Thursday, May 30, 2024

FDA Approves One Pill, Once-Daily Tablets of Deutetrabenazine for Tardive Dyskinesia, Chorea

(5/29, Marco Meglio, Neurology Live) ...The FDA has approved a new one-pill, once-daily tablet administration option for deutetrabenazine (Austedo XR; Teva Pharmaceuticals), a medication for tardive dyskinesia and chorea associated with Huntington disease. Deutetrabenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor, is now available in 4 tablet strengths (30, 36, 42, and 48 mg), adding on to its original dosing options of 6 mg, 12 mg, and 24 mg... Full

FDA Approves Teva Pharmaceuticals' AUSTEDO XR for TD and HD Chorea

(5/30, Pharmaceutical Technology) ...Teva Pharmaceuticals US Innovative Medicines head and senior vice-president Dell Faulkingham stated: "Since our launch of AUSTEDO in 2017, we have been committed to helping people living with TD and HD chorea treat these chronic, involuntary movements. AUSTEDO, backed by the longest efficacy and tolerability data to date, has continued to evolve – having received approval for AUSTEDO XR, our once-daily extended-release formulation, in February 2023."... Full

Teva Wins FDA Nod for New Austedo Formulation

(5/30, Dulan Lokuwithana, Seeking Alpha) ...Teva Pharmaceutical has received regulatory clearance to market its movement disorder therapy Austedo XR as a one-pill, once-daily treatment option in four new dosing strengths in the U.S., according to a company statement late Wednesday..."This latest milestone offers a streamlined treatment regimen for clinically therapeutic doses with the broadest dosing flexibility," said Dell Faulkingham, Teva's U.S. head of Innovative Medicines... Full

Teva Price Target Raised to $21 from $18 at BofA

(5/30, The Fly) ...BofA raised the firm's price target on Teva to $21 from $18 and keeps a Buy rating on the shares. The firm increased its forecasted sales and EBITDA estimates for Teva in 2025-27 to reflect higher assumed biosimilar contribution based on recent market developments, noting that partner Alvotech guided to b-Humira demand ahead of the firm's expectations... Full

Amgen Grabs FDA Thumbs Up for Soliris Biosim, Eyes 2025 Launch

(5/29, Eric Sagonowsky, Fierce Pharma) ...Amgen has made waves in the biosimilar field in recent years with its U.S.-first Humira biosim launch last year and its planned Stelara biosim rollout in 2025. But thanks to a new FDA approval, the company is nearing yet another biosimilar launch...The company will launch the product "no later than March 2025," the spokesperson added. As an interchangeable biosimilar, the Amgen drug will be eligible for substitution at the pharmacy counter without the permission of a patient's doctor... Full

Amgen Sues Celltrion Over Biosimilars of Blockbuster Bone Drugs

(5/29, Christopher Yasiejko, Bloomberg Law) ...Amgen Inc. accused Celltrion Inc. of infringing 29 patents with proposed biosimilar versions of blockbuster bone-strengthening drugs Prolia and Xgeva, whose domestic sales were more than 15% of Amgen's 2023 revenue. The patents cover denosumab, the active ingredient in both biologics, along with methods of manufacturing it and products containing it, according to a complaint filed Tuesday in the US District Court for the District of New Jersey... Sub. Req'd

FDA Grants Final Approval To Cipla's First Generic Somatuline

(5/29, Adam Zamecnik, Generics Bulletin) ...The US Food and Drug Administration has awarded final approval for Cipla's abbreviated new drug application for its rival to Ipsen's Somatuline Depot (lanreotide) injection, making it the only approved generic of its kind on the American market...As part of its longer-term plans, Cipla aims to focus on further develop its pipeline in oligonucleotides and peptides, based on its recently announced results for the 2024 fiscal year...Notably, the company wants to concentrate its organic investments in R&D targeting the US market, with five filed assets for respiratory conditions that includes generic versions of Symbicort (budesonide/formoterol) and Ovar (beclomethasone)... Global Sub. Full

