Friday, October 11, 2024

Please note: Teva Daily News will not publish Monday, October 14 in observance of the U.S. holiday. Publication will resume on Tuesday, October 15.

Teva to Pay $450 Million to Resolve US Kickback, Price-Fixing Cases

(10/10, Nate Raymond, Reuters) ...Teva Pharmaceutical Industries Ltd has agreed to pay $450 million to resolve allegations it used charities that help cover Medicare patients' out-of-pocket drug costs as a means to pay kickbacks to boost sales of its multiple sclerosis drug Copaxone and conspired to fix prices for generic drugs... Full

Teva Pharmaceuticals to Pay $450 Million to Settle Kickback Allegations

(10/10, Connor Hart, Dow Jones) ...The Justice Department on Thursday said the settlement amount was based on the company's, whose U.S. headquarters is in Parsippany, N.J., ability to pay. As part of the settlement, there was no admission of wrongdoing on Teva's part. Teva said it is pleased to put these matters in the past in order to focus on developing and providing access to medicines for patients who need them... Full

Teva to Pay $450 Million Over Copaxone Price Inflation

(10/11, Sophie Shulman, CTech) ...Teva's settlement includes a $425 million payment related to Copaxone and the charitable associations and an additional $25 million for price-fixing in other generic drugs. The original lawsuit sought $10 billion in damages, but the final amount was determined after the Justice Department evaluated Teva's financial situation... Full

Teva Agrees to Pay $450 Million to Settle Kickback and Price-Fixing Allegations

(10/10, Ed Silverman, STAT Plus) ...In the largest settlement of its kind, Teva Pharmaceuticals agreed to pay $425 million to resolve allegations the company and a related business paid kickbacks to charitable foundations in order to boost usage of a pricey medicine. Separately, the drugmaker agreed to pay $25 million to settle charges of participating in a price-fixing scheme with other generic companies... Sub. Req’d

Teva to Pay $425M to Settle Kickback Allegations

(10/10, Andrew Cass, Becker's Hospital Review) ...The settlement was reached after the government's review of Teva's financial disclosures concerning its financial condition, according to the release. The resolution with Teva is the largest copay assistance settlement to date, according to the release... Full

US Approves Temporary Imports of IV Fluids as Hospitals Grapple with Storm-Related Shortages

(10/10, Nathaniel Weixel, The Hill) ...Late Wednesday, the Food and Drug Administration approved temporary imports of IV fluid from Baxter facilities in Ireland, the United Kingdom, Canada and China...Baxter on Wednesday said the goal is to restart production at the plant in phases and return to full allocation of certain IV solution product codes by the end of the year... Full

B. Braun's Florida Facility Largely Unscathed as Hurricane Milton Threatens to Further Upend Supplies Critical IV Fluids

(10/10, Fraiser Kansteiner, Fierce Pharma) ...B. Braun—another major IV solutions maker—has pledged to step up in light of Baxter's plant closure. However, in an unfortunate turn of events, the company's IV facility in Daytona Beach, Florida, has found itself in Milton's path...Thankfully, B. Braun's Daytona beach plant and distribution center "were not seriously impacted" by Milton and will resume operations as planned on Friday morning, Alli Longenhagen, B. Braun's director of corporate communications, told Fierce Pharma Thursday afternoon... Full

Lupin Signs ADHD Drugs Deal With Aytu In Canada

(10/10, Urte Fultinaviciute, Generics Bulletin) ...Indian giant Lupin has signed an exclusive deal with Aytu BioPharma, adding two drugs for the treatment of attention deficit hyperactivity disorder to its Canadian portfolio. The exclusive collaboration, distribution, and supply agreement includes Aytu's Adzenys (amphetamine) and Cotempla (methylphenidate), both extended-release orally disintegrating tablet (ODT) formulations... Global Sub. Full

Elite Pharmaceuticals' Generic Adderall(R) Receives Marketing Approval from the Israeli Ministry of Health

(10/10, Elite Pharmaceuticals, Inc.) ...Elite Pharmaceuticals, Inc., a specialty pharmaceutical company developing niche generic products, today announced the Israeli Ministry of Health approval for Elite's generic version of Adderall®, an immediate-release mixed salt of a single entity Amphetamine product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate) with strengths of 10 mg, 20 mg, and 30 mg tablets... Full

