Monday, June 3, 2024

Teva Presents First Real-World Data from IMPACT-TD Registry Study

(6/2, The Fly) ...Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries, announced new patient- and physician-reported interim results from the Phase 4 IMPACT-TD Registry study, reinforcing that TD has a wide-reaching, multidimensional impact on patients' quality of life... Full

Medincell's Partner Teva Presented New Data Providing Schizophrenia Treatment Insights into Switching to UZEDY® (Risperidone) from Invega Sustenna® (Paliperidone Palmitate)

(6/3, Medincell) ...Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva said: "UZEDY is a long-acting formulation of risperidone with an innovative delivery system that requires no loading dose or oral supplementation and can be dosed at one- or two-month intervals to help with prevention of relapse. It can also be administered subcutaneously under the skin instead of intramuscularly, which is an important feature to discuss with patients. We are proud to share these clinical insights that may help healthcare providers understand more about switching between long-acting options for their schizophrenia patients."... Full

Attorney General Coleman Announces Nearly 8,000 Naloxone Doses Arrive in First Shipment from Teva Settlement

(5/31, Attorney General Russell Coleman) ...Attorney General Russell Coleman announced today nearly 8,000 doses of Naloxone - an opioid overdose reversal drug - have been delivered to distribution sites across Kentucky this week. The delivery is the first of four expected this year as part of a settlement with Teva Pharmaceuticals, Inc... Full

Ky. Receives Naloxone Shipment from Drug Company Accused of Fueling the Opioid Crisis

(5/31, Karla Ward, Lexington Herald Leader) ...The naloxone shipments that arrived in Kentucky this week are the first of four deliveries expected this year by Teva Pharmaceuticals, the Kentucky attorney general's office announced Friday. The drug, which can help restore breathing if an overdose has occurred, was delivered to facilities in Ashland, Frankfort, Florence, Louisville and Paducah, Attorney General Russell Coleman's office said in a news release...Jaggers said the naloxone provided by Teva "will help expand access to this life-saving product to agencies and individuals directly involved in responding to overdoses across the Commonwealth."... Full

What's Next? Five Things To Look Out For In June

(6/1, Dean Rudge, Generics Bulletin) ...Teva can look forward this month to launching the first generic form of Novo Nordisk's liraglutide-containing Victoza in the US, amid the growing global interest in and dominance of GLP-1 agonists to manage diabetes and obesity...Teva and Alvotech, which recently introduced their partnered Simlandi (adalimumab-ryvk) biosimilar to Humira in the US, also have a deal in place with Quallent to supply their high-concentration biosimilar... Global Sub. Full

Some Drugmakers to Cap Cost of Asthma Inhalers at $35 a Month

(5/31, Berkeley Lovelace Jr., Jason Kane and Anne Thompson, NBC News) ...Starting Saturday, the cost of inhalers will fall for many Americans, as new out-of-pocket price caps go into effect for the asthma medications from AstraZeneca and Boehringer Ingelheim. Following years of public outcry about the high cost of inhalers, the two drugmakers — along with a third, GlaxoSmithKline — have committed to capping the out-of-pocket cost at $35 a month. GSK's cap is expected to take effect by Jan. 1... Full

Sandoz And Bio-Thera Get EU Nod For Bevacizumab

(5/31, David Wallace, Generics Bulletin) ...Sandoz and Bio-Thera have seen their partnered Avzivi (bevacizumab) biosimilar rival to Avastin recommended for approval by the European Medicines Agency at the latest meeting of its Committee for Medicinal Products for Human Use...Avzivi will be available as 25mg/ml concentrate for solution for infusion... Global Sub. Full

Outlook Sets Out Plans For Ophthalmic Bevacizumab In Europe

(6/3, David Wallace, Generics Bulletin) ...Outlook Therapeutics has set out details of its initial launch strategy for its Lytenava (bevacizumab gamma), after receiving at the end of May a formal European Commission marketing authorization for the wet age-related macular degeneration treatment...Russell Trenary, Outlook's president and CEO, described the marketing authorization as "a landmark milestone for us," indicating that the firm was "moving toward our potential first commercial launch in an EU member state in the first calendar quarter of 2025."... Global Sub. Full

Aurobindo Pharma Secures Marketing Authorisation for Trastuzumab Biosimilar in India

