Friday, March 7, 2025

Sandoz Breaks $10Bn Barrier With Biosimilars Boost

(3/6, Dave Wallace, Generics Bulletin) ...Sandoz racked up more than $10bn in sales in 2024, with a huge boost from its biosimilars business helping to push the firm's total turnover up by 7% to $10.36bn. "Growth was driven by strong performance of biosimilars," acknowledged CEO Richard Saynor during the firm's earnings call, as the segment grew by 29% to $2.85bn, with generics growth accelerating in the second half to achieve a 1% rise to $7.50bn. "And I'm very proud that all regions contributed, especially North America."... Global Sub. Full

Sandoz Slams ‘Desperate' J&J Attempt To Block US Private-Label Stelara Rival

(3/7, Dave Wallace, Generics Bulletin) ...Reacting to a recently-filed lawsuit from Johnson & Johnson that is seeking to stop partners Samsung Bioepis and Sandoz from introducing a private-label ustekinumab biosimilar rival to Stelara in the US, Sandoz CEO Richard Saynor has spoken of his frustration at what he called "the desperate actions of an originator trying to, I guess, protect its market for as long as practically possible."... Global Sub. Full

J&J to Stop Studies of Depression Drug Due to Low Effectiveness

(3/6, Puyaan Singh, Reuters) ...Earlier this year, Neumora Therapeutics' drug failed, in a late-stage trial, to reduce symptoms such as sadness and pessimistic thoughts. The drug, navacaprant, belongs to the same class as J&J's aticaprant. J&J had said it will explore opportunities to further develop this drug in other areas of high unmet need...J&J is also banking on revenue from newer treatments to drive future growth, as its blockbuster drug Stelara faces competition from cheaper copies... Full

Third Time Lucky? Eli Lilly and Eisai Get Another Shot At English Funding For Alzheimer's Drugs

(3/6, Neena Brizmohun, Pink Sheet) ...In an unusual decision by NICE, the health technology assessment institute for England is giving Eli Lilly and Eisai a third chance to persuade it to reimburse their respective disease-modifying treatments for Alzheimer's disease, Kisunla (donanemab) and Leqembi (lecanemab)...Lilly told the Pink Sheet that it would provide NICE with "new evidence" and said it "remains confident in the clinical efficacy and cost-effectiveness of donanemab and the value that it can bring to patients, their caregivers and to the NHS."... Global Sub. Full

Vertex Non-Opioid Pain Drug Draws Bipartisan Support In House Hearing

(3/6, Laura Helbling, Pink Sheet) ...Vertex's newly approved non-opioid pain reliever Journavx (suzetrigine) may benefit from bipartisan calls for favorable coverage policies. The US Food and Drug Administration approval of Journavx was mentioned several times during a recent House Energy and Commerce Health Subcommittee hearing that focused on combatting illicit drug use. The hearing largely was a discussion of a House Republican bill, the "HALT Fentanyl Act," and the illegal drug trade... Global Sub. Full

Want a Piece of Lilly's $27B US Manufacturing Investment? Please Send Your Application

(3/5, Angus Liu, Fierce Pharma) ...The Indianapolis pharma has established an online portal to accept submissions for possible locations of four future U.S. manufacturing sites...Any state may consider a submission, a Lilly spokesperson told Fierce Pharma. The company is already engaged in negotiations with several states but welcomes additional filings by March 12, the spokesperson said. "We expect to announce all four future site locations in 2025 and to provide more details on the specifics of each at that time," the spokesperson added... Full

Two Telehealth Firms Turn to Branded Zepbound As Restrictions Loom On Copies

(3/6, Sriparna Roy, Reuters) ...Both companies said they had signed deals with Gifthealth, the pharmacy partner of Lilly's direct-to-consumer website, LillyDirect, through which the drugmaker sells vials of Zepbound at discounts for cash-pay customers. The move offers the telehealth companies an avenue to keep selling the highly popular weight-loss drugs even as the compounded drugs industry faces increasing restrictions on making copies of the treatments... Full