Tris Pharma Captures FDA Nod for Non-Stimulant ADHD Treatment Onyda XR

(5/29, Kevin Dunleavy, Fierce Pharma) ...Providing a new alternative is Tris Pharma, which has won FDA approval for Onyda XR (clonidine hydrochloride). The extended-release oral suspension becomes the first liquid non-stimulant medication for ADHD and the only non-stimulant with nighttime dosing in the indication. Onyda XR can be used as a monotherapy or in combination with central nervous system stimulants in pediatric patients ages 6 and older. Tris expects Onyda XR to be available in the second half of this year... Full

J&J's Drug Eases Depression and Insomnia Symptoms in Late-Stage Study

(5/29, Pratik Jain, Reuters) ...Johnson & Johnson's experimental drug helped reduce symptoms of depression as well as insomnia in patients with major depressive disorder in a late-stage trial, the company said in a statement on Wednesday..."While we are still waiting for the detailed data for the drug, these initial findings are encouraging and are supportive of J&J's peak annual sales guidance of $1-$5 billion for the drug", Morningstar analyst Damien Conover said in an emailed response... Full

Alembic Pharma Gets US FDA Nod for Heart Failure-Treatment Drug

(5/30, Business Standard) ...Alembic Pharmaceuticals said that has received final approval from the US Food & Drug Administration for its abbreviated new drug application for Sacubitril and Valsartan Tablets. The approved ANDA is therapeutically equivalent to the reference listed drug product, Entresto Tablets of Novartis Pharmaceuticals Corporation... Full

Bio-Thera And Stada Joins Forces On Golimumab, With Up To $160M On The Table

(5/29, Dean Rudge, Generics Bulletin) ...STADA Arzneimittel AG has shaken hands with Bio-Thera Solutions on an exclusive commercialization and license agreement for the Chinese firm's BAT2506 proposed biosimilar to Janssen's Simponi (golimumab) in the EU, the UK, Switzerland and select other countries...Alvotech emphasized that it was "the first company to announce positive topline results of a clinical trial using a proposed biosimilar to Simponi and Simponi Aria and is one of only two companies known to have initiated such a patient study." The Icelandic firm intends to file marketing applications for AVT05 in major global markets this year, having already wrapped up commercialization arrangements for the biosimilar with firms including Teva in the US, Advanz Pharma in Europe and Fuji Pharma in Japan... Global Sub. Full

India's Jubilant Pharmova Reports Narrower Fourth-Quarter Loss

(5/29, Hritam Mukherjee, Reuters) ...Indian pharmaceutical firm Jubilant Pharmova reported a narrower fourth-quarter loss on Wednesday, aided by strong demand for drugs that contain radioactive ingredients. The company's consolidated net loss narrowed to 586 million rupees ($7 million) in the January to March period, compared with a loss of 979 million rupees a year ago... Full

Sun Pharma Shares Decline On Report of Four Observations from US FDA

(5/30, Money Control) ...Sun Pharmaceutical shares were trading in red on May 30 after reports suggested that the US Food & Drug Administration issued four observations to one of the pharma major's manufacturing facilities...According to reports, USFDA made several observations about Sun Pharma. First, the firm didn't take adequate precautions to prevent API contamination. Another observation highlighted the lack of procedures for routine maintenance. Additionally, Sun Pharma failed to document their material sampling methods... Full

India's Pharma Export Sales to Grow Faster This Year, Trade Body Says

(5/30, Rishika Sadam, Reuters) ...India's pharmaceutical export sales growth is expected to pick up to nearly 11% this fiscal year, from a roughly 10% increase last year, led by the key U.S. and UK markets, a government-backed trade body said on Thursday...The growth markets will be the United States, UK, Latin America and Africa, Udaya Bhaskar, the director general of Pharmexcil, told Reuters on the sidelines of an event in Hyderabad. Among them the U.S. is a key market -- it accounts for about 30% of India's annual pharma exports after a nearly 16% increase in fiscal 2024, according to Pharmexcil... Full

UK and US in Focus As Indian Companies Seeks $31 Bn Pharma Exports in FY25

(5/30, Sohini Das, Business Standard) ...Udaya Bhaskar, director general of the Pharmaceutical Exports Promotion Council, said the group targets $1 billion in exports to the UK where demand for affordable generics is rising. "We were in the UK last month for meetings. We are also planning a road show in Belgium, the Netherlands, and the UK in November or so," he told Business Standard. The UK's publicly funded National Health Service is unable to honour prescriptions immediately due to drug shortages and aims to reduce health care costs -- a step that would lead to higher demand for affordable generics, said Bhaskar... Sub. Req'd

