Tuesday, October 1, 2024

French Fine 11 Firms For Failure To Meet Stock Obligations

(9/30, Ian Schofield, Pink Sheet) ...The French regulator, ANSM, has imposed fines totaling almost €8m ($9m) on 11 pharmaceutical companies for failing to meet their obligations to hold a minimum of four months' stock of certain medicines of "major therapeutic interest" (MMTIs)...The 11 companies fined by ANSM this year are Arrow Génériques, Biogaran, GSK, Leo, Medac, Provepharm, Sandoz, Sanofi Winthrop Industrie, Teva Santé, Viatris Santé and Zentiva France. The penalties were imposed following discussions with the companies concerned, ANSM said, adding that they would have six months to bring their stocks up to the required levels... Global Sub. Full

Organon And Henlius Advance Perjeta Biosimilar

(10/1 David Wallace, Generics Bulletin) ...Organon and Shanghai Henlius Biotech have reported positive progress on their partnered HLX11 proposed biosimilar to Perjeta (pertuzumab), with the candidate meeting the primary endpoint in a Phase III trial... Global Sub. Full

Iconovo Gets Positive FDA Verdict On Ellipta Substitution

(10/2, Adam Zamecnik, Generics Bulletin) ...The US Food and Drug Administration has given a positive nod to the potential generic submission and substitutability of Iconovo's proprietary inhaler ICOpre with the original drug Breo Ellipta (fluticasone furoate/vilanterol), boosting the company's hopes for launching the first generic rival to the product... Global Sub. Full

Biocon Targets GLP-1s In MENA With Tabuk Tie-Up

(9/30, David Wallace, Generics Bulletin) ...Biocon has struck a deal with Saudi firm Tabuk Pharmaceutical Manufacturing Company that will see the Indian company's GLP-1 diabetes and chronic weight management products commercialized by Tabuk in "select countries" in the Middle East. The agreements builds on an existing alliance between Biocon and Tabuk for generics, struck back in 2021 (see sidebar), which Biocon said at the time would pave the way for its expansion into the Middle East and North Africa region... Global Sub. Full

Roche Seeks to Project Confidence On its Obesity Drugs — And Sees Room to Make its Mark

(9/30, Andrew Joseph, STAT Plus) ...Several analysts asked Roche executives if they would add an obesity candidate targeting the amylin hormone to its pipeline. Maybe, if it made sense, was effectively the answer. Roche projected confidence in the future of its drugs, however...Roche executives faced questions about other kinds of assets from analysts on Monday, including the anti-TL1A antibody that it picked up last year as part of a $7.1 billion deal for Telavant Holdings. It is currently testing it in ulcerative colitis and Crohn's disease, a sign of Roche's — as well as the whole pharma industry's — growing interest in immunology... Sub. Req’d

Metsera Partners with Amneal to Manufacture Obesity Drugs, and Clive Meanwell Hands Over CEO Role

(10/1, Kyle LaHucik, Endpoints News) ...On Tuesday, the well-funded startup announced that it would bring on specialty pharmaceutical and generics manufacturer Amneal to produce its obesity and metabolic disease drugs...Bridgewater, NJ-based Amneal will use its current manufacturing network and will build two new facilities in India to help make Metsera‘s injectable and oral drugs, including GLP-1 agonists and amylin receptor agonists, the companies said Tuesday morning... Full

Stelara Biosimilar Nods Arrive In US And EU For Fresenius And Formycon

(9/30, David Wallace, Generics Bulletin) ...Fresenius and Formycon have celebrated simultaneous US and EU approvals for the firms' partnered Otulfi ustekinumab rival to Stelara. And with competing biosimilars already available on the European market, all eyes will soon be on US launches at the start of 2025, with Fresenius providing a significant update on launch timing... Global Sub. Full

Sun Pharma Signs Licensing Pact with Philogen for Cancer Medication

(10/1, Press Trust Of India) ...As per the agreement, Sun Pharma will have the exclusive worldwide rights to commercialise Fibromun, a speciality product of Philogen...As per the pact, Philogen will complete the ongoing pivotal clinical trials for the product, pursue marketing authorisation with regulatory authorities, and manufacture commercial supplies, the Mumbai-based drug major said in a statement... Full

Biohaven Initiates Pivotal Trial of Novel Investigational Drug for Treatment of Migraine

(9/30, Biohaven) ...Biohaven initiated a pivotal Phase 2 trial evaluating BHV-2100 in the acute treatment of migraine. BHV-2100 is a potential first-in-class, potent, orally administered Transient Receptor Potential Melastatin-3 (TRPM3) antagonist— a novel, highly selective, and non-opioid investigational treatment being developed for migraine and other pain disorders... Full

Board of Ipca Laboratories Approves Consolidation of USA Generic Formulations Biz

(9/30, Business Standard) ...The Board of Ipca Laboratories at its meeting held on September 30, 2024 has approved entering into the following agreements by Bayshore Pharmaceuticals LLC, USA (Bayshore) (wholly-owned step down subsidiary) with Unichem Laboratories (Unichem India) (subsidiary company) and Unichem Pharmaceuticals (USA) Inc (Unichem USA) (wholly owned subsidiary of Unichem India), so as to integrate and consolidate all the Ipca Group's USA generic formulations business under one entity... Full

