Monday, April 20, 2026

 

 

Teva Scores in Appeal as Court Revives $177M Verdict Against Lilly in Migraine Patent Spat

(4/17, Fraiser Kansteiner, Fierce Pharma) ...Lilly is disappointed with the decision and disagrees with it, a company spokesperson said in an emailed statement...For its part, Teva is "pleased that the U.S. Court of Appeals for the Federal Circuit reinstated the jury verdict," with a spokesperson telling Fierce that the decision "validates the strength of Teva's intellectual property."... Full

 

Biopharma Bites: Teva's Legal Win in Migraine Patent Battle Against Lilly, and More from ICER, Biovac

(4/18, FirstWord PHARMA) ...Now that Teva has won its appeal, the case now heads back to Massachusetts federal court. Lilly disagrees with the decision and is "evaluating all available options," a company spokesman told Reuters, adding that the ruling doesn't affect its ability to provide Emgality to patients... Full

 

 

Stakeholders Urge Labor Department to Finalize PBM Transparency Rule

(4/17, Rebecca Pifer Parduhn, Healthcare Dive) ..."The dozens of smaller PBMs in America simply cannot sustain the regulatory environment the DOL rule would create," the PCMA wrote in its comment letter. This argument could hold water with the Trump administration, which has hustled to roll back government restrictions on the private sector... Full

 

PBMs Warn Trump's Proposal to Disclose Drug Prices Is Illegal

(4/20, Bob Herman, STAT+) ...Most groups voiced praise for the rule. There was unequivocal support from union health plans, such as the 32BJ Health Fund, and consumer groups, including Patients for Affordable Drugs and AARP. Two Democrats in the House, Bobby Scott of Virginia and Mark DeSaulnier of California, endorsed the rule as well. Others also called for the DOL to copy the language from the PBM reforms in the recent law to minimize confusion... Sub. Req'd

 

Drug Price Relief Is Within Reach — But Only If Washington Moves Now

(4/17, James Gelfand, Washington Examiner) ...If Congress does not act, costs will continue to rise, eroding employer-sponsored coverage. It's time to seize on this growing political momentum and advance patent reforms, accelerate generics and biosimilars approvals, and enact PBM fiduciary requirements... Full

 

Trump Is Right to Rebalance Global Drug Prices

(4/19, Drew Johnson, Washington Examiner) ...Immunotherapies show what scientists can achieve when companies have the incentives to take risks and invest in research. If we want more breakthroughs like these, we need a system where America leads in developing new treatments and where other countries pay fair prices for the fruits of that research... Full

 

Drug Price Controls Sound Good Until You're The Cancer Patient They Leave Behind | Opinion

(4/18, Becky Corbin, Penn Live) ...Cancer care isn't one-size-fits-all. New therapies don't just extend life in abstract terms – they help people stay in the workforce, care for their families, and remain independent. Reducing those outcomes to a calculation designed by distant bureaucracies ignores both human dignity and medical reality... Full

 

Medicare Benefits Would Change for Millions Under New Senate Bill

(4/18, Newsweek) ...The legislation, introduced by Senators James Lankford, a Republican from Oklahoma, and Maggie Hassan, a Democrat from New Hampshire, would require Medicare Part D plans to include lower-cost generics when those alternatives are cheaper than brand-name drugs... Full

 

They Said It! Lawmakers and Health Care Experts Call for Bipartisan Solutions to Boost Generic and Biosimilar Competition to Lower Prescription Drug Prices

(4/17, CSRxP) ...Lawmakers and experts called for action on bipartisan solutions like the Biosimilar Red Tape Elimination Act (S.1954), Ensuring Timely Access to Generics Act (S.3014), Skinny Labels, Big Savings Act (S.43), Fair Accountability and Innovative Research (FAIR) Drug Pricing Act and additional market-based policies to eliminate barriers to greater competition to effectively lower drug prices for American consumers... Full

 

The Accidental Architect of America's Drug Patent Problem

(4/20, KFF Health News) ...Depending on whom you ask, Alfred Engelberg could be a hero or a villain in the story of American pharmaceuticals. The patent lawyer helped write legislation that led to a dramatic increase in the number of generic drugs on the market. He also contributed to a patent system that gives pharmaceutical companies monopolies on their most lucrative drugs, blocking generic competition and keeping prices high along the way. An Arm and a Leg host Dan Weissmann traces Engelberg's story back more than 50 years... Full

 

Momentum Builds for Congress to Stop Big Pharma's Costly Patent Abuse

(4/17, PCMA Blog) ...A federal judge ruled this week that a brand drugmaker must face a lawsuit "claiming it used unlawful methods to block generic competition for its multiple sclerosis drug Copaxone."... Full

 

FDA Warns Firm for Inappropriate Use of AI in Drug Manufacturing

(4/17, Joanne S. Eglovitch, Regulatory Focus) ...An attorney who spoke to Focus noted that this action does not mean the agency is against AI; rather, it emphasizes that manufacturers should not depend on AI without a proper understanding of GMPs... Full

 

Women Can't Get Estrogen Patches. Here's What the FDA Is Doing to Help.

