Thursday, July 25, 2024

Teva, Sanofi Announce Accelerated Timeline for Duvakitug Program

(7/25, The Fly) ...Patient enrollment in the RELIEVE UCCD Phase 2b trial has completed early due to significant acceleration in patient recruitment. As a result, Teva and Sanofi now anticipate having topline results for both UC and CD in Q4 and detailed results will be presented in a scientific forum in 2025... Full

How Monday Overtook NICE and Why Teva is On Course to Becoming Israel's Highest-Valued Company

(7/24, Sophie Shulman, CTech) ...A significant change occurring these days is Teva's surprising potential return to its historical position as the largest Israeli company...Since Mobileye's re-issue on Wall Street, it has held the title...However, Teva and Mobileye are now converging around a value close to $20 billion, with Teva making a comeback after a 58% rise since the beginning of the year, while Mobileye has fallen after once trading at more than $30 billion...The only one that may prevent Teva from returning to its former glory is Check Point... Full

Surge in Sales of Biosimilars Helps Samsung Biologics to a Record-Setting Quarter

(7/24, Kevin Dunleavy, Fierce Pharma) ...The success of the biosimilar business helped spur the parent company to another lucrative quarter as Samsung Biologics topped the 1 trillion mark in South Korean won for the first time at 1.16 trillion ($839 million). It was a 37% increase year over year and a 22% boost sequentially. The sales surge fueled a profit increase of 71% year over year and 96% sequentially to 434 billion South Korean won ($314 million)... Full

Sanofi Lifts 2024 Profit Forecast On Strength in Dupixent, New Products

(7/25, Manas Mishra, Reuters) ...Sanofi on Thursday raised its full-year profit outlook after strong demand for blockbuster asthma drug Dupixent and better-than-expected sales of new launches helped its second-quarter results beat estimates...CFO Francois-Xavier Roger said the improved forecast reflected strength across the board, not just Dupixent but also new products such its Beyfortus shot to protect infants from a common respiratory virus... Full

Roche Lifts 2024 Profit Guidance On Strong Drug Sales

(7/25, Ludwig Burger, Reuters) ...Roche on Thursday raised its full-year earnings forecast after exceeding expectations for the first half, driven by strong demand for newer drugs such as eye medicine Vabysmo. The Swiss drugmaker said it expects growth in adjusted earnings in the "high single-digit range", excluding the effect of currency swings and resolution of tax disputes in 2023, up from previous estimates of "mid single-digit" percentage growth... Full

AstraZeneca Raises Profit Outlook On Strong Medicines Demand

(7/25, Pushkala Aripaka, Maggie Fick, Reuters) ...Sales in AstraZeneca's top business, oncology, grew 19% at constant currency rates to $5.33 billion and accounted for 41% of the total, while its rare disease and heart and kidney disease divisions also each raked in double-digit growth. Second-quarter profit though was dented by a rise in expenses and sales of cancer drugs Enhertu and Imfinzi were slightly softer than expected, analysts said... Full

Second European Stelara Biosimilar Pits Sandoz Against Stada

(7/25, David Wallace, Generics Bulletin) ...Sandoz has confirmed the European launch of its Pyzchiva (ustekinumab) biosimilar rival to Stelara. The introduction of the Samsung Bioepis-partnered biosimilar comes just days after Stada and Alvotech's Uzpruvo version hit the market at the start of this week...Sandoz said the biosimilar represented "a key biosimilar driver, adding value and contributing to the company's mid-term growth strategy."... Global Sub. Full

Lupin And Zentiva Snatch First Generic Raltegravir Approval In UK

(7/24, Urte Fultinaviciute, Generics Bulletin) ...The UK's MHRA has approved the first generic raltegravir to treat HIV in adults and certain pediatric patients and deemed the drug interchangeable with the originator Isentress. The UK's Medicines and Healthcare products Regulatory Agency has granted a marketing authorization to Lupin and Zentiva's raltegravir, the UK's first generic rival to Merck's Isentress... Global Sub. Full

Yaral Continues Build With ‘Unique' Levothyroxine Formulation

(7/25, Dean Rudge, Generics Bulletin) ...Pureplay generics firm Yaral Pharma has become the exclusive supplier in the US of its parent company Institut Biochimique's authorized generic Tirosint (levothyroxine sodium) capsules, which are "specially formulated to improve the tolerability of LT4 therapy."...According to the US Food and Drug Administration's database of approved drugs, Yaral/IBSA's product is the only capsule formulation of levothyroxine... Global Sub. Full

