Wednesday, July 17, 2024

As GLP-1 Sales Surge, Insulin Users Fear Novo Nordisk and Eli Lilly Will Move On Without Them

(7/17, Elaine Chen, STAT) ...Around the world, patients suddenly can't find enough of the insulins made by companies they have long relied on to do so...The reasons for the shortages are complex, but the diabetes community fears one factor driving the phenomenon: Insulin manufacturers may be less interested in making it... Full

Verona's Price for COPD Treatment Ohtuvayre Will Result in Restricted Access, ICER Says

(7/16, Kevin Dunleavy, Fierce Pharma) ...At an annual list price of $35,400, Ohtuvayre costs nearly three times more than the top of ICER's valuation range for the product. In its final evidence report, ICER calculated a health-benefit price benchmark for Ohtuvayre of $7,500 to $12,700 per year. The Boston-based non-profit suggests fair prices for drugs after analyzing their benefits and risks and gathering input from patients, clinical experts and stakeholders... Full

USFDA Approves Glenmark's Generic Formulation to Treat Epilepsy

(7/17, Financial Express) ...Glenmark Pharmaceuticals Ltd. on Wednesday announced that it has received final approval from the United States Food & Drug Administration for Topiramate Capsules USP, 15 mg and 25 mg... Full

Zydus's ‘Transparency Failure' Leads To Block On Indian Perjeta Biosimilar

(7/17, Dean Rudge, Generics Bulletin) ...India's Delhi High Court has signed off an interim injunction blocking the sale of Zydus Lifesciences' Sigrima biosimilar version of Roche's Perjeta (pertuzumab), after the Indian firm failed to disclose to the court that it had earlier received a conditional approval for – and later launched – its biosimilar. Such action "suggests a strategic move by the defendant to establish a market presence before any potential judicial restrictions could be imposed," according to the court... Global Sub. Full

FDA Again Rejects Orexo's Nasal Spray for Opioid Overdose Rescue

(7/16, Max Gelman, Endpoints News) ...For a second time, the FDA has turned away Orexo's nasal spray treatment for opioid overdoses. The company will need to complete another "human factor" study before resubmitting its application, Orexo said Tuesday in a press release, and that entails making sure individuals can reliably and correctly use a drug-device product. Orexo said it received feedback about the potential need for a new study in April, and it has already been completed... Full

Roche Touts Early Trial Success of Second Obesity Drug Candidate

(7/17, Paolo Laudani, Ludwig Burger, Reuters) ...Roche said on Wednesday a second drug candidate from its purchase of Carmot Therapeutics yielded positive results in an early-stage trial, as the Swiss drugmaker asserted itself as a late contender in the race to develop obesity drugs...J.P. Morgan analysts said Roche's data looked competitive but the comparison was fraught with uncertainty... Full

Endo USA, Inc. Issues Voluntary, Nationwide Recall of One Lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV) Lot Number 550147301 Due to Mislabeling: Incorrect Strength On Product Carton

(7/16, Endo, Inc.) ...The product lot is being recalled due to mislabeling where an incorrect strength appears on the cartons of some packs to show the product strength as 0.125 mg and not 0.25 mg due to an error at a third-party packager. The blister strips inside the product pack reflect the correct strength of 0.25 mg... Full

FDA Warns Chinese Drugmaker for Serious GMP Record Violations

(7/16, Zachary Brennan, Endpoints News) ...The FDA on Tuesday released a warning letter sent to China-based drugmaker Jiangsu Hengrui Pharmaceuticals, finding the company failed at multiple levels to ensure its Good Manufacturing Practice records were accurate...A spokesperson for Jiangsu told Endpoints News via email that the company received the warning letter and they will respond to the FDA. "In response to the related Form 483 issued in January 2024, Hengrui Pharma has already submitted an action plan and several progress reports," the spokesperson added... Full

AI And Biosimilars: Untapped Area Full Of Potential – Or Hype?

