Friday, November 22, 2024

Amneal Resubmits New Drug Application for Migraine Treatment, Diabetes Drug Is Approved

(11/21, Connor Hart, Market Watch) ...The Bridgewater, N.J., company on Thursday said its migraine treatment, called dihydroergotamine, is a single-dose autoinjector that doesn't require refrigeration, assembly or priming. It can be self-administered by patients at home when experiencing cluster headaches or other tough-to-treat headaches. Dihydroergotamine's original new drug application was rejected by the FDA due to facility inspection issues at a third-party site. To mitigate these concerns, Amneal said it transferred production of the drug in house. The review is expected to be completed in the second quarter of 2025... Full

Regeneron: Amgen's Eylea Biosimilar Looks To Have An ‘Inferior Profile'

(11/21, Dean Rudge, Generics Bulletin) ...Regeneron has launched another sizeable broadside at rival Amgen's US Food and Drug Administration-approved biosimilar to Regeneron's Eylea (aflibercept) 2mg, casting aspersions on the profile and safety of the firm's Pavblu (aflibercept-ayyh) biosimilar that launched at-risk last month... Global Sub. Full

AstraZeneca Culls Phase 2 Opioid Use Disorder Drug

(11/21, Kyle LaHucik, Endpoints News) ...AstraZeneca ended a Phase 2 trial of an experimental opioid use disorder treatment, the UK pharma confirmed to Endpoints News. The termination was due to "discontinuation of the AZD4041 clinical development program for OUD," according to an update on Thursday to the federal clinical trials database... Full

BeiGene Blocks US Rival To Brukinsa Blockbuster Until 2037

(11/21, Dave Wallace, Generics Bulletin) ...MSN Laboratories will be able to launch its Brukinsa (zanubrutinib) generic from 15 June 2037, under a patent-litigation settlement agreement that the firm has just struck with originator BeiGene. The oral Bruton's tyrosine kinase inhibitor brought in sales of $1.3bn for BeiGene in 2023, with that number set to climb in the years ahead... Global Sub. Full

Celltrion's Prolia and Xgeva Biosimilars Win Approval in Korea

(11/22, Kim Ji-hye, Korea Biomedical Review) ...Celltrion said Friday that it has received approval from the Ministry of Food and Drug Safety (MFDS) for two biosimilars: Stoboclo (CT-P41), a biosimilar of Amgen's osteoporosis treatment Prolia (denosumab), and Osenvelt (CT-P41), a biosimilar of Amgen's Xgeva, which is used to prevent bone complications in adults with advanced cancer that has spread to the bone... Full

Exclusive-US FDA Finds Widely Used Asthma Drug Impacts the Brain

(11/22, Dan Levine and Sheila Dang, Reuters) ...U.S. government researchers have found that a widely prescribed asthma drug originally sold by Merck & Co may be linked to serious mental health problems for some patients, according to a scientific presentation reviewed by Reuters. The researchers found that the drug, sold under the brand name Singulair and generically as montelukast, attaches to multiple brain receptors critical to psychiatric functioning... Full

Torrent Pharma Rises as Pithampur Unit Gets VAI Classification

(11/22, Business Standard) ...Torrent Pharmaceuticals gained 2.37% to Rs 3,178.15 after the USFDA has issued establishment inspection report (EIR) with 'Voluntary Action Indicated' (VAI) classification for the manufacturing facility at Pithampur in Madhya Pradesh... Full

McKinsey Nears $600M Settlement with US Government Over Role in Opioid Crisis

(11/21, Nate Raymond, Mike Spector, Reuters) ...McKinsey & Co is in the final stages of negotiating a deferred prosecution agreement to resolve a U.S. criminal investigation into the consulting firm's work helping opioid manufacturers boost sales that allegedly contributed to a deadly addiction epidemic, people familiar with the matter said... Full

Drug Supply Changes Play Part in Decline Of Overdose Deaths

(11/22, Jan Hoffman and Noah Weiland, The New York Times) ...After years of relentless rises in overdose deaths, the United States has seen a remarkable reversal. For seven straight months, according to federal data, drug fatalities have been declining. Expanded treatment, prevention and education efforts are playing a role, but drug policy experts believe there is another, surprising reason: changes in the drug supply itself, which are, in turn, influencing how people are using drugs... Sub. Req’d

