Wednesday, November 6, 2024

Teva Pharmaceutical Raises 2024 Outlook as Q3 Profit Beats Estimates

(11/6, Steven Scheer, Reuters) ...Teva Pharmaceutical Industries raised its 2024 revenue and earnings guidance after beating third-quarter profit forecasts, boosted by strong sales of copycat medicines and its branded drugs to treat migraines and Huntington's disease... Full

Teva Beats Analysts, Raises Guidance Again

(11/6, Shiri Habib-Valdhorn, Globes) ...Teva Pharmaceutical Industries Ltd. ended the third quarter with $4.33 billion revenue and non-GAAP earnings per share of $0.69, beating the analysts' consensus, which had forecast $4.12 billion revenue and $0.66 per share. The share price is up 7% on the Tel Aviv Stock Exchange (TASE)... Full

Teva Reports Q3 EPS 69c, Consensus 66c

(11/6, The Fly) ...Richard Francis, Teva's President and CEO, said, "The third quarter of 2024 marks our seventh consecutive quarter of growth, with global revenues reaching $4.3 billion, an increase of 15% in local currency terms compared to the third quarter of 2023. Our innovative portfolio and generics business drove strong performance in the third quarter of 2024, reflecting the successful execution of our Pivot to Growth Strategy. Due to our effort and commitment, we are consistently delivering on our growth strategy, executing on our ambitious targets by following our strategic framework, as we remain laser focused on its four key pillars."... Full

Alvotech And Advanz Claim A Global First With Golimumab Filing

(11/5, Dave Wallace, Generics Bulletin) ...Developer Alvotech and marketing partner Advanz have celebrated a major step towards gaining approval for their AVT05 proposed biosimilar rival to Simponi (golimumab), after the European Medicines Agency accepted the pair's marketing authorization application... Global Sub. Full

‘Imitation Is Flattery,' Regeneron Tells Amgen As It Prepares To Compete On Eylea

(11/5, Dean Rudge, Generics Bulletin) ...In the first earnings call since Amgen confirmed launch of the first US biosimilar to Regeneron's near $6bn Eylea brand, the originator spoke of its confidence in defending its brand, while also touching on how supply issues for repackaged Avastin had impacted its operations... Global Sub. Full

Dr Reddy's Labs, Mankind Pharma Riding On Strong Growth Drivers

(11/6, Kiran Somvanshi, The Economic Times) ...Two Indian pharma majors Dr Reddy's Labs and Mankind Pharma reported strong performance for the quarter to September characterised by double-digit growth in revenues and improved business prospects. Despite the slowdown in the growth of acute therapies in India in the quarter, their India performance posted double digit growth... Full

Lack of Strong Launch Pipeline Keep Brokerages Neutral Over Dr Reddy's Labs

(11/6, Vaibhavi Ranjan, Money Control) ...Even though the company stepped up its research and development (R&D) spend to focus on ramping-up its biosimilars, generics as well as biologics segments, it still refrained from providing updates on the major drugs that it might launch in the near-term. Brokerage firm Nuvama Institutional Equities highlighted the issue and stated that while it appreciates Dr Reddy's efforts to focus on developing complex high-value products, the firm still awaits it to show up in its filings and numbers. On the basis of this, Nuvama retained its 'reduce' call on the stock with a target price of Rs 1,215... Full

AstraZeneca Shares Fall On Report of Potential China Probe Fallout

(11/5, Aby Jose Koilparambil and Pushkala Aripaka, Reuters) ...AstraZeneca shares on Tuesday recorded their worst day since March 2020 after a report that dozens of the drugmaker's senior executives in China could be implicated in the largest insurance fraud case in the country's pharma sector in years... Full

Germany's Fresenius Raises 2024 Forecast After Q3 Beat, Shares Rise

(11/6, Tristan Veyet, Rafal Nowak, Reuters) ...Germany's Fresenius raised its full-year outlook on Wednesday after beating third-quarter expectations, citing strong performances at its Kabi and Helios divisions and deleveraging efforts paying off, sending shares up. The healthcare group said it expects organic revenue growth of 6%-8%, from a previously anticipated 4%-7%... Full