Biocon Pushes to Unseal Amgen Eylea Court Filings Before Appeal

(9/30, Christopher Yasiejko, Bloomberg Law) ...Amgen Inc. is "stonewalling" public access to information about its successful avoidance of Regeneron Pharmaceuticals Inc.'s bid to block its biosimilar of the blockbuster eye drug Eylea, two competitors said in a filing urging a judge to release a trove of sealed documents in the case... Sub. Req’d

Bristol Myers Beats $6.4 Billion Lawsuit Over Delayed Cancer Drug

(9/30, Jonathan Stempel, Reuters) ...Bristol Myers Squibb won the dismissal on Monday of a $6.4 billion lawsuit claiming it cheated former Celgene shareholders by delaying federal approval for the cancer drug Breyanzi and two other drugs developed by Celgene... Full

Buyers, Health Plans Achieve Class Status in Diabetes Drug Suit

(9/30, Katie Arcieri, Bloomberg Law) ...Judge Ronnie Abrams of the US District Court for the Southern District of New York in a Monday opinion adopted a magistrate judge's report and recommendation to grant class certification to both groups of plaintiffs, allowing the case to move forward. Abrams said Takeda's objections to the certifications were "meritless" and that she found no clear errors in the Aug. 9 report by Magistrate Judge Stewart Aaron... Sub. Req’d

Renaissance Supports Launch of First Nasal Spray for Anaphylaxis

(9/30, Contract Pharma) ...Renaissance Lakewood, LLC, a global CDMO, is manufacturing neffy, which is now commercially available in the U.S. The FDA approved ARS Pharmaceutical's new drug application for neffy 2mg (epinephrine nasal spray) in August, becoming the first and only needle-free, intranasal spray treatment for Type I allergic reactions, including anaphylaxis in adults and children... Full

Biosimilars Often Reduce Prices by 50 Percent or More

(10/1, Wayne Winegarden, PRI) ...In the competitive biologic markets, biosimilars have reduced average prices by 56 percent. The lower prices have reduced total expenditures by 51 percent in the competitive biologic markets even though total use is higher. Developing biosimilars is a long and costly endeavor that can take up to 9 years and $300 million. Market conditions should encourage uptake and appropriate reimbursement for physicians and manufacturers... Full

Exclusive: CVS Explores Options Including Potential Break-Up, Sources Say

(10/1, Anirban Sen, Reuters) ...CVS Health is exploring options that could include a break-up of the company to separate its retail and insurance units, as the struggling healthcare services company looks to turn around its fortunes amid pressure from investors, people familiar with the matter told Reuters... Full

The Global Threat of Antibiotic Resistance

(9/26, Andrew Jacobs, The New York Times) ...For more than a decade, antimicrobial resistance has been framed as a problem of excess. The willy-nilly consumption of antibiotics, scientists said, has rendered the drugs less effective, leading to the unnecessary death of millions, many of them poor. But as global health officials gathered at the United Nations on Thursday to discuss the challenges posed by antimicrobial resistance, many have been promoting a more expansive understanding of the problem... Full

Hurricane Sends New Shudders Through Health Supply Chain

(10/1, Tina Reed, Axios) ...The already fragile medical supply chain is facing more stress this week, after Hurricane Helene ravaged a huge Baxter International plant in North Carolina that makes IV fluids for many U.S. hospitals...While the damage hasn't been totaled up, and the company says it's lining up backup plants and making other contingencies, the closure of the flooded facility threatens to upend such basics as intravenous dialysis care and complicate the federal disaster response... Full

U.S. Lawmaker Urges FDA to Clarify Drug Patent Listings in a Key Government Registry

(10/1, Ed Silverman, STAT Plus) ...In a letter dated Monday, Sen. Bill Cassidy (R-La.) accused the FDA of failing to take responsibility for an issue that has long vexed a growing number of people over the implications for the availability of lower-cost generics. The reason is that the registry holds a key, behind-the-scenes role in shaping the competitive landscape of the pharmaceutical industry... Sub. Req’d

Legislative Patent Reform Efforts Come Up Short – Yet Again

(10/1, Michael Rosen, AEI) ...As I've detailed in this space, the thus-far quixotic efforts of lawmakers—led chiefly by the bipartisan tag-team of Senators Chris Coons (D-Delaware) and Thom Tillis (R-North Carolina)—to amend the patent statute to bring the system into balance have frequently come up short... Full

Medicare Imposes Savings On 54 Drugs Exceeding Inflation Rate

(9/30, Nyah Phengsitthy, Bloomberg Law) ...Drugmakers Johnson & Johnson, Bristol Myers Squibb Co., and Amgen could be forced to pay rebates to Medicare if they raise the price of their drugs to treat cancer, osteoporosis, and more faster than inflation beginning in October. The US Department of Health and Human Services on Monday announced that some Medicare enrollees will pay a lower coinsurance rate for 54 drugs administered in doctor's offices and hospitals between Oct. 1 and Dec. 31... Full

