Tuesday, April 16, 2024

Teva Announces Final Results from the HD Cohort Study for Austedo at AAN

(4/16, The Fly) ..."90% of HD patients experience chorea, so it's important for patients to have a treatment option that not only helps address symptoms, but helps provide a positive patient experience," said Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva. "We remain committed to exploring ways to evolve the AUSTEDO treatment experience to meet the needs of the HD community, and these latest real-world data reinforce the role of the 4-week Titration Kit for AUSTEDO in empowering patients with HD chorea to find their optimal dose, adhere consistently to their treatment plan, and achieve effective outcomes."... Full

Teva Halts Digital Inhalers, Another Blow to Asthma Options

(4/15, Wendy Mondello, Allergic Living) ...Inhaler options for asthma patients will shrink further when three digitally connected inhalers are discontinued on June 1, 2024. Teva Pharmaceuticals announced in an email to patients and healthcare providers that it will stop making its Digihaler products. "It is unfortunate to hear that more asthma inhalers are being discontinued," says Kenneth Mendez, president and CEO of the nonprofit Asthma and Allergy Foundation of America..."The Teva Digihaler portfolio had offered an innovative approach to encourage adherence to treatment by integrating a digital solution with an inhaler," Mendez says... Full

Teva's Digihaler Products to Be Discontinued

(4/15, Asthma and Allergy News and Research) ...Teva Pharmaceutical Industries Ltd. plans to discontinue all its Digihaler® products sold in the U.S. on June 1. This includes: ProAir Digihaler, AirDuo Digihaler, and ArmonAir Digihaler. Both ProAir and AirDuo are available in Teva's Respiclick products – the same medicine formulations without the digital component. Teva does not offer the ArmonAir formulation in a branded alternative or generic... Full

Viatris Announces Launch of First Bioequivalent Generic Version of Copaxone® 20 mg/mL Once-Daily in Canada

(4/15, Viatris Inc.) ...Viatris Inc., a global healthcare company, today announced the launch in Canada of PrGlatiramer Acetate Injection 20 mg/mL for once-daily injection, the first generic bioequivalent version of Teva's Copaxone® 20 mg/mL, indicated for the treatment of patients with Relapsing-Remitting Multiple Sclerosis, a chronic inflammatory disease of the central nervous system... Full

Thanks to CVS, A Biosimilar Version of AbbVie's Humira is Grabbing Huge Market Share

(4/15, Ed Silverman, STAT Plus) ...On April 1, CVS Caremark, which is one of the largest pharmacy benefit managers in the U.S., removed Humira from its major national formularies for health plans that cover about 30 million lives...During the week ending March 29, the number of new prescriptions written for the biosimilar was about 640, but rose to nearly 8,300 in the week ending April 5, according to a report to investors by Evercore ISI analyst Elizabeth Anderson... Sub. Req'd

Humira Biosimilar Scripts Take Off

(4/16, Tina Reed, Axios) ...Humira biosimilars made up roughly 5% of the market as of March 29, Anderson wrote in a note. But by April 5, Humira biosimilars shares were up to 36%. "It really took a pretty dramatic step up," Anderson said...In April, Sandoz's biosimilar known as Hyrimoz contributed to roughly 93% of all new prescriptions of Humira biosimilars. CVS' Cordavis unit began to co-brand Hyrimoz with Sandoz earlier this year... Full

‘A Global Movement For More Democracy In Medicine' – Formycon Chief Talks Biosimilars Strategy

(4/15, David Wallace, Generics Bulletin) ...Characterizing biosimilars as a global movement towards the democratization of medicine, Formycon CEO Stefan Glombitza speaks to Generics Bulletin in detail about the company's recent deals, launches and key pipeline assets, in the first part of an exclusive two-part interview...Kicking off with a summary of the biosimilars developer's recent history and key assets, the chief executive then offered detail on each of the products that the firm has coming up for approval and launch... Global Sub. Full

‘I Would Love To Have All The Biologic Assets' – Formycon's Glombitza Sets Out Portfolio Approach

(4/16, David Wallace, Generics Bulletin) ...In the second part of an exclusive interview, Formycon CEO Stefan Glombitza talks to Generics Bulletin about key regulatory developments in Europe and the US, the firm's portfolio selection strategy, and upcoming milestones on the horizon. Having walked Generics Bulletin through Formycon's key portfolio and pipeline assets in the first part of his exclusive interview, the second part of the discussion saw CEO Stefan Glombitza taking a step back to discuss the German biosimilars developer's broader portfolio selection strategy in more detail... Global Sub. Full