(4/17, Laura Trujillo, USA Today) ...Now the Food and Drug Administration tells USA TODAY the organization is talking with the five biggest patch manufacturers, ensuring all companies are running at capacity. FDA officials won't categorize the difficulty in finding the patch as a shortage, but say if it gets worse, then they will work with manufacturers and compounding facilities to ensure the need is met... Full

 

Hearings With RFK Jr. Continue, FDA Approps Process Kicks Off

(4/17, Jessica Karins, Inside Health Policy) ...Kennedy will appear before the House Energy & Commerce health subcommittee Tuesday (April 21) at 10 a.m. and the Senate Appropriations HHS subcommittee at 2:30 p.m. On Wednesday (April 22), he'll give testimony to the Senate Finance Committee at 10 a.m. and to the Senate health committee at 2 p.m... Sub. Req'd

 

Addressing Regulatory Issues and the Biosimilar Void: Q&A with Thomas Newcomer

(4/20, Mike Hollan, Thomas Newcomer, PharmExec.com) ...Pharmaceutical Executive spoke with Thomas Newcomer, SVP and head of US commercial at Samsung Bioepis about the biosimilar market in the United States. While FDA's draft guidance may alleviate some of the pressures when biosimilar developers, there are still other significant factors impacting the market... Full

 

Colorado Could Exempt 67 Percent of Prescription Drugs From Affordability Review

(4/17, Eric Galatas, Colorado News Connection) ...Senate Bill 26-140 would bar the board from reviewing hundreds of commonly prescribed drugs initially developed to treat rare diseases... Full

 

 

CGRP Inhibitor Fremanezumab Demonstrates Efficacy in Pediatric Episodic Migraine at AAN 2026

(4/18, Marco Meglio, Neurology Live) ...Results from two randomized, placebo-controlled phase 3 studies presented at the 2026 American Academy of Neurology (AAN) Annual Meeting, held April 18-22 in Chicago, Illinois, demonstrated that fremanezumab (Ajovy; Teva Pharmacueticals) improved outcomes in pediatric episodic migraine, although no significant benefit was observed in chronic migraine... Full

 

argenx Brings Neuromuscular Leadership to AAN 2026 with New Data Supporting Broader VYVGART Use Across MG and CIDP

(4/18, argenx SE) ...Presentations will also highlight new data for adimanebart in congenital myasthenic syndromes (CMS) and argenx's broader neuromuscular pipeline, including Phase 3 programs evaluating empasiprubart in CIDP... Full

 

Lundbeck Presents New Data at AAN 2026 Highlighting Real-World Changes in Migraine-Related Cognitive Symptoms after Starting

(4/19, Lundbeck) ...The one-year INFUSE study observed patient-reported migraine-related cognitive symptoms at baseline and changes over 6 months in those with at least one prior anti-calcitonin gene-related peptide (anti-CGRP) treatment failure... Full

 

Indirect Comparison Analysis of Head-to-Head Migraine Trials Suggests Early Efficacy Advantage With Atogepant Over Erenumab

(4/18, Isabella Ciccone, MPH, Neurology Live) ...A recent indirect treatment comparison presented at the 2026 American Academy of Neurology (AAN) Annual Meeting, held April 18–22 in Chicago, Illinois, indicated that treatment with atogepant (Qulipta; AbbVie) was linked to a greater likelihood of achieving a clinically meaningful reduction in monthly migraine days (MMDs) in the first month vs erenumab (Aimovig; Amgen), suggesting a potentially earlier treatment... Full

 

Parkinson Therapy IPX203 Continues to Show Increased Good ON Time and Reduced OFF Time in Phase 4 ELEVATE-PD Study

(4/18, Isabella Ciccone, MPH, Neurology Live) ...Real-world data of the ELEVATE-PD study, presented at AAN 2026, suggest that switching to IPX203 from other levodopa-based therapies may improve motor function in patients with Parkinson disease... Full

 

Cedars-Sinai Neurologists Present Research at AAN 2026

(4/17, Kelsie Sandoval, Cedars-Sinai) ...Yvette Bordelon, MD, PhD, director of the Cedars-Sinai Huntington's Disease Society of America Partner Center of Excellence, will discuss gene therapy for Huntington's disease, including new therapeutic developments, clinical applications of research and innovative technical advances... Full

 

How Chinese Drug Makers Are Tackling Western Dominance in US$16 Billion Parkinson's Race

