Thursday, October 31, 2024

Teva Leapfrogs Check Point As Israel's Most Valuable Company

(10/30, Shiri Habib-Valdhorn, Globes) ...Teva Pharmaceutical Industries Ltd. is once again Israel's most valuable company. Teva has leapfrogged Check Point Software Technologies Ltd. on Wall Street after the cybersecurity company's share price plunged on missing on third quarter billings revenue and disappointing fourth quarter guidance, which was below analysts' expectations... Full

Teva Hit With €463 Million EU Fine for Talking Down Rivals

(10/31, Samuel Stolton, Bloomberg) ..."Teva disagrees with the commission's legal theories which are legally untested" and "not supported by the facts," the Tel Aviv-based company said in an emailed statement. It said it would appeal the commission's fine... Full

Teva Fined $503 Mln by EU for Disparaging Rival Product

(10/31, Sudip Kar-Gupta, Reuters) ...Teva, the world's largest generic drugmaker, was hit on Thursday with a 462.6 million euro ($503 million) EU antitrust fine for abusing its dominant position to delay competition to its blockbuster multiple sclerosis medicine Copaxone. Teva said it planned to appeal against the judgment... Full

Teva Fined Around $500 Million by EU Over MS Drug Competition Concerns

(10/31, Helena Smolak, The Wall Street Journal) ...The European Union fined Israel's Teva Pharmaceutical 462.6 million euros ($502.3 million), saying it abused its market position in a way that might have delayed competitors from entering the multiple sclerosis market... Sub. Req’d

How Schneider Electric Boosts Supply Chain Decarbonisation

(10/30, Libby Hargreaves, Supply Chain Digital) ...Through Energize, Takeda Pharmaceuticals, Teva Pharmaceuticals, UCB, Avantor, Organon, Perrigo and West Pharmaceutical Services have collectively committed to purchasing a substantial amount of renewable energy – 563.7 GWh per year through Power Purchase Agreements (PPAs) over the next decade..."As a collaborator of this virtual Power Purchase Agreement, we are demonstrating leadership and commitment to renewable energy," says Amalia Adler Waxman, Head of Sustainability at Teva Pharmaceuticals. "By covering most of our electricity needs in Europe and nearly half globally, we are setting the standard for responsible energy use and driving toward our long-term goal of net-zero emissions."... Full

Alvotech Petitions FDA To Deny Interchangeability For Rival Stelara Biosimilars

(10/30, Generics Bulletin) ...In a move aimed at influencing the US Food and Drug Administration's approval decisions for its biosimilar rivals, Alvotech has petitioned the agency in an attempt to prevent certain other Stelara (ustekinumab) biosimilar developers from gaining a coveted interchangeability designation for their products, based primarily on sialyation differences between ustekinumab products developed using different types of cell lines... Global Sub. Full

Sandoz Says Amgen's At-Risk Aflibercept Launch ‘Doesn't Change Our Thinking'

(10/30, Dave Wallace, Generics Bulletin) ...Sandoz has indicated that Amgen's recently-announced at-risk US launch of a rival to Eylea doesn't change its thinking around launch timing for its own FDA-approved aflibercept biosimilar...While Sandoz has been clear that it plans to launch aflibercept in Europe in 2025/2026 – having already received an endorsement from the European Medicines Agency for the biosimilar under the name Afqlir – the firm currently lists its US launch date for Enzeevu as "TBD"... Global Sub. Full

Amgen Posts Higher Profit, Obesity Data On Track for Late This Year

(10/30, Deena Beasley, Reuters) ...Amgen reported a higher quarterly profit on Wednesday, driven by a 24% rise in sales of drugs for high cholesterol and osteoporosis, and said mid-stage trial results for a potentially lucrative obesity medicine will be unveiled late this year... Full

