Friday, February 23, 2024

  Top News

Teva Commits To Dual Branded And Generic Model

(2/23, David Wallace, Generics Bulletin) ...Speaking at a meeting with local media in Tel Aviv, Israel, CEO Richard Francis referred to the firm's "Pivot to Growth" strategy – launched midway through last year – and how the firm was delivering on the strategy's key pillars. Asked whether Teva was "considering splitting its businesses to focus more on branded drugs, given the growing branded business, and generics pricing pressures," Francis was clear that the company would remain committed to generics alongside its burgeoning branded interests... Global Sub. Full

House Democrats Put Teva, Pfizer and Sandoz in the Hot Seat with New Shortage Investigation

(2/22, Zoey Becker, Fierce Pharma) ...Teva, CEO Richard Francis was questioned on the company's Adderall shortage, which has also been ongoing since October 2022. The FDA, in its original shortage notice, pointed a finger at Teva's manufacturing delays as a main contributor to the supply woes...Teva was asked to explain this discrepancy in producing fewer drugs than its allotted quota in 2022, as well as to divulge the output numbers for 2023. The company did not respond to Fierce Pharma's request for comment... Full

House Dems Seek Briefings with Pfizer, Sandoz and Teva On Ongoing Drug Shortages

(2/22, Lia DeGroot, Endpoints News) ...Democrats on the House oversight committee are asking manufacturers of several drugs in short supply — including antibiotics, cancer drugs and ADHD medications — to share their plans for resolving the shortages, which have dragged on for more than a year...The lawmakers told Teva that while some supplies of ADHD medications appear to be returning, there are still certain generics that aren't available or are in short supply, and it's still unclear what led to the shortage in the first place... Full

Fact Check: Yes, The Price of An Inhaler in the U.S. is Massively Higher Than Overseas Cost

(2/23, D.L. Davis, Milwaukee Journal Sentinel) ...Experts say a key reason why inhaler prices remain so high in the U.S. is that there is very little generic competition. The Senate committee, in a letter to the pharma CEOs, cited an online global database and said Boehringer Ingelheim charges $489 for brand name inhaler Combivent Respimat in the United States...The letters were sent to the four biggest manufacturers of inhalers sold in the United States – AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline and Teva... Full

Access! 2024 - Charting a Sustainable Path for Generics and Biosimilars

(2/22, AAM) ...Access! 2024 was a resounding success, uniting industry luminaries, igniting innovation, and tackling pivotal challenges within the generics and biosimilars arena. As the conference concluded, attendees left with new insights, strengthened connections, and a renewed commitment to advancing patient access to affordable medicines. A heartfelt thank you to all our sponsors and exhibitors for their support at Access! 2024. Their partnership contributed significantly to the success of the event. We appreciate your commitment to advancing the generics and biosimilars industry...Platinum Sponsor: Teva Pharmaceuticals USA, Inc... Full

  Industry News

Prices for New US Drugs Rose 35% in 2023, More Than The Previous Year

(2/23, Deena Beasley, Reuters) ...Pharmaceutical companies last year launched new U.S. drugs at prices 35% higher than in 2022, reflecting in part the industry's embrace of expensive therapies for rare diseases like muscular dystrophy, a Reuters analysis found. The median annual list price for a new drug was $300,000 in 2023, according to the Reuters analysis of 47 medicines, up from $222,000 a year earlier. In 2021, the median annual price was $180,000, for the 30 drugs first marketed through mid-July, according to a study published in JAMA... Full

Novo Nordisk, Eli Lilly Lead Industry Wide Sales Surge in Q4

(2/22, Kevin Dunleavy, Fierce Pharma) ...Unlike the first quarter of 2023, when Novo was the only company in the industry with a double-digit revenue boost, several drugmakers scored big gains in the fourth quarter, including Daiichi Sankyo (26%), Amgen (20%) and Teva (15%)...Teva's sales increase in the fourth quarter is evidence that the company is heading in the right direction under new CEO Richard Francis. Each year from 2017, when Teva recorded sales of $22.4 billion, to 2022, when revenue shrunk to $14.9 billion, Teva posted an annual revenue decrease. But the company has reversed the slide with 2023 sales of $15.8 billion... Full

Glenmark Pharma Eyes $80 Mn from it's Nasal Spray Ryaltris Sales Next Year

(2/22, Press Trust Of India) ...Glenmark Pharmaceuticals expects its nasal spray Ryaltris to hit about USD 80 million in sales next year, boosting its overall revenue, according to a top company executive..."Ryaltris is a huge product for us, right? I mean next year, we anticipate sales of close to about USD 80-odd million. So it's a very large product already in a short time," Glenmark Pharmaceuticals Chairman and Managing Director Glenn Saldanha said. The company is yet to launch the product in many of the major markets like China and Brazil, he added... Full

