Friday, April 17, 2026

 

 

US Appeals Court Revives Teva Lawsuit Against Eli Lilly Over Migraine Drug

(4/16, Blake Brittain, Reuters) ...A U.S. appeals court on Thursday revived a patent lawsuit that Teva Pharmaceutical (TEVA.TA) brought against Eli Lilly (LLY.N) over the companies' competing migraine drugs, after a judge previously overturned a $176.5 million jury verdict for Teva in the case... Full

 

Federal Circuit Distinguishes Amgen in Reversal of Invalidation of Teva Headache Treatment Patents

(4/17, Rose Esfandiari, IP Watchdog) ...The district court found that the asserted claims were invalid for failing to satisfy both the written description and enablement requirements of 35 U.S.C. § 112, but the CAFC found the district court's grant of JMOL improper on both counts... Full

 

Teva's $177 Million Ajovy Patent Verdict Reinstated on Appeal

(4/16, Michael Shapiro, Bloomberg Law) ...The court remanded the case to the district court, reinstating what the opinion called "the jury's supportable findings."... Full

 

Extra Credit Not Required: Teva v. Lilly and the Limits of Amgen's Reach

(4/16, Dennis Crouch, Patentlyo) ...The case has been closely watched on Patently-O since the district court's 2023 JMOL decision. The appeal presented a good vehicle for testing the boundaries of post-Amgen disclosure doctrine because the asserted claims are method-of-treatment claims rather than composition claims. That distinction turns out to be dispositive... Full

 

FDA Recalls 300,000 Cartons of Teva Blood Pressure Patches Over Unapproved Ingredient

(4/16, Cris Tolomia, Quartz) ...Actavis Laboratories manufactured the recalled products on behalf of Teva Pharmaceuticals, and they come in three dosage strengths: 0.1 mg/day, 0.2 mg/day, and 0.3 mg/day - all formulated as Clonidine Transdermal System, USP. Teva initiated the recall on March 19, 2026; the FDA assigned it a Class II classification on April 13, 2026, with affected lot expiration dates running from April 2026 into February 2027... Full

 

Viatris, Teva Kick Off Separate Recalls Over Dissolution, Raw Material Issues

(4/16, Fraiser Kansteiner, Fierce Pharma) ...The clonidine patch batches were produced by Actavis Laboratories UT in Salt Lake City, with the pull coming down to good manufacturing practices deviations tied to the use of an "unapproved raw material," the FDA's report reads... Full

 

Bethel Free Health Clinic awarded funding to expand mental health services

(4/17, WLOX) ...Teva Pharmaceuticals provided the funding, sending $75,000 dollars to the Biloxi clinic...Bethel Free Health Clinic Executive Director Jan Vest said the money will allow the clinic to expand its mental health services, including therapy and medication, to serve more people in the community... Full

 

How Teva Pharmaceutical Industries (TEVA) Story Is Shifting With Duvakitug R&D And Biosimilars

(4/17, Simply Wall St.) ...The model fair value for Teva Pharmaceutical Industries has shifted slightly, moving from US$37.82 to US$38.18 per share. Analysts are linking this change to updated views on duvakitug, core neuroscience and immunology R&D, the long term build out of biosimilars, and how Teva handles capital allocation... Full

 

 

Trump's Prescription Drugs Gambit

(4/17, Taylor Millard, Washington Examiner) ...But a closer look shows the major manufacturers are lowering prices on drugs already off patent or nearing the end of exclusivity... Full

 

Bills To Speed Biosimilars Take Center State At Senate Hearing

(4/16, Gabrielle Wanneh, Inside Health Policy) ...Senate health committee chair Bill Cassidy (R-LA) on Thursday (April 16) touted two bipartisan bills aimed at streamlining access to lower-cost generic and biosimilar medicines -- one to eliminate certain study requirements biosimilar manufacturers must complete for FDA approval, and another to bolster FDA's ability to reject citizen petitions deemed intended to slow the entry of generic and biosimilar medicines into the market... Sub. Req'd

 

Confronting The Drug Price Conundrum

(4/16, Megan R. Wilson, The Washington Post) ...Chair Bill Cassidy (R-Louisiana) said Congress should "find a way that supports innovation and protects patients from unreasonably high prices."..."Our goal should be to get more of those new cures to have generic competitors faster in a way that doesn't disincentivize the next cure from being developed," he said... Full

 

Cassidy Pushes Drug Pricing Ideas as Voters Seek Affordability

(4/16, Victoria Knight, Bloomberg Government) ...As affordability remains a top issue in the 2026 midterms, Cassidy released a one-page framework Wednesday outlining a few proposals that the chairman is championing. The agenda involves giving funds to individuals for health savings accounts to cover out-of-pocket costs. It also calls to expand TrumpRx through increasing transparency for drug prices and further develop access to safe and nutritious food... Sub. Req'd

 