Webinar: Streamlining the Regulatory Process to Advance Access to Biosimilars

(11/21, The Center for Biosimilars) ...This webinar celebrating Global Biosimilars Week 2024 was hosted by The Center for Biosimilars® in partnership with the International Generics and Biosimilars Association. Global Biosimilars Week (GBW) 2024 is an annual campaign designed to raise global awareness about biosimilar medicines and their role in improving patient care and access to affordable treatment options... Full

Boosting Health Care Sustainability: The Role of Biosimilars in Latin America

(11/21, Skylar Jeremias, The Center For Biosimilars) ...Biosimilars can significantly improve access to biologic treatments and health care sustainability in Latin America (LA), but addressing misconceptions, regulatory gaps, and weak pharmacovigilance is essential for their broader adoption, according to a new study... Full

Magazine: Pharma's Green Shift with Dry Powder Inhalers

(11/22, Ross Law, Pharmaceutical Technology) ...This month's cover story delves into the debate over whether efforts to supplant pMDIs with DPIs presents the best way forward in achieving sustainability in respiratory care given the lingering doubts that DPIs may not be an effective enough solution for all patients, especially those with reduced inspiratory capacity. Also in this issue, a feature looks at the rise of non-traditional pharmacies, such as retailers and online alternatives, and how these new formats and consumer-centric designs may inform the pharmacies of the future... Full

Bill Boosting Patent Owner Rights Clears Senate Committee

(11/21, Michael Shapiro, Bloomberg Law) ...The Senate Judiciary Committee approved the Promoting and Respecting Economically Vital American Innovation Leadership Act (S. 2220), or PREVAIL Act by an 11-10 vote Thursday morning. The measure would restrict who is allowed to challenge a previously issued patent and bar certain types of duplicative challenges at a special administrative court at the US Patent and Trademark Office... Sub. Req’d

Senate Judiciary Narrowly Approves Patent Bill

(11/21, Victoria Knight, Axios Pro) ...Chris Coons and Thom Tillis have argued that it's a much-needed update to make the current patent system less expensive and easier to navigate...Senators on both sides of the aisle vigorously debated whether the bill would unintentionally increase drug prices for patients by making it easier for pharmaceutical companies to protect their intellectual property... Sub. Req’d

CSRxP Statement On Senate Judiciary Markup of the Prevail Act

(11/21, The Campaign for Sustainable Rx Pricing) ..."The PREVAIL Act would further enable Big Pharma's patent abuse that extends monopolies and blocks competition from more affordable alternatives for patients," said CSRxP executive director Lauren Aronson. "This misguided proposal would undermine recent bipartisan progress toward cracking down on Big Pharma's anti-competitive practices that are the root cause of high drug prices in America and should not be further considered by Congress."... Full

Dr. Oz's Pharma, Medicare Views to Influence US Drug Price Talks

(11/22, Nyah Phengsitthy, Bloomberg Law) ...Oz in the past has signaled his support for Medicare and has criticized the drug industry over high prices, but those comments also came amid investments in pharmaceutical giants. Drug pricing experts say his various positions paint an uneven picture of how he'll manage the negotiation program as it continues to roll out over the next four years. "He is somebody for whom drug pricing has been on the radar, somebody who will come in with a lot of focus on Medicare," said Carmel Shachar, an assistant clinical professor at Harvard Law School... Sub. Req’d

Medicare Price Negotiation Under CMS Chief Oz May See Early 2025 Test

(11/21, Cathy Kelly, Pink Sheet) ...Dr. Mehmet Oz and others could alter the Centers for Medicare and Medicaid Services next Medicare price negotiation process. A delay is releasing the list is possible, but a prolonged delay could be viewed as a giveaway to the pharmaceutical industry, which may not appeal to Trump. The next director of the Center for Medicare likely will be a key player in any changes to the program the Trump Administration may attempt... Global Sub. Full

Democrats Can Still Pull Off a Victory Before Year's End: Lowering Drug Costs Once More

