Tuesday, June 30, 2026

 

 

Eli Lilly, Regeneron Among First Companies Selected for FDA Initiative to Speed Review of New Manufacturing Facilities

(6/29, Angelica Peebles, CNBC) ...Lilly, Regeneron, Amneal, Cellares, Fujifilm Biotechnologies, Kriya Therapeutics and Kyowa Kirin are the first companies that will participate in the FDA's PreCheck pilot program, according to FDA spokesperson Benjamin Nichols. The initiative will allow regulators to start reviewing new manufacturing facilities while they're under construction to catch and correct any issues, which the FDA estimates could save companies up to 14 months... Full

 

Exclusive-US House Committee Opens Investigation into Merck , AbbVie China Drug Trials

(6/30, Deena Beasley, Reuters) ...In the letters dated Monday and first reported by Reuters on Tuesday, lawmakers led by Republican Representative John Moolenaar of Michigan, chair of the China Select Committee, asked the drugmakers to provide by July 17 details of due diligence, data protection processes and other standards at their trial sites in China, particularly in the Xinjiang region and at military hospitals... Full

 

Trump's Push for the World's Lowest Drug Prices Hits Snag With Mid-Sized Companies

(6/30, Michael Erman, Deena Beasley, Reuters) ..."We don't have the breadth of drugs on the market that we can cut deals," Ionis Pharmaceuticals (IONS.O) CEO Brett Monia told Reuters, adding that his company and others had been invited to come to arrangements. "But at the end of the day, we don't see the upside of cutting a deal," he said. Mid-size companies like Ionis account for the development of most new innovative medicines, Monia said, but have different business models than big pharma companies and often rely on licensing deals with overseas partners to commercialize drugs outside the US... Full

 

The Loophole in Trump's Obesity Drug Deal With Eli Lilly and Novo Nordisk

(6/30, John Wilkerson, STAT+) ...When President Trump's team of negotiators got Eli Lilly and Novo Nordisk to agree to a monthly $245 price in Medicare and Medicaid in November, that price was supposed to be for all GLP-1s, including those for obesity, which until then had not been covered by Medicare. But that price was contingent on private Medicare insurers agreeing to cover the drugs for all uses, with a $50 copay. The administration did not publicly mention that condition, but Novo and Lilly recently confirmed it to STAT... Sub. Req'd

 

Medicare Will Start Covering Weight-Loss Drugs on July 1 for the First Time. Here's What You Need to Know

(6/29, Tami Luhby, CNN) ...Only certain Medicare enrollees are eligible. Not only must they be enrolled in a Part D drug coverage plan, they have to meet specific health criteria when they started taking GLP-1 medications, even if it preceded the launch of the Bridge program... Full

 

PBM Lobby Goes on The Offensive

(6/29, Nathaniel Weixel, The Hill) ...David Marin, CEO of the Pharmaceutical Care Management Association (PCMA), acknowledged in an interview that the PBM industry had essentially operated in the shadows for too long. As lawmakers focus on affordability ahead of November's midterm elections, PBMs want to make sure they are not being left out of the discussions... Full

 

How Most-Favored-Nation Pricing Is Reshaping Generic Drug Economics, According to Dr. Reddy's Finance Director

(6/29, Brian Buntz, Drug Discovery & Development) ...The Most-Favored-Nation (MFN) pricing is "definitely driving a reevaluation," said Amber Siddique Hussain, Director of Finance at Dr. Reddy's Laboratories. With the stated goal of ensuring that the U.S. should not pay more for a drug than other comparable countries, "prices are effectively 'benchmarked' to the lowest levels seen globally," Siddique Hussain said. In the following Q&A, Siddique Hussain discusses how manufacturers are responding to these pressures through tighter cost discipline and operational efficiencies... Full

 

