Wednesday, May 13, 2026

 

 

Pharma Warns MFN Pricing Could Erode Access

(5/13, Maya Goldman, Axios) ...U.S. patients can get new medicines paid for by public insurance an average of three months after they launch, compared with nearly three years in other high-income countries, according to a PhRMA analysis shared first with Axios....The drug industry trade group says the data is a sign of what could be undone if policymakers write President Trump's "most favored nation" drug pricing into law, as Trump is insisting on... Full

 

White House MFN Push In Foreign Markets Could Backfire On US, Limit Access

(5/12, Maaisha Osman, Pink Sheet) ...Douglas Holtz-Eakin said entrenched foreign price controls and countries' willingness to deny or delay access to costly medicines make major overseas price increases unlikely... Global Sub. Full

 

Takeda Pitches White House On Rebate Demo For Part B Negotiated Drug Prices

(5/12, Gabrielle Wanneh, Inside Health Policy) ...The model Takeda is recommending would maintain the existing Part B provider reimbursement rate, a drug's average sales price (ASP) + 6%, for separately payable drugs that are selected to undergo price negotiation are thus will have a new maximum fair price (MFP), and would set the applicable beneficiary copayment for such MFP drugs to 20% of the MFP + 6%, not 20% of ASP + 6%... Sub. Req'd

 

E&C Subcommittee To Mark Up FDA Modernization, Import Bills

(5/12, James Jarvis, Inside Health Policy) ...The subcommittee will also take up the Destruction of Hazardous Imports Act, from Reps. Clay Higgins (R-LA) and Troy Carter (D-LA), which would expand FDA's authority to destroy refused imports. The bill would allow HHS to destroy any article refused admission into the United States if the secretary determines the product presents a "significant public health concern."... Sub. Req'd

 

Value-Based Insurance Design In The Modern Era

(5/12, Kimberly Westrich, Yevgeniy Feyman, John Michael O'Brien, Health Affairs) ...Importantly, VBID is not a panacea. However, integrating VBID principles into formulary and benefit design offers a path toward modernizing benefits, identifying low- and high-value services, and aligning coverage decisions with clinical evidence and patient value... Full

 

Makary's Time Atop FDA Over, Diamantas Named Acting Commissioner

(5/12, David Lim, Lauren Gardner, Politico) ...Kyle Diamantas, who previously worked as the top food official at the agency, will lead the FDA in an acting capacity, the administration official said. The decision to move on from Makary was months in the making, according to a senior administration official granted anonymity to discuss the Johns Hopkins surgeon's tenure... Full

 

Makary's Exit Creates New Uncertainty at FDA

(5/13, Adriel Bettelheim, Axios) ...Makary didn't deliver on many actions that industry welcomed, and may have ultimately been done in by his management style and hiring choices, Raymond James analyst Chris Meekins wrote in a note...."Finding someone industry welcomes and MAHA does not despise may be a bit of a challenging channel to navigate," Meekins wrote... Full

 

Off-Patent Industry Loses A Champion As Makary Leaves US FDA

(5/13, Dave Wallace, Generics Bulletin) ...Speaking to Generics Bulletin after news broke of Makary's departure, the US Association for Accessible Medicines said "AAM and the Biosimilars Council are grateful to the FDA for advancing key priorities for the generic drug and biosimilar industry and recognizing their impact on American patients." At the same time, the AAM said, "we look forward to continuing to work with the career staff and new leadership to drive more patient savings and faster approvals for lower-cost generic and biosimilar medicines," with the group underlining that the off-patent sector was "the only segment of US health care that can truly help patients save and cut overall costs."... Global Sub. Full

 

 

Arvinas, Pfizer Find New Partner for 'Protac' Breast Cancer Drug

(5/12, Delilah Alvarado, BioPharma Dive) ...Arvinas and Pfizer will receive $75 million upfront, another $15 million after certain "transition" activities are completed, and are eligible for another $320 million in future payouts as well as sales royalties. In return, Rigel will get global rights to Veppanu, which includes the ability to partner off non-U.S. ownership... Full

 

 

India's Dr Reddy's Plans Generic Ozempic Launch in Canada this Month, Eyes India Semaglutide Tablet Roll-Out