Granules India Q2 Profit Falls On Weak Demand in North America, Europe

(11/6, Yagnoseni Das, Reuters) ...Drugmaker Granules India reported a 4.8% fall in its second-quarter profit on Wednesday, dragged by a slow demand in the North American and European markets. Consolidated profit fell to 972.3 million rupees ($11.54 million) for the quarter ended Sept. 30, from 1.02 billion rupees a year earlier. Granules, which generates 66% of its revenue from North America and 19% from Europe, posted an 18.7% fall in its revenue from operations... Full

Novo Nordisk Affirms 25% Weight-Loss Expectation for Experimental Drug CagriSema

(11/6, Maggie Fick, Reuters) ...Novo Nordisk said the side effects in trials so far for its experimental obesity drug CagriSema were similar to its GLP-1 drugs already on the market, and reiterated its expectation the new injection will deliver 25% weight loss. Martin Holst Lange, Novo Nordisk's head of development, made the comments to Reuters after the company released better-than-expected third-quarter results... Full

Canada Approves GSK's RSV Vaccine for Adults Aged 50 to 59

(11/5, Puyaan Singh, Reuters) ...GSK has received Canadian approval for its respiratory syncytial virus vaccine in adults between 50 and 59, the company said on Tuesday, making it the country's first authorized RSV shot for that age group. The U.S. Centers for Disease Control and Prevention decided to hold off recommending the use of the vaccine, Arexvy, in adults under 60, despite the Food and Drug Administration approving it for that age group... Full

Aurobindo's Lyfius Opens Flagship Penicillin Plant In India

(11/5, Adam Zamecnik, Generics Bulletin) ...Aurobindo's Lyfius Pharma has opened a new flagship antibiotic manufacturing facility in India, with the country's prime minister Narendra Modi in virtual attendance at the inauguration of the new multi-million dollar plant. The INR25.0bn ($297.2m) plant will specifically manufacture Penicillin-G. Also known as benzylpenicillin, the antibiotic is used to treat infections such as meningitis... Global Sub. Full

Pharma's Ethically Questionable Sites Essentially Sell Drugs Directly to Consumers

(11/6, Adriane Fugh-Berman and Judy Butler, STAT) ...This unprecedented move launches a new dystopic era: pharmaceutical companies as health care provider, no pesky physician middlemen needed. It's what the pharmaceutical industry has always wanted: They have long viewed physicians as inconvenient barriers between the company and their customers. Rather than bribing and wheedling physicians to pretty-please-prescribe-our-drug, companies can now deal drugs straight to the consumers who want them, whether or not those consumers need, know anything about, or will benefit from those drugs... Full

Donald Trump Returns to the Presidency with Big Ambitions to Shake Up Health Care

(11/6, Sarah Owermohle, STAT) ...The president-elect campaigned on promises to shake up public health institutions, reshape federal health programs, and slash high costs across the system. Trump has said he's ready for campaign lieutenants like Robert F. Kennedy Jr. to "go wild" on health, medicine, and food policy. Trump repeated that promise in his victory speech. "We can add a few names like Robert F. Kennedy Jr.," Trump told his supporters. "And he's going to help make America healthy again… He's a great guy and he really means that he wants to do some things, and we're going to let him go to it."... Full

Medicare Definitions Of ‘Bona Fide Marketing,' And ‘Single-Source Drug' May Be Inconsistent With Law, Appeals Court Says

(11/5, Sarah Karlin-Smith, Pink Sheet) ...AstraZeneca may not have convinced an appeals court it has standing in its APA challenges against the IRA, but some of the judges' thoughts on the merits might bode well for a company that could show standing. Judges on the appeals panel seemed to think Medicare may have defined key terms in guidance, "bona fide market" and "single source drug," in ways that are inconsistent with the statute. One judge also questioned whether some of the law's bars on judicial review could constitute a Constitutional due process violation... Global Sub. Full

Cassidy, Hassan Unveil Site-Neutral Payment Bill; Propose Reinvestment In Rural, High-Needs Hospitals

(11/5, Jalen Brown, InsideHealthPolicy) ...Sens. Bill Cassidy (R-LA) and Maggie Hassan (D-NH) released a framework Friday (Nov. 1) for site-neutral payment reforms in Medicare with two potential options that include extending site neutral pay to all off-campus hospital-owned facilities or setting a single, uniform payment rate for common outpatient services. The first option would not affect rural or high-needs hospitals' revenue, according to the bipartisan framework, which also offers two ways to redirect Medicare savings to mitigate the potential impact of the second option on those facilities... Sub. Req’d

