Wednesday, November 13, 2024

What is the NHS's New and ‘Improved' Stop Smoking Pill?

(11/12, Danny Rigg, Metro) ...Varenicline – made by pharmaceutical company Teva UK – tackles cravings and neutralises many of the symptoms associated with nicotine withdrawal. Used alongside behavioural support, this prescription-only medication could help one in four people quit smoking for at least six months, according to the NHS... Full

Exclusive: Pfizer Explores Sale of Hospital Drugs Unit, Sources Say

(11/12, Anirban Sen, Reuters) ...The unit, now called Pfizer Hospital, was formed after Pfizer bought Hospira for about $17 billion in 2015. The pharma giant has hired Goldman Sachs to gauge initial interest from potential buyers, which include private equity firms and other pharmaceutical companies, the sources said, requesting anonymity as the discussions are confidential... Full

AstraZeneca CEO Reaffirms Commitment to China Following Executive's Detention

(11/12, Max Gelman and Max Bayer, Endpoints News) ...CEO Pascal Soriot was clear that Wang's detention, along with the detention of other current and former AstraZeneca employees in China, is not welcome news for the company. But he also stressed that the events won't dissuade AstraZeneca from developing drugs for Chinese patients...Analysts asked whether AstraZeneca announced $2 billion in new R&D investments and manufacturing facilities in the US to take attention away from the China investigation and if the timing was linked to the presidential election. Soriot said in prepared remarks that, although the plan had been in store for a while, it was recently accelerated because "we believe the policies that will be put in place will drive economic growth, of course, but also drive innovation."... Full

Sandoz Continues UK Charge With Device Development Center Opening

(11/12, Dean Rudge, Generics Bulletin) ...More than two years after acquiring UK-based drug delivery device development company Coalesce Product Development, Sandoz has opened a device development center in Coalesce's hometown of Cambridge, UK, which will "serve as a global hub for developing advanced drug delivery devices that support the extensive Sandoz pipeline of affordable medicines."... Global Sub. Full

Egis And mAbxience Ally On Multiple Biosimilars In CEE

(11/12, Dave Wallace, Generics Bulletin) ...Two biosimilar candidates developed by mAbxience will be commercialized in key central and eastern European territories by Egis, under a strategic licensing deal that has just been struck between the two companies...During Fresenius' recent third-quarter results call, group CEO Michael Sen highlighted mAbxience's recent second licensing deal with Teva for an anti-PD-1 biosimilar candidate for multiple oncology indications, following an initial alliance announced earlier this year... Global Sub. Full

Aurobindo Pharma's Subsidiary Receives GMP From European Medicines Agency For Biosimilars Facility

(11/12, Prajwal Jayaraj, NDTV Profit) ..."The EU GMP certification marks a significant milestone in CuraTeQ's commitment to manufacturing high-quality biosimilars for patients worldwide. This inspection outcome paves way for securing approvals for our three biosimilars in Europe, currently under review by the Agency, within the next two to five months." Satakarni Makkapati, director of Aurobindo Pharma Ltd. and chief executive officer of biologics, vaccines, and peptides, stated... Full

GSK Pharma MD Bhushan Arshikar Says Affordable Generics Will Stay Relevant Amid a Premiumisation Trend

(11/13, Ashokamithran T., The Hindu) ..."Things like classification or premiumisation are now bandied around by many consultants, and really that's also playing out in several categories. I think our objective in shaping the next century as a company will be to ensure that we continue to provide. affordable access with all our mass based general medicines portfolio, which will still remain relevant" Mr. Akshikar said at an event celebrating hundred years in the pharmaceutical industry held on November 12 at Mumbai... Full

Proposed Biosimilar to Ocrelizumab Shows Comparability With Reference Product

(11/12, Ashley Gallagher, Pharmacy Times) ...Xacrel, a biosimilar to Ocrevus, showed comparable efficacy and safety in treating relapsing-remitting MS, with no significant differences in annualized relapse rate... Full

Baltimore Opioid Lawsuit: McKesson, Amerisource-Bergen Must Pay More Than $266M in Damages

(11/12, Greg Ng, WBAL-TV 11) ...The companies, McKesson and Amerisource-Bergen, will have to pay more than $266 million in damages...Six other pharmaceutical companies opted to settle with the city ahead, bringing the total payout for Baltimore to more than $668 million in restitution funds. Settlements include those with Walgreen's for $80 million, Allergan and CVS for $45 million each, Teva Pharmaceutical Industries for $80 million, Cardinal Health for $152.5 million and Johnson & Johnson, for which the terms were not disclosed... Full