(6/3, G Naga Sridhar, The Hindu BusinessLine) ...Aurobindo received its first marketing authorisation for the biosimilar drug trastuzumab, which is used for breast cancer treatment, in the Indian market in the current financial year. "We have promptly applied for a manufacturing license. which we expect to obtain very soon. So, the plan is to manufacture the batches and launch the product in the second half of this year [FY25] into the domestic market,'' Satakarni Makkapati, CEO - Biosmilars, Aurobindo Pharma said... Full

Key UK Xarelto Patent Knocked Out Again In Boost For Generics Manufacturers

(5/31, Dean Rudge, Generics Bulletin) ...A panel of three UK Court of Appeal justices were in agreement that High Court judge Richard Hacon had made "no error of principle in his assessment of obviousness" of the UK portion of Bayer's European patent 1,845,961, which claims the use of rivaroxaban for the treatment of a thromboembolic disorder by means of once daily administration. Judge Hacon's decision was handed down only in April, following challenges to Bayer's intellectual property by a who's-who of generics manufacturers including Teva, Sandoz, Viatris's Generics UK, Cipla and Stada... Global Sub. Full

Lung Cancer Was a Death Sentence. Now Drugs Are Saving Lives.

(6/2, Brianna Abbott, The Wall Street Journal) ...AstraZeneca's drug Tagrisso can contain lung cancer nearly three years longer than chemotherapy and radiation alone for some stage-three patients, one study released Sunday showed...Another study presented at the American Society of Clinical Oncology conference in Chicago found that 60% of advanced patients were alive without their disease advancing at five years after taking Pfizer's Lorbrena, a drug that targeted a genetic mutation in their tumors. That compares with just 8% of patients on an older drug with the same target. "These results are really outstanding," said Dr. David Spigel, chief scientific officer at Sarah Cannon Research Institute in Tennessee, lead researcher on the Imfinzi trial. "A really major step forward in lung-cancer care."... Sub. Req'd

ASCO24: AstraZeneca Won Cancer's Big Meeting – Again. Will that Help it Fulfill its $80 Billion Ambition?

(6/3, Matthew Herper, STAT Plus) ...More than a third of the company's $45.8 billion in annual sales last year came from cancer drugs, but last month the company's CEO, Pascal Soriot, upped the pressure, promising shareholders that in a mere six years the company would increase its annual sales to $80 billion, with much of the weight falling on the stable of cancer drugs that Galbraith's team has already brought to market and even more on the experimental medicines that are nearing the regulatory finish line... Sub. Req'd

ASCO 2024: Data Put a New Shine On GSK Blood Cancer Drug that Was Pulled from Market

(6/2, Andrew Joseph, STAT Plus) ...At the annual American Society of Clinical Oncology conference in Chicago, researchers on Sunday are presenting trial data showing that the drug, called Blenrep, outperformed a standard therapeutic approach when combined with another medicine in patients with multiple myeloma. It's the second positive study for Blenrep in myeloma in recent months, and next up could be a return to regulatory agencies to get the drug re-approved. In an interview, Hesham Abdullah, GSK's oncology research leader, said the company planned to submit Blenrep to regulators by the end of the year... Sub. Req'd

#ASCO24: Novartis' New CML Treatment Tops Older Drugs, Including Gleevec, In Phase 3 Trial

(5/31, Kyle LaHucik, Endpoints News) ...Novartis said its chronic myeloid leukemia drug Scemblix was better than its own first-generation blockbuster medicine and an investigator's choice of second-generation treatments made by itself, Bristol Myers Squibb and Pfizer. The detailed Phase 3 results presented Friday could potentially open up Scemblix to at least twice as many patients, Novartis' global head of oncology Jeff Legos said in an interview with Endpoints News. The results were presented at the American Society of Clinical Oncology meeting... Full

US FDA Approves Moderna's RSV Vaccine with Lower-Than-Expected Efficacy in its Label

(5/31, Patrick Wingrove, Reuters) ...Moderna's vaccine was approved for the prevention of RSV-associated lower respiratory tract disease in adults aged 60 or older, but with a label indicating the shot was 79% effective at preventing at least two symptoms of RSV, such as cough and fever...Jeffries analyst Michael Yee said in a note that the lower efficacy label was still in line with GSK's RSV shot Arexvy, the current market leader... Full

Natco Pharma Seeks U.S. FDA Nod for Copy of Pfizer's Migraine Drug, Faces Lawsuit

