Tuesday, January 21, 2025

Teva Sues Over IRA Price Negotiation, Its Huntington Disease Drugs On New CMS List

(1/17, Gabrielle Wanneh, Jessica Karins, Inside Health Policy) ...Teva sued in CMS over Medicare drug price negotiation in the DC district court Thursday (Jan. 17), a day before the outgoing Biden administration revealed the company's two Huntington Disease drugs are on the next negotiation list. The suit specifically targets CMS' interpretation of a "single source" drug and "bonafide marketing" of a generic drug biosimilar... Sub. Req’d

Teva Files Lawsuit Against Drug-Price Negotiations

(1/17, Susan Morse, Healthcare Finance) ...Teva filed the civil action on Wednesday in federal court in Washington, D.C. as the Centers for Medicare and Medicaid Services released the next 15 drugs subject to price negotiations. At the top of the CMS list is Ozempic, Rybelsus and Wegovy, semaglutide drugs popular for weight loss made by Novo Nordisk. Teva makes two on the CMS list: Austedo and Austedo XR, drugs used to treat symptoms of tardive dyskinesia and Huntington's disease. Teva Pharmaceuticals also makes generic drugs and biosimilars such as acetaminophen and amoxicillin... Full

Medicare Price Negotiation Round Two: New Administration, More Drugs, Less Time

(1/20, Cathy Kelly, Pink Sheet) ...CMS released the list of 15 Medicare Part D drugs selected for the second cycle on January 17, kicking off a negotiation process that will end nine months later on November 1...Other high-priced specialty drugs selected include Boehringer Ingelheim's Ofev for idiopathic pulmonary fibrosis and Teva's Austedo for chorea in Huntington's disease and tardive dyskinesia. Teva anticipated Austedo's inclusion in a lawsuit filed on January 15. The complaint also argues that its plans for generic versions of three other drugs on the second round list and one negotiated in the first round will be unfairly disrupted by the government price reductions. Teva plans to launch generics for Boehringer Ingelheim's Ofev, AbbVie's Linzess, Xtandi and Johnson & Johnson's Xarelto... Global Sub. Full

Ozempic Among the Next Drugs Up for Medicare Price Negotiations

(1/17, Peter Loftus and Liz Essley Whyte, The Wall Street Journal) ...Some companies with drugs on the list including Pfizer, Teva and Bristol-Myers, criticized the negotiations. Drugmakers have opposed the Medicare negotiations, some even filing lawsuits to try to overturn the portion of the federal law that authorized the negotiations. On Wednesday, Teva's U.S. unit sued federal health officials, seeking a court order that bars the inclusion of Teva drugs in negotiations. The company said it had expected Austedo to be included in the latest list of drugs for Medicare negotiations... Sub. Req’d

Biden's HHS Bids Farewell With List Of 15 Drugs, Including GLP-1s, For Next Negotiations

(1/17, Gabrielle Wanneh and Donna Haseley, Inside Health Policy) ...The Biden administration on Friday (Jan. 17) announced the 15 drugs -- which include GLP-1 diabetes drugs, cancer and asthma treatments -- it has selected for the next round of Medicare price negotiation, unveiling the list before the Feb. 1 deadline in an apparent attempt to shape the next round of price talks before the Trump administration takes over Monday (Jan. 20)...Just ahead of the news, Teva Pharmaceuticals on Wednesday (Jan. 15) filed a complaint in a Washington D.C. district court against HHS' continued implementation of the IRA drug price negotiation provisions... Sub. Req’d

US Targets Novo Nordisk's Ozempic and Wegovy for Medicare Price Talks

(1/17, Michael Erman, Ahmed Aboulenein and Bhanvi Satija, Reuters) ...Other drugs on the list include Pfizer's cancer drugs Ibrance and Xtandi, GSK's asthma and chronic obstructive pulmonary disease (COPD) treatment Trelegy Ellipta, Teva's Huntington's disease treatment Austedo and Abbvie's irritable bowel syndrome drug Linzess...Biden administration officials said all forms of dosages and strengths of drugs selected for negotiation are included... Full

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

(1/17, Annika Kim Constantino, CNBC) ...In separate statements, Bristol Myers Squibb, Teva Pharmaceuticals and Boehringer Ingelheim argued that the price talks could hurt patient access and future innovation in the industry...The government will only select Medicare Part D drugs for the first two rounds of negotiations. It will add more specialized medications covered by Medicare Part B, which are typically administered by doctors, in 2028. But drugmakers will have more opportunities to negotiate with Medicare, based on the final guidance released in October for the second round of price talks... Full