(5/12, Reuters) ...India's drug regulator has also approved the company's generic semaglutide tablets, which it aims to launch in the next few days, said M V Ramana, CEO of global generics... Full

 

Amgen's Pavblu Drives Growth While Prolia/Xgeva Erosion Begins

(5/13, Anabel Costa-Ferreira, Generics Bulletin) ...As of March 30, the US Food and Drug Administration approved Teva's Ponlimsi, a denosumab biosimilar rival to Prolia. Prior to this, at the end of 2025, the regulator approved Amneal's version of the biosimilars, Broncresa and Oziltus. Ten different sponsors have now seen versions of denosumab approved by the FDA... Global Sub. Full

 

 

Bayer to Make 'Careful but Aggressive' Return to Pharma M&A, CEO Says

(5/12, Ayisha Sharma, Endpoints News) ..."We're going to be careful, but also aggressive," [CEO Bill] Anderson said on a first-quarter earnings call with the media Tuesday. He added that the company has "been on the lookout" for product acquisitions and is "not afraid to try a new therapy area" so long as the science is strong. The push for deals comes as two of Bayer's top drugs, Eylea and Xarelto, saw sales plummet further in the first three months of the year due to generic competition... Sub. Req'd

 

Celltrion Acquires France's Gifrer to Accelerate European Push

(5/13, Park Ji-su, Seoul Economic Daily) ...According to industry sources on Wednesday, Celltrion recently acquired a 100% stake in Gifrer through its French subsidiary. Gifrer is a local healthcare company with a sales network spanning approximately 9,000 pharmacies across France and a supply network covering some 800 hospitals. Celltrion plans to operate Gifrer as an independent entity, leveraging its existing brand recognition and sales organization... Full

 

Germany's Merck KGaA Shares Jump After Guidance Lift

(5/13, Adrià Calatayud, The Wall Street Journal) ...The company-with operations spanning lab equipment, pharmaceuticals and chemicals-forecast net sales to range from 20.4 billion to 21.4 billion euros ($23.95 billion to $25.13 billion) this year. This compares with its previous expectations of 20 billion to 21.1 billion euros... Sub. Req'd

 

Indian Drugmaker Cipla's Fourth-Quarter Profit Misses View on Weak US Sales

(5/13, Reuters) ...Total revenue from operations fell 2.8% to 65.41 billion rupees, below the average expectations of 67.49 billion rupees, hurt by a sales decline in its key North America market... Full

 

BMS, Hengrui Build 13-Asset Pipeline in $15b+ Onco-Immune Deal

(5/12, Tristan Manalac, BioSpace) ...BMS has agreed to fork over $950 million, consisting of a $600 million upfront payment and a $175 million commitment to Hengrui, payable at the partnership's first anniversary, according to a news release on Tuesday. The pharma has also pledged to make another contingent payment of $175 million at the deal's second anniversary in 2028... Full

 

Bayer's Eylea Declines by 24%, Bearing the Brunt of Biosmilar Competition

(5/12, Kevin Dunleavy, Fierce Pharma) ...Bayer has managed to keep its annual Eylea sales relatively stable as they have toggled between 3.1 billion euros and 3.3 billion euros in each of the last four years. But that's coming to an end this year as biosimilar competition is hitting the German company with full force... Full

 

Samsung Bioepis, Seoul Biohub Launch Open Innovation for Bio Startups

(5/13, Yeom Hyun-a, The Chosun Daily) ...The '2026 Seoul Biohub-Samsung Bioepis Open Innovation Program' is the first open innovation project jointly operated by the two institutions. It was designed to broaden collaboration opportunities between promising domestic bio startups and global bio companies, and to increase the commercialization potential of next-generation bio technologies... Full

 

Alphabet's AI Biotech Isomorphic Labs Bags $2.1B Series B to Fuel Next-Gen Drug Design Model

(5/12, James Waldron, Fierce Biotech) ...Isomorphic designs potential drugs with AI models such as AlphaFold 3, a Google DeepMind-partnered model that can predict the structures and interactions of molecules. The new money will be used to develop and deploy Isomorphic's AI drug design engine, dubbed IsoDDE, as well as accelerate its in-house drug pipeline into the clinic... Full