(7/16, Urte Fultinaviciute, Generics Bulletin) ...A recent journal article, published by the Multidisciplinary Digital Publishing Institute, explored potential areas in biosimilar development where AI could be applied. Given that biological products have a more complex development process than small molecules, the integration of AI in the R&D process of biosimilars "marks a revolutionary change in the biopharmaceutical industry," the authors suggested... Global Sub. Full

HHS Issues New Guidance for Medicare Drug Payment Program

(7/16, Tony Pugh, Bloomberg Law) ...Additional guidance issued Tuesday by the Biden administration further explores the requirements of a program that allows Medicare prescription drug plan enrollees to pay their out-of-pocket costs in monthly installments next year. The Medicare Prescription Payment Plan will target beneficiaries with high prescription drug costs at the start of the year... Sub. Req'd

US House Panel to Hold Hearing with Pharmacy Benefit Managers On Healthcare Costs

(7/16, Kanishka Singh and Jasper Ward, Reuters) ...The U.S. House of Representatives oversight panel said on Tuesday it will hold a hearing with executives from U.S. pharmacy benefit managers on the role of the firms in rising healthcare costs...The hearing is set for July 23... Full

Product Hopping Ban On Back-Burner Due To Industry Lobbying

(7/16, Gabrielle Wanneh, nsideHealthPolicy) ...Sources say heavy pharmaceutical industry lobbying was a primary factor in why provisions to prohibit drug makers from shifting patient demand to a modified version of an existing brand drug about to face generic competition were left out of a drug patent and competition reform bill passed by the Senate this month... Sub. Req'd

A Senate Bill was Touted as a Cure for ‘Patent Thickets.' Some Say the Drug Industry Watered it Down

(7/17, Ed Silverman and Rachel Cohrs Zhang, STAT Plus) ...A clutch of headlines last week suggested the U.S. Senate had achieved a breakthrough in the battle to prevent pharmaceutical companies from abusing the patent system, an issue that has been blamed for boosting prescription drug costs for Americans. But while the Senate bill clearly represents a step forward, the impact will not be nearly as great as originally intended by lawmakers due to industry lobbying... Sub. Req'd

J&J, BMS and AstraZeneca Strike Back in Appeals After IRA Litigation Losses

(7/16, Fraiser Kansteiner, Fierce Pharma) ...Much of the pharmaceutical industry has been fighting against the Inflation Reduction Act tooth and nail since the bill was passed in summer of 2022. J&J, BMS and AstraZeneca each have drugs up for negotiated prices starting in 2026..."This convoluted regime serves only to deceive the public and obscure the reality of an unprecedented, top-down government takeover of the U.S. pharmaceutical industry," BMS wrote in its Friday appeal... Full

AstraZeneca Criticizes CMS Guidance in Appeal Over Price Negotiations

(7/16, Zachary Brennan, Endpoints News) ...AstraZeneca's diabetes drug Farxiga, which sold $1.45 billion in the US last year, is one of the 10 drugs selected by CMS for the first year of price negotiation. And while those negotiations are ongoing, the UK-based pharma filed an appeal in the Third Circuit court on Monday, claiming that the price negotiations are not really voluntary, due to the excessive fines that could be imposed. The company also calls out CMS' new guidance for drugmakers, which it says runs counter to the language of the law. "AstraZeneca cannot fairly value its product without a judicial determination of whether the guidance is unlawful," the company said... Full

Medicare Negotiation Round Two Will Be Dominated By Oral Cancer Drugs, Researchers Predict

(7/16, Cathy Kelly, Pink Sheet) ...As many as six oral cancer drugs could be selected for Medicare price negotiation in the next round, which begins in 2025 for prices going into effect in 2027, according to a new analysis by researchers at the University of Washington and the University of California San Diego. A number of diabetes drugs may also be targeted, including Novo Nordisk's Ozempic... Sub. Req'd

CAHC: IRA Will Cause Part D Premium Increases, Less Access To Care

(7/16, Sigi Ris, InsideHealthPolicy) ...The Inflation Reduction Act will make it more difficult for Part D beneficiaries to receive care, specifically eliminating plan options and raising premiums, according to a new report from the Council for Affordable Health Coverage (CAHC) that requests Congress intervene to mitigate the potential issues. CAHC says beneficiaries are already seeing increased premiums... Sub. Req'd