Medicare to Negotiate Lower Prices for Weight-Loss Drugs

(1/17, Rebecca Robbins, The New York Times) ...The nonpartisan Congressional Budget Office projected that thanks to the negotiations, Medicare's prices for semaglutide products "will fall substantially beginning in 2027."...That would slow the growth of the government's spending on obesity drugs even as more people on Medicare started using them...Drugs Selected for Medicare's Second Round of Price Negotiations. Prices will go into effect in 2027...Austedo and Austedo XR, for neurological diseases, from Teva Pharmaceuticals... Sub. Req’d

Amneal Is Targeting 70% Of Untapped Biologics In The ‘Golden Era' Of Biosimilars

(1/17, Urte Fultinaviciute, Generics Bulletin) ...However, Amneal is interested in a less popular opportunity – going after biologics with little to no off-patent competition. Patel explained that there are 100 biologics that will be open to competition from biosimilars globally, but only 30 of them are being worked on. While the rest of them are smaller opportunities, in the $500m to $1bn turnover range, Amneal sees it as an untapped area, an approach in which the firm already had some experience... Global Sub. Full

‘Dark Days' Are Over For Generics Division, Says Hikma CEO

(1/20, Adam Zamecnik, Generics Bulletin) ...As of now, the company's injectables division generates "well over" $1bn in revenue, and makes up almost half of Hikma's core operating profits. According to the firm's CEO Riad Mishlawi, Hikma's injectables business now reports revenue growth in the high single-digits, which is now boosted by last year's deal with Xellia for a portfolio of products and a manufacturing facility, which was completed in September 2024... Global Sub. Full

AstraZeneca's Calquence and Amgen's Lumakras Clinch FDA Label Expansions

(1/17, Zoey Becker, Fierce Pharma) ...Calquence, in combination with chemotherapy bendamustine and Roche's Rituxan, can now treat patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation...As for Amgen, the company's Lumakras and Vectibix combination was granted approval to treat patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC) who have received prior fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy... Full

AstraZeneca's Fasenra Set to Revolutionise COPD Treatment as Phase III Data Builds Anticipation

(1/19, Financial Express) ...AstraZeneca's Fasenra (benralizumab), with its highly anticipated Phase III data to be showcased at the 2025 J.P. Morgan Healthcare Conference, is set to transform the chronic obstructive pulmonary disease (COPD) treatment. As the first IL-5-targeting monoclonal antibody in late-stage trials, Fasenra targets eosinophilic inflammation, potentially reshaping treatment standards and reinforcing AstraZeneca's leadership in respiratory and immunology innovations for this unmet medical need, according to GlobalData, a analytics company... Full

Formycon Receives EU Approval for FYB203 (Aflibercept), A Biosimilar to Eylea®, Under the Brand Names AHZANTIVE® and Baiama®

(1/20, Formycon AG) ...Formycon AG and its licensing partner Klinge Biopharma GmbH today jointly announce that the European Commission has granted central marketing authorization for FYB203 (Aflibercept), a biosimilar to Eylea®1, under the brand names AHZANTIVE®2 and Baiama®3...In mid-January 2025, Formycon and Teva Pharmaceuticals International GmbH signed a licensing agreement for the semi-exclusive commercialization of FYB203 across major parts of Europe and Israel. Concurrently, Formycon has concluded an agreement with Teva for product supply... Full

Glenmark Launches Phytonadione Injectable Emulsion USP, 10 mg/mL Single Dose Ampules

(1/21, Pharmabiz.com) ...Glenmark Pharmaceuticals Inc., USA (Glenmark) announces the launch of phytonadione injectable emulsion USP, 10 mg/mL single dose ampules. Glenmark's phytonadione injectable emulsion USP, 10 mg/mL single dose ampules is bioequivalent and therapeutically equivalent to the reference listed drug, Vitamin K1 injectable emulsion USP, 10 mg/mL of Hospira, Inc., ANDA 087955... Full

Functional Similarity Between Ustekinumab Biosimilar ABP 654, Stelara in Crohn Disease

(1/18, Deana Ferreri, PhD, The Center For Biosimilars) ...A series of in vitro studies have confirmed functional similarity of the ustekinumab biosimilar ABP 654 (Wezlana) to the European Union (EU) and US reference products (Stelara), supporting the totality of evidence and extrapolation to all indications of the reference product... Full

Analysts Tip Eisai, Biogen and Lilly to Drive Eightfold Explosion in Alzheimer's Market Value

