Friday, July 18, 2025

'Hard to Know What's Going to Happen': Big Pharmas Put Brave Face On Looming Tariff Threat

(7/18, James Waldron, Fierce Pharma) ...While executives at both Johnson & Johnson and Novartis had a good financial story to tell this week, analysts and journalists were understandably eager to get the companies' take on the tariff threat. On an earnings call with analysts on Wednesday, J&J's CEO Joaquin Duato was keen to deflect the conversation away from tariff uncertainty and toward praise for Trump's "big, beautiful bill."...When Novartis unveiled its own second-quarter earnings results the following day, CEO Vas Narasimhan, M.D., gave a deeper insight into how the company would handle the "significant" hit from the pharmaceutical tariffs proposed this week... Full

Novartis CEO Says Resolution On Trump Plan to Cut US Drug Prices Will Take Time

(7/17, Ned Pagliarulo, BioPharma Dive) ...Novartis is exploring options to meet the Trump administration's goal of bringing U.S. drug prices down to match what European and other high-income countries pay, but doesn't expect any policy resolution soon, CEO Vas Narasimhan said on an earnings call Thursday. "Conversations with the administration, from the Novartis standpoint, have been productive, very open dialogue to find solutions," Narasimhan told analysts. Yet, "in terms of resolution, it's very difficult to say," the executive added later. "There are different approaches that HHS is thinking through," he said, referring to the Department of Health and Human Services... Full

Trump Urges Supreme Court to Reject Challenge to His Tariffs

(7/17, Greg Stohr, Bloomberg) ...President Donald Trump asked the US Supreme Court to turn away a challenge to his sweeping tariffs, telling the justices they should let the legal fight develop before getting involved. The filing comes in a case filed by two educational-toy makers that want the justices to take an unusual shortcut by getting involved before a federal appeals court has ruled. US Solicitor General D. John Sauer, the administration's top Supreme Court lawyer, told the justices Thursday that they "should not leapfrog" the lower court proceedings... Full

Pharma Exports from Ireland Climb Again as Trump's Drug Tariffs Inch Closer

(7/17, Anna Brown, Endpoints News) ...Drugmakers previously told Endpoints News that they were stockpiling drugs in the US as a strategy to curb the impact of potential pharma tariffs. In March, Ireland saw a massive 243% increase in pharma exports, compared to the same month last year. And out of total exports to the US, 94% were chemicals and pharma products. Now with Ireland seeing an exodus of pharma products again, companies could be back to stockpiling more inventory as the industry awaits further details on tariffs. Trump has said that the initial tariffs on pharmaceuticals will be small and that he will give companies a grace period of a year to move manufacturing to the US, before increasing the levies... Sub. Req’d

Cassidy Pushing For Bipartisan Health Bill

(7/17, Luke Zarzecki, Inside Health Policy) ...As the reconciliation process has wound down, Senate health committee Chair Bill Cassidy (R-LA) tells Inside Health Policy he is pushing for a bipartisan health bill that may include many of the topics from the failed December lame duck package. "I've been advocating that we have a bipartisan health bill that would go through normal, regular order," he told IHP Thursday (July 17). "I think there's interest, on a bipartisan basis, to do that."... Sub. Req’d

Part B Negotiation Proposal Would Lower Prices In MA, Private Plans Too, Stakeholders Complain

(7/17, Cathy Kelly, Pink Sheet) ...Stakeholders believe that under the US Centers for Medicare and Medicaid Services' current approach to implementing the Medicare price negotiation program for Part B physician-administered drugs, the impact of lower prices could extend beyond the fee-for-service program and erode reimbursement for a substantial portion of Medicare Advantage and commercial plans... Global Sub. Full

How Cutting Red Tape Could Lower Prescription Drug Prices

(7/17, Patricia Kelmar, PIRG) ...One of ten people say it's tough to afford both health care and prescription medications, according to a 2024 survey. That means about 29 million people have to make difficult decisions about their health and their family budget...The Biosimilar Red Tape Elimination Act (S. 1954) will eliminate unnecessary testing before lower-priced biosimilar drugs can be substituted for brand name biologics at the pharmacy counter... Full

PBM Changes Pick Up Steam Post-Reconciliation

(7/17, Victoria Knight, Axios Pro) ...A group of House Energy and Commerce and Ways and Means members last week introduced a bipartisan PBM package that revives most of the discarded policies. It includes a ban on spread pricing in Medicaid and language delinking PBM compensation from the price of the drug in Medicare Part D. The package also would impose transparency measures on the companies...New Energy and Commerce health subcommittee Chair Morgan Griffith told Axios that he "absolutely" wanted to revisit PBM reform in the committee... Sub. Req’d

'Abuse of Power': Senators Call Out 'Shady Tactics' After Investigating Pfizer, Lilly DTC Platforms

(7/17, Andrea Park, Fierce Pharma) ...After a nine-month investigation into direct-to-consumer telehealth platforms launched by Eli Lilly and Pfizer, a group of senators has released a report suggesting the platforms may allow pharmas to inappropriately influence doctors' prescribing habits...According to the investigation, patients routed to a tele-provider visit via the platforms were given a prescription 85% of the time through PfizerForAll and 74% of the time through LillyDirect. In one example, more than 500 of the 620 LillyDirect patients who had a virtual visit via telehealth partner 9amHealth were prescribed a medication, a rate of around 83%, compared to just 39% of 9amHealth's overall patient population... Full

Three Takeaways from US Senators' Report On Pharma-Telehealth Relationships

(7/17, Shelby Livingston, Endpoints News) ...Pharma and telehealth companies took issue with the report's findings. A Lilly spokesperson said the company is "disappointed that the Senators' report mischaracterizes Lilly's intent in offering patient-focused resources on LillyDirect." Representatives for Lilly and Pfizer said the telehealth providers they link to use their own clinical judgement and aren't paid to write prescriptions. Here are the biggest takeaways from the senators' report, from how much pharma companies pay their telehealth partners, to how many patients and prescriptions are flowing through the relationships... Sub. Req’d

