Friday, November 15, 2024

Immunai and Teva Launch Multi-Year AI Collaboration for Smarter Drug Development

(11/14, CTech) ...This collaboration will leverage Immunai's proprietary immune cell atlas, AMICA, and its AI model, the Immunodynamics Engine (IDE), to enhance clinical decision-making in Teva's Immunology trials. Key focus areas will include drug mechanism of action, dose selection, and biomarker analyses... Full

Immunai and Teva Partner to Innovate New Cancer, Immunology Therapies

(11/14, Raquel Guertzenstein Frohlich, The Jerusalem Post) ...Eran Harary, the Senior Vice President of Global Early Clinical Development at Teva, said Immunai's tools and AI solutions will help them increase innovation, research, and development. "This collaboration will provide important insights into patient responses and treatment mechanisms in immunology and immuno-oncology, allowing us to optimize our clinical trials and improve outcomes for patients," Harary said... Full

Citing 'Capacity Constraints,' Novo Nordisk Plots Global Wind-Down of Human Insulin Pen Production

(11/14, Fraiser Kansteiner, Fierce Pharma) ..."To address our current capacity constraints and reach more people with diabetes with our products in the future, our human insulin, which is currently delivered in pens and vials, will—over time—be transitioned to vials only," a Novo Nordisk spokesperson told Fierce Pharma Thursday... Full

Biosimilars Roll-Out Propels Fresenius Kabi's Growth

(11/14, Dave Wallace, Generics Bulletin) ...Sales for Kabi increased by 5% – and by 10% at constant currencies – to €2.11bn, with the firm's Biopharma segment reflecting "excellent organic growth of 66% [to €177m], driven by the overall good biosimilars rollout in Europe and the US, with Tyenne standing out." Meanwhile, the firm's majority-owned mAbxience unit "also performed strongly, driven by bevacizumab and milestone payments," as it continues to strike deals in various territories across the world... Global Sub. Full

India's Glenmark Pharma Posts Q2 Profit On Strong Demand for Chronic Drugs

(11/14, Kashish Tandon, Reuters) ...Glenmark Pharmaceuticals reported a second-quarter profit on Thursday, helped by strong demand for its drugs that treat long-term illnesses. The drugmaker reported a consolidated profit of 3.54 billion rupees (nearly $42 million) for the quarter ended Sept. 30, compared with a loss of 819.5 million rupees a year ago... Full

Three EU Biosimilar Approvals In Five Months? Aurobindo Thinks So

(11/14, Dean Rudge, Generics Bulletin) ...Aurobindo's India-based biopharma subsidiary CuraTeQ Biologics has marked a "significant milestone" after receiving a good manufacturing certificate of compliance from the European Medicines Agency for its biosimilars manufacturing facility in Hyderabad. The move "paves the way for securing approvals for our three biosimilars in Europe, currently under review by the EMA, within the next two to five months," according to the Indian firm... Global Sub. Full

AbbVie Partner Richter Rides Stock Rally Spurred by Hit Drug

(11/15, Veronika Gulyas, Bloomberg) ...AbbVie forecasts that US sales of the treatment for schizophrenia and depressive disorders, which it markets in America as Vraylar, will rise by about a fifth to $3.3 billion this year. The potential boost to Richter's earnings from the drug "looks under-appreciated" by investors, according to Berenberg analyst Victoria Lambert. The company is also benefiting from its push into women's health care and success in biosimilars, the production of almost identical copies of drugs... Sub. Req’d

European Commission Grants Approval to Sandoz's Biosimilar to Treat Retinal Diseases

(11/15, Financial Express) ...Sandoz, a key player in generic and biosimilar medicines, on Friday announced that the European Commission (EC) has granted marketing authorization for Afqlir (aflibercept) 2 mg vial kit and pre-filled syringe for intravitreal injection, a biosimilar to reference medicine Eylea by Bayer AG... Full

Leqembi Secures EMA Thumbs Up For Narrower Indication

(11/14, Neena Brizmohun, Pink Sheet) ...After an initial rejection, the European Medicines Agency now says that Eisai/Biogen's Alzheimer's disease drug should be approved, albeit with a recommendation for initial generic screening and ongoing safety scans... Global Sub. Full

Breaking Down Biosimilar Barriers: Interchangeability

(11/14, Dracey Poore, The Center For Biosimilars) ...Part 3 of this series for Global Biosimilars Week, penned by Dracey Poore, director of biosimilars at Cardinal Health, explores the critical topic of interchangeability, examining its role in shaping biosimilar adoption and the broader implications for accessibility... Full