U.S. Rep. Lloyd Doggett Pushes for Generic Wegovy, Ozempic to Lessen Costs

(9/30, Nicole Villalpando, Austin American-Statesman) ...Last week U.S. Rep. Lloyd Doggett, D-Austin, and U.S. Sen. Elizabeth Warren, D-Mass., sent a letter to U.S. Secretary of Health and Human Services Xavier Becerra asking him to allow for generic licenses for semaglutide medications, sold under the brand names Ozempic and Wegovy by pharmaceutical company Novo Nordisk... Full

How Minnesota Figures Into the Presidential Politics of Insulin Prices

(10/1, Bram Sable-Smith, KFF Health News) ...Both former President Donald Trump and Vice President Kamala Harris and her running mate, Walz, have sought to appeal to the nation's 8.4 million insulin users and their families by touting policies that make insulin cheaper for some patients. But advocates for diabetes patients fret that neither presidential candidate would go as far as Walz's Minnesota law, which helps patients even if they are uninsured, despite the law being under legal attack by the drug industry... Full

J&J Backs Off 340B Rebate Policy, Evades Sanctions And Ejection From Program

(9/30, Gabrielle Wanneh, InsideHealthPolicy) ...Johnson & Johnson informed HHS Monday (Sept. 30) it will put on hold its controversial new policy to start using rebates instead of up-front discounts for 340B drugs it supplies to disproportionate share hospitals, a J&J spokesman told Inside Drug Pricing, coming after HHS' Health Resources and Services Administration on Friday threatened to kick J&J out of the 340B drug discount program unless it backed off the rebate policy by today. The spokesperson said the drug company hopes to continue discussing new 340B approaches with HRSA... Sub. Req’d

J&J Drops Plan to Dispense Discounted Drugs Through Rebate Model

(9/30, Nyah Phengsitthy, Bloomberg Law) ..."J&J is proud of its strong and unwavering commitment to its patients," the company wrote. "Due to HRSA's unwarranted threats of excessive and unlawful penalties, J&J has no choice but to forgo implementation of the Rebate Model pending resolution of these issues." A J&J spokesperson said the company will "continue to constructively engage with HRSA, and all stakeholders, to explore solutions to modernize the 340B Program with more transparency, accountability, and oversight."... Full

Survey: 89 Percent of Older Americans Took Prescriptions in Prior Year

(9/30, Hannah Docter-Loeb, The Washington Post) ...Nearly 90 percent of adults over 65 took prescription medication in the previous 12 months in 2021 and 2022, according to a recent report by the Centers for Disease Control and Prevention...Those without prescription drug coverage were more likely to not take medication and to not get or not take medication as prescribed because of cost. The researchers also assessed reasons for not getting or taking prescription medication... Sub. Req’d

A Policy Prescription to Help the Next Administration Combat the Drug Shortage Crisis

(9/30, Angie Boliver, RealClearHealth) ...To help prevent and mitigate additional drug shortages, we urge policymakers to take a holistic approach that addresses manufacturer quality and transparency, provides incentives to increase domestic manufacturing, and creates buffer inventory of certain medications. Patients cannot afford to wait... Full

Califf Calls for Mandatory Reporting of Device Shortages

(9/30, Joanne S. Eglovitch, Regulatory Focus) ...Robert Califf, commissioner of the US Food and Drug Administration (FDA), called for greater FDA authorities to better monitor medical device shortages, including mandatory reporting from manufacturers. He also said that greater attention should be paid to onshoring the production of medical devices in the US... Full

Califf: FDA International Strategy ‘Needs To Be Revitalized'

(9/30, Jessica Karins, InsideHealthPolicy) ...FDA Commissioner Robert Califf said FDA needs to improve its work on international regulation and other issues that cross borders, while acknowledging the agency faces steep obstacles in the current geopolitical climate, in a Friday (Sept. 27) webinar with the Alliance for a Stronger FDA... Sub. Req’d

PhRMA, Drugmakers Lose Suit Against Louisiana Pharmacy Law

(9/30, Nyah Phengsitthy, Bloomberg Law) ...Judge Robert Summerhays for the US District Court for the Western District of Louisiana on Monday denied motions for summary judgment from AstraZeneca PLC, AbbVie Inc., and the Pharmaceutical Research and Manufacturers of America in their lawsuits challenging Louisiana's Act 358. The state law prevents drug companies from denying or restricting the acquisition or delivery of a drug under the federal 340B Drug Pricing Program at contract pharmacies... Sub. Req’d

Czech MEP Urges EU to Tackle Pharma Reliance, Cut Bureaucracy, Curb Monopolies

(9/30, Aneta Zachová, Euractiv) ...The EU's increasing reliance on pharmaceutical production from non-EU countries, particularly India and China, has raised serious concerns, newly elected Czech MEP Ondrej Dostál (NI) said in an interview with Euractiv Czechia. He points out that basic medicines are being sourced from outside Europe, making the EU vulnerable to supply chain disruptions. "In 2023, we witnessed certain supply chain disruptions, especially in antibiotics," Dostál, Czech MEP and ENVI committee member, noted... Full

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