Tuesday, September 3, 2024

What's Next? Five Things To Look Out For In September

(9/1, Dean Rudge, Generics Bulletin) ...This month, Teva's president and CEO Richard Francis will be among attendees, sitting for a fireside chat, at the Sidley Healthcare Investment Conference 2024. Taking place on September 24, at The Francis Crick Institute in London, the conference brings together senior pharma, biotech, healthcare, private equity, and venture capital executives to share their perspectives on critical issues, trends, and opportunities... Global Sub. Full

Sanofi Says its New Pill for Multiple Sclerosis Succeeded in a Key Trial, Boosting its Research Ambitions

(9/2, Matthew Herper, STAT Plus) ...Sanofi said an oral treatment for multiple sclerosis, tolebrutinib, met its key goal in a Phase 3 study, potentially clearing the way for regulatory approval, although in two other studies, patients earlier in the disease failed to see a benefit. A top company executive said he believes that the positive result would help build confidence among investors in the company's research and development efforts... Sub. Req'd

Aurobindo Pharma to Step Up Focus On Biosimilars, Lines Up a Slew of Products

(9/2, G Naga Sridhar, The Hindu BusinessLine) ...Aurobindo Pharma is stepping up its focus on biosimilars with a huge line-up of products in investments in capacity creation. The Hyderabad-based firm is adopting a two-pronged approach to biosimilars by developing innovative products as well as contract manufacturing. Through its CuraTeQ Biologics, a wholly-owned subsidiary, its strategy is to develop Oncology and Immunology biosimilars. Its broader pipeline of 14 biosimilars positions, under CuraTeQ, aim at a sustained growth and long-term value creation... Sub. Req'd

Celltrion Pharm's 3 Biosimilars 24-36% Cheaper Than Originals in Korea

(9/2, Lee Han-soo, Korea Biomedical Review) ...Celltrion Pharm said it has launched three biosimilar products in Korea following the Ministry of Health and Welfare's pricing notification last Sunday. The newly launched biosimilars are Omlyclo (Xolair biosimilar), Steqeyma (Stelara biosimilar), and Eydenzelt (Eylea biosimilar)... Full

Zydus Gains Final USFDA Approval for Amantadine Extended-Release Capsules 68.5 mg and Tentative Approval for 137 mg

(9/3, Express Pharma) ...Zydus Lifesciences has received final approval from the United States Food and Drug Administration to market Amantadine extended-release capsules, 68.5 mg, and tentative approval for 137 mg (USRLD: Gocovri (amantadine) extended-release capsules, 68.5 mg and 137 mg)... Full

Biocon Subsidiary Gets USFDA Nod for Generic Drug for Chronic Heart Failure

(9/1, Press Trust Of India) ...Biocon Pharma has received approval of its ANDA for Sacubitril/Valsartan Tablets, in 24 mg/26 mg, 49 mg/51 mg and 97 mg/103 mg strengths, from the US Food and Drug Administration, the company said in a regulatory filing. Sacubitril and valsartan combination is used to treat chronic heart failure in adults to help reduce the risk of death and hospitalisation... Full

European Commission Approves Celltrion's Stelara Biosimilar

(9/2, Adam Zamecnik, Generics Bulletin) ...The European Commission has approved Celltrion's Steqeyma (ustekinumab) biosimilar to Johnson and Johnson's Stelara after previously scoring a positive nod from the bloc's European Medicines Agency, paving the way to a launch in a key global market for the South Korean player...However, no Stelara biosimilars have yet launched in the US, with the first launches expected next year. Specifically, Amgen's Wezlana can launch as early as January 1, 2025. The company also received the first US approval of a Stelara biosimilar in October 2023... Global Sub. Full

Days After US Aflibercept Approval, Sandoz Is Hit By Regeneron Lawsuit

(9/2, David Wallace, Pink Sheet) ...A few weeks after the US Food and Drug Administration approved Sandoz's Enzeevu (aflibercept-abzv) biosimilar of Regeneron's Eylea, the originator sued Sandoz alleging the firm failed to comply with the "patent dance" information-exchange requirements of the US Biologics Price Competition and Innovation Act, arguing that it was only able to confirm Sandoz's aflibercept filing on the day of its clearance... Sub. Req’d

Hikma Seeks Rehearing In Vascepa Skinny-Label Case

(9/2, David Wallace, Generics Bulletin) ...Hikma has asked the US Court of Appeals for the Federal Circuit for a full court rehearing of a panel decision that earlier this year reopened a dispute with Amarin over a skinny-label generic version of Vascepa...Noting that the appeals court had previously been "split sharply over whether to rehear its decision in GlaxoSmithKine v Teva" – separate litigation which ultimately saw GSK triumph in an induced-infringement battle over its Coreg (carvedilol) brand (see sidebar) – Hikma said "the concurrence made clear, however, that GSK's holding was ‘narrow and fact dependent'."... Global Sub. Full