Paragon Presses Senators To Remove Biosimilar Access Obstacles

(4/16, Gabrielle Wanneh, Inside Health Policy) ...A conservative health policy think tank with notable ties to the Trump administration is urging the Senate health committee to codify FDA policies that eliminate switching and comparative efficacy study requirements for biosimilars to be deemed interchangeable by FDA, and to remove rebate-related barriers that impede appropriate formulary access for low-cost biosimilars... Sub. Req'd

 

Lankford Tackles High Prescription Drug Costs for Seniors

(4/16, US Senator James Lankford) ...The legislation ensures patients benefit from lower-cost options instead of unnecessarily paying more due to pricing practices by pharmacy benefit managers (PBMs), the drug pricing middlemen. It establishes clear pricing tiers separating low-cost generics and biosimilars from higher-cost brand-name drugs to lower out-of-pocket costs, increase competition, and incentivize investment in the generic and biosimilar markets... Full

 

PCMA Urges Congress to Promote Competition by Addressing Patent Abuse, Reining In Big Pharma's DTC Advertisements

(4/16, PCMA Blog) ...In the statement, PCMA underscored the need to focus on how brand drug manufacturers game the system to discourage price competition: "The most powerful thing policymakers can do is ensure the market is not starved of competition. When more than one option exists, prices come tumbling down. Manufacturers of expensive brand drugs already enjoy the generous government protections, and they must not be allowed to extend these monopolies through dubious means."... Full

 

Buying Time: How Much Is Lilly's Foundayo CNPV Worth?

(4/16, Michael McCaughan, Pink Sheet) ...The US Food and Drug Administration's rapid approval of Eli Lilly's novel weight loss therapy Foundayo (orforglipron) is the most commercially significant use of the new Commissioner's National Priority Voucher program, as well as an opportunity to determine the value of a CNPV. The going price for a PRV is about $125m, suggesting the price pharma companies will pay for a four-month acceleration of market entry, i.e. the difference between a standard and priority review timeline. At the same rate, a 10-month launch acceleration should be worth over $300m... Global Sub. Full

 

Kennedy: 90% Of FDA Reviewers Are Using AI For Faster Drug Approvals

(4/16, Jalen Brown, Inside Health Policy) ..."We're driving the use of AI across all the federal agencies of government we're leading. We now have over 90% of reviewers at FDA using AI," Kennedy said in response to a question from Rep. Aaron Bean (R-FL)..."We have broken every record for drug approvals," Kennedy said. "We're using AI to dramatically shorten the times to approval."... Sub. Req'd

 

CPA Applauds FDA Proposal to Strengthen U.S. Generic Drug Manufacturing and Supply Chain Integrity

(4/16, The Coalition for a Prosperous America) ..."FDA's proposal is an important step toward restoring domestic generic drug manufacturing and addressing long-standing vulnerabilities in the pharmaceutical supply chain," said Jon Toomey, President of the Coalition for a Prosperous America. "Giving U.S.-based manufacturers a better chance to secure Paragraph IV exclusivity creates a direct incentive to build and expand here at home."... Full

 

RFK Jr.: HHS Making Plans To Hire 12,000 New Employees

(4/16, Jessica Karins, James Jarvis, Inside Health Policy) ...Although many HHS agencies are currently hiring, a total of only about 168 jobs are currently listed on the federal hiring portal, 104 of them at the Indian Health Service. It's unclear how a major hiring push would square with the Trump administration's proposal to cut $15.8 billion from the HHS budget for fiscal 2027... Sub. Req'd

 

RFK Jr. Defends FDA, Makary Following Republican Questions

(4/16, Zachary Brennan, Endpoints News) ...Kennedy pushed back on LaHood's characterization of Makary. He then incorrectly pointed to "record" new and generic drug approvals last year. While Kennedy said the 91 first generic approvals are a record, the FDA approved 107 first generic drugs in 2022. And according to the FDA, 2018 is considered the record year with the most approvals of new drugs... Sub. Req'd

 

Former Deputy Surgeon General Erica Schwartz, M.D., Nominated as CDC Director

(4/16, Dave Muoio, Fierce Healthcare) ...President Donald Trump announced Thursday Erica Schwartz, M.D., as his nominee to fill the long-vacant role of director of the Centers for Disease Control and Prevention. Schwartz, who also has a law degree and a master's of public health, previously served as deputy surgeon general during the president's first term... Full

 

Illinois Legislation Would Cap Some Prescription Drug Prices

(4/16, Brian Weckerly, Our Quad Cities) ...Under House Bill 1443 and Senate Bill 66, medications that qualify would need to cost more than $60,000 a year or have acquisition costs that increase by more than $3,000 dollars a year. Some generic medications with significant price increases would also be capped. Maximum prices would be determined by a prescription drug affordability board... Full

 

AG Jackley Joins Multistate Coalition Supporting Prescription Drug Pricing Transparency Rule

(4/16, Tamara Chibe, KOTA) ...Under the proposal, PBMs would have to report revenue details twice a year and allow employers to audit their practice, addressing concerns that many employers currently lack insight into rising prescription costs... Full

 

 

