Tuesday, October 15, 2024

Teva Inks $450M Deals Over US Kickback Claims, Including For Generic Price-Fixing

(10/11, Dean Rudge, Generics Bulletin) ...Teva has resolved a pair of civil US Department of Justice lawsuits accusing the firm of violating the US Anti-Kickback Statute and the False Claims Act through its alleged conduct conspiring to fix the price of three generic drugs and for allegedly paying Medicare patients' copays for its multiple sclerosis brand Copaxone... Global Sub. Full

Teva Hands Over $450M to Resolve Kickback Lawsuits Involving MS Drug Copaxone and Generics

(10/11, Fraiser Kansteiner, Fierce Pharma) ..."Teva is pleased to put these matters behind us so we may continue to focus our efforts on developing and providing access to medicines for patients who need them through the success of our Pivot to Growth strategy," a company spokesperson told Fierce Pharma over email. She added that the settlements "include no admission of wrongdoing," and noted that Teva will pay out the $450-million sum over six years... Full

Teva to Pay $450M in Settlement With DOJ Over Kickback and Price-Fixing Allegations

(10/11, Tristan Manalac, BioSpace) ...Teva has agreed to pay $425 million to resolve the kickback claims, plus another $25 million to settle the price-fixing allegation. The aggregate settlement value of $450 million was determined according to Teva's ability to pay based on its financial statements, per a press release issued by the Department of Justice... Full

Baxter Imports IV Fluids as Hurricane Helene Triggers U.S. Shortage

(10/14, Leroy Leo, Reuters) ...Baxter International began shipments of intravenous products to the United States from two international facilities last week, it said on Monday, as it works to bring a hurricane-hit plant in North Carolina back online amid a shortage of the essential medical product...Baxter is one of the four leading U.S. suppliers of IV fluids. Germany's Fresenius and medtech company B. Braun Medical last week said they were ramping up production of IV fluids and mitigate the shortage... Full

IV Fluid Shortage Due to Hurricane Prompts Hospitals to Postpone Surgeries

(10/14, Fenit Nirappil and Rachel Roubein, The Washington Post) ...Michael Felberbaum, an FDA spokesman, said the agency has taken several steps to help address the shortage as quickly as possible, such as working with manufacturers to increase supply and issuing guidance for compounding pharmacies to help fill the gap... Full

Hurricane Impact On Medical Manufacturing Renews Talks On Nearshoring, Domestic Production

(10/11, Caleb Revill, Freight Waves) ...Premier's survey stated 88% of respondents reported they were receiving less than half of their requested orders for IV fluids. This left 54% of respondents 10 days or less of IV fluids in inventory, which the report stated is down from a more typical supply of 15 to 22 days on hand...The data also showed that nearly 17% of surveyed providers have canceled elective surgeries and other procedures with another 58% considering that option in the near term... Full

FDA Approves Imuldosa, A Biosimilar to Stelara

(10/11, Skylar Jeremias, The Center For Biosimilars) ...The approval of Imuldosa comes shortly after the FDA approved Otulfi (ustekinumab-aauz) in September 2024. It is the fifth ustekinumab biosimilar to be approved for the US market, following those for Pyzchiva (ustekinumab-ttwe) in July 2024, Wezlana (ustekinumab-auub) in November 2023, and Selarsdi (ustekinumab-aekn) in April 2024. Pyzchiva was created by Samsung Bioepis, Wezlana was developed by Amgen, and Selarsdi was developed by Alvotech and will be marketed in the US by Teva Pharmaceuticals as part of a commercialization partnership... Full

Lupin Launches First Generic of $200 Mn Eye Drop Pred Forte in USA with 180-Day Exclusivity

(10/15, CNBC TV 18) ...Lupin Ltd has launched the first generic version of Pred Forte Ophthalmic Suspension USP, 1% in the US, a drug used to treat steroid-responsive inflammation in the eye. This marks a significant milestone for Lupin, as it secures 180-day competitive generic therapy (CGT) exclusivity for the product... Full

J&J Lifts Profit and Sales Forecasts, Beats Wall Street Expectations

(10/15, Patrick Wingrove and Bhanvi Satija, Reuters) ...Sales of J&J's oncology drugs rose nearly 19% worldwide for the quarter, driven by sales of its cancer treatment Darzalex of more than $3 billion, which rose 20.7% or more than $500 million on the previous year...Sales of J&J's blockbuster psoriasis drug Stelara fell 6.6% to $2.68 billion in the third quarter, but beat analyst estimates of $2.43 billion, according to LSEG data. Of this, two-thirds came from sales in the U.S. Stelara has long been a key driver of revenue growth for J&J, with analysts forecasting sales of over $10 billion this year. But this could fall to about $7 billion in 2025 when as many as six close copies of the drug launch in the U.S... Full