(1/17, Nick Paul Taylor, Fierce Pharma) ...The analysts valued the Alzheimer's market across the U.S., France, Germany, Italy, Spain, U.K., Japan and China at a combined $2.4 billion in 2023. That figure says more about the dearth of treatment options than the needs of patients: Western populations are aging, and an estimated 4% of people aged 65 years and older in the U.S. alone have a dementia diagnosis, according to the Centers for Disease Control and Prevention. The constraint has been a lack of good drugs to treat those patients... Full

Cipla's Goa Facility Receives Single FDA Observation Following Inspection

(1/20, Jomy Jos Pullokaran, CNBC TV-18) ...Pharma major Cipla Ltd on Monday (January 20) announced that the United States Food and Drug Administration conducted an inspection of its wholly-owned subsidiary, Medispray Laboratories Private Ltd, located in Kundaim, Goa, from January 14-20, 2025...Following the inspection, the facility received one observation in Form 483. Cipla stated its commitment to working closely with the FDA to address the observation comprehensively within the stipulated timeline... Full

Sun Pharma Unit Poised to Buy Canadian Biotech Antibe

(1/19, Phil Taylor, Pharma Phorum) ...A subsidiary of Sun Pharma has reached an agreement to buy the assets of Canada's Antibe Therapeutics, a developer of drugs for pain and inflammation that fell into receivership last year... Full

Sandoz Settlement Suggests J&J Buyout Caplyta May Be Tough Nut To Crack

(1/20, Dean Rudge, Generics Bulletin) ...Sandoz has yielded to the intellectual property shielding Intra-Cellular Therapies' closely-watched schizophrenia and bipolar depression brand Caplyta (lumateperone) capsules, striking a patent-litigation settlement agreement that – for now – ensures that the antipsychotic will all but reach its ultimate patent expiry in December 2040... Global Sub. Full

Sage Sues Biogen Days After $469M Buyout Offer

(1/17, Max Bayer, Endpoints News) ...The full lawsuit was sealed, and the court said the case was confidential after being contacted by Endpoints News. But a separate court filing from Sage states that it is "seeking preliminary injunctive relief to enforce a standstill agreement and a trial on a paper record on an expedited basis." Biogen declined to comment on ongoing litigation. A spokesperson for Sage said that "any discussions between Biogen and Sage regarding an acquisition of Sage should be conducted in private." The spokesperson added that the company is seeking a temporary restraining order "to preserve our rights and enforce the standstill provision previously agreed to with Biogen."... Full

US Accuses Walgreens of Filling Unlawful Opioid Prescriptions

(1/17, Nate Raymond, Reuters) ...The U.S. Justice Department on Friday accused pharmacy chain operator Walgreens Boots Alliance of contributing to the U.S. opioid epidemic by filling millions of unlawful prescriptions for addictive painkillers and other drugs... Full

Why Big Pharma Will Continue To Choose India For Clinical Research In 2025

(1/21, Vibha Ravi, Pink Sheet) ...India's role both as a clinical trials destination and a marketplace is seen amplifying as multinational companies rely on a combination of in-house R&D and acquisitions to restock a depleting arsenal of blockbusters. Meanwhile, Indian majors are seeking to develop novel molecules keeping in mind not just the country's disease profile, but also the global commercial potential of candidates, ranging from antibiotics to fight "superbugs" to drugs for rare diseases. A Pink Sheet examination of Citeline's Pharmaprojects data for trials with an actual or anticipated trial start date from January 1, 2024 to December 31, 2025 show a total of 2,918 trials with 531 trials open, completed or closed... Global Sub. Full

Beaten Down Under Biden, Big Pharma Hopes for New Chapter Under Trump

(1/20, David Wainer, The Wall Street Journal) ...Now as Donald Trump takes office, the industry is cautiously optimistic that its fortunes might finally begin to shift—or at least not get any worse. At last week's annual JPMorgan Healthcare Conference in San Francisco, industry executives pointed to Trump's promises to cut taxes and to crack down on pharmacy-benefit managers as evidence that his policies might benefit the industry as a whole... Sub. Req’d

Novartis CEO Says They Will Have to 'Tackle Rhetoric' in US Healthcare

(1/21, Francine Lacqua, Bloomberg) ...Vas Narasimhan, Novartis CEO speaks with Francine Laqcua about the Trump administration and the future of pharmaceuticals on the sidelines of the 2025 World Economic Forum in Davos... Full

IRA Drug Price Reforms On Reconciliation Wish List, PhRMA Pushes ‘Pill Penalty' Fix

