Tuesday, December 24, 2024

Please note: Teva Daily News will resume publication on January 2, 2025. Happy Holidays!

Federal Appeals Court Says Teva Must Delist Orange Book Inhaler Patents

(12/23, Nicole DeFeudis, Endpoints News) ...The Federal Trade Commission is praising an appeals court decision calling for Teva to delist five inhaler patents from the FDA's Orange Book...A Teva spokesperson told Endpoints News on Monday that the company "disagrees with the decision," and is "reviewing next steps."... Full

Federal Circuit Decides Case Involving Orange Book Listing of Device Patents

(12/23, Chad A. Landmon, Andrew M. Solomon, The National Law Review) ...Although this decision appears to put to bed the dispute over listing patents in the Orange Book that are directed solely to a delivery device, Teva may still file for a rehearing or rehearing en banc of the December 20 ruling with the Federal Circuit. In addition, it's possible that Teva could also file an appeal to the United States Supreme Court... Full

FTC Orders Teva to Delist Inhaler Patents

(12/23, The Pharma Letter) ...The appellate court order stems from a case brought by Teva against drugmaker Amneal Pharmaceuticals after the latter sought Food and Drug Administration approval to bring a generic version of the asthma inhaler ProAir HFA to market... Sub. Req’d

7 Drugs Now in Shortage

(12/23, Paige Twenter, Becker's Hospital Review) ...Morphine sulfate extended-release tablets: As of Dec. 12, eight presentations of the painkiller medication are on back order and 16 are available. Rhodes Pharmaceuticals, Major Pharmaceuticals and Teva Pharmaceuticals said they expect more supply to be available between late December and early January. The ASHP said Mallinckrodt Pharmaceuticals refuses to provide availability information... Full

US FDA Approves Hikma's Generic Version of Novo's Diabetes Drug Victoza

(12/23, Bhanvi Satija, Sriparna Roy and Puyaan Singh, Reuters) ...The U.S. Food and Drug Administration on Monday approved Hikma Pharmaceuticals' generic version of Novo Nordisk's diabetes drug Victoza, clearing the way for the launch of another copy of the treatment in the country. Hikma's branded generic will compete with Teva Pharmaceuticals authorized generic of Victoza in the United States that was launched earlier this year... Full

There's Still No Generic Ozempic, But a Lower-Priced Daily Injected GLP-1 is Coming

(12/23, Meg Tirrell, CNN) ...The generic liraglutide is sold by Hikma Pharmaceuticals USA, and a spokesman told CNN by email that the company expects to make the drug available nationwide before the end of the year. The company didn't disclose the planned price of the generic, noting only that it "will cost less than branded Victoza."...Teva Pharmaceuticals, another maker of generic medicines, introduced an authorized generic version of liraglutide in June in the US, under a settlement agreement struck with Novo Nordisk in 2019. The authorized generic is manufactured by Novo Nordisk, and distributed and sold by Teva... Full

Biocon, Zentiva Get EU Approval for Generic Diabetes, Weight Management Drug

(12/24, Press Trust Of India) ...Biocon Ltd and Zentiva have secured decentralised procedure approval in the EU for Liraglutide, a complex formulation used for diabetes and weight management. This approval targets the generic versions of Novo Nordisk's Victoza and Saxenda, authorising their use in multiple EU member states simultaneously... Full

Lilly Obesity Drug Mounjaro to Be Offered in Britain's NHS After Watchdog Nod

(12/23, Maggie Fick, Reuters) ...Eli Lilly's obesity drug Mounjaro will be available through Britain's state health system for some patients from March, after the drugs cost-effectiveness watchdog NICE on Monday gave its blessing. Mounjaro launched in Britain in February but has been available only for those paying privately, mainly through online pharmacies... Full

AstraZeneca Withdraws EU Application for Experimental Lung Cancer Drug

(12/24, Vasudha Mukherjee, Business Standard) ...AstraZeneca has voluntarily withdrawn its marketing authorisation application to the European Medicines Agency for datopotamab deruxtecan (Dato-DXd), an experimental precision drug for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer. In a press release on Tuesday, the pharma said that the decision follows feedback from the EMA's Committee for Medicinal Products for Human Use... Full

