Tuesday, November 12, 2024

NHS Rolls Out ‘Stop-Smoking' Pill to Help Tens of Thousands Quit

(11/12, NHS England) ...Varenicline has been shown to work as well as vapes to help people stop smoking and be a more effective aid than nicotine-replacement gum or patches. The daily pill is now set to be offered by the NHS to tens of thousands of smokers each year in England to provide another option to help them quit...The treatment is being made available through a collaboration between NHS England and pharmaceutical company Teva UK, who have agreed to provide a new generic version of the treatment to the NHS... Full

'Game-Changer' Stop-Smoking Pill Varenicline to Be Offered On NHS

(11/12, Sky News) ...A branded version of the smoking cessation pill - known as Champix - was previously prescribed, but then withdrawn by Pfizer in 2021 as a precaution after an impurity was discovered. However, the NHS said a generic version of the drug, from pharmaceutical firm Teva UK, has now been approved as safe by the Medicines Health and Regulatory Authority. It said another pill that works in a similar way, cytisine, is also being reviewed by the National Institute for Health and Care Excellence and could be made available in the future... Full

Anti-Smoking Drug Varenicline to Be Rolled Out for 100,000 On NHS

(11/12, Michael Searles, The Telegraph) ...The return of a new, improved version, manufactured by Teva UK, has been called a "game changer" by Amanda Pritchard, the NHS chief executive, who is expected to confirm a nationwide rollout during a speech at the NHS Providers' conference on Tuesday...The pill could help one in four people stop smoking for at least six months when used alongside behavioural support, according to NHS England... Full

NHS Offers 'Improved' Stop Smoking Pill

(11/12, Michelle Roberts, BBC) ...Varenicline, a daily tablet given over a few months, is as effective as vapes and more effective than nicotine replacement gum or patches, NHS England says. The drug, which fights cravings, was available a few years ago on the NHS under the brand name Champix but was withdrawn due to some impurities. The new version has been approved as safe... Full

'Game Changer' Stop Smoking Pill to Be Rolled Out On NHS

(11/12, Matt Watts, The Standard) ...Health Secretary Wes Streeting said: "Prevention is better than cure. The rollout of this pill can save the NHS millions of pounds, save appointments to help other patients be seen faster, and save lives."...News of the rollout of varenicline has also been welcomed by health charities and researchers. Dr Sarah Jackson, a principal research fellow at the UCL Tobacco and Alcohol Research Group, said: "It is excellent news that varenicline is now available again in England. "Large evidence reviews have consistently found it to be one of the most effective treatments for helping people to stop smoking."... Full

NHS England Relaunches Anti-Smoking Pill Programme

(11/12, Phil Taylor, Pharma Phorum) ...Research by University College London has suggested that widespread use of varenicline on the NHS could help over 85,000 people try to stop smoking each year and its use over the next five years could prevent up to 9,500 smoking-related deaths. Meanwhile, an analysis by NICE of the impact of Champix when it was available found that, for every £1 spent on the drug, £1.65 was saved through the prevention of smoking-related illnesses. The generic will also be cheaper, so the return on the use of Teva's product should be greater... Full

New ‘Game Changer' Pill to Stop Smoking to Be Given to Thousands for Free

(11/12, Albert Toth, Independent) ...Speaking the at NHS Providers' Annual Conference and Exhibition in Liverpool, Ms Pritchard will say: "This simple, daily pill could be a game changer for people who want to quit smoking and is another vital step in shifting our NHS further towards prevention."...Made by pharmaceutical company Teva UK, the pill is a generic version of the branded pill Champix, which was withdrawn in 2021 after a potentially carcinogenic impurity was found in its formula... Full

Teva Welcomes Potential For Olanzapine ‘Running Start' Amid Positive Clinical Data

(11/11, Dean Rudge, Generics Bulletin) ...Teva has welcomed positive initial data from its Phase III clinical trial evaluating a proposed olanzapine long-acting injectable as something "we have not seen to-date," as the Israeli firm confirmed that the development program – in partnership with MedinCell – was "right on track."..."We've exceeded, as expected, the targeted number of injections that we need for the submission package," noted Teva's global head of R&D and chief medical officer, Eric Hughes... Global Sub. Full

Can Teva Sustain Its Comeback?