PERA, PREVAIL Acts Delayed Again As Senators Tackle Stakeholder Concerns

(11/14, Gabrielle Wanneh, InsideHealthPolicy) ...The bills' sponsors said they will continue working to address the concerns over the bills' reforms to the Patent and Trademark Office's Patent Trial and Appeal Board operations and the clarification of accepted and excluded subject matter for patent eligibility, but Patients for Affordable Drugs Now told Inside Health Policy it will be impossible for the committee to fix flaws that could keep drug prices high... Sub. Req’d

RFK Jr Vow to Purge FDA Sets Up Collision With Big Pharma

(11/15, Ahmed Aboulenein, Michael Erman, Stephanie Kelly and Maggie Fick, Reuters) ...Robert F. Kennedy Jr. vowed to purge the U.S. Food and Drug Administration shortly before being chosen as President-elect Donald Trump's nominee for health secretary. Any changes he wants to make will come up against a pharmaceutical industry that pays much of the regulator's bills... Full

Speed Of Novel Approvals In Jeopardy As RFK Jr. Lands US HHS Secretary Nod

(11/15, Sarah Karlin-Smith, Pink Sheet) ...The FDA's Peter Marks warned novel approvals will suffer if the agency is forced to spend its time relitigating vaccines. At the top HHS post Kennedy could impact pharma from basic research funding to drug pricing...Marks suggested the best way for the FDA to handle the potential threats posed by some of Trump's likely health care picks is to "be kind of stealth below the radar screen." The problem for the FDA and industry is that if Kennedy wants to disrupt activities, agency staff may be limited in their ability to stop him... Global Sub. Full

Trump's Pick of RFK Jr. at HHS: The Scientific Community, and Biopharma Investors, Respond

(11/14, Jonathan Wosen, Adam Feuerstein, Allison DeAngelis, Matthew Herper, and Ed Silverman, STAT Plus) ...Some biotech and pharma insiders were shocked. "It's such a controversial pick for the health care world," said Brian Skorney, a biotech analyst at RW Baird. "It's hard to see HHS functioning, hard to see medical care functioning. Most of the medical establishment is in 180-degree opposition to him." John L. LaMattina, the former president of Pfizer's global research and development team and a board member of PureTech Health, wondered: "How do you put an anti-vaxxer in charge of HHS? How do you come out of a major pandemic where vaccines save literally millions and millions of lives and now put somebody [like that] in charge of the whole system? … I don't get it."... Sub. Req’d

Califf Urges Next FDA Chief To Prioritize Science Over Politics

(11/14, Maaisha Osman, InsideHealthPolicy) ...FDA Commissioner Robert Califf calls for whoever takes over the agency's helm under the incoming Trump administration to prioritize evidence-based decision-making and uphold the independence of civil servants from political pressures, speaking to attendees Wednesday (Nov. 13) at the Milken Future of Health Summit... Sub. Req’d

Louisiana's Bill Cassidy Named Next Chair of Senate Health Committee

(11/14, Zachary Brennan, Endpoints News) ...Cassidy, a doctor who has served as ranking member of HELP in the previous Congress, stressed in a statement that he's passed multiple bills through committee to lower prescription drug costs, including reforms aimed at misaligned incentives for PBMs and passing drug discounts to patients...He'll take over from Sen. Bernie Sanders (I-VT), a progressive lawmaker who also pushed drug cost issues, particularly on insulin... Full

Crapo Expected To Continue Bipartisan PBM, Doc Pay Efforts, But Chart New Finance Paths On ACA, Medicaid

(11/14, Jalen Brown, InsideHealthPolicy) ...Sen. Mike Crapo (R-ID) has collaborated with his Democratic counterpart on a number of initiatives, such as pharmacy benefit manager and Medicare physician payment reforms, but health care experts and lobbyists expect him to diverge next year in his role as Senate Finance Committee chairman on issues surrounding the Affordable Care Act, Medicaid and the Inflation Reduction Act... Sub. Req’d

Trump Promised To Make Your Medicines Cheaper. His Tariffs Will Make Them More Expensive

(11/14, Alex Knapp, Forbes) ..."Drug supply is not easy to change overnight," Mariana Socal, associate professor at the Johns Hopkins Bloomberg School of Public Health told Forbes. Just shifting from one production facility to another requires FDA inspections and approvals. "These are things that take a long time to materialize, if ever–it depends on a series of factors. And the real short run impact would simply be higher prices." If such a shift occurs, it's more likely that production would move from a higher tariff area like China to a country that has a lower one, like India–not back to the United States... Full

Overturning Chevron Doctrine Could Impact Medicare's Drug Selections For Price Negotiations

