Wednesday, May 27, 2026

 

 

Teva Commits to Veeva Vault CRM

(5/27, The Fly) ...Veeva Systems announced that Teva Pharmaceuticals has committed to Veeva Vault CRM globally. "We are excited to expand our strategic partnership with Veeva by moving to Vault CRM," said Lavanya Narasimhamurthy, global vice president of IT at Teva. "We share a deep commitment to customer success, and Vault CRM will provide Teva the technical foundation to drive commercial execution."... Sub. Req'd

 

 

Senate Bill Would Compel Release Of Info On Pharma Tariffs

(5/26, Dan Dupont, Inside Health Policy) ...The "Section 232 Public Transparency Act" would "strengthen transparency requirements for tariff investigations conducted by the U.S. Department of Commerce" under the Trade Expansion Act of 1962, [Sen. Gary] Peters' office said in a statement shared with Inside U.S. Trade ahead of the release of the bill text. The measure "would require the Secretary of Commerce to publish summaries of its investigations examining alleged national security risks tied to imports of certain goods," the statement adds... Sub. Req'd

 

Taxpayer Group Urges Senate To Reject MFN Legislation As TrumpRx Talks Continue

(5/26, James Jarvis, Inside Health Policy) ...In a May 20 letter to senators, TPA President David Williams argued lawmakers should "stand firm" against most favored nation (MFN) mandates and instead focus on policies that expand supply and lower costs without tying U.S. prices to those paid in other countries. "Price controls implemented through an MFN model - which would tie U.S. drug prices to those imposed by foreign socialist healthcare systems - would mean fewer treatments for millions of patients," Williams wrote. "Drug manufacturers will only spend this time and money developing new products if they are able to recoup these investments via flexible pricing strategies."... Sub. Req'd

 

TrumpRx Keeps Delivering for Hard-Hit Patients

(5/26, Justin Leventhal, The Washington Times) ...When patients can see real prices, compare options and buy medicine without unnecessary middlemen, competition starts working again. DTC tools like TrumpRx facilitate a prescription drug market where patients know what they are paying, have more than one place to buy and are no longer forced to navigate a system designed to hide prices rather than lower them simply by bringing purchasing decisions directly to patients... Full

 

This Trump Policy Could Slow Cancer Cures Worldwide

(5/27, Andrew Spiegel, Washington Examiner) ...Because the greatest threat to patients is not high drug prices alone. It is a world in which the lifesaving medicines they are counting on are never developed - or never reach them at all. MFN would move us closer to that world. And patients everywhere would pay the price... Full

 

As Calls for COINS Act Expansion Grow, Will New Rules Sweep up China Biotech Licensing?

(5/26, Angus Liu, Fierce Biotech) ..."Given the commercial reality of how intertwined U.S. and Chinese biotech companies are today and the timeline for promulgation of the COINS Act regulations, the likelihood of the initial regulations imposing an outright ban on all licensing activities in this sector seems low," Brian Curran, a partner at Hogan Lovells who focuses on national security and U.S. investment security policies, told Fierce... Full

 

Makary's FDA Reforms 'Continue to Move Forward' Despite Leadership Turmoil

(5/26, Darren Incorvaia, Fierce Biotech) ...A Department of Health and Human Services spokesperson told Fierce that there will be "no change to the name or direction of the CNPV program at this time."..."Additional reforms initiated under the previous commissioner continue to move forward," the spokesperson added... Full

 

After 50+ Years, FDA Finalizes DESI Notice on Estrogen-Androgen Fixed Combination Drug Products

(5/26, Bob Pollock, The Lachman Blog) ...The Federal Register (FR) notice (here) appearing on today's pre-publication page describes the long and tedious process of finalizing one of the last remaining Drug Efficacy Study Implementation (DESI) notices, and ends with a final FDA decision that there is a lack of substantial evidence of efficacy for the use of certain estrogen-androgen fixed combination drug products... Full

 

Proposed Government Nondisclosure Agreement Could Include US FDA Pre-Decisional Memos

(5/26, Sue Sutter, Pink Sheet) ...The Office of Personnel Management is requesting comment on a draft nondisclosure agreement for use across the government. If agencies elect to use the agreement, it would be administered to current federal employees as well as newly hired employees as part of the onboarding process... Global Sub. Full

 

Maryland PDAB Approves US Medicare-Negotiated Price As Payment Ceiling For Ozempic

(5/27, Cathy Kelly, Pink Sheet) ...The UPL for Ozempic will be $274 per 30-day supply, which is based on the Medicare maximum fair price for the drug. The price also will be implemented in Medicare Part D beginning in January... Global Sub. Full

 

Attorney General Raoul Reaches $8.25 Million Settlement With Pharmaceutical Company Over Alleged Anticompetitive Epipen Practices

(5/26, Illinois Attorney General Kwame Raoul) ...Attorney General Kwame Raoul today announced an $8.25 million settlement with Mylan Inc. (Mylan), the company that sells the EpiPen, resolving concerns about the company's anticompetitive conduct related to EpiPen products. Mylan's alleged anticompetitive scheme resulted in the state of Illinois paying excess amounts for EpiPens purchased through its Medicaid and employee health benefits programs... Full

 

 

FDA Delays Ruling on AstraZeneca's Breast Cancer Drug after Negative Adcomm Vote

(5/27, Nick Paul Taylor, Fierce Biotech) ...The FDA has delayed a decision on the approval of AstraZeneca's camizestrant, deferring its ruling to review analyses filed after an advisory committee voted against the breast cancer prospect...[T]he FDA raised questions about the study design and its advisory committee voted six to three that AstraZeneca failed to show camizestrant provides a clinically meaningful benefit... Full

 

Three CRLs Later, Outlook Says FDA Will Sign off on its Version of Avastin for Wet AMD

