Tuesday, February 27, 2024

Teva, Jiangsu Nhwa Ink Strategic Partnership Deal Focused on Patient Access to Austedo in China

(2/26, Don Tracy, PharmExec.com) ...Teva announced that it has entered into a collaboration with Nhwa Pharmaceutical Co., Ltd with the goal of providing easier access to Teva's drug Austedo in China..."We are committed to addressing the pressing needs of patients in China with more innovative medicines, in line with our commitment throughout our International Markets region and across the globe," said Mark Sabag, EVP, head, international markets, Teva... Full

Teva Partners With Jiangsu Nhwa for Austedo in China

(2/26, The Pharma Letter) ..."Nhwa has deep neuro-psychiatry expertise and capabilities, from research and development to commercialization," commented Theodor Wee, general manager of Teva Greater China. "Together, we can promote cost-effective delivery of safe, quality medicines and contribute to the sustainability of China's healthcare system," he added... Sub. Req'd

Will TL1A Be The Gateway to Precision Medicine in Inflammation?

(2/23, Lauren Martz, BioCentury) ...Eric Hughes, EVP of global R&D and CMO at Teva, isn't convinced that TL1A inhibitors will set off a paradigm shift in IBD management. "I don't think we've seen great selectivity in programs to date. In the future, certainly if there's a very compelling case, I would love to see a world where we have a companion diagnostic that can do that. I don't think we're close to that," he told BioCentury...As it prepares for a Phase III study with Sanofi that could start next year, "our plan is to focus on all-comers, but obviously it will be dependent on interim analysis."..."What really got us interested in Teva's program is that it binds TL1A in a different way than the competitors," said [Naimish Patel, CEO Sanofi]. "Two receptors bind TL1A and turn on signaling: the DR3 receptor and a decoy receptor, DCR3. The DR3 is the receptor that conveys the message to activate inflammation. The decoy receptor serves as a way to get rid of TL1A. It binds, but it doesn't signal and prevents binding to the receptor that causes inflammation."... Sub. Req'd

Humira Biosimilar from Alvotech, Teva Wins FDA Approval On Third Attempt

(2/26, Jonathan Gardner, BioPharma Dive) ...The Food and Drug Administration on Saturday approved Alvotech and Teva Pharmaceuticals' Simlandi, a biosimilar of the most popular version of AbbVie's rheumatoid arthritis drug Humira. The drug, which can be directly substituted by a pharmacist, was rejected by the FDA twice before due to manufacturing issues at a plant in Iceland... Full

FDA Approves Simlandi, A Citrate-Free, High-Concentration, Interchangeable Biosimilar to Humira

(2/26, Brian Park, PharmD, MPR) ...The Food and Drug Administration has approved Simlandi (adalimumab-ryvk), a citrate-free, high-concentration, interchangeable biosimilar to Humira® (adalimumab)...Findings showed Simlandi met the primary end point achieving therapeutic equivalence to Humira as measured by the Psoriasis Area and Severity Index percent improvement at week 16. Moreover, there were no clinically meaningful differences between Simlandi and Humira on the secondary endpoints, including safety, tolerability, immunogenicity and serum trough levels at steady state through the entire study duration... Full

Alvotech, Teva Get Hard-Fought Humira Biosim Approval

(2/26, Pharma Manufacturing) ...Alvotech and the U.S. arm of Teva Pharmaceuticals announced that the U.S. FDA has approved the Simlandi injection, as an interchangeable biosimilar to Humira...The Alvotech-Teva biosim will be the third interchangeable biosim to hit the market. Boehringer Ingelheim's Cyltezo was the first FDA-approved interchangeable biosimilar to Humira. It became commercially available in July 2023. Pfizer's Abrilada nabbed the interchangeable designation as well, hitting the market in October 2023... Full

FDA Approves First Interchangeable High-Concentration, Citrate-Free Biosimilar to Humira

(2/26, Contract Pharma) ...Dr. Eric Hughes, Executive Vice President Global R&D and Chief Medical Officer at Teva. "Biosimilars create opportunities for cost savings across the healthcare system and introduce additional treatment options for patients. This approval marks an important milestone for Teva and Alvotech's partnership to collaborate on seven biosimilars and expand the availability, access, and uptake of biosimilars in the U.S."... Full

