Friday, April 18, 2025

U.S. District Court Grants Summary Judgment in Favor of FDA, Salix, and Teva, and Against Norwich

(4/17, Bausch Health) ...Norwich had asked the District Court for a judgment declaring the FDA's decision to issue tentative approval for Norwich's Abbreviated New Drug Application (ANDA) for XIFAXAN® (rifaximin) 550 mg and failure to determine Teva Pharmaceuticals USA, Inc. (Teva) had forfeited its 180-day exclusivity were arbitrary, capricious, and contrary to law. Norwich sought an injunction directing the FDA to immediately grant Final Approval to Norwich's ANDA for XIFAXAN® (rifaximin) 550 mg...Today, the District Court denied Norwich's motion and granted summary judgment in favor of the FDA, Salix, and Teva, and closed the case... Full

Sanofi Licenses Immune Disease Drugs from Startup Earendil

(4/17, Kristin Jensen, BioPharma Dive) ...French drugmaker Sanofi agreed to pay $125 million to startup Earendil Labs for two drug candidates designed to treat autoimmune and inflammatory bowel diseases...The candidates, HXN-1002 and HNX-1003, are bispecific antibodies designed to engage two different proteins in the body involved in inflammation and immune cell activation...HXN-1002 is designed to inhibit a4ß7 and TL1A, while HXN-1003 takes aim at TL1A and IL23, the latter two of which have become popular targets for drugmakers. The approved medicines Tremfya, Skyrizi and Ilumya are all IL23 inhibitors. TL1A, meanwhile, is the focus of a raft of research by top drugmakers including Merck & Co., Roche, AbbVie and a collaboration between Sanofi and Teva Pharmaceuticals... Full

Aurobindo Plots Rivaroxaban Roll-Out As FDA Approves 2.5mg Strength ANDA

(4/17, Dean Rudge, Generics Bulletin) ...Aurobindo plans to launch shortly its generic version of Johnson & Johnson/Bayer's blockbuster blood thinner Xarelto (rivaroxaban) 2.5mg tablets, after receiving US Food and Drug Administration approval for its abbreviated new drug application..."The product will be launched in Q1FY26," Aurobindo disclosed, putting the projected launch in the three months to June 30,. Citing IQVIA data, Aurobindo put annual US sales of Xarelto 2.5mg at around $447m... Global Sub. Full

Roche Discontinues Low Dose in Huntington's Trial, Will Switch Patients to High Dose

(4/17, Lei Lei Wu, Endpoints News) ...Roche is stopping patients on the low dose of its experimental Huntington's drug tominersen, and will be transitioning them to the high dose following recommendations by an independent data monitoring committee..."The 100mg dose was found to be more likely than the 60mg dose to result in clinical benefit. Therefore for the remainder of the study only the 100mg dose will be tested against placebo, and the 60mg dose will be discontinued," Roche's neuroscience patient partnership leader Mai-Lise Nguyen wrote in a letter to patient advocates Thursday... Full

Hikma Acquires Rights To Trametinib Generic, Gains U.S. Market Exclusivity

(4/17, RTT News) ...Hikma Pharmaceuticals Thursday announced that it has acquired the FDA-approved ANDA for trametinib tablets from Novugen and entered a U.S. commercialization agreement. Novugen will manufacture the cancer drug, while Hikma handles U.S. sales and marketing. Trametinib, a kinase inhibitor used in cancer treatment, will grant Hikma 180 days of generic market exclusivity upon launch... Full

GSK Kicks Off Blenrep's Market Return with First Myeloma Combo Nod in UK

(4/17, Angus Liu, Fierce Pharma) ...The approval allows the BCMA-targeted therapy to be used with either Takeda's Velcade (bortezomib) or Bristol Myers Squibb's Pomalyst (pomalidomide), plus dexamethasone in second-line myeloma treatment. This world-first approval marks a milestone in GSK's plan for Blenrep to reach peak annual sales of more than 3 billion pounds sterling (about $4 billion). Blenrep's potential global reentry also gave GSK confidence to boost its 2031 sales target to more than 40 billion pounds despite uncertainties around the company's flagship vaccines business... Full

Zanubrutinib Plus Venetoclax and Obinutuzumab Yields Deep Remissions in Patients With Chronic Lymphocytic Leukemia

(4/17, Alexandra Gerlach, Pharmacy Times) ...In the prospective, open-label, multicenter phase 2 trial, investigators explored the efficacy and safety of bendamustine (Bendeka; Teva Pharmaceuticals) followed by obinutuzumab, zanubrutinib, and venetoclax in patients with relapsed/refractory CLL...The primary end point of the analysis is the uMRD rates, with other key end points including safety, progression-free survival (PFS), and overall survival (OS). Patients treated with obinutuzumab, zanubrutinib, and venetoclax achieved significant uMRD rates with remissions deepening over time... Full

