Wednesday, September 25, 2024

Teva CEO Francis Urges UK To ‘Wake Up And Understand' Life Sciences Potential

(9/24, Dean Rudge, Generics Bulletin) ...Teva's CEO Richard Francis believes the UK life sciences sector needs to "realize what's under their nose," as he stressed that the nation's leaders were failing to grasp an opportunity that could see the country compete with the world-leading biotech hubs on the east and west coast of the US "like no other European country could."... Global Sub. Full

TEV-‘749 Demonstrates No Incidence Of Postinjection Delirium/Sedation Syndrome in New Data

(9/24, Leah Kuntz, Psychiatric Times) ..."Teva is dedicated to building on its commitment to neuroscience by developing new long-acting injectable treatment options like TEV-‘749 that may help address unmet needs in schizophrenia for patients and health care providers," said Eric Hughes, MD, PhD, executive vice president of global R&D and chief medical officer at Teva. "PDSS is a major barrier to the utilization of intramuscular olanzapine LAIs that exists today, and our SOLARIS findings fuel the continued development of TEV-‘749."... Full

Roche Narrows Pharma Pipeline Amid Push Into Obesity Market

(9/24, Helena Smolak, The Wall Street Journal) ...The Swiss pharma giant is trying to establish a presence in the increasingly crowded obesity field and expand in therapeutic areas such as ophthalmology, in an attempt to turn a page on past setbacks with drug candidates for Alzheimer's disease and lung cancer. Roche is narrowing the pipeline to 11 disease areas and continuing to invest in a targeted way, said Teresa Graham, chief executive of Roche's pharma division, in an interview with The Wall Street Journal... Sub. Req’d

ANI Completes Alimera Merger After Legal Back And Forth

(9/24, Adam Zamecnik, Generics Bulletin) ...After being sued by Alimera earlier this month, ANI has now completed its acquisition of the company, boosting its commercialized drug portfolio with two original products...This move added two commercialized ophthalmological compounds known as Iluvien (fluocinolone acetonide intravitreal implant 0.19mg) and Yutiq (fluocinolone acetonide intravitreal implant 0.18mg) to ANI's portfolio. According to the company, the two products will add about $105m to its pro forma revenues this year... Global Sub. Full

Alvotech Initiates Confirmatory Patient Study for AVT16, a Proposed Biosimilar to Entyvio®

(9/25, Alvotech) ...The objective of the study is to demonstrate comparative efficacy, safety, and immunogenicity of AVT16 and Entyvio, in male and female participants 18-80 years old with moderate to severe active Ulcerative Colitis...Alvotech is one of two companies known to have initiated a global or multi-country confirmatory patient study for a biosimilar candidate to Entyvio... Full

Biocon Biologics Presents New Data On Psoriasis Drugs; Shares Dip

(9/25, Anupama Ghosh, The Hindu BusinessLine) ...Biocon Biologics Ltd, a subsidiary of Biocon Ltd, announced new dermatology data at the European Academy of Dermatology and Venereology (EADV) 2024 Congress in Amsterdam on September 25, 2024. The company presented results from two pivotal Phase 3 clinical studies supporting interchangeability between the drugs adalimumab and adalimumab-fkjp, as well as demonstrating biosimilarity of b-ustekinumab (biologic ustekinumab)stekinumab... Full

Allergy Pen Maker Sues Colorado Over State Affordability Program

(9/24, John Daley, CPR News) ...A pharmaceutical corporation sued Colorado Friday in federal court aiming to bring a halt to a law approved in 2023, which the New Jersey-based company said makes it provide generic allergy pens to pharmacies for free. Amneal Pharmaceuticals argues in its complaint that the law has resulted in an "ongoing, unconstitutional taking" of its auto-injectors by the state as part of its efforts to make the pens affordable... Full

Baltimore Claims Biogen ‘Bribed' PBMs to Favor its Pricey MS Drug Over Generics

(9/24, Ed Silvermna, STAT Plus) ...In the latest slap at a pharmaceutical company by a local government, the city of Baltimore has filed a lawsuit accusing Biogen of striking an "unlawful" scheme with the largest pharmacy benefit managers to block generic competition of a best-selling multiple sclerosis treatment. The effort allegedly originated as Biogen planned to fend off generic companies that hoped to sell lower-cost alternatives to Tecfidera which, several years ago, had been a franchise product and generated nearly half of its revenue... Sub. Req’d

Former DEA Agent Testifies Against Drug Distributors in Baltimore Opioid Case: ‘They Did Not Respond to Red Flags'

(9/24, Alex Mann, The Baltimore Sun) ..."In my opinion, they did not respond to the red flags in a timely manner or in an adequate manner. I don't believe they did an adequate job preventing diversion," Ruth Carter told jurors, referring to the phenomenon of legal drugs being distributed illegally... Sub. Req’d

Docs Discuss Sluggish Switch to Humira Biosimilars, Name Preferred Off-Patent Options

