Tuesday, March 26, 2024

FTC Escalates Battle With Teva Pharmaceuticals Over Inhaler Patents In Court

(3/25, Maaisha Osman, InsideHealthPolicy) ...Senate health committee Chair Bernie Sanders (I-VT) says there are indications Teva plans to lower its inhaler prices, but legal experts say that would sidestep the bigger issue of Teva using device patent listings to block generic drug makers from entering the market... Sub. Req'd

FTC Weighs in On Teva's Inhaler Litigation Against Amneal Amid Far-Reaching Patent Crackdown

(3/25, Fraiser Kansteiner, Fierce Pharma) ...Late last week, the FTC filed an amicus brief in New Jersey federal court, arguing that Teva "improperly listed" patents on its asthma inhaler ProAir HFA in the Orange Book. Teva used those patents to block Amneal Pharmaceuticals' approval bid for a generic version of the inhaler, the FTC contends. In turn, the agency thinks the court should order Teva to retract the five patents at the center of the lawsuit... Full

FTC Intervenes in Teva's Inhaler Litigation Against Amneal Amid Patent Crackdown

(3/25, CPI) ...In the latest development, the FTC filed an amicus brief in a New Jersey federal court, taking aim at Teva Pharmaceuticals for what it alleges are "improperly listed" patents related to its asthma inhaler, ProAir HFA. According to the FTC, Teva employed these patents to obstruct Amneal Pharmaceuticals' efforts to secure approval for a generic version of the inhaler. Consequently, the FTC is urging the court to compel Teva to retract the five patents central to the dispute...As the legal battle unfolds, the outcome could have far-reaching implications not only for Teva and Amneal but for the broader landscape of pharmaceutical patent enforcement and its impact on drug accessibility and affordability for consumers... Full

Asthma Inhalers Get A Price Cut. Black Users Shouldn't Breathe Easy

(3/25, Joseph Williams, The Seattle Medium) ..."This is obviously good news for some patients but it doesn't address the problem at as large a scale as it would seem," Ana Santos Rutschman, a health law professor at Villanova University said in an email interview. Rutschman studies patients' ability to access medicine, including affordability issues...Along with other large manufacturers like AstraZeneca, GlaxoSmithKline and Teva, Boehringer Ingelheim charges between $200 and $600 for a single inhaler — a drug that asthma patients usually have to buy each month. In January, during a Senate hearing, Sanders slammed pharmaceutical manufacturers for out-of-control inhaler prices... Full

Teva UK and Closed Loop Medicine Announce Partnership to Advance Personalised Medicines

(3/26, Liza Laws, Outsourcing Pharma) ...Kim Innes, Teva's general manager, UK & Ireland, said: "We are excited to be working with Closed Loop Medicine, who have demonstrated themselves to be compelling innovators in the area of personalised medicine. We know that the patient experience can sometimes be less than optimal and as the largest supplier of medicines to the NHS, the potential to combine ‘drug' & ‘digital' could create significant improvements to the lives of patients at great scale. We are very excited about the future of this partnership."... Full

Teva Pharmaceutical Industries: Potential Outweighs Concerns

(3/25, Seeking Alpha) ...Teva Pharmaceutical is deeply undervalued, trading at a 77% discount per my calculations, and the new CEO's turnaround plan looks promising...I am optimistic about the new CEO's turnaround plan and think that the planned direction and the timeline look realistic. The turnaround plan is long-term and its execution commenced only in 2023, meaning there is still a lot of work to be done by the management. At the same time, the last few quarters under the new CEO were marked with a return to revenue growth path, while profitability is improving consistently after several years of stagnation... Full

Celltrion Eyes Near-Term Omalizumab Opportunity With CHMP Backing

(3/25, Dean Rudge, Generics Bulletin) ...Celltrion has emerged as the first company to win an EU recommendation for a marketing approval for a biosimilar to Genentech/Novartis's Xolair (omalizumab), setting up a potential near-term launch with key Xolair compound and formulation patents having already expired or imminently about to run their course...Other chasers include Teva, which is conducting a Phase III trial investigating its TEV-45779 candidate compared to Xolair also in adults with chronic idiopathic urticaria. According to the clinicaltrials.gov website, the study is scheduled to finish in June 2024... Global Sub. Full