Blue Cross Blue Shield to Stop Covering Popular Weight-Loss Drugs

(4/17, Jon Chesto, The Boston Globe) ...About 50,000 of Blue Cross's 3 million members were taking GLP-1s as of Jan. 1, with 80 percent of those members taking it for weight loss. Under the new policy, people whose employers decline to cover the drugs would have to pay out of pocket. While there is variation, the average monthly retail price of the class of obesity medications is about $1,200 without insurance... Full

Mark Cuban Backs Trump's Health Care Executive Order On Prescription Drugs

(4/17, Erick Revell, FOX Business) ..."Shark Tank" star Mark Cuban, who founded pharmaceutical firm Cost Plus Drugs in 2022 as a public benefit corporation to lower prices for generic drugs, said that the Trump administration executive order released earlier in the week could result in significant savings on prescription drug costs...He outlined six policies that he thinks will lead to those savings by changing how drugmakers, pharmacy benefit managers (PBMs) and pharmacies interact to save consumers money on their drugs... Full

Trump-Aligned Think Tank Pushes Tariffs As Tool to Lower U.S. Drug Prices

(4/17, Maaisha Osman, Inside Health Policy) ...A conservative think tank allied with President Donald Trump, the America First Policy Institute (AFPI), is calling on U.S. trade officials to take aim at foreign drug pricing policies that it says force Americans to shoulder the global burden of pharmaceutical innovation -- by using tariffs to force other countries to abandon what it calls "freeloading" practices... Sub. Req’d

Beyond Tariffs: The Silver Lining Of The US Pharma Security Investigation

(4/17, Jessica Merrill, Pink Sheet) ...The Secretary of Commerce announced it is seeking public comment on an investigation to determine the effects on national security of imports on pharmaceuticals and ingredients, including generics and brand drugs, in a notice published in the Federal Register on 16 April..."We're very hopeful that they're going this route, which is a defined statutory opportunity to hear from the public, to hear from the regulated industries, to hear from trading partners," Association for Accessible Medicines CEO John Murphy III said in an interview with Pink Sheet's sister publication, Scrip. "It gives them an opportunity to have much more holistic view on trade barriers as well as potential trade remedies."... Global Sub. Full

Tariffs 'Could Cancel Out Discounts with Biosimilars'

(4/17, Phil Taylor, pharmaphorum) ..."In order for biosimilars to offer cost-savings of up to 85% discounts on reference product medicines, the industry has had to design and implement one of the most efficient supply chains and manufacturing processes in the world," [Juliana Reed of the Biosimilars Forum,] said. "We are concerned that, following this investigation, tariffs on pharmaceuticals could raise prices for patients, exacerbate drug shortages, and dangerously disrupt supply chains for life-saving medicines, including biosimilars," according to Reed... Full

US Drugs Rely Heavily On Ingredients Made Overseas, New Report Shows

(4/17, Anna Brown, Endpoints News) ...Under the US Trade Agreements Act, a drug's origin is defined by where its active pharmaceutical ingredient (API) is sourced from, unless it's been "substantially transformed" in a different country...While it's still unknown how the Trump administration will implement drug tariffs — lawyers and analysts estimate a rate of about 25% — the global nature of the supply chain for brand-name and generic drugs suggests widespread impact... Full

ICYMI: Experts Discuss Value of PBMs at Capitol Hill Briefing

(4/17, PCMA) ...JC Scott, president and CEO, PCMA, welcomed Congressional staffers and noted that Americans are facing an affordability challenge due to high list prices set by drug companies and unprecedented demand for new drugs. He highlighted how PBMs have responded to evolving consumer demands by launching new innovations that lower out-of-pocket costs, help more patients access the drugs they need, and strengthen the pharmacy market. Scott emphasized the importance of every health plan sponsor having the ability to choose what best fits their needs and urged Congress to protect that flexibility... Full

Rules Could Vanish As Soon As Saturday With No Public Notice

(4/17, Maaisha Osman, Inside Health Policy) ...As federal agencies face an April 19 deadline to submit their deregulatory blueprints to the White House Office of Management and Budget (OMB), industry attorneys say some regulations potentially could be axed as early as that day -- without public input -- under the "good cause" exception in the Administrative Procedure Act (APA) invoked by the Trump administration... Sub. Req’d