Final GLOBE, GUARD Model Regulations Pending At OMB

(6/29, Gabrielle Wanneh, Inside Health Policy) ...Final rules on two CMS innovation center models the Trump administration hopes will ensure Medicare pays prices comparable to those in other wealthy countries for certain Parts B and D drugs are now under review at the White House Office of Management and Budget. The policies have received pushback from conservative policy groups like the Taxpayers Protection Alliance (TPA), which argues implementing the models would import price control mechanisms that have failed overseas and threaten future drug development for future treatments, and several questions from Democratic lawmakers demanding more details on the models be shared ahead of their finalization and eventual launch dates... Sub. Req'd

 

Cassidy 340B Bill Clashes With Hospitals' Stance Against Claims Reqs, Rebates

(6/29, Garbielle Wanneh, Inside Health Policy) ...The discussion draft for Cassidy's pending legislation to ramp up 340B oversight, released Thursday (June 25), gives drug companies the choice of either providing 340B drug discounts upfront to covered entities or pay a rebate to them after they've purchased 340B drugs at their wholesale acquisition costs. But the first option has strings attached. The first option couples the longstanding tradition of drug makers offering discounts for 340B drugs before they're purchased with a new requirement that covered entities submit 340B claims data to a claims repository... Sub. Req'd

 

SCOTUS Rules President Can Fire FTC Commissioners, Giving Trump More Power On Health Oversight

(6/29, Jessica Karins, Inside Health Policy) ...The Supreme Court on Monday (June 29) overturned a pivotal precedent by ruling that President Donald Trump acted legally in firing a Democratic appointee to the Federal Trade Commission, intensifying the president's control over FTC, which plays a major role in regulating the health care and pharmaceutical industry, and other "independent" federal agencies... Sub. Req'd

 

Pileup of Health Nominees Awaits Senate Health Panel

(6/30, Peter Sullivan, Axios) ...Stephen Lewerenz told Axios the panel plans to hold hearings in July on the nominations of Schwartz and Saphier, as well as Sean Kaufman for assistant secretary for preparedness and response... Full

 

US FDA Nixes User Fee Capacity Planning Adjustments Until 'Fully Restaffed'

(6/29, Derrick Gingery, Pink Sheet) ...Josh Barton, of the resource capacity planning staff in the FDA Office of Program and Strategic Analysis, said during a June 23 meeting on FDA user fee finances that the capacity planning adjustment would remain a key tool to address workload, but would not influence fee setting again until "the review functions have been fully restaffed."... Global Sub. Full

 

BsUFA IV: Industry and FDA at Impasse Over Reference Product Exclusivity

(6/29, Joanne S. Eglovitch, Regulatory Focus) ...The exclusions apply to the following categories: whole blood or blood components intended for transfusion; allergenic extracts; in vitro diagnostic biological products; products intended solely for further manufacturing use; and bovine blood products used for topical application or large-volume parenteral (IV fluids) that were approved before September 1, 1992. The law does not specify the number of products that qualify for RPEs... Full

 

EPA Will Not Monitor Drugs, Microplastics In Water Despite MAHA Push

(6/29, Emma Gardner, Inside Health Policy) ...Citing research gaps, the Environmental Protection Agency is declining to require drinking water systems to monitor for microplastics or pharmaceuticals in its proposed Unregulated Contaminant Monitoring Rule 6 (UCMR6), bucking pressure from "Make America Healthy Again" (MAHA) activists, environmentalists, Democratic officials and anti-abortion groups... Sub. Req'd

 

 

AbbVie , Genmab 's Lymphoma Treatment Meets Primary Endpoint in Phase 3 Trial

(6/29, Kelly Cloonan, Dow Jones Newswires) ...The companies said Monday the combination of epcoritamab and lenalidomide demonstrated statistically significant improvement in progression-free survival in adult patients with relapsed or refractory diffuse large B-cell lymphoma who received at least one prior line of therapy, as compared to treatment with rituximab plus gemcitabine plus oxaliplatin. In the trial, the drug combination reduced the risk of disease progression and death by about 60%, the companies said... Sub. Req'd

 

