Wednesday, March 26, 2025

UK Medicines and Healthcare Products Regulatory Agency Confirms Acceptance of Marketing Authorization Application for Proposed Biosimilar to Xolair® (Omalizumab)

(3/26, Alvotech, Advanz Pharma and Kashiv BioSciences) ..."This represents an important step in the development of our proposed biosimilar to Xolair, with the key goal to increase patient access to an important biologic," said Joseph McClellan, Chief Scientific Officer of Alvotech. "At Kashiv, we are committed to developing high-quality, cost-effective therapies. The successful acceptance by MHRA of the marketing authorization for AVT23 reflects our dedication to innovation and improving access to vital biosimilars on a global scale," said Chirag and Chintu Patel, Executive Chairman and Co-Founders of Kashiv Biosciences... Full

Bio-Thera and Dr. Reddy's Execute Exclusive Commercialization Agreement for BAT2206, A Proposed Stelara® Biosimilar, and BAT2506, A Proposed Simponi® Biosimilar, for Southeast Asia

(3/26, Bio-Thera Solutions and Dr. Reddy's) ...Under the agreement, Bio-Thera will maintain responsibility for development, manufacturing, and supply of BAT2206 and BAT2506. Dr. Reddy's will be responsible for seeking regulatory approvals as well as commercialization in the licensed territories in Southeast Asia, including Cambodia, Indonesia, Malaysia, Philippines, Thailand, Vietnam. In addition, Dr. Reddy's will also receive the exclusive commercial rights to BAT2206 in Colombia... Full

Axsome Touts Success of Phase 3 Trial of Sunosi in ADHD, Adding to 'String of Recent Wins'

(3/25, Kevin Dunleavy, Fierce Pharma) ...As for the 300 mg dose of Sunosi, results were numerically superior to placebo, but came up short of statistical significance. The results square up with those produced by Supernus' Qelbree, "which showed a similar 3.8-point placebo-normalized reduction in AISRS at Week 6," William Blair analyst Myles Minter, Ph.D., wrote in a note to investors Tuesday, though he warned of the difficulty in making cross-trial comparisons... Full

Cipla Becomes Formosa's Latest Clobetasol Partner With 11-Country Deal

(3/25, Dean Rudge, Generics Bulletin) ...Cipla has welcomed the firm's first multi-regional licensing agreement in ophthalmology, after striking an exclusive licensing agreement bringing onboard Formosa Pharmaceuticals' clobetasol propionate 0.05% ophthalmic suspension in 11 countries in Asia, Africa, and South America. Under the terms of the agreement, Cipla will hold exclusive rights to market the treatment for post-operative inflammation and pain following ocular surgery – known as APP13007 – across 11 countries including India, Nepal, Sri Lanka, Bangladesh, Malaysia, Myanmar, Kenya, Nigeria, South Africa, Argentina, and Colombia... Global Sub. Full

Bayer Acquires Rights in Puhe BioPharma Cancer Drug Candidate

(3/26, Ludwig Burger, Reuters) ...Bayer said on Wednesday it struck a global licence agreement for an experimental oral cancer drug for targeted therapies with China's Puhe BioPharma. Bayer, which did not disclose financial terms, said it had enrolled the first patient to test the drug, a PRMT5 inhibitor that selectively targets MTAP-deleted tumors, in the first phase of clinical trials... Full

Eisai Lays Out Road Map to Blockbuster Sales Projections for Leqembi's 'Milestone' 2027 Year

(3/25, Zoey Becker, Fierce Pharma) ...Sales in fiscal year 2027, which wraps up in March 2028, are projected to reach 250 to 280 billion yen ($1.6 billion to $1.8 billion), the company said in a recent update. As Eisai sees it, 2027 is a key step to achieving the company's big expectations for 2032. It set those aspirations at 1.3 trillion yen ($8.6 billion) last March. To get to the 2027 sales expectations, the company ran a revenue simulation that takes into account the delayed uptake in the U.S. and reflects "learnings from launches in each region."... Full

