Monday, May 12, 2025

JPMorgan Upgrades Teva Pharma (TEVA) to Overweight

(5/12, StreetInsider.com) ...The analyst comments: "With TEVA's recently announced cost-cutting program providing much-needed clarity on the drivers of the company's margin expansion in 2026/2027, we are upgrading shares to OW from N...And looking beyond this cost program, we see TEVA growth improving significantly as we look out to 2027 and beyond driven by the company's branded business including Austedo (which co ntinues to grow nicely), Olanzapine LAI (launching in 2026) and Duvakitug (TL1a, which we see having a path for differentiation in Crohn's Disease and the broader IBD market)."... Sub. Req’d

Eye On Pharma: Interchangeability, Private Labels, and Patent Settlements for Biosimilars

(5/9, Skylar Jeremias, The Center For Biosimilars) ...Alvotech/Teva and Biocon Biologics advanced US biosimilar access with FDA interchangeability for ustekinumab biosimilars, Selarsdi and Yesafili, plus broad 2025 formulary coverage for Biocon's Yesintek...The FDA's designation of interchangeability allows Selarsdi to be substituted at the pharmacy level, enhancing access and lowering healthcare costs. This approval is part of the broader Teva-Alvotech biosimilars collaboration, which recently launched Simlandi (adalimumab-ryvk), a biosimilar to Humira (adalimumab). Three additional biosimilars under the partnership are currently under FDA review, with decisions expected by late 2025... Full

India's Dr Reddy's Says Open to Boosting U.S. Manufacturing as Tariff Threat Looms

(5/9, Rishika Sadam, Kashish Tandon, Reuters) ..."We are more than open to work in the United States, to make in the United States when the opportunity comes," CEO Erez Israeli said in a press call on Friday. "We want to invest (in the U.S.)... we are not rushing, and we are not obliged to any commitment," he said, adding that the company is also working to avoid any potential disruption to its supply chain that tariffs, if imposed, could lead to. India's drugmakers that derive significant revenue from North America through their cheaper version of innovator drugs are on tenterhooks about U.S. tariffs on pharma imports... Full

Dr. Reddy's Pins Hopes On a Diabetes Treatment Drug, But Analysts Remains Cautious

(5/12, Meghna Sen, CNBC TV-18) ...While the Q4 gross margin decline was partly due to one-off factors, Emkay believes underlying weakness is also linked to rising pricing pressures in the core US portfolio, especially for gSuboxone, the largest contributor excluding gRevlimid... Full

Fresenius Kabi Lauds Tocilizumab Momentum As ‘Intense' Transfer To mAbxience Continues

(5/9, Dean Rudge, Generics Bulletin) ...Driven by the strong uptake of its Tyenne biosimilar to Actemra/RoActemra in the US and Europe, Fresenius Kabi's Q1 Biopharma revenues shot up by 37% as reported and by two-fifths in constant currencies to €190m ($214m). Total Q1 revenues increased by 5% both as reported and in constant currencies to €2.15bn, with the firm's ‘growth vectors' – Biopharma, MedTech and Nutrition – contributing €1.20bn of sales and 11% ‘organic' growth... Global Sub. Full

Apotex Extends Formosa Ophthalmic Alliance Into Mexico

(5/9, Dave Wallace, Generics Bulletin) ...Apotex and Formosa Pharmaceuticals have broadened an existing alliance on clobetasol propionate ophthalmic suspension to cover Mexico as well as Canada. The product – approved in the US last year – is used to treat inflammation and pain following ocular surgery. Apotex is continuing to build up its branded business, striking a series of deals since acquiring brand company Searchlight Pharma in 2024... Global Sub. Full

Roche Pledges Nearly $300M to Establish New Vabysmo Production Plant in China

(5/9, Fraiser Kansteiner, Fierce Pharma) ...Roche is investing roughly 2.04 billion Chinese yuan ($282 million) to erect a new biomanufacturing hub in Shanghai, China. The plant, which will mark Roche's second for branded medicines in the country, will mainly be used for domestic production of the eye med Vabysmo, which goes by the commercial moniker Luoshijia in China. The name combines Roche's Chinese name "Luo Shi" and two words "Shi Jia" that mean good vision... Full

Zepbound Beats Wegovy for Weight Loss in First Head-to-Head Trial of Blockbuster Drugs