Sanofi, Regeneron Get a Step Closer On Dupixent COPD Nod with FDA Priority Review

(2/22, Kevin Dunleavy, Fierce Pharma) ...Regeneron and Sanofi have reached another milestone as they look to add to their megablockbuster immunology drug Dupixent a new U.S. indication for uncontrolled chronic obstructive pulmonary disease with type 2 inflammation...An approval would make it available as an add-on maintenance treatment for adults with uncontrolled COPD with type 2 inflammation, making in the process Dupixent the first biologic therapy for COPD and the first new treatment approach for the disease in more than a decade, and could also add an extra $3.5 billion in peak sales to the drug's already impressive coffers... Full

AbbVie's Aquipta Effective in Preventing Migraine in Patients Who Failed Oral Therapy

(2/23, Kim Chan-hyuk, Korea Biomedical Review) ...AbbVie's oral migraine prophylaxis Aquipta (atogepant) met its primary endpoint in a phase 3 clinical trial of patients who failed prior oral prophylaxis, reducing the average number of migraine days per month. AbbVie Korea said Friday that the full results of the phase 3 ELEVATE study were published in Lancet Neurology on Feb. 13... Full

Pharmacies Across US Disrupted Following Hack at Change Healthcare Network

(2/22, Raphael Satter and Sriparna Roy, Reuters) ...Pharmacies across the United States are experiencing disruptions following a hack at UnitedHealth's technology unit, Change Healthcare, several pharmacy chains said in statements and on social media. The problems began on Wednesday after a "suspected nation-state associated cybersecurity threat actor" gained access to Change Healthcare's information technology systems, UnitedHealth said in a filing on Thursday... Full

Pharmacies Across America Are Having Trouble Processing Some Prescriptions Because Of A Cyberattack

(2/23, David Goldman and Caroll Alvarado, CNN) ...Walgreens said a "small percentage" of its prescriptions "may be affected" but that the company had procedures in place to process and fill them "with minimal delay or interruption."...Publix Super Markets didn't immediately respond to a request for comment, but on social media some users complained of issues when trying to fill their prescriptions. "This is a nationwide disruption," Publix said in a response to one user on X, formerly known as Twitter. Other companies including GoodRX and BlueCross BlueShield of Montana also flagged potential disruptions on social media. Independent pharmacies also reported problems... Full

SHARx and Mark Cuban Cost Plus Drug Company, PBC Join Forces to Save Underinsured Families Thousands of Dollars Per Year On High Cost and Specialty Medications

(2/22, SHARx) ...SHARx, one of the fastest-growing patient advocacy companies in the United States, and Mark Cuban Cost Plus Drug Company, PBC announced today that they will be teaming up to address the High Cost and Specialty drug markets by offering underinsured members access to those medications at affordable prices. The agreement expands SHARx's extensive sourcing channels, opening the catalog of medications carried by Cost Plus Drugs to SHARx members... Full

  U.S. Policy & Regulatory News

State AGs Call On Congress to Pass PBM Legislation

(2/22, Lauren Berryman, Modern Healthcare) ...The National Association of Attorneys General sent a letter to House and Senate leaders Tuesday asking them to address drug costs by passing legislation that would require PBMs to disclose more about their prescription drug price negotiations..."With stronger federal law, state and federal regulators can work together to better meet their shared responsibility to hold PBMs accountable and improve the country's healthcare system overall," the attorneys general wrote to House Speaker Mike Johnson (R-La.), House Minority Leader Hakeem Jeffries (D-N.Y.), Senate Majority Leader Chuck Schumer (D-N.Y.) and Senate Minority Leader Mitch McConnell (R-Ky.)... Sub. Req'd

NY AG Urges Stricter Asthma Drug Warnings Due to Children's Mental Health Risks

(2/22, Christina Jewett, Benjamin Mueller, The New York Times) ...The New York attorney general on Thursday urged the Food and Drug Administration to "take immediate action" and renew alerts to doctors and patients about the dangerous effects of Singulair for children, saying that the current warnings about the drug's psychiatric side effects were not sufficient. In a letter, the attorney general, Letitia James, also called on the federal agency to consider discouraging the prescription of Singulair, an asthma and allergy drug, to children... Sub. Req'd

US Prices of Some Psoriasis Drugs Need to Be Lowered to Match Benefits, New Study Says

(2/22, Katherine Lewin, Endpoints News) ...The prices of drugs for psoriasis need to be reduced by about 71% to match their efficacy, researchers from Harvard Medical School and the Brigham and Women's Hospital said in a study published in JAMA Dermatology on Wednesday...Researchers concluded that using a new approach to calculating cost effectiveness and negotiating prices, known as the "efficiency frontier" approach, "could lead to substantial price reductions and better align prices with clinical benefits."... Full