Hyloris Closes A Dramatic 2024 With A Move Towards Profit

(3/25, Adam Zamecnik, Generics Bulletin) ...Hyloris Pharmaceuticals has reported a slight rise in its total revenue as part of its full year results for 2024, marking a close to a particularly tumultuous period for the Belgian value-added medicines specialist that has moved closer to profit. For the whole of the 2024 financial year, Hyloris reported growth in its total revenue and other operating income to €10.04m ($10.9m), compared to the reported figure of €4.2m for 2023... Global Sub. Full

Walgreens, Kroger Sue Pharma Companies With Drug Collusion Claim

(3/25, Katie Arcieri, Bloomberg Law) ...Walgreen Co., Kroger Co., and Albertsons Cos. Inc. accused two pharmaceutical companies Tuesday of conspiring to delay the generic version of a drug to treat gastroesophageal reflux disease and causing the retailers to pay more for the branded product. Defendants Takeda Pharmaceutical Co. Ltd. and TWi Pharmaceuticals Inc. allegedly engaged in a reverse payment deal in which TWi agreed to refrain from launching a generic version of Takeda's Dexilant product until January 2022, according to a complaint in the US District Court for the Northern District of California... Sub. Req’d

Trump Turbulence Stalls Large Pharma and Biotech Deals, Bankers Say

(3/26, Sabrina Valle, Reuters) ...Large deals involving pharmaceutical and biotech companies are stalling as executives grapple with mercurial White House economic policies that have roiled markets and set off a global trade war, according to four top healthcare investment bankers...Merck & Co, Pfizer, Bristol Myers Squibb and AbbVie are among the companies that stand to lose billions of dollars in revenue by the end of the decade as some of their biggest drugs go off patent... Full

Humira Biosimilars Gain Ground as Doctors Adjust And New Therapies Rise

(3/26, Annalee Armstrong, BioSpace) ...Prescribers seem to be finally coming around, according to Lynn Price, insights franchise head at Spherix Global Insights. She told BioSpace in an email that the firm's network of rheumatologists, dermatologists and gastroenterologists are reporting an increased uptake of Humira (adalimumab) biosimilars... Full

The New Amphetamine Crisis

(3/25, Mark S. Gold M.D., Psychology Today) ...Recent studies estimate that approximately 15.5 million adults have a current diagnosis of ADHD. Some experts argue this number reflects better awareness and screening, while others suspect overdiagnosis and ADHD-medication-seeking for performance enhancement are underlying factors... Full

Trump Tariffs Would Increase Costs for Almost Every Biopharma Company, Survey Claims

(3/26, Max Bayer, Endpoints News) ...Of every company polled, 94% said that tariffs on products from the European Union would increase manufacturing costs. Tariffs on imports from Canada would increase costs for 82% of companies polled, and tariffs on imports from China would spur cost increases for 70% of companies. The Biotechnology Innovation Organization, or BIO, conducted the survey last month. It included 42 companies, almost half of which were large companies with revenue of more than $1 billion... Full

Trump Again Threatens Tariffs On Pharmaceuticals in 'Not Too Distant' Future

(3/25, Angus Liu, Fierce Pharma) ..."Significant tariffs on our industry will harm access to medicines [and] could potentially raise the prices of medicines intentionally or unintentionally," John Crowley, CEO of the Biotechnology Innovation Organization (BIO), said during a recent "Biotech Hangout" discussion, citing findings from an industry survey conducted by the trade group. Following Trump's initial tariffs imposed on Canada, Mexico and China, John Murphy, CEO of the Association for Accessible Medicines, said that those tariffs "could increase already problematic drug shortages."... Full

Cuban ‘Hopeful' About Trump Administration Lowering Prescription Drug Prices

(3/25, Julia Manchester, The Hill) ..."CEOs are signing deals that under-reimburse [independent] pharmacies," Cuban said in an interview for The Hill's Health Next Summit. "CMS, HHS, the government is approving Medicare Advantage plans where they under-reimburse those independent pharmacies. It's horrific." "Hopefully all of this changes. And actually, you know, I have some high hopes for this administration to take action there," he said... Full