Walgreens Agrees to Be Acquired by Private Equity Firm for Almost $10 Billion

(3/7, The Associated Press) ...Walgreens said Thursday that Sycamore will pay $11.45 per share, giving the deal an equity value just under $10 billion. Shareholders could eventually receive up to another $3 per share under certain conditions. A buyout to take the drugstore chain private would give it more flexibility to make changes to improve its business without worrying about Wall Street's reaction. The company has already been making some big changes as it seeks to turn around its business... Full

McKinsey Lawyer Says Trustee Opioid Suit Poses ‘Dangerous Path'

(3/6, James Nani, Bloomberg Law) ...McKinsey & Co. pushed a judge to dismiss a bankruptcy trustee's quest for it to pay for alleged harm it caused pharmaceutical maker Endo International Plc through its "reckless" advice on marketing and selling opioids. Accusations that the global consulting firm and its affiliates helped destroy billions of dollars of Endo's value must be tossed because it had no control over the company, McKinsey attorney Andrew K. Glenn of Glenn Agre Bergman & Fuentes LLP said at a hearing Thursday in the US Bankruptcy Court for the Southern District of New York... Sub. Req’d

From Amjevita to Zarxio: A Decade of US Biosimilar Approvals

(3/6, Skylar Jeremias, The Center For Biosimilars) ...Despite contributing significantly to reduced drug costs and market growth, biosimilars account for only about 23% of the overall biologics market, ranging from 8% for insulin lispro to 82% for bevacizumab, according to IQVIA data... Full

Mapping Supply Chains: Global Health Agencies Lead the Way

(3/6, Prashant Yadav, Think Global Health) ...Shortages of generic drugs now and during the COVID-19 pandemic illustrate the vulnerabilities of the U.S. pharmaceutical supply chain. The risks of overconcentrating upstream pharmaceutical manufacturing in China and downstream formulation in India has highlighted the need for better understanding of and transparency in the global pharmaceutical supply chain... Full

Ozempic, Cetaphil Makers Warn of Impact From Trump Tariffs

(3/6, Naomi Kresge and Allegra Catelli, Bloomberg) ...The European makers of Ozempic for diabetes and Cetaphil for dry skin said they would feel an impact from President Donald Trump's threatened tariffs, adding to a chorus of warnings from executives. Novo Nordisk A/S, which makes Wegovy for obesity as well as Ozempic, isn't "immune" to tariffs, Chief Executive Officer Lars Fruergaard Jorgensen said Thursday, despite pouring billions into US production. Over the longer term, the Danish company expects to make more medicines for the US market inside the country, and last year announced plans for a $4.1 billion factory in North Carolina... Full

Merck KGaA Says Earlier Moves to Localize Manufacturing Help Ease Trump Tariff Impact 

(3/6, Anna Brown, Endpoints News) ...Merck KGaA flagged that it might get hit by President Donald Trump's tariffs against China, but CEO Belén Garijo said this is likely to be "manageable" due to its earlier execution of regionalizing its supply chains. "We have made significant efforts to diversify and regionalize our supply chain," Garijo told the media Thursday, adding that it is nonetheless "working on scenarios and mitigation plans" due to "uncertainty" surrounding the tariffs... Full

Senate Democrats to Introduce PBM Changes, Health Provisions Dropped from December Spending Bill

(3/6, Nathaniel Weixel, The Hill) ...Senate Democrats on Thursday are introducing as standalone legislation a package of health policies, including changes to the pharmacy benefit manager (PBM) industry that was left out of December's government spending bill. The effort, led by Sens. Ron Wyden (D-Ore.), Bernie Sanders (I-Vt.) and others, is an attempt to revive bipartisan reforms and funding extensions without trying to attach it to a continuing resolution. It lays the groundwork for Democrats to try to force a floor vote... Full

Blackburn, Hassan, Colleagues Introduce the "Patients Before Middlemen Act" to Bring Down Cost of Prescription Drugs

