Friday, September 20, 2024

Drugmakers to Stop Making Controversial Fentanyl Lollipops, FDA Says

(9/19, Alexander Tin, CBS News) ...Drugmaker Cephalon had the FDA's approval to market these drugs, old under brand names like Actiq, as a sweetened lozenge on a stick, or Fentora, a tablet that was designed to dissolve in the mouth, for treating cancer patients who had developed a tolerance to less powerful opioids...Generic pharmaceutical manufacturer Teva Pharmaceuticals moved to acquire Cephalon in 2011, at a time when the market for Actiq was worth around $173 million a year. It is unclear why Teva has moved to stop selling the drugs... Full

Race to the Bottom: Hard Bargain

(9/19, Tradeoffs) ...[Leslie Walker] So basically for a while, there were two big drug companies making generic versions of this drug vincristine. There was Teva and there was Pfizer. But then in 2019, a few months before Abby hits this shortage, Teva, one of the two companies, decides to stop making the drug...Right, here's how Christine Baeder, a generic drug executive who worked at Teva during this shortage, put it for me. [Christine Baeder] It was never a big industry of buyers. It was sort of like that big Thanksgiving table. But what happened is it went to the breakfast table in your kitchen... Full

Role of Leaders in Fostering Talent in Modern Pharma Supply Chains

(9/20, Indian Transport & Logistics News) ...This video captures an insightful discussion on "What is the role of leaders in developing talents with a sense of responsibility in modern pharma supply chains?" at the Global Pharma Logistics Summit 2024 conference. Industry leaders from Teva Pharmaceuticals, Koye Pharmaceuticals, Merck Life Science, Reliance Retail Pharma, and GSK share their perspectives on leadership strategies for nurturing responsible talent... Full

David Kappos | Thank Patent Laws, Not Their Critics, for Generic GLP-1s

(9/19, David Kappos, The Tribune-Democrat) ...In late June, generic drug maker Teva Pharmaceuticals launched a generic version of Victoza, a blockbuster diabetes drug, in the U.S...With the first low-cost GLP-1 generics entering the market, we're about to change and save lives on an unprecedented scale. But that's not good enough for some. U.S. Sen. Bernie Sanders has led a charge against the price tags on brand-name versions of these medications, calling them "unacceptable." More dangerously, he suggested that weakening drug patent protections is the solution... Full

Granules India Scolded Over Truckloads of Torn Manufacturing Documents After Recent FDA Inspection

(9/19, Fraiser Kansteiner, Fierce Pharma) ...From truckloads of torn documents to avian incursions in the production plant, Granules India's recent manufacturing reprimand from the FDA is alarming no matter which way you look at it. Earlier this month, Granules was slapped with a Form 483 from the FDA following an inspection of its Telangana facility in India that ran from Aug. 26 to Sept. 6. The FDA's report cites six observations around poor quality control procedures, subpar cleaning, cross-contamination risks and more... Full

Torrent Pharma Gets An Observation from USFDA for Pithampur Plant

(9/20, The Press Trust Of India) ...Torrent Pharmaceuticals on Friday said the US health regulator has issued a Form 483 with one observation after inspecting its Pithampur-based manufacturing facility...The drug maker will respond to the USFDA within the prescribed timeframe and will work in close collaboration with it to address the observation at the earliest possible time, the company said... Full

New Migraine Drugs Less Effective Than Previous Generation of Triptan Meds: BMJ Study

(9/19, Kevin Dunleavy, Fierce Pharma) ...A study from The BMJ indicates that the newest class of migraine drugs—which includes Pfizer's Nurtec, AbbVie's Ubrelvy and Eli Lilly's Reyvow—is less effective in the acute treatment of migraines than a previous class of medicines. What's more, the newer drugs are no more effective in treating migraines than traditional headache remedies such as Tylenol, ibubrofen and aspirin, according to The BMJ's analysis... Full

Sanofi's BTK Inhibitor Again Slows MS Progression, But Liver Enzymes Continue to Be Tricky

(9/20, Max Gelman, Endpoints News) ...Sanofi released new Phase 3 data for its BTK inhibitor tolebrutinib in non-relapsing secondary progressive multiple sclerosis (nrSPMS), showing a 31% improvement in delaying onset of disease progression compared to placebo. But safety issues that have dogged the drug class could complicate the readout... Full