Biosimilars: US FDA's Updated Scientific Thinking Led To Interchangeability For Amgen's Wezlana

(2/22, Sue Sutter, Pink Sheet) ...Pink Sheet's Drug Review Profile explores Amgen's Wezlana, an interchangeable biosimilar to Janssen's Stelara. FDA determined late in the review that switching studies generally would not be needed for interchangeable ustekinumab products, prompting Amgen to seek the designation... Sub. Req'd

Two BLAs, One Suffix: FDA Diverges From Nonproprietary Naming Guidance For Amgen's Wezlana

(2/22, Sue Sutter, Pink Sheet) ...Assigning different suffixes to the prefilled syringe and intravenous formulations of Amgen's ustekinumab biosimilar could create confusion and would not further the goals of the naming convention, the FDA said in explaining why it departed from its January 2017 final guidance... Sub. Req'd

Industry Urges FDA to Do More to Help Companies Prepare for DSCSA

(2/22, Joanne S. Eglovitch, Regulatory Focus) ...The pharmaceutical industry urged the US Food and Drug Administration to take a more "assertive and forward-leaning" approach in assisting pharmaceutical manufacturers prepare their track and trace systems for full implementation of the Drug Supply Chain Security Act once these systems go live in November 2024... Full

FDA Science, Research, and Collaboration Advance Generic Medicines

(2/22, Iilun Murphy, M.D., FDA Voices) ...Americans may recognize the U.S. Food and Drug Administration's regulatory role in approving generic drugs, but few may know our work to advance generic drug development and assessment through our regulatory science and research programs. We conduct, support, and encourage scientific research on new methods to help us assess generic drug applications, and we promote innovation that leads to the development of new and often more streamlined approaches for making generic medicines. Here are some highlights from the newest edition of the Office of Generic Drugs Annual Report... Full

Office of Generic Drugs 2023 Annual Report

(2/22, U.S. Food & Drug Administration) ...In 2023 generic drugs continued to play a critical role in the U.S. health care system allowing patients greater access to needed medicines...Our 2023 Annual Report provides highlights of activities and accomplishments including generic drug approvals, first generic approvals, science and research innovations for generic medicines – including complex generics, and international collaboration, as well as how we are doing on agreements made under the third iteration of the Generic Drug User Fee Amendments... Full

FDA Officials: Guidance, Mitigations Will Support Device Supply Chain

(2/22, Cara Smith, InsideHealthPolicy) ...FDA is looking for regulatory flexibilities to help support medical supply chain resiliency, officials told Inside Health Policy at a conference hosted by the Association for the Advancement of Medical Instrumentation Wednesday (Feb. 21). Tammy Beckham, associate director of the resilient supply chain and shortages prevention program in FDA's Center for Devices and Radiological Health, said FDA wants to find new opportunities for the agency to provide guidance and flexibility to manufacturers to help avoid shortages... Sub. Req'd

2024 May Test Success Of State Drug Affordability Boards

(2/22, Luke Zarzecki, InsideHealthPolicy) ...Movement by states to set up prescription drug affordability boards is growing in 2024, but the boards' ultimate success in lowering drug prices hinges on details written into state bills, including how a board would evaluate affordability, and whether drug makers are able to successfully challenge the efforts in court. "I think we've seen broadening efforts within legislatures to either enact them or to update their existing statutes," Manatt Health Partner Michael Kolber told Inside Health Policy... Sub. Req'd

Minnesota Says Court Erred in Pausing Generic Drug Pricing Law

(2/22, Celine Castronuovo, Bloomberg Law) ...The US Court of Appeals for the Eight Circuit should vacate a preliminary injunction issued by the US District Court for the District of Minnesota over a state law prohibiting certain price increases for generic drugs, Minnesota Attorney General Keith Ellison (D) wrote in a brief filed Thursday...Ellison's filing marks the latest attempt to push back on AAM's history of successfully challenging state anti-price gouging laws. AAM's arguments have centered mainly on the commerce clause, which gives Congress broad authority to regulate business among the states... Sub. Req'd

Colorado Could Cap Payments for Amgen's Enbrel

(2/22, Rachel Cohrs, STAT) ...Last week, Colorado's board declared that Enbrel, which costs more than $46,000 per year per patient, per the state's claims database, is unaffordable for Colorado patients. Friday, the board will begin to discuss whether it wants to move forward with setting an upper payment limit for programs including Medicaid and commercial payers in the state. The same drug is also subject to Medicare's drug price negotiation program...Democrats on the House Oversight Committee are taking a different tack on their probe of drug shortages, and requesting briefings from Pfizer, Teva, and Sandoz, each of which make key drugs in shortage... Full