BeOne's Brukinsa Succeeds in Frontline Mantle Cell Lymphoma Study

(6/30, Lei Lei Wu, Endpoints News) ...The Phase 3 study, known as MANGROVE, pitted Brukinsa combined with rituximab against chemotherapy plus rituximab. According to BeOne, it's the first chemotherapy-free regimen to extend progression-free survival over the standard care of chemoimmunotherapy in a Phase 3 trial... Sub. Req'd

 

Ipsen Pens $1.7B Deal to Acquire Kartos for Potential Jakafi Add-On Therapy for Myelofibrosis

(6/29, James Waldron, Fierce Biotech) ...The acquisition of Kartos gives the French biopharma access to an oral MDM2 inhibitor called navtemadlin. The drug is aimed at restoring the function of p53, a critical tumor suppressor in myelofibrosis... Full

 

NEJM Retracts Pivotal Data for Amgen's Tavneos

(6/29, Nicole DeFeudis, Endpoints News) ...Two academic authors requested the retraction citing an ongoing FDA investigation that suggested results for nine patients were reevaluated after the trial was unblinded. NEJM editor-in-chief Eric Rubin said on Monday this "was not disclosed in the article and is inconsistent with proper research conduct."... Sub. Req'd

 

Eli Lilly Transfers Commercialization Rights for Breast Cancer Drug in China Amid Generic Competition

(6/30, Andrew Silver, Reuters) ...In a statement, Innovent said it entered into an agreement that grants it sole commercialization rights for Verzenios, which Lilly has also called Verzenio, in mainland China, adding that Lilly would continue manufacturing, supplying and developing the drug. Innovent's statement did not mention financial terms... Full

 

 

Sandoz Starts Generic Tirzepatide Race With FDA Filing Acceptance

(6/29, Urte Fultinaviciute, Generics Bulletin) ...The two abbreviated new drug applications were submitted for tirzepatide autoinjector products referencing Eli Lilly's GLP-1 blockbusters Mounjaro and Zepbound... Global Sub. Full

 

Canada Approves Apotex's Bid to Sell Generic Version of Wegovy

(6/29, Paul Vieira, Dow Jones) ...Canada's health department, which is in charge of drug approvals, said Monday it authorized Apotex's bid following a review of evidence from the company that meets the regulator's criteria for generic drugs. Wegovy is produced by Danish drug maker Novo Nordisk... Sub. Req'd

 

Hybio's Generic Weight-Loss Drug Set for FDA Review

(6/30, Reuters) ...The U.S. Food and Drug Administration has agreed to review Chinese generics drugmaker Hybio Pharmaceutical's two experimental generic tirzepatide GLP-1s that, if approved, would rival obesity and diabetes drugs made by Eli Lilly... Full

 

EirGenix Showcases Dual-Track Biosimilars and CDMO Strategy in U.S. Market Push at BIO 2026

(6/30, EirGenix) ...In an industry shifting from single-product competition toward platform-based and combination-therapy strategies amid geopolitical uncertainty, EirGenix addresses the challenge of finding new growth engines in mature markets through its dual-track approach. By combining targeted biosimilar development with a flexible CDMO model, the company captures high-potential oncology opportunities while helping partners accelerate global commercialization... Full

 

Pembrolizumab Biosimilar Meets Primary Phase 1 and Phase 3 End Points in NSCLC

(6/29, OncLive) ...SB27, a proposed pembrolizumab (Keytruda) biosimilar, has met the primary pharmacokinetic (PK) and efficacy end points of both its phase 1 (NCT06268613) and phase 3 (NCT06348199) studies, respectively, according to preliminary topline data... Full

 

Orion Pharma Announces Agreement with Shilpa Medicare for Nivolumab Biosimilar for European Market

(6/30, Orion Pharma) ...Under the terms of the agreement, Orion will gain exclusive right to distribute, market and sell Shilpa's iv nivolumab biosimilar in Europe. Shilpa will supply the product to Orion, and is entitled to receive from Orion certain development and regulatory milestone payments... Full

 

