Tuesday, June 16, 2026

 

 

Senate Democrats Explore Drug Pricing Proposals for Next Year

(6/16, Victoria Knight, Bloomberg Government) ...Some of the proposals Senate Democrats floated would significantly expand Medicare drug price negotiations by factoring international prices into the process, increasing the number of drugs negotiated, or starting the negotiation process earlier in a drug's cycle. One section focuses on ideas to address healthcare affordability: applying out-of-pocket caps to other drugs besides insulin, further overhauls of pharmacy benefit managers' business practices, and addressing vertical integration. Another aims to strengthen the US's research capabilities by incentivizing universities and small biotechnology companies to develop new drugs and treatments, and increase clinical trial participation... Sub. Req'd

 

Dems Offer Roadmap to Expand Drug Price Talks

(6/16, Peter Sullivan, Axios) ...Democrats contrasted their drug pricing proposals with Trump's "most favored nation" agreements that 17 major manufacturers struck with the administration. "Trump has tried to capitalize on Americans' frustration by claiming that he is bringing drug prices in the United States down to international levels," the document states. "None of his efforts, however, have delivered results." Democrats, it says, "delivered durable policy change" through the Inflation Reduction Act but "recognize more must be done to lower prices."... Full

 

Medicare Drug Price Rule May Target Under-the-Skin Keytruda and Opdivo

(6/15, Jonathan Gardner, BioPharma Dive) ...The Centers for Medicare and Medicaid Services said the rule would close a "loophole" that allows drugmakers to extend the patent-protected life of blockbuster drugs, commonly called "evergreening." However, Medicare could exempt the newer formulation from its price ceiling should biosimilars of the IV version enter the market and compete on price... Full

 

CMS Targets Combo Drug Workaround Used To Dodge Medicare Drug Price Negotiation

(6/15, Maaisha Osman, Pink Sheet) ...Under a proposal published in the Federal Register on June 12, fixed-dose combinations and single agent products with the same NDA/BLA holder could be aggregated as the "same potential qualifying single source drug" when the additional ingredient both creates a new formulation and enables an alternative route of administration for the shared active moiety... Global Sub. Full

 

Trump's Obesity Drug Plan Creates a Temporary Medicare Program That May Be Hard to End

(6/15, John Wilkerson, STAT+) ...Drugmakers also fare better in Bridge than BALANCE. Eli Lilly and Novo Nordisk agreed to considerably lower net prices of GLP-1 treatments, for all indications, to $245 a month in Medicare and Medicaid in BALANCE. In Bridge, the drug companies will only have to charge the lower $245 price for weight loss drugs, and they can continue selling GLP-1s at higher prices for other conditions... Sub. Req'd

 

The IRA Fixed One Medicare Part D Distortion-But Patients Now Face New Tradeoffs

(6/16, Bryce Platt, Drug Channels) ...Early evidence suggests the IRA reduced patient catastrophic drug spending, but shifted financial risk to plans, which responded by tightening utilization management and narrowing coverage. Combined with the loss of rebate revenue and mandatory coverage of Maximum Fair Price (MFP) drugs, these pressures contributed to the decline of Part D plans... Full

 

PDUFA VIII Riders: China, Rare Disease, Affordability Loom as Add-Ons to 2027 Vehicle

(6/15, Nielsen Hobbs, Pink Sheet) ...The legislation expected to reauthorize the Prescription Drug User Fee Act could carry a substantial policy load next year, with congressional and former Hill staff pointing to China-related competition, rare disease pathways, and drug affordability as the three areas most likely to generate riders on the must-pass vehicle... Global Sub. Full

 

FDA Issues Guidance on Sharing Potential NDA Patent Information

(6/15, Ferdous Al-Faruque, Regulatory Focus) ...The US [FDA] has published draft guidance for applicants for new drug applications (NDAs) and NDA holders on submitting patent information to their NDAs using Form FDA 3542a or Form FDA 3542. The guidance is intended to help applicants and holders submit patent information using the correct form to their NDA and aims to answer commonly asked questions... Full

 

Public Complete Response Letters Have Changed FDA/Sponsor Interactions, Attorney Says

(6/15, Sue Sutter, Pink Sheet) ...The US [FDA's] publication of unapproved product complete response letters has changed how companies interact with the agency during drug development and how the FDA frames its regulatory decisions... Global Sub. Full

 

Rethinking The Value Of The 180-Day Exclusivity Period For Generic Drugs

(6/15, Keith M. Drake, Health Affairs) ...The exclusivity period is not needed to motivate patent challenges for at least some categories of drugs. And it clearly reduces competition and increases drug prices in several ways. Policies that tailor or even eliminate the exclusivity period might reduce spending on drugs by billions of dollars per year... Full

 

Warnings About Generic Drug Quality Reach Capitol Hill

(6/15, Lisa Fletcher, Andrea Nejman, Nathan Aaron, Spotlight on America) ...Their latest findings examined 25 generic drugs from more than 350 suppliers. According to Valisure, 72% of the products tested received a green rating, indicating no significant concerns. But 15% received a red rating, signaling concerns about manufacturing quality, dissolution performance or the presence of contaminants such as toxic metals or nitrosamines, compounds linked to cancer... Full

