Tuesday, May 20, 2025

Cipla Leadership's Early Take On Trump's Pricing EO And Pipeline Progress

(5/19, Anju Ghangurde, Generics Bulletin) ...Cipla believes President Trump's EO is targeted at the branded drugs segment rather than generics. ‘Simple' 505(b)(2)s are reimbursed in the same manner as ANDAs, says management. Leadership shares views on MFN pricing and number of channels in trade. The company is monitoring tariff-related activity. Gx Advair is set for FY26 debut... Global Sub. Full

Gedeon Richter: General Medicines Unit Deserves ‘More Attention And Credit'

(5/19, Dean Rudge, Generics Bulletin) ...Gedeon Richter said its General Medicines division was on a "good streak and dynamically growing" as Q1 sales rose by 12% as reported and by 9% in constant currencies in the first quarter. Richter's CEO Gábor Orbán observed that in the small molecule generics space, "there continues to be a relatively benign pricing environment," while there is also an increased appreciation for local and/or nearshore production. The firm is looking at "portfolio freshness" in 2025, including the immediate availability of generic Tecfidera (dimethyl fumarate) in the UK and the prepared launch of generic Gilenya (fingolimod) in Central and Eastern Europe markets... Global Sub. Full

Novo Nordisk is Betting On a CEO Shake-Up to Regain its Weight Loss Drug Edge Over Eli Lilly

(5/19, Annika Kim Constantino, CNBC) ...The Danish drugmaker on Friday abruptly announced that longtime CEO Lars Fruergaard Jørgensen is stepping down, as its obesity injection Wegovy loses ground to Eli Lilly's rival treatment, Zepbound. While Eli Lilly entered the market later, it is emerging as the front-runner in a space that some analysts believe could be worth more than $150 billion by the early 2030s. Novo Nordisk's new top executive will need to help the company close the gap with Eli Lilly, fend off emerging rivals and navigate other challenges... Full

Amgen Locked Out Of Canadian Eculizumab Market Until 2027

(5/19, Dean Rudge, Generics Bulletin) ...Amgen's Bekemv biosimilar has been found to infringe Alexion's Canadian Soliris patent 2,645,810 after a pair of invalidity challenges proposed by Amgen failed to convince Canada's Federal Court. An exercise proposed by Amgen's expert witness to reach the claimed invention based on prior art "amounts to more than mere direction from" the disclosure, the court found. Amgen has already launched its eculizumab biosimilar in the US with the rather similar named Bkemv, under an earlier patent-litigation settlement agreement... Global Sub. Full

Regeneron Win Underscores Importance of Simple Market Definition

(5/19, Katie Arcieri, Bloomberg Law) ...A federal jury on May 15 awarded Regeneron $407 million in damages, finding the Tarrytown, N.Y.-based biotech proved a market consisting of just two cholesterol-reducing drugs—Regeneron's Praluent and Amgen's Repatha. The jury rejected Amgen's argument that the market was far broader. The win highlights the importance of defining a market as narrowly as possible to prove monopolistic behavior, said Christine Bartholomew, a law professor at the University at Buffalo focused on antitrust and evidence. Defendants often try to broaden a market to show there is a wide swath of healthy competition at play... Sub. Req’d

Pfizer in Deal with China's 3SBio to License Cancer Drug Candidate, Take Equity Stake

(5/19, Kanjyik Ghosh, Mrinmay Dey and Andrew Silver, Reuters) ...The deal underscores solid demand for Chinese assets from global pharmaceutical firms looking to replenish their drug pipelines and boost their presence in the China market, even as the trade war between Beijing and Washington and potential U.S. tariffs on pharmaceuticals pose risks to the sector...Pfizer plans to manufacture the drug substance for SSGJ-707 in Sanford, North Carolina, and the drug product in McPherson, Kansas... Full

Lupin Collaborates with Honeywell, Plans for HFO Technology in Inhalers

(5/20, Express Pharma) ...Lupin announced its plan to use Honeywell's Solstice Air (HFO-1234ze(E) cGMP) propellant to transform respiratory care through the development of next-generation inhalers. Designed for patients with asthma and chronic obstructive pulmonary disease (COPD), Honeywell Solstice Air has the potential to prevent the release of high global warming potential (GWP) molecules. Lupin intends to become the first pharmaceutical company in India to use Honeywell's Solstice Air product at scale as a next-generation propellant in pressurised metered-dose inhalers (pMDIs)... Full

AstraZeneca's Airsupra Cuts Risk of Severe Exacerbations by 47% in Patients with Milder Asthma

(5/19, Kevin Dunleavy, Fierce Pharma) ...On Monday, AZ filled in the blanks, presenting data from the BATURA study, which showed that as-needed use of Airsupra reduced patients' risk of severe exacerbations by 47% compared to as-needed use of albuterol, the bronchodilator commonly used for immediate relief from asthma attacks for five decades... Full