Samsung Biologics Unveils New Platform

(10/14, Hwang Joo-young, The Korea Herald) ...Samsung Biologics announced Monday that it has launched S-HiCon, a new platform specializing in high-concentration formulation development, designed to meet rising demand for high-concentration biopharmaceuticals...These drugs also help reduce storage and transportation costs, making them an attractive option in the pharmaceutical industry... Full

Novartis Loses Bid to Vacate FDA Approval of Rival Entresto

(10/14, Nyah Phengsitthy, Bloomberg Law) ...A spokesperson for Novartis said the company disagrees with court's decision denying their request to reverse the FDA's approval of MSN's generic version of Entresto. "We believe that FDA's approval does not comply with the applicable statutes and regulations," the spokesperson said in a statement. "Novartis is considering all available options to vigorously defend our regulatory rights, including an appeal of the decision."... Sub. Req’d

CGRP Monoclonal Antibodies Not More Effective Than Topiramate or Botox for Treating Migraine

(10/11, Chelsie Derman, HCPLIve) ...CGRP monoclonal antibodies showed modest efficacy in reducing headache days compared to topiramate and Botox, but were not significantly superior. Despite higher costs, CGRP monoclonal antibodies were considered cost-effective, offering quality-adjusted life-year gains. The study identified a need for further research on candesartan and flunarizine, highlighting gaps in current evidence. Limitations included the exclusion of several oral drugs due to insufficient data, affecting the study's comprehensiveness... Full

Glenmark Arm Recalls Products in US for Manufacturing Issues

(10/13, Press Trust Of India) ...Glenmark Pharmaceuticals is recalling 45,504 bottles of Ryaltris Nasal Spray and 11,568 tubes of Ciclopirox Gel in the US due to manufacturing defects, including a clogged dip tube and broken tube seals. The USFDA has classified the recalls as Class II and Class III respectively... Full

Sacklers Lay Out Strategy for Defending Opioid-Related Lawsuits

(10/14, David Ovalle, The Washington Post) ...Attorneys for Sackler family members disclosed their lines of defense as part of a court filing Monday in the long-running bankruptcy saga of Purdue Pharma. Creditors are also seeking to recover billions of dollars they claim the Sacklers withdrew from the company in the years before the bankruptcy to evade future claims, an allegation the family denies... Sub. Req’d

How Mark Cuban Cost Plus Drug Company Is Approaching Drug Pricing Transparency

(10/14, Brian Nowosielski, Drug Topics) ...Erin Albert, vice president of pharmacy relations and chief privacy officer at Mark Cuban Cost Plus Drug Company, PBC, discussed drug pricing and what her company is doing to revolutionize transparency.. Full

Amazon Pharmacy's Rapid Growth Will Soon Make Instant Access To Medication The New Normal

(10/14, Dr. Sai Balasubramanian, M.D., J.D., Forbes) ...In its latest announcement last week, Amazon Pharmacy announced that it plans to open pharmacies in 20 new cities in 2025, aspiring to nearly double the number of communities where customers can leverage same-day medication delivery services. These cities include Boston, Dallas, Philadelphia and many more, meaning that millions of people will be able to enjoy rapid medication access... Full

From Skepticism to Success: Insights Into Biosimilar Market Acceptance

(10/13, Cameron Santoro, The Center For Biosimilars) ...Ivo Abraham, PhD, RN, director of the Center for Health Outcomes and PharmacoEconomic Research at the University of Arizona Cancer Center, discusses the potential of biosimilars and challenges in the US, emphasizing partnerships for market growth... Full

Streamlining PA Process, Promoting Biosimilars With Automated Informatics

(10/11, Kyle Munz, AJMC) ...At The James at The Ohio State University Comprehensive Cancer Center (OSUCCC), the use of an informatics program has automated the selection of biosimilars, accounting for a patient's insurance preferences and that of the hospital, to effectively optimize the prior authorization and approval process... Full