(3/6, U.S. Senator for Tennessee Marsha Blackburn) ..."The Patients Before Middlemen Act would increase transparency and reduce prescription drug costs for seniors at the pharmacy counter. For too long, middlemen have taken advantage of misaligned incentives in the pharmaceutical supply chain at the expense of taxpayers and seniors. We need to put patients before the profits of pharmacy benefit managers," said Senator Blackburn... Full

Congress Keeps PBMs in the Hot Seat

(3/6, Molly Jenkins, PhRMA) ...Similar reforms passed the Senate Finance Committee with strong bipartisan support more than a year ago, but lawmakers failed to act on them before Congress adjourned last year. The latest hearing shows members on both sides of the aisle are eager to get the job done. For the patients, employers, pharmacists, consumer advocates and others who support strong PBM reform, lawmakers should hold middlemen accountable as soon as possible... Full

NACDS Statement On Advancing PBM Reform Through Senate "Hotline"

(3/6, NACDS) ..."PBM reform is ready to go, and that is the case thanks to extraordinary bipartisan work and agreement. NACDS praises this most recent effort to enact these reforms. NACDS urges that these reforms not become a political football in any way, and rather that they become the long-overdue and urgently-needed law of the land."... Full

Through ‘Radical Transparency,' Kennedy Can Finally Rein in Big Pharma

(3/6, Brandon Novick, The Hill) ...The newly confirmed secretary of the Department of Health and Human Services, Robert F. Kennedy Jr., can take immediate action as part of his prioritization of "radical transparency" to aid his mission to "Make America Healthy Again." In order to get a drug on the market, the Food and Drug Administration (FDA) has to determine that it is safe and effective for at least one specific use and patient population. Pharmaceutical companies sponsor and fund clinical trials to test their products, and the FDA analyzes the results when making an approval decision... Full

ICYMI: CSRxP Survey Finds American Voters Overwhelmingly Hold Big Pharma Responsible for High Drug Prices

(3/6, The Campaign for Sustainable Rx Pricing) ...In case you missed it, new polling from Fabrizio Ward, conducted for the Campaign for Sustainable Rx Pricing, found American voters overwhelmingly hold Big Pharma responsible for high prescription drug prices and support market-based solutions to lower prices by holding big drug companies accountable, including for gaming the U.S. patent system to block competition... Full

Federal Judge Stops Compounded Copies of Eli Lilly Weight Loss, Diabetes Drugs

(3/6, Nathaniel Weixel, The Hill) ...In a sealed decision filed late Wednesday, Judge Mark Pittman of the Northern District of Texas declined to issue an injunction to stop the Food and Drug Administration (FDA) from declaring there was no longer a shortage of the medicines' active ingredient, tirzepatide...Eli Lilly in a statement said the decision "marks the end of the road for mass compounding of risky, unapproved knockoffs that threaten the health and safety of Americans."... Full

In Confirmation Hearing, FDA Nominee Martin Makary Talks Drug Reviews, Vaccines, Ethics and More

(3/6, Zoey Becker, Fierce Pharma) ...Makary outlined a wider goal to "use common sense" to answer some questions "we've never asked before at the FDA," such as the long timeline for drug approvals and whether some prescription products can be shifted to over-the-counter offerings. If confirmed, the nominee said he would push for quicker generic and biosimilar approvals, he noted... Full

Makary Vows To Speed Up Drug Approvals, Expand OTC Access

(3/6, Maaisha Osman, Inside Health Policy) ...President Donald Trump's FDA nominee, Marty Makary, pledged Thursday to accelerate the approval of biosimilars and generic drugs, allow over-the-counter access to certain prescription products, crack down on pharmaceutical patent tactics, and integrate artificial intelligence to enhance the agency's review process. Testifying before the Senate health committee Thursday (March 6), Makary argued that streamlining FDA approvals would lower drug prices without sacrificing safety, while AI could help regulators identify risks, improve drug development, and prevent crises like past recalls of dangerous medications... Sub. Req’d

