Friday, January 17, 2025

 

Please note: Teva Daily News will not publish January 20 in observance of the U.S. Martin Luther King Jr. holiday. Publication will resume on Tuesday, January 21.

Ozempic is in the Next Round of Medicare Drug Price Negotiations. See the Full List of 15 Medications

(1/17, Annika Kim Constantino, CNBC) ...The agreed-upon prices for the second wave of drugs are scheduled to go into effect in 2027. Here are the 15 drugs subject to the initial talks this year...Austedo, Austedo XR, made by Teva Pharmaceuticals, is used to treat involuntary movements caused by tardive dyskinesia or Huntington's disease... Full

Teva Says it Has a 'Unique Position' in Latest IRA Challenge

(1/16, Nicole DeFeudis, Endpoints News) ...The drugmaker is not currently involved in negotiations under the Inflation Reduction Act, though it says one of its top-selling products could be impacted by the next cycle. Teva is specifically challenging CMS' implementation of the IRA, including how it selects drugs for eligibility. The company told Endpoints News on Thursday that its position as a manufacturer of both brand-name drugs and generics means it has "different grounds" to challenge certain aspects of the law... Full

CMS Faces Renewed Legal Pressure On Drug Price Negotiation Program

(1/16, Noah Tong, Fierce Healthcare) ...Teva claims the program is a "fiction" and "upsets the delicate balance between innovation and affordability," in its lawsuit. The company argues CMS guidance contradicts key elements of the IRA, which dictate drugs are only eligible for the program if they've been marketed for a specified amount of time or declares they are exempt when non-branded competitors enter the market... Full

Teva Price Target Raised to $30 from $23 at Piper Sandler

(1/17, The Fly) ...The firm discussed the development of anti-TL1A antagonist duvakitug beyond just inflammatory bowel disease in the wake of its recent positive results in ulcerative colitis and Crohn's disease. It believes further multiple expansion for the shares is justified amid Teva's growing brand neuropsychiatry sales footprint and advancing pipeline... Full

AbbVie Retains Humira Market Share Above 70%: Report

(1/16, Dualn Lokuwithana, Seeking Alpha) ...AbbVie has managed to keep its market share for its bestselling arthritis therapy, Humira, above 70%, generic drugmaker Samsung Bioepis said in a new report on Thursday as the blockbuster marks its second anniversary of its U.S. biosimilar threat...Meanwhile, the contributions from other notable adalimumab makers, Amgen, Teva/Alvotech, and Pfizer, to the market stand at 3% or less, according to Samsung Bioepis... Full

Biosimilars Drive Cost Savings and Achieve 53% Market Share Across Treatment Areas

(1/16, Skylar Jeremias, The Center For Biosimilars) ...Biosimilar launches have resulted in both 53% market share in biosimilar markets and a 53% reduction in average drug costs after 5 years of biosimilar competition, according to Samsung Bioepis' First Quarter (Q1) 2025 Biosimilar Market Report. The report details the Q1 2025 average sales price (ASP) and wholesale acquisition cost (WAC) for commercially available biosimilars in the US, along with price and market share trends since each biosimilar's launch... Full

M&Ms And PBMs: Sandoz CEO Talks Antibiotics And Ustekinumab

(1/17, Dave Wallace, Generics Bulletin) ..."Sandoz has been in antibiotics since 1945. So it's part of our history, part of our DNA," he set out. And the business had "certainly given me phenomenal access," he observed. "Most governments, including the US government, want to talk to us." But "I think now we need to find ways to think about a more sustainable business model to make sure that these are strategic assets," Saynor suggested, having previously pushed back against the "dysfunctional" market model for antibiotics that treated such essential products as commodities... Global Sub. Full

Richter, Mochida To Move Ahead On European, Japanese Tocilizumab Filings

(1/17, Dean Rudge, Generics Bulletin) ...Japan's Mochida Pharmaceutical has confirmed plans to file its Gedeon Richter-partnered RGB-19 biosimilar tocilizumab candidate in Japan after achieving positive topline results from Phase I and Phase III clinical studies – but has stopped short of providing a firm date for action. Meanwhile, Richter expects to file for marketing authorization applications for RGB-19 in "major European markets in the coming months."... Global Sub. Full

