Friday, May 29, 2026

 

 

Lilly Obesity Drugs Get Expanded Private Plan Access As Medicare Readies Coverage Test

(5/28, Cathy Kelly, Pink Sheet) ...Known as the GLP-1 Bridge Program, the demo will launch July 1 and is scheduled to continue until Dec. 31, 2027...The Bridge program initially was planned as a six-month initiative, but was extended to 18 months after CMS failed to sign up enough Medicare Part D plan sponsors to begin BALANCE in 2027. CMS hopes the extra time will alleviate insurer uncertainty about the size and cost of demand for the treatments in Part D, as well as generate data on the health benefits of their use... Global Sub. Full

 

After Entering Market, Top Brand Name Drug Prices Surge in US While Dropping Elsewhere

(5/28, Leigh Purvis, AARP) ...Building on prior AARP Public Policy Institute research, this Spotlight examines list price changes that occurred after 25 top brand name drugs first entered the market in the US and other high-income countries... Full

 

Prices for Top Brand Name Drugs Increase After Entering the US Market but Fall in Other High-Income Countries

(5/28, Leigh Purvis, AARP) ...This AARP Public Policy Institute (PPI) Spotlight finds that list prices for 25 top brand name drugs have increased by an average of 81 percent since they first entered the US market. In contrast, lifetime list prices for the same products decreased by an average of 13 percent in 19 other highincome countries. These dramatically different price trajectories play a noteworthy role in the US's comparatively high brand name drug prices and reaffirm the importance of Medicare drug price negotiation and other ongoing efforts to give Americans access to lower drug prices... Full

 

Cost-Effectiveness Thresholds: Overvaluing Innovation, Undervaluing Health

(5/28, Leah Z. Rand, Mike Paulden, and Adam J. N. Raymakers, Health Affairs) ...In this article, we discuss cost-effectiveness analysis, how it works, and why it matters. We explain how current cost-effectiveness thresholds already exceed the marginal cost of a unit of health, thus countering claims that such thresholds necessarily undercut incentives for innovation. We conclude with a call for not abandoning cost-effectiveness thresholds but instead more rigorously determining their appropriate levels and recognizing that the current system incentivizes innovation... Full

 

When Cost-Effectiveness Thresholds Drift: Global HTA, MFN Pricing, And The Need For A Coherent Framework

(5/28, William V. Padula, Health Affairs) ...HTA is evolving in a conflicted way. While there is growing recognition that traditional cost-effectiveness analysis fails to capture important dimensions of patient-centered value, HTA bodies have been reluctant to move beyond familiar frameworks... Full

 

PBM Lobby Presses Trump Admin To Focus More On Drug Wholesalers

(5/28, Gabrielle Wanneh, Inside Health Policy) ...Specifically, the pharmacy benefit manager (PBM) lobby is calling on the Department of Justice and Federal Trade Commission to offer guidance cracking down on the alleged anticompetitive nature of pharmacy services administrative organizations (PSAOs), businesses owned by drug wholesalers that negotiate on behalf of pharmacies to purchase drugs from the wholesalers, in any potential reinstatement of the 2000 Antitrust Guidelines for Collaborations Among Competitors the agencies withdrew in 2024... Sub. Req'd

 

BsUFA IV: If Dates Known, US FDA Looks To Speed Biosimilar Approval Once Exclusivity Expires

(5/28, Derrick Gingery, Pink Sheet) ...FDA officials proposed as part of the biosimilar user fee program reauthorization to add a timeline for biosimilars in the provisional determination stage, meaning the applications are approvable but cannot be cleared because of unexpired exclusivity... Global Sub. Full

 

US FDA Finalizes BE Guidance With ICH, Study Design Updates

(5/28, Derrick Gingery, Pink Sheet) ...The guidance, titled "Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA," includes recommendations for in vivo BE studies with PK endpoints, as well as establishing BE for multiple dosage forms... Global Sub. Full