FDA Approves Humira Biosimilar Adalimumab-ryvk

(2/26, Lana Pine, HCP Live) ...The US Food and Drug Administration has approved adalimumab-ryvk (Simlandi), the first interchangeable, high-concentration, citrate-free biosimilar to adalimumab (Humira), according to a press release published by Alvotech and Teva Pharmaceuticals...While Alvotech oversees the development and manufacturing of the biosimilar, Teva is focused on the sales and marketing infrastructure... Full

Teva And Alvotech: Simlandi Approval Opens New Generic Market Opportunities (NYSE:TEVA)

(2/26, Stephen Ayers, Seeking Alpha) ...Teva made a regulatory announcement that generated some interest. Simlandi, an arthritis injectable developed in partnership with Alvotech, an Iceland-based company that specializes in biosimilars, has been approved by the FDA. Simlandi is an "interchangeable biosimilar" to AbbVie Inc.'s popular arthritis treatment, Humira...Generic entry is not new to AbbVie's Humira. The popular medication is expected to see another ~30% decline in sales in 2024, going from $12.1 billion to $9.6 billion. Simlandi will stand out among a generic crowd since switching is made easier for patients thanks to its "interchangeable" status... Full

FDA's New PSG Batch Features GSK's Inhalers

(2/26, Urte Fultinaviciute, Generics Bulletin) ...The US Food and Drug Administration has released a new batch of product-specific guidances, which included the revision of guidelines for developing generic versions of several GSK's powder inhalers, as well as Novartis and Sanofi's oncology drugs. The agency also released new PSGs for products to treat amyotrophic lateral sclerosis, human immunodeficiency virus, several oncology indications, and opioid overdose... Global Sub. Full

Coherus Delivers First US Rival To Neulasta OnPro, As Biosimilar Interest Peters Out

(2/26, Dean Rudge, Generics Bulletin) ...Coherus BioSciences has become the first company to offer biosimilars in the US to Amgen's complete range of Neulasta (pegfilgrastim) products after announcing that the company's version of the Neulasta Onpro on-body injector device using Coherus' Udenyca (pegfilgrastim-cbqv) biosimilar was "successfully underway." Approved at the very end of last year, Udenyca Onbody was supported by a comprehensive analytical and clinical data package, including pharmacokinetic and pharmacodynamic bioequivalence data as well as adhesive performance and tolerability data... Global Sub. Full

Roche Launches Ocrevus for Treatment of Multiple Sclerosis in India

(2/27, ETHealthWorld) ...Roche Pharma India today announced the launch of its blockbuster breakthrough drug, Ocrevus (Ocrelizumab), for the treatment of multiple sclerosis, expanding its neurology portfolio to cater to the unmet needs of numerous patients grappling with this debilitating disease in India. The majority of individuals are diagnosed with multiple sclerosis between the ages of 20 and 40, making the disease a leading cause of non-traumatic disability in younger adults... Full

‘Not Just Growth In AG Xyrem' Hikma Underlines Following Strong 2023

(2/26, Dean Rudge, Generics Bulletin) ...Hikma welcomed a strong and profitable 2023, driven by the nourishing effects of its authorized generic Xyrem product, which will fall back this year as the rate of royalties owed to the brand's innovator climbs. But the company is optimistic it can continue growth in 2024, including through its $1.2bn Injectables division, which rushed in to fill supply gaps last year...Moving into 2024, Hikma will step up significantly the royalties it will pay Jazz for the product. The firm debuted the product at the beginning of 2023, with a six-month exclusivity period and much more favorable royalties... Global Sub. Full

Merck's Bridion Faces Generic Threat from Drugmaker Hikma

(2/26, Sriparna Roy, Reuters) ...Merck has received a letter that Hikma Pharmaceuticals US unit has sought a pre-patent expiry approval from the US FDA to sell a generic version of its Bridion injection, the drugmaker said in filing on Monday. Merck said, on Feb. 5, it received the letter under the Hatch-Waxman Act, through which a company can seek FDA approval to market a copycat before the expiration of patents related to the brand-name drug... Full

