Monday, December 23, 2024

Teva Loses US Appeal to Keep Inhaler Patents On FDA Protected Drug List

(12/20, Blake Brittain, Reuters) ...Teva Pharmaceuticals failed to convince a U.S. appeals court on Friday to reverse a decision that would remove patents related to its ProAir HFA inhaler from the U.S. Food and Drug Administration's Orange Book, which lists patents that protect drugs the FDA has deemed safe and effective...A Teva spokesperson said the company disagrees with the decision and is considering next steps... Full

Siding With FTC, Court Orders Teva To Delist Inhaler Patients From Orange Book

(12/20, Maaisha Osman, Inside Health Policy) ...The court dismissed Teva's effort to list patents solely covering inhaler components, clarifying that the listing statute mandates patents to "claim the drug," meaning they must specifically identify and distinctly claim at least the active pharmaceutical ingredient... Sub. Req’d

Orange Book Device Patent Listings: Understanding Teva v. Amneal

(12/20, Dennis Crouch, Patentlyo) ...[O]ur analysis of the numerous relevant statutory provisions and the relevant case law leads us to only one conclusion: To list a patent in the Orange Book, that patent must, among other things, claim the drug for which the applicant submitted the application and for which the application was approved. And to claim that drug, the patent must claim at least the active ingredient. Thus, patents claiming just the device components of the product approved in an NDA do not meet the listing requirement of claiming the drug for which the applicant submitted the application... Sub. Req’d

Who Will Emerge Victorious In US Showdown On Stelara?

(12/20, Dave Wallace, Generics Bulletin) ...In general, ustekinumab stakeholders will be hoping that lessons have been learned from the adalimumab experience, and that the market is able to be more receptive to Stelara biosimilars when they launch from the start of next year...Conversely, Teva's senior vice president of US market access Tom Rainey took a slightly more optimistic view. "I think now that they have the right recipe for these types of agents," he said. So in future, "you won't see that slow uptake that you've seen with the adalimumab market because everybody kind of knows what they're doing now."... Global Sub. Full

‘This Was Always Going To Be A Multi-Year Journey' – Sandoz's CEO On The Road Ahead

(12/23, Dave Wallace, Generics Bulletin) ...In the first instalment of a three-part interview with Richard Saynor, the Sandoz CEO talks about the aftermath of the company's spinoff from former parent Novartis and the work still left to do; the increasing prominence of biosimilars for Sandoz; the firm's investments in manufacturing; thoughts on the potential for significant M&A; and future opportunities for the industry leader... Global Sub. Full

Celltrion's Actemra Biosimilar Wins Approval in Korea

(12/23, Kim Ji-hye, Korea Biomedical Review) ...Celltrion said Monday that its biosimilar for Roche's autoimmune disease treatment Actemra (tocilizumab), branded as Avtozma (development code: CT-P47), has received approval from the Ministry of Food and Drug Safety in Korea... Full

Aurobindo Pharma Arm Secures UK MHRA Approval for Bevacizumab Biosimilar Bevqolva

(12/21, Jomy Jos Pullokaran, CNBC TV-18) ...Drug maker Aurobindo Pharma Ltd on Saturday (December 21) said its step-down subsidiary CuraTeQ Biologics s.r.o. has received marketing authorisation from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for Bevqolva, its biosimilar version of bevacizumab... Full

Lilly's Zepbound Scores 2nd Approval with Landmark FDA Nod in Obstructive Sleep Apnea

(12/20, Fraiser Kansteiner, Fierce Pharma) ...With the FDA's green light on Friday, Lilly's dual GIP/GLP-1 blockbuster Zepbound has become the first prescription medicine cleared to treat adults with moderate to severe obstructive sleep apnea and obesity. The nod marks the second indication for Zepbound after the inaugural obesity approval it scored in November 2023. The molecule underpinning the drug, tirzepatide, is also approved at lower doses for Type 2 diabetes under the brand name Mounjaro... Full