 

New Guidance On Statistical Approaches For BE Includes Updated Analysis Info

(5/28, Derrick Gingery, Pink Sheet) ...The document includes recommendations for sponsors using equivalence criteria in analyzing BE studies for INDs, NDAs and ANDAs and amendments or supplements. Statistical methods for BE comparisons and their use in specific situations also are discussed... Global Sub. Full

 

FDA Watchers Forecast Long Tenure For Acting Commissioner

(5/28, James Jarvis, Jessica Karins, Inside Health Policy) ..."If you look around at FDA and you say who might we have in here for some undetermined period of time who is capable and politically astute, Kyle jumps to the top of the list," Stuart Pape, FDA chair at law firm Polsinelli, told Inside Health Policy. "And, even when you think someone is only going to be acting for a short while, it often does not turn out that way."..."I think this is less about substance and policy and more about process and stability," Pape said... Sub. Req'd

 

Industry Confidence In FDA May Hinge On CBER, CDER Leadership

(5/28, Jessica Karins, Inside Health Policy) ..."With acting directors at CDER and CBER, and those folks being really new in those positions themselves, it strikes me as a pretty challenging formula," said Maarika Kimbrell, a partner at law firm Morgan Lewis focused on regulation of drugs and biologics... Sub. Req'd

 

A Less Chaotic FDA Is a Win for the White House: Editorial

(5/28, Bloomberg) ...Whoever ends up running the FDA will need to earn the trust of the staff who remain. Selecting competent deputies for the two centers that regulate drug reviews would be a good place to start. Regular, well-documented communication should be reestablished, as should engagement with publicly vetted outside experts. A strong commitment to readopting standards for drug approvals might also ease concerns - with the promise that future reforms be conducted with input from career staff and rolled out methodically. Above all, the next commissioner should pledge to act as a buffer from political interference... Full

 

Florida Sen. Rick Scott Tallies Up Supply Chain Fears At Tampa Roundtable

(5/28, Mike Jenkins, Tampa Free Press) ...Scott, who serves as the Chairman of the U.S. Senate Special Committee on Aging, emphasized that the lack of clear origin tracking presents a significant safety and security vulnerability for Americans... Full

 

 

With Elahere Building Steam, AbbVie Nets FDA Nod for Another ImmunoGen Cancer Asset

(5/28, Fraiser Kansteiner, Fierce Pharma) ...The FDA on Wednesday announced the approval of AbbVie's CD123-direct ADC pivekimab sunirine-pvzy, which will hit the market under the Decnupaz moniker, as a treatment for adults with the rare blood cancer blastic plasmacytoid dendritic cell neoplasm (BPDCN)... Full

 

Daiichi Sankyo Showcases Progress Across Industry-Leading Oncology Portfolio with Latest Research Updates at ASCO

(5/28, Daiichi Sankyo) ...Data at ASCO will highlight the company's progress toward advancing new standards of care for patients with cancer, including new analyses from five landmark trials in breast and gastric cancer, including the DESTINY-Breast05 (#516), DESTINY-Breast06 (#1063), DESTINY-Breast09 (#1021) and DESTINY-Gastric04 (#4111) phase 3 trials of Enhertu® (trastuzumab deruxtecan), and the TROPION-Breast02 (#1002) phase 3 trial of Datroway® (datopotamab deruxtecan)... Full

 

Parexel to Present Real-World Oncology Research and Launch New Patient-Focused Campaign at ASCO 2026

(5/29, BioSpace) ...As part of ASCO 2026, Parexel is presenting two virtual research posters, one analyzing common deficiencies in oncology marketing applications that lead to FDA rejections and another focused on the pulmonary safety profile of trastuzumab deruxtecan (T-DXd) in HER2-positive metastatic breast cancer... Full

 

