, Bhanvi Satija, Reuters) ...Eli Lilly is investing $1.8 billion across two manufacturing sites in Ireland to boost production of its hugely popular obesity drug and a newly approved treatment for Alzheimer's, the drugmaker said on Thursday. The investments are part of Lilly's ongoing commitment to expand production, especially for its top-selling diabetes and obesity drugs, Mounjaro and Zepbound, respectively... Full

Granules India Shares Fall 15% On Concerns Over 6 USFDA Observations to the Gagilapur Unit

(9/12, Ekta Batra, CNBC TV 18) ...Granules India, in a statement, reassured investors that they are actively addressing the observations and are fully committed to resolving the issues raised. "We will work with the USFDA to address the issues raised in the observations." At Granules, quality and compliance are paramount, and these principles are deeply embedded in our ongoing review and governance processes, the company said, adding that it will continue to provide updates in a timely manner and as appropriate... Full

Judge Tosses Vanda Generic Sleep Drug Approval Suit Against FDA

(9/11, Nyah Phengsitthy, Bloomberg Law) ...Vanda's lawsuit challenging the agency's approval of MSN Pharmaceuticals, Inc.'s generic sleep-disorder drug tasimelteon lacks ripeness and fails to exhaust mandatory administrative remedies, Judge Christopher R. Cooper for the US District Court for the District of Columbia wrote in a Tuesday order... Sub. Req’d

FDA Scolds AbbVie Over ‘Misleading' TV Ad for a Migraine Pill Featuring Serena Williams

(9/11, Ed Silverman, STAT Plus) ...The U.S. Food and Drug Administration has scolded AbbVie for making false and misleading claims in a TV ad about a migraine pill that features Serena Williams, the third time this year the agency has taken a major pharmaceutical company to task for its marketing...An AbbVie spokeswoman sent us a note saying the company is "actively addressing the FDA enforcement action regarding the TV commercial referenced in the letter, which stopped airing in the first half of this year. We will continue to further correspond with the FDA on this matter."... Sub. Req’d

Celebs Bring Extra Scrutiny To Advertisements, US FDA Tells AbbVie

(9/11, Sarah Karlin-Smith, Pink Sheet) ...AbbVie's Ubrelvy ad misleadingly overstates how fast its migraine drug provides relief, the FDA said. Using tennis star Serena Williams in the ad makes the misleading information more problematic because research has shown the presence of a celebrity "amplifies" the information and makes people more likely to believe it, the agency added. Additional FDA research on the impact of an endorser's status and explicitness of payment is pending peer review and publication... Sub. Req’d

Ozempic, Other GLP-1 Drugs at Center of Sweeping Class Action that Kicked Off in Philadelphia

(9/12, Hanna Webster, Pittsburgh Post-Gazette) ...While celebrities and diabetes patients alike have heralded the swift success of Ozempic and similar drugs, more than 900 complaints have piled up, alleging injury from the medications. Those nationwide complaints are at the center of first-of-its-kind class action lawsuit against glucagon-like peptide, or GLP-1, drugs...At least one of the 929 cases against pharmaceutical companies Novo Nordisk and Eli Lilly involves a Pittsburgh plaintiff, in addition to numerous cases with ties to Western Pennsylvania... Full

Pharma Groups to Tackle Greenhouse Gases from Asthma Inhalers

(9/12, Michael Peel and Ian Johnston, Financial Times) ...Pharmaceutical groups GSK and AstraZeneca are vying to be the first to finally upgrade their popular inhalers which deliver a life-saving puff of medicine but damage the planet. GSK plans to start final trials to improve the gas propellant in its 55-year old Ventolin inhaler used by tens of millions of people with asthma worldwide. This could cut the company's entire carbon footprint by more than 40 per cent... Full

Biden Drug Pricing Law Threatens New Products, J&J's Duato Says

(9/11, Robert Langreth and David Gura, Bloomberg) ...The Biden administration's drug-price negotiation law threatens new product development and will lead to fewer new medicines in the future, Johnson & Johnson Chief Executive Officer Joaquin Duato said. Biden's signature Inflation Reduction Act "is misguided and it's going to chill innovation," Duato said in an interview on Bloomberg Chief Future Officer. "The number of medicines that will be there will be less," because drug development will become less attractive for investors, he said... Sub. Req’d