GSK's Nucala Shows Consistent Efficacy in COPD

(5/19, The Pharma Letter) ...In the Phase III MATINEE trial, Nucala reduced moderate or severe exacerbations by 25% in patients with a history of severe exacerbations and by 21% in those without such a history. The therapy also lowered the rate of exacerbations requiring emergency department visits or hospitalization-by 32% in the severe subgroup and 40% in the non-severe group-over a period of up to two years. All participants were already receiving triple inhaled therapy, reflecting current standard care. According to GlobalData analysts, the consistent benefit observed in both high-risk and lower-risk eosinophilic COPD patients highlights Nucala's broad potential as a foundational therapy... Sub. Req’d

FDA Approves Interchangeability of Formycon and Fresenius Kabi Stelara Copy

(5/19, The Pharma Letter) ...Formycon and its commercialization partner Fresenius Kabi have announced that the US Food and Drug Administration has designated FYB202/Otulfi (ustekinumab-aauz) as interchangeable with Johnson & Johnson's reference biologic Stelara (ustekinumab). As of now, Otulfi is interchangeable in all presentations matching the reference product... Sub. Req’d

Stelara Biosimilars Look to Gain Traction, Helped by Recent Lessons from Humira

(5/19, Zachary Brennan, Endpoints News) ...Cigna's private-label distributor Quallent and Optum's private-label distributor Nuvaila are both ready to go with Stelara biosimilar deals made earlier this year, and CVS' subsidiary Cordavis, which cracked AbbVie's hold on Humira, could potentially follow suit, although the company didn't respond to a request for comment. "The conditions are looking more favorable" for initial uptake of Stelara biosimilars compared to Humira, Andrew Bourgoin, principal of the biosimilar consultancy Bourgoin Insights Group, told Endpoints News. "The private label infrastructure is in place and pricing appears more competitive."... Sub. Req’d

For Eisai and Biogen's Leqembi, First FDA-Approved Alzheimer's Blood Test Will Take Time to Boost Launch: Analyst

(5/19, Angus Liu, Fierce Pharma) ...With the FDA approval of the first blood-based test to help diagnose Alzheimer's, the first component of that plan has been set in motion. But, in a note to clients Monday, Mizuho analyst Salim Syed argued that bending the Leqembi sales curve may still take time...The next big piece is reimbursement: Lumipulse will likely need coverage to make a significant impact on the Leqembi launch, Syed said... Full

Why Regeneron is Buying 23andMe

(5/19, Andrew Dunn, Endpoints News) ...Regeneron is best known for developing blockbuster drugs like Dupixent and Eylea rather than selling saliva-test kits. The Tarrytown, NY-based biotech has minimal experience, or previously stated interest, in the world of direct-to-consumer healthcare. The agreement includes Regeneron carrying on all consumer genome services uninterrupted, according to the press release...It still needs to be finalized in bankruptcy court, but Regeneron expects to close the $256 million acquisition in the third quarter... Sub. Req’d

Amid US Investment Push, Lilly Eyes Houston as Potential Home for $5.9B API Plant

(5/19, Fraiser Kansteiner, Fierce Pharma) ...Should the proposal move forward, Lilly plans to purchase roughly 236 acres at Houston's Generation Park from the commercial development's owner, McCord Development. The final project would comprise multiple buildings and outdoor facilities, plus infrastructure buildout and equipment installation, according to the filing. Assuming Lilly settles in Houston, the drugmaker expects the new plant will employ 604 full-time staffers upon ramp-up completion... Full

2025 Prescription Drug Expenditure Projections for Health System Leaders

(5/19, Logan Lutton, Managed Healthcare Executive) ...Drug spending at clinics in 2025, the paper predicts, will likely be higher than spending at hospitals, with an 11.0% to 13.0% increase. Lead author Eric Tichy, Pharm.D., M.B.A., vice chair of pharmacy formulary at Mayo Clinic Health System, explained there has been an effort to move more care into the outpatient setting. Additionally, innovation is allowing more drugs to be approved that can be administered in the ambulatory setting. Tichy sat down with Managed Healthcare Executive to discuss the trends that are impacting health system pharmacy... Full

Trump's MFN Pricing Plan Likely to Face Legal Hurdles Despite CMMI Workaround

(5/19, Maaisha Osman, Inside Health Policy) ...Top health policy experts argue that President Donald Trump's executive order to lower drug prices using a most favored nation (MFN) policy lacks a clear legal basis and say the administration is likely to pursue the policy through an experimental Center for Medicare & Medicaid Innovation (CMMI) model. But former Congressional Budget Office director Douglas Holtz-Eakin tells Inside Health Policy even that approach would likely face legal challenges under the Supreme Court's Loper Bright decision... Sub. Req’d