Oz Confirmation Vote Advances Out Of Senate Finance Committee

(3/25, Noah Tong, Fierce Healthcare) ...The committee voted 14-13 in favor, with all 14 Republicans voting in favor and 13 Democrats siding in opposition. The full Senate will now vote on his nomination. He is expected to win the nomination, though Josh Hawley, R-Missouri, has said he is skeptical over Oz's record on abortion and trans rights. Mitch McConnell, R-Kentucky, was the sole vote against during last month's confirmation of Department of Health and Human Services Secretary Robert F. Kennedy Jr... Full

Oz Open To Considering March-In Rights, Vague On IRA Issues

(3/25, Maaisha Osman, Inside Health Policy) ...Mehmet Oz said he would work with lawmakers to learn more about the federal government's march-in rights as an approach to lowering drug prices but offered little concrete on his views on drug pricing for senators to consider ahead of voting on his confirmation as head of CMS. Oz addressed the issue in new written responses to questions for the record... Sub. Req’d

Oz Signals Interest In Tackling Drug Shortages, Insulin Coverage

(3/25, Maaisha Osman, Inside Health Policy) ...Pressed on how he would address shortages of essential medicines and generics by Sen. Ben Ray Lujan (D-NM), Oz told lawmakers in a written response that he would "explore what role CMS can play" in ensuring access to life-saving therapies if confirmed... Sub. Req’d

Oz Says He'll Work On GLP-1 Affordability, Doesn't Show Hand On Biden Rule

(3/25, Maaisha Osman, Inside Health Policy) ...Warren also asked Oz to respond in writing whether he would instruct the Medicare drug price negotiation team at the CMS to "aggressively negotiate the lowest possible price on Ozempic and Wegovy for Medicare patients, consistent with the law." Oz responded by reiterating the Trump administration's stance on prescription drug prices, stating, "Lowering the cost of prescription drugs for Americans is a top priority of President Trump and his administration."... Sub. Req’d

A Plea From Seniors: Eliminate the Biden Pill Penalty

(3/25, Jim McLaughlin, RealClearHealth) ...Congress has a choice. It can allow the IRA to continue choking off innovation or pass the EPIC Act in reconciliation to ensure small molecule drugs are given the same thirteen-year exemption as biologics. The solution is clear. Lawmakers must act now to protect seniors' access to the medications they need. The EPIC Act isn't just good policy. It is a lifeline for millions of older Americans who deserve better than government-induced drug shortages... Full

Optum, CVS, Express Scripts GLP-1 Programs Entice Employers

(3/26, Lauren Berryman, Modern Heathcare) ...CVS Caremark, OptumRx and Express Scripts are pitching CVS Weight Management, Weight Engage and EncircleRx, respectively, which they say help employers provide highly coveted glucagon-like peptide-1 agonists, or GLP-1s, to the right employees in a financially sustainable way. Employers are buying into these programs to satisfy worker demand for coverage of GLP-1s such as Wegovy, Zepbound and Saxenda. Others incorporate the PBM offerings into their employee health benefits to constrain access to the $1,000-per-month medicines... Sub. Req’d

Pharmacy Benefit Managers Lining Pockets at Expense of Patients, Say Lawmakers

(3/25, Dana Gentry, Nevada Current) ...Third-party companies known as pharmacy benefit managers, which administer prescription drug benefits for health insurance plans, employers, and other organizations including governments, are driving up prescription drug costs, putting small pharmacies out of business, and interfering in the relationship between doctors and their patients, says Sen. Rochelle Nguyen, a Democrat from Las Vegas and the sponsor of Senate Bill 316, a measure that seeks to reform PBMs... Full

Net Prices for Medicines Inched Up in Last Year's Fourth Quarter After Falling a Year Ago, Analysis Finds

(3/25, Ed Silverman, STAT+) ...The net prices that health plans paid for medicines — after subtracting rebates, discounts, and fees — rose a modest 0.4% in last year's fourth quarter, but that compared unfavorably with a 3% decline in the same period a year earlier, according to the latest data from SSR Health, a research firm that tracks the pharmaceutical industry and its pricing trends. A key reason was that net prices rose for so-called protected oncology medicines, one of six classes of drugs for which Medicare Part D generally covers an entire category... Sub. Req’d

