Wednesday, July 3, 2024

Please note: Teva Daily News will not publish Thursday, July 4 in observance of the U.S. Independence Day holiday. Publication will resume on Friday, July 5.

Teva Stands By Orange Book Listings As FTC Takes Further Action

(7/2, David Wallace, Generics Bulletin) ...Following reports of the FTC escalating its investigations into Teva over inhaler patents listed in the FDA's Orange Book, the firm is standing by its intellectual property. Teva has responded to reports of further US Federal Trade Commission action over some of its US inhaler patents by emphasizing its confidence in its intellectual property and its belief that its patents are properly listed in the US Food and Drug Administration's Orange Book... Global Sub. Full

US FTC Ramps Up Patent Crusade with Investigation into Teva's Inhaler IP: Report

(7/2, Fraiser Kansteiner, Fierce Pharma) ...While certain other drugmakers have relented in the face of the U.S. Federal Trade Commission's assault on alleged "junk" patents in the FDA's Orange Book, Teva has largely stood its ground. Now, as the situation escalates, the FTC has launched an investigation into the Israeli-American drug giant over Teva's refusal to remove roughly two dozen patents for its asthma and chronic obstructive pulmonary disease inhalers, The Washington Post first reported, citing confidential agency documents... Full

FTC Investigates Teva Over Contested Product Patents

(7/2, Justine Ra, Pharmaceutical Technology) ...Months after sending warning letters to pharma manufacturers challenging patents targeting drugs for diabetes, weight loss, and asthma, the Federal Trade Commission has opened an investigation into Teva Pharmaceuticals...The Orange Book is an "unusual" system that has encouraged generic developers to challenge patents, Rohit Singla, a litigation partner at US law firm Munger, Tolles & Olson previously told Pharmaceutical Technology. Moreover, its purpose is to "give generic drug companies certainty before coming to market."... Full

EAN 2024: Treatment Cessation and Reinitiation Can Reduce Benefits of Ajovy

(7/2, Clinical Trials Arena) ...On June 30, at the tenth Congress of the European Academy of Neurology, during an e-presentation session on the topic of ‘Headache', interim analysis from the observational, prospective Phase IV Pan-European Real-Life (PEARL) study of Teva Pharmaceuticals' Ajovy for the management of migraine was presented. The results focused on the effects of treatment cessation and reinitiation... Full

EU Court Rejects Appeals Over Perindopril Settlements

(7/2, David Wallace, Generics Bulletin) ...In long-running litigation over perindopril ‘pay for delay' settlements, appeals have been refused and certain earlier findings by Europe's general court have been set aside in a fresh ruling by the Court of Justice of the EU...In the latest decision in the case, the CJEU has dismissed appeals by Lupin, Niche Generics, Unichem Laboratories, Matrix, Teva and Biogaran, confirming the judgments of the general court that held that agreements concluded by Servier and Biogaran constituted market-exclusion agreements and restricted competition. These firms "therefore remain liable for the fines imposed by the Commission," the court explained... Global Sub. Full

Formycon's US Eylea Biosimilar Is Third In Six Weeks – But Timing Still Uncertain

(7/2, Dean Rudge, Generics Bulletin) ...Formycon and its licensing partner Klinge Biopharma have become the third biosimilar sponsors to pick up a US Food and Drug Administration approval for a rival to Regeneron's Eylea (aflibercept) 2mg in less than two months, with a nod for their Ahzantive (aflibercept-mrbb). The approval is "another key milestone on our way to becoming the leading pure-play biosimilar developer," Formycon believes, while helping the company "achieve an outstanding position in ophthalmic biosimilar therapies."... Global Sub. Full

Proposed Denosumab Biosimilar AVT03 Demonstrates Positive Topline Data

(7/2, Lana Pine, HCPLive) ...Positive topline data of a confirmatory patient study for the proposed denosumab biosimilar AVT03 were announced by Alvotech today. The drug was compared to both denosumab reference product Prolia (denosumab) and Xgeva (denosumab). Results will be used to further support indications of the drug as a proposed biosimilar to Xgeva based on data extrapolation... Full

EU Approves Sanofi's Dupixent for 'Smoker's Lungs'

(7/3, Ludwig Burger, Reuters) ...Sanofi and partner Regeneron on Wednesday won European Union approval for wider use of their Dupixent injection in patients with a chronic lung disease, a rare case of the EU clearing a drug faster than the United States. The EU Commission approved Dupixent to treat chronic obstructive pulmonary disease in patients that cannot be helped by standard inhaled drugs, Sanofi said in a statement, following a recommendation by the European Medicines Agency at the end of May... Full

Approval of Newest Alzheimer's Drug Will Accelerate New Era of Treatment

(7/2, Peter Loftus and Joseph Walker, The Wall Street Journal) ...The approval Tuesday of Eli Lilly's new Alzheimer's drug will hasten the transformation of treatment of the dementia-causing condition...An Eisai spokeswoman said that the new treatment option "will accelerate the development of the healthcare infrastructure needed" to treat more early-stage Alzheimer's patients... Sub. Req'd

