Monday, August 4, 2025

  Top Teva News

Analysts See Huge Upside in Teva

(8/4, Shiri Habib-Valdhorn, Globes) ...According to "The Wall Street Journal," the average target price of 11 investment institutions covering Teva's stock is $24.29, a 57.9% premium on the current share price, and almost all of them have positive recommendations for the stock...One of the investment banks whose price target for Teva's stock is among the highest is Oppenheimer with a price target of $30, 95.1% higher than the price on the NYSE. Oppenheimer's recommendation for Teva is "outperform." Oppenheimer writes, "In our opinion, the current market value of Teva's stock does not reflect its future earnings potential, and constitutes an excellent buying opportunity for long-term investors."... Full

Truist On Teva Pharma (TEVA): 'BUY On Weakness'

(8/1, StreetInsider.com) ...Truist Securities analyst Les Sulewski reiterated a Buy rating and $25.00 price target on Teva Pharm. The analyst commented: "Solid Mgmt Team And Well Positioned To Navigate Uncertainty | BUY On Weakness; We hosted TEVA mgmt over a 2-day oversubscribed NDR. Investors honed in on IRA pricing impact to Austedo and competitor's strides to win market share - mgmt appears comfortable with the LT guidance..."... Sub. Req’d

  U.S. Policy & Regulatory News

Trump Says He Will Get Drug Prices Down By 500% To 1500%

(8/2, Bruce Y. Lee, Forbes) ...U.S. President Donald Trump has promised an even greater reduction, a 500% to 1500% reduction...How that specifically is going to happen is unclear. But on Thursday, Trump did send letters to the heads of 17 major pharmaceutical companies pushing them to cut the prescription medication prices that Americans face down to the levels that people in other countries pay, which by the way would be around a 66% reduction...That 1500% number may not have been in the letters that Trump sent on Thursday to pharmaceutical manufacturers including AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, EMD Serono, Genentech, Gilead, GSK, Johnson & Johnson, Merck, Novartis, Novo Nordisk, Pfizer, Regeneron and Sanofi... Full

Why Drug Prices for Some Big Medicines Will Remain High for a Longer Time

(8/4, Joseph Walker, The Wall Street Journal) ...Thousands of Medicare recipients will have to wait longer to get some price relief on the expensive cancer drugs they depend on for treatment, while others might not get any reprieve at all. Two little-known provisions in the One Big Beautiful Bill Act signed by President Trump in July will delay Medicare price negotiations for some of the biggest-selling drugs in the world, including Merck's Keytruda, which is used to treat cancer and had $17.9 billion in U.S. sales in 2024. Other drugs, such as Johnson & Johnson's Darzalex, will be excluded entirely... Sub. Req’d

Drugmakers Are Pouring Billions of Dollars Into New US Manufacturing. It Still Won't Achieve All of Trump's Tariff Goals

(8/2, Tami Luhby, CNN Business) ...But the pharma companies’ moves are not expected to decrease the United States’ reliance on foreign sources for key pharmaceutical ingredients and drugs, experts say. Nor are they likely to result in lower costs for American consumers... Full

Trump Wants Drugs Made in the U.S. This Company Plans to Do It in Baltimore.

(8/1, Meredith Cohn, The Baltimore Banner) ..."Coming to America makes a lot of sense because it's where our customer base is," Syngene CEO Peter Bains said in a recent interview at the Bayview plant. "We hope this foothold becomes a stronghold." The expected reopening comes as President Donald Trump has pushed companies to make more drugs in the United States, sometimes using tariffs on overseas imports to prod them to comply. But Syngene had already made the decision to open its first U.S. plant in Baltimore months before Trump took office, eventually paying $36.5 million to Emergent for a facility that would have taken years and millions to build. It's already been cleared to operate by the U.S. Food and Drug Administration... Sub. Req’d

Regeneron CEO Stresses Need for Drug Price 'Equilibrating in Europe'

(8/1, Kyle LaHucik, Endpoints News) ...Regeneron's CEO and co-chair said he agreed with President Donald Trump's view that European nations should pay more for new drugs..."I have been, and the company has been, outspoken that we agree with the president that the Europeans are not paying their fair share of innovation, and some way that needs to change," [Leonard Schleifer] said on the earnings call. "It's complicated and it does have to be done at a trade and policy level, because it can't be done at an individual company level. It's very difficult." He added that "the solution is simply not to lower cost prices in the US without some equilibrating in Europe, because then there'll be no innovation."... Sub. Req’d