Amgen Boots Up Ohio 'Smart Facility' Where it Plans to Employ 400—and a Trio of Robots, Too

(2/26, Fraiser Kansteiner, Fierce Pharma) ...Amgen is now open for business in Central Ohio after cutting the ribbon at its "most advanced facility to date." Dubbed "Amgen Ohio," the nearly 300,000-square-foot biomanufacturing plant in New Albany, Ohio, is set to employ 400 full-time employees and leverage the "latest innovation and technology," Amgen said in a Monday release...In addition to cutting-edge manufacturing tech, the facility features open workspaces for collaboration and has been designed to meet stringent environmental sustainability standards as part of Amgen's goal to achieve carbon neutrality across all its operations by 2027... Full

IQVIA Executive Director Discusses Global Use of Medicines 2024 Report - Part 1

(2/23, Miranda Schmalfuhs, PharmExec.com) ...Murray Aitken, Executive Director of the IQVIA Institute for Human Data Science, discusses key findings from their Global Use of Medicines 2024 report as well as the significant projected growth in spending and growth in diabetes and global obesity... Full

IQVIA Executive Director Discusses Global Use of Medicines 2024 Report - Part 2

(2/27, Miranda Schmalfuhs, PharmExec.com) ...Murray Aitken, Executive Director of the IQVIA Institute for Human Data Science, discusses how climate events and COVID-19 have impacted medicine use and spending... Full

US Pharmacy Outage Triggered by 'Blackcat' Ransomware at UnitedHealth Unit, Sources Say

(2/26, Raphael Satter and Christopher Bing, Reuters) ...Hackers working for the 'Blackcat' ransomware gang are behind the outage at UnitedHealth's technology unit that has snarled prescription deliveries for six days, two people familiar with the matter told Reuters on Monday...One expert said the news suggested that digital disruptions, while important, could not be counted on to knock ransomware groups out for good. "It's inevitable that if you have a group that's making millions of bucks, they are going to attempt to make a comeback," said Brett Callow, a threat analyst at the cybersecurity firm Emsisoft... Full

Experts Say Scale of Change Cyberattack Shows Risk of Centralized Claims Processing

(2/27, Brittany Trang, Tara Bannow and Bob Herman, STAT Plus) ...Change Healthcare's recent cyberattack has hospitals, doctors' offices, and pharmacies across the country reeling as they struggle to process claims and bill patients. Experts told STAT it's a glaring example of the risk of consolidation in health care..."Where you have this concentration of mission-critical services, that also results in the concentration of risk if those services become unavailable for any reason," said John Riggi, a former leader in the Federal Bureau of Investigation's Cyber Division who now advises the American Hospital Association on cybersecurity... Sub. Req'd

Grassley Slams FTC For Slow PBM Probe, Urges Senate Vote On PBM Bills

(2/26, Gabrielle Wanneh, InsideHealthPolicy) ...Sen. Chuck Grassley (R-IA) is calling on Majority Leader Chuck Schumer (D-NY) to immediately hold floor votes on pharmacy benefit manager reform bills passed by key committees throughout 2023, noting a lackluster update he just received from the Federal Trade Commission on its investigation into common PBM business practices and their effect on patient and payer drug costs. Grassley's request comes as PBM reforms appear increasingly unlikely to be part of a potential scaled-back health care package in March... Sub. Req'd

Congress Punts On PBM Reform Efforts

(2/26, Rachel Cohrs and John Wilkerson, STAT Plus) ...Congress has abandoned its attempt to reform how pharmacy middlemen operate in an upcoming package to fund the federal government, 11 lobbyists and sources following the talks told STAT. It's a missed opportunity to pass one of the health care priorities that has attracted the most bipartisan interest and activity this Congress, though lawmakers could revive the negotiations on the issues in the future... Sub. Req'd

Congress Appears Likely to Exclude PBMs, Other Health Priorities from Spending Package