At Hearing, Makary Nods to MAHA's Goals But Says Little About Basic FDA Policies

(3/6, Lizzy Lawrence, STAT+) ...Makary faced a smattering of questions related to day-to-day regulatory questions. He said he supported streamlining the approval of biosimilars, generics, and over-the-counter drugs to bring down costs. He pledged to crack down on an influx of illegal vapes with the FDA's investigator force, and indicated some interest in using real world data to speed medical product reviews... Sub. Req’d

February 2025 OGD Unofficial Approval Totals and Projections from First Quarter Results

(3/6, Bob Pollock, Lachman Consultants) ...The OGD unofficially issued 53 full approval actions and 16 tentative approval actions for a total of 69 approval actions. For a month with only twenty-eight days and one federal holiday, the OGD's approval-action total is not too bad. Coupled with the great uncertainty regarding terminations and reduction in force of CDER employees, I think that the OGD did pretty well, even though it produced the fewest total number of approval actions in FY 2025 thus far... Full

Senate Passes Singh Bill to Safeguard Affordable Prescription Drugs for Underserved Communities

(3/6, State Senator Sam Singh) ...Today, the Michigan Senate passed bipartisan legislation sponsored by Senate Majority Floor Leader Sam Singh (D-East Lansing) to increase accountability for pharmaceutical companies and protect access to health care services and low-cost prescription drugs for Michiganders who are uninsured, older, or have lower incomes. By prohibiting drug manufacturers from denying access to low-cost medications to health care institutions covered in the federal 340B program, Senate Bill 94 would ensure kids, families, and older adults around the state can access critical health care programming they rely on... Full

In Discussion With Medicines For Europe: The Year Of The Critical Medicines Act And Pharma Legislation Review

(3/6, Urte Fultinaviciute, Generics Bulletin) ...2025 is likely to be a game-changing year for the pharmaceutical industry. Generics Bulletin sat down with Medicines for Europe's Adrian van den Hoven and Beata Stepniewska to discuss the opportunities of the Critical Medicines Act and EU pharmaceutical legislation revision...One clear consensus is that the European market, which is built on the lowest price single winner model, has been drastically consolidated. The latest data by Teva has shown that 46% of generics from the EU Critical List of Medicines are supplied by only one provider. Moreover, 83% of critical generic products are provided by a single supplier with over 60% of the market share... Global Sub. Full

EU Explains New Health Data Space Rules As Framework Becomes ‘A Reality'

(3/6, Eliza Slawther, Pink Sheet) ...The European Commission has confirmed that pharmaceutical companies will be able to request access to data for research under the new European Health Data Space Regulation, which has been published in the EU Official Journal and will enter into force on March 26... Global Sub. Full

Health Canada Greenlights Kashiv's Pegfilgrastim Biosimilar

(3/6, Adam Zamecnik, Generics Bulletin) ...Health Canada has authorized Kashiv BioSciences' Neulasta (pegfilgrastim) biosimilar, setting it up for commercial launch in the North American country. The Canadian approval follows on a positive nod from the US Food and Drug Administration in May 2022 under the name Fylnetra... Global Sub. Full

Semaglutide Not a Miracle Drug, It's a Medicine: Top Pharma Executive Explains

(3/7, Daphne Clarance, India Today) ...Semaglutide is not a magic pill, Vikrant Shrotriya, Managing Director, India division of the weight-loss drug-maker said while speaking at a discussion on the weight-loss drug at the India Today Conclave 2025...While semaglutide helps lose weight, it doesn't change the very nature of people's lifestyles. "This is not a criticism but an important point to consider. Lifestyle, exercise, and diet are integral to a person's well-being. Attitude, behaviour, and choices also play a crucial role. This is not a magic pill, it is a medication," Novo Nordisk India's Managing Director said... Full

NPPA Fixes Retail Prices of 53 Drug Formulations, Including Painkillers

(3/6, Business Standard) ...The National Pharmaceutical Pricing Authority (NPPA) has fixed retail prices for 53 drug formulations, including those used to treat Type-2 diabetes, high cholesterol, bacterial infections, and painkillers... Full

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