Zydus Marks Biosimilar Entry Into Mexico With Bevacizumab Approval

(7/25, Urte Fultinaviciute, Generics Bulletin) ...Mexico's health authority COFEPRIS granted Zydus marketing approval for its bevacizumab biosimilar, marking the Indian firm's entry into the country's biosimilar market. The biosimilar rival to Roche's Avastin will be marketed as Bhava...The firm has launched twelve "lifesaving" biosimilars in the market, aiming to bridge "the unmet need for affordable therapies" in India... Global Sub. Full

ANI Announces Final US Approval And Launch Of Endari Generic

(7/24, Adam Zamecnik, Generics Bulletin) ...ANI Pharmaceuticals has announced the final approval and launch of its Endari (L-glutamine oral powder) generic, marking the company's second introduction of a generic drug in the US in July. After receiving final approval from the US Food and Drug Administration for the drug's abbreviated new drug application, this is the launch of the first AA-rated Endari generic... Global Sub. Full

Biogen and Sage to Scrap Neurological Disorder Drug Development After Trial Failure

(7/24, Sriparna Roy, Reuters) ...Biogen and Sage Therapeutics do not plan to conduct further studies for their neurological disorder drug after it failed in a mid-stage trial, the drugmakers said on Wednesday...The setback is the latest after Sage and partner Biogen's pill, Zurzuvae, could not secure the U.S. health regulator's nod for treating clinical depression, a much larger market, while it was approved as a treatment for postpartum depression. The key question is whether Zurzuvae is enough to keep the Biogen partnership, said Mizuho analyst Uy Ear... Full

Chinese Biotech Developing Semaglutide Biosimilar Files for Hong Kong IPO

(7/24, Amber Tong, Endpoints News) ...A Chinese company with plans to commercialize biosimilar GLP-1 drugs is seeking to go public in Hong Kong, in a test of investor enthusiasm amid a prolonged slowdown. The Wednesday filing marks Hangzhou Jiuyuan Genetic Engineering's second attempt at an IPO, after its first application from January lapsed. It has yet to disclose the target raise amount... Full

Australia's Mayne Pharma Sues Indian Drugmaker Sun Pharma Over Patent Infringement

(7/25, Rajasik Mukherjee, Reuters) ...In the lawsuit filed at the United States District Court for New Jersey, Mayne Pharma accused its rival of violating all 20 Orange Book-listed patents linked to IMVEXXY - a vaginal insert aimed at reducing pain during sexual intercourse after menopause... Full

Nationwide Recall: Migraine Relief Medication

(7/24, Danielle Langenfeld, FOX 8) ...The U.S. Food and Drug Administration has announced a nationwide recall of migraine relief medication sold through Amazon. According to the alert, Aurobindo Pharma USA, Inc., on behalf of AuroHealth, is voluntarily recalling the pain medication because it's missing the manufacturer label which would include required drug facts and patient usage information... Full

Gland Pharma's Hyderabad Facility Gets Two US FDA Observations

(7/25, Shreya Sur, NDTV Profit) ...These observations are procedural in nature. The corrective and preventive actions for these observations will be submitted to the US FDA within the stipulated period. They are neither repeated observations nor related to data integrity, the filing said... Full

HCPs Embrace Podcasts to Stay Abreast of Drug Options: Survey

(7/24, Nick Paul Taylor, Fierce Pharma) ...Drugmakers have recognized the opportunities podcasts present. SMI found pharma companies spent more on podcast ads over the first two months of 2023 than across the previous five years combined. In 2024, Belharra Therapeutics has used a podcast to tell its biotech origin story and Eisai has supported a miniseries about Alzheimer's disease. The report suggests advertisers should prioritize audio advertising opportunities within podcasts over banner ads adjacent to podcast pages "for a more immersive content and customer experience."... Full

A Harris Win Could Boost FTC, NIH Drug Pricing Roles Given Presumptive Candidate's Prior Anticompetitive Crackdown, March-In Support

(7/24, Gabrielle Wanneh, Maaisha Osman, InsideHealthPolicy) ...If Harris becomes president, it's likely she would continue to tout the cost savings for patients and payers associated with the Medicare drug price controls passed under the IRA back in 2022, according to John Stanford, executive director of the life sciences investor coalition Incubate...Stanford says it's also likely Harris will carry on Biden's request for drug price negotiation in Medicare to be expanded to the commercial market. However, he said a Harris presidency may present opportunities for the drug industry to address aspects of the IRA the industry says will harm innovation and impede access and affordability for patients in the long run... Sub. Req'd