(2/26, Nathaniel Weixel, The Hill) ...It is increasingly likely that only a handful of programs facing imminent deadlines could be included in legislation needed to fund the government by March 8, such as community health center funding, a reversal of Medicaid cuts to hospitals serving low-income and uninsured patients, and at least a partial rollback of Medicare physician payment cuts. A reauthorization of a federal pandemic preparedness program and a sweeping bill to address opioid and substance use disorder are among the policies likely to be left on the cutting room floor, sources said... Full

The Biden Giveaway to China

(2/26, William S. Smith, RealClearPolicy) ...Under the guise of lowering drug prices, the Biden administration is moving forward with a proposal that could dismantle the intellectual property framework that has enabled the US to bring life changing treatments to patients. Politicized attempts to strip patent protections from medical innovations would have had a chilling effect on university research, negative impacts on health outcomes and undermine US global leadership and national security... Full

Part 4: Dr James Robinson on the Impact of 340B Programs and Drug Pricing Policies

(2/26, Maggie L. Shaw and Mary Caffrey, AJMC) ...In this final part of our interview with James Robinson, PhD, MPH, he underscores the need for employer education about the health plans they offer, fostering managed competition among hospital systems to drive down costs, and innovation in financing drug development... Full

DEA Shuts Down Drug Factory Even as Adderall Shortage Persists

(2/26, Joe Lancaster, Reason) ...Last week, James Walsh of New York magazine reported on the ongoing saga of drug manufacturer Ascent Pharmaceuticals. The company estimates that its products made up 20 percent of the market for generic ADHD medications, including generic versions of not only Adderall but Concerta, Vyvanse, and Ritalin...It's entirely possible that Ascent did keep shoddy records, and perhaps it did misplace doses of drugs like opioids or stimulants that are ripe for abuse (allegations that the company denies). But the DEA's policy of artificially constraining the supply of those drugs continues to harm those patients who actually need them... Full

Singulair's Psychiatric AE Risks Still A Problem, But US FDA Has Limited Mitigation Options Remaining

(2/26, Derrick Gingery, Pink Sheet) ...Stakeholders suggested a ‘Dear Healthcare Provider' letter or speaking about the risks to professional societies to emphasize the psychiatric adverse events that prompted a boxed warning for the now-generic asthma drug montelukast. The NY Attorney General is adding more pressure...The FDA said patient safety is paramount, but did not indicate further regulatory action was under consideration at this time. "Since montelukast's approval, the agency has diligently monitored reports of side effects possibly associated with montelukast, taken regulatory action when appropriate, and communicated our findings and actions," the agency told the Pink Sheet. "The FDA continues to monitor and investigate this important issue and will take additional regulatory action when appropriate and necessary... Sub. Req'd

OGD Releases 2023 Annual Report

(2/26, Bob Pollock, Lachman Consultants) ...With that in mind, the 2023 Annual Report from the OGD has a treasure trove of data as well as a laundry list of accomplishments that the program achieved in 2023. It also has a series of links in the appendix for conferences, public meetings, webinars, training programs, and workshops held over the year that you can access directly. There are also links to select online resources regarding the generic drug program and the review and approval process, along with a list of helpful acronyms and abbreviations for those of you that do not speak fluent FDA-ese... Full

FDA Officials, Drug Developers Discuss How to Streamline Safety Monitoring for Biologics

(2/26, Lia DeGroot, Endpoints News) ...FDA officials, academic researchers and drug developers gathered at the FDA's headquarters on Monday to discuss the landscape for monitoring the safety and efficacy of biologic drugs...Speakers laid out several challenges to administering therapeutic drug monitoring (TDM), citing high costs, a lack of insurance coverage and the difficulty identifying the right patients to receive TDM. Issam Zineh, director of the FDA's Office of Clinical Pharmacology, said continuing to monitor biologics after they've been approved is key to ensuring that patients are getting the most out of the medications... Full

The Wait Is Over: US FDA Advisory Committees Returning To In-Person Meetings Come Fall

(2/26, Sue Sutter, Pink Sheet) ...‘We're coming back,' Oncology Center of Excellence Director Richard Pazdur says. Office of New Drugs Director Peter Stein says transition from virtual to in person will be gradual because FDA is trying to be sensitive to adcomm members' need to schedule travel and demands on their time..."First of all, we're coming back," Oncology Center of Excellence Director Richard Pazdur said on February 26,. "I think that's very important to get back in person."... Sub. Req'd