Dong-A ST Achieves U.S. FDA Approval for Stelara Biosimilar IMULDOSA

(10/11, Choi Mun-hee, Business Korea) ...Dong-A ST has achieved a significant milestone with the U.S. FDA approval of its Stelara biosimilar, IMULDOSA, marking a pivotal moment in the company's global expansion strategy. The approval, granted on Oct. 10 (U.S. local time), comes one year after Accord Biopharma, a subsidiary of Intas, Dong-A's U.S. partner, submitted the Biologics License Application (BLA) to the FDA... Full

Fresenius Kabi Slapped With Infringement Suit Over US Denosumab Biosimilars

(10/10, Dean Rudge, Generics Bulletin) ...Fresenius Kabi has joined the list of biosimilar sponsors sued in the US for allegedly infringing a swathe of patents shielding Amgen's denosumab-containing brands, Prolia and Xgeva – just months ahead of denosumab's main US patent reaching the end of its life in February 2025. The California-based originator has hit Kabi with a complaint in the US District Court for the Northern District of Illinois alleging infringement of 33 patents related to its denosumab brands... Global Sub. Full

Three More Join Viatris In Dealing Out Of US Ozempic Patent Challenge

(10/11, Dean Rudge, Generics Bulletin) ...Just days after Viatris Inc.'s Mylan settled itself out of patent litigation proceedings before the the US Patent and Trademark Office's Patent Trial and Appeal Board involving Novo Nordisk's Ozempic (semaglutide), a trio of other generics manufacturers have announced that they intend to follow suit. Apotex Inc, Dr. Reddy's Laboratories Ltd. and Sun Pharmaceutical Industries Ltd. have all requested that the patent tribunal office terminate their respective inter partes reviews concerning US semaglutide dosing patent 10,335,462... Global Sub. Full

Zydus Gets US Nod for Schizophrenia Generic Medicine

(10/10, Press Trust Of India) ...Zydus Lifesciences Thursday said it has received final approval from the US health regulator to manufacture its generic version of Paliperidone extended-release tablets, used to treat schizophrenia. The approval by USFDA is for Paliperidone extended-release tablets of strengths 1.5 mg, 3 mg, 6 mg, and 9 mg, Zydus Lifesciences said in a regulatory filing... Full

Sandoz US Launches Generic Paclitaxel in Single-Dose Vial, Further Expanding US Oncology Portfolio

(10/11, Sandoz) ...Sandoz, the global leader in generic and biosimilar medicines, today announced that it has launched a generic paclitaxel formulation in the US, the first generic to its reference medicine to be approved by the US Food and Drug Administration. Sandoz paclitaxel protein-bound particles for injectable suspension (albumin-bound) is indicated for the treatment of patients with metastatic breast cancer... Full

Sanofi Discontinues Denali-Partnered MS Trial After Phase 2 Failure

(10/10, Max Bayer, Endpoints News) ...Denali said in an SEC filing Thursday that Sanofi notified the company that the drug, oditrasertib, did not meet primary or key secondary endpoints in the study. The drug looked to block RIPK1, a signaling protein that when overstimulated can drive neuroinflammation and cell death, root causes of diseases like multiple sclerosis. A Sanofi spokesperson said the company has no other planned studies... Full

Indivior's Opioid Treatment Sales Slump Prompts Second Profit Warning

(10/10, Yamini Kalia, Reuters) ...British drugmaker Indivior on Thursday issued its second profit and revenue warnings in three months, citing lower than expected sales from its opioid addiction treatment, sending its shares down as much as 21.5%. The company said that revenues from its opioid addiction treatment Sublocade have been negatively impacted by the rapid adoption of Brixadi, a competing drug developed by Swedish pharmaceutical firm Camurus... Full

Dave Ricks, CEO of Eli Lilly | The All-In Interview

(10/8, YouTube.com) ...Responding to criticism and research of GLP-1 dependency... Full

As Eli Lilly, Compounders Battle Over Weight Loss Drugs, Patients Are Caught in the Middle