Biden FTC Distorts Cost-Saving Role of Pharmacy Benefit Managers

(7/24, Pat Toomey, Townhall) ...The Commission's unbalanced and unempirical report strongly implies scale is inherently harmful. The opposite is true. In the case of PBMs, scale enables these companies to effectively negotiate savings from pharmaceutical companies on behalf of health plan sponsors, like America's employers. This role provides a critical counterbalance to the pricing power of big drug companies, delivering billions of dollars in savings that health plan sponsors—mostly employers—pass on to their employees and their families through lower cost-sharing and lower premiums... Full

The Biosimilars Forum Supports House Committee On Oversight and Accountability Probe Into the PBM Monopoly

(7/24, Biosimilars Forum) ...[Juliana M. Reed, Executive Director the Biosimilars Forum:] "The time to act is now - policymakers cannot wait any longer. The Biosimilars Forum stands ready to work with both sides of the aisle and the Administration to help patients better afford their prescription drugs. But without reform, the cost-savings promise of biosimilars could be lost forever."... Full

LTC Pharmacies Demand ‘Sustainable' Payment Model Ahead of 2026 Drug-Pricing Changes

(7/24, Kimberly Marselas, McKnights) ...Many of the nation's long-term care pharmacies are going to fall below "break-even" and may be forced out of business without additional support when drug-pricing policy changes kick in, sector advocates warned Wednesday. The Senior Care Pharmacy Coalition is launching a new campaign for federal payment reform as the White House finalizes lower prices on 10 drugs widely used by Medicare beneficiaries and Congress toys with legislation that could loosen pharmacy benefit managers' grip on most other US drug pricing... Full

The Crucial Role of Risk Assessment in Pharmaceutical Visual Inspection Programs

(7/24, Tracey Sinjen, Lachman Consultants) ...In pharmaceuticals, maintaining product quality and safety is paramount. Visual inspection plays a vital role in detecting particulate matter and/or container/closure defects, though it may fall short in pinpointing the root cause of defects or material origins. To fortify visual inspection programs effectively, a comprehensive risk assessment serves as the foundational pillar. This blog delves into the significance of risk assessment for pharmaceutical visual inspection programs... Full

Product-Specific or Class-Specific Biosimilar Guidances? US FDA Wants Feedback

(7/24, Sarah Karlin-Smith, Pink Sheet) ...Biosimilars sponsors are asked to give the FDA feedback on whether product-specific or class-specific guidance would be most helpful for speeding development. The agency also wants to know if guidances should focus on biological products with no approved biosmilars and if guidance in areas where there are approved products would be helpful. The generic industry's experience with product-specific guidance has not always been smooth, but the agency has adjusted the program to address concerns over the years... Sub. Req'd

FDA Finalizes Guidance On Using EHR Data to Support Drug Submissions

(7/24, Zachary Brennan, Endpoints News) ...The FDA on Wednesday finalized guidance from 2021 that aims to help pharma companies understand when they may use data from electronic health records or medical claims as part of drug approval packages. The guidance expands on the regulator's work from 2013, and the FDA has now provided more details about the selection of data sources and how best to evaluate the relevance and reliability of EHR and medical claims data for use in a clinical study... Full

States Keep Legal Pressure On PBMs Ahead of Potential FTC Suit

(7/25, Katie Arcieri and Celine Castronuovo, Bloomberg Law) ...States are charging ahead with drug price-fixing lawsuits against pharmacy benefit managers, viewing the litigation as a more effective way to provide direct relief to local taxpayers than potential federal action would be. Vermont is the latest to sue, last week accusing CVS Health Corp.'s Caremark and Evernorth's Express Scripts of inflating drug prices... Sub. Req'd

Insulin Could Cost $0 Under Bay State Plan to Regulate Pharmacy Benefit Managers

(7/24, Matthew Medsger, Boston Herald) ...The bill, according to Rep. John Lawn, of Watertown, would dramatically change the cost of prescription drugs in the Bay State by "shedding light on pharmacy benefit managers, whose deceptive practices increase drug prices, decrease transparency and harm consumers and independent pharmacies."... Full