 

Investors Say Unstable FDA Is Harming Rx Innovation, Driving Companies To China

(6/15, Gabrielle Wanneh, Inside Health Policy) ...Incubate founder and executive director John Stanford said FDA needs a leader invested in reprioritizing science and establishing the predictability and certainty needed to keep drug development in the United States... Sub. Req'd

 

FDA Approves Colorado's Plan to Import Cheaper Drugs From Canada

(6/15, Lizzy Lawrence, Ed Silverman, STAT+) ...The [FDA] said Monday that it will allow Colorado to import certain prescription drugs from Canada in an effort to bring prices down for residents, making it the second U.S. state to be granted such authorization... Sub. Req'd

 

 

Lilly Oncology Chief Went from 'Extremely Nervous' to 'Blown Away' by New Jaypirca CLL Data

(6/15, Angus Liu, Fierce Pharma) ...Because the control arm is very active, experts knew the trial had a good chance of failing, Jake Van Naarden, president of Lilly Oncology, recalled to Fierce. "I was extremely nervous about this readout," Van Naarden said in an interview. "In light of that, to see data that are this compelling, I was blown away when we unblinded this." The data Van Naarden saw, presented Sunday at the 2026 European Hematology Association, showed that the addition of Jaypirca to a fixed-duration regimen with venetoclax and rituximab reduced the risk of disease progression or death by 45.3%... Full

 

Data Could Move J&J's Talvey Earlier in Myeloma Therapy

(6/16, Phil Taylor, pharmaphorum) ...[Wake Forest University School of Medicine's Peter Voorhees] said the results suggest the two Talvey/Darzalex Faspro regimens are a potential new bispecific combination for patients with relapsed or refractory multiple myeloma in earlier lines - a critical time for treating patients with the most effective regimens. There are some things to consider in the results, including the fact that most patients had grade 3 or higher adverse events - although, overall rates were similar between the three arms - and that the study excluded patients with prior exposure to CD38-directed drugs... Full

 

Crexont Increased Good "On" Time in Phase 4 Parkinson Disease Study

(6/15, Practical Neurology) ...Participants who switched from immediate-release carbidopa/levodopa (IR CD/LD; n=156) had a 3.33-hour increase in daily good "on" time and a 3.20-hour reduction in daily "off" time... Full

 

 

Prestige Biopharma Seeks Collaboration Opportunities at BIO USA

(6/16, Lee Sungmin, The Asia Business Daily) ...Prestige Biopharma Group plans to discuss joint development and commercialization strategies for its follow-up pipeline with global pharmaceutical and biotechnology companies, based on its integrated value chain that connects development, production, and commercialization. The company will also showcase its technology for subcutaneous (SC) formulation conversion of antibody medicines, as well as its AI-based research and development and biomanufacturing capabilities... Full

 

CinnaGen Converts Teriparatide Setback Into European Regulatory Breakthrough

(6/16, Dean Rudge, Generics Bulletin) ...Iranian player CinnaGen is celebrating a significant milestone after the European Commission approved its Zandoriah (teriparatide) biosimilar to Forsteo, handing the Tehran-based biopharma its first EU marketing authorization and a foothold in one of the world's major regulated markets... Global Sub. Full

 

 

Global Drugmakers Invest Billions to Boost US Presence

(6/15, Reuters) ...Global drugmakers are expanding their U.S. footprint, pledging billions of dollars to ramp up manufacturing capacity and research in the country. Pharmaceutical companies including Eli Lilly, Pfizer, AstraZeneca and Roche have announced roughly $500 billion in U.S. investments as they seek to strengthen infrastructure, mitigate supply-chain risks and reassure investors... Full

 

Amid US Investment Tour, J&J Makes $1B Stop in Florida to Upgrade Contact Lens Plant

(6/15, Fraiser Kansteiner, Fierce Biotech) ...J&J is plugging more than $1 billion into its operations in Jacksonville, Florida, to boost its production and distribution firepower for the widely prescribed Acuvue line of contact lenses, the company said in a June 15 press release... Full

 

Pharma Billionaire Eyes Crown of World's Top Insulin Supplier

(6/16, Satviki Sanjay, Bloomberg) ..."In five years, we could be the number one insulin company in the world," the 73-year-old pharma billionaire and Biocon Executive Chairperson said in an interview with Bloomberg Television's Latitude with Haslinda Amin. "We are one of the few companies globally that has the scale to address that opportunity."... Full

 

Formycon Started 2026 On A Strong Financial Note - Can It Be Maintained?