Sen. Menendez's Conviction May Cost Pharma a Key Ally in Congress

(7/16, Annalisa Merelli, STAT) ...A New York jury on Tuesday found Sen. Bob Menendez guilty on 16 counts for bribery, extortion, and fraud charges. Calls for Menendez's resignation quickly followed. Whether or not he immediately listens to them, Menendez is unlikely to continue his regular congressional activities given that he's now been convicted — among other charges — of acting as a foreign agent on behalf of Egypt. Without Menendez, the pharmaceutical industry will lose an important friend in Congress... Full

PBM Power: The Gross-to-Net Bubble Reached $334 Billion in 2023—But Will Soon Start Deflating

(7/16, Adam J. Fein, Ph.D., Drug Channels) ...PBMs' negotiating leverage against pharmaceutical manufacturers has been a key factor inflating the gross-to-net bubble-the ever-growing dollar gap between sales at brand-name drugs' list prices and their sales at net prices after rebates, discounts, and other reductions...Multiple forces are poised to pop the gross-to-net bubble for high-list/high-rebate products. This will force PBMs to further evolve their business models, while challenging plan sponsors and the FTC to follow the dollars... Full

We've Been Here Before: The Politicization of Drug Pricing

(7/16, Richard Hughes IV, JD, MPH, MedPage Today) ...Ensuring patients can afford drugs does not have to come at the cost of innovation. Health insurance companies and policymakers have the keys to lower patient costs. If President Biden and Sen. Sanders are serious about making GLP-1s affordable, they have the tools, and those don't involve scare tactics and puffery over retail drug prices... Full

Healthcare Costs to Grow 8% Next Year: PwC

(7/17, Alex Kacik, Modern Healthcare) ...The projection from PricewaterhouseCoopers' Health Research Institute tops the consultancy's 2024 estimate, which was adjusted to 7.5% from 7%. Next year's 8% cost growth forecast matches the 2023 estimate and the highest increase since 2012. For PwC's annual report, researchers spoke with actuaries who work with insurers covering 100 million employer-sponsored members and 10 million Affordable Care Act members to forecast healthcare inflation. The results were weighted by each health plan's size... Sub. Req'd

Analysis Finds Misinformation About Interchangeable Biosimilars Undermining US Health Policy, Physician Confidence, and Patient Health

(7/16, The Alliance for Safe Biologic Medicines) ...The Alliance for Safe Biologic Medicines announces the publication of a paper underscoring the critical role of the FDA's interchangeable biosimilar data requirements in maintaining the safety and efficacy of biosimilar substitutions. Titled "Misinformation about interchangeable biosimilars undermines US health policy, physician confidence, and patient health," the paper discusses the successes of the FDA's data-driven approach in building physician and patient confidence in biosimilars and provides an analysis of the potential risks associated with weakening these proven standards... Full

Drug Development Costs Predicted to Soar As BIOSECURE Act Gains Momentum

(7/17, Phalguni Deswal, Pharmaceutical Technology) ...In an exclusive interview with Pharmaceutical Technology, Anshul Mangal, President of Project Farma, a consulting firm specialising in manufacturing and technical operations for complex biologics and novel therapies, talks about the impact of BIOSECURE Act on pharmaceutical companies and outlines the steps the companies can take to mitigate its impact... Full

FDA Issues Final Guidance User Fees for Combination Products

(7/16, Joanne S. Eglovitch, Regulatory Focus) ...The US Food and Drug Administration on Tuesday finalized guidance for sponsors explaining how it assesses user fees for combination products and the different programs available to sponsors for requesting user fee waivers under the Prescription Drug User Fee Act and the Medical Device User Fee Amendments programs... Full

Large Group of State Attorneys General Backs Oregon Drug Price Transparency Law

(7/16, Nicole DeFeudis, Endpoints News) ...In the latest chapter of years of legal back-and-forth, attorneys general from 20 states and the District of Columbia have asked a federal appeals court to reverse a decision that an Oregon drug price transparency law is unconstitutional...A PhRMA spokesperson told Endpoints News on Tuesday that it agrees with the lower court's decision... Full

Two Drugmakers File Lawsuits to Block Kansas' Attempt to Tinker with Discount Drug Program