(1/17, Maaisha Osman, Inside Health Policy) ...House Republicans are floating reconciliation options that include reforming the Inflation Reduction Act's drug negotiation process to "discourage price setting" for orphan drugs, a change that could cost up to $20 billion over a decade, and a separate unspecified measure to stem "innovation killing parts of IRA...Under the IRA, small-molecule drugs like pills and tablets are exempt from Medicare price setting for nine years after FDA approval, while biologics are exempt for 13 years. PhRMA is pushing to extend the exemption period for small-molecule drug to 13 years as well, arguing the current timeline is too short and hampers innovation... Sub. Req’d

AAM Hits Out At ‘Flawed' Medicare Price Negotiation List

(1/20, Dave Wallace, Generics Bulletin) ...Responding to the announcement by the US Centers for Medicare & Medicaid Services of the 15 additional drugs that will soon be subject to price negotiation – including Ozempic, Rybelsus and Wegovy – the Association for Accessible Medicines has called out the "short-sighted government price setting scheme" for undermining generic and biosimilar competition... Global Sub. Full

Departed Biden Medicare Chief Lauds Landmark Drug Negotiations

(1/20, Tony Pugh and Nyah Phengsitthy, Bloomberg Law) ...After leading the Center for Medicare, within the Centers for Medicare & Medicaid Services at the HHS, Seshamani's work to help launch the Medicare prescription drug negotiations unit concluded last week with the announcement that 15 costly drugs, including Novo Nordisk blockbusters Wegovy and Ozempic, are slated for talks. The resulting negotiated prices will take effect in 2027... Full

What Trump's CMS Can and Can't Change with the Second Round of Drug Price Negotiations

(1/17, Zachary Brennan, Endpoints News) ...If the Trump administration were to make changes to the negotiations, a CMS official said Friday that "it would require additional guidance and potential rulemaking and potentially new information." The incoming administration hasn't said anything public yet on its direction. Rachel Sachs, law professor at Washington University in St. Louis, told Endpoints News that the Trump administration may not even need to push to repeal the IRA. Instead, the administration could direct its lawyers to walk away from the dozens of court cases from biopharma companies seeking to halt the law... Full

Trump's Executive Order Blitz Likely to Hit Health

(1/20, Adriel Bettelheim, Peter Sullivan, Axios Pro) ...During his first term, Trump sent shockwaves by proposing an international pricing index to tie Medicare drug prices to those paid in other countries. His campaign backed off that idea last year, and he has since directed much of his drug cost ire at PBMs. But it's possible Trump could revive the proposal in some form. There is also the question of how he handles the next round of Medicare drug price negotiations under the IRA, and if he seeks to make changes to how the program operates... Sub. Req’d

Trump Announces US Withdrawal from World Health Organization

(1/21, Betsy Klein, CNN) ...President Donald Trump announced Monday he is withdrawing the US from the World Health Organization, in a significant move that drew criticism from public health experts on his first day back in the White House...Dr. Ashish Jha, who served as White House Covid-19 response coordinator during the Biden administration, called Trump's decision to withdraw from the WHO in his second term a "strategic error." "WHO is a pretty essential organization — and with America's withdrawal, it creates a political vacuum that only one country can fill — and that is China," Jha said in an interview with CNN on Monday... Full

Tariff Threats, Drug Pricing Will Be 2 Key Pharma Issues During Trump's First Year

(1/18, Anjalee Khemlani, Yahoo! Finance) ...The three key issues in the spotlight are China, tariffs, and drug pricing...Billions hang in the balance as Trump's pro-business reputation could clash with congressional efforts to pass the Biosecure Act, according to Jefferies analysts..."Lowering drug prices is a focus area for both Republicans and Democrats, and Chinese CDMOs [manufacturers] such as Wuxi Group play a key role as it helps the US pharma cut costs by 30-60%. Trump administration is also likely to be more business-friendly and there is pressure from US Pharma against Biosecure Act, which makes it less likely for the act to come back next year," the analysts wrote... Full

India's Pharmaceutical Sector Wary of Upheavals Caused by Potential Trump Tariffs

(1/20, Ishan Garg, Channel News Asia) ...Trump, who will be sworn in as the US' 47th president on Monday (Jan 20), has pledged to impose reciprocal tariffs in retaliation for the high tariffs imposed by India on imports of some American products. Indian drugmakers are also worried about Trump's America First policy, which could see a boost in domestic manufacturing and less need for Indian exports... Full

FTC Says It Sued CVS, Cigna Over Drug Documents for PBM Probe

(1/17, Leah Nylen, Bloomberg Law) ...The US Federal Trade Commission said it sued CVS Health Corp. and Cigna Group for failing to turn over documents requested by the antitrust and consumer protection agency about their role as drug middlemen. In statement late Friday, outgoing FTC Chair Lina Khan said the agency filed legal actions to enforce subpoenas it sent as part of a probe into potentially unlawful business practices by the companies' pharmaceutical benefit managers... Sub. Req’d