What Novo Nordisk's Disappointing Trial Results Mean for the Obesity Drug Market

(12/20, Elaine Chen, STAT+) ...Novo reported that, in a late-stage study, a next-generation obesity drug called CagriSema led patients to lose 20% of their weight at 68 weeks when looking at all participants — less than the company's own projection of about 25% weight loss...The results, and ensuing stock moves, raise questions for the broad landscape of obesity drug development and the way investors view emerging candidates. Here's a breakdown of the key questions and what we know so far... Sub. Req’d

Pharmacy Benefit Manager Reform Fails to Make the Cut in Federal Funding Package

(12/21, Tami Luhby, CNN) ...The slate of measures that would have injected more transparency into the industry and changed some of its practices were stripped from the massive bipartisan government funding package that was torpedoed by President-elect Donald Trump and billionaire Elon Musk on Wednesday. The final, vastly slimmed-down legislation, which prevented the federal government from shuttering, was signed by President Joe Biden on Saturday. However, the efforts to overhaul the PBM industry will likely continue next year... Full

Congress Passes CR Without Key Health Care Reforms, Setting Stage For March Bill

(12/20, Jalen Brown, Jessica Karins, Inside Health Policy) ...On a second attempt without the controversial debt ceiling measure, the House passed a three-month extension of key health programs, including Medicare telehealth flexibilities, in a continuing resolution (CR) to keep the government open through March 14, but excluded a physician payment patch, pharmacy benefit manager (PBM) reforms, and full reauthorization of the SUPPORT Act and PAHPA, and FDA's pediatric priority review voucher (PRV) program. President Joe Biden signed the bill Saturday... Sub. Req’d

CMS To End Costly MA VBID Model After 2025, Stakeholders Upset

(12/20, Amy Lotven, Inside Health Policy) ...But the agency says the Inflation Reduction Act’s expanded low-income subsidies and $2 generic drug list will help protect VBID enrollees from cost increases moving forward... Sub. Req’d

CSRxP: Disappointed Congress Did Not Pass Cornyn-Blumenthal and Q1/Q2 Reforms to Hold Big Pharma Accountable, Increase Competition

(12/21, The Campaign for Sustainable Rx Pricing) ..."CSRxP is disappointed Congress was not able to pass Cornyn-Blumenthal and Q1/Q2 reforms that would help hold Big Pharma accountable for gaming the system to extend monopolies and keep drug prices high," said CSRxP executive director Lauren Aronson. "These market-based solutions have previously garnered overwhelmingly bipartisan support, and CSRxP will continue working with a new administration and new Congress to pass these, and additional solutions, to lower drug prices for patients by cracking down on Big Pharma's egregious anti-competitive practices."... Full

Warren, Smith Reintroduce Bill to Strengthen US Pharmaceutical Supply Chains

(12/20, Joseph Choi, The Hill) ...Democratic Sens. Elizabeth Warren (Mass.) and Tina Smith (Minn.) are reintroducing legislation aimed at strengthening U.S. pharmaceutical supply chains, warning the U.S. is overly relying on other countries for medications. The Pharmaceutical Supply Chain Defense and Enhancement Act was first introduced in 2020, not long after the start of the COVID-19 pandemic. The bill was spurred by concerns over the U.S.'s pharmaceutical supply chain resilience... Full

HHS Releases Latest Round of Prescriptions in Medicare Rebate Program Including Cancer Drugs

(12/20, Emma Beavins, Fierce Healthcare) ...As part of the Inflation Reduction Act, drug manufacturers must give rebates to the federal government for single source drugs and biological products, including certain biosimilar biological products, whose price increased more than the rate of inflation. The list of discounted drugs changes each quarter. The 64 drugs (PDF) with reduced co-insurance costs for Medicare patients include Kepivance, which treats mouth sores caused by chemotherapy, Talvey, used to treat patients with multiple myeloma, and Yescarta for recurrent or treatment-resistant blood cancer... Full