(5/27, Zachary Brennan, Endpoints News) ..."The FDA concluded that substantial evidence of effectiveness has been established" for the ophthalmic reformulation - to be known as Lytenava - if approved in the US, the company said in a statement Tuesday. Outlook held meetings with the agency in March and April, and said the FDA granted the appeal as part of a formal dispute-resolution process through its Office of New Drugs... Sub. Req'd

 

Acadia Boosts 'More to Parkinson's' Campaign with Ryan Reynolds, Parkinson's Voices

(5/26, Ben Adams, Fierce Pharma) ...Now, the campaign includes six new longer-form videos on the More To Parkinson's website as it broadens its outlook... Full

 

 

Ozempic Maker Cuts Price as Generic Versions Hit Pharmacy Shelves

(5/26, Chris Hannay, The Globe and Mail) ...Meanwhile, Danish drug manufacturer Novo Nordisk, the maker of Ozempic, announced Tuesday it would start offering discounts to patients not covered by insurance so they could pay the generic price for the brand-name product... Sub. Req'd

 

Lupin Downs Otsuka On US Jynarque Appeal

(5/26, Dean Rudge, Generics Bulletin) ...Lupin has secured victory after the US Court of Appeals for the Federal Circuit affirmed that its generic version of Otsuka's Jynarque (tolvaptan) does not infringe two US patents, while also upholding a ruling that asserted claims of one of the patents are invalid for obviousness... Global Sub. Full

 

Brazil Clears First Generic Copy of Novo Nordisk's Ozempic Shot

(5/26, Rachel Gamarski, Leonardo Lara, Bloomberg) ...Brazilian pharmaceutical company EMS on Tuesday was cleared to sell its copycat drug, Ozivy, to treat adults with type 2 diabetes as an adjunct to diet and exercise. EMS plans to sell Ozivy for 30% less than Ozempic, and expects it to hit the market within 30 days... Full

 

Italy Probes Biogen for Allegedly Hindering Sales of Rival's MS Drug

(5/27, Reuters) ...Biogen said in an emailed statement that it was "fully cooperating with the authorities" and confirmed representatives of the AGCM visited its Milan offices on Tuesday morning... Full

 

 

Novo Nordisk's CEO Has a Comeback Plan

(5/26, Jessica Mendoza, Ryan Knutson, WSJ: The Journal) ...When Maziar Mike Doustdar took over as CEO of Novo Nordisk last year, the company had lost ground in the anti-obesity drug market. Doustdar spoke with Jessica Mendoza about his plans to turn the company around, the recent success of their Wegovy pill and what keeps him up at night... Sub. Req'd

 

Aurobindo: US Govt Shutdown Delayed Lannett Deal Closure; $2Bn Is FY27 US Target

(5/27, Vibha Ravi, Generics Bulletin) ...Santhanam Subramanian, Aurobindo's chief financial officer said the company's earlier confidence of the FTC waving the deal through quickly didn't factor a government closure for 76 days between February and April this year. "And when the government shuts down, the FTC does not function. I think the first time we had some flexibility, but the second time it was very long, and it took 76 days. But I think they've largely made up the time," he observed... Global Sub. Full

 

Facing Looming Xtandi Patent Cliff, Astellas Pins Hopes on More Deals While Still Cutting Costs

(5/26, James Waldron, Fierce Biotech) ...The Japanese pharma may be expecting to rake in sales of 2.2 trillion yen ($13 billion) from Xtandi this year, but this is likely to be as good as it gets for the Pfizer-partnered blockbuster going forward. Astellas' own slides show these prostate cancer sales withering away toward a "pipeline-led inflection point" in 2029... Full

 

Can AI Do Scientific Research? Billions Are Pouring in to Find Out

(5/26, Andrew Dunn, Endpoints News) ...The promise of AI in scientific research is to find a similar alien-like creativity that unlocks ideas the human brain could never devise... Sub. Req'd

 

 

Irish CJEU Referral Offers Route To Challenge UWWTD

(5/26, Dave Wallace, Generics Bulletin) ...A further opportunity to challenge the EU's Urban Wastewater Treatment Directive has opened up, after an Irish court referred questions over the validity of the legislation's controversial extended producer responsibility scheme to the Court of Justice of the European Union... Global Sub. Full

 

EMA Eyes Pharma Reform To Fix Unpredictable Drug Approval Filings

(5/26, Vibha Sharma, Pink Sheet) ...Rather than continuing to monitor the impact of measures introduced under the current legislative framework - which a recent EMA report notes yielded only "slight improvement" in MAA submission predictability - the agency is now focusing on new opportunities presented by the forthcoming EU pharmaceutical reform legislation... Global Sub. Full

 

Pharma Giants Lose Drug Price Lawsuits

(5/27, Hong Da-yeong, The Chosun Daily) ...Major domestic pharmaceutical companies, including Dong-A ST, Daewon Pharmaceutical, and Boryung, have suffered consecutive defeats in lawsuits challenging the government's decision to reduce drug prices. While the reasons for the price reductions varied-such as sanctions following the detection of illegal rebates or price adjustments due to the release of generic drugs-the courts uniformly ruled in favor of the government... Full

 

Korea's New Shorter Approval Period Backed By Simultaneous, Parallel Reviews

(5/27, Jung Won Shin, Pink Sheet) ...[T]he MFDS is now developing and will provide a checklist to applicants to improve the completeness of the documentation required to support approvals. This covers areas such as safety, efficacy, quality, GMP (good manufacturing practice), GCP (good clinical practice) and a RMP (risk management plan), which must be confirmed before filing based on items that frequently require supplementary information during the application process and which make take a long time to prepare when supplementary data are requested... Global Sub. Full

 

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