AstraZeneca Pharma Gets Nod To Import New Drug Eculizumab

(1/16, NDTV Profit) ...AstraZeneca Pharma India Ltd. on Thursday said that it has received the permission to import a new drug formulation into India. According to the exchange filing, regulatory authority Central Drugs Standard Control Organisation has allowed it to import pharmaceutical formulations of its drug Eculizumab for sale or for distribution in India... Full

AstraZeneca's Calquence Clears First-Line Mantle Cell Lymphoma Hurdle

(1/17, Elizabeth S. Eaton, FirstWord Pharma) ...The US regulator on Thursday handed down a full approval for Calquence to be used in combination with bendamustine and rituximab to treat adults with treatment-naïve MCL who are ineligible for autologous haematopoietic stem cell transplantation. The FDA also converted the 2017 accelerated approval of Calquence monotherapy into a full approval for second-line MCL... Full

Xentria Ramps Up Clinical Focus On Biosimilars In 2025

(1/16, Adam Zamecnik, Generics Bulletin) ...Specifically, Xentria is working on pushing its anti-TNFa monoclonal antibody XTMAB-16 through the clinical arena. The pulmonary sarcoidosis treatment is now in a Phase Ib/2a clinical trial, having already started in the United Kingdom last year while also receiving the green light for operations in the EU. Pulmonary sarcoidosis is a chronic, multisystem inflammatory disorder... Global Sub. Full

After Delay, FDA Approves Amgen's Lumakras, Vectibix Combo for Second-Line CRC

(1/17, Pavan Kamat, FirstWord Pharma) ...Following a three-month review extension, the FDA stuck to its target action date, approving Amgen's KRAS inhibitor Lumakras (sotorasib) in combination with the EGFR antibody Vectibix (panitumumab) to treat patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), who have progressed on standard fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy regimens... Full

USFDA Issues Warning Against Use of Anti-Allergic Nasal Spray Intravenously

(1/17, Sushmita Panda, Financial Express) ...The United States Food and Drug Administration has warned health care professionals not to use unapproved epinephrine nasal solutions..."The nasal solution and injectable products have similar packaging and containers and are manufactured by the same companies. The similarities of the bottle and packaging labels between the nasal product and the sterile injectable make it difficult to distinguish them from each other which can lead to health care professionals accidentally injecting the nasal solution instead of the injection product," it stated on Thursday... Full

Mylan to Pay $73.5 Mln to Settle Drug Wholesalers' EpiPen Antitrust Claims

(1/16, Mike Scarcella, Reuters) ...Drug wholesalers including KPH Healthcare and FWK Holdings said Mylan conspired with Pfizer to delay launching a generic EpiPen, causing commercial and other buyers to pay more for the life-saving device. Mylan is now part of Viatris. Mylan did not admit to any wrongdoing, and neither did Pfizer, which settled related claims from the drug wholesalers for $50 million in 2023... Full

DC Appeals Court Halts Launch of Generic to Novartis' Heart Drug

(1/16, Zachary Brennan, Endpoints News) ...The US Court of Appeals for the DC Circuit placed a temporary pause on MSN Pharmaceuticals' Entresto generic launch, which could've come as soon as Thursday. The appeals court Wednesday evening made clear that it's only pausing the launch to consider Novartis' emergency motion, and its decision is not based on the merits of that motion. Earlier Wednesday, the district court paved the way for the launch of MSN's generic, denying Novartis's motion to stop it... Full

Roche's Cardiometabolic Chief Warns Against Weight Loss 'Obsession' with GLP-1s

(1/16, Max Bayer, Endpoints News) ...The rise of GLP-1s has made treating obesity one of the largest market opportunities in history. It also has reinforced a detrimental relationship between physical health and size, according to one pharma executive. "Unfortunately, our society is obsessed with physical image," Manu Chakravarthy, Roche's head of cardiometabolic and renal product development, said on the sidelines of the JP Morgan Healthcare Conference... Full