(11/22, Howard Dean, Salon) ...Americans of all political stripes want lawmakers to rein in PBMs, who are inflating prescription drug costs at patients' expense. One recent poll conducted by Morning Consult found that over two-thirds of registered voters think Congress should consider passing PBM reform legislation before the end of the year... Full

Compounders Challenge Gottlieb's Assertion FDA Policy Is Tied To Pricing

(11/21, Maaisha Osman, InsideHealthPolicy) ...Former FDA Commissioner Scott Gottlieb says FDA appears to be selectively enforcing compounding regulations to influence drug pricing, which he says could weaken FDA's ability to regulate compounded drugs and erode its authority over compounding pharmacies. But Alliance for Pharmacy Compounding CEO Scott Brunner tells Inside Health Policy that tying compounded drug regulation to the drug pricing debate is misguided, noting FDA has not cited price or affordability in its statements or warning letters on compounded drugs... Sub. Req’d

Kaine, Cotton, Spanberger, & Smith Introduce Bipartisan, Bicameral End Drug Shortages Act

(11/21, United States Senator Tim Kaine) ...Today, U.S. Senator Tim Kaine (D-VA), a member of the Senate Health, Education, Labor and Pensions Committee, and U.S. Senator Tom Cotton (R-AR), alongside U.S. Representatives Abigail Spanberger (D-VA-07) and Adrian Smith (R-NE-03) introduced the End Drug Shortages Act, bipartisan, bicameral legislation to help reduce the prevalence and severity of drug shortages... Full

Biopharma Status Quo 'Likely to Persist' Under Trump 2.0, Though Changes to IRA, FTC and More Could Be On The Way: Analyst

(11/21, Fraiser Kansteiner, Fierce Pharma) ...Still, given Trump's focus on matters beyond healthcare and a more hands-off approach to government regulation, the life sciences realm is unlikely to face a major shakeup—at least for now—Baird's biotech specialist Mike Perrone said in a research report. Overall, "healthcare does not seem to be at the top of the Trump agenda," Perrone, who is also a senior research analyst at Baird, opined Thursday. With other items like trade, immigration and the economy already populating the Trump agenda, any potential healthcare policy changes are "likely to come further down the line," he predicted... Full

How Agencies Should Decide Which Costly Drugs To Target With Government March-In Rights

(11/21, Jishian Ravinthiran Aaron S. Kesselheim Steve Knievel, Health Affairs) ...US taxpayers provide enormous contributions to global biomedical research and drug development, investing $54 billion in 2023. Yet, US patients also face the highest brand-name drug prices in the world. According to a US government report, over the past two decades, the median price for a year of treatment with drugs protected by patents linked to National Institutes of Health funding was more than $100,000, and in almost every instance, the price for US residents was higher than for patients in other high-income countries around the world... Full

Pharmacists To NAIC: Create Form For States To Gather PBM Abuse Complaints

(11/21, Luke Zarzeck, InsideHealthPolicy) ...The National Community Pharmacists Association is urging the National Association of Insurance Commissioners to create a standardized complaint form on prescription middlemen states can use to collect data on bad actors and to gather more understanding around pharmacy benefit managers... Sub. Req’d

ICH Embraces Innovation In Clinical Trial Design

(11/21, Vibha Sharma, Pink Sheet) ...The International Council for Harmonisation has issued for comment draft guidance, which when finalized, is expected to provide the industry with flexibility to embrace non-traditional, innovative approaches in clinical trial design...Its finalization is expected to provide the industry with flexibility and regulatory clarity to embrace non-traditional, innovative approaches in clinical trial design... Global Sub. Full

HTA Bodies In England, US and Canada Collaborate On Developing Health Economic Methods

(11/21, Leela Barham, Pink Sheet) ...The Health Economics Methods Advisory group (HEMA) is a new, independent group of health technology assessment agencies from the US, England and Canada that will work together to develop recommendations on adopting novel health economic methods to support decision making by health care systems. HEMA will also consider the need for modifications to current methods, the uncertainties in the application of new methods and suggestions for further research... Global Sub. Full

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