 

Obesity Drug Prices Undercut Healthcare Savings, CVS CEO Says

(5/12, Ike Swetlitz, Bloomberg Law) ...CVS Health Corp. Chief Executive Officer David Joyner said that drugmakers must significantly reduce the price of anti-obesity medicines before the drugs will save money for commercial health insurance plans. "That needs to be less than what Medicare's paying," Joyner said in an interview Monday at Bloomberg News' office in New York. Medicare recently announced a plan to cover Eli Lilly & Co.'s Zepbound and Novo Nordisk A/S' Wegovy at $245 a month starting July 1... Full

 

Iran War Disruptions Begin to Emerge Upstream of the Pharma Supply Chain

(5/12, Anna Brown, Endpoints News) ...While the Middle East is barely a player in drug production, the oil and gas it provides are nonetheless critical for almost every manufacturing business around the world. Pharma manufacturers and suppliers have responded by looking at raising prices, stockpiling materials and changing their shipping patterns... Sub. Req'd

 

Specialty Drug Costs and Complexity Steadily Rising Since 2025

(5/12, Brian Nowosielski, Drug Topics) ..."This year's report highlights a market at an inflection point, with payers increasingly challenged to balance the potential benefits of groundbreaking treatments with the escalating cost of care-a tension that's driving health plans and employers to rethink their strategies to manage the specialty drug benefit," wrote the authors of PSG's Trends in Specialty Drug Benefits Report...."By examining these topics, we aim to shed light on how the landscape is evolving in response to payers' priorities and pain points."... Full

 

Coupon Use for Brand-Name Drugs Falls as Pricing Models Shift

(5/12, Ella Jeffries, Becker's Hospital Review) ...Use of manufacturer-sponsored coupons for brand-name drugs declined among commercially insured patients between 2017 and 2024, even as the value of coupon offsets increased, according to a study published April 6 in JAMA... Full

 

Metastatic Breast Cancers on the Rise, U.S. Study Shows

(5/12, Mike Bassett, Medpage Today) ...The age-adjusted incidence rate of de novo stage IV breast cancer significantly increased from 9.5 cases per 100,000 females in 2010 to 11.2 cases in 2021, an annual percentage change (APC) of 1.2% (95% CI 0.8-1.6), reported José P. Leone, MD, of the Dana-Farber Cancer Institute in Boston, and colleagues... Sub. Req'd

 

 

EU Reaches Provisional Deal on Critical Medicines Act

(5/12, Anna Brown, Endpoints News) ...The proposed regulation aims to improve the European Union's supply chains for critical medicines, including antibiotics, insulin and pain medication, by funding EU manufacturing projects, and to encourage member states to try to supply drugs and their ingredients from within the EU....Tuesday's update brings the regulation one step closer to being implemented. Next, it needs to be formally approved by both the European Parliament and the Council... Sub. Req'd

 

Germany Aims To Link Drug Rebates To Local R&D Activity

(5/12, Francesca Bruce, Pink Sheet) ...The Statutory Health Insurance Contribution Stabilization Bill, which includes a range of cost cutting measures, including the higher rebates, has caught the pharmaceutical industry off guard, Adem Koyuncu, a Frankfurt-based partner at the law firm Covington & Burling told the Pink Sheet... Global Sub. Full

 

Note: Article links may expire over time or require a free registration. All news articles are the property of their respective publishers and copyright holders. [contextual emphasis added].

 

Teva global subscription access: registration is required to access FirstWord Pharma+ News and The Generics Bulletin. Please note you must be on the Teva Network (in a Teva location or connected via VPN) to access Teva's InfoNOW news resources. If you have any questions or issues, please email InfoNOW@tevapharm.com.

•      FirstWord Pharma+ News registration: first-time users, register here with your Teva email address. You will automatically receive a daily FirstWord Pharma+ newsletter; click on any news item to access your account.

•      Generics Bulletin, Pink Sheet, Scrip (Citeline) registration: go to the Generics Bulletin site and choose "Sign In" in the upper right-hand corner. First-time users, choose "Sign Up Here" and enter your Teva email address.