AbbVie's Immunology Blockbusters Make Up for Humira Sales Drop in Q3

(10/30, Katherine Lewin, Endpoints News) ...Global Skyrizi net revenues were $3.2 billion, an increase of about 50% from last year, while Rinvoq net revenues were $1.6 billion, an increase of about 45%. Thanks to the two blockbusters, AbbVie is raising its adjusted diluted EPS guidance for the year from between $10.67 and $10.87 to between $10.90 and $10.94, despite dipping sales of its once top-selling Humira. Global Humira net revenues for the quarter were $2.2 billion, a decrease of about 37% year-over-year... Full

Biogen Boosts Profit Guidance Despite Modest Quarter for Leqembi and Multiple Sclerosis Downturn

(10/30, Fraiser Kansteiner, Fierce Pharma) ...Despite a somewhat ambling launch, Biogen's Eisai-partnered Alzheimer's disease drug Leqembi continues to grow. But to truly unlock the amyloid-busting antibody's potential, the company will need to keep pushing for simpler delivery formats and work to dismantle barriers related to testing and more, Biogen executives said on an analyst call Wednesday... Full

Biocon Q2 Falls Short of Estimates; Net Profit Dives 84% But Revenue Up 4%

(10/30, Jomy Jos Pullokaran, CNBC TV 18) ...Biocon Ltd on Wednesday (October 30) reported an 84.2% year-on-year (YoY) decline in net profit at 27.1 crore for the second quarter that ended on September 30, 2024. In the corresponding quarter last fiscal, Biocon posted a net profit of 172 crore, the company said in a regulatory filing. The CNBC-TV18 poll had predicted a profit of 54.7 crore for the quarter under review... Full

Hints of Impatience Grow with Biogen as it Tries to Find a Bridge to Growth

(10/30, Max Gelman, Endpoints News) ...Viehbacher acknowledged on the earnings call that Biogen is "in one of those classic situations in our industry" where a company attempts to bridge a dwindling legacy portfolio with a largely early-stage pipeline. He emphasized that Biogen isn't content to just wait for all the readouts to come over the next few years, and reiterated that the company has $8 billion to $10 billion for potential acquisitions and partnerships through the end of 2025. But that can't be just acquiring near-term sales, he said... Full

Roche, Chugai Weigh In As Tocilizumab Biosimilars Fail To Hit The Mark In Q3

(10/30, Dean Rudge, Generics Bulletin) ...Biosimilars to Roche's Actemra/RoActemra (tocilizumab) in the US and Europe have not hit as hard as expected, the Swiss originator has outlined..."We do know that biosimilars are coming for Actemra," noted Roche's pharma division head, Teresa Graham, during Roche's Q3 earnings call. But "the launches in the US and the EU were frankly just slower than were expected," she commented. "And that's not only by us, I believe that's by the market as well."... Global Sub. Full

Roche Presents Early-Stage Results for Latest Amyloid-Based Alzheimer's Attempt

(10/30, Max Gelman, Endpoints News) ...Roche revealed early-stage data for a new Alzheimer's program on Wednesday as it seeks to jump back into a field littered with failures...The program's next steps are murky, as Roche still needs to complete the trial and its open-label extension, trontinemab program lead Luka Kulic told Endpoints News. The trial also did not measure the drug's effects on patient cognition, which is likely what regulators would seek in a pivotal trial... Full

Japan's Takeda Raises Full-Year Profit Forecast Amid Restructuring

(10/31, Rocky Swift, Reuters) ...Operating profit in the three months through September stood at 184.2 billion yen ($1.21 billion), the company said, versus a loss of 49.3 billion a year prior and a consensus profit estimate of 93.6 billion in an LSEG survey of four analysts. Takeda raised its full-year operating profit guidance to 265 billion yen from 225 billion, citing a stronger than expected first-half performance and updated currency assumptions... Full

Eli Lilly CEO David Ricks On Q3 Results: The Underlying Growth Story is Fantastic

(10/30, Angelica Peebles, CNBC) ...Eli Lilly CEO David Ricks joins ‘Squawk Box' to discuss the company's quarterly earnings results, which reported third-quarter adjusted profit and revenue that missed expectations, weighed down by disappointing sales of its blockbuster weight loss drug Zepbound and diabetes treatment Mounjaro, why the company is slashing its full-year adjusted profit guidance, and more... Full

