Wednesday, September 11, 2024

Exclusive: Teva Faces EU Fine for Disparaging Rival Multiple Sclerosis Medicine, Sources Say

(9/10, Foo Yun Chee, Reuters) ...Teva, the world's largest generic drugmaker, will be hit with an EU antitrust fine in the coming weeks for disparaging a rival product to its blockbuster multiple sclerosis medicine Copaxone, people with direct knowledge of the matter said on Tuesday... Full

Teva Faces European Union Antitrust Fine Over Shenanigans to Thwart Rivals

(9/10, The Times Of Israel) ...The European Commission in 2022 charged the Israeli company with breaching EU antitrust rules, saying its anti-competitive practices included misusing the patent system to artificially extend Copaxone's patent and shield it from competition...The long-running case against Teva started with EU dawn raids in 2019 that led to the opening of an investigation in 2021... Full

Teva Set to Be Hit by EU Fine for Talking Down Rivals

(9/10, Samuel Stolton and Ike Swetlitz, Bloomberg) ...Teva Pharmaceutical Industries Ltd. is set to be hit with an antitrust fine from the European Union over allegations it tried to talk down rival makers of a multiple sclerosis drug. The bloc's executive arm is also prepping the fine over concerns it illegally delayed competition to its multiple sclerosis medicine, Copaxone, according to people familiar with the matter... Sub. Req’d

Baltimore Settles with Teva, Walgreens Ahead of Scheduled Opioid Trial

(9/10, Brendan Pierson, Reuters) ...Baltimore said on Tuesday that it has settled with Walgreens over claims that the pharmacy operator fueled opioid addiction in the Maryland city, the latest in a series of settlements totaling $402.5 million ahead of a trial scheduled to begin next week. The announcement came a day after the city reached an $80 million settlement over opioids with drug

maker Teva Pharmaceutical... Full

Walgreens, Teva Pharmaceuticals Settle with Baltimore in Opioid Lawsuit

(9/10, Bryna Zumer, WMAR) ...Walgreens pharmacy, and major drug company Teva Pharmaceuticals, have reached settlements with Baltimore City after claims that they helped fuel the city's opioid crisis...Teva will pay the city $80 million, announced the city on Monday...Mayor Brandon Scott said the Teva settlement "marks another major victory for the City of Baltimore and further validates our decision to carry on in the fight to hold these companies accountable."... Full

UnitedHealth to Remove AbbVie's Humira from Some US Drug Reimbursement Lists Next Year

(9/10, Patrick Wingrove, Reuters) ...UnitedHealth Group said on Tuesday it will remove AbbVie's blockbuster rheumatoid arthritis drug Humira from some of its lists of preferred drugs for reimbursement as of Jan. 1, 2025, and recommend less expensive biosimilar versions of the medicine instead...Cigna has said Boehringer Ingelheim's Cyltezo, Simlandi from Teva and Alvotech and an unbranded version of Sandoz's Hyrimoz will be covered on its lists in place of Humira next year... Full

Optum's Biosimilar Business to Exclude Brand-Name Stelara, Humira in 2025

(9/10, Katherine Lewin, Endpoints News) ...Optum Rx is moving into the biosimilar business with a company it's calling Nuvaila, and it's starting out with biosimilars to AbbVie's blockbuster rheumatoid arthritis drug Humira and J&J's psoriatic arthritis drug Stelara, according to a formulary update...Optum Rx added that the company has decided to wait on preferring only biosimilars until "all drug strengths are interchangeable at the pharmacy without a new prescription, which is expected later in 2025."... Full

Celltrion Earmarks Billion Dollars to Build CDMO Plant: Chairman

(9/11, Dae-Kyu Ahn and Jeong Min Nam, The Korea Economic Daily) ...Celltrion Inc., South Korea's largest biosimilar maker, will spend several billion dollars to build a factory to crack the contract development and manufacturing organization market, led by Swiss pharmaceutical company Lonza, Celltrion founder and Chairman Seo Jung-jin said on Wednesday... Full

