Thursday, June 6, 2024

Amneal Expands Broad Injectables Portfolio to Over 40 Products with the Addition of Six New Therapies

(6/5, Amneal Pharmaceuticals, Inc.) ...Amneal Pharmaceuticals, Inc. today announced the continued expansion of its injectables portfolio with six new injectable product launches during the second quarter of 2024, bringing the Company's total number of commercial injectable products available for the U.S. institutional market to over 40. The growth of Amneal's broad injectables portfolio will help address shortages of critical products where there may be little or no clinical alternative, including in key categories such as oncology. The American Society of Health System Pharmacists currently lists 323 active U.S. drug shortages, with about half representing injectables... Full

Viatris Waves Goodbye To API Business

(6/6, David Wallace, Generics Bulletin) ...Viatris has completed another stage in the ongoing transformation of its business by closing the divestment of its active pharmaceutical ingredient business to India's Matrix Pharma Private Limited...The strategic realignment of Viatris has been a years-long project since the company was formed through the combination of Mylan and Pfizer's Upjohn off-patent business back in 2020. It comes at a time when other major off-patent players, such as Teva and Sandoz, have also been going through major changes of their own... Global Sub. Full

Improving Access for Patients: Launch of Lisdexamfetamine Further Broadens Sandoz Canada Portfolio

(6/5, Sandoz) ...Sandoz Canada announced today the launch of PrSandoz® Lisdexamfetamine, a generic equivalent of Vyvanse*, approved for the same indications. It follows the recent launches of PrSandoz® Amoxicillin, PrSandoz® Desvenlafaxine and PrSandoz® Riociguat..."As a key product in the country, the introduction of Lisdexamfetamine will generate savings of around $375M3 for patients, governments and private insurers, and all without compromising on quality," says Michel Robidoux, President and General Manager, Sandoz Canada... Full

Novo Nordisk Braces for Generic Challenge to Ozempic, Wegovy in China

(6/5, Andrew Silver, Reuters) ...Novo Nordisk is facing the prospect of intensifying competition in the promising Chinese market where drugmakers are developing at least 15 generic versions of its diabetes drug Ozempic and weight loss treatment Wegovy, clinical trial records showed. The Danish drugmaker has high hopes that demand for its blockbuster drugs will surge in China, which is estimated to have the world's highest number of people who are overweight or obese... Full

FDA Hands Chinese Drug Manufacturer a Form 483 Noting Employees Destroyed Documents 

(6/5, Anna Brown, Endpoints News) ...Employees of Chinese drugmaker Jiangsu Hengrui Pharmaceuticals "diverted" FDA inspectors as colleagues tore up and threw away documents in a "rapid-like manner" at a manufacturing facility, according to a newly-released Form 483...The eight-page document outlined eight observations found by the FDA. The inspection was conducted between Jan. 8 and Jan. 16 of this year at the company's facility in Jiangsu, China... Full

ASCO 2024 Posters Showcase Positive Data On Denosumab, Pegfilgrastim Biosimilars

(6/5, Skylar Jeremias, The Center For Biosimilars) ...Posters from the American Society of Clinical Oncology (ASCO) 2024 annual meeting demonstrate positive safety and efficacy data for denosumab and pegfilgrastim biosimilars...Despite pegfilgrastim being essential for preventing chemotherapy-induced neutropenia and newer biosimilars emerging as promising alternatives with trials showing comparable efficacy, conclusive clinical benefit evidence is lacking, likely due to low statistical power in these trials... Full

Influx of Biosimilar Set to See Significant Market Growth

(6/6, The Pharma Letter) ...As more biologics drugs lose their patent protection, the influx of biosimilars is set to expand, offering cost-effective alternatives and significantly impacting their respective markets...According to GlobalData's forecasts, sales of biosimilar will increase from 5.7% in 2022 to 18.3% in 2032 of the total sales throughout the eight major markets (8MM: the US, Canada, France, Germany, Spain, Italy, the UK, and Japan). This rise in market share translates to expansion from $0.5 billion to $2.8 billion in biosimilar sales... Sub. Req'd

Rural Pharmacies Fill a Health Care Gap in the US. Owners Say it's Getting Harder to Stay Open

(6/4, Devi Shastri, Associated Press) ...Pharmacy benefit managers, or PBMs, help employers and insurers decide which drugs are covered for millions of Americans. And the the lack of transparency around fees and low reimbursements from is one of the biggest financial pressures for rural pharmacies, said Delesha Carpenter of the University of North Carolina at Chapel Hill, who leads a research alliance of more than 140 rural pharmacies and seven universities... Full

Medicare Negotiation: Therapeutic Alternatives Selection Will Become More Predictable, CMS Says