(/24, Nick Paul Taylor, Fierce Pharma) ...Significantly more gastroenterologists than rheumatologists or dermatologists expressed favorable views of biosimilars, Spherix said. Nearly half of gastroenterologists proactively choose to prescribe biosimilar brands, the survey found, but rheumatologists and dermatologists have largely been driven to off-patent options by "external pressures." Those pressures have intensified slower than some people expected... Full

10 of 20 Most Common Drugs in Shortage

(9/24, Alexandra Murphy, Becker's Hospital Review) ...Amphetamine mixed salts: Multiple formulations of the ADHD medication have been in shortage since 2022, with no release dates provided... Full

Strategic API Sourcing: Offshoring Vs. Nearshoring For A Resilient Supply Chain

(9/25, Ash Gude, Pharmaceutical Online) ...While offshoring can offer cost advantages, it also introduces risks related to supply chain disruptions, regulatory compliance, and quality management. Nearshoring, on the other hand, provides greater control over these factors but may come with higher up-front costs... Full

US Senator Sanders Says Middlemen Won't Punish Novo if it Cuts Weight-Loss Drug Prices

(9/24, Ahmed Aboulenein, Patrick Wingrove, Reuters) ...U.S. Senator Bernie Sanders said on Tuesday he had commitments from the nation's top pharmacy benefit managers that they would expand coverage of Novo Nordisk's popular diabetes and weight-loss medicines if the company lowered the list prices... Full

Novo Nordisk CEO Skeptical Of PBMs' Pledge To Ensure Access If GLP-1 Prices Reduced

(9/24, Luke Zarzecki, InsideHealthPolicy) ...Novo Nordisk CEO Lars Fruergaard Jørgensen agreed to meet with pharmacy benefit managers who promised Senate health committee Chair Bernie Sanders (I-VT) in writing they would not limit access to Wegovy and Ozempic if the list prices of the drugs are reduced, but Jørgensen said he was skeptical they would uphold the pledge and stopped short of promising Novo would reduce list prices, despite continued pressure from Sanders at the committee's Tuesday (Sept. 24) hearing on the drugs' pricing... Sub. Req’d

Senate Panel Questions Novo Nordisk CEO Over Decision to Discontinue this Popular Insulin

(9/25, Ken Alltucker, USA Today) ...The Danish drugmaker previously announced it would stop sales of Levemir vials by the end of December. Novo Nordisk's decision has been criticized by some patients with Type 1 diabetes who prefer Levemir over other long-acting "basal" insulins such as Sanofi's Lantus and Novo Nordisk's Tresiba. During a Senate panel hearing Tuesday, Novo Nordisk CEO Lars Fruergaard Jørgensen blamed insurance coverage barriers and limited manufacturing capacity... Full

Senate Hearing On Ozempic, Wegovy Again Highlights Concerns About PBMs

(9/24, Cathy Kelly, Pink Sheet) ...The PBMs also were asked whether coverage and access would change if the drugs' prices for the plans were lowered to $100 or less per month, Sen. Maggie Hassan, D-NH, said. In response, Express Scripts replied "we expect the majority of our clients to expand access," she said. Ozempic has a US list price of $969 a month, while Wegovy is $1,349 per month...Sen. Bill Cassidy, R-LA, worried the PBMs may not hold up their end of the deal if the Ozempic and Wegovy list prices are reduced... Sub. Req’d

Lawmakers Push 1498 Statute To Cut GLP-1 Drug Prices, Generic Lobby Seeks Broader Reform

((/24, Maaisha Osman, InsideHealthPolicy) ...A group of House and Senate Democrats are backing drug pricing advocates' call for the administration to lower the cost of GLP-1 drugs by invoking a rarely used patent-breaking process, coming as the generic drug lobby pushes for broader reforms to the patent system..."By utilizing your competitive licensing authority to permit generic competitors to Wegovy and Ozempic, you can stabilize supplies at a time of enormous demand and lower outrageous prices that have severely limited access to these life-changing drugs," the lawmakers wrote... Sub. Req’d

PBMs Commit To Continued GLP-1 Coverage Options; Pharma Companies Won't Commit To Setting Lower List Prices

(9/24, PCMA) ...Despite PBMs pledging to continue facilitating coverage of these drugs, Big Pharma companies are still unwilling to commit to lowering the price of the drugs they create and instead, continue to try to redirect blame onto PBMs... Full

CSRxP: Big Pharma's Egregious GLP-1 Prices and Anti-Competitive Tactics Unsustainable for Patients and U.S. Health Care System

(9/24, The Campaign for Sustainable Rx Pricing) ..."We commend the U.S. Senate Committee on Health, Education, Labor and Pensions (HELP) for holding this important proceeding to highlight manufacturers' egregious pricing practices on these products and the implications for patients, taxpayers and the health care system. We encourage members of the committee and lawmakers in both chambers of Congress to advance bipartisan, market-based solutions to hold Big Pharma accountable."... Full