WuXi Biologics' Licensing Deals Help Offset Biosecure Threat in the US

(3/25, Anna Brown, Endpoints News) ...Western companies are increasingly licensing experimental therapies developed in China. In some cases, the companies form so-called NewCo's, which have become popular as global drugmakers pursue assets developed by Chinese companies, sometimes at a discount. WuXi Biologics said its licensing deals "contributed mid single digit growth" in 2024... Full

APIIC White Paper: Building a Resilient Domestic Drug Supply Chain

(3/25, API Innovation Center) ...The white paper, the second of five scheduled annual updates on the state of U.S. generic drug production, distills APIIC's work over the past 12 months to research, advise, invest and collaborate with key stakeholders to address this critical risk. APIIC recommends a national all-encompassing industrial plan to revitalize the U.S. generic drug industry and ensure a reliable supply of essential medications... Full

Final January 2025 Stats Released—We Have Some Predictions for You!

(3/25, Bob Pollock, Lachman Consultants) ...Of the 63 approval actions, nine were for first-time generic approvals and eleven (17.5%) were first-cycle approvals. Of the 27 tentative approvals, five (18.5%) were first-cycle approvals. I believe that the OGD needs to take a closer look to find out what factors are preventing ANDAs from being approved in the first cycle. If the OGD can find out what those factors are and communicate them back to industry in an actionable manner, then that will certainly improve the OGD's efficiency... Full

Senate Confirms Makary as FDA Chief with Agency Cuts, Return-to-Office in Force

(3/25, Zachary Brennan, Endpoints News) ...During his confirmation hearing, Makary offered few clues on what he might change when it comes to the FDA's drug approval process, although he did criticize the two-trial standard required for approval, and suggested he might try to speed up drug development. "I am a big believer that we need to figure out a way to get [drugs] approved quicker without cutting course in the scientific review," Makary said at the time. He also vowed to look into DOGE-led staffing cuts and said he would revive a safety review of the abortion drug mifepristone... Full

Minnesota House Bills Aim to Lower Prescription Drug Costs

(3/25, Emma Ritter, Brainerd Dispatch) ...Two bills heard recently by the Minnesota Health and Finance House Committee aim to make prescription drugs cheaper for patients. HF1075, which was brought before the committee on Wednesday, March 19, would require pharmacy benefit managers (PBMs) to use drug rebates to reduce out-of-pocket costs... Full

Independent Pharmacists Urge Lawmakers to Adopt PBM Bill

(3/26, Whitney Downard, Indiana Capital Chronicle) ...Webb was joined by a handful of other owners and association leaders to urge House committee members to push forward Senate Bill 140, a proposal that would implement several new regulations on PBMs... Full

Health Ministry Announces Plan to Simplify, Speed Up Medicine Approval Process

(3/26, The Jerusalem Post) ...The Health Ministry announced on Tuesday a new plan to simplify and speed up the process for approving new medications. The new framework aims to shorten the time of registering new medications in Israel, making drugs more readily available to the public, according to the ministry. The plan, which is set to begin at the end of March 2025, is based on advanced Western regulatory standards and will help bring treatments to patients faster while maintaining high safety standards... Full

Mounjaro in India: Eli Lilly CEO Explains High Cost of Drug and When Prices Could Fall | Exclusive

(3/26, Shereen Bhan, CNBC TV-18) ...Eli Lilly CEO David Ricks reveals that developing a new drug costs around $4 billion before marketing. In an exclusive interview with CNBC-TV18, he discusses drug pricing in India vs the US and the impact of tariffs on pharma sector. Eli Lilly's global CEO David Ricks has highlighted the significant costs of bringing new drugs to market, revealing that the average cost of developing a single drug is around $4 billion—even before factoring in marketing expenses... Full

Global CEO of Eli Lilly, World's Pioneer Insulin Manufacturing Company, David Ricks Called On Union Minister Dr. Jitendra Singh to Discuss Strengthening Partnership, With a Focus On Insulin and Non-Communicable Disease (NCD) Therapies as Well as Biomanufacturing