(6/5, Cathy Kelly, Pink Sheet) ...CMS likely will not disclose its therapeutic alternative selections that will inform prices for the drugs in the Medicare negotiation program earlier in the next round. But the agency believes its approach will become clearer as the program matures and manufacturers will more accurately predict the alternatives that will be used, CMS' Kristi Martin said. CMS is open to suggestions for improving the program and its workability for manufacturers, but the agency still must work within the confines of the law, Martin added... Sub. Req'd

Regulators Tackle Challenges With Pharmacoepidemiological Studies That Use RWD

(6/5, Neena Brizmohun, Pink Sheet) ...Feedback is being sought on proposed guidance that seeks to address the need for global regulatory harmonization when it comes to designing and analyzing pharmacoepidemiological studies that use real-world data to study the safety of medicines...It notes that while many countries and regions have published guidelines on how to conduct and analyze these types of pharmacoepidemiological studies, mainly for the purpose of assessing the safety of medicines, the lack of global regulatory harmonization in this area can cause challenges for sponsors and regulators... Sub. Req'd

PhRMA Warns Federal Agencies: Consolidation and Vertical Integration Among Insurers, PBMs, and Hospitals Threaten Patients, Health Care Industry

(6/5, Molly Jenkins, PhRMA) ...In comments submitted to the Department of Health and Human Services, Department of Justice, and the Federal Trade Commission, PhRMA detailed the growing threat posed by consolidation and vertical integration across the health care markets. Our letter urges HHS, DOJ, and FTC to continue addressing the growing threat to patient interests caused by the questionable practices of large PBM and insurer conglomerates... Full

Senate Finance Chair Presses HHS to Crack Down On Cybersecurity in Wake of UnitedHealth Attack

(6/5, Lia DeGroot, Endpoints News) ...Senate Finance Committee Chair Ron Wyden (D-OR) is urging HHS to take a stronger stance on healthcare companies' cybersecurity practices as the healthcare system is still piecing together what happened with the ransomware attack on UnitedHealth's Change Healthcare. In a four-page letter sent to HHS Secretary Xavier Becerra on Wednesday, Wyden said the department isn't doing enough to protect against cybersecurity incidents. Specifically, he said HHS should require companies to use multifactor authentication, something he said could have helped prevent the Change attack... Sub. Req'd

Wyden To SEC, FTC: If UHG Broke Laws, Hold It Accountable

(6/5, Cara Smith, InsideHealthPolicy) ...Wyden points to prior actions both agencies took against other companies to make his case. Wyden detailed FTC's previous enforcement action of other industries through the FTC Act to mandate privacy protections, which he hopes will be used against UHG. In the past, SEC made clear cybersecurity practices are important to every publicly traded company and that reasonable investors considering whether to purchase or sell stock would have considered it important, according to Wyden... Sub. Req'd

FDA Issues Draft Guidances Covering BIMO Inspections

(6/5, Joanne S. Eglovitch, Regulatory Focus) ...The US Food and Drug Administration has issued two draft guidances on bioresearch monitoring (BIMO) inspections. The first covers information to assist the agency in planning these inspections, while the second covers best practices for communicating to the FDA before, during, or after an inspection. Both cover sponsors that have submitted new drug applications, biologics license applications, and supplements... Full

My Patients Can't Afford Two Crucial Medications, and Big Pharma Should Be Held Accountable

(6/6, Megan Purdy, Colorado Newsline) ...In February, Colorado's PDAB found Enbrel to be unaffordable after exhaustive research and testimony from patients and other health care stakeholders. This conclusion set the stage for an important next step — setting an upper payment limit that can help rein in the high costs of Enbrel. Colorado's PDAB should take similar action when it reviews two other prescription drugs this summer: Cosentyx and Stelara... Full

In New Radio Ad Campaign, NACDS Urges Massachusetts to ‘STAND UP' to PBM Middlemen and Pass PBM Reform Now

(6/5, NACDS) ...In support of pharmacy benefit manager reform legislation in Massachusetts, the National Association of Chain Drug Stores (NACDS) launched this week 60-second and 30-second ads, titled ‘STAND UP', for Boston news and talk radio stations. The newly-released radio ads urge Massachusetts legislators to stand up for Bay Staters' care in the face of "pharmaceutical benefit manipulation" — and to enact, without delay, needed PBM reforms in the state. The Massachusetts advertising campaign comes as part of NACDS' broader advocacy work in collaboration with in-state partners... Full

Drug Stores Press For Advancement Of MA State-Level PBM Regulation

(6/5, Gabrielle Wanneh, InsideHealthPolicy) ...In new radio advertisements launched Tuesday (June 4), NACDS says PBMs play a major role in dictating what medications patients can access as well as when and where patients can fill their prescriptions, all while driving up costs. Nearly nine in 10 voters in Massachusetts are likely to support PBM reform legislation, according to a 2024 Breakthrough Research survey commissioned by NACDS. The drug store association is urging MA residents to call their legislators and push them to act on new legislation in development... Sub. Req'd

New Primer Highlights Unanswered Questions and Unintended Consequences of State Prescription Drug Affordability Boards