Senate Markup Of Controversial Patent Bills Now Set For Thursday

(9/24, Jessica Karins, InsideHealthPolicy) ...The Senate Judiciary Committee has rescheduled a postponed markup of two patent reform bills for Thursday (Sept. 26) that aim to improve the patent eligibility process and the tribunal review of patents, but the changes are opposed by the generic drug industry and key drug price reform advocates... Sub. Req’d

Off-Patent Industry Uproar On Two Acts Potentially Harming Generics And Biosimilars

(9/24, Urte Fultinaviciute, Generics Bulletin) ...Together with stakeholders from other affected industries, the AAM sent out coalition letters, stating that the PREVAIL Act will "damage US industry, discourage commerce, and place further inflationary pressure on the prices that Americans pay for goods and services," while the PERA Act "would upend centuries of established law and would do serious harm to the American innovation economy."... Global Sub. Full

CSRxP Encourages HELP Committee to Advance Bipartisan Solutions to Promote Greater Competition in the Prescription Drug Market

(9/24, The Campaign for Sustainable Rx Pricing) ...The Biosimilar Red Tape Elimination Act (S. 2305), introduced by Senators Mike Lee (R-UT), Ben Ray Luján (D-NM), Mike Braun (R-IN) and J.D. Vance (R-OH), would promote policies that increase the uptake of more affordable pharmaceuticals by increasing biosimilar substitution... Full

AAM Calls For Action To Boost Generics Market On Hatch-Waxman Anniversary

(9/24, Jessica Karins, InsideHealthPolicy) ...Marking the 40th anniversary of the Hatch-Waxman Amendments Tuesday (Sept. 24), the generic drug industry lobby released a white paper calling for Congress to pass bills that would allow the generic drug industry to remain viable in the face of declining prices, including reforms to the 340B program, pharmacy benefit managers practices and the Inflation Reduction Act... Sub. Req’d

40 Years of Hatch-Waxman: How Can We Secure its Legacy?

(9/24, Jocelyn Ulrich, PhRMA) ...Today, the Drug Price Competition and Patent Restoration Act—better known as the Hatch-Waxman Act—celebrates its 40th anniversary, marking four decades of success in fueling biopharmaceutical innovation while growing the U.S. generic market into the powerhouse it is today. So far, we've explored the bill's origins, key provisions and its positive impact for patients. However, to celebrate the day of its signing, we must turn our attention to how its legacy can be secured... Full

Convergence: FDA Officials Offer Updates On START, STAR Pilots

(9/24, Joanne S. Eglovitch, Regulatory Focus) ...US Food and Drug Administration officials shared an update on the status and progress of two pilot programs that aim to promote the development of innovative medicines at RAPS Convergence 2024. One addresses the development of treatments for rare diseases, while the other is intended to speed the development of therapies that address an unmet medical need... Full

EU HTA Regulation: Some Member States Could Be ‘Deselected' From Joint Assessments

(9/24, Eliza Slawther, Pink Sheet) ...The EU HTA Regulation will see clinical comparisons of medical products conducted at an EU level. However, the needs of some smaller nations may not be represented, experts from Cencora explain in this second of two articles on the new EU joint clinical assessments... Sub. Req’d

UK MHRA First-Half New Drug Approvals Show Overwhelming Use Of EU Reliance Procedures

(9/25, Ian Schofield, Pink Sheet) ...The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs. Of the 16 products containing a new active substance (NAS) approved by the UK regulator, the MHRA, in the first half of 2024, 15 were the subject of a reliance procedure that took account of existing EU decisions on marketing authorization. Seven of the products were orphan drugs for rare diseases... Sub. Req’d

French Agency Fines 11 Pharmaceutical Labs €8 Million Over Drug Shortages

(9/24, Euro News) ...French authorities have imposed financial penalties totalling €8 million on 11 pharmaceutical laboratories for not maintaining a four-month safety stock of key medicines...French legislation now requires laboratories to maintain a minimum safety stock of four months for essential medicines to secure their supply if the medicines have been subject to shortages in the last two years. The penalties come after the agency launched a campaign to monitor the stocks of 422 key medicines... Full

Korea Lays Out Roadmap For Use Of AI Across Drug Development

(9/24, Jung Won Shin, Pink Sheet) ...South Korea has released a five-year roadmap to research and develop artificial intelligence in healthcare as part of a wider vision to harness innovation in the technology to improve national health. The Ministry of Health and Welfare intends for the plan, which extends to 2028, to strengthen support of AI R&D in essential health care and new drug development, as well as advance medical data usage systems to enable its safe use... Sub. Req’d

Japan Aims to Cut Antibiotics Reliance On China by Resuming API Production

(9/25, Sarasa Shimizu, Japan Forward) ...Antibiotics are essential for treating and preventing infections. In Japan, efforts to reduce dependence on China for the raw materials and ingredients needed to produce these drugs are intensifying. Without a stable supply of these materials, proper medical treatments and surgeries would be impossible, making antimicrobial drugs a lifeline for the Japanese people. To address this risk, the government has designated these drugs as critical goods for economic security. With Japan's heavy reliance on China, the urgency to address this issue is growing. Pharmaceutical companies are scrambling to ramp up domestic production... Full

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