Fresenius Continues its Biopharma Momentum with Launch of Subcutaneous Formulation of Tyenne® (Tocilizumab-aazg) in the United States

(7/2, Fresenius Kabi) ...Fresenius, via its operating company Fresenius Kabi, announced today the immediate availability in the U.S. of its biosimilar Tyenne® (tocilizumab-aazg), in a subcutaneous formulation, which will increase access to affordable and cost-effective treatment options for use in the treatment of chronic autoimmune diseases. Tyenne is indicated for use in the treatment of chronic autoimmune diseases for certain indications of the reference product, Actemra® (tocilizumab)... Full

Pharma Matters Podcast: Contract Pharma Talks with Tom Wilson of Pfizer CentreOne

(7/2, Contract Pharma) ...Vice President and Global Contract Manufacturing Leader for Pfizer CentreOne talks about supply chain reliability trends... Full

Mylan, CVS Defeat Class Status in EpiPen Price-Gouging Suit

(7/2, Thomas Gleason, Bloomberg Law) ...Mylan, CVS Health Corp. units, and other health-care companies dodged a proposed class action from drug wholesalers over alleged price-gouging of the EpiPen after a Minnesota federal judge ruled the class doesn't meet the standard for certification...Separately, the Department of Justice removed Mylan and its former president as subjects of an antitrust investigation into the generic drug industry, Viatris announced Tuesday... Full

Lipitor Ruling Raises Class Status Bar in Pay-for-Delay Cases

(7/3, Katie Arcieri, Bloomberg Law) ...Sun Pharmaceutical Industries Ltd.‘s win against claims the company conspired to hinder the release of a generic cholesterol-reducing drug raises the standard for plaintiffs to win class status in pay-for-delay cases. The denial of class certification to two groups of purchasers of the blockbuster Lipitor drug from Judge Peter G. Sheridan of the US District Court for the District of New Jersey in June reinforces the high bar plaintiffs counsel must clear in cases challenging patent litigation settlements that include payments from brand drug companies to keep generic brands off the market... Full

FDA Again Warns Sun Pharma Over Dadra Facility

(7/2, Joanne S. Eglovitch, Regulatory Focus) ...Generic drugmaker Sun Pharmaceuticals was reprimanded by the US Food and Drug Administration for several violations of good manufacturing practices (GMPs) at one of its facilities in India. The warning letter cites the company for inadequately investigating batch failures and for cleaning lapses and follows other recent warning letters and a consent decree related to similar GMP issues... Full

As Confidence Falls, Biopharma Companies Take Precautions with Chinese Partnerships, Survey Finds

(7/2, Amber Tong, Endpoints News) ...Geopolitical tensions and threats of decoupling have led to a steep decline in American companies' confidence in working with Chinese partners, although few have taken steps to end relationships, according to a new survey. The survey — conducted by LEK Consulting and featuring responses from 73 professionals across biopharma, CDMO, CRO and investor sectors — also found that 68% of global life sciences companies have adjusted their operations in response to looming US legislation targeting Chinese service providers... Full

Novo Nordisk, Lilly Must Cut US Prices of Weight-Loss Drugs, Biden Says

(7/2, Patrick Wingrove, Manas Mishra, Reuters) ...U.S. President Joe Biden and Senator Bernie Sanders called on Novo Nordisk and Eli Lilly to reduce the prices of their weight-loss and diabetes drugs, in a jointly authored opinion piece published in USA Today on Tuesday..."The cost of both Ozempic and Wegovy has decreased about 40% since launch and over 80 percent of Americans with insurance only pay $25 or less per month for these important medicines", Novo Nordisk told Reuters in an emailed response. "Unfortunately, even when we lower our prices, patients in the United States often don't receive the savings - this is a problem," Novo said... Full

Biden Joins Sanders' Campaign Targeting Novo Nordisk, Eli Lilly's Diabetes and Obesity Drug Prices

(7/2, Eric Sagonowsky, Fierce Pharma) ...Novo Nordisk, for its part, is "disappointed that a very difficult and complex problem is being oversimplified and mischaracterized for political purposes," a company spokesperson said in a statement. "Each country has its own healthcare system and making isolated and limited comparisons ignores this fundamental concern," Novo's spokesperson added..."Comparing list prices in the United States to other countries ignores patient affordability programs and hundreds of billions of dollars in discounts and fees paid to PBMs by pharmaceutical companies that should lower the costs of medicines for Americans, but unfortunately this system can drive prices higher," a Lilly spokesperson said in a statement... Full

Novo Nordisk, Eli Lilly Singled Out by Biden, Sanders Over Drug Prices

(7/2, Eleanor Laise, Market Watch) ...The comparison of drugs' list prices in the U.S. versus other nations mirrors the criticism that Sanders has aimed at other major drugmakers, including Merck & Co. Inc., Johnson & Johnson, and Bristol Myers Squibb Co. Yet those comparisons do little to illuminate the U.S. prescription-drug affordability issues, drug-pricing experts say... Full