(5/11, Jonel Aleccia, Associated Press) ...People taking Eli Lilly's obesity drug, Zepbound, lost nearly 50% more weight than those using rival Novo Nordisk's Wegovy in the first head-to-head study of the blockbuster medications. Clinical trial participants who took tirzepatide, the drug sold as Zepbound, lost an average of 50 pounds (22.8 kilograms) over 72 weeks, while those who took semaglutide, or Wegovy, lost about 33 pounds (15 kilograms). That's according to the study funded by Lilly, which was published Sunday in the New England Journal of Medicine... Full

Eli Lilly Expands Purdue University Partnership With $250M Investment

(5/9, Darren Incorvaia, Fierce Biotech) ...The boosted pact with the boilermakers will focus on artificial intelligence drug discovery methods, speeding up the process of moving drugs through clinical trials and into regulatory approval and manufacturing and enhancing the Indiana life sciences workforce, according to a May 9 release...The overall goal of the partnership is to get medicines to patients faster, accelerate the translation of new science into clinical trials, strengthen the pharmaceutical supply chain and improve the local economy of Indiana, the partners said... Full

Hawaii in $700 Million Settlement with Bristol-Myers, Sanofi Over Plavix Warning Label

(5/9, Kanishka Singh, Reuters) ...Hawaii said on Friday it entered a $700 million settlement with pharmaceutical firm Bristol-Myers Squibb and units of French pharmaceutical company Sanofi in a case about warning labels related to health risks from blood thinner Plavix... Full

Yesintek Biosimilar Shows Comparable Efficacy, Lower Immunogenicity Than Stelara, Says Elena Wolff-Holz, MD

(5/11, Cameron Santoro and Elena Wolff-Holz, MD, The Center for Biosimilars) ...Elena Wolff-Holz, MD, global head of clinical development at Biocon Biologics, discussed the approval of BMAb-1200 (Yesintek; ustekinumab-kfce), for psoriasis treatment, a biosimilar referencing Stelara (ustekinumab). She highlighted the comparable efficacy and safety with reference Stelara, including positive switching data... Full

Biosimilars: Unlocking Access, Closing the Cost Divide

(5/9, Josh Canavan, Pharmaphorum) ...For those with chronic conditions like asthma, arthritis, and diabetes, those decisions can carry serious health consequences. Cost-related nonadherence (CRN) – the act of skipping doses, splitting pills, or delaying refills to save money – is a major issue among US adults with chronic conditions. For instance, studies have shown that approximately 25% of adults with diabetes reported rationing insulin in the previous year due to cost concerns. This behaviour can lead to adverse health outcomes and increased healthcare utilisation... Full

U.S. Drug Spending Up 10.2% in 2024, with Weight Loss Drugs Remaining Top Driver

(5/9, ASHP) ...U.S. prescription drug expenditures rose to $805.9 billion in 2024 - an increase of 10.2% over the previous year - fueled in large part by soaring demand for weight-loss drugs, known as GLP-1 receptor agonists, according to a new report from ASHP (American Society of Health-System Pharmacists). GLP-1s, which are increasingly prescribed for both diabetes and obesity, are now the top drug category by total spending and the fastest-growing segment in the market... Full

Weight-Loss Jabs Could Halve Risk of Obesity-Related Cancers, Study Finds

(5/11, Anna Bawden, The Guardian) ..."The protective effects of GLP-1RAs against obesity-related cancers likely arise from multiple mechanisms, including reducing inflammation," said co-lead author Prof Dror Dicker from Hasharon Hospital, Rabin Medical Center, Petah Tikva, Israel. Newer drugs could prove even more beneficial, he added. "New generation, highly potent GLP-1RAs with higher efficacy in weight reduction may convey an even greater advantage in reducing the risk of obesity-related cancers, but future research is needed to make sure these drugs do not increase the risk for non-obesity-related cancers."... Full

Walgreens Doubles Down On Prescription-Filling Robots to Cut Costs, Free Up Pharmacists Amid Turnaround

(5/11, Annika Kim Constantino, CNBC) ...Walgreens is expanding the number of its retail stores served by its micro-fulfillment centers as it works to turn itself around and prepares to go private. Those centers use robots to fill thousands of prescriptions for patients who take medications to manage or treat diabetes, high blood pressure or other conditions. Relying on those centers frees up time for pharmacy staff, reducing their routine tasks, eliminating inventory waste and allowing them to interact directly with patients and perform more clinical services such as vaccinations and testing... Full

Trump to Sign Executive Order to Cut Prices of Medicine to Match Other Countries

(5/11, Michael Erman, Patrick Wingrove, Reuters) ...U.S. President Donald Trump said on Sunday he would sign an executive order to cut prescription prices to the level paid by other high-income countries, an amount he put at 30% to 80% less. In a post on Truth Social, Trump said he would sign the executive order on Monday morning to pursue what is known as "most favored nation" pricing or international reference pricing... Full