Makary Says FDA Will Remove Pharma Representatives from Advisory Panels

(4/17, John Wilkerson, STAT+) ...The Food and Drug Administration will remove industry representatives from advisory committees and replace them with patients and caregivers, Commissioner Marty Makary announced Thursday...Makary acknowledged that industry representatives do not vote, but he said that letting them sit on the panel creates a cozy relationship with the voting members. Many of the members are usually clinicians and scientists who specialize in products or diseases areas under discussion... Sub. Req’d

Exclusive: FDA Fires Most Negotiators for Pharma User Fee Talks, Sources Say

(4/17, Maggie Fick, Marisa Taylor, Reuters) ...The layoffs of experienced and senior staff risk giving the upper hand to seasoned industry negotiators at the bargaining table, according to experts. "You can always find a warm body to get into a room with biotech and pharma, but they will get their lunch eaten," said Paul Kim, a health policy lawyer who worked at the FDA to draft the first user fee agreement in 1992 and has worked in Congress and in private practice for industry on every subsequent renewal... Full

US FDA User Fee Collection Safe In Preliminary Trump 2026 Budget Plan

(4/17, Cathy Kelly, Pink Sheet) ...HHS Secretary Robert F. Kennedy, Jr.'s past criticism of user fees as an undue influence over the FDA drug review program has raised concerns that the Administration would not honor the existing prescription drug user fee agreement. Although the budget document is subject to change and the ultimate authority rests in Congress, it appears that won't be the case for fiscal 2025. But industry will likely face a challenging environment in the next PDUFA reauthorization cycle... Global Sub. Full

Leaked FY 26 FDA Budget Document Explained

(4/17, Steven Grossman, FDA Matters) ...The table (below) compares the FY 26 leaked proposal with the FY23 numbers for the budget authority (BA) portion of FDA funding... Full

Trump Order Risks Triggering Lawsuits Over Drug Consulting Fees

(4/17, Lauren Clason, Bloomberg Law) ...The order signed Tuesday instructs the Labor Department to propose within 180 days regulations that would improve "employer health plan fiduciary transparency into the direct and indirect compensation received by pharmacy benefit managers," which oversee the prescription drug benefit for health insurance companies. An accompanying fact sheet said the order targets "middlemen" by improving disclosure of fees PBMs "pay to brokers for steering employers to utilize their services."... Sub. Req’d

Novartis, FDA Battle Over Generic Drug Labeling in DC Circuit

(4/17, Nyah Phengsitthy, Bloomberg Law) ...A three-judge panel wrestled Thursday with Novartis AG's challenge against the FDA over its approval of a generic version of its heart failure drug, pressing both the manufacturer and agency on the accuracy of the drug labels. The US Court of Appeals for the District of Columbia Circuit tried to drill down into Novartis's reasoning for opposing the Food and Drug Administration's approval of MSN Laboratories' generic Entresto... Sub. Req’d

White House Seeks More Drug Imports From Canada While Also Mulling Tariffs

(4/17, Chris Hannay, The Globe and Mail) ...On Wednesday, Florida said it had not yet imported any drugs from Canada because of "significant roadblocks put up by pharmaceutical companies and the Biden Administration," but planned to do so soon...Health Canada said at the time that it was concerned that large drug exports to the U.S. could lead to domestic shortages. Florida's population is about half of all of Canada's. Health Canada also said it had regulatory power to block exports of drugs in the case of a shortage... Sub. Req’d

Industry Keen On ‘Stepwise' PIPs, But Future Hinges On EU Pharma Legislation Reform

(4/17, Eliza Slawther, Pink Sheet) ...Industry is "eager" to use stepwise pediatric investigation plans (sPIPs) following an EU initiative piloting this approach to pediatric medicines development...However, the European Medicines Agency said the future of sPIPs in Europe will depend on pharmaceutical legislation negotiations, which are ongoing. The EMA plans to publish a report later this year based on eight sPIP opinions granted under the pilot, and it will work with industry on a joint journal publication... Global Sub. Full

Regulator Bans 35 Combination Drugs Over Safety Issues

(4/17, Teena Thacker, The Economic Times) ...India's drug regulator has ordered companies to stop manufacture and sale of 35 fixed dose combinations (FDCs), saying they compromise "patient safety" and "may lead to adverse reactions." The Drug Controller General of India (DCGI) has also asked state and union territory drug controllers to review their approval process for combination drugs and ensure strict compliance of legal provisions, health ministry insiders told ET. The move comes amid increasing worries over FDCs flooding the market without being tested for safety and effectiveness over the past two years, they said... Full

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