Many Americans Unable to Afford Medications, Navitus Survey Finds

(11/12, Denise Myshko, Formulary Watch) ...The cost of prescription drugs continues to be a key issue for Americans. In a new survey of 2,000 people, many say price has affected their ability to get a medicine they needed at least once. The survey conducted by Navitus Health Solutions looked at consumer attitudes around drug pricing and awareness around issues impacting pricing... Full

Overcoming Challenges to Improve Access and Reduce Costs

(11/12, Skylar Jeremias, The Center For Biosimilars) ...The article sought to examine the adoption patterns of infliximab biosimilars across insurance types and to highlight the barriers and policy changes needed to enhance biosimilar uptake, ultimately aiming to make these cost-effective treatments more accessible and affordable within the health care system... Full

Industry Support Key To US FDA's Prospects Under Trump, Califf Says

(11/12, Sue Sutter, Pink Sheet) ...Industry support for the FDA's work and staff will be important to the agency's prospects under the incoming Trump Administration, Commissioner Robert Califf said. Califf said the FDA's next leader must have good executive functioning capability, a commitment to using evidence to make decisions, and a belief in expertise. Although almost all medical product decisions are made by career staff, the line between politics and science is fuzzier than most realize when it comes to policymaking, he said... Global Sub. Full

FDA Commissioner Suggests RFK Jr. and Trump Might Compromise An Agency ‘At Peak Performance'

(11/12, Lizzy Lawrence, STAT) ...Food and Drug Administration Commissioner Robert Califf said he's unsure about the future of the agency under the incoming Trump administration and "disappointed" about the election's outcome...The agency's ability to hire and retain skilled employees may be in jeopardy given Trump ally Robert F. Kennedy Jr.'s hostility to civil servants, Califf said. Trump has said he plans to give Kennedy, leader of the "Make America Healthy Again" movement, power over health care policy in his administration... Full

Former HHS Secretary Again Suggests Trump May Keep Rx Price Negotiation

(11/12, Gabrielle Wanneh, InsideHealthPolicy) ...During a conference held by America's Physician Groups Monday (Nov. 11), Azar and Donna Shalala, who served as HHS secretary in the Clinton administration, predicted Trump would also back allowing the United States to import more affordable drugs from select foreign countries as he did in his previous term. Azar had suggested before that Trump might not try to discontinue Medicare drug price negotiation, predicting he may try to out-do the Biden administration by seeking to achieve even greater discounts... Sub. Req’d

PCMA To CMS: Make Pharma, Not Plans, Ensure Patients Benefit From Negotiated Prices

(11/12, Gabrielle Wanneh, InsideHealthPolicy) ...The Pharmaceutical Care Management Association more broadly is calling on CMS to stabilize the marketplace for stand-alone Medicare Part D plans in light of several increases to the amount of prescription drug costs plans must take on due to the Inflation Reduction Act's redesign of the Part D benefit, calling for the agency to adopt new interpretations of incurred costs and the threshold for plan sponsors to meet the benefit's meaningful difference standard... Sub. Req’d

Stop Big Pharma's Money Grab From America's Seniors

(11/12, PCMA) ...A research paper, "Ending Pay for PBM Performance: Consequences for Prescription Drug Prices, Utilization, and Government Spending," from University of Chicago Professor of Economics Casey Mulligan, Ph.D, and published by the National Bureau of Economic Research, examined the consequence of "delinking" in Medicare Part D. According to the report, such a policy would undermine incentives for pharmacy benefit companies to maximize competition in the market and secure savings for patients and health plan sponsors, resulting in higher drug prices and handing drug companies a profit-boosting windfall... Full

The PBM Industry's Desperate Attempt to Stop Reform

(11/12, Nick McGee, PhRMA) ...One key proposal, backed by wide bipartisan support, would delink PBM fees from the list price of a medicine, instead tying PBM payments to the services they provide. This policy would eliminate incentives for PBMs to favor higher-priced medicines that make them more money through rebates and fees over lower cost alternatives that save patients money. The PBM trade association, PCMA, is trying to scare patients and seniors with false claims that these bipartisan reforms will raise costs and provide a "bailout" to the pharmaceutical industry... Full