Mabpharm Moves Ahead On Cosentyx Biosimilar, With Phase I Thumbs Up

(9/11, Dean Rudge, Generics Bulletin) ...Sales of Cosentyx are tracking close to $6bn this year, as biosimilar sponsors step up R&D efforts to launch their own versions of the interleukin-17A inhibitor that has proven a gamechanger for people suffering with psoriasis and psoriatic arthritis... Global Sub. Full

AbbVie's Ubrelvy to Be Top Migraine Seller in 2033 As Total Market to Hit $16B-Plus Across Biggest Pharma Countries

(9/10, Ben Adams , Fierce Pharma) ...That's according to new migraine market figures out by analysts at GlobalData. They see Ubrelvy hitting sales of $1.07 billion in 2033, primarily because it has one of the later patent expiry dates in what has become a large and highly competitive migraine market. Drug treatments and preventive meds include the likes of AbbVie's other migraine meds, Qulipta and Botox, as well as Pfizer's Nurtec ODT, Lundbeck's Vyepti, Eli Lilly's Emgality and Reyvow, and Teva's Ejovy. There are also a lot of older, cheaper drugs on the market... Full

Strides Pharma Secures Approval for OneSource CDMO Creation

(9/11, Anupama Ghosh, The Hindu BusinessLine) ...Strides Pharma Science Limited announced today that it has received approval from equity shareholders and secured creditors to create OneSource, India's first specialty pharma Contract Development and Manufacturing Organization. The approval, granted with an overwhelming majority, is a crucial step towards establishing OneSource as an independent entity covering advanced sectors like biologics, complex injectables, and oral technologies... Full

Aurobindo Pharma Arm's Injectable Facility Gets Product Nod from U.S. FDA

(9/11, The Hindu) ...The U.S. FDA inspected the unit in Parawada mandal of Anakapalli district, Andhra Pradesh, from March 28 to April 5. It has now received its first product approval from the U.S. FDA for Lidocaine Hydrochloride Injection, USP, 1% (10 mg/mL) and 2% (20 mg/mL)... Full

FDA Sends Warning Letter to Indian Drugmaker After Finding Glass in Injections 

(9/10, Anna Brown, Endpoints News) ...Indian generic manufacturer Zydus Lifesciences was hit with an FDA warning letter on Tuesday after it shipped vitamin B injections containing glass particles...The FDA inspectors found the company distributed batches of cyanocobalamin injection, used to treat vitamin B deficiency, that could contain glass particles as small as 150 micrometers. Zydus didn't locate the source of the glass and only used visual inspections to determine if injections were safe or not... Full

GTCR Is Said in Advanced Talks to Buy German Drugmaker Stada

(9/11, Pamela Barbaglia, Eyk Henning and Dinesh Nair, Bloomberg) ...Buyout firm GTCR is in advanced talks on a potential acquisition of German generic drugmaker Stada Arzneimittel AG, people with knowledge of the matter said...Stada's private equity owners Bain Capital and Cinven could reach a final agreement as soon as this month, the people said. A deal is still contingent on GTCR completing its final due diligence and securing the necessary financing, they said. It could rope in some other institutional investors to join its consortium, according to some of the people... Sub. Req’d

Weight-Loss Market to See 16 New Drugs by 2029, Report Estimates

(9/10, Sneha S K, Reuters) ...In a joint report published on Monday, analysts estimated the market for obesity treatments could expand to $200 billion by 2031. The 16 drugs could launch by 2029, with roughly $70 billion of the GLP-1 market coming from these new challengers...Analysts expect significant acquisitions by major pharmaceutical companies in the obesity sector over the next 18 months, targeting smaller companies specializing in obesity drug development... Full

Pharma is Still Struggling to Widen Access to Medicines — and Reach Patients — in Low- and Middle-Income Countries

(9/10, Ed Silverman, STAT Plus) ...Amid calls to expand access to medicines in low- and middle-income countries, a new analysis finds that most of the world's 20 largest pharmaceutical companies have taken steps to reach patients, but many efforts are yielding decidedly mixed results. On the one hand, 19 companies have established methods for providing treatments to these countries — but only nine of the drugmakers created comprehensive plans... Sub. Req’d