(10/11, Elaine Chen, STAT) ...On Thursday, Lilly, which has long warned about the risks of knockoff products, also ramped up its fight against compounders, reportedly sending hundreds of cease-and-desist letters telling them and telehealth platforms to stop making their versions. At the same time, despite the FDA's declaration, pharmacies are still having trouble getting Lilly's treatment in stock. And even if they had supplies, many patients still can't afford the branded drugs, which carry a list price of over $1,000 a month and are not widely covered by insurers... Full

Eli Lilly Inks Another Obesity Pact, Doubling Down On Small Swiss Partner

(10/10, Kyle LaHucik, Endpoints News) ...Eli Lilly is returning to KeyBioscience, a nimble Swiss biotech, seven years after originally linking arms with the startup to work on dual amylin calcitonin receptor agonists for obesity and other conditions...Beyond its hallmark tirzepatide franchise, the drugmaker has at least five other experimental medicines in late-stage or Phase 2 testing for obesity. If KeyBioscience follows through with its projected timeline, it could expand Lilly's obesity pipeline to half a dozen drugs in mid- or late-stage trials by the end of 2024... Full

Wegovy Maker Novo Nordisk Bets Big On Talent, AI Partnerships in India

(10/11, Rishika Sadam and Haripriya Suresh, Reuters) ...Novo Nordisk, whose global profile has risen along with demand for its Wegovy weight-loss drug, is bolstering operations in the world's most populous nation by beefing up senior leadership in India and partnering with local AI start-ups, a top executive told Reuters... Full

Sandoz Report: A Unified Approach to Overcoming Drug Shortages

(10/10, Skylar Jeremias, The Center For Biosimilars) ...With drug shortages for chemotherapy drugs and generic medications are impacting over 90% of hospital systems nationwide, all stakeholders will need to collaborate and enact policy changes to eliminate them, according to a report from Sandoz... Full

Fresenius Medical Care Ramping Up Supply of IV Fluids and PD Products Post-Hurricane Helene and is Ensuring Safety of Patients and Employees in the Face of Hurricane Milton

(10/10, Fresenius Medical Care) ...Fresenius Medical Care, the world's leading provider of products and services for individuals with renal diseases, is supporting customers, patients, staff, and clinics to ensure there is no disruption in current or potential Fresenius Kidney Care Home patients receiving their peritoneal dialysis care. FME has a plan in place to monitor and conserve supplies, adjust prescriptions, and use other suppliers to help mitigate potential shortages from Hurricane Helene's impact on Baxter International's manufacturing site in western North Carolina... Full

Surging Demand Leaves Many Without Crucial Diabetes and ADHD Medications

(10/10, NBC) ...The sudden surge in popularity of drugs like Ozempic, driven in part by its weight loss benefits, is contributing to a record-high number of prescription drug shortages and sparking tense exchanges on TikTok...ADHD medications like Adderall and Vyvanse are also facing shortages, due in part to a significant increase in diagnoses during the COVID-19 pandemic...Although the two types of medication have joined some 300 drugs experiencing a shortage, the underlying reasons often differ. While manufacturing issues and supply chain bottlenecks are common culprits in most prescription drug shortages, ADHD and diabetes medications are particularly affected by an unprecedented surge in demand... Full

More Than 15 Million US Adults Have ADHD, New Study Estimates

(10/10, Puyaan Singh, Reuters) ...Roughly 15.5 million U.S. adults have attention-deficit hyperactivity disorder, and most of them struggle with gaining access to treatment for the condition, according to data from a U.S. study released on Thursday... Full

The Importance of Partnership: A Conversation with Takeda

(10/10, Lori Reilly, PhRMA) ...Strategic partnerships within the biopharmaceutical industry are key to accelerating the process of getting medicines to patients. I recently sat down with Pallavi Garg, Head of the U.S. Oncology Business Unit at Takeda, to explore how collaboration in our industry is driving progress in the fight against cancer. Our discussion highlights how Takeda's partnerships are not just addressing unmet needs in oncology, but also breaking down barriers to innovation. These efforts align with our industry's goal: ensuring groundbreaking medicines reach patients when they need them most... Full