Abbott India Joins Hand with Takeda Pharma to Launch Vonoprazan Tablets in India

(9/20, Business Standard) ...Abbott India said that it has signed a non-exclusive patent license agreement with Takeda Pharmaceuticals Company to commercialize Vonoprazan, a novel molecule in the gastrointestinal therapy area, under the brand name Vonefi...This license will enable the company, a leader in the gut health space, to enhance access to this novel therapy to more patients across India... Full

Gilead's Kite Uncouples from Fosun in China as Yescarta Faces Coverage Obstacles

(9/20, Ayisha Sharma, Endpoints News) ...Gilead Science's Kite Pharma is separating from its cell therapy joint venture with Fosun Pharma in China, handing Fosun the reins for its CAR-T therapy Yescarta in the region. The break-up is the latest in a series of recent China divestitures by foreign drugmakers, including UCB and CSL Behring. Kite's decision in particular reflects the challenges of securing reimbursement for more complex medicines in the country... Full

3 GLP-1 Updates

(9/19, Paige Twenter, Becker's Hospital Review) ...The GLP-1 market is expected to be worth $200 billion by 2031. In a race to enter the lucrative market, pharmaceutical companies could launch up to 16 new weight loss drugs between 2026 and 2029, according to investment research company Morningstar. Novo Nordisk, the maker of Ozempic and Wegovy, is already facing direct competition from Teva Pharmaceuticals and Sandoz. In June, Teva announced the launch of liraglutide, the first approved generic version of Novo Nordisk's Victoza, a GLP-1 diabetes drug... Full

Truveris Collaborates With Mark Cuban Cost Plus Drug Company to Reduce Pharmacy Benefits Spend

(9/19, Truveris) ...Truveris, a leading healthcare technology company focused on reducing pharmacy spend, announced today that they are collaborating with Mark Cuban Cost Plus Drug Company, PBC (Cost Plus Drugs), to drive pharmacy transparency and make prescription drugs more affordable... Full

How I Fought Big Pharma On Insulin Prices — and Won

(9/20, Elizabeth Pfiester, STAT) ...The access to medicines space needs more funding from philanthropists of all types for small, independent grassroots groups like ours to ensure we exist as long as we need to in order to achieve our goals, while being able to speak freely without risk of compromising our voices at the behest of funders... Full

Lawmakers Urge U.S. Patent Office and Drugmakers to Correct Patent Mistakes

(9/19, Ed Silverman, STAT Plus) ...A group of lawmakers wants the U.S. Patent & Trademark Office and drug companies to change their approach toward handling mistakes in disclosing patent terms, because the errors can be exploited in ways that thwart competition and, ultimately, raise the cost of medicines...The Federal Trade Commission has also warned companies about improper patent listings and opened an investigation into Teva Pharmaceuticals... Sub. Req’d

Cassidy Seeks to Exempt Small Biotechs from Medicare Drug Price Negotiation

(9/19, John Wilkerson, STAT Plus) ...Cassidy's bill, obtained by STAT, would exempt "research and development-intensive small biotech manufacturers" after the current exemption expires. It also would create a new way of determining what qualifies as a small biotech by basing that calculation on a company's research and development expenditures... Sub. Req’d

Q&A: PBM Legislation "Highly Likely" to Pass This Year

(9/19, Peter Wehrwein, Drug Topics) ...It is "highly likely" that pharmacy benefit management legislation will cross the legislative finish line this year, according to Patrick Cooney, president of The Federal Group, a Washington, DC-based lobbying firm. Cooney was interviewed during the 2024 Pharmacy Benefit Management Institute Annual National Conference by Drug Topics' sister publication, Managed Healthcare Executive, where he discussed the role of the Federal Trade Commission (FTC) interim report in galvanizing legislators, as well as his predictions on what provisions the potential PBM legislation might contain... Full

Pfizer Hints at Curbing Assistance In Part D Next Year In Notice Asking Patients To Enroll In M3P

(9/19, Lauren Flynn Kelly, Pink Sheet) ...New terms for Medicare Part D beneficiaries interested in enrolling in Pfizer's oncology patient assistance program in 2025 involve attestations that assistance is still needed after enrolling in the new M3P program and that they have not yet met the $2,000 out-of-pocket spending cap... Sub. Req’d