Menarini Group Presents New Data from the Phase 1b/2 ELEVATE Study of Elacestrant in Combination with Capivasertib in Patients with ER+, HER2- Metastatic Breast Cancer (mBC) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting

(5/28, Menarini Group) ...The efficacy data highlight how the combination of elacestrant and capivasertib has the potential to address key resistance mechanisms for patients with ER+/HER2- mBC, including ESR1 and PIK3CA co-existing mutations... Full

 

ASCO Using Ryght AI's Advanced Platform to Accelerate Site Selection for Breast Cancer Clinical Trial

(5/28, Ryght) ...The collaboration leverages Ryght AI's proprietary AI Site Twin platform to match the metastatic breast cancer trial with research sites based on investigator expertise, operational capacity, prior success, and access to appropriate patient populations. This initiative reduces the manual, administrative work that can delay feasibility assessments and site activation... Full

 

Novartis 'Always Looking' for Further Ways to Shuttle Drugs to Brain Despite Run of Recent Deals

(5/28, James Waldron, Fierce Biotech) ...Novartis may be launching an array of vehicles to shuttle drugs across the blood-brain barrier, but executives told Fierce that the Swiss pharma is "always looking" for new ways to traverse this final frontier of neuroscience... Full

 

Innovent Biologics, Pfizer Strike $10.5 Bln Cancer Drug Deal amid China Biotech Boom

(5/28, Reuters) ...The partnership spans a portfolio of antibody-drug conjugates (ADCs) with novel differentiated payloads and multi-specific antibodies, comprising eight Innovent-originated early-stage assets and four Pfizer-proposed discovery programs. Under the terms of the agreement, Innovent will lead development of the 12 programs through Phase 1 clinical trials before Pfizer takes on global development... Full

 

 

Sun's Organon Deal Won't Dim Generics Commitment

(5/28, Dean Rudge, Generics Bulletin) ...Sun sought to avoid any suggestion that it was stepping back from generics..."We are not changing our view on the attractiveness of the generics business," Dilip Shanghvi underlined...That continued commitment to generics now sits alongside Sun's proposed acquisition of Organon, a transaction that management believes will be largely complementary rather than one that would create significant product-overlap issues... Global Sub. Full

 

Innovation, Biosimilars, Complex Generics to Drive Cipla's Growth: Achin Gupta, MD & Group CEO

(5/29, Rica Bhattacharyya and Vikas Dandekar, The Economic Times) ...Cipla is increasingly focusing on innovation which it expects to account for "a meaningful chunk of revenues" by the time the drug maker reaches its centenary in about 10 years, says managing director and group chief executive Achin Gupta. In an interview, he tells ET that the company will look at assets in the US and Europe that can strengthen its market presence and product pipeline, but is not considering any large acquisitions in India... Full

 

Generic Ozempic Is Now About $100 a Month Across the Country. Canadians Are Taking Note

(5/29, Jennifer La Grassa, CBC) ...Tim Brady, a southwestern Ontario pharmacist, says getting his hands on generics for his two pharmacies wasn't easy. "It came out on the weekend and then probably within an hour if you didn't order it right away, they [were] already out of stock," said Brady, owner of Brady's Drug Store locations in Windsor-Essex. While he's got the generic version from Toronto-based Apotex, Brady said the one from India's Dr. Reddy's Laboratories is currently on back order from his supplier... Full

 

Hims & Hers Positions Apotex's Semaglutide As A Weight Loss Drug In Canada

(5/28, Urte Fultinaviciute, Generics Bulletin) ...Canadians will soon be able to get their hands on Hims & Hers generic semaglutide for weight loss, even though the drug is only allowed to be sold as a treatment for diabetes. In the launch press release, Hims & Hers presented its generic semaglutide as an offering for patients in Canada seeking an affordable GLP-1 treatment, highlighting the country's obesity rates...The generic semaglutide is not manufactured by Hims & Hers but rather by Apotex, reported Reuters... Global Sub. Full

 