First Off The Blocks, Fresenius Launches US Tocilizumab Biosimilar

(4/16, David Wallace, Generics Bulletin) ...As Fresenius Kabi's third approved biosimilar available in the US – after Idacio (adalimumab-aacf) and Stimufend (pegfilgrastim-fpgk) – the launch of Tyenne "contributes directly to growing Fresenius' (Bio)Pharma platform, a substantial cornerstone of the #FutureFresenius strategy," the firm declared. Fresenius group CEO Michael Sen said Tyenne's US launch represented "another important milestone in accelerating our strong (Bio)Pharma momentum. Growing this platform is a substantial cornerstone of our #FutureFresenius journey."... Global Sub. Full

Boehringer Ingelheim Leans On Late-Stage Pipeline, Plots 25 New Launches Over the Next Decade

(4/16, Zoey Becker, Fierce Pharma) ...Boehringer Ingelheim's 2023 was largely marked by the highly anticipated launch of its Cyltezo, the first interchangeable biosimilar to AbbVie's Humira. But with sales disappointing, the company is now turning its attention to a deep late-stage pipeline that could bring 25 new treatments to market through 2030. Alongside that ambitious goal, Boehringer plans to kick off 10 new phase 2 and 3 trials in the next 12-18 months, it said in its full-year earnings release... Full

J&J First-Quarter Revenue Misses as Stelara Sales Disappoint

(4/16, Bhanvi Satija, Mariam Sunny and Patrick Wingrove, Reuters) ...Johnson & Johnson reported quarterly revenue below analysts' estimates as sales from its blockbuster psoriasis drug Stelara, which is expected to face competition from biosimilar versions in some markets later this year, fell short of expectations...J&J has struck deals to delay U.S. launches of close-copy versions of Stelara until 2025, a key patent for which expired last year. Analysts have said the delayed competition will make the drug a larger contributor for J&J's 2024 and 2025 revenue than previously anticipated... Full

Korea's Celltrion, SK Biopharmaceuticals Benefit from Direct US Sales

(4/16, Jeong Min Nam, The Korea Economic Daily) ...Celltrion Inc. and SK Biopharmaceuticals Co. are witnessing their sales revenue and profitability improve by selling their products through their marketing channels instead of using local sales partners in the US market...In less than eight months of Vegzelma's launch in the US, Celltrion secured 35% of public and private subscribers to the US pharmacy benefit manager groups... Full

Eli Lilly's Nationwide Insulin Pricing Settlement Called Off

(4/15, Brendan Pierson, Reuters) ...A settlement between Eli Lilly and purchasers of its insulin drugs that would have capped prices and provided $13.5 million to resolve claims that the company inflated the drugs' cost has fallen apart, after an unfavorable ruling from the judge overseeing the case... Full

Mylan Investors Get Swift Rebuff in EpiPen, Drug Pricing Appeal

(4/15, Martina Barash, Bloomberg Law) ...The lower court found that the investors lacked proof of deceptive intent by the pharmaceutical company and its executives in statements about the EpiPen's rebate classification, the appeals court said in an unsigned, unpublished decision. The panel rejected the investors' argument that the judge's finding on intent didn't apply to those statements... Sub. Req'd

Smart Sensor Cleared for Use with AZ Asthma, COPD Inhalers

(4/16, Phil Tayler, Pharma Phorum) ...A high-tech device that can monitor medication use and compliance has been cleared by the FDA for use with AstraZeneca's Airsupra and Breztri inhalers...The Hailie Smartinhaler device has also been cleared for use with inhalers from other manufacturers, including GSK, Boehringer Ingelheim, and Teva, and Adherium also sells the device directly to patients with asthma and COPD under a 510(k) over-the-counter clearance... Full

Sanders Presses For Lower Semaglutide Drug Prices, Novo Nordisk Responds

(4/15, Maaisha Osman, InsideHealthPolicy) ...Senate health committee Chair Bernie Sanders (I-VT) is pressing pharmaceutical company Novo Nordisk to lower prices of its blockbuster semaglutide drugs Ozempic and Wegovy, claiming Medicare will go bankrupt if the prices of the diabetes and obesity drugs are not lowered. Novo Nordisk tells Inside Health Policy that the public debate doesn't consider the "complex reality" of developing these medications, but it remains committed to making these medications affordable to patients... Sub. Req'd

In Toledo, Brown Fights to Lower Cost of Insulin

(4/15, U.S. Senator For Ohio Sherrod Brown) ...Today, U.S. Senator Sherrod Brown (D-OH) joined Doni Miller, CEO of Neighborhood Health Association, Gregory Kramp, Pharmacist at Neighborhood Health Association, as well as Ohioan Terry Hinkle to discuss his fight to lower insulin prices for Ohioans. During the event, Brown highlighted how the $35 monthly cap on the cost of insulin, made possible by the Inflation Reduction Act that Brown helped write and pass, has helped lower costs for Ohioans on Medicare. He also discussed his continuing push to cap the price of insulin at $35 for all Americans... Full