(11/11, Shiri Habib-Valdhorn, Globes) ...Leader Capital Markets head research analyst Sabina Levy wrote that Teva does not expect a significant change in the generics price environment in the US in 2025, while new launches, including complex generics, combined with continued expansion in the biosimilar field (generic versions of biological drugs) will contribute to good performance in the segment, and compensate for the expected decline in Revlimid revenue in 2026... Full

Announcing the Launch of the This Week in Policy and Medicine Podcast

(11/11, Thomas Sullivan, Policy & Medicine) ...With Trump confirmed as the President-elect, significant shifts are expected that could influence everything from pharmaceutical pricing strategies to regulatory oversight. Featured Topics...Legal Developments: We cover the recent $450 million settlement by Teva Pharmaceuticals with the DOJ and a €462.6 million fine imposed by the European Commission for anti-competitive practices... Full

Teva v. Amneal -- Amneal's Responsive Brief

(11/11, Kevin E. Noonan, Patent Docs) ...The Federal Circuit has been petitioned by plaintiff Teva Branded Pharmaceutical Products R&D, Inc. to reverse a decision in favor of Defendant Amneal Pharmaceuticals, wherein the District Court entered an injunction ordering Teva to delist five Orange Book-listed patents, in Teva Pharms. Inc. v. Amneal Pharms. LLC. This post concerns Amneal's response to Teva's arguments in its Opening Brief... Full

Hikma Stays On Track By Bolstering Injectables And Generics

(11/11, Dave Wallace, Generics Bulletin) ...Hikma was upbeat as it delivered a third-quarter trading update, suggesting that recent strategic moves – such as its acquisition of Xellia's finished dosage form business, as well as a key contract manufacturing agreement signed for its generics business – have kept the company on the right track to meet its full-year growth forecasts... Global Sub. Full

AstraZeneca Lifts 2024 Outlook After Q3 Beat, Doubles Down On U.S. Investments

(11/12, Maggie Fick, Yadarisa Shabong, Reuters) ...Drugmaker AstraZeneca lifted its annual sales and profit forecast for the second time this year on Tuesday, helped by strong demand for its cancer and rare diseases medicines, after third-quarter results beat estimates. The London-listed company doubled down on plans for U.S. expansion, announcing $2 billion in new spending on research and development and on plants that manufacture biologics medicines and cell therapies... Full

AstraZeneca, Daiichi Sankyo Change Strategy On Closely Watched Cancer Drug

(11/12, Andrew Joseph, STAT Plus) ...The medicine, datopotamab deruxtecan, or Dato-DXd, is a type of next-generation chemotherapy called an antibody-drug conjugate that AstraZeneca and other companies have been pouring investments into. AstraZeneca, which is partnered with Daiichi Sankyo on the drug, has cited Dato-DXd as one of the products that will help it achieve its goal of nearly doubling its revenue to $80 billion by 2030... Sub. Req’d

India's Zydus Life Posts Q2 Profit Rise On Steady US Demand

(11/12, Kashish Tandon, Reuters) ...Indian drugmaker Zydus Lifesciences reported a 14% rise in second-quarter profit on Tuesday, helped by strong demand for generic drugs in its key United States and Indian markets...Its total revenue climbed 20% to 52.37 billion rupees, boosted by a nearly 30% growth in its U.S. market and a 10% climb in its India business. The two markets contribute about 85% to Zydus Life's total revenue... Full

API Prices Expected to Stabilise by Q4FY25, Says Akums Drugs' Maheshwari

(11/11, Jessica Jani, Mint) ...The contract development and manufacturing organisation which works on active pharmaceutical ingredient production as well as generic and branded drug formulations, reported a weak second quarter with revenue falling 12% on the back of softening API prices and weak volume growth. "Volume was very strong in Q1 with double digit growth but in Q2 given the API prices were a bit unstable, the industry volumes were relatively flat," Sahil Maheshwari, general manager, Strategy at Akums, told Mint on Monday... Full

Natco Pharma Q2 Results: Net Profit Surges 83%, Topline and Margin Expand from Last Year

(11/12, Meghna Sen, CNBC-TV18) ...Natco Pharma Ltd. reported its September quarter results on Tuesday, November 12, which were higher on a year-on-year basis on all parameters. The growth during the second quarter was driven by a strong performance in exports formulation business and stable domestic pharma business. The pharma company reported a 83% jump in its net profit at 676.5 crore for the September quarter. It had reported a net profit of 369 crore during the same period last year. Revenue for the said quarter also increased by 33% to 1,371 crore, compared to 1,031 crore in the same period last year... Full

Alembic Pharma Secures USFDA Nod for Generic Heart Failure Medication

(11/12, CNBC-TV18) ...Alembic Pharmaceuticals has received final USFDA approval for Ivabradine tablets, aimed at reducing hospitalisations due to heart failure. Shares rose over 1.3% following the announcement, reflecting market optimism... Full

With US Launch Progressing, ARS Inks Another Licensing Deal for Epinephrine Spray Neffy Worth Up to $465M

