Tuesday, October 8, 2024

Teva Biosimilar Candidate is Accepted for Review by U.S. FDA, E.U. EMA

(10/8, The Fly) ...Teva Pharmaceutical Industries announced that the United States Food and Drug Administration, FDA, has accepted, and the European Medicines Agency, EMA, has validated, applications for TVB-009P, a biosimilar candidate to Prolia... Full

AstraZeneca Heads to Regulators After Airsupra Asthma Trial Stops Early Thanks to 'Overwhelming Efficacy'

(10/7, Fraiser Kansteiner, Fierce Pharma) ...In the phase 3b BATURA trial, Airsupra—a pressurized metered-dose inhaler containing albuterol and budesonide—significantly reduced the risk of severe exacerbation when used as an as-needed rescue medication versus albuterol alone, AZ said in a release Monday... Full

AbbVie's Skyrizi Leapfrogs Lilly's Omvoh to Take Early Lead in IL-23 Colitis Space: Survey

(10/7, Nick Paul Taylor, Fierce Pharma) ...Spherix Global Insights said AbbVie's Skyrizi has quickly blasted past Eli Lilly's Omvoh in ulcerative colitis, capturing more than double the market share of its rival two months after launch. But AbbVie now faces another challenger, with Spherix predicting a similarly speedy launch for Johnson & Johnson's Tremfya... Full

Sage Therapeutics to Discontinue Development of Alzheimer's Drug

(10/8, Christy Santhosh, Reuters) ...Sage Therapeutics said on Tuesday it would discontinue the development of its experimental drug for Alzheimer's disease as it did not meet the main goal in a mid-stage trial, sending its shares down about 12% to $5.89 in premarket trading... Full

Backed By Briumvi Collaboration, Neuraxpharm Makes A Base In Middle East

(10/8, Dean Rudge, Generics Bulletin) ...The company's Neuraxpharm Middle East operation comprises the Kingdom of Saudi Arabia, the United Arab Emirates, Bahrain, Kuwait, Oman and Qatar, marking the next step in Neuraxpharm's plans to make the anti-CD20 antibody Briumvi (ublituximab) for relapsing forms of multiple sclerosis available to patients in the Middle East over the coming years... Global Sub. Full

Biocon Biologics' Highlights Pathways to Increase Adoption of Biosimilars in LMICs

(10/8, Pharmabiz.com) ...The article titled ‘Increasing Adoption of Quality-Assured Biosimilars to Address Access Challenges in Low- and Middle-Income Countries' outlines six policy recommendations for accessing and using quality-assured biosimilars in LMICs. These are strengthening regulatory systems. National policies to increase access and adoption of biosimilars. Encourage local manufacturing. Guidance for prescribing biosimilars and increasing education on biosimilars. Encouraging stakeholders' initiatives promoting access to biosimilars and focusing pharmacovigilance... Full

Biogen Turns to Telehealth Company to Boost its Postpartum Depression Drug

(10/8, Mario Aguilar, STAT Plus) ...As Biogen aims to grow sales of postpartum depression drug Zurzuvae, it's turning to well-funded telehealth company Talkiatry to boost awareness of and care for the often overlooked condition...This difficulty in getting care may also make it hard for people to get Zurzuvae. But Jason Hawbecker, head of external growth and innovation at Biogen, said the deal with Talkiatry is intended to be "further up the journey" in care than other direct-to-consumer telehealth efforts launched by drug companies... Paid Sub. Req'd

Amgen Sues Fresenius to Block Biosimilars of Prolia, Xgeva Drugs

(10/7, Christopher Yasiejko, Bloomberg Law) ...Fresenius SE & Co.‘s proposed biosimilar versions of Amgen Inc.'s Prolia and Xgeva infringe 33 patents for the blockbuster bone-strengthening drugs, a federal lawsuit says... Paid Sub. Req'd

Amid GLP-1 Craze, Novo and Mylan Ink Patent Settlement in Ozempic Case

(10/7, Fraiser Kansteiner, Fierce Pharma) ...Mylan Pharmaceuticals and Novo Nordisk have reached a settlement in a patent lawsuit tied to Ozempic, also known as semaglutide, India's Natco Pharma said (PDF) in a filing on India's National Stock Exchange Monday. The settlement terms are confidential, according to Natco... Full

Purdue Says Judge Wrongly Axed OxyContin Abuse-Deterrent Patents

(10/7, Michael Shapiro, Bloomberg Law) ...During oral argument Monday, the drugmaker said a Delaware federal district court erred in finding its technology predictable. It argued the court should've credited the company for solving a problem that stymied it and other rival companies after federal regulators expressed grave concerns about patients crushing and then snorting or injecting the popular painkiller in its original formulation... Paid Sub. Req'd