Bio-Thera Signs Latin American Partnership Deal For Two Undisclosed Biosimilars

(3/25, Adam Zamecnik, Generics Bulletin) ...The Chinese company Bio-Thera Solutions has signed a partnership deal with specialty healthcare company SteinCares over commercialization rights for two biosimilars in Brazil and the rest of Latin America...Bio-Thera did not specify in its announcement what biosimilars are included as part of this deal that gives the Costa Rica-headquartered SteinCares exclusive distribution and marketing rights in the region... Global Sub. Full

Amneal Pharma Gets FDA Nod for Infection Fighting Drug Combination

(3/25, Dean Seal, Dow Jones) ...Amneal Pharmaceuticals said the Food and Drug Administration has approved its abbreviated new drug application for ciprofloxacin and dexamethasone otic suspension, a combination used to treat infections... Full

In Small Acquisition, AbbVie Adds Landos and its IBD Drug to Post-Humira Plans

(3/25, Max Gelman, Endpoints News) ...For AbbVie, the acquisition will add another IBD program to the pipeline as it looks to build its post-Humira future. Landos' drug, known as NX-13, is an oral NLRX1 agonist currently in the enrollment stage of a Phase 2 ulcerative colitis trial. Both companies touted it as a potential "first-in-class" therapy. NX-13 will join lutikizumab in AbbVie's immunology pipeline, which recorded an under-the-radar win in a Phase 2 study for the chronic skin condition hidradenitis suppurativa in January. AbbVie is also researching lutikizumab, formerly ABT-981, in ulcerative colitis... Full

Annual STADA Report Shows Record Profit Growth for 2023

(3/25, Cameron Santoro, Center For Biosimilars) ...In 2023, STADA Arzneimittel's group adjusted sales were up by 14% with a 19% improvement rate in earnings before interest, taxes, depreciation, and amortization, according to the company's annual earnings report. Overall, 2023 sales were around $4 billion and $870 million in the annual EBITDA. Additionally, the company had a total of 95 business development and licensing deals signed in 2023... Full

CBO Weighs in On PBM Reform, AI in Healthcare

(3/25, Paige Minemyer, Fierce Healthcare) ...The Congressional Budget Office addressed a series of questions from lawmakers on health policy priorities ranging from pharmacy benefit management to Medicare spending...CBO said there are multiple avenues where this technology has potential, such as identifying which patients may benefit most from certain interventions or identifying diseases more quickly...In the same post, CBO addressed questions about the Lower Costs, More Transparency Act, which includes multiple PBM reforms such as a ban on spread pricing in Medicaid and additional reporting on drug costs, rebates and sales... Full

Incorporating Pharmacy Spending In Value-Based Payment Models Remains Challenging

(3/25, Tim Casey, Pink Sheet) ...Payers face challenges incorporating drug spending into value-based payment models, making it difficult to reduce overall health care costs, according to panelists who participated in a session at the recent Value-Based Payment Summit. The speakers were encouraged by the increased attention being paid to expensive medications and difficulties in ensuring people take their prescriptions. However, they stressed that more needs to be done to educate providers and ensure pharmacy spending is in check... Sub. Req'd

ICYMI: More Evidence of the IRA's Harmful Consequences On Post-Approval Research and Development

(3/25, Andrew Powaleny, PhRMA) ...A new study published in The Journal of Medical Economics adds to a growing body of research demonstrating harmful consequences that stem from the price-setting provisions in the Inflation Reduction Act...The study found significant amounts of critical R&D occurred at least seven years after initial approval: Approximately half (49%) of all approved indications and three-quarters of industry-funded clinical trials for the medicines analyzed are the result of post-approval R&D activity... Full

Insulin Caps Lowered Costs But Didn't Improve Access, Study Finds

(3/26, Tina Reed, Axios) ...State caps on insulin costs lowered privately insured patients' out-of-pocket spending, but they didn't appear to increase insulin use, according to a new Annals of Internal Medicine study...The research suggests increasingly popular insulin caps alone aren't enough to improve insulin uptake among patients with diabetes in commercial insurance... Full

Off-Label Communication: Industry Opposes Exclusion Of Phase II Data From US FDA's Guidance

(3/25, Brenda Sandburg, Pink Sheet) ...The US Food and Drug Administration's revised draft guidance on scientific communications to health care providers about a medical product's unapproved uses did not dampen industry's decade-long objections to its regulation of such speech. The Medical Information Working Group, comprised of nine pharma companies, said the guidance exceeds the statutory and constitutional limits on the agency's authority and are likely to chill a significant amount of truthful and non-misleading communication regarding unapproved uses... Sub. Req'd