(5/31, The Hindu) ...Natco Pharma has been named defendant in a lawsuit filed in the U.S. by Pfizer Inc and Pfizer Ireland Pharmaceuticals amid the abbreviated new drug application the Hyderabad-based drugmaker has submitted to the U.S. Food and Drug Administration seeking approval for a generic version of migraine drug Rimegepant Sulfate tablet Eq 75mg base strength... Full

Sun Pharma Expects High Single-Digit Top Line Growth in Current Fiscal

(6/2, Press Trust Of India) ...Drug major Sun Pharmaceutical Industries expects a high single-digit top line growth in the current fiscal, according to Managing Director Dilip Shanghvi. The Mumbai-based firm reported a consolidated total revenue from operations at Rs 48,497 crore for FY24. The number stood at Rs 43,886 crore in FY23. "We expect high single-digit consolidated top line growth for FY25. All our businesses are positioned for growth," Shanghvi said in an analyst call... Full

Delaware Judge Lets More Than 70,000 Zantac Lawsuits Go Forward

(6/1, Brendan Pierson, Reuters) ...The ruling on Friday by Judge Vivian Medinilla of the Delaware Superior Court in Wilmington is a setback for former Zantac makers GSK, Pfizer, Sanofi and Boehringer Ingelheim, which had argued that the expert witnesses' opinions lacked scientific support...GSK, Pfizer and Sanofi said in separate statements that they disagreed with the decision and would appeal. They said there was no reliable evidence showing Zantac caused cancer... Full

Antibiotic Innovation is Ailing. ‘Brain Drain' May Kill It

(6/3, Henry Skinner, STAT) ...In today's life sciences market, antibiotics represent a perilous career path with diminishing opportunities, and researchers young and old are steering clear. A recent analysis from The AMR Industry Alliance estimated that there are only 3,000 active researchers in the world focused on antibiotic resistance, compared with some 46,000 cancer researchers. The report also found that the number of individuals listed as authors on publications related to antibiotic resistance declined by 50% from a high of 3,599 in 1995 to just 1,827 in 2020... Full

Generic Drug Lobby Presses For FTC, DOJ Action On GPOs

(5/31, Maaisha Osman, InsideHealthPolicy) ...The generic drug trade group Association for Accessible Medicines is urging the Federal Trade Commission and the Department of Justice to issue a new guideline that limits group purchasing organization market share to 20% and ban certain contract terms, like failure-to-supply drugs or most favored nation provisions. The organization says such policies make it harder for generic drug suppliers to secure sustainable contracts... Sub. Req'd

Biosimilars Council Urges Global Comparators And Dropping ‘Unnecessary' Studies

(6/3, David Wallace, Generics Bulletin) ...Underlining that "around 80% of biologics currently do not have a biosimilar product in the works" – with around half of originator biologics facing loss of exclusivity within the next 10 years having no biosimilars in development – Biosimilars Council executive director Craig Burton said "let's reduce that percentage and pave the way for a new generation of lower-cost medications."... Global Sub. Full

NEWS: Sanders Applauds Major Pharmaceutical Companies for Capping Inhaler Costs at $35, Following HELP Committee Investigation

(6/1, U.S. Senate Committee On Health, Education Labor & Pensions) ...”Today is the first day of a new program instituted by the major pharmaceutical company Boehringer Ingelheim, which will allow people with asthma and COPD to purchase brand name inhalers at their local drugstore or pharmacy for only $35 dollars. This is a major reduction in cost, and I thank Boehringer Ingelheim for making their important products affordable for the millions of Americans who need them to breathe...We look forward to AstraZeneca moving in the same direction – applying its $35 cap automatically at the pharmacy counter – in the next few weeks, and to GlaxoSmithKline following suit in the coming months. We are waiting on word from Teva, the fourth major inhaler manufacturer, as to how they will proceed.”... Full

'We're Going to Miss the Next Keytruda': Lilly, Merck, Gilead and PhRMA CEOs Talk IRA Consequences

(6/2, Zoey Becker, Fierce Pharma) ...It was a "once-in-a-lifetime, lighting-in-a-bottle" discovery that wouldn't be possible to develop the same way under the Inflation Reduction Act, Merck CEO Robert Davis warned at a Pharmaceutical Research and Manufacturers of America panel Friday on the sidelines of this year's annual American Society of Clinical Oncology conference. While Davis says the drug and its development on its own is "not a repeatable model," Eli Lilly's CEO David Ricks argues that lighting could still strike twice—if it weren't for the IRA... Full