Senate Panel Eyes Price Transparency, PBM And 340B Reforms As Bipartisan Solutions To Tackle Health Care Costs

(8/1, Jalen Brown, Inside Health Policy) ...Despite deep ideological divisions between Senate health committee Chairman Bill Cassidy (R-LA) and Ranking Member Bernie Sanders (I-VT), bipartisan momentum may be building around price transparency, 340B and pharmacy benefit manager (PBM) reform as potential avenues to address rising health care costs -- but it remains unclear whether Democrats are willing to engage across the aisle so soon after the passage of the GOP's nearly $1 trillion in Medicaid cuts... Sub. Req’d

The Murkiness of Drug Companies' Price Transparency Reports

(8/4, Bob Herman, STAT) ...Over the past decade, pharmaceutical companies have released carefully curated "price transparency" reports that make it appear the prices of their medicines are barely increasing — or even going down. But the reports disclose no pricing information about specific drugs, manipulating the reality of how much Americans spend on prescription drugs..."These reports are essentially part of a larger strategy by the industry to blame high drug prices on pharmacy benefit managers and hospitals and avoid any role that they play in setting high drug prices," said Ben Rome, a primary care doctor and researcher at Harvard Medical School and Brigham and Women's Hospital... Full

CMS Mulls Proposal for Some Medicare, Medicaid Plans to Cover Weight Loss Drugs — Report

(8/1, Max Bayer, Endpoints News) ...CMS is considering a new program that would allow some state Medicaid plans and Medicare Part D to voluntarily cover GLP-1 drugs for weight management, according to a new report..."All drug coverages undergo a cost-benefit review," CMS spokeswoman Catherine Howden told Endpoints News on Friday. "CMS does not comment on potential models or coverage." If the pilot program comes to fruition, it would be a boost to obesity drugmakers that have been clamoring for expanded government coverage of GLP-1s... Sub. Req’d

Competition Has Already Reduced Prices for Obesity Medicines

(8/1, Kirsten Axelsen and Melanie Whittington, RealClearHealth) ...Biopharmaceutical innovators have researched, developed, and gained regulatory approval for multiple obesity medicines, and yet Medicare continues to not cover treatments for weight loss, in the context of the costly chronic disease of obesity. Rather than remove that restriction from the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to expand patient access to these cost-effective treatments for the serious disease of obesity, the government is moving to price regulation which can disrupt the market dynamics and incentives that are already successfully reducing drug prices... Full

More Pharma Giants Embrace Direct-to-Consumer Sales

(8/4, Maya Goldman, Axios) ...While Trump is pushing direct-to-consumer drug sales, Health Secretary Robert F. Kennedy Jr. has long been interested in limiting pharmaceutical companies' ability to advertise to consumers. Health and Human Services is "exploring ways to restore more rigorous oversight and improve the quality of information presented to American consumers who deserve nothing less than radical transparency," spokesperson Emily Hilliard told Axios... Full

Congress Can Save the Biosimilar Market and Patients' Wallets

(8/1, James Gelfand, InsideSources.com) ...Increasing the affordability of prescription drugs is not a Republican or Democratic issue — it is a patient issue. Millions of Americans are looking to Congress to provide relief from high and rising prescription drug costs that are threatening the health and financial well-being of our nation's families, large employers, small businesses and communities. The time to act is no to take action in the House to introduce and pass the Lee-Luján bill... Full

FDA Shortage List Reports 83 Shortages – How Can That Be?