What the Sandoz CEO is Thinking About the 2024 Elections

(10/15, Richard Saynor, STAT Plus) ...Unfortunately, much less attention has been paid to the practical consequences of the first, or the most practical solution to the second. The reality is that protectionist policies will work against the goal of expanding patient access to essential medicines. And railing loudly against "Big Pharma" while failing to actively support the highly competitive and system-critical market for generic and biosimilar medicines is simply missing the forest for the trees. Expanding access for patients requires strong global supply chains and fair pricing for generic and biosimilar medicines. And it requires governments to react rapidly to changing market conditions, not to leave it to companies developing these medicines to pick up the pieces on their own... Sub. Req’d

With Election Nearing, BMO Analysts Don't Expect Major Pharma Shake-Ups from Either Candidate

(10/14, Zoey Becker, Fierce Pharma) ...For the pharma industry, though, the already-in-place Inflation Reduction Act (IRA) and a divided Congress make it unlikely that either candidate will bring about major changes to drug regulations. That's the takeaway from a recent note by BMO Capital Markets analysts Evan David Seigerman and Kostas Biliouris, Ph.D., as well as a joint interview with them... Full

PBMs Seek Recusal Of FTC Members In Insulin Pricing Case, Experts Doubt Motion's Success

(10/11, Maaisha Osman, InsideHealthPolicy) ...The three pharmacy benefit managers accused of inflating insulin prices have filed motions to recuse three Democratic Federal Trade Commission members, including the chair, claiming bias against their industry. A former FTC general counsel, however, tells Inside Health Policy that there is insufficient evidence for the recusal and that FTC will likely dismiss the request as unfounded... Sub. Req’d

PBM Reform Legislation: PhRMA ‘Laser Focused' On Passage This Year

(10/14, Cathy Kelly, Pink Sheet) ...PhRMA will continue pushing for congressional passage of meaningful PBM reform legislation before the end of the year, CEO Steve Ubl said. The strong bipartisan support for reform in Congress will help, but a lot will depend on whether PBM legislation can ride with an end-of-year federal spending package. Meanwhile, rebate reform legislation continues to gain supporters on Capitol Hill... Global Sub. Full

Comprehensive Analysis Of PBMs From Prominent Economists Confirm Value of PBMs, Dispel FTC Findings

(10/11, PCMA) ...The analysis is one of the most comprehensive analyses of PBMs' role in drug pricing to date, looking into roughly 20 billion, 30-day equivalent prescriptions and representing more than a trillion dollars in drug expenditures...According to the data, the manufacturer rebates-passed through by PBMs or distributed by PBMs as discounts-along with fees, are not the driver of increased drug costs... Full

As Drug Middlemen Influence Grows, Independent Pharmacies Face Fresh Challenges

(10/11, McKenzie Beard, The Washington Post) ...There's ongoing debate over the role that pharmacy benefit managers — widely known as PBMs — play in the high cost of prescription drugs in the United States...To learn more about the issue, I spoke with Anne Cassity, senior vice president of government affairs at the National Community Pharmacists Association... Sub. Req’d

Confidential Files Detail PBMs' Backroom Negotiations—and Their Role in the Opioid Crisis

(10,11, Catherine Dunn, Barron's) ...Several academic researchers told Barron's that PBMs could have done more sooner..."I think the writing was on the wall for a very long time before PBMs acted," says Caleb Alexander, a professor of epidemiology and medicine at the Johns Hopkins Bloomberg School of Public Health, who has served as an expert witness for plaintiffs in opioid litigation. "This epidemic was in plain sight."... Full

How ‘Green' Inhalers Could Evade Biden's Drug Pricing Legacy

(10/14, Ariel Wittenberg, Politico) ...Drug companies are taking advantage of a global climate treaty to boost profits. The treaty, signed by some 120 countries nearly a decade ago, is now providing inhaler makers with a golden escape hatch from Biden's reforms that could earn them hundreds of millions of dollars annually...GSK Medicine Development Leader Laura Clow said in an interview with POLITICO's E&E News that developing low-emission Ventolin "is clearly a big win for us" and the company's sustainability goals, but acknowledged the Kigali Amendment is among "external factors that have contributed to our own sustainability and business ambition here."... Full

In Win for Compounders, FDA Will Review its Decision to Put Eli Lilly's Tirzepatide On Shortage List

(10/14, Kevin Dunleavy, Fierce Pharma) ...In a court filing in Fort Worth, Texas, the FDA said it would allow compounding pharmacies to continue to manufacture and sell copycat versions of Lilly's in-demand drugs Mounjaro and Zepbound, while it reviews whether there is a shortage of the active ingredient used to make both products... Full

