Monday, October 7, 2024

‘Quiet Giant' Biocon Sets Out Vision For Biosimilars

(10/7, David Wallace, Generics Bulletin) ...Biocon Biologics chief commercial officer for advanced markets Matt Erick says the firm is a " quiet giant" in the biosimilars space, but speaks up about the firm's plans to grow its business in Europe, explore in-licensing as well as in-house development, and capitalize on the upcoming loss of exclusivity for Stelara in the US... Global Sub. Full

Amneal Invests Up To $200M In Manufacturing Under Metsera GLP-1 Pact

(10/4, Dean Rudge, Generics Bulletin) ...Amneal was credited for its product development and manufacturing capabilities, including in-house API and sterile fill-finish manufacturing, as the US-based firm penned a collaboration agreement with New York City start-up Metsera to enable the efficient development and large-scale supply of a portfolio of new obesity medicines globally... Global Sub. Full

Regeneron Head Says Weight-Loss Drugs Could Cause ‘More Harm Than Good'

(10/6, Oliver Barnes, Financial Times) ...Clinical studies suggest that patients treated with the new class of weight- loss drugs, known as GLP-1s, lose muscle at far faster rates than people losing weight from diet or exercise, exposing them to health problems, said George Yancopoulos, who also serves as Regeneron's chief scientific officer..." I do think that the GLPs should be viewed with a lot of concern in terms of the way they're actually being used in the real world," said Yancopoulos. " They could be leading to successive changes in body composition that could be creating more harm than good in the long term."... Sub. Req’d

Mylan and Novo Nordisk Settle US Generic Ozempic Dispute, Natco Pharma Poised for Market Entry

(10/7, Ekta Batra, CNBC TV 18) ...In a significant development, global pharmaceutical companies Mylan and Novo Nordisk have reached a confidential settlement in the US regarding the generic version of Ozempic (Semaglutide). The Indian firm Natco Pharma has partnered with Mylan for the highly sought-after diabetes drug... Full

Old Drug Repurposed for Schizophrenia Could Reap Alzheimer's Windfall

(10/7, David Wainer, The Wall Street Journal) ...The path to discovering a blockbuster drug is often unpredictable. A promising molecule might be overlooked for decades, only to regain attention when new scientific insights spark fresh interest from pharmaceutical companies. Such is the case with newly approved Bristol-Myers Squibb drug Cobenfy. The underlying drug was first studied in Alzheimer's patients in the 1990s, but it was abandoned because of severe side effects... Sub. Req’d

For Bristol Myers Squibb's Newly Approved Schizophrenia Drug, What a Long, Strange Trip it's Been

(10/7, Kevin Dunleavy, Fierce Pharma) ...Boston-based Karuna Therapeutics rolled the dice on xanomeline, licensing it from Lilly in 2012...In a phase 2 trial of Alzheimer's patients in the 1990s, its cognitive benefits were evident. And as a bonus from the study, Lilly stumbled upon its antipsychotic value. "They made an accidental, serendipitous discovery," Andrew Miller, Ph.D., the co-founder and former CEO of Karuna, said in an interview with Fierce Pharma. "They discovered these antipsychotic effects, but along with that came dose-limiting, tolerability, predominantly (gastrointestinal), issues."... Full

US' Top IV Fluid Maker Baxter Voices Uncertainty About Recovery Timeline at North Carolina Facility Hit by Helene

(10/4, Fraiser Kansteiner, Fierce Pharma) ...The plant in question primarily manufactures intravenous and peritoneal dialysis solutions and is the largest producer of those critical drugs in the U.S. To help ease supply constraints spurred on by storm damage, Baxter has implemented an allocation system to limit stockpiling and support equitable access to products including saline, dextrose and PD solutions. The company is also working with the FDA to leverage Baxter's global supply network as it works to restore operations at North Cove... Full

Lupin's Pune Facility Gets Five Observations After USFDA Inspection

(10/5, Shubhayan Bhattacharya, NDTV Profit) ...The US Food and Drugs Administration completed a pre-approval inspection of Lupin Ltd.'s biotech facility in Pune, the company said on Saturday. The inspection was carried out from Sept. 25 to Oct. 4 and concluded with five observations... Full

Alkem And Torrent Defend Their Generics Over Failed Quality Test Claims

(10/4, Urte Fultinaviciute, Generics Bulletin) ...Alkem and Torrent said the tested batches were not manufactured by them, as a recent CDSCO report pinned their drugs as "not of standard quality". Meanwhile, other firms informed the agency themselves about counterfeit drugs on the market. Over 50 drugs were listed in the Indian Central Drugs Standard Control Organisation's latest ‘not of standard quality' reports, flagging potential quality issues in widely used medicinal products in the country... Global Sub. Full