How the Pandemic Gave Power to Superbugs

(5/29, Gabrielle Emanuel, NPR) ...Globally, about 75% of patients hospitalized with COVID were given antibiotics, despite only 8% having a bacterial coinfection where antibiotics would be medically useful. This comes from new data published in late April that was collected through the World Health Organization's Global Clinical Platform in 65 countries between January 2020 and March 2023...Antibiotic practices during the pandemic reversed progress that had been made before the pandemic. And new data show the impact can still be seen in the number of infections caused by superbugs in U.S. hospitals... Full

Novo Attempts to Parry Sanders' GLP-1 Pricing Complaints by Calling Out Pharma Middlemen

(5/29, Fraiser Kansteiner, Fierce Pharma) ...In a letter to the HELP committee, Novo blamed so-called pharma middlemen (pharmacy benefit managers and insurance companies) for the steep costs of its diabetes and obesity blockbusters, Bloomberg reports. The company argued that it only keeps around 60% of the list prices of its star GLP-1 drugs in the U.S. after paying out rebates and fees to middlemen, according to the news service. A Novo Nordisk spokesperson confirmed over email that the letter was sent to Sen. Bernie Sanders, who chairs the HELP committee, on Friday... Full

Insulin Cap Supporters Say Schumer Could Bridge Senate Divides

(5/29, Alex Ruoff, Bloomberg Law) ...Senate Majority Leader Chuck Schumer has spent nearly two years promising to extend Medicare's $35 per-month cap on insulin costs to private insurance. Backers of the legislation in the Senate now say it's Schumer keeping it off the floor...A spokesperson for Schumer, who spoke on condition of anonymity, said the issue remains a priority. Warnock said Schumer has promised to hold a vote on it this year... Sub. Req'd

US Senator Warren Pushes to Cement Pharmaceutical Patent Seizure Policy

(5/30, Patrick Wingrove, Reuters) ...U.S. Senator Elizabeth Warren and another Democratic lawmaker on Thursday said they had sent a letter urging the Department of Commerce to finalize its policy on when the government can seize patents on drugs and other products whose research it funded...The government, which gave the public until February to comment on the proposal, is expected to make a decision on whether to finalize the change to so-called march-in rights within days, according to a source close to the matter... Full

Value-Based Payment is Getting Renewed Attention. What it Means isn't Getting Any Clearer

(5/30, John Wilkerson, STAT Plus) ...Rachel Werner, executive director of the Leonard Davis Institute of Health Economics at the University of Pennsylvania, said value is the cost paid for a given outcome. Costs can go down for an outcome, which is valuable, or outcomes can get better, which also is of value. "But it doesn't have to necessarily save money," she said... Sub. Req'd

PCMA Launches New Campaign to Elevate the Voice of the Employer, Critical Value of the Employer-PBM Relationship

(5/29, PCMA) ...The Pharmaceutical Care Management Association announced today the launch of How PBMs Work, a national campaign to highlight the critical relationship between employers and pharmacy benefit managers...The How PBMs Work campaign includes a new website, testimonials from employers, resources, including background and data on the PBM-employer relationship, and the launch of a new advertising campaign, elevating the critical perspective of employers in their own words... Full

House Republicans' New 340B Bill 'A Pharmaceutical Industry Wish List,' Hospitals Say

(5/29, Dave Muoio, Fierce Healthcare) ...Republican lawmakers in the House have introduced a bill Tuesday that tightens eligibility and public reporting requirements within the 340B Drug Discount Program, earning the applause of industry groups that argue the 1992 safety net program has swelled beyond its original intent...Hospitals gave the bill a frigid reception. Maureen Testoni, president and CEO of 340B Health, the association representing over 1,500 hospitals participating in the 340B program, said the bill reads as "the legislative version of a pharmaceutical industry wish list" and would ultimately decrease the number of patients eligible for discounts... Full

The Democratic Bill To Raise Drug Prices By Protecting Patent Trolls

(5/29, Avik Roy, Forbes) ...Those who value free-market principles for prescription drugs should especially value the role of the patent opposition process to reduce unfair monopolies and increase competition. Not all patents are created equal, and not all bureaucratic decisions to issue patents are infallible. Patent examiners in the U.S. routinely issue patents—and thereby 20-year monopolies—for claims that aren't real inventions. Just as pruning a rose bush helps it grow, clearing out weak patents improves the quality and legitimacy of the truly innovative ones... Full

Opinion | Angry at High Drug Prices? A Letter in The Post is to Blame (Sort Of).