Eli Lilly's Rare Sales Miss for Weight-Loss Drug Sends Shares Tumbling

(10/30, Bhanvi Satija, Patrick Wingrove, Reuters) ...Lilly CEO David Ricks said during an investor call that a factor in the sales miss was customers of wholesalers and resellers choosing how many doses to stock based on their own physical and financial constraints. The drugs must be refrigerated during transport and storage. Ricks told CNBC there was excess supply of the drugs but that the company had not yet started advertising Zepbound and had held back on international launches to focus on increasing U.S. inventory. "We haven't been stimulating demand the way we had originally planned," Ricks said... Full

AstraZeneca's China Legal Woes Follow Push For Market Share

(10/31, Amber Tong, Bloomberg) ...China's probe into AstraZeneca Plc has reached its uppermost echelons, ensnaring local president Leon Wang and throwing into question the future of the most successful Western pharmaceutical company in the country. The investigation is focused on aggressive sales tactics used in at least two of its oncology drugs, the lung cancer treatment Tagrisso and the immunotherapy Imjudo, people familiar with the matter said... Full

Novo Nordisk's Ozempic and Wegovy, Long in Shortage, Are Now Listed As Available by FDA

(10/30, Elaine Chen, STAT Plus) ...All doses of Novo Nordisk's blockbuster diabetes and obesity treatments are listed as available on the Food and Drug Administration's drug shortage list as of Wednesday, raising the possibility that the medications could soon be taken off the list entirely, a development that could affect compounding pharmacies and patients relying on compounded drugs... Sub. Req’d

Novo Takes Big Step Toward Ending Ozempic, Wegovy Shortages

(10/30, Ned Pagliarulo, BioPharma Dive) ...In an emailed statement, Novo cautioned that, "even when a medication is available, patients may not always be able to immediately fill their prescription at a particular pharmacy." The statement added that people seeking to fill a prescription may experience this "variability" regardless of whether a drug is actively in shortage... Full

Ozempic and Wegovy Considered ‘Available' After More Than 2 Years in Shortage

(10/31, Joseph Choi, The Hill) ...While the drugs remain on the shortage list for now, they are no longer listed as "currently in shortage" by the FDA. Both Ozempic and Wegovy are forms of semaglutide, a GLP-1 agonist drug manufactured by Novo Nordisk. When reached for comment, an FDA spokesperson told The Hill, "The FDA is currently working to determine whether the demand or projected demand for semaglutide within the United States exceeds the available supply... Full

Baxter Exits China IV Fluids Market Amid Tough Local Competition, US Shortage

(10/30, Angus Liu, Fierce Pharma) ...Baxter China confirmed the move to Yicai. Fierce Pharma has reached out to the Illinois-based company for comments. "With the changes in the environment and market, Baxter's IV therapy business in China faces numerous challenges," Baxter China said in a statement, as quoted by Yicai. "Over the past few years, Baxter has actively explored and attempted various business transformation plans to find a suitable long-term sustainable development strategy for the infusion business."... Full

Cigna Tops Quarterly Profit Estimates On Strength in Pharmacy Benefit Management Unit

(10/31, Sriparna Roy, Reuters) ...igna beat Wall Street estimates for third-quarter profit on Thursday, as its unit that runs the pharmacy benefit management business added new clients and saw strong demand for close copies of a blockbuster arthritis drug. Cigna expects the biosimilar opportunity to go beyond Humira and sees an additional $100 billion of annual specialty drug spend to be subject to biosimilar and generic competition in the U.S. by 2030... Full

FDA Accepts Organon's Application for Prolia Biosimilar

(10/30, Formulary Watch) ...The FDA has accepted the biologic license application (BLA) for HLX14, a biosimilar referencing Amgen's Prolia/Xgeva (denosumab)...The U.S. application of HLX14 follows Teva's application for its Prolia biosimilar candidate TVB-009P. The FDA's decision for Teva's product is also expected in the second half of the 2025. The application is based on an analytical and clinical data package including results from a phase 3 trial investigating the safety and efficacy of TVB-009P versus Prolia in women with postmenopausal osteoporosis... Full

