Thursday, December 12, 2024

Teva Announces New Patient Access Program with Direct Relief

(12/11, The Fly) ...Teva will make two inhaler products available through this program: generic versions of the AirDuo RespiClick and ProAir HFA. Teva will donate the inhalers to Direct Relief for distribution by request to free & charitable clinics, to then be dispensed to uninsured patients served by these clinics. The program will continue for a minimum of three years to ensure reliable and continuous supply to these patients... Full

Grünenthal Reaches Settlement with Teva in US Patent Litigation

(12/11, Grünenthal GmbH) ...Grünenthal GmbH, a pharmaceutical company specialized in treatment of pain, today announced that Grünenthal has entered into a settlement agreement with Teva Pharmaceuticals, Inc. resolving their patent litigation in the U.S. in response to Teva's Abbreviated New Drug Application seeking approval by the US. Food and Drug Administration to market a generic version of Nucynta® ER (tapentadol)...Under the terms of the settlement agreement, Teva cannot sell a generic version of Nucynta® ER in the U.S. until July 1, 2027 (subject to U.S. FDA approval) or earlier under certain circumstances... Full

Hikma and Richter Announce FDA Submission Acceptance for Denosumab Biosimilar Products

(12/12, Hikma) ...Gedeon Richter Plc. and Hikma Pharmaceuticals PLC today announced that the U.S. Food and Drug Administration had accepted for review the Biologics License Applications for RGB-14, a Denosumab biosimilar candidate comprising two biosimilar products referencing Prolia® and Xgeva®, a human monoclonal antibody for the treatment of osteoporosis and fractures due to bone metastasis... Full

Rosemont And Hyloris Agree US Tie-Up On Valacyclovir

(12/12, Dave Wallace, Generics Bulletin) ...Under the terms of the exclusive license and supply agreement, Hyloris will handle US registration and supply of valacyclovir oral suspension, while Rosemont will be responsible for commercialization. Hyloris "will receive milestone payments and royalties from US product sales, in line with its strategic objectives."... Global Sub. Full

Regeneron Disputes Sandoz's Eylea Patent-Misconduct Allegations

(12/11, Christopher Yasiejko, Bloomberg Law) ...Regeneron Pharmaceuticals Inc. urged a West Virginia federal judge to dismiss Sandoz Group AG's claims it misled the US Patent and Trademark Office during the Eylea patent-application process... Sub. Req’d

The FDA Hasn't Inspected This Drug Factory After 7 Recalls for the Same Flaw, 1 Potentially Deadly

(12/12, Patricia Callahan, Debbie Cenziper and Megan Rose, ProPublica) ...The FDA's anemic response underscores longstanding weaknesses in the way the agency oversees the safety of generic medications manufactured in foreign factories. The agency failed to act on clear patterns of trouble, was slow to warn the public about the potentially deadly pills and never mentioned that millions of them had been sold to consumers... Full

Sandoz Charts Path to Swift Generic Ozempic Launch in Canada

(12/11, Paula Doenecke and Naomi Kresge, Bloomberg) ...The Swiss drugmaker is betting that the existing generation of GLP-1 weight-loss drugs will stay in demand — and that generics will prove popular given the hefty price tags of the branded products — even as Novo and US rival Eli Lilly & Co. push forward with more powerful contenders. Sandoz is investing in production to be one of the first sellers of a reliable generic version of semaglutide, the main ingredient in Ozempic, for diabetes in Canada, one of the few countries where it can be sold, according to Chief Executive Officer Richard Saynor... Full

Gland Pharma Gets US FDA Approval for Vitamin K Deficiency Injectable

(12/11, Jomy Jos Pullokaran, CNBC TV-18) ...Drug firm Gland Pharma Ltd on Wednesday (December 11) said it has received the approval of the United States Food and Drug Administration for phytonadione injectable emulsion USP, 10 mg/mL single dose ampoules...The company expects to launch this product through its marketing partners in the near future. According to IQVIA, the product had US sales of approximately $15 million for the 12 months ending September 2024... Full