FDA Creates New Center Of Excellence To Boost Use Of Modeling, Simulation

(3/25, Maaisha Osman, InsideHealthPolicy) ...FDA's Center for Drug Evaluation and Research is creating a new "Quantitative Medicine Center of Excellence" (QM CoE) to bolster its use of modeling and simulation in the drug development and regulatory process. The new center will leverage data from nonclinical, clinical and real-world sources, translated into mathematical models, to provide a more comprehensive understanding of a drug's benefits and risks to improve FDA's regulatory decision-making... Sub. Req'd

US FDA's CDER Creates Quantitative Medicine Center Of Excellence; Job Includes AI Oversight

(3/25, Derrick Gingery, Pink Sheet) ...The FDA told the Pink Sheet that an executive board with leadership from the Office of New Drugs, Office of Generic Drugs, Office of Pharmaceutical Quality and Office of Translational Sciences also will help govern it, along with the executive board chair and board project manager...Along with pharmacometrics, mechanistic modeling, biomarker-endpoint development, clinical trial simulations and in silico predictions, the QM Center of Excellence also will oversee machine learning and artificial intelligence approaches, the FDA said... Sub. Req'd

FDA's Clinical Inspections Declined Amid Staffing Challenges

(3/25, Nyah Phengsitthy, Bloomberg Law) ...The federal watchdog's report found clinical research inspections by the Food and Drug Administration have faced challenges in recruiting and retaining investigators in its Bioresearch Monitoring (BIMO) program, which have resulted in fewer inspections and a less experienced workforce. The accountability office was asked to review the FDA's BIMO program as it relates to ensuring drugs approved for marketing in the US are safe and effective... Sub. Req'd

Amgen Files Suit Against Colorado's PDAB

(3/25, Luke Zarzecki, InsideHealthPolicy) ...Amgen filed litigation in a Colorado federal district court late Friday (March 22) against Colorado's prescription drug affordability board, saying the board's actions are "unconstitutional." The board is currently considering whether to set an upper payment limit on Amgen's drug Enbrel, used to treat various forms of arthritis and psoriasis, after the board declared the drug "unaffordable" in February... Sub. Req'd

Pharmaceutical Company Amgen Sues Colorado Over Price-Setting Prescription Drug Board

(3/25, John Ingold, The Colorado Sun) ...The company is seeking not just to overturn the board's recent decisions about Enbrel but also to strike down major parts of the law creating the board. "We have significant concerns with the Colorado Prescription Drug Affordability Board's decision to move forward with its flawed policy and process," Amgen said in a statement. "There is no legal basis for the Board's actions or haphazard process throughout the review period."... Full

‘Profits Over Patients': Philly DA Goes After Insulin Makers and Distributors On Price-Fixing Collusion Allegations

(3/25, Tom MacDonald, WHYY) ...Philadelphia District Attorney Larry Krasner has filed a lawsuit against nearly 20 pharmaceutical companies and pharmacy benefit managers for what he said is colluding to inflate the consumer cost of insulin. He said the cost increase has come even though insulin's production costs are cheaper than ever. Krasner accused the companies of a pricing "scheme" to artificially inflate the cost of a drug that is essential to the life of some diabetes patients... Full

Independent Pittsburgh-Area Pharmacists Blame Closures On Middlemen

(3/25, Meghan Schiller, CBS News) ...KDKA-TV investigator Meghan Schiller learned independent pharmacists in the Pittsburgh area blame middlemen who they say are sucking the life out of your community pharmacy...In a statement, Express Scripts said in part: "Express Scripts relentlessly advocates on behalf of the people we serve to make lifesaving therapies and medications more accessible and affordable. We are committed to reimbursing pharmacies fairly while ensuring our customers have safe, quality pharmacies in their network." CVS Caremark says it recently introduced true cost and plans to launch CVS CostVantage... Full

Maryland Drug Affordability Board Considers Eight Drugs for First Cost Review

(3/26, Angela Roberts, The Baltimore Sun) ...Maryland's Prescription Drug Affordability Board Monday selected eight drugs to consider for its first cost review – an intensive process that will determine whether the drugs are too expensive and suggest strategies for making them more affordable...That group, which meets April 29, will provide feedback that members of the Prescription Drug Affordability Board will consider when making their final vote to approve the list May 20. Only at that time will the board begin its inaugural cost review process. And there will be ample opportunity for public comment between then and now, said Andrew York, the board's executive director... Full