Iconovo's Partner Amneal Has Taken the Next Important Step in the Clinical Development of ICOres® Budesonide/Formoterol

(10/30, Iconovo AB) ...Iconovo AB, a leader in the development of inhalable drugs based on proprietary inhalers and dry powder formulations, today announces that the company's development partner Amneal Pharmaceuticals has completed a clinical pharmacokinetic pilot study comparing ICOres® budesonide/formoterol and Symbicort® Turbuhaler®. The results from the study indicate that ICOres® budesonide/formoterol will meet the criteria for demonstrating bioequivalence in an appropriately designed and powered study... Full

Why Do Hospitals Keep Running Out of Generic Drugs?

(10/30, Sally Helm, NPR) ...Drug shortages have been a problem for years. We look at the economics that affect the availability of the common cheap drugs in which hospitals rely... Full

Psoriasis Biosimilars and Pricing Changes Herald Treatment Paradigm Disruptions

(10/31, Akosua Mireku, Pharmaceutical Technology) ...Experts predict that physicians may favour emerging biosimilar versions of Stelara over more effective originator IL-23 drugs..."When generics and biosimilars join the market, drug prices plummet," says Dr. Robert Popovian, founder of the New York-based strategic consulting firm Conquest Advisors. However, concurrent with the entry of Stelara biosimilars, factors like the Inflation Reduction Act (IRA) are influencing drug pricing and patient access... Full

Enhancing Adoption of Infused Biosimilars for a Sustainable Future

(10/31, Skylar Jeremias, The Center For Biosimilars) ...A recent IQVIA Institute report on the long-term sustainability of infused biosimilars in the US highlighted challenges in uptake and sustainability, providing background on issues and potential policy solutions... Full

Drugmakers Urge Appeals Court to Revive Challenge to US Drug Price Negotiation Program

(10/30, Brendan Pierson, Reuters) ...Yaakov Roth of Jones Day, arguing for Bristol Myers, told a three-judge panel of the 3rd U.S. Circuit Court of Appeals on Wednesday that the law does not give the companies a choice to negotiate but is instead a "gun to the head," since a company that refuses to negotiate must pay exorbitant fines or drop out entirely from Medicare, which represents close to half of the prescription drug market... Full

Medicare Negotiations: Industry Makes Headway At Appeals Court With First Amendment Argument

(10/30, Sarah Karlin-Smith, Pink Sheet) ...Bristol Myers Squibb Co. and Janssen Pharmaceutical Cos. found some sympathy for their First Amendment claims from at least two of the three judges on the appeals court panel hearing their consolidated case against the Inflation Reduction Act's Medicare drug price negotiation program... Global Sub. Full

Lawmakers Eager To Move PBM Reform, Rare Disease Bills Before Session Ends

(10/30, Gabrielle Wanneh, InsideHealthPolicy) ...At a summit for the National Organization for Rare Disorders (NORD) held earlier this month, congressional staffers said key lawmakers on the House Energy & Commerce Committee and Senate health and Finance committees are aiming to pass pharmacy benefit manager bills by the end of the year and reauthorize FDA's pediatric priority review voucher (PRV) program through 2029... Sub. Req’d

The Need for Regulation to Positively Impact Drug Formulary Decisions to Ensure Appropriate Patient Access: A Little-Discussed Topic in Pharmaceutical Policy and Pricing Debate

(10/30, Jan E. Berger, MD, MJ, AJMC) ...Medications are being discovered that treat conditions that either were undertreated or had no treatment at all. This creates the opportunity to improve health and decrease costs...We need to create a model where all parties have their clinical and financial needs met. Legislative remedies can help pave the way to a pharmacy-based value benefit... Full

Spanberger Seeks Additional Answers from DEA, FDA On Efforts to Stop Ongoing ADHD Medication Shortages