US Taps Negotiated Drug Prices in J&J, Bristol Myers Legal Fight

(9/10, Nyah Phengsitthy, Bloomberg Law) ...Johnson & Johnson and Bristol Myers Squibb Co.'s argument that the US Department of Health and Human Services' Medicare Drug Price Negotiation Program forces them to sell their drugs to the government at below-market value and agree to program participation is incorrect, the agency wrote in an opposition brief Monday before the US Court of Appeals for the Third Circuit... Sub. Req’d

Scoop: Senate Finance Eyes Drug Price, ACA Hearing

(9/10, Peter Sullivan, Axios Pro) ...The Senate Finance Committee is planning a Sept. 18 hearing on the Inflation Reduction Act's drug pricing measures and the need to extend enhanced Affordable Care Act subsidies, sources say...But Republicans are likely to highlight premium increases in Medicare Part D that the Biden administration is trying to head off with a demonstration program providing funding to insurers. The hearing will also be a preview of next year's battle over extending the enhanced ACA subsidies... Sub. Req’d

Republicans Grill CMS On Part D Stabilization Demo

(9/10, Luke Zarzecki, InsideHealthPolicy) ...House Republicans again voiced concerns over the administration's last-minute Medicare Part D Premium Stabilization Demonstration program in a letter to CMS on Monday (Sept. 9), saying the potential $15 billion move by the administration to avert premium hikes is too costly and asking for answers to 15 questions... Sub. Req’d

Dose of Reality: Big Pharma Sets Drug Prices, Hikes Drug Prices and Blocks Competition to Keep Drug Prices High

(9/10, The Campaign for Sustainable Rx Pricing) ...On Wednesday, September 11, the U.S. House Committee on the Judiciary is scheduled to hold a hearing on prescription drug affordability. Lawmakers on the committee should use the hearing as an opportunity to focus attention on Big Pharma's egregious pricing practices and anti-competitive tactics that are the root cause of high prescription drug prices in America — and build on recent bipartisan momentum to hold Big Pharma accountable for patent abuse that keeps drug prices high... Full

IRA Negotiated Drug Prices Can't Come "On the Backs of Providers"

(9/10, Alexandra Gerlach and Laura Joszt, MA, AJMC) ...As subsequent rounds of drug price negotiations take place under the Inflation Reduction Act, the process will get more difficult and there are concerns that providers will potentially face a 49% reimbursement cut just in oncology drugs, said Nick Ferreyros, managing director, Community Oncology Alliance... Full

Harris and Trump Are Ready To Take On Big Pharma

(9/10, Stephanie Armour, KFF Health News) ...Former president Donald Trump and Vice President Kamala Harris are both eager to take on high drug prices, leaving pharmaceutical companies on the defensive as they spend millions of dollars this election season...Another shift in the pharmaceutical industry is emerging in its political contributions...Harris has received $518,571 from the industry, and Trump has received $204,748. Catherine Hill, a spokeswoman for Pharmaceutical Research and Manufacturers of America, or PhRMA, said the industry trade group looks forward to collaborating with any future presidential administration... Full

Mark Cuban is Lauding Kamala Harris for Joining Him in His Big Fight to Lower Prescription Drug Prices

(9/10, Kwan Wei Kevin Tan, Business Insider) ...Vice President Kamala Harris wants to lower drug prices, and billionaire investor Mark Cuban is all for it...On Sunday evening, the Harris campaign unveiled its policy platform on their website. The wide-ranging platform cuts across multiple areas, ranging from abortion, crime, healthcare, housing, and national security... Sub. Req’d

PCMA Statement On House Judiciary Subcommittee Hearing

(9/10, PCMA) ..."We urge the House Judiciary Subcommittee to focus on the root cause of the prescription drug pricing problem: Egregious patent abuse by some drug companies. Addressing patent abuse and encouraging greater competition in the prescription drug supply chain is the most effective way to drive down costs for all Americans."... Full