RSV Vaccines Off to a Sluggish Start in US This Season, With Volumes Behind 2023

(10/4, Ayisha Sharma, Endpoints News) ...This season's uptake of RSV vaccines in the US has been slower than expected, according to Wall Street analysts tracking prescriptions, and appears to be missing even modest projections for growth compared with 2023. The RSV, or respiratory syncytial virus, space is dominated by GSK's first-to-market vaccine Arexvy, which has around 60% retail market share, according to Jefferies analysts, who put out an analysis of the market on Friday... Full

Cancer Risk Found in Popular Acne Products, Second Study Finds

(10/7, Anna Edney, Bloomberg Law) ...A new analysis of acne creams and cleansers found dozens, including popular products like Proactiv and Clearasil, contain high levels of a chemical linked to cancer...They found about a third were contaminated with high levels of benzene, a chemical that can cause cancer. Proactiv contained 18 times the amount of the potent carcinogen allowed in US drugs, the analysis published on Monday in the Journal of Investigative Dermatology found. A CVS-brand face wash had 13 times levels considered safe by the FDA... Sub. Req’d

DeGette, Bilirakis Ask Novo Nordisk How It Will Maintain Insulin Supply

(10/4, Luke Zarzeck, InsideHealthPolicy) ...Lawmakers wrote to Novo Nordisk CEO Lars Fruergaard Jørgensen on Sept. 23 asking what the company is doing to maintain supply of insulin for the diabetes community, voicing concerns over supply disruptions and continuity of care for patients. Rep. Diana DeGette (D-CO) and Rep. Gus Bilirakis (R-FL), who are co-chairs of the Congressional Diabetes Caucus, asked Jørgensen eight questions with a requested response by Oct. 15... Sub. Req’d

FDA and State Boards Eye GLP-1s Amid Larger Compounding Scrutiny

(10/4, Bruce Buckley, Pharmacy Practice News) ...State-level oversight has also intensified. "It's almost as if boards of pharmacy have opened the floodgates for inspections, especially in the GLP-1 [glucagon-like peptide-1] compounding space," said Lucas W. Morgan, JD, a partner at Frier Levitt. State boards are apprehensive that the increased public demand for GLP-1 agonist weight-management drugs is creating quality and product sourcing concerns—and "first and foremost" patient safety issues, he added during the three-part webinar series (box) titled "Mastering GLP-1 Compounding Regulatory Insights."... Full

US Chamber Appeals Drug Price Negotiation Suit to Sixth Circuit

(10/4, Nyah Phengsitthy, Bloomberg Law) ...The US Chamber of Commerce and affiliates appealed its challenge against the Biden administration's drug price negotiation plan to the Sixth Circuit after a federal judge dismissed the lawsuit for issues on standing and improper venue...The US Chamber argued the plan would reduce access to new medicines and harm businesses. The group of plaintiffs defended associational standing when it identified drugmaker AbbVie Inc. as one its members to be harmed by the program. AbbVie's cancer treatment Imbruvica was one of the 10 drugs the Biden administration selected for price negotiations... Sub. Req’d

Prior Authorization Reform: 2025 Could Be A Year Of Changes

(10/4, Laura Helbling, Pink Sheet) ...CMS is developing a proposed rule to streamline the prior authorization process for certain in Medicare Advantage and Affordable Care Act exchange plans. The agency said it recognized the need to balance the goal of easing patient and prescriber burdens with protecting plans' ability to establish and maintain formularies... Global Sub. Full

Proposed Drug Patent Reforms Would Do More Harm Than Good

(10/4, Andrei Iancu and David Kappos, RealClearHealth) ...America already prohibits the sort of patent gaming that lawmakers are concerned about, and the United States has the highest rate of generic drug usage in the developed world. There's simply no evidence that the patent process is unduly delaying the introduction of generic medicines. Blurring the lines of authority around the comprehensive processes already in place at USPTO and the FDA won't make patients better off. It'll only jeopardize American companies' competitive edge, squander government resources, and help foreign competitors and copycats... Full

Alternative Approaches to Reducing Prescription Drug Prices

(10/4, Congressional Budget Office) ...In this report, the Congressional Budget Office discusses the factors underlying prescription drug prices and examines a set of policy approaches aimed at reducing those prices. The agency assesses how each approach, if implemented in 2025, would affect average drug prices for purchasers in the United States in 2031. Inclusion or exclusion of any approach does not imply an endorsement or a rejection by CBO. Some of the approaches that CBO examined aim to reduce prescription drug prices by capping them or limiting their growth; others would reduce prices by promoting price competition or affecting the flow of information... Full

