Friday, October 16, 2026

 

 

Mayne Pharma Agrees To Settle IMVEXXY Patent Litigation With Teva Pharmaceutical

(10/16, RTTNews) ...On Friday, Mayne Pharma Group Ltd., said it has agreed to settle U.S. patent litigation with Teva Pharmaceuticals USA concerning IMVEXXY, its estradiol vaginal inserts for treating moderate to severe dyspareunia due to menopause... Full

 

Mayne Pharma Settles Patent Dispute with Teva over Menopause Drug

(10/16, Capital Brief) ...The settlement resolves a patent litigation initiated in 2020, concerning Imvexxy's Orange Book-listed patents, providing a pathway for Teva Pharmaceuticals USA to potentially launch a generic version of the treatment from 2 September 2032, or earlier under certain circumstances, subject to court approval... Full

 

Mayne Pharma Clears Another Legal Hurdle as Teva Agrees to 2032 Generic Entry for Imvexxy

(10/16, Business News Australia) ...The Teva and Sun settlements still need court approval... Full

 

 

Trump Hasn't Lowered Drug Prices for These Voters

(10/16, Rebecca Robbins, The New York Times) ...President Trump has said for months that his efforts to reduce drug prices should alone be enough for Republicans to win the midterm elections in November. But the president's initiatives have not brought financial relief for voters like James Evans, 37, a real estate agent who does not have insurance coverage for most prescription medicines. He said he worried that he was one bad diagnosis away from bankruptcy... Sub. Req'd

 

A New Medicare Season Begins, but Some Shifts Will Arrive in 2027

(10/15, Fatima Hussein, Associated Press) ...New changes to Medicare coming in 2027 include higher Part D out-of-pocket caps, the end of temporary federal Part D premium subsidies, and new drug price negotiations... Full

 

Trump Increased Investments in Drugmakers That Benefited from Medicare Exemptions, Democrats Say

(10/16, Fatima Hussein, Associated Press) ...The report, released Friday by the Joint Economic Committee's minority arm, found that Trump's pharmaceutical stock holdings grew from a maximum reported value of $1.7 million in 2024 to as much as $56.2 million at the end of 2025. The report said that included up to $39.1 million worth of stock held in companies that benefited from exemptions to Medicare's drug price negotiation program, which came through a provision in Republicans' 2025 tax and spending law... Full

 

Epic Teams up With Amazon Pharmacy, Eli Lilly and Mark Cuban to Launch Prescription Drug Pricing Tool

(10/15, Heather Landi, Fierce Healthcare) ...Through the prescription marketplace, slated to launch next summer, clinicians and patients at health systems using Epic will compare medication costs at different pharmacies—patients' insurance prices and pharmacies' cash prices—before the prescription is sent. Depending on the medication, the patient's insurance plan, and the pharmacy, paying cash can sometimes cost less, Epic executives said in a press release... Full

 

Paragon Health, Former FDA Commissioner Push Bipartisan Drug Development Reforms

(10/15, Lauren Brensel, Inside Health Policy) ...Among their recommendations, which they said weren't exhaustive, is a pilot for lower-risk Phase 1 trials modeled after Australia's drug development process where sponsors notify FDA when an institutional review board (IRB) completes its pre-clinical safety evaluations... Sub. Req'd

 

Trump Says US Will Have More 'Narcan-Type' Products Coming Out

(10/15, Cam Kettles, Bloomberg Law) ...President Trump says the US will have more "Narcan-type" products coming out soon...Trump does not elaborate further on the products... Sub. Req'd

 

User Fee Deflation: PDUFA Goals Letter Shrinking Along With Fees

(10/15, Michael McCaughan, Pink Sheet) ...FDA officials are considering written and oral comments on the agreement in anticipation of sending a final version to Congress in January. However, PDUFA VIII will not only be known as the first time the FDA agreed to collect less money under the program. The agreement also is the first time the FDA and industry agreed the agency also should do less in terms of user-fee-funded activities... Global Sub. Full