Donald Trump Urged to Target ‘Lazy Patent Expansion' in US Drug Bill Push

(5/19, Hannah Kuchler, Financial Times) ...Richard Saynor, chief executive of Switzerland's Sandoz, said he backed the intention of the administration's "most favoured nation" policy — where it is seeking to cut prescription drug prices to the lowest level paid by other rich countries — but said more focus was needed on the plight of generic medicines, which make up 90 per cent of those used in the US... Sub. Req’d

Trump Should Support Effective Drug Policy Reforms Not The MFN Gimmick

(5/19, Wayne Winegarden, Forbes) ...The president's justification for the MFN is simple: Americans are getting ripped off because drug prices are cheaper in other industrialized countries. This justification misreads the problems plaguing the U.S. healthcare system. Three flaws drive up list prices for innovative medicines relative to other industrialized countries (OECD, or Organization for Economic Cooperation and Development). First, the U.S. drug market is plagued with inefficiencies. Second, other industrialized countries impose uneconomical price controls on innovative drugs. Third, the higher U.S. drug prices simply reflect the disfunction of the broader U.S. healthcare system... Full

What Is The Right Price To Pay For Drugs? Part I

(5/19, John C. Goodman, Forbes) ...More than one critic has noted that if you limit drug company income, we will get fewer new drugs. But the converse is also true. If we do things to increase drug company profits, we will get more new drugs. The right question is: what is the optimal policy? My approach to this subject is the same one economists take toward most public policies. It is an approach introduced by Adam Smith, the father of economics. We begin by asking what would happen in a completely free market. Then, we ask whether government intervention of some sort would improve social welfare. By a free market, I mean a market in which companies are free to develop drugs and (once they are found to be safe and effective) charge whatever price the market will bear for the life of a patent... Full

Drug Companies Should Lower Rx List Prices

(5/19, PCMA Blog) ...Rising drug prices limit the ability of PBMs to effectively secure savings to address the affordability challenge that some patients face. The sticker price is the starting point for all PBM and drug company negotiations - and often the basis for cost sharing obligations. A lower sticker price means employers, unions, plan sponsors, and most importantly, patients, will pay less... Full

Pharma 340B Rebate Model Stopped For Now As Court Defers To HRSA

(5/19, Gabrielle Wanneh, Inside Health Policy) ...Hospitals chalked up an initial win in their bid to stop drug makers from replacing upfront 340B drug discounts with back-end rebates when a federal DC district judge ruled last week the ultimate decision on the policy rests with the Health Resources and Services Administration -- but the win could be short-lived as HRSA has sent warning letters against four drug makers asking them to stop their rebate policies although the Trump administration has yet to issue a broad policy decision... Sub. Req’d

FDA Deputy Commissioner Hints at Potential Changes to PDUFA

(5/19, Joanne S. Eglovitch, Regulatory Focus) ...[Grace Graham, the newly named deputy commissioner for policy, legislation, and international affairs at the annual meeting of the Food and Drug Law Institute,] also said that FDA is looking at other ways to tweak the program. For instance, she pointed out that under the Generic Drug User Fee Amendments (GDUFA) program, foreign facilities are assessed a higher fee than domestic ones to address the cost difference in assessing those facilities. "That may be a concept worth expanding to other product areas," Graham said... Full

Trump Drug Order Ignores the Government's Interest in High Drug Prices, Ohio Expert Says

(5/20, Marty Schladen, Ohio Capital Journal) ...The issue of drug pricing has been as pressing in Ohio as anywhere. President Donald Trump last week issued an executive order requiring drugmakers to offer their products as cheaply here as they do overseas. But players in the industry say the order lacks detail about how it would make that happen. An Ohio expert said the order ignores the arcane, often self-serving way drug prices are inflated by myriad players in the United States — including the government itself... Full

PDAB Weighs Diabetes Drug Affordability, As Moore Weighs Bill to Expand PDAB

(5/20, Danielle J. Brown, Maryland Matters) ...The Prescription Drug Affordability Board unveiled a 92-page draft report Monday for Farxiga, a brand-name medication for dapagliflozin, to help board members determine if the drug is "unaffordable" for Marylanders... Full

EFPIA Report Highlights Persistent Access Gaps for New Medicines in Europe

(5/19, The Pharma Letter) ...The European Federation of Pharmaceutical Industries and Associations (EFPIA) has released new data that sheds light on why patients in some European countries wait significantly longer than others for access to innovative medicines. The findings, drawn from two comprehensive reports, reveal that structural and procedural barriers-not company decisions alone-are the main culprits behind these disparities... Sub. Req’d

Power of Collaboration More Pertinent Than Ever Says Pharma Experts

(5/19, Abigail Beaney, Pharmaceutical Technology) ...Swiss Biotech Association CEO Michael Altorfer said: "International cooperation is in the heart of our city because our city lies in daily life in three countries….In these times, it's important to be stable and predictable, to continue our policies as we always did, and will do in future—policies to support science, that leave it the independence it needs."... Full

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