(8/1, Bob Pollock, Lachman Consultants) ...The FDA's listing criteria represent a more critical evaluation of the overall national drug supply and demand... Full

Generic Drugs And AI: Maximum Daily Dose Tool Could Help US FDA Be ‘At The Forefront'

(8/1, Michael McCaughan, Pink Sheet) ...FDA officials are developing an AI tool that can help generic drug sponsors calculate the maximum daily dose, a key component of development. OGD Office of Regulatory Science Director Robert Lionberger said the tool is an example of the required work to ensure AI is useful for regulatory activities. The FDA also wants to know whether AI is helping industry speed drug development, Lionberger said... Global Sub. Full

Appeals Court Denies Rehearing of Minnesota Drug Price Law Pause

(8/1, Celine Castronuovo, Bloomberg Law) ...Minnesota's law prohibiting excessive price hikes on generic drugs will remain paused after a federal appeals court on Friday declined to reconsider its decision affirming a lower court's preliminary injunction on the statute...The ruling is another win for the Association for Accessible Medicines, the trade group representing generic and biosimilar manufacturers that has repeatedly secured court rulings against state efforts to rein in drug costs. AAM asserts that the Minnesota law that penalizes drugmakers for certain price increases improperly regulates transactions that take place completely outside of Minnesota's borders... Sub. Req’d

  Innovative News

Sanofi Pens $395M China Pact for Arrowhead Metabolic Med

(8/1, James Waldron, Fierce Biotech) ...Sanofi is handing over $130 million upfront for the China rights to Arrowhead Pharmaceuticals' rare metabolic disease treatment that is currently being considered for approval by Chinese regulators. The RNA interference (RNAi) therapeutic, called plozasiran, already aced a phase 3 trial last year, which tied 25-mg and 50-mg doses of the drug to 80% and 78% reductions, respectively, in triglycerides at 10 months for patients with familial chylomicronemia syndrome (FCS)... Full

  Generics & Biosimilars News

Dr Reddy's On Semaglutide Prospects, Capacity And There's An IP Hearing To Watch

(8/1, Anju Ghangurde, Generics Bulletin) ...Dr Reddy's Laboratories is betting big on the upcoming opportunity for semaglutide in markets like Canada, even as a crucial court case pertaining to Novo Nordisk's GLP-1 agonist plays out in India. Dr Reddy's CEO Erez Israeli indicated that the Indian company was prioritizing the capacity it had to launch generic semaglutide - marketed by Novo as Ozempic for type 2 diabetes - in Canada next year and assuming that happens, launches in over 80 markets overall are anticipated after March 2026... Global Sub. Full

Boryung Launches Samsung Bioepis' Bone Cancer Biosimilar With Storage Edge Over Amgen's Xgeva

(8/4, Kim Ji-hye, Korea Biomedical Review) ...Boryung has officially launched Xbryk, a denosumab biosimilar developed by Samsung Bioepis, in the Korean market. The product became available last Friday following its addition to the national reimbursement list...Boryung said in Monday's release that Xbryk offers improved storage flexibility over the originator, which must be discarded after 14 days at room temperature. Xbryk can be stored at room temperature for up to 60 days before being returned to refrigeration... Full

Arrotex and Celltrion Partner On Biosimilars

(8/1, Pharmacy Daily) ...Celltrion Healthcare Australia and Australian-owned Arrotex Pharmaceuticals have entered into a strategic agreement to launch two new biosimilar medicines - Steqeyma (ustekinumab) and Omlyclo (omalizumab)...As the sponsor of the medicines, Celltrion will be responsible for engaging with key prescribing physicians, while Arrotex will be the brand's exclusive distribution partner in Australia, covering community pharmacy distribution as well as representation across the dermatology segment... Full

  Industry News

Takeda Sees Limited Tariff Exposure as US Remains Strategic Priority

(8/4, Pharma Japan) ..."We are highly invested in the US," [Takeda CEO Christophe Weber] emphasized, noting that the country hosts the company's largest manufacturing presence in terms of the number of sites, products manufactured, and employees involved. "That's also why our exposure to tariffs is limited," he added, reiterating that Takeda continues to invest in its US manufacturing network while strategically assessing various parameters. While the company has already announced plans to invest roughly US$30 billion in the US over the next five years, the CEO did not specifically mention further investment initiatives on the call... Sub. Req’d

Regeneron Posts Better-Than-Expected Q2 Results, Downplays Tariff Impact

(8/1, Siddhi Mahatole, Reuters) ...Under the U.S.-EU trade deal announced earlier this week, all branded medicines will be subject to a 15% broad tariff. As the company gains clarity on details of the agreement and other potential tariffs, CEO Leonard Schleifer said the 15% duties were not expected to have a material impact. Investors have set a high bar for Regeneron and French partner Sanofi's Dupixent, one of the U.S. drugmaker's growth drivers... Full

