Tuesday, September 17, 2024

US Interchangeability ‘Irrelevant' And ‘Makes No Sense' Says Sandoz

(9/17, David Wallace, Generics Bulletin) ..."The way the FDA has originally characterized interchangeability, to me, makes no sense whatsoever." That was the blunt assessment of Sandoz CEO Richard Saynor as he was asked about biosimilar interchangeability in the US at the recent Morgan Stanley Healthcare Conference in New York in early September... Global Sub. Full

Strides Pharma Science Gets USFDA Nod for Generic Antidepressant Tablets

(9/16, Press Trust Of India) ...The approval granted by the US Food & Drug Administration to wholly owned subsidiary Strides Pharma Global Pte. Ltd, Singapore, is for Fluoxetine tablets of strength 60 mg, Strides Pharma Science said in a regulatory filing...The addition of the Fluoxetine tablets 60 mg will allow for enhanced flexibility in dosing, catering to a broader spectrum of patient needs, the company said, adding that it planned to launch all three strengths in the near future... Full

Zydus Lifesciences to Acquire Sterling Biotech's API Biz for Rs 84 crore

(9/17, Press Trust Of India) ...Zydus Lifesciences Ltd on Tuesday said it will acquire the 'Target Business' of Sterling Biotech primarily engaged in manufacturing of fermentation-based active pharmaceutical ingredients products and a production facility at Masa in Gujarat for a pre-agreed sum of Rs 84 crore... Full

US FDA Approves Roche's Ocrevus Zunovo to Treat Relapsing Multiple Sclerosis and PPMS

(9/17, Pharmabiz.com) ...Roche announced that the United States Food and Drug Administration (FDA) has approved Ocrevus Zunovo (ocrelizumab & hyaluronidase-ocsq) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS)... Full

Denmark's Orifarm Gains Investment From Carlyle

(9/16, David Wallace, Generics Bulletin) ...While the value of the investment was not disclosed, Orifarm specified that Carlyle had agreed to "commit strategic capital to Orifarm to support its future growth," with the deal due to close in the fourth quarter of this year "subject to relevant regulatory approvals." "This strategic investment will look to strengthen Orifarm's ongoing expansion, both organic and inorganic, building on its strong pan-European presence, and expand its coverage of accessible, high-quality, and affordable medicines," the company indicated... Global Sub. Full

Future Of GLP-1s: Iconovo Starts Development Of Intranasal Semaglutide

(9/17, Urte Fultinaviciute, Generics Bulletin) ...With asthma inhalers already in development, Iconovo has turned to a more innovative approach and looks at transforming injectable semaglutide into an intranasal drug. Iconovo has set GLP-1s as its new goal and announced the start of development for a nasally administrated semaglutide. The Swedish inhalation specialist plans to develop the nasal semaglutide inhaler into a pre-clinical proof-of-concept and then seek partners for clinical development... Global Sub. Full

Roche Outlines Commercial Manufacturing Strategy for GLP-1/GIP Assets 

(9/16, Anna Brown, Endpoints News) ..."The organization is gearing up with all of the necessary requirements to supply the medicines [GLP-1/GIPs] that we need not only for clinical [trials], but hopefully for the launch as well," said Manu Chakravarthy, Roche's SVP and global head of cardiovascular, renal and metabolism product development. Capacity constraints have been a major issue for pharma companies like Eli Lilly and Novo Nordisk that market GLP-1 drugs. Now, Roche is outlining its production strategy for assets still being tested in mid-stage trials... Full

Baltimore Settles Opioid Lawsuit with Johnson & Johnson

(9/16, Rushaad Hayward, WMAR) ...Baltimore City has settled another opioid lawsuit and this time it's with Johnson & Johnson...This news comes a week after the city settled with the Walgreens Pharamacy and Teva Pharmaceuticals. Teva will pay the city $80 million and the full terms of the Walgreens agreement will be made public on October 3... Full

Baltimore to Take Drug Distributors to Trial Over Opioids

(9/16, Brendan Pierson, Reuters) ...The city of Baltimore is scheduled to go to trial this week in its $11 billion lawsuit accusing drug distributors McKesson and Cencora of fueling an epidemic of opioid addiction and overdose deaths...The city joined some other hard-hit jurisdictions around the country in opting out of the national deals. It has already reached its own settlements with several companies ahead of the trial, most recently with pharmacy operator Walgreens and drugmaker Teva, totaling $402.5 million... Full

Navigating Biosimilars: Expert Perspectives on Integration, Challenges, and Future Trends Within Health Systems

(9/16, AJMC) ...A Q&A with Sophia Humphreys, PharmD, MHA, BCBBS; Robert Gluckman, MD, MACP; and Elie M. Bahou, PharmD, MBA. This interview features 3 prominent figures in health care management and pharmacy who will share their insights and experiences with biosimilars and offer predictions about their future impact on health care... Full