(10/30, Congresswoman Abigail Spanberger) ...In a letter sent to DEA Administrator Anne Milgram and FDA Commissioner Robert M. Califf, Spanberger underscored her continued concern for the ongoing shortage of medications used to treat ADHD. The Congresswoman also urged the agencies to provide additional information about the implementation of DEA's strategies to alleviate ongoing shortages, potential adjustments to Adderall's production quota, and how the agencies are continuing to work with manufacturers to increase the supply of ADHD medications. Additionally, the Congresswoman asked what actions Congress can take to support these continued efforts... Full

Fixing IV Fluid Shortage Only a Start in Addressing Drug Supply

(10/30, Kevin B. O'Reilly, AMA) ...In a letter to HHS Secretary Xavier Becerra earlier this month, the AMA applauded the administration's "quick action" to address the immediate crisis. But AMA Executive Vice President and CEO James L. Madara, MD, urged a more proactive approach "to ensure that supply chains for drugs at risk of shortages are bolstered before shortages actually occur." The nation "should not let drugs fall into predictable shortages before we take action to maintain their availability," he wrote... Full

Demand for Obesity Drugs Pressures FDA's Shortage Review

(10/30, Nyah Phengsitthy, Bloomberg Law) ...The Food and Drug Administration's methodology for monitoring drug shortages wasn't heavily scrutinized before weight-loss drugs arrived, attorneys say, but the agency is now facing calls to increase its transparency around how it determines whether compounding pharmacies are free to make copycat versions of Eli Lilly & Co.‘s popular diabetes and obesity treatment, which are branded as Mounjaro and Zepbound... Full

Drug Wholesalers, Others Ask US Appeals Court to Revive Lipitor Antitrust Lawsuits

(10/30, Mike Scarcella, Reuters) ...A group of drug wholesalers, retailers, health plans and others have asked a U.S. appeals court to revive their lawsuits accusing pharmaceutical company Ranbaxy of conspiring with Pfizer to delay the release of a generic version of the cholesterol medication Lipitor... Full

US Drug Import Plan from Canada Faces Hurdles, New Research Suggests

(10/30, Freschia Gonzales, BPM) ...Research from the Canadian Health Policy Institute (CHPI) indicates that the United States is unlikely to achieve healthcare cost savings by importing prescription drugs from Canada...CHPI CEO Brett Skinner, PhD, conducted an analysis of 2023 sales volumes in both Canadian and US markets for 27 drugs included in the Colorado and Florida proposals. The study estimated that US demand would deplete the Canadian supply of these drugs in just 57 days, on average... Full

‘Ambitious Platform' Among EU Proposals For Increasing mHealth Data Use In Regulatory Decision-Making

(10/30, Neena Brizmohun, Pink Sheet) ...A newly published EU report reviews relevant literature related to the use of mHealth data in the context of medicine regulation and aims to discuss their utility for regulatory uses. Smartphones, health applications, smartwatches and other wearables can provide measurements of patient function in the real world "on a more granular level" than any other real-world data source used in medicine regulation, the report said... Global Sub. Full

PLI & Digital Technology Propel Indian Pharma's Growth Prospects and Competitiveness in Global Markets

(10/31, Nandita Vijayasimha, Pharmabiz.com) ...According to Tejinder Pal Singh, founder director & senior partner, pharma, healthcare & life sciences, Transearch India, Covid-19 pandemic has reshaped global views on health, especially raising the stakes for strong pharmaceutical manufacturing capabilities. Running parallel with these changes, recent US trade policy actions against China have accelerated a global supply chain realignment, placing India as a leading manufacturer for international markets... Full

DoP Orders NPPA to Reassess Price of Cipla's Advent, Synclar and Azee Drugs

(10/30, Farhat Nasim, Medical Dialogues) ...The Department of Pharmaceuticals (DoP), under the Ministry of Chemicals & Fertilizers, has issued orders to the National Pharmaceutical Pricing Authority (NPPA) to review its price fixation decisions for three pharmaceutical formulations, namely, Advent 1.2 gm Injection, Synclar 125 mg Dry Syrup, and Azee 250 mg Tablets manufactured by Cipla Limited... Full

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