Cassidy Suggests FDA Scrub Entire Reg Agenda Post-Chevron, Targets LDT Rule

(7/2, Jessica Karins, InsideHealthPolicy) ...The Senate health committee's top Republican accuses FDA of "thumbing its nose at the Constitution" by allegedly overstepping food and drug law in its regulation of laboratory developed tests and orphan drugs, and suggests the agency scrub its entire regulatory agenda of any items that cross the line now that the Supreme Court has axed the longstanding Chevron principle that gave agencies wide swath to interpret ambiguous laws... Sub. Req'd

Experts: Chevron Deference Ruling Could Impact Recent FDA Regulations

(7/2, Ferdous Al-Faruque, Regulatory Focus) ...Legal experts say a recent US Supreme Court (SCOTUS) ruling that struck down Chevron deference could be used to challenge the Food and Drug Administration's authority on issues such as its recent decision to regulate laboratory-developed tests. However, they noted that the courts will likely continue to defer to the agency on most decisions involving its expertise... Full

Here's How Biden Team Plans to Raise Cost of Prescription Drugs for All Americans

(7/3, Michael R. Pompeo, Fox News) ...By targeting pharmacy benefit managers, the Federal Trade Commission will advance the Biden administration's war on American business, expand government power, and raise drug costs for all Americans. Rather than go along with the FTC's policies that will hurt patients and families, Congress should step in and put a stop to it... Full

New GoodRx Report Underscores Need for Congress to Hold Big Pharma Accountable

(7/2, The Campaign for Sustainable Rx Pricing) ...The Campaign for Sustainable Rx Pricing (CSRxP) released a statement Tuesday reacting to a new report from GoodRx examining the rising price of prescription drugs. "The new report from GoodRx exposes Big Pharma for hiking prescription drug prices on the American people by 40 percent since 2016, costing patients $21 billion," said CSRxP executive director Lauren Aronson. "To deliver relief for patients from Big Pharma's price-gouging and patent abuse, policymakers must crack down on Big Pharma's price hikes on existing products, increasingly out-of-control launch prices on new products and egregious anti-competitive tactics."... Full

PBMs Claim Opioid Plaintiffs Destroyed Evidence, Seek Sanctions

(7/2, Shweta Watwe, Bloomberg Law) ...The PBMs said three out of four of the bellwether plaintiffs have failed to implement litigation holds for crucial evidence including messages from local government employees, according to a papers submitted Monday to the US District Court for the Northern District of Ohio. The PBM suits are a piece of the sprawling consolidated litigation against opioid makers, distributors, and other entities that allegedly fueled misuse of the prescription painkillers. Benefit managers in the Cleveland federal court-based litigation include Express Scripts and OptumRx... Sub. Req'd

US Patent Office Plan To Expand Settlement Disclosure Requirements Welcomed By FTC

(7/2, Cathy Kelly, Generics Bulletin) ...The Federal Trade Commission supports a US Patent and Trademark Office proposal that would require patent settlement agreements be disclosed even if they are reached before a Patent Trial and Appeal Board proceeding. The policy would extend the disclosure window, which now is required only after a proceeding is instituted. PhRMA argued the plan threatens to expose confidential information and should be more fully vetted in a separate rulemaking before advancing, while AAM maintains the policy is unnecessary... Global Sub. Full

Novartis, PhRMA Lose Bid to Block Mississippi Drug Pharmacy Law

(7/2, Nyah Phengsitthy, Bloomberg Law) ...Judge Halil Suleyman Ozerden for the US District Court for the Southern District of Mississippi denied preliminary injunctions Monday in separate lawsuits filed by Novartis Pharmaceuticals Inc. and the Pharmaceutical Research and Manufacturers of America, writing plaintiffs haven't shown a "substantial likelihood of success on the merits as required to obtain a preliminary injunction."... Sub. Req'd

New Danish ‘Critical Medicine' Stockpiling Rules Take Effect, With 6-Month Grace Period

(7/2, Ian Schofield, Pink Sheet) ...The Danish regulator says the new stockpiling and reporting requirements will give stakeholders time to take steps to mitigate the impact of long-term supply issues, but the pharma industry body, LIF, fears the move could create more problems than it will solve... Sub. Req'd

60 Drug Makers Join Govt Scheme to Modernise Pharma Manufacturing Units

(7/3, Vasudha Mukherjee, Business Standard) ...Sixty small drug manufacturers have enrolled in a government scheme aimed at modernising their units to align with global good manufacturing practices (GMP), according to a report by the Mint. This initiative follows a series of incidents where Indian pharmaceuticals were found to be toxic in regions such as North America, Africa, and Central Asia, leading to fatalities and raising serious questions about Indian pharma exports... Full

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