Tuesday, December 17, 2024

Teva and Sanofi Step On The Gas with Anti-TL1A in IBD

(12/17, Nicole DeFeudis, Endpoints News) ...The duo's duvakitug met the primary endpoints in a Phase 2b trial evaluating patients with ulcerative colitis and Crohn's disease, two forms of IBD, Teva and Sanofi said Tuesday morning. In ulcerative colitis, 36.2% of patients taking a low dose of duvakitug and 47.8% of patients taking a high dose achieved clinical remission, compared to 20.45% of placebo patients at week 14. P-values came in at 0.05 and 0.003 for the low and high doses, respectively... Full

Teva, Sanofi Say Drug to Treat IBD Met Primary Targets

(12/17, Steven Scheer, Reuters) ...The companies said the treatment was consistent across subgroups and that this was the first and only randomized, placebo-controlled study to evaluate the impact of a TL1A antibody in Crohn's disease. "The results from the ... study have exceeded our expectations," said Eric Hughes, head of global R&D and chief medical officer at Teva. Detailed results are expected to be presented at a scientific forum in 2025... Full

Teva Makes Two Inhalers Free For Charity Amid Ongoing Patent Battle With Amneal

(12/16, Urte Fultinaviciute, Generics Bulletin) ...Teva vows to make two of its inhalers more accessible in the US through charity Direct Relief, despite still being tangled up in a lawsuit with Amneal over ProAir HFA..."In the US, while 93% of Teva's inhaler medicines are generic products with access at lower prices – particularly for insured patients – there still remain uninsured patients who cannot access affordable generic inhalers," commented Teva's US commercial executive vice president Chris Fox... Global Sub. Full

Goldman Sachs Takes Control Of Synthon

(12/16, Dave Wallace, Generics Bulletin) ...Synthon's current owners, BC Partners, are selling a controlling stake in the Dutch complex generics specialist to Goldman Sachs Asset Management...Adam Dawson, managing director and global co-head of healthcare private equity at Goldman Sachs Alternatives, said the firm would "look forward to collaborating with management to drive value creation through product and pipeline development and operational excellence initiatives as well as execute on our joint vision to strengthen Synthon's global impact." Global Sub. Full

Sandoz Agrees On $275 Million Settlement in U.S. Price-Fixing Case

(12/17, Elena Vardon and Helena Smolak, Dow Jones) ...The Swiss generics-medicine company said Tuesday that it reached an agreement with end-payer plaintiffs, which follows previous settlements with the U.S. Justice Department in 2020 and 2021 and with direct-purchaser plaintiffs in February...The settlement helps to resolve Sandoz's past legal issues and allows it to focus on its new product launches for next year, Vontobel analyst Stefan Schneider said in a research note... Sub. Req’d

Granules India Gets USFDA Nod for Generic Drug

(12/17, Press Trust Of India) ...Granules Pharmaceuticals, Inc. secured USFDA approval for generic Lisdexamfetamine Dimesylate chewable tablets. The tablets treat ADHD in children and adults. They also treat binge eating disorder in adults. The drug is available in various strengths. This approval addresses drug shortages. Granules India's chairman emphasized their commitment to patient needs... Full

UCB's Orchestra Hits Dud Note: Novartis-Partnered Parkinson's Asset Fails Phase 2

(12/16, Gabrielle Masson, Fierce Biotech) ...UCB's Novartis-partnered investigational small molecule has failed to improve symptoms of Parkinson's disease in a phase 2a trial...After seeing the results, the Belgium-based company has decided to terminate the program's extension phase. The company is still analyzing disease biomarker data, with the study findings submitted for publication in a peer-reviewed journal... Full

Celltrion Launches CDMO Subsidiary to Drive Growth Beyond Biosimilars

(12/17, Kim Hae-yeon, The Korea Herald) ...Celltrion Group has launched a new contract development and manufacturing organization, Celltrion BioSolutions, signaling its strategic ambition to position CDMO services as the group's next growth engine beyond its core biosimilar business. "We will start contract research and development services from 2025, with the facility construction set to start by the first half. By 2030, we aim to record 1.5 trillion won ($1.04 billion) in CDMO business," Chairman Seo Jung-jin said during a press conference Tuesday... Full

Drugmakers Paid PBMs Not to Restrict Opioid Prescriptions

(12/17, Chris Hamby, The New York Times) ...Why hadn't the middlemen, known as pharmacy benefit managers, acted sooner to address a crisis that had been building for decades? One reason, a New York Times investigation found: Drugmakers had been paying them not to. For years, the benefit managers, or P.B.M.s, took payments from opioid manufacturers, including Purdue Pharma, in return for not restricting the flow of pills... Sub. Req’d

Mark Cuban's Drug Company Saves MultiCare $1M in Six Months

(12/16, Paige Twenter, Becker's Hospital Review) ...Using data analytics, MultiCare identified 125 medicines with lower wholesale acquisition costs at Cost Plus Drugs compared to competitors. The system participates in Cost Plus Drugs' inpatient and retail medication portfolios, and Dr. Frodin told Becker's his department has seen the greatest success in the retail sector...The partnership has also increased transparency around spending on drug shortages. In 2023, the organization spent $733,000 on replacement therapies for drugs in short supply; so far this year, it has halved that to $350,000... Full