Regeneron Says Novo Plant Problems Caused Another CRL and Will Delay 2 Eylea Decisions

(8/1, Kevin Dunleavy, Fierce Pharma) ...Regeneron is having difficulties again with its manufacturing partner Novo Nordisk, reporting that it expects two FDA decisions due this month for its eye disease drug Eylea will be delayed, while another application for its cancer bispecific has received a complete response letter—again...Regeneron CEO Len Schleifer said during a Friday quarterly conference call that he doesn't expect the Eylea HD delay to last long, calling the plant issues as "procedural." "Novo has been in communication with the FDA and expects to file its comprehensive and robust response next week," he said. "Based on our review of the observation and Novo's proposed response—along with the progress that we have made with alternate third-party fillers—we anticipate an expeditious resolution of our filling issues for Eylea HD."... Full

Lilly Rises On Plan to Expand Medicare Weight-Loss Coverage

(8/1, Madison Muller, Rachel Cohrs Zhang, Bloomberg Law) ...Lilly shares rose as much as 3.8% in New York trading on Friday, while Novo Nordisk A/S gained as much as 4.2% in Copenhagen. Opening up the gigantic Medicare and Medicaid market to cover their drugs for weight loss — rather than just diseases like diabetes, sleep apnea or heart disease — would be a boon for the drugmakers, potentially expanding access to millions of patients...A spokesperson for Lilly said it's "dedicated to ensuring that all patients, regardless of their insurance provider, can access evidence-based obesity care." The company "believes access should be guided by clinical evidence, not insurance design" and is committed to working with payers and policymakers to expand coverage... Sub. Req’d

Exclusive: Lilly to Sell New Jersey Facility as it Nears Picks for New US Sites

(8/1, Drew Armstrong, Endpoints News) ...Eli Lilly is selling its Branchburg, NJ manufacturing facility as it shifts capacity away from monoclonal antibodies and toward more complex forms of biologics, the drugmaker told Endpoints News. The Indianapolis-based pharma is entering into late-stage talks with one buyer and hopes to close a sale by the end of this year, said Edgardo Hernandez, president of Lilly's manufacturing operations. It's looking for a buyer who is willing to take on the workforce at the facility and keep it operating... Sub. Req’d

Independent Sandoz Doing Much More Than Standing On its Own Two Feet

(8/2, Guy Martin, The Pharma Letter) ...Through 2028, the company is confident that it will achieve mid-single-digit growth. Together with the ambition that by 2028 Sandoz wants to be paying out at least 30% of recurring net income as a total dividend, and the trusted nature of the brand—a Swiss pharma institution dating back to the 1800s—it is no wonder the investment opportunity appears attractive. The company's confidence is shown by its recently-initiated construction of a new biosimilars production facility in Brnik, Slovenia... Sub. Req’d

  International News

Uncertainty About Medicines in US-EU Trade Deal, Says VIG

(8/4, The Pharma Letter) ...US President Donald Trump stated that medicines are excluded from the agreement, while Commission President von der Leyen confirmed that medicines are subject to a 15% tariff cap. "Import duties should never be levied on medicines," says Carla Vos, general director of the VIG. "Ultimately, this would be detrimental to patients and burden the healthcare system with unnecessary additional costs. At a time of increasing pressure on healthcare systems, this is irresponsible," she noted... Sub. Req’d

Danish Pharma Body Warns EU Health Data Law Could Stifle Innovation

(8/4, The Pharma Letter) ...Denmark's pharmaceutical industry body has warned that a new European health data regulation could hamper medical innovation and weaken public-private research efforts if left unchanged. Lif, the association representing Denmark's pharma sector, said that while it supports the idea of greater access to health data across the EU, the current language in the European Health Data Space (EHDS) proposal risks introducing legal uncertainty for companies seeking to use that data for research and development... Sub. Req’d

Medicines UK's Samuels: Off-Patent Drugs Are Finally Gov's Priority But The Picture Still ‘Nuanced'