GLP-1s: Compounders Get Temporary Reprieve But US FDA May Be Building Stronger Case

(10/14, Sarah Karlin-Smith, Pink Sheet) ...Some experts believe the agency's reconsideration may be more about building a stronger case, while others said new information may have emerged about the GLP-1 drug supply. "I think they're buying themselves some time," Kalah Auchincloss, executive VP, regulatory compliance and deputy general counsel at Eliquent Life Sciences told the Pink Sheet... Global Sub. Full

Novo Nordisk Files 18 Lawsuits Against GLP-1 Compounders in 44 Days

(10/14, Nicole DeFeudis, Endpoints News) ...Both Novo Nordisk and Eli Lilly have launched legal campaigns against medical spas, weight loss clinics and compounding pharmacies marketing their own versions of blockbuster weight loss and diabetes drugs. In a win for compounders last week, the FDA said it will reconsider removing Lilly's tirzepatide from its national shortage list, reopening the door for some compounders to sell their own copies while the agency assesses... Full

Industry Stakeholders Call for Changes to ICH M14 RWD Guideline

(10/14, Joanne S. Eglovitch, Regulatory Focus) ...Pharmaceutical industry stakeholders from both sides of the Atlantic generally supported the International Council for Harmonization's (ICH) M14 guidance on using real world data (RWD) for pharmacoepidemiological studies, but suggested areas for improvement, such as adding more examples of how these principles will work in practice, addressing the use of artificial intelligence and machine learning (AI/ML), and expanding its scope to include combination products... Full

Death of a PBM Reform Bill: Why Big Employers Helped Scuttle California's SB 966

(10/14, Leslie Small, Pink Sheet) ...National employers are fighting state PBM reform laws, while still supporting federal PBM reform. The recent veto of a California bill illustrates the dichotomy some national employers are facing. The US Supreme Court may opine on ERISA preemptions questions that may impact state PBM reform efforts... Global Sub. Full

Government And Industry Stakeholders Debate Future Of European Drug Supply

(10/11, Adam Zamecnik, Generics Bulletin) ...from different corners of the pharmaceutical industry and European institutions displayed their often-opposing views on how to solve the issue of improved access to critical medicines as part of a September 26, session at the European Health Forum in Bad Hofgastein, Austria... Global Sub. Full

Eli Lilly Reveals £279M Investment in the UK Through New Government Deal

(10/14, Anna Brown, Endpoints News) ...The pharmaceutical giant also signed a memorandum of understanding with the UK's Department of Health and Social Care, the Department for Science, Innovation and Technology, and NHS England that aims to improve care for patients with obesity, which costs the UK health service over £11 billion ($14.4 billion) a year... Full

France Freaks Out Over Proposed Sale of Paracetamol-Maker to American Fund

(10/11, Giorgio Leali, Politico) ...French pharmaceutical giant Sanofi said on Friday that it was in talks to sell a majority stake of its subsidiary that produces over-the-counter drugs to an American private equity firm CD&R for €15 billion. The proposed takeover is already proving highly controversial in France, with politicians from across political spectrum voicing fears it could threaten manufacturing jobs in France and fall afoul of Europe's push to secure its supply chains for critical medicines... Full

What's Behind Medication Shortages in Germany?

(10/13, Stephanie Höppner, Deutsche Welle) ...It only costs a few cents but it is currently in short supply: saline solution has become a scarce commodity in German hospitals and pharmacies — yet it is urgently needed for operations, and irrigation and infusion procedures. According to Thomas Preis, the head of the North Rhine Chamber of Pharmacists, the situation has worsened dramatically in recent months... Full

India's Pharma Industry Reduced US Healthcare Costs by $219 Billion in 2022

(10/15, Daphne Clarance, India Today) ...Indian-made medicines have helped the US healthcare system save $219 billion in 2022. India manufactures nearly half the world's vaccines, over 4 billion doses in 2023. 40 million vaccine doses are being manufactured for cancer prevention efforts... Full

Prices of Key Drugs Hiked by 50%

(10/14, Teena Thacker, The Economic Times) ...India's drug pricing regulator has increased the ceiling price of 11 scheduled formulations by 50%, in a bid to ensure their availability. Most of these drugs are used as first-line treatment for various conditions including asthma, glaucoma, thalassemia, tuberculosis and mental health disorders... Sub. Req’d

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