Drug Distributors Strike $300 Mln Opioid Settlement with US Health Plans

(8/30, Nate Raymond, Reuters) ...The three largest U.S. drug distributors have agreed to pay $300 million to resolve claims by health insurers and benefit plans that they helped fuel the deadly U.S. opioid epidemic, according to court papers filed on Friday. The proposed class action settlement with McKesson Corp, Cencora Inc and Cardinal Health Inc was disclosed in a filing in federal court in Cleveland, Ohio, and requires a judge's approval... Full

Merck Opens London Lab as it Makes Push into Immunology and the UK

(8/30, Anna Brown, Endpoints News) ...Merck has opened the doors to a new lab in London, part of the US drugmaker's plans to grow its footprint in the UK and leverage its scientific expertise as it works to refill its pipeline...The new laboratory will focus on preclinical development of Merck's neuroscience pipeline as well as launching the company into immunology research for the first time in the UK. There's a large lab for chemistry, two smaller labs for antibody development, one for biologics and one for biomarkers... Full

Novo Nordisk's Ozempic Shortage Expected to Continue into Q4

(9/2, Shanima A in Bengaluru, Reuters) ...Novo Nordisk said the shortage of lower strengths of its diabetes drug Ozempic has deteriorated, with intermittent shortages for all strengths expected into the final quarter of 2024 due to increased demand and along with capacity constraints at some of its manufacturing sites... Full

New Study Looks at the Environmental Impact of Asthma Inhalers

(8/30, Alejandra Borunda, NPR) ...Millions of people depend on asthma inhalers, but most people don't know that using those inhalers creates a carbon footprint. That's according to a new study published in the medical journal JAMA this week. But as Alejandra Borunda from NPR's climate desk reports, there is a climate-friendly alternative... Full

Navigating the Rapid Growth of Specialty Drugs: Opportunities, Challenges, and the Path Ahead

(9/2, Andy Szczotka, PharmD, Pharmacy Times) ...The specialty drug market is experiencing unprecedented growth, driven by the rapid development and adoption of innovative therapies...This surge highlights the increasing demand for advanced treatments for patients with complex and chronic conditions or rare diseases. However, this growth also presents challenges, including high costs, regulatory complexities, and issues with medication access... Full

Analysis-US Will Still Pay at Least Twice as Much After Negotiating Drug Prices

(9/3, Deena Beasley, Reuters) ...The U.S. government's first-ever negotiated prices for prescription drugs are still on average more than double, and in some cases five times, what drugmakers have agreed to in four other high-income countries, a Reuters review has found... Full

Medicare Draws Ire for Plan to Hold Down Drug Premium Increases

(8/30, Tony Pugh, Bloomberg Law) ...The Medicare Part D Premium Stabilization Demonstration "will shift financial liability away from large health insurers and onto American taxpayers," Republican lawmakers said in a letter this week seeking Congressional Budget Office review of the proposal. The conservative American Action Forum estimates the demonstration would pay drug plans $7.2 billion, making it "not so much a demonstration as it is a bailout."... Full

Patent Reform Bill Risks Higher Drug Prices and Delayed Generics

(9/3, Coke Morgan Stewart, Bloomberg Law) ...Congress is considering a bill that would politicize the patent system, increase the likelihood of errors, and increase costs for everyone. The Medication Affordability and Patent Integrity Act is expected to be on the Senate Committee on Health, Education, Labor and Pensions' markup schedule in mid-September... Full

Hospitals Protest Johnson & Johnson's Planned Changes to 340B Drug Discounts

(9/2, Ron Southwick, Chief Healthcare Executive) ...Johnson & Johnson is planning to change its policy on two drugs: Xarelto, a blood thinner, and Stelara, a drug for Crohn's disease and colitis. Instead of giving hospitals in the 340B program reduced prices at the time of purchase, Johnson & Johnson says hospitals will now need to submit applications for rebates and the company will reimburse them. The company is making the new policy effective Oct. 15... Full

AHA: Chevron Ruling Could Undermine J&J's 340B Rebate Model

(8/30, Maaisha Osman, InsideHealthPolicy) ...The American Hospital Association is pressing the Health Resources and Services Administration (HRSA) to slap civil monetary penalties on Johnson & Johnson for shifting to a new rebate model for 340B drugs, and told Inside Health Policy the Supreme Court's recent decision to ax the Chevron principle hurts rather than helps J&J's stance... Sub. Req’d

Independent Pharmacies Say They're Being Squeezed by Shadowy Middlemen Tied to Big Health Chains

(9/1, Lisa M. Krieger, The Mercury News) ...For more than a decade, independent pharmacist Jay Patel has built a close and enduring relationship with his customers, who come to him for help in sickness and in health. But now there are interlopers: Drug middlemen, companies known as pharmacy benefit managers that influence which medicines can be bought, where to buy them and at what cost... Full

Rules? Where We're Going, We Don't Need Rules: FDA Goes Back to the Future With Recent Hatch-Waxman Policy Shifts; What's a Company to Do?