AAM and the Biosimilar Council Host Patent Abuse Congressional Briefing: What's Truly Preventing Low-Cost Medicines from Getting to Patients: A Look at the Broken Patent System

(9/10, AAM) ...The Association for Accessible Medicines and its Biosimilars Council today hosted a policy briefing: What's Truly Preventing Low-Cost Medicines from Getting to Patients: A Look at the Broken Patent System, for Congressional staff regarding ways to expedite patient access to lower-cost generic and biosimilar medicines. The panel of subject matter experts discussed patent policies—including patent thickets, patent settlements and "skinny labeling"—and the potential impacts of proposed reforms on patient costs... Full

Want to Save Patients Money on Medicine? No Need to Reinvent the Wheel

(9/10, AAM) ...Policymakers must act to preserve the Hatch-Waxman Act's integrity and ensure competition continues to thrive. The pathway to lower drug costs is clear: streamline the FDA approval process, combat abusive patent tactics, rein in PBM practices, and ensure that government interventions—like the IRA—don't inadvertently stifle the very competition that's been saving American patients billions... Full

Generic and Biosimilar Savings Report for 2024 Issues – Worry On the Horizon?

(9/10, Bob Pollock, Lachman Consultants) ...Generic drugs continue to struggle with uptake and placement on formularies, even Medicare Part B, which is where one would assume uptake would be the highest...As generic manufacturers begin to reach that point with products, they tend to discontinue manufacturing, which many times results in drug shortages. The report that we're about to discuss supports this fact as it indicates that "generic prices continue to experience severe deflation; the overall value of all generic sales in the U.S. has declined by $6.4 billion since 2019 despite increased volume and new generic launches."... Full

340B Contract Pharmacy Battle May Spur Supreme Court Showdown

(9/11, Alex Kacik, Modern Healthcare) ...States continue to notch victories in legal battles with pharmaceutical manufacturers over the use of contract pharmacies to dispense 340B drugs, potentially setting up a Supreme Court showdown... Sub. Req’d

House Republicans Seek Drug Industry Input Following BIOSECURE Passage

(9/10, Jessica Karins, InsideHealthPolicy) ...Reps. Brad Wenstrup (R-OH), Blake Moore (R-UT) and August Pfluger (R-TX) released a request for information (RFI) Tuesday (Sept. 10) asking for feedback on improving domestic medical supply chains, stating that they are seeking feedback from "independent experts, stakeholders, industry leaders, and coalition groups to inform how Congress may best achieve this goal."... Sub. Req’d

Congress Spars Over Whether the Biosecure Act is An Overdue Crackdown or a Rushed Witch Hunt

(9/10, Zachary Brennan, Endpoints News) ...Some of the loudest opposition to the bill has been led by Rep. Jim McGovern (D-MA), whose Massachusetts district is home to a WuXi Biologics facility — one of the companies the law would bar. McGovern has said the bill lacks any specific explanation as to why one Chinese supplier might be deemed a "company of concern," while another wouldn't be. Chinese groups that would be barred from working with US biopharma companies include WuXi Biologics, WuXi AppTec, BGI and others... Full

After BIOSECURE Act Passes in House, Targeted Chinese Companies Say They're 'Deeply' Concerned

(9/10, Fraiser Kansteiner, Fierce Pharma) ...Despite uncertainty over the future of the bill, a certain degree of reputational damage has already been done, as evinced by a recent L.E.K. Consulting survey. The group recently found that the bill had dramatically undermined U.S.-based life science companies' confidence in working with Chinese firms. U.S. companies were most concerned about working with Chinese CDMOs, followed by contract research organizations and drug development partners, according to L.E.K.'s poll... Full

Would National US HTA/Price Negotiation Process Slow Drug Access? Maybe Not

(9/10, Cathy Kelly, Pink Sheet) ...Newly approved prescription drugs were slower to gain reimbursement in the US than those approved in Switzerland and Germany, even though the drugs undergo health technology assessments (HTA) and price negotiation before they are reimbursed in those countries, a new analysis found... Sub. Req’d

Lilly Challenges US FDA Classification Of Obesity Drug Retatrutide, Citing Chevron Overturn