(7/16, Tim Carpenter, Kansas Reflector) ...The Kansas Legislature and Gov. Laura Kelly adopted a potentially unconstitutional budget provision forbidding pharmaceutical manufacturers from inhibiting the sale of discounted medications to pharmacies such as CVS and Walgreens under contract with hospitals or clinics. Two drugmakers have challenged a proviso tucked into Senate Bill 28 — signed by the governor in April — that said the companies couldn't limit the ability of pharmacies working with eligible health providers from acquiring outpatient prescription drugs at discounts of 25% or more through a federal cost-cutting program... Full

Colorado Moves Forward with Price Caps for Unaffordable Prescriptions Despite Possible Litigation

(7/16, Gabe Allen, KUNC) ...At a July 3 meeting, Colorado's Prescription Drug Affordability Review Board voted unanimously to proceed with setting price caps for two prescription drugs: Stelara and Cosentyx...Though no litigation has been filed so far, some opponents are already making their voices heard. At the July 3 meeting, public commenters, including a Johnson & Johnson spokesperson and a Maryland-based pediatric rheumatologist, spoke out in frustration... Full

Biosimilars Report Bolsters IGBA's Calls To Streamline Development Process

(7/16, David Wallace, Generics Bulletin) ...The IGBA has renewed calls to streamline biosimilar development by reducing comparative clinical studies and using the same comparator product across international jurisdictions, citing the findings of a recent publication by the International Pharmaceutical Regulators Programme's Biosimilars Working Group... Global Sub. Full

EMA's New Medicines Safety Chief Takes Charge Of Packed Agenda

(7/16, Vibha Sharma, Pink Sheet) ...Swedish regulator Ulla Wändel Liminga, the incoming chair of the European Medicines Agency's Pharmacovigilance Committee, will oversee a number of projects including those she was already with such as those related to the safety of medicines during pregnancy and breastfeeding... Sub. Req'd

Pilot Shows EU Needs A ‘Robust' Shortage Signaling System for ‘Critical' Drugs

(7/16, Ian Schofield, Pink Sheet) ...The EU needs a "robust signaling system" that can accurately detect and mitigate vulnerabilities in the supply chains for "critical" medicines using a risk-based approach with harmonized definitions and quality standards, says a new report from the European Commission's Health Emergency Preparedness and Response Authority. Marketing authorization holders see manufacturing and logistical issues as the main reasons for supply chain discontinuities, notably the complexity of production processes and the cost of investing and gaining regulatory approval for new production lines, the report says... Sub. Req'd

Scottish Government Publishes Prescribing Guidance Aiming to Save Millions of Pounds

(7/16, Corrinne Burns, The Pharmaceutical Journal) ...The Scottish government has launched a consultation on guidance aimed to reduce the use of low value medicines, as well as cutting prescribing variation across health boards. The draft guidance — ‘Prescribing — achieving value and sustainability‘ — published on July 11, 2024, sets out a list of 17 products that are of "low clinical value", for which it states no prescribing is appropriate, and for which no exceptions apply. These include homeopathic remedies, minocycline for acne, probiotics, and bath and shower emollients... Full

Note: Article links may expire over time or require a free registration. All news articles are the property of their respective publishers and copyright holders. [contextual emphasis added].

Teva global subscription access: Registration is required to access FirstWord and Generics Bulletin. Click on the links below to register. If you have any questions or issues with access, contact InfoNOW or visit InfoNOW's Industry News page for more details regarding these subscriptions.

                                                         

FirstWord Pharma Plus: Enter your work email address on the Registration page along with your contact information in order to receive access.

  

Generics Bulletin by Informa:

•      Registration: Click on "Sign In" (link on the upper right side of the page). Enter your work email address in the "username" box and press the "Tab" button on your keyboard or click out of the box. You will then be automatically logged into the Informa news resource (no password required). You may be redirected to the Account Settings page to update your contact information.                                

•       Subsequent Access: If you're not automatically logged in, click on "Sign In" (link on the upper right side of the page). Enter your work email address. You will be automatically logged in (no password is required).

•      Note: You must be on the Teva Network (in a Teva location or connected via VPN) in order to access the Informa news resources. You can toggle between the Informa news resources by clicking the news resource on the top.