Indian Pharma Companies Ignite Innovation in Diabetes

(1/17, The Pharma Letter) ...Even as the global diabetes war continues to rage, Indian pharmaceutical companies are emerging from the shadows, armed with an arsenal of innovative drugs and therapies. Several homegrown giants are not only tackling the diabetes crisis within the country, but also making waves on the international stage, reports The Pharma Letter's India correspondent... Sub. Req’d

Pharma Companies "Really Responsible" for Drug Prices, Brian Thompson's Boss Says

(1/16, Nathan Bomey, Axios) ...The CEO of the company whose insurance leader was killed in New York pledged to help fix the health care industry while also defending his business and blaming pharmaceutical companies for driving up healthcare costs with drug prices... Full

Optum Rx Commits to Passing Through 100% of Drug Rebates, Witty Says

(1/16, Paige Minemyer, Fierce Healthcare) ...CEO Andrew Witty told investors on Thursday during the company's earnings call that Optum currently passes through 98% of rebates to the insurers, states and unions that contract with it. The remaining 2% remain in a more traditional rebate model because that's their preference, he said... Full

JP Morgan 2025: GoodRx Takes Aim at US Drug Pricing Challenges

(1/16, Jenna Philpott, Pharmaceutical Technology) ...At the 2025 JP Morgan Healthcare Conference, GoodRx's recently appointed CEO Wendy Barnes highlighted the company's strategic position to address the gaps in the US healthcare landscape. Referring to these gaps as "white space," Barnes emphasised GoodRx's ability to bridge the divide between pharmaceutical manufacturers, pharmacies, pharmacy benefit managers, and healthcare providers. This fragmented ecosystem often results in misaligned incentives, complicating access to affordable medication for patients... Full

CRS Report: Congress Could Reform Orange Book To Tackle High Rx Prices

(1/16, Maaisha Osman, Inside Health Policy) ...A Congressional Research Service report says Congress could address drug companies' patent abuses by overhauling the FDA's Orange Book system, with potential reforms including expanding FDA's oversight, clarifying eligible patent types, and limiting the 30-month stay that delays generic drug approvals during patent litigation...The stakes are high for both the pharmaceutical industry and consumers. Brand-name drugmakers warn that narrowing Orange Book protections could stifle innovation, while advocates for generic drugs argue that the current system prioritizes corporate profits over patient access... Sub. Req’d

CMS Floats New Part D Policies In Draft CY 2026 Instructions

(1/16, Gabrielle Wanneh, Inside Health Policy) ...The Jan. 10 draft instructions suggest that creditable Part D coverage must pay at least 72% of an enrollee's drug expenses, an increase from 60% under the current methodology. The instructions also lay out potential ways to allow automatic substitution of interchangeable and non-interchangeable biosimilars, as well as more details on subsidies provided to beneficiaries receiving drugs for which prices have been negotiate... Sub. Req’d

Novartis Enters Fight Against HHS for Denying its 340B Rebate Model

(1/16, Alexis Kramer, Endpoints News) ...Novartis is the latest drugmaker to sue the government for allegedly rejecting its proposed model to distribute federal drug discounts. The lawsuit marks the fifth drugmaker to challenge HHS' Health Resources and Services Administration over its refusal to let companies shift to a rebate model under the 340B drug discount program. Novartis filed its complaint Wednesday in the US District Court for the District of Columbia... Full

HHS Blasts Boehringer's Drug Price Case, Reveals New Details On Jardiance Talks

(1/16, Nicole DeFeudis, Endpoints News) ...The government on Wednesday urged the US Court of Appeals for the Second Circuit to uphold that decision. It argued in a court brief that "economic incentives for manufacturers to participate in Medicare and Medicaid do not make such participation involuntary."... Full

Califf: US FDA Center Directors Should Engage With Staff Earlier To Avoid Public Disagreements

(1/17, Sarah Karlin-Smith, Pink Sheet) ...FDA center directors should engage with staff earlier in an application review to avoid internal agency disputes about a drug's approval becoming public, outgoing commissioner Robert Califf said. Califf, in response to a Pink Sheet question, said he'd rather the agency make some decisions he disagreed with rather than set a precedent of a political appointee interfering in approvals... Global Sub. Full