A Promise Unfulfilled: The State of Biosimilars

(9/16, Mark Campbell, PharmD, Pharmacy Times) ...Given the high cost of biologic drugs when the first biosimilars-highly similar, lower-cost alternatives-began to be developed, expectations for their cost-saving potential were high. Unfortunately, in the near decade since the first biosimilar was approved of filgrastim-sndz (Zarxio; Sandoz) in 2015, this promise has failed to materialize... Full

Superbugs Death Toll Could Swell by Millions Over Coming Years

(9/16, Lisa Pham, Bloomberg) ...More than 39 million people could die globally from antibiotic-resistant infections over the next 25 years, according to a study published in The Lancet...If left unchecked, AMR could lead to an estimated $1 trillion in additional healthcare costs by 2050, as well as a 3.8% loss of global gross domestic product, according to a report published last month... Full

Antibiotic-Resistance Deaths to Surge from 2025-2050, Study Says

(9/16, Nancy Lapid, Reuters) ...Bacterial illnesses that are resistant to available antibiotic medicines will cause more than 39 million deaths worldwide over the next 25 years and indirectly contribute to an additional 169 million deaths, according to a forecast published on Monday. By 2050, annual death tolls attributed directly to antibiotic resistance, or associated with it, will reach 1.91 million and 8.22 million, respectively, if remediation measures are not in place, an international team of researchers reported in The Lancet... Full

Hill GOP Sets Sights On Scrapping Drug Price Talks

(9/17, Peter Sullivan, Axios) ...The tension surfaced this week when multiple high-ranking Republicans told Axios they want to repeal the Inflation Reduction Act's Medicare drug price negotiations next year if they prevail in the elections...Rep. Buddy Carter (R-Ga.) said the IRA drug pricing provisions are "the worst legislation I've ever witnessed in 10 years in Congress and 10 years in the state legislature" and he "absolutely" wants to repeal them... Full

Drug Price Talks a Target in GOP Congress

(9/16, Peter Sullivan, Axios Pro) ...Although former President Trump and his running mate, Sen. JD Vance, have expressed support for lowering drug prices in some form, many GOP lawmakers are openly discussing killing a process they've widely condemned, saying it hinders innovation and artificially sets prices...Some well-placed congressional Republicans told Axios that they, at a minimum, want to repeal Medicare drug price talks, though plans for any replacement are less concrete... Sub. Req’d

Express Scripts Sues FTC Over Drug Pricing Report

(9/17, Jody Godoy, Reuters) ...Pharmacy benefit manager Express Scripts sued the U.S. Federal Trade Commission on Tuesday over the regulator's recent drug pricing report, calling the report's conclusion that the prescription middlemen raise drug costs defamatory... Full

ANALYSIS: Biden's Drug Price Program Hangs On Nature of Medicare

(9/17, Alexis Kramer, Bloomberg Law) ...The key question in the cases is whether the drug price scheme improperly forces drugmakers to give up property and speech rights (through product sales and negotiation agreements). But drugmakers' ability to walk away from Medicare altogether, coupled with a string of Biden administration victories in the lower courts, suggests that the negotiation program is in good legal standing... Sub. Req’d

Doctors Call For Action To Lower GLP-1 Drug Costs

(9/16, Luke Zarzecki, InsideHealthPolicy) ...A group of 253 clinicians are asking lawmakers to address the high cost of diabetes and obesity treatments in a letter sent to Senate health committee Chair Bernie Sanders (I-VT) and ranking Republican Bill Cassidy (LA) on Monday (Sept. 16). The letter, which comes as the committee gears up for a hearing on the issue next week, drew praise from Sanders. The groups call out Eli Lilly's tirzapetide and Novo Nordisk's semaglutide by name, saying the medicines can't help patients if they cannot access them... Sub. Req’d

Top Staffer On Drug Pricing to Depart Senate Finance Committee

(9/16, John Wilkerson and Rachel Cohrs Zhang, STAT Plus) ...Shawn Bishop, a Democratic staffer who has played a major role on some of the most impactful health care laws of the past 20 years, is leaving the Senate Finance Committee next month, according to five sources familiar with the departure... Sub. Req’d

AAM Opposes Patent Bills To Be Marked Up By Senate Judiciary Thursday

(9/16, Gabrielle Wanneh, InsideHealthPolicy) ...The generic drug lobby is urging lawmakers to vote against two patent reform bills to be taken up by the Senate Judiciary Committee Thursday (Sept. 19), saying the bills aimed at reforming the patent eligibility process and the tribunal review of patents that may have been wrongfully granted will make it harder for generic and biosimilar manufacturers to challenge patents for brand drugs... Sub. Req’d