Biocon Grows Malaysian Insulin Presence With A $54M Government Tender Deal

(6/29, Urte Fultinaviciute, Generics Bulletin) ...Valued at over MYR225m ($54.6m), the agreement includes three contracts for short-acting recombinant human insulin, insulin glargine, and insulin aspart. The products will be distributed by the local partner's wholly owned subsidiary Duopharma Sendirian Berhad... Global Sub. Full

 

The Supreme Court Just Made It Easier for You to Get Cheaper Generic Drugs-With 1 Major Catch

(6/29, Amaya Nichole, Inc.) ...Pharmaceutical intellectual property litigator Alan Clement told Inc. that brand manufacturers will have to rethink both their litigation and patent strategies in light of the decision. "Brand manufacturers will have to couch their allegations in the pleadings as to active steps taken by the generic to induce, instead of relying on allegations of how a medical practitioner might perceive what the generic is doing," he said... Full

 

 

Zymeworks Expands into COPD, Buying Beleaguered Theravance for $929M

(6/29, Matthew Dennis, FirstWord PHARMA) ...Zymeworks on Monday entered into an agreement to purchase Theravance Biopharma for $17 per share in cash, or about $929 million, building on a strategy outlined earlier this year and diversifying its business into treatments for chronic obstructive pulmonary disease (COPD). The transaction, which also includes a contingent value right (CVR) linked to an experimental drug, is expected to close in the second half... Full

 

John Reed on J&J's R&D Model, Recent Oncology Deals and Pipeline Expansion Potential

(6/29, Kyle LaHucik, Endpoints News) ...J&J employs an "end-to-end" model, meaning the R&D apparatus spans from research all the way to late-stage development with a "commercial co-partner" guiding the path to market for each therapeutic area. That means the spectrum of R&D staffers are "aligned" on a molecule "right from the beginning," [John] Reed said... Sub. Req'd

 

Why AI Can Transform Pharma - But Nature Cannot Be Hurried

(6/29, Aanu Adeoye, Financial Times) ...The pharma sector has long embraced technology to improve the process of discovering and delivering new treatments to patients. "In the research space, AI has been used for decades in the industry," says Thorsten Rall, global industry lead for life sciences at Capgemini, the IT services group. "Pharma is a data-rich environment and applications like AI for [identifying treatment targets] and molecule design have been around for a while and deployed quite broadly."... Sub. Req'd

 

'We Have Plans For Rapid Expansion' - How Newcomer Evumed Is Seeking To Compete In Europe

(6/30, Dave Wallace, Generics Bulletin) ...While Evumed is a newcomer to the European generics and biosimilars market, the company is backed by the financial firepower and experience of its parent company, China's Nanjing King-Friend, as well as its US sister company Meitheal Pharmaceuticals... Global Sub. Full

 

 

Biopharma Investors Urge EU to Boost Life Sciences Amid US Pricing Pressure

(6/29, Anna Brown, Endpoints News) ...More than 200 biopharma investors and firms have signed an open letter calling for European governments to improve Europe's life sciences sector...It comes as the US is investigating Germany's healthcare plans and as President Donald Trump's "most-favored nation" policies threaten drug prices in Europe...The core action points of the letter include freeing up more investment for European drugmakers across the whole supply chain and drawing upon concepts laid out in the EU Biotech Act, which includes simplifying drug approvals in Europe... Sub. Req'd

 

Smaller European Countries Call For Deeper Collaboration On Pricing And Reimbursement

(6/29, Francesca Bruce, Pink Sheet) ...Geopolitical developments highlight "fundamental challenges in pharmaceutical policy across Europe" and the need for a review of these policies, according to the BeNeLuxA cross-country access to medicines group. In practice, this could mean more information sharing and greater unity on pricing and reimbursement procedures, BeNeLuxA said in a statement... Global Sub. Full

 

India's Pharma Exports Find a New Growth Engine in Brazil

(6/29, Viswanath Pilla, Moneycontrol) ...Brazil has emerged as India's second-largest pharmaceutical export destination, according to the latest trade data from the Directorate General of Commercial Intelligence and Statistics (DGCIS), accessed by Moneycontrol, revealing a striking shift in global trade lanes... Full

 

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