Prime Therapeutics Announces New, Cost-Effective Humira® Biosimilar Solutions, Offering Clients Flexibility and Choice

(10/7, Prime Therapeutics) ...Beginning in 2025, Prime will recommend four manufacturers that offer new biosimilar options for plans, including Organon (Hadlima®), Teva (Simlandi®), Sandoz (adalimumab-adaz), and Celltrion (adalimumab-aaty). Plan options will include retaining Humira in a parity position to biosimilars, biosimilars first, or biosimilars only strategies. All solutions offer clients access to four, low list-price biosimilar options, with net costs as low as $500-600 per 30-day supply... Full

What Went Wrong: How Formularies, Contracts, and Rebates Created a Headwind for Biosimilars

(10/7, Mark Campbell, PharmD, Pharmacy Times) ...The promise of biosimilars was supposed to be simple: more competition, lower costs and better access for patients. Yet as the dust settles from the introduction of adalimumab biosimilars following Humira's (AbbVie) patent expiration at long last, it's clear that formularies have become one of the biggest barriers to realizing the cost-saving potential of biosimilars... Full

CBO: Oft-Debated Drug Policies Would Barely Cut Prices, Except Reference Pricing

(10/7, Gabrielle Wanneh, InsideHealthPolicy) ...The Congressional Budget Office threw cold water on drug importation and a slew of other oft-debated drug pricing policies it said would have little to no effect on cutting prices, finding only one option -- basing U.S. drug prices on those overseas -- could cut U.S. prices by 5% or substantially more. But the latter idea was recently scrapped by the Trump campaign and was earlier cast aside by Democrats in favor of the Inflation Reduction Act's Medicare price negotiation of select high-priced drugs... Paid Sub. Req'd

Unintended Consequences of IRA Drug Price Negotiations

(10/7, A. Mark Fendrick, RealClearHealth) ...An undesirable interaction between two well-intended IRA provisions may result in reduced access and/or higher out-of-pocket drug costs for many Medicare beneficiaries, particularly for those in underserved populations. Lawmakers must quickly implement a remedy to this problem such that the aim of the law -- lower drug prices for Medicare beneficiaries -- will be achieved. By doing so, they can bolster access to medications, enhance equity, and ensure better health outcomes for seniors... Full

E&C Members Urge More FDA-Compounder Collaboration To Fight Drug Shortages

(10/7, Jessica Karins, InsideHealthPolicy) ...FDA should combat drug shortages by working more closely with compounding pharmacies and should consider more sources of information in compiling its drug shortage list, according to a letter sent by Republican members of the House Energy & Commerce Committee... Paid Sub. Req'd

AHA Calls On White House to Help Ease IV Fluid Shortage

(10/7, Hayley DeSilva, Modern Healthcare) ...The American Hospital Association is calling on the White House to help increase the supply of IV solutions after a massive Baxter International plant was taken offline by Hurricane Helene..."While we look forward to returning to full operations in the future, there are many components to the recovery process given the nature of sterile drug manufacturing," Baxter said in a statement Thursday. "We are working with the greatest urgency, but we do not yet have a timeline for when operations will be back up and running."... Paid Sub. Req'd

White House Should Declare National Emergency Over IV Fluid Shortages Caused by Helene, Says Hospital Group

(10/7, Brittany Trang, STAT Plus) ...Amid Hurricane Helene shuttering a major IV solution manufacturing plant and Hurricane Milton now barreling toward other IV manufacturing facilities in central Florida, the American Hospital Association on Monday asked the Biden administration to declare a shortage of IV solutions and invoke national emergency powers to ease the crisis...Alex Lucio, CEO of new IV fluid manufacturer Assure Infusions, said that he is estimating that the North Carolina Baxter plant will be out of commission for nine to 12 months... Paid Sub. Req'd

How Extreme Weather Could Lead to Drug Shortages

(10/8, Adriel Bettelheim, Axios) ...The RAND simulation looked at how events like extreme heat days, hurricanes and wildfire-associated changes in air quality could affect the prevalence of cardiovascular disease, asthma, end-stage renal disease and Alzheimer's — and, in turn, alter drug usage. Demand for three common frontline treatments — the inhalation drug albuterol for asthma, the blood-thinner heparin used in dialysis, and the Alzheimer's drug donepezil, or Aricept — is likely to rise through 2040... Full

Compounding Group Sues FDA for Removing Lilly's Weight Loss Drug from Shortage List