Henlius Files Chinese Application For Perjeta Biosimilar

(12/11, Adam Zamecnik, Generics Bulletin) ...China's National Medical Products Administration has accepted the filing for Shanghai Henlius Biotech's Perjeta (pertuzumab) biosimilar HLX11 several months after the announcement of positive results from a late-stage clinical trial...US filing for HLX11 in the second half of this year, no news has yet been revealed of this submission. Although the companies' Perjeta rival still has a few years to commercialization, Organon is also moving further with the regulatory journey of HLX14... Global Sub. Full

Lonza Streamlines Business With Capsules Unit Exit

(12/12, Andrea Figueras, The Wall Street Journal) ...Lonza said it will focus on its core business including drug development, with restructuring and a divestment planned to boost growth. As part of the review, the Swiss life-science company said it will exit the capsules and health-ingredients business and outline next steps in the coming year. It will keep its CDMO division providing drug development and manufacturing to other pharmaceutical companies, but simplify its setup. The new structure is set to be operational from the second quarter of next year, it said Thursday... Sub. Req’d

Stada Said to Sound Out Investors Ahead of €1.5 Billion-Plus IPO

(12/11, Pablo Mayo Cerqueiro, Swetha Gopinath and Manuel Baigorri, Bloomberg) ...Stada Arzneimittel AG is sounding out investors for its initial public offering that could potentially raise around €1.5 billion ($1.6 billion) of fresh capital for the consumer health-focused drugmaker, people familiar with the matter said... Full

Review Confirms Clinical Safety of Sandoz Denosumab Biosimilar vs Originator

(12/11, Skylar Jeremias, The Center For Biosimilars) ...Sandoz's biosimilar denosumab (Jubbonti/Wyost; denosumab-bddz) has demonstrated analytical, pharmacokinetic (PK), pharmacodynamic (PD), and clinical equivalence to the reference denosumab (Prolia/Xgeva), justifying its approval and extrapolation to all indications, according to a study published in Clinical Therapeutics... Full

The Brain is Eli Lilly's Next Target for its Obesity Meds

(12/11, Max Bayer, Endpoints News) ...On Tuesday, Ricks said the Indianapolis-based company will begin large studies in alcohol and drug abuse next year, looking to validate existing research that suggests a potential benefit from the obesity drugs...And on Wednesday, Laura Fernandez Lando, Lilly's US medical advisor for the diabetes therapeutic area, said during an investor briefing that the company was "truly considering" assessing the incretin portfolio in brain health, including cognitive disorders. Lilly is one of two companies with a marketed treatment for the underlying cause of Alzheimer's... Full

Lilly to Offer Single-Dose Vials of Weight-Loss Drug On Telehealth Platform Ro

(12/11, Sneha K, Reuters) ...Telehealth company Ro said on Wednesday it will offer single-dose vials of Eli Lilly's weight-loss drug Zepbound to patients with obesity, becoming the first alternative platform for the lower-cost version of the drug to Lilly's own website...The 2.5 milligram and 5 mg vials, the lowest doses of the drug cost $399 and $549, respectively, for a month's supply on Lilly's website. The vials are available for the same price through Ro, the telehealth firm said... Full

Dose De-Escalation of Humira and Stelara Generates Significant Savings

(12/11, Peter Wehrwein, Managed Healthcare Executive) ...Dialing back doses of the two biologics saved $13.2 million over three years, researchers report at an American Society of Health-System Pharmacists meeting. A dose de-escalation program targeting Humira (adalimumab) and Stelara (ustekinumab) saved more than $86,000 per successful intervention, according to research findings presented today at the American Society of Health-System Pharmacists 2024 Midyear Clinical Meeting in New Orleans... Full