EMS Readies Synthetic Semaglutide Launch 'Within Weeks'

(5/28, Dean Rudge, Generics Bulletin) ...EMS is preparing to launch its follow-on semaglutide product Ozivy in Brazilian pharmacies within weeks after Brazil's regulator Anvisa recently approved the company's synthetic semaglutide GLP-1 pen, allowing EMS to move through the "subsequent operational steps necessary for the start of commercialization."... Global Sub. Full

 

Samsung Epis Sets Up 1st Overseas Bio R&D Center in Beijing

(5/29, Kan Hyeong-woo, The Korea Herald) ...Samsung Epis Holdings, the holding company of biosimilar drug developer Samsung Bioepis, said Friday it has established a research and development center in China as part of efforts to strengthen its new drug development capabilities. According to the biotech company, it recently set up a wholly owned subsidiary, Samsung Bioepis China, in Beijing's Changping district as its first overseas R&D foothold... Full

 

Samsung Bioepis Launches OPUVIZ™ (Aflibercept) 40 mg/mL Vial Across Europe, to Treat Ophthalmic Conditions

(5/29, Samsung Bioepis) ...Samsung Bioepis Co., Ltd. today announced the launch of OPUVIZ™ 40 mg/mL solution for injection in a vial, a biosimilar referencing Eylea (aflibercept), across Europe, starting today... Full

 

 

Innovent Could Pocket More than $10b in 12-asset Tie-Up with Pfizer

(5/28, Elizabeth S. Eaton, FirstWord PHARMA) ...Innovent, which will take home $650 million upfront, will be responsible for moving these programmes through Phase I testing, after which Pfizer will helm global development. The Chinese firm is eligible for up to $9.85 billion in development, regulatory and commercial milestones... Full

 

Drugmaker Apotex Files for Canada IPO Showing Revenue Jump

(5/28, Thomas Seal, Bloomberg) ...The share sale will include the company's treasury shares and a secondary offering including holdings of controlling shareholder SK Capital Partners. Apotex applied to list on the Toronto Stock Exchange under the symbol APTX... Full

 

Viatris Top Brass Sued by Investor Over India Facility Problems

(5/28, Bloomberg Law) ...The stockholder derivative suit, filed publicly Wednesday in the US District Court for the District of Delaware against 14 current and former Viatris directors and officers, seeks damages and corporate governance changes following FDA enforcement actions that shut down the company's Indore, India, manufacturing facility... Full

 

 

India-US Interim Trade Pact 'Close', Says Piyush Goyal as Talks Focus on Deeper Investment and Supply-Chain Ties

(5/29, PTI, Fortune India) ...Commerce and Industry Minister Piyush Goyal gave assurances that the India-US interim agreement is close as he provided an "encouraging update" on bilateral trade negotiations during an interaction with eminent business leaders, the US-India Strategic Partnership Forum (USISPF) said. Goyal also discussed ways to further deepen India-US trade, investment and supply-chain partnerships during the closed-door roundtable interaction on Thursday... Full

 

Pharma Leaders Meet With PM Takaichi in Push for Japan to Retain R&D Edge

(5/28, Zoey Becker, Fierce Pharma) ...Over 20 pharma leaders from local companies, the U.S. and Europe joined the meeting in Japan, which marked "an important opportunity to discuss the actions needed for Japan to retain its leadership in life sciences," Roche CEO Thomas Schinecker, Ph.D., who chairs the Biopharmaceutical CEO Roundtable (BCR), said in a May 26 release from global pharma trade group the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)... Full

 

Japan Passes Bill to Raise Co-Payments for Prescription Drugs Similar to OTC Counterparts

(5/29, Tomoko Otake, The Japan Times) ...Japan on Friday passed legislation to raise co-payments for prescription medicines with ingredients and effects similar to over-the-counter (OTC) drugs, in a bid to curb insurance premium hikes for the working population... Full

 

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