Chuck Schumer's Broken Promise On Affordable Insulin

(4/16, Rachel Cohrs Zhang, STAT Plus) ...Democrats have achieved piecemeal progress in making insulin more affordable for millions of people during President Biden's more than three years in office, but they've yet to do so for everyone. And despite Schumer's repeated promises to hold a vote on whether to expand cost protections to people with all types of insurance, he hasn't done it... Sub. Req'd

PhRMA Defends Standing Before Fifth Circuit in Drug Price Battle

(4/15, Nyah Phengsitthy, Bloomberg Law) ...The Pharmaceutical Research and Manufacturers of America, along with plaintiffs National Infusion Center Association and Global Colon Cancer Association, are asking the US Court of Appeals for the Fifth Circuit to reverse a lower court decision in its case against the Medicare drug price negotiation program..."Plaintiffs challenge the constitutionality of provisions outside the Medicare subchapter and do not seek ‘to recover on any claim arising under' that statute," PhRMA said... Sub. Req'd

MedPAC Wrestles With Wide Variation in Generic Rx Prices, Availability

(4/15, Cheryl Clark, MedPage Today) ...From a document developed by MedPAC staff, commissioners learned that the price of a generic Part D drug was based on the cost of the ingredients, a dispensing fee, and a pharmacy fee, which pharmacies pay to the plan sponsor but are not public, although they are reported to the Centers for Medicare & Medicaid Services. However, there are many other elements that influence the price at the point of sale, and much of it is unknown... Full

Chinese Company Under Congressional Scrutiny Makes Key U.S. Drugs

(4/15, Christina Jewett, The New York Times) ...A New York Times review of hundreds of pages of records worldwide shows that WuXi is heavily embedded in the U.S. medicine chest, making some or all of the main ingredients for multibillion-dollar therapies that are highly sought to treat cancers like some types of leukemia and lymphoma as well as obesity and H.I.V. The Congressional spotlight on the company has rattled the pharmaceutical industry, which is already struggling with widespread drug shortages now at a 20-year high... Full

Americans Are Paying Billions to Take Drugs That Don't Work

(4/15, Robert Langreth, Fiona Rutherford and Tanaz Meghjani, Bloomberg) ...One ALS drug made $400 million in sales for its maker. It doesn't work. A cancer treatment brought in $500 million. That one turned out to have no effect on survival. A blood cancer medication made nearly $850 million before being withdrawn for two of its uses. That drug had been linked to patient deaths years prior. All of them were allowed to be sold to Americans because of the US Food and Drug Administration's drive to get new drugs to patients quickly — sometimes even before they're done testing... Sub. Req'd

FDA is Ready to Eliminate the Interchangeability Designation for Biosimilars

(4/15, Zachary Brennan, Endpoints News) ...As part of efforts to level the playing field between biologics and biosimilars, the FDA is calling on Congress to remove the interchangeability designation for biosimilars, claiming that the two-tier system is only causing confusion...Sarah Yim, director of the FDA's Office of Therapeutic Biologics and Biosimilars, said in an interview with Endpoints News that having two separate classes of biosimilars has been "confusing people for a long time."...Instead, Yim said the FDA wants to make all biosimilars interchangeable with a legislative proposal that would eliminate the statutory distinction between biosimilars and interchangeables... Full

Patent Office Issues Proposed Rule For Rarely Successful Director Review Requests

(4/15, Sarah Karlin-Smith, Pink Sheet) ...A new proposed rule describes when and how parties can request Director Reviews of the US Patent and Trademark Office's Patent Trial and Appeal Board proceedings, as well as when the PTO Director may initiate a review, but still highlights the rareness of success using the process... Sub. Req'd

FDA To Hold Financial Transparency Meeting For User Fee Programs

(4/15, Jessica Karins, InsideHealthPolicy) ...FDA is planning to hold a public meeting on financial transparency and efficiency of the prescription drug, generic drug and biosimilar user fee programs in June, and is soliciting public comments ahead of the event on topics addressed in the programs' commitment letters...FDA staff will present on the five-year plan for each of the three user fee programs and the agency's progress on implementing resource capacity planning as part of the fee setting, as well as modernizing time reporting... Sub. Req'd