Henlius Targets One Of Oncology's Toughest Biosimilars

(4/16, Dean Rudge, Generics Bulletin) ...China's biosimilars sector may be edging closer to one of oncology's most technically challenging and notorious targets, after Shanghai Henlius Biotech secured regulatory clearance to advance its cetuximab biosimilar candidate. The Chinese firm has announced that the country's National Medical Products Administration has approved the investigational new drug application for HLX05-N, a proposed biosimilar to Eli Lilly/Merck KGaA's Erbitux targeting metastatic colorectal cancer... Global Sub. Full

 

Apotex Snatches First FDA Generic Approval For Sandoz's Multivitamin Injection

(4/16, Urte Fultinaviciute, Generics Bulletin) ...The US Food and Drug Administration has approved Apotex's two abbreviated new drug applications for Sandoz and Baxter's Infuvite injection for adults. The two ANDAs cover a single-dose and pharmacy bulk package, with the latter also eligible for 180-day competitive generic therapy exclusivity... Global Sub. Full

 

Mochida Chases Gap In Japanese IVF Biosimilars

(4/17, Dean Rudge, Generics Bulletin) ...Under the agreement, Mochida will take responsibility for development activities in Japan, working toward regulatory approval, while collaborating closely with Qilu on commercialization. The partners stated they aim "to achieve an early market launch" of the product. No financial terms of the agreement were disclosed... Global Sub. Full

 

Sandoz Builds New Model For African Drug Access

(4/16, Dean Rudge, Generics Bulletin) ...Sandoz has signed a direct supply and manufacturing agreement with the Rwandan government to secure access to critical medicines across Rwanda and selected African markets, marking what both parties describe as a first step toward a more sustainable regional procurement model for generics and biosimilars. The deal will initially cover around 60 products, including antibiotics and oncology therapies, with the potential for expansion over time... Global Sub. Full

 

Semaglutide API Price Plunges Amid GLP-1 Rush

(4/17, Rica Bhattacharyya, Vikas Dandekar, The Economic Times) ...Industry experts told ET that synthetic semaglutide prices have plummeted to $90-$160 per gram, from $900 per gram three years ago, while recombinant variants have fallen to nearly $50 per gram... Full

 

 

Towa Targets Supply Resilience With Networked Manufacturing Shift

(4/16, Dean Rudge, Generics Bulletin) ...Under the agreement, Adragos Pharma Kawagoe will expand production lines at its Kawagoe plant, while Towa will increase outsourcing volumes to improve capacity utilization and manufacturing efficiency. At the same time, Towa will use the arrangement to secure manufacturing capacity and rebalance its internal production toward higher-demand products, rather than simply shifting output externally... Global Sub. Full

 

Hidden Supply-Chain Risks Threaten 100 Essential US Medicines

(4/16, Laine Bergeson, CIDRAP) ...Of the 100 drugs on the list, 50 are used in acute care and 50 for chronic conditions. To create the list, USP focused on medicines most susceptible to disruption, regardless of whether the drug is currently available. In total, "70% of the VML listed drugs are not in shortage but are structurally vulnerable," the authors note. Rather, those drugs are included on the list because of vulnerabilities in their supply chains... Full

 

Lupin's US Arm Settles Civil Antitrust Litigation With Humana for $30 Million

(4/17, Business Standard) ...Under the agreement, Lupin Pharmaceuticals Inc. will pay $30 million for a full and final release of all claims by Humana against the company and its affiliates. "The settlement amount has already been provided for in the companys prior consolidated financial statements, Lupin said... Full

 

Specialty Drugs, They Rule and Are Not Exception | AMCP Annual 2026

(4/16, Denise Myshko, Managed Healthcare Executive) ..."Orphan drugs continue to represent a disproportionate share of FDA approvals, accounting for more than half of all approvals in 2025, which is consistent with trends from recent years," said Nicole A. Caffiero, Pharm.D., MBA, senior clinical pharmacist at Evernorth Health Services. "When we look ahead at the novel specialty pipeline, that pattern holds," she said. "Cancer accounts for the largest share, representing 45% of the specialty pipeline. Orphan drugs are 40% of the pipeline, so that reflects this sustained investment in rare conditions. When you put that together, more than 85% of specialty drug development."... Full

 

OpenAI Deepens Life Sciences Push with Launch of GPT-Rosalind

(4/16, Pavan Kamat, FirstWord PHARMA) ...OpenAI on Thursday unveiled GPT-Rosalind, a frontier reasoning model designed specifically for biological research and drug discovery workflows, marking the company's most targeted foray to date into AI for life sciences...The model is currently available as a research preview via ChatGPT, Codex and OpenAI's API, accessible to certain customers in the US through a trusted-access programme... Full

 

 

Pharma Exports Fall to Five-Year Low in March Amid West Asia Crisis

(4/17, Teena Thacker, The Economic Times) ..."Generic drugs were flowing without interruption to the US, Europe and Africa. The industry was on course to close FY26 as one of its strongest years on record. Then in March, the war disrupted the flow," said Dinesh Dua, former chairman at Pharmexcil, the industry's exports promotion council. Overall, pharma exports grew 2.13% in FY26, he added... Full

 

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