Trump Says He Will Cut Drug Prices by 59% as Shares Drop

(5/12, Susan Heavey, Reuters) ..."Drug prices to be cut by 59%" Trump wrote on Monday in capital letters on his social media platform as global pharma shares traded lower. Shares of U.S. drugmakers fell between 2% and 3% following his weekend comments before Trump's latest post Monday morning. Trump is scheduled to hold an event at the White House with U.S. Health Secretary Robert F. Kennedy Jr. at 9:30 a.m. (1330 GMT)... Full

Trump Vows US Drug Price Cuts of Up to 80% in Industry Blow

(5/12, Rachel Cohrs Zhang, Derek Wallbank and Hadriana Lowenkron, Bloomberg) ...Trump's Truth Social post — preceded by an earlier one that promised "one of the most important and impactful" posts he has ever issued — didn't offer specifics on the order. He also didn't outline potential limits on the policy, such as whether it would apply only to government programs such as Medicare or Medicaid, if it would be limited to certain drugs or categories of drugs or if the White House sees a way to apply this more broadly. While it's still unclear which drug companies will be affected by the executive order, investors are most worried about blockbuster drugs in Medicare Part-B and drugs serving large Medicaid populations, according to Jared Holz, a health-care strategist at Mizuho Securities USA LLC... Full

Trump Confirms He Will Sign ‘Most-Favored Nation' Executive Order in Bid to Lower Drug Prices

(5/11, Daniel Payne, STAT+) ...Almost immediately, the pharmaceutical industry lobby group PhRMA called the planned executive order a "bad deal for American patients." In a statement from CEO Stephen Ubl, the group said there was no guarantee that any lower prices required by the order would improve patients' access to medication...PhRMA said the executive order risks undermining Trump's push to bring more manufacturing to the U.S., and could instead leave the U.S. more reliant on China. The industry group said lawmakers should instead target drug-industry middlemen such as pharmacy benefit managers and the 340B drug discount program... Sub. Req’d

Trump Promises to Order that the US Pay Only the Price Other Nations Do for Some Drugs

(5/11, Will Weissert and Amanda Seitz, Associated Press) ...Under the planned order, the federal government would tie what it pays pharmaceutical companies for those drugs to the price paid by a group of other, economically advanced countries — the so-called "most favored nation" approach. The proposal will face fierce opposition from the pharmaceutical industry... Full

Generics Won't Be Affected by Trump's Pricing Policy, Says Dr. Reddy's

(5/12, CNBC) ...Erez Israeli, CEO of Dr. Reddy's, discusses the potential impact of Trump's proposed drug pricing changes, noting that "generics normally give significant discounts," and shares how the company plans to expand its diabetes and obesity drug offerings amid increasing competition... Full

Here's How Trump Might Approach His Drug Pricing Plan

(5/9, John Wilkerson and Daniel Payne, STAT+) ...As with other policy announcements, the actual impact of any executive order would depend largely on the details...In this case, lobbyists and consultants in Washington told STAT they already have a fair number of questions — perhaps chiefly about whether the policy would apply to all or part of Medicare, Medicaid, or even the commercial market...Despite the open questions, some pharmaceutical companies, according to one person familiar with the planning, are already considering their options to fight the policy: whether by trying to cut a deal with Trump, fighting the administration in court — or some combination of both. They're looking back to Trump's first administration to try to chart out a path forward... Sub. Req’d

Why US Generic Drug Prices Can't Fall Much Further — Even if Trump Wants Them To

(5/12, N Mahalakshmi, Money Control) ...Moreover, with 40–50% of generics imported, aggressive price cuts could make exports unviable for supplier and trigger a supply shock instead, a risk the US administration would like to take. Here's a breakdown of how concentrated the US generic purchasing landscape really is... Full

Pioneer Institute Launches Tracker Showing Drug Price Controls Are Raising Out-of-Pocket Costs for Medicare Patients

(5/9, Pioneer Institute Public Policy Research) ...The IRA Medicare Drug Access Tracker, developed by Dr. William Smith and Dr. Robert Popovian, monitors the impact of the Inflation Reduction Act's (IRA) drug pricing provisions. Its first analysis shows that among nine commonly prescribed medications which were subject to price setting by the IRA —used to treat conditions like heart failure, diabetes, and blood clotting—seven saw an increase in patient out-of-pocket costs... Full

Medicare Negotiation Does Not Violate Due Process, Appeals Court Rules, Other Suits At Risk