More Guardrails Proposed for Insurer ‘Fail First' Medication Requirements

(5/31, Theresa Marsenburg, WROC) ...Lawmakers in Albany are being asked to add more safeguards to a prescription drug practice known as step therapy or "fail first." It's when insurance companies require patients to first use a medication other than what a provider initially prescribed. It may be a generic drug that is cheaper than the preferred medication. If the alternative drug fails, then the insurer will typically pay for the original prescription ordered by the doctor... Full

Vermont Passes Bill Creating PDAB-Like Framework On Drug Pricing

(5/31, Luke Zarzecki, InsideHealthPolicy) ...Vermont Republican Gov. Phil Scott on Thursday (May 30) signed a bill directing the state's Green Mountain Care Board to create a framework for regulating the cost of prescription drugs. The bill is a variation on prescription drug affordability board (PDAB) legislation that states across the country have enacted, and lawmakers hope to learn from the other boards' successes and mistakes... Sub. Req'd

Novartis Sues Maryland Over State Law Banning Limits On Discounts to 340B Contract Pharmacies

(5/31, Lia DeGroot, Endpoints News) ...Novartis is suing the state of Maryland to block a state law that will ban drugmakers from placing limits on discounts to pharmacies that supply drugs to hospitals serving low-income and uninsured patients...Novartis is asserting that it will face irreparable harm from complying with Maryland's law and requests a preliminary injunction while the court decides on the merits of the case... Full

Drugmakers to Maryland Affordability Board: Capping List Prices May Not Help Patients

(5/31, Zachary Brennan, Endpoints News) ...Drugmakers are pushing back against Maryland's Prescription Drug Affordability Board and its list of six medicines that will be reviewed for potential price caps. The board is conducting studies of six drugs to decide if there are affordability issues, including Novo Nordisk's weight loss drug Ozempic, AstraZeneca's kidney disease drug Farxiga, Boehringer's diabetes drug Jardiance, Eli Lilly's diabetes drug Trulicity, Sanofi and Regeneron's Dupixent, and AbbVie's Skyrizi. Jardiance and Farxiga were also selected for negotiations with Medicare earlier this year under the Inflation Reduction Act... Full

Canada Puts a Chill in Biosimilar Switches

(6/1, Karen Blum, Specialty Pharmacy Continuum) ...For lessons in how to avoid biosimilar switching pitfalls, one need only look north to Canada. The country's recent reliance on a nonmedical approach to this complex process caused several problems, including patient confusion, interrupted access to financial support programs and a breakdown in continuity of care, according to several experts who are familiar with the model... Full

No Relief from Bloated Swiss Drug Prices

(5/31, Swissinfo.ch) ...The price difference for medicines between Switzerland and other countries has further increased. In Switzerland, patent-protected medicines cost on average 8.9% more than in other European countries. A year ago, the price difference was 5.4%. People abroad now pay 14.3% less for off-patent original preparations. A year ago, the price difference was only 10.8%, as the health insurance association Santésuisse and the association of research-based pharmaceutical companies Interpharma announced on Friday... Full

Alliance of India's 26 Top Drugmakers Opposes Generic Drug Substitution at Janaushadhi Kendras

(5/31, Sumi Sukanya Dutta, ThePrint) ...A group of top Indian pharma companies has reached out to the central government opposing a proposal to allow government-run Janaushadhi Kendras to dispense substitutes of prescription medications, including anti-cancer, antibiotics, and habit-forming drugs, ThePrint has learnt...According to IPA secretary general Sudarshan Jain, shifting the responsibility of prescribing generics from doctors to trade channels could severely undermine patient safety..."Our channel partners are more likely to dispense drugs with a higher profit margin, regardless of the drug's quality, which can result in spurious generic drugs being dispensed putting patient care and human life at risk," he told ThePrint... Full

Japan Aims To Broaden RWD Use By Allowing Pseudonymised Data

(6/3, Lisa Takagi, Pink Sheet) ...The revised Next Generation Medical Infrastructure Act, which came into effect on April 1, 2024, newly allowed pseudonymised in addition to anonymized data, and also the use of several government-certified cloud platforms. The moves form part of wider initiatives for enhancing the country's drug discovery and development capabilities, and the country's Cabinet Office has been promoting awareness of the modified legislation... Sub. Req'd

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