Health Execs Reckon with Patient Outrage After UnitedHealthcare Killing

(12/11, Michele Gershberg, Michael Erman, Reuters) ...Health care companies are taking a step back to better understand patients' experiences after a powerful U.S. health insurance executive was murdered last week, executives from drugmaker Pfizer and Amazon.com said at a panel at the Reuters NEXT conference in New York on Wednesday..."I think all of us are taking a step back and trying to understand what's happening with patients and their experiences," Pfizer Chief Sustainability Officer Caroline Roan said... Full

ADHD Diagnosis in Older People Has Increased

(12/11, Christina Caron, The New York Times) ...An analysis by Truveta, a health care data and analytics company, shows that the rate of first-time A.D.H.D. diagnoses has been on the rise since 2021, but the increase has occurred only among people 30 and older. From January 2021 to October 2024, the rate of first-time diagnoses rose about 61 percent among those ages 30 to 44 and 64 percent among those ages 45 to 64... Sub. Req’d

Lawmakers Plot to Force Health Insurers to Sell Off Pharmacies

(12/11, Liz Essley Whyte and Joseph Walker, The Wall Street Journal) ...A Senate bill, sponsored by Sens. Elizabeth Warren (D., Mass.) and Josh Hawley (R., Mo.), would force the companies that own health insurers or pharmacy-benefit managers to divest their pharmacy businesses within three years. A companion bill, which sponsors say draws on a history of government prohibitions on joint ownership within industries, was also scheduled to be introduced in the House on Wednesday... Sub. Req’d

Wall Street Wags Say a Bill to Force Insurers or PBMs to Sell Pharmacies Has Low Odds

(12/11, Ed Silverman, STAT Plus) ...Shares in each of those three insurers were down substantially in midday trading on Wednesday. That said, Wall Street watchers believe the lower stock prices are an overreaction. Although the insurers are a juicy target, various factors suggest the bill is far from a sure bet, given the upcoming change in administrations. Securities analysts believe other legislative priorities will get more attention, despite a focus on health care matters more broadly. So here is what the wags are saying... Sub. Req’d

PCMA Statement On Hawley-Warren Legislation

(12/11, PCMA) ..."It's important at this time to take a step back from the rhetoric around health care and recognize that PBMs exist to serve patients by enabling employers and others to offer benefits. Whether it's through negotiations to lower costs, partnerships with pharmacies, or clinical care programs, our value is in helping patients access affordable prescription drugs..."... Full

Pharma's ‘Middleman' Message Still Resonates With Trump

(12/11, Michael McCaughan, Pink Sheet) ...Just like at the start of his first term, pharma industry CEOs met with Donald Trump to convey their willingness to work with him, with mixed results. Trump appeared to accept the industry message about pharmacy benefit managers causing drug prices to remain high. But Trump still harbors questions about vaccines, and said industry will be working with his expected HHS Secretary nominee Robert F. Kennedy Jr... Global Sub. Full

Trump FTC Chair Pick May Redirect PBM Enforcement Efforts, Not Deter Them

(12/11, Gabrielle Wanneh, InsideHealthPolicy) ...Andrew Ferguson, President-elect Donald Trump's pick to chair the Federal Trade Commission (FTC), offered no mention of his plans for ongoing enforcement efforts against deceptive or anticompetitive pharmacy benefit manager business practices in his recent pitch to chair the commission, but he did call for FTC to be selective in its anti-merger efforts and previously abstained from voting for FTC to release a controversial interim report blasting PBMs in July... Sub. Req’d

CRFB Urges Trump To Scrap CMS Obesity Rule, Musk Says Lower Drugs' Cost

(12/11, Luke Zarzecki, InsideHealthPolicy) ...GLP-1s have widely been expected to be part of the next round of Medicare price negotiations, and President-elect Donald Trump's CMS faces a Feb. 1 deadline to publish the list. Elon Musk, who will help lead Trump's Department of Government Efficiency, posted on Wednesday (Dec. 11) on X, previously known as Twitter, lowering the costs of the medicines will help patients. "Nothing would do more to improve the health, lifespan and quality of life for Americans than making GLP inhibitors super low cost to the public," he wrote. "Nothing else is even close."... Sub. Req’d