(4/19, Julie Zhang, South China Morning Post) ...Chinese biomedical companies deploying cutting-edge technologies are emerging as serious competitors to Western dominance in the race to treat Parkinson's disease, in a market that could reach US$16 billion over the next decade... Full

 

Nancy Wexler Looks Back on a Life Spent Unraveling the Mystery of Huntington's Disease

(4/17, Alice Park, TIME) ...In 1993, 25 years after her family launched [The Hereditary Disease Foundation (now called the Huntington's Disease Foundation, or HDF)], the group of scientists they supported finally identified the Huntington's gene, called, huntingtin, or HTT. Years later, Wexler began noticing the motor symptoms of the disease in herself, though it took time for her to accept that she was likely affected. "When I saw myself in video interviews, I noticed the movements. I could tell what was happening," she writes in her new memoir, My Life, My Science: Pursuing a Cure for Huntington's Disease. "But for a long time, I didn't accept it. Denial was my mode of operation, carrying on the family tradition."... Sub. Req'd

 

 

Amneal Builds Scale In US Drug-Device Respiratory Market

(4/17, Dean Rudge, Generics Bulletin) ...Amneal has entered the US metered-dose inhaler market with generic versions of ProAir and the original, discontinued QVAR formulations, marking its first launches in a technically complex, device-driven category... Global Sub. Full

 

Hikma Hits Back Over Amarin's 'Strawman' Induced Infringement Claims

(4/17, Dave Wallace, Generics Bulletin) ...In its reply brief to a recent Amarin filing, Hikma attacks the originator's "strawman assertions" and insists it is "not asking for a safe harbor."...Instead, Hikma says the originator has failed to assert plausible allegations that the generics firm expressly advertised or instructed an infringing use for its icosapent ethyl... Global Sub. Full

 

ANI Pharmaceuticals Announces the FDA Approval and Launch of Pimozide Tablets With 180 Day CGT Exclusivity

(4/20, ANI Pharmaceuticals) ...ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced the launch of Pimozide Tablets 1 mg and 2 mg. ANI's Pimozide Tablets is the generic version of the reference listed drug (RLD) Orap®... Full

 

 

Xanax Maker Recalls One Batch of Common Anxiety Drug

(4/20, The New York Times) ...The drug's distributor, Viatris, said it was recalling one lot containing 51 bottles of 3 milligram extended release tablets because of concerns that they might not dissolve in the body as expected. This can affect how much of the drug is released and absorbed over time, making the effects less predictable. The pills were sold nationwide under the brand name Xanax XR... Sub. Req'd

 

 

EU Pharma Reform: The Changes Ahead

(4/17, Eliza Slawther, Anabel Costa-Ferreira, Pink Sheet) ...The reform of the EU pharmaceutical legislation has now been finalized, with draft versions of the new directive and regulation recently released. The Pink Sheet offers an infographic comparing the key changes ahead compared to the existing rules for industry... Global Sub. Full

 

UK 'Turns A Corner' On Clinical Trial Set-Up Times But Low Recruitment Still A Concern

(4/17, Vibha Sharma, Pink Sheet) ...New data released on April 15 show that the average time to set up commercial clinical trials in the UK has fallen significantly, exceeding the Prime Minister's original target to have clinical trials up and running within 150 days by March 2026... Global Sub. Full

 

Indian Weight-Loss Market Becomes 'Bloodbath' as Drugmakers Pile In

(4/18, Chris Kay, Krishn Kaushik and Aanu Adeoye, Financial Times) ...Analysts at Jefferies said the semaglutide patent expiry in India had seen the launch of "brands galore" by about 10 drugmakers so far as they chase a "magic pill moment" and a local market worth potentially $500mn-$1bn... Sub. Req'd

 

RDCA Slams Misleading Media Coverage on Generics, Calls for Regulatory Context

(4/18, Peethaambaran Kunnathoor, Pharmabiz.com) ...The association's intervention comes at a sensitive time for the Indian Pharmaceutical Market (IPM), where generic penetration is a cornerstone of patient access. The RDCA highlighted that, portraying generics in a negative light without citing statutory benchmarks, is a disservice to the public and the pharmaceutical fraternity alike... Full

 

Korean Medical Association Opposes Ingredient-Name Prescriptions

(4/19, Hong Da-yeong, The Chosun Daily) ...Kim Taekwoo, president of the Korean Medical Association, stated on the 19th, "We will confront attempts to enforce ingredient-name prescriptions." Kim made this remark during the 78th regular general meeting of delegates held at Dragon City Hotel in Yongsan-gu, Seoul, on the same day... Full

 

Ministry of Food and Drug Safety Appoints 195 to Speed Approvals

(4/20, Heo Ji-yoon, The Chosun Daily) ...The Ministry of Food and Drug Safety announced on the 20th that it has newly appointed 195 public officials to expedite the approval and review of new drugs, biosimilars, medical devices, and other products... Full

 

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