Walgreen Sues to Set Aside Controlled Substance Pharmacy Policy

(1/17, Mary Anne Pazanowski, Bloomberg Law) ...Walgreen Co. has sued a federal regulator to invalidate a policy that it says unlawfully imposes an obligation on pharmacies to ensure the legitimacy of prescriptions for controlled substances, including opioids like fentanyl, before filling them... Sub. Req’d

New Release: Global Drug Supply Chain Diversification Alert White Paper

(1/17, Patrick Day, Lachman Consultants) ...Much has been written about drug shortages, but this new White Paper provides expert-level analysis of the role of geographic diversification, including significant regulatory actions and legislative activities, as well as key recommendations for the industry. These insights should be used by the industry not only to influence next year's corporate objectives but be considered in enterprise risk-management plans. This White Paper outlines significant recommendations and is a great reference source for ongoing legal, regulatory, and industry initiatives... Full

Building A Sustainable Market: New Medicines For Europe President Sets Out Priorities

(1/20, Dave Wallace, Generics Bulletin) ...Recently-appointed president of Medicines for Europe Stephan Eder speaks to Generics Bulletin about the off-patent association's priorities to secure a sustainable operating environment for the generics, biosimilars and value-added medicines sector in Europe... Global Sub. Full

EMA Pushes For Industry Collaboration On Psychiatric And Psychedelic Drug Innovations

(1/17, Eliza Slawther, Pink Sheet) ...The European Medicines Agency wants to work with other regulators as well as industry, scientists and patients to "find solutions for the most pertinent problems in psychedelic research" and improve treatment options for psychiatric disorders more broadly, says the agency... Global Sub. Full

Biosimilars in the UK: Insights from Biocon Biologics

(1/21, BioPharma-Reporter) ...Josh Gissing is Cluster Head (UK, Ireland & Nordics) for Biocon Biologics: a biosimilars company whose business model seeks to make biologic therapies affordable, accessible and available to all. He sits down with BioPharma-Reporter and shares how he expects to see the sector evolve... Full

Romanian Raids On Boehringer Result In Eight-Figure Fine For COPD Market Abuse

(1/17, Dean Rudge, Pink Sheet) ...Boehringer Ingelheim has been slapped with a RON128.5m ($26.4m) fine by Romania's competition authority after being judged to have abused its dominant position in the country's chronic obstructive pulmonary disease (COPD) market, heaping more costs on payers and patients by limiting market access to generic versions of the German originator's own Spiriva (tiotropium) inhalers... Global Sub. Full

German Pharma Industry Unveils Plan to Address Drug Shortages

(1/20, The Pharma Letter) ...Germany's pharmaceutical sector is taking steps to combat worsening drug supply shortages, which have been driven by production bottlenecks, global dependencies, and increasing demand...The VFA has now outlined a five-point plan to improve supply chain resilience, focusing on early detection of vulnerabilities, diversification of supply chains, optimizing stock management, building reserve production capacity, and fostering innovation... Sub. Req’d

India's Biocon Urges Government to Exempt Cancer, Rare-Disease Drugs from Tax in Budget

(1/20, Rishika Sadam, Reuters) ...India should eliminate tax on drugs for cancer treatment and for chronic and rare diseases, the chairperson of major drugmaker Biocon Ltd said ahead of Prime Minister Narendra Modi's budget announcement, expected next month...To make cancer care more affordable in price-sensitive India, Mazumdar-Shaw said, the government must also cut import duties for high-tech instruments, input materials and consumables used to develop life-saving precision medicines... Full

China's Healthcare Watchdog to Investigate New Drugs List After Quality Issues Flagged

(1/20, Phoebe Zhang, South China Morning Post) ...China's healthcare regulator has pledged to investigate the quality of drugs under a new list covered by national insurance, after policy advisers in Shanghai warned that they might be substandard. In a statement on its website on Monday, the National Healthcare Security Administration said it would send a team to Shanghai to seek suggestions, as well as collect evidence and clinical data on drug quality... Full

China Looks Into Generic Drug Quality After Doctors Speak Up

(1/20, Amber Tong, Bloomberg) ...Hospital chiefs and doctors in Beijing and Shanghai said the cheaper generic drugs mandated for use at public hospitals don't appear to have the same efficacy or side effects as drugs from major international pharmaceutical companies, local media Caixin and China Business News reported over the weekend. They fear their widespread use risks breeding mistrust among doctors and patients... Sub. Req’d

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