AAM Applauds Senate Bill to Protect Patient Access to Affordable Medicines

(12/19, AAM) ...Today, the Association for Accessible Medicines, the leading trade association for generic and biosimilar manufacturers, applauds and supports S. 5573, The Skinny Labels, Big Savings Act. S. 5573 provides a safe harbor for skinny labeling, propelling patient access to lower-cost generic medications and protecting the overall health care system. AAM thanks Senators Hickenlooper, Cotton, Welch, and Collins, for their commitment and dedication to patients—especially as skinny label generics decrease the cost of a given drug across branded and generics by 98 percent, on average... Full

Califf, On His Way Out at FDA, Predicts Agency Tug-of-War Between Ramaswamy and RFK Jr.

(12/20, Zachary Brennan, Endpoints News) ...FDA Commissioner Rob Califf has only a few weeks left before he steps down with the change in administrations. But he recently predicted that the next person to head the agency will face a battle over its direction waged by two of President-elect Donald Trump's top deputies..."If you try to reconcile" Kennedy and Ramaswamy's viewpoints, Califf said Friday, "it's like totally opposite. So I don't know who's going to win out."... Full

NPPA Sets Retail Prices for 65 Drugs, Revises Ceiling for 20 Formulations

(12/23, Sanket Koul, Business Standard) ...The National Pharmaceutical Pricing Authority (NPPA) has fixed retail prices for 65 new drug formulations and notified ceiling price fixation of 13 formulations. The regulatory body, under the Department of Pharmaceuticals, also revised the ceiling prices of seven other drugs to include the impact of the 0.00551 per cent increase in drug prices in the National List of Essential Drugs (NLEM), based on the changes in the wholesale price index (WPI) for 2024... Full

Over 14,000 Janaushadhi Kendras Set Up To Make Generic Medicines Affordable, Says Nadda

(12/20, Press Trust Of India) ...Under the Pradhan Mantri Bhartiya Janaushadhi Pariyojana Scheme, 2,047 types of medicines and 300 surgical devices have been brought under its ambit, including cardiovascular, anti-cancer, anti-diabetic drugs, JP Nadda said in a written response to a question... Full

Which Pharma Companies Will Benefit from Latest Government Policies? Sumit Gupta Explains

(12/23, The Economic Times) ...Sumit Gupta, AVP-Research, Centrum Broking, says the government is providing a push towards manufacturing and R&D. Indian pharma has technical know-how. Now, the government wants to do technical ‘know-why'. Say Indian companies are currently doing CDMO manufacturing for MNC players. The government wants us to do R&D, build on some basically blockbuster drugs and then outsource that to some other countries... Full

Weight-Loss Drugs: A Game Changer for India's Top Pharma Companies

(12/23, Sonia Boolchandani, Mint) ...As the patent expirations of blockbuster weight-loss drugs like liraglutide and semaglutide open the door for generics, Indian pharmaceutical companies are positioning themselves to take advantage of this rapidly growing market. With a focus on both developing their own GLP-1 drugs and bringing affordable generics to the market, companies like Sun Pharma, Cipla, Dr. Reddy's, Lupin, Biocon and Natco are positioning themselves as key players in this expanding sector. As demand for effective and affordable obesity treatments continues to rise, these companies are well-placed to capture a significant share of the global weight-loss drug market... Sub. Req’d

Three Ministers Agree On Off-Year Drug Price Revision in FY2025

(12/23, Pharma Japan) ...The policy was agreed upon by Chief Cabinet Secretary Yoshimasa Hayashi, Finance Minister Katsunobu Kato, and Health Minister Takamaro Fukuoka. Here is the summary of their agreement, which was made exactly eight years after their then predecessors decided to introduce the scheme of annual drug re-pricing: The NHI price revision for FY2025 will be implemented as follows based on a drug price survey conducted in 2024... Sub. Req’d

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