Biden Officials Take Credit for ‘Largest Drop' in Overdose Deaths. Experts Are More Cautious

(12/11, Lev Facher, STAT) ...On Wednesday, to the surprise of some experts, Biden administration officials sought to take credit for the decrease. The officials said the White House's efforts to distribute naloxone have helped to reverse 500,000 overdoses and attributed the overall improvement to increased availability of addiction treatment medications and harm-reduction services like test strips used to detect fentanyl or xylazine...While experts celebrate the sudden decrease in deaths, they have done so cautiously. It remains unclear not only which factors have contributed to the decline, but also whether they're the result of government interventions or forces outside the Biden administration's control... Full

Congress Should Pass Legislation to End the Shenanigans That Allow Brand-Name Drug Manufacturers to Delay Generic Competition and Charge Higher Prices for Longer Periods

(12/11, John Murphy III, AAM) ...Congress needs to act now to clarify and codify the FDA's authority to disclose Q1/Q2 sameness information to generic drug manufacturers, and to avert a legal challenge to the FDA's current regulations and process that could further slow generic drug access and availability. Absent clarity from Congress, generic drug approval deadlines may be delayed even further, and U.S. patients may have to wait longer and pay more for drug products that are poised for lower-cost generic competition... Full

After a Hiatus, the BLOCKING Act is Back!

(12/11, Kurt R. Karst, FDA Law Blog) ...Based on what we've heard from the talk on Capitol Hill, the latest version of the BLOCKING Act that is poised for introduction in Congress within the next few days is the same language proposed for inclusion in the never-passed "Food and Drug Administration Safety and Landmark Advancements Act of 2022."...More ANDA approvals does not necessarily translate into more launches. Over time, a new exclusivity regime for Paragraph IV ANDAs may mean fewer ANDA approvals and launches. And that ultimately means more drug shortages of critical medicines, fewer choices for consumers, and higher costs to the U.S. healthcare system... Full

Using the Inflation Reduction Act to Rein in Patenting & Evergreening Abuses

(12/11, Jishian Ravinthiran, Public Citizen) ...The Inflation Reduction Act provides the government a powerful tool to remedy the harms and exploitation of American patients by the pharmaceutical industry. We urge CMS to account for unfair monopoly extensions that exact huge financial tolls on patients and Medicare in arriving at maximum fair prices for enrollees during the negotiation process... Full

Drugs Are Approved — And Made Available — Faster in US Than Most of EU, Data Show

(12/11, Nicole DeFeudis, Endpoints News) ...New drugs in the US were, on average, approved months before winning approval in the EU, according to new data from The IQVIA Institute for Human Data Science. The difference can be attributed in part to faster US review and the use of expedited review programs, according to IQVIA's latest report. The data highlight several challenges to bringing new medicines to market in the EU, as the European Medicines Agency looks to speed up its review process... Full

Pharmaceutical Groups Say More Slots Needed for Joint Scientific Consultations

(12/11, Joanne S. Eglovitch, Regulatory Focus) ...EU pharmaceutical industry groups said the demand for joint scientific consultation (JSC) meetings is exceeding the number of meetings scheduled for next year. These meetings focus on discussing the design of clinical trials and plans for evidence generation regarding new medicines and are part of the joint clinical assessment (JCA) process under the health technology assessment (HTA) regulation... Full

Denmark's AMGROS Sees Surge in Alternative Pricing Proposals, But Few Make the Cut

(12/11, Pink Sheet) ...Interest in alternative pricing agreements in Denmark is growing, but the number of proposals accepted by AMGROS, the Danish procurement body for hospitals, is relatively small, according to the organization's own figures. Alternative agreements are aimed at helping new, expensive and innovative medicines reach patients using mechanisms other than flat discounts, according to AMGROS. For example, they may involve risk sharing or the gathering of further data where there is uncertainty over the extent of the product's benefits... Global Sub. Full

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