FDA Beats EMA to Most Approved New Drugs in 2024

(1/17, Robert Barrie, Pharmaceutical Technology) ...Whilst racking up 50 novel drug approvals, the FDA approved fewer than it did in 2023, when there were 55 greenlit to market. Conversely, the EMA's 2024 figure of 46 was a step up from the 39 new active substance drugs approved in 2023... Full

Pharmaceutical Companies Spike EpiPen Prices 600% While Allegedly Deceiving Hoosier Consumers

(1/16, Office Of The Indiana Attorney General) ...Attorney General Todd Rokita has filed a lawsuit alleging that Mylan and Pfizer have conspired to increase EpiPen's price by more than 600% in order to continue to profit from EpiPen prescriptions and prevent other similar products from coming to market and being available to consumers. EpiPens are potentially life-saving devices used to inject adrenaline into patients to combat severe allergic reactions... Full

Wisconsin Democrats Want to Cut Cost of Prescription Drugs, School Meals and Housing with New Bills

(1/17, Baylor Spears, Wisconsin Examiner) ...Freshman Rep. Ryan Spaude (D-Ashwaubenon) said at a press conference that the package of bills is "just the first of many proposals to come that will help Wisconsinites, who are struggling with the cost of living." At a press conference, Spaude introduced the first bill, aimed at alleviating the cost of prescription drugs and increasing price transparency... Full

Arkansas Lawmakers Seek to Ban Prescription Drug Middlemen from Owning Pharmacies in the State

(1/16, Tess Vrbin, Arkansas Advocate) ...Lawmakers and pharmacy advocates promoted the newly filed House Bill 1150 at a press conference in the Capitol rotunda Thursday. They said the policy would eliminate "anticompetitive" business practices by PBMs, which negotiate prescription benefits among drug manufacturers, distributors, pharmacies and health insurance providers... Full

EMA's Conflict Of Interest Rules Must Not Limit Access To Experts And Risk Innovation, Warns Industry

(1/16, Francesca Bruce, Pink Sheet) ...Strict interpretations of ‘conflict of interest' (CoI) in the European Medicines Agency policy on handling such concerns among committee members and experts could exacerbate "significant workforce challenges," particularly as research is becoming increasingly specialized, according to EFPIA, the federation representing the R&D-based pharmaceutical industry in Europe... Global Sub. Full

EMA in 2024 Recommended Highest Number of Drug Approvals in 15 Years

(1/16, Ayisha Sharma, Endpoints News) ...The EMA's human medicines committee recommended 114 medicines for approval in 2024, marking the highest number of positive opinions issued in 15 years, according to the regulator's latest report. Of the 114 recommendations, 46 were for new active substances, the EMA's chief medical officer Steffen Thirstrup said at a press conference on Thursday. Cancer remained the therapeutic area with the most approvals in 2024, followed by immunology, rheumatology, blood and coagulation disorders, and endocrinology, he added... Full

UK's MHRA To Offer Private Meetings For Innovative RWE Strategies

(1/16, Eliza Slawther, Pink Sheet) ...A new real-world evidence (RWE) program, set to be launched by the UK's Medicines and Healthcare products Regulatory Agency, will see innovative drug developers benefit from private meetings with representatives from the agency and England's health technology assessment (HTA) body, NICE. A pilot version of the RWE scientific dialog program will begin this year, and an MHRA spokesperson told the Pink Sheet that it "anticipate[s] offering approximately four closed-door, confidential meetings and one pre-competitive, ‘safe harbor', workshop jointly convened with NICE."... Global Sub. Full

WHO Outlines Best Practices for Continuous Manufacturing

(1/16, Joanne S. Eglovitch, Regulatory Focus) ...The "points to consider" document mainly focuses on solid oral dosage forms, but its principles also apply to biologics and vaccines. The initial working document was published in June 2024 and was finalized by an informal drafting group in November 2024. WHO plans to review comments and issue a working document for possible adoption by its Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) in June 2025... Full

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