(6/15, Urte Fultinaviviute, Generics Bulletin) ...Formycon said the new year had started successfully and showed "a clear growth trend" - confirmed by the company's proposed financial forecast...While the US and EU remain key markets, Formycon is equally interested in reducing its dependency on them and putting more focus on other regions, which it has successfully done through multiple global partnerships... Global Sub. Full

 

Aurobindo Looks To Bolster French Footprint With Facility Purchase

(6/15, Dave Wallace, Generics Bulletin) ...Aurobindo has taken a "new step" in France by acquiring a former Bristol Myers Squibb facility in Meymac, as part of a strategy to cement its operations in the country and strengthen local production and supply security..."This acquisition strengthens Aurobindo's and Arrow's industrial footprint in France, a key market where local presence plays an important role in pricing discussions," an Aurobindo spokesperson told Generics Bulletin... Global Sub. Full

 

Healthcare Costs Poised to Jump 9% in 2027 as Health Plans Blame AI Adoption, Drug Prices

(6/11, Heather Landi, Fierce Healthcare) ...Payers are pointing the finger at several inflationary factors, including the increasing use of artificial intelligence tools by health systems, hospitals and medical practices. AI-enabled documentation and coding tools allow providers to capture greater specificity and reimbursable severity without proportionate increases in care intensity, according to PwC's report. As a result, payers see higher paid amounts per claim... Full

 

What Do You See as The Next Phase of Obesity Innovation?

(6/15, Nicholas Jacobus, PharmExec.com) ...Brian Hilberdink, president of U.S. Human Pharma, Boehringer Ingelheim, who has worked in the obesity space since the earliest days of modern pharmacologic treatment and previously spent 26 years at Novo Nordisk, discusses how the next phase of obesity innovation must move beyond a narrow focus on weight loss to a broader concept of metabolic health... Full

 

Nearly 375,000 Bottles of Popular Antidepressant Recalled Over High Levels of Carcinogen

(6/15, Megan Divers, WNEP) ...Breckenridge Pharmaceuticals is pulling both the 30mg and 60mg versions of duloxetine delayed-release capsules - a generic form of the brand-name drug Cymbalta - from shelves nationwide. The recalls cover multiple lots across both doses and remain ongoing... Full

 

 

German Government to Abandon Variable Drug Discounting Plans, Source Tells Reuters

(6/15, Andreas Rinke, Reuters) ...The variable discounts will be replaced with new discounts at a fixed level so that companies can plan ahead, the source said, without specifying the size of the new discounts... Full

 

Drug Groups Warn US Pricing Policy Is Choking Off New Medicines in Sweden

(6/16, Monica Kleja, Euractiv) ...The agency interviewed the Swedish affiliates of ten major pharmaceutical multinationals and found that, while none had withdrawn existing drugs from the market, most had postponed new launches for some time as headquarters sought additional information on Swedish pricing and reimbursement conditions... Full

 

UK's MHRA To Pilot Up To Five AI Drug Safety Tools Via Regulatory Sandbox

(6/15, Eliza Slawther, Pink Sheet) ...The MHRA, which regulates drugs and medical devices in the UK, said its sandbox would allow innovators to test AI tools that have the potential to predict how medicines behave in the body, "including how they are absorbed, processed and whether they may cause harm."... Global Sub. Full

 

How Clinical Trial Inspectors Look Beyond Buzzwords To Spot Real Quality Culture At Companies

(6/15, Vibha Sharma, Pink Sheet) ...The International Council for Harmonisation's good clinical practice (GCP) guideline E6(R3) calls for quality culture to be embedded in the core processes of trial sponsors and backed by senior leadership. GCP inspectors can tell when this is not the case, according to Jason Wakelin-Smith of the UK's Medicines and Healthcare products Regulatory Agency... Global Sub. Full

 

Japan, South Korea Challenge the West's Place in Research Rankings: Report

(6/15, Will Maddox, Fierce Biotech) ...Nature Index's latest research rankings show that China continues to be the clear leader in contributions to scientific journals, with a 22% increase between 2024 and 2025. While China remains well ahead of the rest of the top 10, nearly 10% growth in journal contributions from Japan and South Korea outpaced higher-ranked Western countries such as the U.S., Germany and the UK... Full

 

FAQ: Strait of Hormuz Reopening - What It Means for Pharma Supply Chains

(6/15, Stephen Appezzato, Pharmaceutical Commerce) ...The connection is less obvious than it appears. The US gets nearly 47% of its generic prescriptions and 15% of the volume of biosimilars from India. India, in turn, depends on the Strait of Hormuz for around 40% of its crude oil imports, and that oil feeds directly into the petrochemical inputs used throughout pharmaceutical manufacturing. The dependency doesn't stop at APIs: pharmaceutical supply chains also rely on petrochemical inputs, petroleum-based packaging materials, and logistics systems all tied, directly or indirectly, to the free flow of energy and goods through the Middle East... Full

 

Brazil Aligns With Global Consensus On Biosimilar Switching

(6/15, Dean Rudge, Generics Bulletin) ...Brazil's health regulator Anvisa has formally endorsed switching patients between reference biologics and their biosimilars, concluding that the practice is not expected to produce clinically relevant differences in safety, efficacy or immunogenicity when carried out under approved conditions of use and with appropriate monitoring, traceability and pharmacovigilance... Global Sub. Full

 

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