340B Rebate Dispute: HRSA Threat To Bar J&J From Medicare Part B, Medicaid ‘Unprecedented'

(10/4, Cathy Kelly, Pink Sheet) ...HRSA threatens nuclear option and Johnson & Johnson suspends its 340B rebate model. But the company also ‘reserves all of its legal rights with respect to this matter.' The Health Resources and Services Administration brandished a formidable and rarely used enforcement tool to deter Johnson & Johnson's plan to provide 340B rebates to certain hospitals instead of the usual up-front discounts for Stelara and Xarelto... Global Sub. Full

Stakeholders Warn of Potential Burdens in FDA's Drug Delivery Guidance

(10/4, Emily Hayes, Regulatory Focus) ...Industry stakeholders have asked the US Food and Drug Administration (FDA) to revise a new draft guidance on essential drug delivery outputs (EDDOs) to clarify key terminology and avoid costly and burdensome new regulatory requirements. Some also asked FDA to change the title of the guidance to better reflect all of the products that fall under it... Full

EMA's AI Principles Intended To Be ‘Flexible & Long Lasting'

(10/4, Eliza Slawther, Pink Sheet) ...There is "a lot of flexibility" in the European Medicines Agency's reflection paper on the use of artificial intelligence during drug development, which is principles-driven rather than setting rigid recommendations, says the agency's Florian Lasch. The European Medicines Agency recently finalized a reflection paper on the use of artificial intelligence (AI) during the lifecycle of medicinal products to help manufacturers use AI in a safe and effective way... Global Sub. Full

EMA/PRAC Latest Meeting Highlights

(10/4, The Pharma Letter) ...The European Medicines Agency's pharmacovigilance committee, PRAC, has started a review of medicines containing finasteride and dutasteride following concerns regarding suicidal ideation (suicidal thoughts) and behaviors... Sub. Req’d

England Plans New Model For Use Of Lilly's Mounjaro In Weight Loss

(10/4, Ian Schofield, Pink Sheet) ...NHS England says it is proposing a "realistic but challenging uptake trajectory" that will make "this clinically and cost-effective drug" available to as many patients as possible without overwhelming health care providers... Global Sub. Full

Ireland's 30 Million-Euro Budget for New Medicines is Significant for Patients, Says IHPA

(10/7, The Pharma Letter) ...The Irish Pharmaceutical Healthcare Association (IPHA), the representative body for the research-based biopharmaceutical industry in Ireland, says it welcomes the allocation of 30 million euros ($32.9 million) for new medicines in Budget 2025... Sub. Req’d

Policy Support Important As India Largely An Out-Of-Pocket Market: Panchal

(10/6, Shine Jacob, Business Standard) ...British drug major AstraZeneca is working on several clinical trials and several cancer-related projects in India. The company is trying to bring in technology to speed up the introduction of its global products. AstraZeneca Pharma India Managing Director and Country President Sanjeev Panchal talks to Shine Jacob about the company's future plans in a face-to-face interview... Sub. Req’d

India Unleashes Bio-RIDE to Spur Biotech Growth and Innovation

(10/7, The Pharma Letter) ...Streamlining two existing programs into a unified initiative with a renewed focus on biomanufacturing and biofoundries, the $1.1 billion ambitious scheme, aims to propel India to the forefront of biotech innovation and commercialization, reports The Pharma Letter's India correspondent. This scheme, approved by the Cabinet chaired by Prime Minister Narendra Modi, is focussed on accelerating R&D in the biotech sector and paving the way for biotech breakthroughs... Sub. Req’d

Japan Patients To Pay Part Of Price Difference When Insisting On Branded Drugs

(10/6, Lisa Takagi, Pink Sheet) ...Japan has started charging patients extra for non-generic drugs from October 1, to further raise generic use and control healthcare costs. The country aims raise the volume share of generics to 80% in all 47 prefectures, and to 65% on a price basis, by the end of March 2026. Japan's overall generic volume share has reached 83.5% but the country is still working to resolve long-running supply issues... Global Sub. Full

Treatment Persistence, Safety After Switching to Infliximab Biosimilars in Canadians With IBD

(10/5, Deana Ferreri, PhD, The Center For Biosimilars) ...A retrospective study of a mandatory nonmedical switch from the infliximab reference product (Remicade) to biosimilars CT-P13 (Inflectra) or SB2 (Renflexis) found no significant differences in rates of treatment persistence, loss of response, or adverse events in patients with inflammatory bowel disease (IBD) on maintenance therapy 1 year post-switch... Full

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