(3/25, PIB Delhi) ...Global CEO of Eli Lilly, world's pioneer Insulin manufacturing Company, David Ricks called on Union Minister of State (Independent Charge) for Science and Technology; Earth Sciences and Minister of State for PMO, Department of Atomic Energy, Department of Space, Personnel, Public Grievances and Pensions, Dr. Jitendra Singh to discuss strengthening partnership, with a focus on Insulin and Non-Communicable Disease (NCD) therapies as well as biomanufacturing... Full

Combating Bioequivalence Data Fraud: Indian CROs Face Mandatory Registration

(3/25, Urte Fultinaviciute, Generics Bulletin) ...As Indian CROs are bracing for new registration mandates, an expert panel at the IGBA's 3rd Bioequivalence conference discusses the implications of non-compliance in bioequivalence studies...Speaking at the International Generic and Biosimilar Medicines Association's 3rd Bioequivalence conference at the end of February, Janja Luksa, head of preclinical and clinical development quality at Sandoz, described the registration requirements as "really good news." While she remained cautious about how effective it would be, nevertheless, it was still better than nothing, she added... Global Sub. Full

IGBA Statement On Trade Barriers and Their Impact On Healthcare Systems and Patients' Health

(3/25, IGBA) ...A key priority for IGBA is to maintain patient access to medicines by advocating for the removal of trade barriers, including tariffs, that hinder the efficient supply and distribution of medicines across regional and international markets. Robust and well-functioning global supply chains are fundamental to ensuring the consistent availability of medicines to patients across the world... Full

Europe Faces Innovation Slowdown as Medical and Pharma Patents Decline

(3/26, Marta Iraola Iribarren, EuroNews) ...While the overall number of patent applications from companies remained stable in 2024, those for medical technology and pharmaceuticals experienced a decline, according to the annual Patent Index published on Tuesday by the European Patent Office (EPO). The EPO registered 199,264 patent applications last year, following three years of growth. Applications from Europe increased by 0.3%, while those from outside Europe fell slightly by 0.4%... Full

Russian Drugmakers Strengthen Positions in Insulin-Containing Drugs Market

(3/26, The Pharma Letter) ...According to analysts' predictions, in the segment of public procurements of insulin-containing drugs, local producers will account for almost 44% of contracts by the end of the current year. This will be also due to those preferences that will be provided by the government for such companies at state auctions... Sub. Req’d

Russia is Facing New Shortages of Drugs for Rare Diseases

(3/25, The Pharma Letter) ...Russia may face a new wave of drugs' shortages, particularly those, which are used for the treatment of rare diseases, as sanctions continue to bite, reports The Pharma Letter's local correspondent. As part of this, recently the Russian Ministry of Healthcare Center reported a disruption in supplies of Trileksa - a drug for the treatment of cystic fibrosis. The drug is produced by the Argentinian company Tuteur, being an analogue of the original drug Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) from the US drugmaker Vertex Pharmaceuticals... Sub. Req’d

China Approvals Rise But Conditional-To-Full Conversion Slips

(3/26, Xu Hu, Pink Sheet) ...The newly released annual drug review report for 2024 from China's Center for Drug Evaluation (CDE) shows the center approved a total of 45 innovative small molecules and biologics last year, of which 17 (38%), 11 (24%) and 13 (29%) were approved via priority review, conditional or breakthrough therapy designation (BTD) pathways, respectively. This compares with the total of 35 innovative small molecules and biologics approved by the CDE in 2023 (for which no comparative breakdown figures are available), reflecting the increasing innovation coming out of originators in China... Global Sub. Full

Note: Article links may expire over time or require a free registration. All news articles are the property of their respective publishers and copyright holders. [contextual emphasis added].

Teva global subscription access: registration is required to access FirstWord Pharma+ News and The Generics Bulletin. Please note you must be on the Teva Network (in a Teva location or connected via VPN) to access Teva's InfoNOW news resources. If you have any questions or issues, please email InfoNOW@tevapharm.com.

 

•      FirstWord Pharma+ News registration: first-time users, register here with your Teva email address. You will automatically receive a daily FirstWord Pharma+ newsletter; click on any news item to access your account.

•      Generics Bulletin, Pink Sheet, Scrip (Citeline) registration: go to the Generics Bulletin site and choose "Sign In" in the upper right-hand corner. First-time users, choose "Sign Up Here" and enter your Teva email address.