Congress Nears Deal to Rein in PBMs After Years of Debate

(12/16, Rachel Cohrs Zhang, STAT+) ...The policies in the package would put guardrails around how PBMs can operate. Measures expected to be included would prohibit PBMs from linking their payments to drug prices in Medicare, increase transparency, and regulate how PBMs get paid for drugs by Medicaid programs... Sub. Req’d

PBM Lobby Punches Back at Provisions Within End-Of-Year Package

(12/16, Noah Tong, Fierce Healthcare) ...Pharmacy benefit manager reform is included in a larger-than-anticipated healthcare package, but the PBM lobby is fighting the legislation at the eleventh hour...The PCMA says the delinking policy will increase premiums in Part D by $13 billion and will benefit drug companies...Rep. Chip Roy, R-Texas, said the the pharma lobby will be the package's biggest winners and that PBMs should not be scapegoated as the only problem... Full

PCMA Statement On Pending Health Care Spending Package

(12/16, PCMA) ..."The end-of-year health care package accompanying the Continuing Resolution has morphed into a massive 400-page bill that includes provisions that would undermine the role that pharmacy benefit managers, PBMs, play in lowering costs and providing choices for employers in the prescription drug marketplace. Sweeping health reform policies like this should be the result of a more thoughtful and intentional approach. The health care provisions included in the latest draft, as reported in the media, risk increasing costs for health plan sponsors, like employers and labor unions, patients, and families, and hiking up premiums for seniors."... Full

What Trump's FTC Picks Mean for Biopharma Dealmaking and PBMs

(12/16, Jared Whitlock, Endpoints News) ...A review of public statements by Commissioner Andrew Ferguson — Trump's choice to lead the regulator — and Mark Meador, his pick for another GOP slot, shows a strong focus on big tech and far less about drugmakers. That would be a departure from Biden-era Chair Lina Khan, who has made the pharma industry one of the agency's primary anti-consolidation targets... Full

Trump's CMS Inherits Medicare Price ‘Facilitator' System Build Out; Should Pharma Be Worried?

(12/16, Cathy Kelly, Pink Sheet) ...The incoming Trump Administration could balk at the resources needed after taking over the complicated task of building the data hub to enable implementation of the Medicare negotiated prices, former senior CMS official Kristi Martin said in an interview with the Pink Sheet... Global Sub. Full

Most Glaring Problem in the Inflation Reduction Act

(12/16, Kirsten Axelsen, RealClearHealth) ...Mistakes were made in the IRA design that Congress can rectify. There is no basis of evidence for the nine-year price controls for NDA-approved medicines, and this should be fixed. If the government feels price controls are necessary, putting them at 13 years for both NDA and BLA approval would mimic the time that most drugs experience generic competition. Fixing this error in the law is essential; complex and vital science is at risk... Full

Sanofi Sues HHS Over Rejection of Drug Discount Rebate Model

(12/16, Nyah Phengsitthy, Bloomberg Law) ...The company filed a lawsuit Monday in the US District Court for the District of Columbia alleging the US Health Resources and Services Administration acted unlawfully when it denied Sanofi's 340B Credit Model—a system that would change the way health providers under the 340B Drug Pricing Program purchase drugs... Sub. Req’d

US FDA's RWE Efforts Gain ‘Focal Point' With New CDER Center

(12/16, Bridget Silverman, Pink Sheet) ...The new Center for Real-World Evidence (CCRI) will integrate with the Center for Drug Evaluation and Research's ongoing RWE activities and will problem-solve as needed. One of CCRI's early tasks will be creating a strategic plan for the FDA's RWE Program now that the first generation of guidances and commitments have been addressed... Global Sub. Full

AbbVie, Novartis Drop Suit Over Kansas Drug Discount Limit Law

(12/16, Nyah Phengsitthy, Bloomberg Law) ...Abbvie Inc., Novartis AG, AstraZeneca PLC, and the Pharmaceutical Research and Manufacturers of America backed down from their challenge against Kansas' S.B. 28, filing a joint stipulation in the US District Court for the District of Kansas to dismiss the case without prejudice. Manufacturers and the state determined that there is no controversy between the parties for the court to resolve at this time... Sub. Req’d

West Virginia Settles Lawsuit in Which Two Companies Allegedly Delayed the Introduction of a Drug

(12/16, John Lynch, WTRF) ...West Virginia Attorney General Patrick Morrisey said the Circuit Court of Mason County has approved a settlement between the state and pharmaceutical companies Pfizer Inc. (and related companies) and Ranbaxy Inc. (and related companies) in an antitrust lawsuit involving a generic version of cholesterol drug Lipitor... Full

Three Is The Magic Number: Celltrion Lines Up A Trio Of European Biosimilars

(12/17, Dave Wallace, Generics Bulletin) ...Celltrion is celebrating after lining up a trio of biosimilars for approval in the EU. The European Medicines Agency's Committee for Medicinal Products for Human Use issued positive opinions for four Celltrion products across three molecules at its December meeting, recommending that the European Commission grant marketing authorizations for the Korean firm's aflibercept, denosumab and tocilizumab biosimilars... Global Sub. Full

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