(6/5, National Pharmaceutical Council) ...Many uncertainties and gaps remain as to how state prescription drug affordability boards will assess the "affordability" of drugs and cap drug prices by setting upper payment limits, according to a new publication from the National Pharmaceutical Council published in Health Affairs Forefront...Overall, the review found that a singular focus on price-related factors into PDAB reviews and price setting in the absence of statutory requirements to prioritize value-related elements amplifies concerns about the potential unintended consequences while providing no assurance that PDABs will achieve their intended goals of improving affordability for patients... Full

Unanswered Questions And Unintended Consequences Of State Prescription Drug Affordability Boards

(6/5, Julie A. Patterson, James Motyka, Jonathan D. Campbell, and John Michael O'Brien, Health Affairs) ...In this article, we describe key components of PDAB legislation in four states - Colorado (2021 and 2023), Minnesota, Maryland, and Washington because these states have passed legislation giving PDABs the purported authority to set upper payment limits for prescription drugs deemed "unaffordable." The authorities granted to PDABs in other states vary, from recommending policies to reach spending targets for specific drugs or negotiating supplemental Medicaid rebates, to conducting affordability reviews while developing a plan for establishing UPLs... Full

Industry Body Calls For Action In Response To EU Initiatives

(6/5, Adam Zamecnik, Generics Bulletin) ...Off-patent industry body Medicines for Europe has responded to two freshly presented EU initiatives, calling on regulators to place biosimilar and generic drugs in the front and centre of their efforts. Most recently, MFE has called on the EU to level up the formally established European Health Union, which seeks to improve access to affordable medicines in its member states... Global Sub. Full

EU HTA Regulation: Draft Conflicts Of Interest Rules Fail To Consider Orphan Drugs

(6/5, Francesca Bruce, Pink Sheet) ...Proposed rules on managing conflicts of interest (CoIs) among stakeholders involved in forthcoming EU-level joint clinical assessments under the Health Technology Assessment Regulation risk excluding rare disease and ultra rare disease experts from the JCA process, warned speakers at an industry webinar... Sub. Req'd

European Pharma Regulation Changes Signal Tumult and Transformation

(6/6, Manasi Vaidya, Pharmaceutical Technology) ...The ongoing European Union elections, a revision of key legislation governing the pharmaceutical and biotech industry in Europe, and a new way of doing health technology assessments are all culminating in a maze-like endeavour for the healthcare space in Europe...While these changes are centred in Europe, experts said they would be applicable for any biotech or pharmaceutical company looking to enter the healthcare landscape. Midway through the discussion, the panellists acknowledged how confusing the changes to the regulatory structures, not just at the EU level but also at the individual EU member level, could be for biotechs... Full

Novartis and Others Face Italy Antitrust Probe Over Eye Drug

(6/6, Giulia Segreti and Paul Arnold, Reuters) ...Italy's antitrust regulator said on Thursday it had launched a probe into several pharmaceutical companies, including Novartis and Roche-controlled Genentech, for having potentially restricted competition in the sale of an eye drug. Biopharma developer Samsung Bioepis, biotechs Biogen and Genentech, and Novartis, and some of their Italian, Dutch and UK units, allegedly coordinated their commercial strategies to delay the launch in Italy of Byooviz, a drug made with ranibizumab and developed and sold by Samsung Bioepis, the watchdog said in a statement... Full

DHL Supply Chain Expands Pharma Logistics Operations in France

(6/6, Hazel King, Parcel and Postal Technology International) ...Global healthcare company Sanofi has agreed a long-term partnership with DHL Supply Chain that will expand its specialized logistics services for the life sciences and healthcare sector in France. DHL Supply Chain will provide warehousing, inventory management, picking and packing, and order fulfillment across three of Sanofi's sites in France – Amilly Distribution, Croissy-Beaubourg and Saint-Loubès... Full

Note: Article links may expire over time or require a free registration. All news articles are the property of their respective publishers and copyright holders. [contextual emphasis added].

Teva global subscription access: Registration is required to access FirstWord and Generics Bulletin. Click on the links below to register. If you have any questions or issues with access, contact InfoNOW or visit InfoNOW's Industry News page for more details regarding these subscriptions.

                                                         

FirstWord Pharma Plus: Enter your work email address on the Registration page along with your contact information in order to receive access.

  

Generics Bulletin by Informa:

•      Registration: Click on "Sign In" (link on the upper right side of the page). Enter your work email address in the "username" box and press the "Tab" button on your keyboard or click out of the box. You will then be automatically logged into the Informa news resource (no password required). You may be redirected to the Account Settings page to update your contact information.                                

•       Subsequent Access: If you're not automatically logged in, click on "Sign In" (link on the upper right side of the page). Enter your work email address. You will be automatically logged in (no password is required).

•      Note: You must be on the Teva Network (in a Teva location or connected via VPN) in order to access the Informa news resources. You can toggle between the Informa news resources by clicking the news resource on the top.