Sen. Baldwin Introduces Bill to Cap Prescription Drug Costs for Wisconsinites

(7/24, Enjoyiana Nururdin, M.A., WKOW) ...U.S. Sen. Tammy Baldwin (D-WI) introduced legislation Wednesday to lower the cost of prescription drugs. The Capping Prescription Costs Act builds on the Inflation Reduction Act which capped drugs for Medicare beneficiaries, and would place annual caps on out-of-pocket costs for prescription drugs on the commercial healthcare market... Full

Capping Prescription Costs Act Aims to Reform Drug Pricing

(7/24, Caleb Carr, Rochester First) ...Senator Kirsten Gillibrand announced legislation Wednesday she said would cap the cost of prescription drugs...The Capping Prescription Costs Act would cap the annual out-of-pocket cost of prescription drugs at $2,000 for individuals and $4,000 for families with private insurance... Full

Illinois House Hearing into How Pharmacy Benefit Managers Affect Drug Prices

(7/24, Kevin Bessler, WGIL) ...Pharmacists have urged Illinois lawmakers to enact legislation banning certain drug pricing practices by PBMs, which they said hurt local pharmacies. They have testified that they are being damaged by PBMs through the price of acquiring drugs wholesale and dispensing them at little or no profit. During a House Health Care Availability and Accessibility Committee hearing, Chad Worz, CEO of the American Society of Consultant Pharmacists, said if conditions don't change, more local pharmacies will be forced to close... Full

Work Continues On Reining in Prescription Prices

(7/24, Andy Zay, The Journal Gazette) ...The large benefit managers exist within a vertically integrated business structure, giving them the upper hand in cutting deals with their own preferred pharmacies. This results in independent pharmacies being pushed out of the market. In other words, these smaller independent pharmacies are forced to close their doors because it's nearly impossible to withstand the financial pressures caused by benefit managers — and it's even worse for the patients...Indiana's pharmacy benefit manager audit should be completed by Sept. 1. Upon the conclusion of the investigation, I plan to meet with the attorney general to discuss the results and what can come from the findings... Full

In Six Swing States, Democrats and Republicans Agree on How to Lower Health Care Costs

(7/25, Program for Public Consultation) ...As the price of health care continues to rise faster than wages, a new public consultation survey by the Program for Public Consultation finds bipartisan majorities of Americans in the six swing states of Arizona, Georgia, Michigan, Nevada, Pennsylvania, and Wisconsin, as well as nationally, support major proposals for lowering health care costs... Full

Availability of Treatment in Slovakia Within the Framework of European Legislation - Expert Forum Brings Solutions

(7/24, Medicines for Europe) ...The international conference Expert Forum, organized by the GENAS association, attracted key healthcare players to Bratislava on Monday, including representatives from the European Commission, the Permanent Representation of the Slovak Republic to the EU, Medicines for Europe, Slovak and European experts and analysts. The participation of significant stakeholders underscores the importance of the topic of treatment availability and the need for discussion on current challenges and solutions, all in the context of the ongoing revision of EU pharmaceutical legislation... Full

Switzerland's Drug Approval Process Lags Behind Europe

(7/24, Swissinfo.ch) ...According to a recent study, medicines are approved on average 249 days later in Switzerland than by the European Medicines Agency. The Swiss pharmaceutical association Interpharma said this means that access to vital medicines is becoming increasingly difficult... Full

India Focuses On New-Age Oncology Care Through New Drugs and Novel Delivery Devices

(7/25, Pharmabiz.com) ...India's focus on new-age oncology care through new drugs and novel delivery devices underscores its role to address critical medical needs...From Aurobindo, Biocon, Sun Pharma, Zydus Cipla, Dr Reddy's Laboratories, Lupin, Glenmark to Venus Remedies, Shilpa Medicare, Odon Lifesciences, Intas and Torrent to name a few, are exploring innovative therapies and delivery methods. India aims to improve patient outcomes and contribute significantly to the fight against cancer on a global scale... Full

Chinese-Made New Drugs Big Hit Overseas

(7/24, Li Jiaying, China Daily) ...With more Chinese-developed innovative drugs entering both US and European markets, China's pharmaceutical sector is showing escalating prowess in innovation and global market penetration, said industry experts. "This (entering the European market) is a significant milestone. Fruquintinib is the first product approved in Europe completed by our research and development engine," said Su Weiguo, CEO and chief scientific officer of Shanghai-based biopharmaceutical company Hutchmed... Full

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