FDA Aims for Greater Use of Remote Assessments for Low-Risk Facilities

(4/15, Joanne S. Eglovitch, Regulatory Focus) ...The US Food and Drug Administration has conducted more than 20 remote regulatory assessments of manufacturing facilities through its preapproval inspection program and hopes to use this remote method more for assessing low-risk facilities, said Derek Smith, deputy director of the Office of Pharmaceutical Manufacturing Assessment in the Office of Pharmaceutical Quality at the April 11, Generic Drug Forum, which was held virtually and onsite in Bethesda, MD... Full

New FDA Trial Innovation Center Launches with Demonstration to Increase Industry Interactions

(4/15, Lia DeGroot, Endpoints News) ...The new Center for Clinical Trial Innovation (C3TI) will focus on implementing lessons already gleaned from CDER's work in the area and will give clinical trial sponsors additional access to staff to discuss trial designs. Specifically, the new hub will focus on keeping sponsors up to speed with current innovations, bolstering trial participant diversity, and improving clinical trial data... Full

GAO Examines State PBM Regulation as Congress Weighs Wider Reforms

(4/15, Lia DeGroot, Endpoints News) ...Looking at five states that have enacted substantial PBM reforms — Arkansas, California, Louisiana, Maine, and New York — the GAO interviewed each state's health plan association, pharmacy association and regulators to glean information on how the reforms were implemented. The report found that four out of the five states preferred granting regulators broad authority to regulate PBMs over specific statutory requirements, with one state saying that it allowed them to more quickly respond to issues as they come up... Full

Pharmacy Middlemen Need Robust Oversight, States Tell GAO

(4/15, Celine Castronuovo, Bloomberg Law) ...This year, more than 160 bills to impose PBM regulations have been introduced in 41 states, according to the National Academy for State Health Policy...Greg Lopes, vice president of public affairs and communications for PCMA, said in an emailed statement that pharmaceutical companies have helped fuel the push to regulate the PBM industry, and that state PBM laws "ultimately only result in higher drug costs for employers and patients... Sub. Req'd

Generic Drug Group Defends Pause On Minnesota Pricing Law

(4/15, Celine Castronuovo, Bloomberg Law) ...The US District Court for the District of Minnesota "applied binding precedent to hold that the Minnesota law violates the dormant Commerce Clause when it directly regulates prices charged in wholly out-of-state transactions," the Association for Accessible Medicines wrote in a brief filed April 12 in the US Court of Appeals for the Eighth Circuit...AAM said in its filing that Ellison doesn't dispute that the Minnesota drug pricing law "directly regulates out-of-state transactions." ... Sub. Req'd

EMA Releases Guidance On How & When Its RWE Generation Service Can Be Used

(4/15, Eliza Slawther, Pink Sheet) ...New EU guidance outlines the process through which scientific committees, national competent authorities and other relevant decision-makers can request real-world evidence studies for regulatory purposes...While companies themselves can generate RWE by conducting studies, the EMA also provides an evidence generation service based on requests from specific groups such as its own scientific committees and national competent authorities... Sub. Req'd

UK Explains New Rules On Parallel Imports From EU

(4/15, Ian Schofield, Pink Sheet) ...The UK has issued further guidance for companies wishing to parallel import medicines from the EU to the UK from January 2025, including rules on the "UK-only" label requirement and when companies can begin making updates to their labeling and packaging. Under the UK's post-Brexit licensing scheme, medicines approved in a member state of the EU or European Economic Area can be parallel imported into the UK "as long as the imported product has no therapeutic difference from the cross-referenced UK product," according to the UK regulatory agency, the MHRA... Sub. Req'd

Reuters Pharma Europe 2024 – Day One

(4/16, Eloise McLennan, Pharma Phorum) ...Alongside technology giants, including Microsoft and AWS, we'll hear from executives at Bayer, Johnson & Johnson, Novartis, and Novo Nordisk, to name but a few, as industry experts discuss some of the leading trends, challenges, and future forecasts in pharma. From revitalising Europe's pharmaceutical landscape to unlocking the promise of today's "golden age for medicine" -– the first day of Reuters Pharma Europe 2024 is sure to provide insightful and thought-provoking discussions across a variety of industry topics... Full

Mabwell Snaps Up China-First Approval For Xgeva Biosimilar

(4/15, Adam Zamecnik, Generics Bulletin) ...Mabwell has scored a country-wide first as China's National Medical Products Administration approved its 120mg biosimilar to Amgen's Xgeva (denosumab) for use in the nation. Marketed under the name Maiweijian, the product will tap into the lucrative denosumab market, where several companies pursue a potential approval. Specifically, Maiweijian will serve as a biosimilar to Xgeva and its indications, rather than Prolia, which is a separate brand name for the drug in differing indications... Global Sub. Full

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