GLP-1s Could Drive Insurer, Manufacturer Decisions On Medical Devices

(9/19, Jessica Karins, InsideHealthPolicy) ...At the Medical Device Innovation Consortium conference Sept. 11, some experts speculated the growth of GLP-1 drug usage could have a significant impact on the medical technology industry especially as FDA labeling for the drugs changes rapidly. Derek Van Amerongen, an associate professor at the University of Cincinnati School of Medicine, said it's possible that widespread adoption of the drugs could lead to fewer bariatric surgeries, joint replacements and other procedures... Sub. Req’d

Q&A: PCMA On Drug Pricing and the Pharmaceutical Supply Chain

(9/19, Brian Nowosielski, Drug Topics) ...In the most recent episode of Over the Counter, Johnny Garcia, Senior Director of Policy at the PCMA, sat down with Drug Topics to discuss the pharmaceutical supply chain in greater depth and the growing issue of rising drug costs. He talked about systemic flaws within the supply chain and how his organization is working to provide valued care to all patients... Full

Convergence: FDA Official Reviews Common BLA Deficiencies, Offers Advice On Avoiding CRLs

(9/19, Joanne S. Eglovitch, Regulatory Focus) ...The number of complete response letters issued to sponsors of biologics license applications by the US Food and Drug Administration has been increasing over the past decade, with facility deficiencies being the most frequent issue cited, said Leslie Rivera Rosado, a supervisory interdisciplinary scientist for the Office of Pharmaceutical Quality within the agency's Center for Drug Evaluation and Research... Full

Pharmacy Benefit Managers Will Have to Pay Arkansas Drugstores Dispensing Fees Under New Rule

(9/19, Tess Vrbin, Arkansas Advocate) ...The Arkansas Insurance Department will require pharmacy benefit managers to include dispensing fees in their reimbursements to pharmacies for prescription drugs, a legislative panel ruled Thursday. The new rule will financially benefit pharmacies, especially independently-owned ones in rural areas, as a remedy for years of unfair PBM reimbursements that put them at risk of closing, pharmacists and Insurance Department officials told the Arkansas Legislative Council's Executive Subcommittee... Full

Guest Editorial | People Deserve Affordable Lifesaving Drugs

(9/19, The Tribune-Democrat) ...The Prescription Drug Affordability Board is finally moving on the task for which it was created back in 2019 – ensuring so called high-cost prescription drugs are affordable for Marylanders...The board recently selected six drugs for "cost review" that could be subject to the new procedures approved recently, which would use a variety of methods to bring down costs for medications that pose an "affordability challenge," according to the Maryland Matters story... Full

New EU Health Commissioner Will Have Full Pharma In-Tray

(9/19, Ian Schofield, Pink Sheet) ...The EU's new health commissioner is to be Hungary's Olivér Várhelyi, pending the go-ahead from the European Parliament. Among the dossiers to be overseen by the commissioner will be the EU pharma reform package, a "Critical Medicines Act" and action on tackling antimicrobial resistance. The European pharmaceutical industry body EFPIA says the agenda laid out for the new commission will require "engagement between industry partners, relevant stakeholders, member states and EU policy makers."... Sub. Req’d

UK MHRA To Retain Multiple Approval Pathways From 2025

(9/19, Ian Schofield, Pink Sheet) ...The UK medicines regulator, the MHRA, plans to continue offering new drug authorizations through numerous pathways, including national approvals, reliance routes and worksharing initiatives, when it becomes responsible for UK-wide licensing of new medicines on January 1, 2025. The agency told the Pink Sheet that its approach to assessing drug marketing applications would involve a balance of three assessment methods – national reviews, cooperative efforts with international counterparts, and reliance on overseas evaluations... Sub. Req’d

Irish Pharma Seeks Election Commitments On Innovation Investment, Clinical Trials

(9/19, Brian Maguire, Euractiv) ...Shane Ryan, General Manager for Takeda Ireland, was recently appointed as President of the Irish Pharmaceutical Healthcare Association (IPHA). Central to his presidency, Ryan has pledged a focus on partnership to create an ecosystem that values innovation and improves health outcomes for all..."Ireland does have challenges to overcome, especially in giving more patients faster access to new medicines and remaining competitive to attract the next wave of investments."... Full

AMIP, The Moroccan Pharmaceutical Industry Association, Joins IGBA

(9/19, IGBA) ...IGBA, the International Generic and Biosimilar medicines Association, representing global manufacturers of generic and biosimilar medicines, announced today that AMIP has been accepted and welcomed as a new IGBA Associate Member. AMIP is the Moroccan Pharmaceutical Industry Association, representing the most important generic and biosimilar manufacturing laboratories established in Morocco... Full

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