 

Transparency Makes Modern Regulatory Science Stronger — FDA's Transparency Roadmap

(10/16, Lowell M. Zeta, JD, FDA Voice) ...The Transparency Roadmap reflects the agency's intention to maximize disclosure, guided by what is appropriate and good for public health. It was shaped by soliciting ideas and expertise from innovators across the agency, and it may continue to evolve as we seek the best ways to inform the public and protect public health while maintaining IP protections that cultivate a healthy innovation environment... Full

 

Experts Favor a New Regulatory Framework for Clinical AI Models

(10/15, Joanne S. Eglovitch, Regulatory Focus) ...Congress should enact a specific regulatory framework for artificial intelligence (AI) models developed and used in academic medical centers, Scott Gottlieb argued in an opinion piece published in JAMA Health Forum. Such systems should not be regulated as commercial medical devices or left unregulated, according to Gottlieb, a former Commissioner of Food and Drugs, now at the American Enterprise Institute. Three experts who spoke with Focus said they support the plan... Full

 

Exempt Prescription Drugs From Canadian Tariffs

(10/16, Francisco Raul "Quico" Canseco, DC Journal) ...There is a solution sitting in plain sight: personal importation of prescription drugs from trusted, Western-aligned allies like Canada. It works... Full

 

Prescription Drug Affordability Boards Reshape Reimbursement While Leaving Core Problems Unresolved

(10/15, William V. Padula, Health Affairs) ...Affordability policy should therefore distinguish between spending and patient financial burden. Until reviews are more directly connected to the mechanisms that determine what patients actually pay, and whether they can access treatment, PDAB interventions may alter reimbursement without resolving the problem they were created to address... Full

 

Virginia Is for Manufacturing: State Leads by Winning $12.6B in Onshoring Projects

(10/15, Anna Brown, Endpoints News) ...While the tally represents just a portion of the roughly $585 billion that major companies have pledged since the start of 2025 under Trump's threat of tariffs, Virginia leads in projects that have been announced with specific locations and price tags, an Endpoints News analysis shows... Sub. Req'd

 

 

With New Omvoh Analyses, Lilly Argues 'Higher Bar' for IBD Treatment Is Within Reach

(10/15, Fraiser Kansteiner, Fierce Pharma) ...The new findings, which tied Omvoh (mirikizumab) to patients meeting multiple simultaneous treatment goals in ulcerative colitis (UC) and Crohn's at one year of treatment, leveraged fresh analyses of Lilly's Lucent and Vivid programs in the respective IBD indications, including through the use of a newly devised composite outcome metric in UC, Lilly said Thursday... Full

 

Merz Concludes Enrolment in Phase III Xeomin Trials for Migraine

(10/16, Salong Debbarma, Clinical Trials Arena) ...The studies enrolled around 1800 participants to test the therapy's safety and efficacy in preventing both chronic and episodic migraine. Patient intake reached completion six months ahead of schedule across 109 investigation sites located in Europe and North America... Full

 

 

Accord Builds On US Portfolio Dream With Filgrastim Biosimilar Launch

(10/15, Urte Fultinaviciute, Generics Bulletin) ...Filkri is available in 300mcg/0.5ml and 480mcg/0.8ml pre-filled syringe presentations, with pack sizes of one or 10 pre-filled syringes per carton. It will be manufactured by Accord's parent company Intas... Global Sub. Full

 

 

Companies Pour Billions of Dollars Into New 'Protein Degrader' Drugs

(10/16, Lizzy Lawrence, The Wall Street Journal) ...Virtually all major pharmaceutical companies are developing protein degraders, through their own research or licensing deals. Around 200 protein degraders are being studied worldwide, with more than $5 billion in deals for these drugs from 2021 to 2026, according to biopharma-intelligence service Sleuth... Sub. Req'd

 

Analysis-Revolution Medicines' Europe Efforts Signal Solo Launch Ambitions for Cancer Drug