(5/9, Cathy Kelly, Pink Sheet) ...The US Third Circuit Court upheld a lower court determination that the Medicare price negotiation program does not violate AstraZeneca's constitutional due process rights. The decision is precedent-setting blow to manufacturer efforts to strike at the negotiation program's core framework. The court also affirmed the district court's conclusion that AstraZeneca lacks standing to challenge program guidance on drug eligibility and when generic competition can exclude a drug from a negotiated price... Global Sub. Full

Arrington Introduces ETHIC Act to Increase Competition in the Prescription Drug Market

(5/9, House Budget Chairman Jodey Arrington) ...New research shows that the thickets used by certain branded pharmaceutical companies are duplicative, and fail to make substantial improvements to the original drug. This practice delays competition and keeps drug prices high for hardworking American families. The ETHIC Act would curb the practice of patent thicketing, bringing much-needed competition to the domestic biosimilars market and increasing access to lower cost treatments and cures... Full

Cassidy Discusses Bringing Medicine Manufacturing to Northwest Louisiana

(5/9, U.S. Senator for Louisiana Bill Cassidy, M.D.) ..."President Trump is doing his best to make the United States a place where businesses invest in," said Dr. Cassidy. "We need increased domestic manufacturing of drugs. I'm committed to the economic development of Northwest Louisiana, and bringing in full production facilities for drugs and other goods."... Full

EFPIA Says Europe Still Divided On Medicines Access

(5/12, The Pharma Letter) ...New figures from the European Federation of pharmaceutical Industries and Associations (EFPIA) paint a stark picture of the growing divide in access to innovative medicines across the European Union, with patients in some countries waiting more than seven times longer than others for the same treatment...The reports also emphasize how economic decisions by pharmaceutical companies — such as delaying market entry due to poor commercial outlook — can exacerbate these challenges. That nuance matters, especially as EU lawmakers weigh policy reforms designed to reduce access gaps... Sub. Req’d

Pharma Still in Waiting Mode After UK-US Trade Agreement

(5/9, Phil Taylor, Pharmaphorum) ...Pharma was not mentioned at all as Trump and UK Prime Minister Keir Starmer unveiled the 'agreement in principle', as it was described by the office of the US Trade Representative (USTR). It focused mainly on the car industry, which saw US tariffs fall from 27.5% to a blanket levy of 10%, while those on steel and aluminium fell to zero...Moreover, Downing Street has indicated that the UK will receive "preferential treatment in any further tariffs imposed" as part of the US Department of Commerce's ongoing Section 232 investigation into pharma, which is viewed as the first stage before tariffs are imposed, potentially within the next couple of weeks... Full

India Rejects UK's Data Exclusivity Demand in FTA to Shield Generics

(5/12, Press Trust Of India) ...India has not accepted the demand of the UK for inclusion of a 'data exclusivity' provision in the free trade agreement, announced on May 6, in a bid to protect the interests of the domestic generic drugs industry, an official said. During the negotiations, the UK had asked to include this provision in the trade pact... Full

Pie in the Sky? Trump's Executive Order On Pharma Unlikely to See the Light of Day: N Jayakumar

(5/12, The Economic Times) ...N Jayakumar, MD, Prime Securities, views the US executive order on pharma prices as unrealistic. He anticipates legal challenges. He highlights the dominance of large pharmacy chains and their markups on generic drugs. He suggests the core issue is inefficient distribution, not price control. He believes reducing distribution costs is key... Full

Trump's Move to Bring Down US Drug Prices May Take Some Sheen Off Indian Generics

(5/12, PT Jyothi Datta and Naga Sridhar, The Hindu BusinessLine) ...In his last term as President, Trump had taken on Big Pharma in the US along similar lines. So his latest statement may not come entirely as a surprise to large US drug makers including Pfizer, Eli Lilly, Merck etc — although the impact will become clear once the exact details are made public. The announcement though could impact Indian drugmakers, for whom the US is a significant market — albeit largely in the generic drugs segment, say industry insiders... Full

Indian Pharma Stocks Fall as Trump Moves to Cut U.S. Drug Prices

(5/12, Kashish Tandon, Reuters) ..."A price cut of prescription drugs by 50% or more would hurt the U.S. formulations market, more on the branded size due to immediate potential impact, while over the medium term it will also impact generics as it reduces the potential market size of new drugs," said Shrikant Akolkar, an analyst at Nuvama Institutional Equities. "Indian branded players like Sun Pharma, Biocon and Zydus Life may see an impact upon strict implementation," Akolkar said... Full

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