(10/7, Brendan Pierson, Reuters) ...A drug compounding industry group on Monday sued the U.S. Food and Drug Administration over its decision to take Eli Lilly's blockbuster weight loss and diabetes drugs off its list of medicines in short supply last week. Shortages of drugs such as Lilly's Mounjaro and Novo Nordisk's Ozempic have fueled demand for compounding facilities' own versions of the medicines... Full

Blue Shield of California Lowers Humira Biosimilar Costs, Challenges PBM Pricing

(10/7, Cameron Santoro, AJMC) ...The adalimumab biosimilar Idacio (adalimumab-aacf) will be available to beneficiaries of Blue Shield of California at a steep reduction over the price of the reference product (Humira), which treats patients with inflammatory diseases. The biosimilar will be purchased at a net price of $525 per monthly dose compared with the $2100 net market price for the originator... Full

FDA Compliance Official Highlights Priorities, Return to Onsite Inspections, and Warning Letter Trends

(10/7, Joanne S. Eglovitch, Regulatory Focus) ...Francis Godwin, director of the Office of Manufacturing Quality at the Office of Compliance FDA's Center for Drug Evaluation and Research (CDER), discussed compliance trends in an interview with Focus. He stressed the importance of firms building a culture of quality and what keeps him up at night. The interview has been edited for length and clarity... Full

Janet Woodcock, Former FDA Official, Joins Board of Patient Group Focused On ‘Rediscovering' Old Drugs

(10/7, Matthew Herper, STAT Plus) ...An organization scouring thousands of existing drugs to see if any can cure hard-to-treat diseases has a powerful new ally: Janet Woodcock, who for decades was one of the most influential figures at the Food and Drug Administration. The group, Every Cure, is led by physician David Fajgenbaum... Paid Sub. Req'd

SCOTUS Seeks Solicitor General Input On Oklahoma PBM Law Case

(10/7, Gabrielle Wanneh, InsideHealthPolicy) ...The Supreme Court on Monday (Oct. 7) asked the Solicitor General to weigh in on whether a 2019 Oklahoma law establishing minimum, uniform pharmacy network access for patients and prohibiting pharmacy benefit managers from steering patients to obtain their prescription drugs from affiliated pharmacies is preempted by federal ERISA law or should be allowed to stand... Paid Sub. Req'd

Supreme Court Invites Briefs On Oklahoma Drug Pricing Case

(10/7, Lauren Clason, Bloomberg Law) ...The Pharmaceutical Care Management Association argues that state laws like Oklahoma's are preempted by the Employee Retirement Income Security Act of 1974 because they essentially regulate the business of self-funded health insurance plans. But Oklahoma says that PBMs are not ERISA-regulated plans themselves, nor do they contract solely with ERISA-regulated plans... Paid Sub. Req'd

EU Launches Safety Review Of Finasteride & Dutasteride Over Suicidal Thoughts & Behavior

(10/7, Ian Schofield, Pink Sheet) ...The European Medicines Agency has launched a safety review of medicines containing finasteride and dutasteride after the French regulator raised concerns about continuing reports of psychiatric disorders including suicidal ideation and sexual dysfunction, despite the measures that have been taken to address these potential side-effects... Global Sub. Full

Need to Strengthen National Policies to Increase Access and Adoption of Biosimilars, Reveals New Report

(10/8, Financial Express) ...Biocon Biologics Limited on Tuesday announced that it has published the results of a detailed study that provides key insights into creating a more supportive environment for biosimilars in low- and middle-income countries (LMICs). According to the company's press statement, the study is aimed at boosting uptake and expanding access to affordable healthcare solutions... Full

Boost For India's Generic Pharma Majors

(10/8, Joe Mathew, Fortune India) ...The Indian drug regulator has also been proactive in ensuring that domestic companies get a conducive regulatory environment to develop and launch biosimilars. As a result, over the past decade, India has seen the largest number of approved biosimilars serving the needs of patients globally...Though not a leading player internationally, many Indian biosimilars are being supplied to highly regulated and advanced markets in North America, Europe, and Japan... Paid Sub. Req'd

Generics Push Continues With New Measures In Japan

(10/7, Lisa Takagi, Generics Bulletin) ...Japan has started charging patients extra for non-generic drugs from October 1, to further raise generic use and control healthcare costs. The country aims raise the volume share of generics to 80% in all 47 prefectures, and to 65% on a price basis, by the end of March 2026. Japan's overall generic volume share has reached 83.5% but the country is still working to resolve long-running supply issues... Global Sub. Full

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