(9/10, Sue Sutter, Pink Sheet) ...Determining what falls within the statutory definition of ‘biological product' is an interpretative question that courts, rather than the agency, must resolve, Lilly said in a lawsuit repeatedly citing the US Supreme Court's June decision in Loper Bright...Lilly is challenging the FDA's determination that its investigational anti-obesity product retatrutide is a drug, not a biologic... Sub. Req’d

Life After Chevron: US Supreme Court Ruling Cited In FDA Exclusivity Decision Challenges

(9/10, Sue Sutter, Pink Sheet) ...Parties involved in litigation with the FDA over drugs and biologics are starting to cite the Supreme Court's Loper Bright decision in court filings. Early cases that reference the elimination of Chevron deference include several involving marketing exclusivity determinations. The growing number of lawsuits with Loper Bright citations suggests entities are willing to challenge the FDA's determinations in a post-Chevron world, said Hyman, Phelps and McNamara's Kurt Karst... Sub. Req’d

Pharma, Device Groups Ask for More Leeway to Address Misinformation

(9/10, Ferdous Al-Faruque, Regulatory Focus) ...Stakeholders want the US Food and Drug Administration (FDA) to give them even more leeway in responding to misinformation about their products. Some of the proposed changes include looking beyond enforcement discretion and online communications, addressing how artificial intelligence (AI) aggregation may affect misinformation, and dealing with people impersonating a company or its officials... Full

Maryland Drug Affordability Board Takes Step to Limit Drug Prices

(9/10, Scott Maucione, WYPR) ...Maryland's Prescription Drug Affordability Board took one of its biggest steps in regulating drug prices today as it voted on an upper payment limit plan for drugs bought by state and local governments...The structure still needs to be approved by the General Assembly's Legislative Policy Committee. By law, the committee has 45 days to approve the plans... Full

New Risks Discovered as U.S. and EU Drug Shortage Efforts Start to Merge

(9/10, Patrick Day, Lachman Consultants) ...U.S. and EU efforts to manage supply chain shortages are slowly converging; however, the political winds in the Rest of World (ROW) may be diluting required oversight...Additional hidden issues are being uncovered, which enables targeted mitigation plans that are needed to address global supply chain problems... Full

New EU Filings Include A Range Of First-Of-Their-Kind Therapies

(9/10, Neena Brizmohun, Pink Sheet) ...Pridopidine, sebetralstat and mirdametinib, which are novel treatments that are yet to approved anywhere in the world, are among the latest products for which marketing applications are now under review by the European Medicines Agency... Sub. Req’d

Pharma's ‘Whatever It Takes' Moment?

(9/11, Euractiv) ...On Monday, September 9, former President of the European Central Bank and former Italian Prime Minister Mario Draghi, who saved the euro, finally set out his analysis and plan to save the European economy from "a slow agony"...In summary, Draghi identifies four broad areas for improving productivity in the pharma sector. He wants faster and fitter authorisation processes for medicines and medical devices, ways to improve joint purchasing to support more advanced treatments, a lot more funding to help more cutting-edge research, as well as support for SMEs, and special attention paid to how data and AI, can ensure Europe keep apace with the US and Chinese markets... Full

Spain Consults On Plans To Regulate HTAs

(9/10, Francesca Bruce, Pink Sheet) ...Spain is consulting on plans to regulate its HTA system for medicines, medical devices and other technologies for the first time. The draft decree would prepare Spain for the EU HTA Regulation that introduced EU-level joint clinical assessments. At the end of the HTA process there will be two reports, one on the product's clinical effectiveness and another on non-clinical aspects, which will inform decision making... Sub. Req’d

Why India, The Pharmacy of the World, Needs Government Support

(9/10, Dhanendra Kumar, Business Today) ...The industry had a market size of $50 billion in 2023, which is estimated to grow to $130 billion by 2030. There are several world-class pharmaceutical companies in India, such as Sun Pharmaceuticals, Cipla, Dr. Reddy's, Lupin, Zydus, and Mankind Pharma, among others, that are rapidly expanding... Full

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