(9/3, Kurt R. Karst, FDA Law Blog) ...But the point is this: How are companies supposed to plan and coordinate submissions to new patent information to ensure first applicant status and eligibility for 180-day exclusivity when the rules for doing so are unclear and in flux? How are companies supposed to plan for product launches that may be pegged to 180-day exclusivity eligibility when they don't even know that they may be eligible for the exclusivity... Full

US FDA September User Fee Calendar Slims Down, Still Boasts More Than Five Novel Agents

(9/2, Bridget Silverman, Pink Sheet) ...Five novel agents are known to have been assigned September 2024 user fee goal dates and two more could see action in the month. The FDA's September 2024 novel approval count probably will not match the seven novel agents cleared in August. Difficult decisions could be ahead in Niemann-Pick disease type C, gastroparesis and immunoglobulin A nephropathy... Sub. Req’d

Bill Aimed at Regulating Drug Middlemen Heads to Gov. Newsom

(8/30, Ron Leuty, San Francisco Business Times) ...A bill that would regulate drug middlemen — known as pharmacy benefit managers, or PBMs — will head to California Gov. Gavin Newsom after state lawmakers passed the legislation Thursday. Senate Bill 966, introduced by Sen. Scott Wiener and Sen. Aisha Wahab, would require PBMs to be licensed by the state insurance department and to disclose prices paid to drug makers and the discounts they negotiate with those companies... Sub. Req’d

Broward School Board Sues Drug Manufacturers, Pharmacies Over Insulin Prices

(9/2, Carlton Gillespie, WLRN PBS) ...The Broward County School Board is suing a group of insulin manufacturers they allege have conspired to inflate prices for the drug — whose price they say has risen more than tenfold in the last 20 years...Eli Lilly and Company, Novo Nordisk and Sanofi, which the board in an executive summary refers to as "the Insulin Cartel," control 99% of the insulin market. The suit also names pharmacy benefits managers CVS Health, Express Scripts and OptumRx — and claims they collude to widen the gap between the manufacturer's price and the selling price... Full

Elisabeth Stampa: ‘Many Drugs That Used to Be Produced in Europe Are Now Manufactured in Asia. This Makes Us Vulnerable to Shortages'

(8/30, Oriol Güell, El Pais) ...The Spaniard Elisabeth Stampa, 56, knows the problem first-hand. A member of the board of directors of Medichem, one of Europe's leading manufacturers of active ingredients, and president of Medicines for Europe — the European generic manufacturers' association — for years she has been witnessing the continent's loss of autonomy in the pharmaceutical sector and how Asia has monopolized the manufacture of most drugs. This was one of the main issues discussed at the Medicines for Europe Annual Conference, held in August in Dublin where this interview took place... Full

UK Regulator Explains Changes To Pharmacovigilance Rules From 2025

(9/2, Eliza Slawther, Pink Sheet) ...While pharmacovigilance requirements for medicines in the UK will remain "broadly in line" with current rules from January 1, 2025, companies should be aware of changes for some products after this date, the UK's MHRA says... Sub. Req’d

Indian Pharma Industry to Play a Crucial Role in Global Market: Raja Bhanu

(8/31, Pharmabiz.com) ...The Indian pharmaceutical industry is set to further strengthen its position in the global market, said K Raja Bhanu, director general of the Pharmaceuticals Export Promotion Council of India (Pharmexcil). Speaking at the concluding day of the iPHEX 2024 event, Bhanu stated that India's role in the global pharmaceutical landscape is not only pivotal but also transformational, underscoring the nation's contributions to healthcare advancements and economic growth... Full

Indian Pharmaceutical Industry Leads Global Market with Record Regulatory Approvals & Ambitious Growth Plans

(9/2, Pharmabiz.com) ...The Indian pharmaceutical industry is making headlines with its remarkable achievements in regulatory approvals and strategic growth plans, positioning itself as a key player on the global stage, said K Raja Bhanu, director general of the Pharmaceuticals Export Promotion Council of India (Pharmexcil). "India's pharmaceutical sector has consistently demonstrated its commitment to quality and regulatory compliance, securing a significant share of market authorizations globally," he said... Full

Patent Cliff Can Turn Indian Pharma Stocks into Investor's Goldmine

(8/31, Jimeet Modi, The Economic Times) ...Over the past few months, the market witnessed a sharp rally in pharma sector stocks, one of the key drivers behind this surge is ‘Patent Cliff.'...While the patent cliff poses challenges for innovator companies, it also creates significant opportunities for generic drug manufacturers across the world, particularly those based in India. When a drug's patent expires, generic companies can produce bioequivalent versions of the drug at a fraction of the original price. This not only makes the drug more accessible to patients but also allows generic manufacturers to strengthen their financials... Full

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