(11/11, Fraiser Kansteiner, Fierce Pharma) ...On Monday, the California-based drugmaker said that Denmark's ALK-Abelló is paying $145 million upfront for the rights to market Neffy in Europe, Canada and "other geographies outside of the U.S." In Europe, where ARS' needle-free EpiPen alternative was approved for emergency anaphylaxis treatment late this summer, the drug goes by the name EURneffy... Full

GSK Snags Parkinson's Drug from Flagship Startup Vesalius

(11/12, Kyle LaHucik, Endpoints News) ...The UK pharma will make an $80 million cash and equity investment, and could pay as much as $570 million more in milestones or other payments, the companies said Tuesday morning. Tiered royalties could also come Vesalius' way for the Parkinson's small molecule, which is in the preclinical stages and could be tested in additional areas down the road... Full

‘We Will Continue to Explore Options to Further Reduce Debt in the Near Term'

(11/12, Financial Express) ...Biocon Group's generics business continues to face pricing and demand challenges as was reflected in the July-September quarter also. Peter Bains, Group CEO, tells FE in an interview that the company's long-term debt restructuring through a combination of $800 million dollar-denominated bonds and a $300 million new syndicated loan facility, with better terms will provide better financial liquidity to Biocon Biologics... Full

MC Interview | Dr Reddy's Looking to Jump Ranks in Domestic Market, Eyes M&As in Chronic Segment

(11/12, Vaibhavi Ranjan, Money Control) ...In an exclusive interview with Moneycontrol, Dr Reddy's CFO, M.V. Narasimham highlighted the company's plans on moving up the ranks in the Indian pharma market, areas of inorganic growth opportunities and prospects emerging from the US Biosecure Act... Full

Sandoz Pushes for Biosimilars Uptake

(11/12, Pharmacy Daily) ...Despite their advantages, data shows biosimilar uptake in Australia remains among the lowest in the OECD, with usage rates under 25%, compared to more than 90% in countries like the UK, Netherlands, and Denmark. Sandoz Australia and New Zealand's General Manager, Clint Holland, said, "we are dedicated to improving access to high-quality, affordable medicines"... Full

CEO of Pharma Giant Sanofi Says Businesses Should Stop ‘AI Washing'

(11/11, Alexa Mikhail, Fortune) ...AI's role in health care is rapidly evolving to solve some of the largest problems, including access, drug discovery, and physician burnout. However, Paul Hudson, CEO of Sanofi, one of the world's leading biopharmaceutical companies, says executives may need to rein themselves in when it comes down to how they describe their AI capabilities... Full

IV Fluid Shortage Reveals Some Hospitals Were Using Too Much

(11/12, Ike Swetlitz, Bloomberg) ...After the hurricane, hospitals scrambled, postponing some procedures and figuring out how to conserve supplies. Some of those conservation methods demonstrate that hospitals may have been using more than they needed to in the first place... Full

Anticipation And Trepidation About Trump's Election Rise

(11/11, Alaric DeArment, Pink Sheet) ...The recent presidential election elicited some jokes and some anxiety about the coming Trump Administration and its impact on the biopharma industry. Galien Forum speakers discussed the potential implications for the IRA and NIH funding. One panelist stressed the importance of emphasizing that the NIH is vital to the life sciences industry and biomedical innovation... Global Sub. Full

Experts Say RFK Jr. Could Play Big Role in Trump 2.0, FDA Leadership to Face Scrutiny

(11/11, Ferdous Al-Faruque, Regulatory Focus) ..."I think the big difference this time is [President-elect Trump and his supporters] are much more explicitly talking about FDA changes in sweeping ways in terms of personnel, in terms of radical policy changes, at least different from the past," Daniel Kracov, a partner at Arnold & Porter and chair of its global life sciences industry group, told Focus. "That opens up our historical assumptions about FDA and its role and what it does and so forth."... Full

Republicans Vie for Leadership of Powerful House E&C Committee

(11/12, Nancy Vu, Bloomberg Law) ...The top two candidates in a tight race to lead the House Energy and Commerce Committee are Reps. Brett Guthrie (R-Ky.) and Bob Latta (R-Ohio), who have eyed the position since Rep. Cathy McMorris Rodgers (R-Wash.) announced her plan to retire earlier this year...Whoever wins the position will exert significant influence over health care policy during the 119th Congress especially if Republicans win a trifecta, following calls from House leadership to overhaul Obamacare, former President Barack Obama's health care law... Sub. Req’d