Showdown Set Between Minnesota and Drug Industry Over Rising Costs

(3/25, Jeremy Olson, StarTribune) ...Publicly available pricing data offer plenty of starting points for the Prescription Drug Affordability Board, which was created by the Minnesota Legislature last year to identify unaffordable drugs and cap the prices at which they can be sold...Colorado and Washington limited their boards to spending caps on 12 drugs, but Minnesota's board has no limit. That authority drew the swiftest rebuke from PhRMA leaders, who argued that payment limits could reduce access to medications while failing to address the middle-man markups that drive up costs... Full

Vote to Level Up The European Health Union in Upcoming Elections

(3/25, Medicines for Europe) ...The upcoming European elections will have a significant impact on the future of health policy in Europe...Medicines for Europe is launching its vision for the future of health policy in Europe...LEAVE NO PATIENT BEHIND: Reform EU pharmaceutical laws for equitable access by fostering timely competition and sustainable uptake of generic, biosimilar and value added medicines... Full

Latest Changes To EU Regulatory Data Protection Mean New ‘Uncertainties & Risks'

(3/25, Ian Schofield, Pink Sheet) ...Law firm Sidley Austin says the net overall effect of the pharmaceutical package on innovation and investment is "uncertain at best."...Others have highlighted what they see as the positive and negative aspects of the amended proposals passed by the committee, which also changed the amount of RDP that companies could recoup by meeting certain conditions, and capped the total amount of protection at 8.5 years... Sub. Req'd

Why Personalized Medicine Poses HTA & Funding Challenges In England

(3/25, Eliza Slawther, Pink Sheet) ...England's health technology assessment body, NICE, must allocate resources towards medicines that "have the greatest impact on the whole population," something that makes it "tricky" to implement personalized medicine within the National Health Service, according to Clare Morgan, director of implementation and partnerships at NICE... Sub. Req'd

BGMA Warns That Policy Vacuum Risks UK Becoming ‘Supply Backwater'

(3/25, David Wallace, Generics Bulletin) ...With a UK general election looming, local generics and biosimilars industry association the BGMA has warned that the country will be "deprioritized as a supply market" without a more focused and supportive policy environment for the off-patent sector...Commenting as it published a "manifesto" white paper setting out recommended solutions to address the lack of government action for the sector, the BGMA suggested that in the absence of a more supportive and focused policy environment, the UK risked becoming a "backwater" supply market for medicines... Global Sub. Full

UK Faces Risk of Becoming a ‘Backwater' Supply Market for Medicines, BGMA Manifesto Warns

(3/25, Longjam Dineshwori, Pharmacy Business) ...The BGMA manifesto outlines the challenges facing the UK off-patent medicines sector and details the key policy areas that need greater focus from the next UK government. Mark Samuels, chief executive of the BGMA, highlighted that the EU-UK Trade and Cooperation Agreement has hurt the domestic manufacturing capacity, adding "regulatory and logistical complexity" to an industry that relies on simplicity to survive... Full

Russia to Tighten Control for Global Drugmakers Operating in Local Market

(3/25, The Pharma Letter) ...Pharmaceutical companies from so-called "unfriendly" countries for Russia will be required to coordinate transactions for the sale of brands and means of individualization in the country's pharmaceutical market to local legal entities with the specially established state regulator in order to tighten a control for them and prevent the illegal withdrawal funds from the local market. The latest initiative became part of the recently adopted amendments to Presidential Decree No 322, which were prepared by the Russian Ministry of Industry and Trade, reports The Pharma Letter's local correspondent... Sub. Req'd

Sweden Makes Naloxone Spray An OTC Product, To Prevent Opioid Overdose Deaths

(3/25, Monica Kleja, Euractiv) ...Naloxone nasal spray, which can save opioid users from overdoses, will soon be available without prescription in Sweden. The move seeks to increase early interventions outside healthcare settings, marking a major shift in Swedish drug policy...More suppliers of naloxone may soon follow since Jakob Forssmed told the media that he has been talking to other manufacturers, asking them to apply to the agency for OTC approvals... Full

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