US FDA Restricts Imports of Some Viatris Drugs Made at India Facility

(12/23, Sneha S K, Reuters) ...Viatris said on Monday the U.S. Food and Drug Administration has restricted imports of 11 products made at the drugmaker's facility in India after the regulator's inspection found it had violated federal requirements...It was not immediately clear which products were affected. The drugmaker said the facility makes oral finished doses such as tablets and capsules. Due to shortage concerns, the agency has made conditional exceptions for four products, Viatris said. There could be potential for additional exceptions based on further discussions with the FDA... Full

Generic Platinum Chemotherapy Shortages Did Not Increase Deaths

(12/23, Penn Today) ...During a shortage of the generic platinum chemotherapy drugs cisplatin and carboplatin that began in early 2023, there was no difference in mortality rates among patients with advanced cancer compared to the previous year, and prescription rates for the two drugs fell less than 3% overall—and 15.1% at the peak—according to an analysis published in the Journal of the National Cancer Institute by researchers from the Perelman School of Medicine and Penn Medicine's Abramson Cancer Center... Full

Welch Joins Hickenlooper, Cotton, Collins in Introducing Bipartisan Skinny Labels, Big Savings Act to Safeguard Generic Drugs, Slash Drug Prices

(12/23, U.S. Senator for Vermont Peter Welch) ..."Big pharma uses endless patent litigation to squeeze patients and stop competitors from coming into the market," said Senator Hickenlooper. "Our bill levels the playing field so generic drug manufacturers can help working people afford life-saving medication."... Full

Employers Mourn Loss of Drug Data Transparency in Stopgap Bill

(12/23, Lauren Clason, Bloomberg Law) ..."If the incoming administration wants to reduce wasteful spending and inefficiencies, relooking at this provision is a great place to start," Purchaser Business Group on Health CEO Elizabeth Mitchell said in a statement... Sub. Req’d

CMS Explains What Went into its First Round of Drug Price Negotiations

(12/23, Zachary Brennan and Nicole DeFeudis, Endpoints News) ...CMS said it wants earlier and more flexible communication with drugmakers during this next round of negotiations. Multiple drugmakers participating in the first round of negotiations have complained that the process was not transparent or objective, likening the process to price-setting. A Novartis spokesperson told Endpoints News on Monday that the process "does not reflect the true value of a medicine."... Full

Amgen, Lilly Sue HHS Over Clinics in Drug Discount Program

(12/23, Nyah Phengsitthy, Bloomberg Law) ...Amgen Inc., Eli Lilly & Co., and UCB Inc. are challenging approvals from the US Department of Health and Human Services that allow certain clinics to obtain discounted drugs from manufacturers under the federal 340B Drug Pricing Program, according to a complaint filed Dec. 20 in the US District Court for the District of Columbia... Sub. Req’d

Colorado's Pharma, Hospital Industries Prepare for Fight Over Drug Discounts

(12/23, Analisa Romano, Denver Business Journal) ...The battle is expected to erupt over proposed changes to the federal 340B Drug Pricing Program, which requires drug manufacturers to sell some of their medications at a significant discount to safety net hospitals in exchange for payment from federal Medicaid and Medicare programs... Sub. Req’d

PhRMA Dues Fell Almost $100 Million as Major Drugmakers Exited

(12/23, Rachel Cohrs Zhang, STAT+) ...Since Democrats passed the drug pricing law, which allowed Medicare for the first time to negotiate with drugmakers over the prices the country's largest purchaser pays for medications, several members decided to leave PhRMA, including AbbVie, Teva, and AstraZeneca. The most recent tax filings are the first to reflect the departures in PhRMA's financial results... Sub. Req’d

Indian Pharma Companies Focus On Innovative Research in Foreign Countries Through Dedicated Entities

(12/24, Financial Express) ...Prashant Khadayate, Pharma Analyst at GlobalData, comments: "By demerging R&D units and creating new R&D companies, parent firms de-risk their main business from the risks associated with the failure of research projects without impacting the profit and loss of the main business. Moreover, research companies could expect to raise more funds from investors."... Full

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