Prescription Drug Price Caps Could Get Limits in Colorado

(2/22, Matt Mauro, FOX 31) ...Should some prescription drugs be exempt from having their prices capped in Colorado? That was the debate at the Colorado Capitol on Thursday, when a bill to limit which drugs could be capped advanced out of a Senate committee...The drug review board has not capped the price of any drug just yet, but it could on Friday. That's when the board will vote on capping the price of Enbrel, which treats auto-immune diseases... Full

Colorado Weighs Bill Nixing Orphan Drugs From PDAB Review

(2/22, Luke Zarzecki, InsideHealthPolicy) ...After Colorado's prescription drug affordability board ruled Trikafta "not unaffordable" largely in part from patient assistance programs offered by the manufacturer, a bill introduced in the state's legislature would not allow for Trikafta -- or any other orphan drug -- from being considered by the new board. Colorado's PDAB said in its report that it would consider reviewing Trikafta in the future if patients' access to the drug subsided... Sub. Req'd

The Backward Economics of Importing Prescription Drugs from Canada

(2/22, Tomas J. Philipson, National Review) ...Importation proponents' main argument — that the United States should mimic the European Union's or Canada's drug pricing — is misguided. We should reduce foreign free-riding through trade agreements and other policies, not increase U.S. free-riding. Otherwise, we will end up dramatically reducing both U.S. and global innovation and thereby harming U.S. citizens and patients across the world... Sub. Req'd

  International News

Generics Are 45% Cheaper In Canada Than In 11 Key Markets

(2/23, Adam Zamecnik, Generics Bulletin) ...The average price of generic drugs in Canada is 45% lower than in other 11 comparator countries that represent some of the world's leading economies, according to a recent report published by the Canadian Generic Pharmaceutical Association. Based on the December 2023 report, Canada's public payers pay significantly lower prices than in international comparator countries. These countries include the likes of Australia, Germany, and Sweden, among others... Global Sub. Full

Czech Shadow Rapporteur Weighs Contentious New Pharma Package Proposals

(2/22, Aneta Zachová, Euractiv) ...The European Parliament is refining its position on two new proposals in the EU's ongoing pharmaceutical package deliberations – a contested directive and a regulation. Czech MEP, Katerina Konecná, shadow rapporteur of the new pharma package, favours the European Commission's proposal for a regulatory data protection period while criticizing a shift from paper to digital medicine leaflets... Full

Trade Deal Between India, European Free Trade Association Likely Within a Few Days, Says Norwegian Minister

(2/23, Dinakar Peri, The Hindu) ...The Free Trade Agreement between India and the European Free Trade Association is in the final stages and is expected to be concluded within the next few days, Norway's Deputy Foreign Minister Andreas Motzfeldt Kravik said on Thursday, February 22,2024... Full

IPC Releases Draft Pharmacovigilance Guidance Document for Pharmaceutical Products

(2/23, Pharmabiz.com) ...The Indian Pharmacopoeia Commission has released the Draft Pharmacovigilance Guidance Document for Pharmaceutical Products for its latest Version 2.0. The Commission has now invited comments and suggestions from Marketing Authorization Holders on the draft document...The comments and feedbacks mark a crucial step towards enhancing pharmacovigilance standards and safeguarding public health across India's pharmaceutical landscape... Full

French Agency Sets Up New Body To Advise On Biosimilar Substitution

(2/23, Ian Schofield, Generics Bulletin) ...The French regulatory agency, ANSM, has set up a new temporary scientific committee to advise it on the conditions under which pharmacists can substitute a biosimilar medicine in place of the originator drug. The move is part of ongoing government efforts to increase the number of biosimilar products and help curb drug spending... Global Sub. Full

Drugs Shortage Sees France Restart Local Production, Target Antibiotics Use

(2/22, RFI) ...As in much of Europe, France is facing increasing shortages of medications of all kinds – from insulin to anti-cancer drugs, though the most problematic are antibiotics, paracetamol and corticoids. In 2023, the National drug safety agency logged 4,925 low stock alerts, compared to 3,761 the year before. The new three-year "roadmap" to address these shortages from 2024 to 2027, published Wednesday, plans to increase oversight on 450 drugs considered essential. Drug shortages are linked to an increase global demand for medication as well as an insufficient local production capacity. Critics also point to pharmaceutical companies who have been raising prices on certain products... Full

Australia Gears Up For More Action On Drug Shortages

(2/22, Ian Schofield, Pink Sheet) ...The Australian medicines regulator, the TGA, is planning to draw up a strategic plan to help boost efforts to reduce the impact of drug shortages, saying that all stakeholders in the supply chain will need to cooperate in developing ways to better prevent, manage and communicate shortages. The TGA says that shortages continue to have an impact on people's health and on the health professionals who support them, despite the numerous improvements that have been made in preventing and tackling supply issues... Sub. Req'd

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