Setting and Implementing Standards for Narrow Therapeutic Index Drugs

(2/26, U.S. Food & Drug Administration) ...In this CDER Conversation, Liang Zhao, PhD, director of the Division of Quantitative Methods and Modeling in the Office of Generic Drugs (OGD), and Mehul Mehta, PhD, FAAPS, director of the Division of Neuropsychiatric Pharmacology in the Office of Translational Sciences (OTS), discuss how CDER helps ensure the dosage range of these NTI drugs falls within a safe and effective therapeutic window for patients. The experts also discuss the specific challenges and opportunities in developing NTI generic drugs... Full

Patients, Colorado Lawmakers Debate Placing Price Caps On 'Orphan Drugs'

(2/26, Marissa Ventrelli, Colorado Politics) ...Depending on who's arguing, placing upper payment limits on "orphan drugs" will either increase or decrease their access and affordability... Full

Canada's Finance Minister Says Pharmacare Deal No Fiscal Threat, Globe and Mail Reports

(2/25, Angela Christy, Reuters) ...A "pharmacare" deal between Canada's ruling Liberals and the New Democrats (NDP) will not threaten the country's fiscal standing, Finance Minister Chrystia Freeland told a news conference on Sunday, The Globe and Mail. NDP leader Jagmeet Singh told a Canadian public broadcaster on Friday that the two parties had now reached a deal on "pharmacare" which a Reuters' government source confirmed... Full

France: Repatriating Drug Production Among Actions In ‘Roadmap' For Tackling Shortages

(2/26, Ian Schofield, Pink Sheet) ...The key themes of France's latest initiative on shortages are repatriating the production of certain essential medicines and their active substances, earlier detection of potential supply problems, and more effective and transparent communications with all actors in the supply chain...Among the measures envisaged are better ways of anticipating shortages, a list of "medicines of major therapeutic interest" (MMTIs), and clear rules for pharmacists on dispensing alternative products to replace drugs in short supply... Sub. Req'd

Pharma Companies Producing Drugs, Supplements in Same Unit Under Lens

(2/27, Teena Thacker, The Economic Times) ...Under the revised Schedule M of Drugs and Cosmetics Act 1940, a manufacturing facility approved for drugs cannot be used for manufacturing other products. The Drugs Controller General of India has now directed the state authorities to take action against units that have licences to manufacture both drugs and food products and are flouting this norm, the people cited earlier told ET. According to the Federation of Pharma Entrepreneurs (FOPE), any clampdown in this regard will pose a significant challenge to the industry, affecting not only exports but also the domestic market... Sub. Req'd

Swiss Trade Deal: Is India Changing Its Tune On Pharma Patents?

(2/27, Jessica Davis Pluss and Pauline Turuban, Swissinfo.ch) ...In mid-January, Swiss Economics Minister Guy Parmelin flew to India directly from the World Economic Forum in Davos to advance talks on a trade agreement between India and members of the European Free Trade Association: Switzerland, Norway, Iceland, and Liechtenstein. He returned full of optimism. Sixteen years after talks were initiated, Parmelin tweeted, there was agreement on the "basic principles" of a free trade deal and the parties had found "balanced solutions to the main open issues"... Full

Bristol Myers CEO Says India to Have Largest R&D Presence Outside US by 2025

(2/27, Rishika Sadam and Leroy Leo, Reuters) ...Bristol Myers Squibb aims to expand its research and development presence in India and expects its newly inaugurated Hyderabad facility to become its largest unit outside the U.S. by 2025, CEO Christopher Boerner said on Tuesday... Full

Uzbek Court Sentences 23 Over Contaminated Cough Syrup Deaths

(2/26, Olzhas Auyezov, Reuters) ...A court in Uzbekistan sentenced 23 people to prison terms on Monday over the deaths of 68 children linked to contaminated cough syrups produced by India's Marion Biotech, following a six-month-long trial...The defendants, including one Indian national, faced jail terms ranging from two to 20 years. They were found guilty of tax evasion, sale of substandard or counterfeit medicines, abuse of office, negligence, forgery, and bribery... Full

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