Geopolitics, US BIOSECURE: Pharma Looks To Redistribute CDMO Footprint

(9/16, Anju Ghangurde, Pink Sheet) ...Biopharma firms are rethinking their contract development and manufacturing organization (CDMO) network against the backdrop of geopolitical tensions and the advancement of the US BIOSECURE Act, but the size of the shift away from China in the short and long term remains in question... Sub. Req’d

PhRMA Pushes FDA to Change ‘Overly Simplistic' and ‘Unduly Restrictive' Online Misinformation Proposals

(9/16, Nick Paul Taylor, Fierce Pharma) ...PhRMA is pushing the FDA to expand drug manufacturers' powers to correct misinformation about their products, including by allowing them to respond to opinions, value judgments or personal experiences and communications made offline... Full

FDA Publishes Its Draft Strategy Document On Innovative Manufacturing Technologies

(9/17, Mark I. Schwartz, FDA Law Blog) ...FDA recently published a Federal Register (FR) Notice [Docket No. FDA-2024-N-3945] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies... Full

FDA Tells Oncology Companies How to Run Multi-Regional Cancer Trials with a US Approval in Mind

(9/16, Zachary Brennan, Endpoints News) ...The FDA on Monday released new draft guidance on conducting multi-regional oncology trials, saying its "paramount consideration" is whether the results apply to the intended use population and standard cancer care practices in the US...While the FDA's new nine-page draft doesn't specifically mention China, it notes that there has been a "decreasing proportion of US participants" in cancer drug trials. If a sponsor is planning a multi-regional trial to support a new drug approval, the FDA recommends "that such a trial be conducted across major geographical regions (e.g., across several continents) rather than predominantly in a single country or in a single geographical region (e.g., Asia)."... Full

AI Adds Complexities to Real-World Data in FDA Drug Approvals

(9/17, Nyah Phengsitthy, Bloomberg Law) ...The FDA in July finalized guidance on harnessing EHRs and medical claims data in clinical studies to support drug and biologic regulatory decision making. Notably, the guidance acknowledged artificial intelligence when collecting and analyzing such data, as more drug sponsors and the companies they work with gravitate toward using advanced technology tools. Life sciences attorneys expect AI to emerge as a double-edged sword as real-world data can be used to extract critical health information for studies used in the approval or post approval process, while also adding more scrutiny to the product's application when reviewed by the FDA... Sub. Req’d

California May Regulate and Restrict Pharmaceutical Brokers

(9/16, Bon Thomson, KFF Health News) ...California Gov. Gavin Newsom will soon decide whether the most populous U.S. state will join 25 others in regulating the middlemen known as pharmacy benefit managers, or PBMs, whom many policymakers blame for the soaring cost of prescription drugs...The proposed law, spearheaded by state Sen. Scott Wiener of San Francisco, a Democrat, would require PBMs to apply for a license by 2027 and would mandate that licensed PBMs pass along 100% of pharmaceutical manufacturers' rebates to health plans or insurers... Full

Medicines Shortage is 'Unprecedented', GP Says

(9/17, Anne-Marie Tasker, BBC) ...Dr Dan Lane, a GP partner at Willingham by Stow Surgery, Lincolnshire, said the situation was "unprecedented", with common drugs such as statins and insulin recently very difficult to find...The Department of Health and Social Care said the government "inherited ongoing global supply problems that continue to impact medicine availability" and was working with industry, the NHS and manufacturers... Full

European Regulators Fortify Single-Arm Trial Advice, But Underscore Preference for Placebo-Controlled Designs

(9/16, Max Bayer, Endpoints News) ...The European Medicines Agency has solidified its recommendations to drugmakers that want to use single-arm designs in a pivotal trial, but emphasized that any such case "needs justification." The regulator's advice was detailed in an updated working paper released Monday, which makes clear that randomized, controlled trials are expected as the norm. When drugmakers use a single-arm design to create pivotal evidence, they need to clearly define the success criteria ahead of time, the regulator said... Full

French Plan To Require Pregnancy Risk Pictogram On All Medicines

(9/16, Ian Schofield, Pink Sheet) ...The French medicines regulator, ANSM, is proposing to require the outer packaging of all medicines to carry a new pictogram showing the likelihood of teratogenicity or fetotoxicity if they are taken during pregnancy. The risks displayed by the new pictograms would also take account of the likelihood of neurodevelopmental problems in the child and the possibility of miscarriage... Sub. Req’d

Saudi Arabia To Mandate Economic Evaluation Studies For New Drugs From July 2025

(9/16, Vibha Sharma, Pink Sheet) ...An enhanced framework developed by the Saudi Food & Drug Authority as part of its remit to determine the added value of pharmaceutical products over the current standard of practice in healthcare systems is set to become mandatory from next year... Sub. Req’d

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