PwC Insight into Health Policy and 2026 Cost Projections

(7/18, The Pharma Letter) ...PwC has released its Medical Cost Trend: Behind the Numbers 2026 report, outlining the primary inflators and deflators of healthcare costs across the industry. It finds that AI investments, new drugs like GLP-1s, and behavioral health treatments are keeping costs elevated - a steady but high 8.5%... Sub. Req’d

‘Our Position Has Naturally Shifted' – How Standalone Sandoz Is Taking On Originator Abuses

(7/17, Dave Wallace, Generics Bulletin) ...As a standalone generics and biosimilars company, Sandoz now feels freer to speak out against originator abuses of intellectual property, the firm's global IP head Julia Pike tells Generics Bulletin, including challenges to Bayer on rivaroxaban and Amgen on etanercept...Meanwhile, commenting on the recent sanctions by the European Commission over the abuse of divisional patents in its case against Teva over Copaxone (glatiramer acetate), Pike was clear that such action did not go far enough. "What we need isn't more antitrust enforcement – we need real reform," she urged... Global Sub. Full

Knight Therapeutics Announces Filing of New Drug Submission for CREXONT(R) (Carbidopa and Levodopa) Extended-Release Capsules in Canada

(7/18, Knight Therapeutics) ... CREXONT(R) is a novel, oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules for the treatment of Parkinson's disease. The innovative design of CREXONT(R) allows for rapid onset, while leveraging a mucoadhesive polymer for slow LD release, potentially enabling longer LD absorption in the gut. CREXONT(R) is expected to compete in a market size of over $50 million in Canada and over $120 million in Brazil. In each of these markets, the controlled release portion of the market was $15 million, during the twelve-month period ended on September 2024, according to IQVIA... Full

‘Missed Opportunity': GSK Failed To Optimize Blenrep Dosage, US FDA Panel Says

(7/17, Sue Sutter, Pink Sheet) ...An FDA advisory committee said the benefit-risk profile for Blenrep in two second-line multiple myeloma indications is not favorable. Failing to optimize the dose for efficacy, while also minimizing ocular toxicity, was a missed opportunity in belantamab's development, panelists said. FDA officials said obtaining good information on dosage optimization and the applicability of efficacy and safety results to US patients through postmarketing commitments is challenging... Global Sub. Full

CivicaScript® Launches Low-Cost Cancer Drug to Make Treatment More Affordable

(7/17, CivicaScript) ...CivicaScript will offer capecitabine 500 mg film-coated tablets for sale to pharmacies for $63 per bottle of 120 tablets. CivicaScript recommends that pharmacies charge patients no more than $84 per bottle (CivicaScript's maximum retail price, or MaxRPTM policy). CivicaScript will offer the 150 mg and 500 mg strengths of capecitabine tablets for sale... Full

Bristol Myers, Pfizer Offer Eliquis at a Discount Through DTC Online Program

(7/17, Kevin Dunleavy, Fierce Pharma) ...The drugmakers have established a direct-to-patient online program, Eliquis 360 Support, which offers the anticoagulant at a discount price to those in the United States who are uninsured, underinsured or pay for their drugs out of pocket. Eliquis will be available through the program at $346 per month, which is a 43% reduction from its list price of $606 per month. The new offering kicks off on Sept. 8... Full

Health Insurers Are Denying More Drug Claims, Data Shows

(7/18, Sarah Kliff, The New York Times) ...Prescription drug denials by private insurers in the United States jumped 25 percent from 2016 to 2023, according to a new analysis of more than four billion claims, a practice that has contributed to rising public outrage about the nation's private health insurance system... Sub. Req’d

After Recall, Pfizer Warns of 'Near-Term Stock Out' of Penicillin Product Used to Treat Syphilis in Pregnant Women

(7/17, Fraiser Kansteiner, Fierce Pharma) ...The move is expected to cause a "near-term stock out of Bicillin L-A," Pfizer said in its statement, with the drugmaker now allocating "limited quantities of inventory to customers during this period as we establish a path to full recovery." Pfizer defined supply recovery as having "8 weeks of inventory available in our own distribution centers, in addition to product fully stocked in the distribution chain." In a separate letter (PDF) to customers, Pfizer committed to providing an update on the supply situation "no later than mid-August."... Full

More Than 57,000 Bottles of a Cholesterol Medication Have Been Recalled in One State

(7/17, Emily Surpless, The Healthy) ...On Thursday, the U.S. Food and Drug Administration (FDA) announced a recall of 57,504 bottles of 2-milligram (mg) pitavastatin tablets. Each bottle contains 90 tablets. Pitavastatin, a cholesterol-lowering drug in the statin family, is a prescription medication that can be associated with brand names such as Livalo and Zypitamag, says the Cleveland Clinic. According to the FDA's report, the drug was recalled due to "Failed Impurities/Degradation Specifications."...It appears that the affected medication was distributed to only one state: New Jersey...Manufactured for: Teva Pharmaceuticals in Parsippany, New Jersey... Full

Mallinckrodt Receives Necessary Ruling from Irish High Court to Combine with Endo, Inc.

(7/17, Mallinchkrodt plc) ...The Court's ruling is the final substantive legal step required for the transaction and follows a vote by each company's shareholders last month to approve the merger. With these approvals in hand, Mallinckrodt and Endo expect to complete their combination in early August, pending the satisfaction of the remaining closing steps. Mallinckrodt's headquarters in Dublin, Ireland, will serve as the combined company's global headquarters... Full

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