NH Report: State Would Save Money If It Used CMS' Negotiated Prices

(11/5, Luke Zarzecki, InsideHealthPolicy) ...A new report from the New Hampshire prescription drug affordability board (PDAB) found $6 million would have been saved if Medicare's maximum fair prices (MFPs) were applied to the state's plans in 2023 and found the top 25 costliest prescription drugs cost the state $127.5 million, with seven of the 10 drugs with a MFP on New Hampshire's list... Sub. Req’d

Firms Could Earn ‘Platinum Card,' Less Frequent Inspections With Third-Party Audits, Califf Says

(11/6, Derrick Gingery, Pink Sheet) ...During an appearance at the Association for Accessible Medicines' GRx-Biosims conference, FDA Commissioner Robert Califf suggested agency officials are searching for ways to incentivize manufacturers to provide more information about their facilities outside of the traditional inspections. Ideally, the data could help determine when or whether another agency visit is necessary... Global Sub. Full

Stakeholders Want More Opportunities to Discuss MIDD with FDA

(11/5, Ferdous Al-Feruque, Regulatory Focus) ...Stakeholders want more discussions on the kinds of data that can be used when stakeholders consider using model-informed drug development (MIDD) approaches. They note that there is uncertainty about what kinds of data the US Food and Drug Administration (FDA) will accept when such models are employed... Full

Editorial: Should Oregon Set Price Limits On Prescription Drugs?

(11/5, The Bulletin) ...A state board, the Oregon Drug Prescription Affordability Board, may recommend the Legislature set an upper price limit on some prescription drugs. It would come with a tangle of complications: affordability and innovation, legality and morality...There may be other repercussions. Drug companies may pull drugs. Profit margins for struggling pharmacies may narrow. It may lower rebates for the drugs that consumers had been receiving, resulting in consumers not really paying less... Full

Council Adoption of Urban Waste Water Treatment Directive Will Generate a Tsunami of Essential and Critical Medicine Shortages Across Europe

(11/5, Medicines for Europe) ...The generic, biosimilar and value-added pharmaceutical sector represented by Medicines for Europe condemns today's adoption of the EU Urban Waste Water Treatment Directive (UWWTD), which will require only the pharmaceutical and cosmetic sectors to finance the upgrades of several hundreds of wastewater treatment plants across Europe and their running costs. If implemented in the current form, the direct economic impact of the directive will lead to massive shortages of essential and critical medicines in Europe, due to lack of economic viability... Full

Urban Wastewater Treatment Directive Will Undermine the Availability, Affordability and Accessibility of Medicines

(11/5, Medicines for Ireland) ...Medicines for Ireland, alongside our colleagues in Medicines for Europe, are seriously concerned about the impact of the Urban Wastewater Treatment Directive (UWWTD). The direct economic impact of the directive could lead to massive shortages of essential and critical medicines in Ireland and across Europe if implemented in its current form... Full

TN Govt Notifies Launch of ‘Mudhalvar Marundhagam', TNCDA Asks Govt to Introduce Scheme Through Their Shops

(11/6, Pharmabiz.com) ...Even as the government of Tamil Nadu is taking all steps to launch the subsidized generic pharmacy network scheme, ‘Mudhalvar Marundhagam' (Chief Minister's Pharmacy) on the day of Tamil New Year (January 14, Pongal Day), the state Chemists and Druggists Association (TNCDA) has urged the government to involve their members also into the scheme to run the government sponsored generic stores... Full

Japan Raises Out-of-Pocket Costs for Off-Patent Drugs

(11/6, The Japan Times) ...Under the new system, patients pay more for brand-name drugs prescribed by medical institutions if the patents have expired. A quarter of the price difference between these drugs and their generic equivalents is no longer covered by insurance, adding to patients' out-of-pocket costs, which typically range from 10% to 30% of total expenses. A senior health ministry official said, "The new system does not apply if brand-name drugs are prescribed at a doctor's discretion or if generic drugs are unavailable at pharmacies."... Full

Germany's Medication Supply Issues Persist Despite New Law

(11/6, Michael van den Heuvel, Medscape) ...The German government introduced a law last year aimed at ensuring a stable and secure supply of medicines. However, few improvements have been seen in the 15 months since the Act to Combat Drug Shortages and Improve Supply (ALBVVG) came into force. This article explores the possible reasons... Full

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