CVS Says it Won't Correct Congressional Testimony

(9/11, Drew Armstrong, Endpoints News) ...The head of CVS Health's PBM unit won't correct testimony given to Congress, the company's lawyers said in a letter to the House Oversight Committee, arguing that the executive's comments were accurate. In a letter sent to the committee Tuesday, the lawyers described CVS Caremark president David Joyner's comments as "accurate" and said the company "fully stands behind" them... Full

E&C Markup Next Week May Include Telehealth, PBM Delinking Bills

(9/11, Luke Zarzecki, Cara Smith, InsideHealthPolicy) ...The House Energy & Commerce Committee will hold a full committee markup on Wednesday (Sept. 18) that sources tell Inside Health Policy could include bills extending pandemic telehealth flexibilities and requiring pharmacy benefit managers to delink what they are paid from the price of drugs, although the agenda is still being worked out... Sub. Req’d

Can PBM Reform Lower Drug Prices?

(9/11, Keerthi Vedantam, BioSpace) ...Pharmacy benefit managers, once a shrouded part of the healthcare system, are now under intense scrutiny by lawmakers and drugmakers for their part in rising drug prices in the United States. Congress, which reconvened this week, will soon review several bills that would require PBMs to declare how much of a profit they're making while negotiating drug prices... Full

Harris Defends ACA While Trump Calls for 'Much Better' Health Plan During Debate

(9/11, Giuliana Grossi, AJMC) ...Health care emerged as a pivotal topic at last night's presidential debate as moderator Linsey Davis questioned former President Donald Trump and Vice President Kamala Harris on their differing visions for the future of the Affordable Care Act (ACA), also known as Obamacare... Full

How to Keep the BIOSECURE Act from Hobbling U.S. Biotech and Pharma

(9/12, Kendalle Burlin O'Connell, STAT Plus) ...Without significant investment and commitment, our country is simply not yet prepared to host the entire drug development supply chain. As it stands today, the limited pool of skilled labor, including chemists and molecular biologists, is not enough to satisfy our world-leading biotechnology companies. If the legislation were to become law as passed by the House, the industry's ability to conduct the R&D that derives new medicines will become considerably weaker... Sub. Req’d

PDA/FDA Joint Regulatory Conference 2024 – Day 1

(9/11, Paul Dexter, Lachman Consultants) ...I offer here a short synopsis of the updates and/or interesting points that were takeaways for me on Day 1 of the conference... Full

PDA Conference Day 2 – An Overview

(9/11, Patrick Day, Lachman Consultants) ...Day 2 of the 2024 PDA/FDA Joint Regulatory Conference kicked off in a similar format to Day 1 with a panel discussion, moderated by Andrew Hopkins, that delivered key messages from various FDA leaders. An explanation of the imminent changes in the Agency's organizational structure (CBER, CDER, and CVM) dominated the conversation. However, an impactful response from Jill Furman (Director of the Office of Compliance, CDER) resonated during the Q&A when asked about priorities in 2025—her reply was, "Maximizing effectiveness of enforcement actions," and this is "including distributors."... Full

Draft US FDA Innovative Manufacturing Strategy Takes On Global Inconsistency

(9/11, Bridget Silverman, Pink Sheet) ...The US FDA draft strategy on innovative manufacturing meets a PDUFA VII commitment, builds on a 2023 public workshop and sets performance goals for communication and collaboration. Stakeholders cited inconsistent international regulations as a barrier to adoption of advanced manufacturing technologies... Sub. Req’d

FDA Drafts New Strategy to Boost the Use of Advanced Manufacturing Tech

(9/11, Zachary Brennan, Endpoints News) ...The FDA on Wednesday unveiled the outline of its plans to support the use of new drug manufacturing technologies, part of the agency's commitments under the latest user fee program. The seven-page strategy document explains what the agency plans to do in this developing space, such as optimizing CDER's Emerging Technology Program and CBER's Advanced Technologies Team, which can allow for advanced talks with the FDA on new technologies before they're included in submissions... Full

Korea Revamps Drug Review Processes, Cuts Approval Timelines

(9/11, Jung Won Shin, Pink Sheet) ...As part of ongoing efforts to grow the biohealth industry, Korea is revamping its drug approval processes and timelines to encourage new drug development on par with global norms. The government aims to sharply raise the fees, while enhancing its expert review staff, but will exempt a portion of the fees for smaller firms to reduce their burden... Sub. Req’d

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