For Generic Manufactures, New Medicare Drug Pricing Demo Is a Dud

(10/10, Sarah Karlin-Smith, Pink Sheet) ...The proposed CMS innovation center's $2 drug list model will not address the barriers to newer generics getting on Part D formularies and plans may have little incentive to participate in the demo, an industry group said...New information on Medicare's $2 generic drug copay innovation center model did not excite the generic drug industry because the list is dominated by medicines that are already highly genericized... Global Sub. Full

Inflation Reduction Act Proves Positive Boost for Biosimilars

(10/10, Ben Hargreaves, Pharma Phorum) ...For the pharma industry, the IRA has made headlines due to it allowing price negotiations on top-selling treatments. However, Ben Hargreaves finds that another provision within the Act was designed to encourage biosimilar uptake, and it seems to be working... Full

IQVIA: Patients Unlikely to See Savings from Medicare's Drug Price Negotiation

(10/10, Formulary Watch) ...The impact of the Inflation Reduction Act's drug price negotiations is likely to be more complex, and patients may not see the expected higher out-of-pocket savings, according to a new analysis from IQVIA Institute for Human Data Science that was commissioned by We Work For Health, a life-sciences focused policy organization... Full

Novo Blames Insurance, Not Its Programs, For Wegovy Cost Disparity

(10/10, Luke Zarzecki, InsideHealthPolicy) ...Novo Nordisk points to a lack of insurance coverage rather than its own pricing as the reason for patients' access issues when asked about the less robust patient assistant program it offers for weight-loss medication Wegovy compared with its diabetes counterpart Ozempic, coming as the company faces pressure from a patient advocate group to offer obesity patient assistance similar to that offered to diabetes patients... Sub. Req’d

Sen. Warren Urges FTC to ‘Carefully Scrutinize' Novo-Catalent Deal Over Competition Concerns

(10/10, Anna Brown, Endpoints News) ...Sen. Elizabeth Warren (D-MA) has put the spotlight on Novo Holdings' acquisition of Catalent, expressing concerns that the deal could give Novo Nordisk "unprecedented visibility" into its competitors' manufacturing and allow it to potentially dominate the obesity and weight loss market unfairly... Full

Michigan AG Seeks State Justices' Aid in Eli Lilly Insulin Probe

(10/10, Eric Heisig, Bloomberg Law) ...The Michigan attorney general's department, which wants to probe Eli Lilly & Co.'s insulin pricing practices, urged the state Supreme Court on Thursday to revisit precedent that it says hamstrings its investigative efforts...Lilly's attorney, John C. O'Quinn of Kirkland & Ellis LLP, said that overturning the cases would invite regulation through lawsuits in areas that are already "comprehensively regulated."... Sub. Req’d

EU Drug Regulators Seek Help To Shape Network's Future Until 2028

(10/10, Neena Brizmohun, Pink Sheet) ...More details on how the EU network of medicines agencies plan to leverage AI and foster competitiveness is now available in their draft 2025-2028 strategy, which they have published for comment...The strategy "will guide the network as it seizes opportunities and meets the challenges of the near future, including preparing for and responding to public health emergencies and threats such as antimicrobial resistance," said EMA executive director Emer Cooke... Global Sub. Full

EU Regulators Propose Updated Medicines Strategy to Include AI Growth, New Pharma Legislation

(10/10, Ferdous Al-Faruque, Regulatory Focus) ...The European Medicines Agency (EMA) and EU Heads of Medicines Agencies (HMA) have proposed an updated strategy for fostering the development and supply of drugs in the region over the next several years. The agency said that advancements in areas such as artificial intelligence (AI) and new legislative developments have led it to reconsider some aspects of its current five-year strategy... Full

Japan Takes Steps to Protect Pharmaceutical Supply to Forestall Potential China Curbs

(10/11, Julian Ryall, South China Morning Post) ...Japan is seeking to protect its pharmaceutical supply chain for the long term, with analysts saying the pre-emptive move is due to fears of China using exports to its neighbour as a bargaining chip in the event of a deterioration in bilateral ties. Such a scenario for the local pharmaceutical sector is plausible given that China curbed shipments of rare earth minerals to Japan following a dispute in the East China Sea in 2010, according to analysts... Full

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