(8/1, Urte Fultinaviciute, Generics Bulletin) ...Medicines UK's CEO Mark Samuels discussed the current state of the UK market for off-patent medicines. The government has recognized generics and biosimilars for the first time in its recently published Life Science Sector Plan, marking a new era for the sector. However, Samuels suggested that drug evaluator NICE needs "radical" change to fit the needs of the off-patent industry. While biosimilars have taken the limelight on savings, Samuels urged not to forget the importance of generic drugs... Global Sub. Full

Pharma Left in Limbo as Section 232 Probe Drags On

(8/4, Vasiliki Angouridi, Euractiv) ...While the 15% US tariffs are set to impact most European sectors from August 7, the EU pharma industry seems to be exempt – at least until the ongoing so-called "Section 232" investigation is concluded. This could prolong the period of uncertainty well into next year...If the investigation concludes that such imports pose a risk or are contrary to US interests, Trump could decide to impose tariffs or quotas on the affected products... Full

Black Day for Switzerland as Trump Imposes 39% Tariffs

(8/4, The Pharma Letter) ...The 39% tariffs imposed by the USA threaten Switzerland with enormous economic damage. Even though pharmaceutical products are exempt from tariffs for the time being, with the latest decision on "Most Favored Nation Drug Pricing," the US government is jeopardizing the global supply of innovative medicines, said the Swiss pharma trade group Interpharma... Sub. Req’d

‘Knives Out': Switzerland Descends into Blame Game After US Tariff Shock

(8/3, Mercedes Ruehl, Financial Times) ...Swiss President Karin Keller-Sutter is accused of grossly miscalculating the trade deal she thought she was able to secure with the Trump administration. Other critics are rounding on the country's vast pharmaceutical industry for having sparked the ire of the US president...Swiss officials were blindsided because they were led to believe their talks with US trade representative Jamieson Greer and Treasury secretary Scott Bessent were going well and a provisional deal had been reached, the people said... Sub. Req’d

Canada Holds Out Hope of Trade Deal as US Talks Tough On Tariffs

(8/3, Steff Chávez, Financial Times) ..."We think there is an option of striking a deal that will bring down some of these tariffs", Dominic LeBlanc, Canada's minister responsible for trade with the US, told CBS on Sunday. He was "encouraged by the conversations" his government has had with US trade representative Jamieson Greer and commerce secretary Howard Lutnick, though "we're not yet where we need to go to get the deal that's in the best interest of the two economies". LeBlanc added that he expects Trump and Canadian Prime Minister Mark Carney to speak "over the next number of days"... Sub. Req’d

Faster HTA Reviews & Pricing Reform Could Help Fix Canada's Drug Access Woes

(8/1, Eliza Slawther, Pink Sheet) ...The Canadian Chamber of Commerce has called on political representatives to introduce policy reforms that will combat drug reimbursement and access challenges in Canada. The organization advocates for a broader eligibility for faster health technology assessment (HTA) reviews, changes to how quickly drugs are reimbursed and enhanced collaborations with international regulators. The letter was written in light of political changes within Canada that could see faster access to new medicines being prioritized, and ongoing threats of tariffs from the US... Global Sub. Full

Simpler Tests Could Slash Biosimilar Costs, Widen Patient Access

(8/3, Gayatri Saberwal, The Hindu) ...Biosimilars need to be made less expensively while ensuring efficacy and minimal adverse effects. The larger the number of affordable biosimilars, the more options we will have for our patients... Full

'Irreplaceable For Americans': Pharmexcil Chief Says India's Low-Cost Drug Edge Can't Be Matched Overnight

(8/4, Himani Chandna, News18) ...The chief of India's pharmaceuticals export body, Namit Joshi told News18 that India exports 55 percent to the United States and United Kingdom - the most stringent markets in the world...For Joshi, the latest tariff talk is more about politics than policy. "There is a big difference between announcement and reality," he said. "On diplomatic levels, such announcements, I believe, are made to enter into bilateral negotiations."... Full

How Trump Tariffs Could Impact Indian Pharma's $8.7 Bn Dream Run

(8/3, M G Arun, India Today) ...The Indian industry was hoping against hope that Trump would not hike tariffs on generic drugs since these are life-saving. However, Trump had indicated earlier this year too that tariffs on pharma products would be 25 per cent from April 2 onwards, without pinpointing any nation. He later gave a 90-day reprieve to countries, and the new deadline for the tariffs was put as August 1... Full

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