(5/30, Peter S. Arno and Kathryn Ardizzone, The Washington Post) ...In 2002, Peter and a co-author published an op-ed in The Post arguing that the federal government should step in to lower high prescription drug prices...Not long after, The Post published a letter responding to that op-ed...And ever since, the drug industry and its allies have used that letter as a cudgel to beat back any government attempts to rein in skyrocketing drug prices for Americans... Sub. Req'd

ANDA Suitability Petitions: The Timelines They Are A-Changin'

(5/30, Anju Ghangurde, Pink Sheet) ...US suitability petitions may be seeing renewed interest from sponsors following a surge of filings after the introduction of goal dates in October and then a drop-off of submissions after that. Nimish Mehta, founder of the pharma-focused Indian business analytics firm Research Delta Advisors, told the Pink Sheet that the surge in suitability petitions could be ascribed to the change in FDA guidelines as the US Food and Drug Administration works towards new goals and assessment processes laid out in the Generic Drug User Fee Amendments (GDUFA III)... Sub. Req'd

Nevada Enforcing Copay Accumulator Ruling In 2025 Health Benefit Plan

(5/29, Luke Zarzecki, InsideHealthPolicy) ...Nevada will begin mandating insurers count prescription drug coupons toward cost-sharing limits except when a generic alternative is available -- a policy patient advocates have called for that enforces a court ruling that payers cannot use copay accumulators to omit the value of patient assistance. Nevada's Division of Insurance 2025 Health Benefit Plan Filing Guidance mandates the change for the 2025 plan year... Sub. Req'd

PBMs, Cost Sharing Eyed by State Legislatures

(5/29, Karen Blum, Specialty Pharmacy Continuum) ...Getting more transparency from pharmacy benefit managers and manufacturers, and curbing state costs for prescription drugs, were among the areas of focus for numerous pieces of legislation proposed by states last year, speakers said during AMCP 2024, in New Orleans. Many policies first enacted by states were later implemented at the federal level and provide a good barometer for legislative trends, said Adam Colborn, JD, the director of government affairs for the Academy of Managed Care Pharmacy. At the state level, some 504 bills are in play that could affect managed care pharmacy, he continued... Full

Focus On National Competence and Drug Prices in EU Pharma Package, Says Bulgaria

(5/29, Krassen Nikolov, Euractiv) ...According to the document seen by Euractiv, Sofia opposes granting the European Commission additional powers that would affect national authorities' ability to determine the country's drug policy independently. "In order to avoid unclear interpretation on this matter, clear definitions of the texts in the Directive are necessary," the Bulgarian position says. The position of the institutions in Sofia regarding the pharmaceutical package is almost entirely centred around fears of increased costs due to future EU legislation... Full

French Pharmacists Strike Over Drug Shortages and Pay, Closing Shops Nationwide

(5/30, AFP) ...After poster and email campaigns to warn of the closures in recent days, patients were set to find around 90 percent of pharmacies across France closed for the day, with every single one in some regional towns shutting their doors...Professionals say they are just as concerned about drug shortages, rural closures and training reform as about pay and conditions... Full

Japanese Pharma Companies Focusing On Neurological Therapeutics: GlobalData

(5/30, ET Pharma) ...As the Asia-Pacific region emerging the hotspot for neurological disorders like Alzheimer, epilepsy, Parkinson and depression Japanese Pharma companies appears to have sensed the change and have already started in extending their foothold through launching various related therapeutics stated GlobalData a data-analysis firm...According to the data-analysis company focusing on the therapeutic area several Japan's pharma companies have launched key assets such as Eisai Co. Ltd.'s Aricept, and Leqembi for Alzheimer's disease, and Fycompa for epilepsy; Otsuka Holding's Abilify and Rexulti to treat schizophrenia and depression; Takeda commercializing Azilect (developed by Teva Pharmaceuticals) for Parkinson's disease, and Trintellix (developed by H. Lundbeck A/s) for major depressive disorder in the country... Full

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