(11/14, Joshua P. Cohen, Forbes) ...Courts have long deferred to CMS's decisions concerning implementation of laws and statutory stipulations that govern the Medicare program. But this could change moving forward. The Supreme Court decision to overturn the Chevron doctrine could open the door to challenges to actions taken by health agencies, such as CMS... Full

Eli Lilly Sues the US Government Over its Proposed 340B Rebate Model

(11/14, Nicole DeFeudis, Endpoints News) ...The company announced Thursday that it wants to enact a "cash replenishment program" for 340B discounts, which were established in 1992 to help hospitals serving low-income patients...Under Lilly's proposal, those entities would purchase 340B drugs at market price and then recoup discounts later through rebates. Lilly said those changes would "prevent abuses" of the current 340B program, including "unchecked duplicate discounts."... The agency rejected Lilly's plan in a September letter. In the lawsuit, filed Thursday in DC federal court, Lilly asked the court to "set aside the letter" and declare its new payment model lawful... Full

GAO Takes FDA to Task Over Lagging Plant Inspections, Recommends Action Plan

(11/14, Joseph Keenan, Fierce Pharma) ...The Government Accountability Office (GAO) issued a 67-page report that urges the FDA to begin implementing more aggressive steps to attract and retain inspectors in response to a shortfall of drug plant inspections during and following the global COVID-19 pandemic...Although the FDA conducted 1,065 total drug plant inspections in fiscal 2023—a 40% increase compared to the same period in 2022—it was 36% below the 1,671 the agency conducted in 2019 prior to the coronavirus outbreak, the GAO report said... Full

FDA Drug Rejections Have One Fatal Flaw

(11/14, Ross Marchand, RealClearHealth) ...It's notoriously difficult to get a medication approved through the Food and Drug Administration. In fact, bringing a new drug to market takes more than a decade and costs about $2 billion. Empirical analyses using the U.S. Burden of Disease Study support the idea that the FDA is far too cautious in approving life-saving medications. Unfortunately, the agency is doubling down on its rigid and risk-averse approach... Full

Maryland is Taking Steps to Lower Prescription Drug Prices; Big Pharma Isn't Happy About It

(11/15, Sean Tunis and Glenn E. Schneider, Maryland Matters) ...Drug companies' biggest arguments against drug pricing reform are that setting an upper payment limit for high-cost prescription drugs sold in Maryland will reduce drug company investment in new drug development or make it harder for people to access the drugs already prescribed to them. There are plenty of academic papers that dispute these suggestions. Few, however, would disagree that drug companies are swimming in profits... Full

Comprehensive Approach for a Treaty to End Plastics Pollution: Perspectives from the Biopharmaceutical and Consumer Health Industries

(11/14, IGBA, IFPMA, and GSCF) ...We believe it is possible to achieve an instrument that protects both the environment and human health, through harmonized, targeted extended compliance periods, in line with regulatory timelines, and limited exemptions where no feasible and safe alternatives exist at sufficient quality and scale. Establishing harmonized rules through a health-protective treaty will ensure society benefits from plastics while promoting patient safety, climate resilience, and sustainability in healthcare... Full

UK MHRA's ILAP: High Interest But Low Uptake Of Benefits

(11/14, Eliza Slawther, Pink Sheet) ...ILAP, the UK's flagship initiative that connects the medicines regulator with health technology assessment bodies, is set to be revamped in 2025. The pathway aims to deliver safe, effective, financially sustainable, and early patient access to innovative medicines, but companies have so far not used all the tools that the ILAP has to offer. Many companies were simply unaware of the benefits of using ILAP tools such as the target development profile roadmap service, the MHRA says... Global Sub. Full

Australia Seeks To Tighten Drug Shortages/Discontinuations Reporting

(11/14, Neena Brizmohun, Pink Sheet) ...Drug companies and other pharmaceutical stakeholders have until 13 Jan 2025 to comment on the proposals that the Therapeutic Goods Administration believes will improve its regulatory framework for medicine shortages and discontinuations. One of the proposals would mandate a streamlined 12-month notice period for discontinuations of any reportable medicine included in the Australian Register of Therapeutic Goods. Another would see more critical non-prescription medicines being added to the list of reportable drugs... Global Sub. Full

Pharma Industry Pushes for Revamp in Drug Quality Inspection to Meet Global Standards

(11/15, Neetu Chandra Sharma, Business Today) ...In a letter to Dr Rajeev Singh Raghuvanshi, the Drugs Controller General of India (DCGI), the IPA outlined several proposals to streamline the drug investigation process. Business Today has reviewed the letter. The industry body urged the CDSCO to give companies 30 days' notice to respond to allegations about drug samples before releasing such information to the public... Full

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