Election Throws Uncertainty Into Lame Duck Package Size, Timing

(11/11, Amy Lotven, InsideHealthPolicy) ...The increasingly likely prospect that Republicans will retain control of the House -- giving the party a trifecta on the White House and both chambers of Congress -- increases tension between some Republicans who want to punt any substantive legislative action to the new Congress and lawmakers who want to tackle the expiring health care extenders and finish years-long bipartisan work on key health issues like pharmacy benefit manager reform, hospital transparency and more, say lobbyists who expect the plan to come into focus after the congressional leadership elections on Wednesday (Nov. 13)... Sub. Req’d

PhRMA Rolls Out Ad Pushing PBM Reform Amid Lame-Duck Uncertainty

(11/11, Donna Haseley, Maaisha Osman, InsideHealthPolicy) ...PhRMA's new national ad, launched Monday (Nov. 11), claims PBMs treat medicines as profit centers, pushing up costs for both patients and the health care system. The leading pharmaceutical lobbying group argues that while PBMs and insurers benefit from billions in drug rebates and discounts, these savings rarely reach patients at the pharmacy. Instead, PhRMA calls for PBMs to pass these savings directly to patients to help lower their out-of-pocket costs... Sub. Req’d

FTC to Expand Drug Middlemen Price Hike Fight in 2025: Analysis

(11/11, Laura Travis, Bloomberg Law) ...Congress has long sought to pass legislation curbing PBM power. Because this is largely a bipartisan issue, the switch from the Biden to Trump administrations will not necessarily impede its progress—although other new legislation under the new leadership might take priority in 2025. Additionally, the FTC complaint will put other industry players on alert for their role in high drug prices and may motivate them to lower their prices... Full

Breaking Down Biosimilar Barriers: The Patent System

(11/11, Skylar Jeremias, The Center For Biosimilars) ...Biosimilars offer critical savings and increased access to treatments, but they face substantial barriers before reaching patients. This series for Global Biosimilars Week, a worldwide online biosimilar advocacy event hosted by the International Generics and Biosimilars Association, focuses on 3 major areas where obstacles limit access in the US: The Patent System, Interchangeability, Payer and pharmacy benefit managers policies... Full

Pharmacy Benefit Managers and Pharmacies to Duel in Denver

(11/11, Allison Bell, Benefits Pro) ...One NAIC panel, the Regulatory Framework Task Force, plans to hear a presentation on PBM transparency initiatives by Rob Nolan, the chief compliance officer at AffirmedRx, Sunday. AffirmedRx is a new PBM that says it's more transparent than the big PBMs... Full

Grateful Dad: In Praise of New Hampshire's Prescription Drug Affordability Board

(11/12, Donald M. Kreis, New Hampshire Bulletin) ...What makes the PDAB annual report noteworthy, however, is not just that it offers up factoids like that as illustration of just how much the bloated cost of cutting edge prescription medications is driving the cost of health care to unsustainable levels. The PDAB report then goes on to explain exactly what the problem is, in blunt and unmistakable terms... Full

UK MHRA: ‘At Least Half' Of Novel Drug Filings To Take National Assessment Route

(11/11, Ian Schofield, Pink Sheet) ...With approval applications for new active substances expected to rise by 25% by 2026, the UK regulator says it wants to focus its national assessment procedure on new innovative therapies. It will also review progress with the new International Recognition Procedure... Global Sub. Full

UK Toolkit To Accelerate Research Set-Up Across England, NI, Scotland And Wales

(11/11, Neena Brizmohun, Pink Sheet) ...The Health Research Authority says its new toolkit explains the differences and similarities in the research approval and set-up processes across the four UK nations so that researchers and sponsors are clear on what they need to do if they want to conduct a study in more than one of the countries...It should reduce the time it takes to set up research in the UK, according to the HRA... Global Sub. Full

MSF Calls On Lilly, Novo and Sanofi to Cut Insulin Pen Prices to $1

(11/11, Nick Paul Taylor, Fierce Pharma) ...The call for a $1 price is the latest in a series of actions by MSF focused on insulin pens. The nonprofit put the insulin price data at the center of a paper titled "Defeating the double standard in diabetes care" earlier this year. And it turned up the heat on Novo when the Danish drugmaker outlined plans to stop making insulin pens... Full

Japan Recommends Approval Of Brukinza, Balversa

(11/11, Lisa Takagi, Pink Sheet) ...Japan recommends approval of J&J's Balversa and BeiGene's Brukinza. Sakigake status also proposed for Boehringer Ingelheim's iclepertin for schizophrenia-associated cognitive impairment and Nippon Shinyaku DMD therapy brogidirsen. Japan's drug regulator, the PMDA, has opened its first full-time overseas office, in Washington D.C... Global Sub. Full

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