Manufacturers Launch Seven-Figure Ad Campaign Urging PBM Reforms in Lame Duck

(11/12, The National Association of Manufacturers) ...The National Association of Manufacturers has launched a seven-figure video and digital advertising campaign urging Congress to pass legislation this year to bring much-needed reform to pharmacy benefit managers, whose practices increase health care costs for manufacturers and manufacturing workers. The NAM's Q3 2024 Manufacturers' Outlook Survey found that 78% of small manufacturers with fewer than 50 employees cite rising health care costs as a primary business challenge—the top concern among small business respondents in the survey... Full

AAM Urges Trump Administration To Take Action For Off-Patent Sector

(11/12, Dave Wallace, Generics Bulletin) ...AAM president and CEO John Murphy - who himself recently took over as leader of the generics and biosimilars organization after serving in key roles at brand industry associations PhRMA and BIO - said "we congratulate president-elect Donald Trump and the newly elected and re-elected members of congress," adding that "AAM and the Biosimilars Council as always looks forward to working with congress, regulators, and the White House on real solutions to help patients increase access to generic and biosimilar medicines and solidify a sustainable and robust generic marketplace that is currently under threat."... Global Sub. Full

CSRxP: Senate Judiciary Committee Should Reject Pharma-Supported Policies That Would Undermine Bipartisan Progress On Patent Abuse

(11/12, The Campaign for Sustainable Rx Pricing) ...In case you missed it, The U.S. Senate Committee on the Judiciary scheduled a markup of legislation this Thursday, November 14, including The Patent Eligibility Restoration Act (PERA) and The Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act). The Campaign for Sustainable Rx Pricing (CSRxP) opposes these two bills that would further enable Big Pharma's abuse of the patent system. CSRxP released the following statement on these misguided proposals ahead of a previously scheduled markup in September that was postponed... Full

Taxpayers Deserve Better Than Wasteful Defense Contracts

(11/12, David Williams, DC Journal) ...Given the FDA's excessive risk aversion and meddling in drug development, the agency could probably take its foot off the gas and do its job on a leaner budget. However, given the agency's overzealous enforcement, it makes little sense to duplicate already robust FDA efforts. It makes even less sense to entrust this effort to Valisure... Full

APC Opposes Lilly's Bid To Add GLP-1 To Difficult-To-Compound List

(11/12, Jessica Karins, InsideHealthPolicy) ...The advocacy group for pharmacy compounding is objecting to Eli Lilly's nomination of its GLP-1 drug tirezepatide, the active ingredient in Mounjaro and Zepbound, to the FDA list of drugs that present demonstrable difficult in compounding, saying there's no reason compounders can't make the drug and that Lilly is trying to limit access even if it will harm patients... Sub. Req’d

Johnson & Johnson Sues Biden Administration Over Payment Terms for 340B Hospitals

(11/12, Ed Silverman, STAT Plus) ...In its lawsuit, the company argued the U.S. Health Resources and Services Administration has wrongfully interpreted a federal law concerning the use of rebates in the 340B Drug Pricing Program, which was created to help hospitals and clinics care for low-income and rural patients. J&J recently sought to change payment terms for its Xarelto blood thinner and the Stelara plaque psoriasis treatment... Sub. Req’d

EMA's Final Call On Alzheimer's Drug Leqembi Imminent

(11/12, Neena Brizmohun, Pink Sheet) ...Patient representatives are due to have their say today at a high-stakes meeting at the European Medicines Agency, which, after re-examining its previous rejection of Leqembi, is expected to deliver its final decision on whether the drug should be approved for marketing in the EU... Sub. Req’d

Belgium a Pharma Leader, Investing €15.5 Million Per Day in Pharmaceutical R&D

(11/12, Nicole Verbeeck, Euractiv) ...Belgium's biopharmaceutical sector is at the forefront of European research and development (R&D) expenditure per capita. The country's investments are nearly double those of Denmark, the runner-up, and more than four times those of Slovenia, which ranks third. Belgium's R&D expenditures are approximately seven times higher than the EU27 average, highlighting the country's significant commitment to pharmaceutical innovation... Full

Korea Can Play To Strengths But Also Improve Regulatory Flexibility For Clinical Trials

(11/13, Jung Won Shin, Pink Sheet) ...At the recent KoNECT international conference in Seoul, experts shared views that South Korea remains a "top tier" country for clinical trials, with diverse strengths such as the excellence of its research institutes and researchers, highly accessible key opinion leaders and rapid trial initiation. However, some point out the need for improved flexibility in Korea's acceptance of innovative approaches and novel trial designs, amid rapid changes in the global clinical trial environment... Global Sub. Full

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