(10/15, Sriparna Roy and Bhanvi Satija, Reuters) ...Revolution Medicines is laying the groundwork for a broad European commercial rollout of its pancreatic cancer drug, signaling confidence in its ability to bring the therapy to market without relying on a local partner to help sell it... Full

 

Par Health Recalls 22 Lots of IV Blood Thinner, its 3rd US Product Pull in a Month

(10/15, Donavyn Coffey, Fierce Pharma) ...Par Health has issued a voluntary recall of 22 lots of the direct thrombin inhibitor argatroban for IV injection that could be contaminated with cellulose, polystyrene, polyethylene terephthalate, stopper material, and potentially even stainless steel. The recall, which was published to the FDA's website on Oct. 14th, is Par's third in a matter of weeks... Full

 

 

MHRA Announces Strategy to Streamline Regulation in the AI Era

(10/14, Ferdous Al-Faruque, Regulatory Focus) ...While scientific and technological discoveries are transforming products used to prevent, diagnose, and treat disease, MHRA CEO Lawrence Tallon singled out AI as a key driver, reshaping both product regulation and the operations of healthcare companies. Cell and gene therapies, personalized medicine, and advanced diagnostics are also advancing medical care, he added... Full

 

Faster Decisions And Earlier Access: UK Generics Industry Welcomes MHRA's 2030 Targets

(10/16, Dave Wallace, Generics Bulletin) ...Speaking to Generics Bulletin, Medicines UK made it clear that it welcomed the MHRA's new strategy while also pointing to post-Brexit issues that still need to be addressed. Robert Russell-Pavier, Medicines UK's director of policy and economics, said "we welcome the MHRA's new 2030 strategy and its clear emphasis on accelerating decisions on generics and biosimilars to increase NHS savings and improve patient access."... Global Sub. Full

 

Sitharaman Says Trade Barriers A Hurdle to China-India Ties

(10/16, Srinidhi Ragavendran and Ruchi Bhatia, Bloomberg) ...India faces growing trade imbalances with China as Beijing's non-tariff barriers continue to restrict access for Indian products, Finance Minister Nirmala Sitharaman said on Friday. "With China, I think our trade balance is against us, and it is growing exponentially," Sitharaman said on the sidelines of the International Monetary Fund meeting in Bangkok, speaking with the Atlantic Council. "China uses non-tariff barriers unhesitatingly" and that is "the biggest hurdle in the in the trade between India and China."... Sub. Req'd

 

India Overhauls Drug Patent Guidelines to Curb Evergreening and Speed up Cheap Generics

(10/16, Priyanka Sharma, Mint) ...New draft guidelines issued by the Office of the Controller General of Patents, Designs and Trade Marks under the ministry of commerce and industry propose to set stricter evidentiary benchmarks to verify inventions and prevent patent extensions that delay generic versions... Full

 

Better Analytics Leads to Fewer Regulator Questions

(10/16, Dan Stanton, pharmaphorum) ...Biocon and Ipca both intensify to bring down cost of goods sold (COGS), and both put the analytics on the same footing as the process itself, with the payoff landing in the regulatory file. Kumaran Sivalinga Vasu, functional leader for upstream at Biocon Biologics, and Sanjeev Gupta, senior vice president and head of biosimilar and advanced biotech lab at Ipca Laboratories, spoke in separate interviews at Sartorius's Process Intensification Forum in Hyderabad, held from 2nd to 4th June 2026... Full

 

India's Pharmacy Sector Strengthens Focus on Affordable, Uninterrupted Medicine Supply

(10/15, Nandita Vijayasimha, PharmaBiz) ...Rajesh Kumar, CEO, Generic Remedy, said that our country's pharmacy market is entering a phase where execution will matter more than expansion. Government initiatives and private players have significantly improved access to medicines, but the next challenge lies in ensuring that this access translates into a reliable consumer experience... Full

 

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