Wednesday, May 14, 2025

Teva's Uzedy Continues Surge As Olanzapine LAI Filing Nudges Closer

(5/14, Dean Rudge, Generics Bulletin) ...Ahead of a planned filing in the US in the coming months, Teva feels that there is "real excitement" about the firm's TV-44749 proposed long-acting injectable olanzapine product, as Teva's first LAI for schizophrenia, Uzedy (risperidone), continued its impressive start in the first quarter of the year. "We believe olanzapine is a great new product in development, that will build upon our franchise in long-acting injectables on top of Uzedy, which has been doing great," Teva's head of global R&D and chief medical officer, Eric Hughes told investors during the firm's recent Q1 earnings call... Global Sub. Full

Community Behavioral Health Clinics Can Be Instrumental in Switching Patients to Long-Acting Injectable Antipsychotics

(5/13, Aislinn Antrim, Pharmacy Times) ...The research presented at AAPP focused on risperidone intramuscular LAI (Uzedy; Teva) and paliperidone palmitate (Invega Sustenna; Johnson & Johnson), which are 2 LAI options on the formulary for the CBHCC in the study. Paliperidone is the active metabolite of risperidone, meaning both medications have similar efficacy and adverse effect profiles. However, risperidone intramuscular LAI is administered every 2 weeks, whereas paliperidone palmitate is administered once per month... Full

ADHD Medication Shortage Hits Canberrans Hard with GPs Forced to 'Cobble Together' Prescriptions

(5/13, Rosie King, Australian Broadcasting Corporation) ...Australia has been in the grips of an ADHD medication shortage since late last year, with the Therapeutic Goods Administration warning it is likely to persist until at least the end of this year...The causes of the shortages are complex, with manufacturing and supply chain issues playing a part as well as increased demand for the medications across the globe. Concerta, Ritalin and Teva XR are in the shortest supply in Australia, with Rubifen expected to join that list next month... Full

Some Generics, Biosimilar Drugmakers Say They Can Withstand Tariff Impact

(5/13, Anna Brown, Endpoints News) ...Sandoz CEO Richard Saynor told Endpoints News that "less than 20%" of its sales are from the US. "So, we don't believe we're particularly exposed," Saynor said, adding it has already calculated any tariff impact into its 2025 guidance. Generic drugmaker Hikma and biosimilar company Alvotech have also said they are shielded from tariff impact. Hikma is benefiting from earlier moves to build up its US footprint, CEO Riad Mishlawi said in its first-quarter earnings call in April... Full

Dr Reddy's Gears For Tariffs Scenario To Ensure No US Supply Disruption

(5/13, Anju Ghangurde, Generics Bulletin) ...Dr Reddy's preps for "all options" to secure US supplies amid spectre of tariffs. Working closely with customers on inventories, other aspects. Signals appetite for inorganic growth backed by ‘very good' balance sheet. On track for global generic semaglutide opportunities. Has had unannounced US FDA facility inspections in India, ready for more. Expects strong growth in India market... Global Sub. Full

Pfizer Discusses Tariffs Amid International Slump For Oncology Biosimilars Revenue

(5/13, Adam Zamecnik, Generics Bulletin) ...Pfizer's CEO Albert Bourla is "cautiously optimistic" about the developing situation surrounding the potential imposition of tariffs on pharmaceutical products by the Trump administration. Company reported an increase in revenue from its US oncology biosimilars while also disclosing a revenue drop abroad. Pfizer's overall revenue also dropped from $14.9bn to $13.7bn, with the company reaffirming its revenue guidance for 2025 between $61bn and $64bn... Global Sub. Full

Don't Expect Immediate Impact of US Tariff Threat, Price Cuts On Business, Says Cipla Head

(5/13, Jessica Jani, Mint) ...Cipla does not expect any immediate impact from potential tariffs imposed by the US on pharmaceutical imports or from US President Trump's recent order to bring down prescription drug prices, the company's managing director and global CEO, Umang Vohra, said...The company is focusing on continuing its growth momentum, Vohra said, adding that the company has a pipeline of imminent launches which will drive the growth in the US... Full

With Several Moving Parts, Next Six Months Will Be a Challenge, Says Cipla Chief Umang Vohra

(5/13, PT Jyothi Datta, The Hindu BusinessLine) ...The next six months will be challenging, said Cipla Managing Director and Global Chief Executive Officer Umang Vohra, as the pharmaceutical industry faces several moving parts including tariffs in the US. "Every week or 10 days we're solving for something new. It's just become the way in the world. We were solving for – first the tariffs...that began to settle down a bit. Then we began to solve for a potential conflict at the border. So we are hoping for calm," Vohra told businessline, at a post-quarterly-results media interaction. "As more policy promulgations begin to stabilise, ... the period after six months may have more certainty than the immediate next six months," he added... Full

Cipla Eyes Growth in FY26 Driven by New Launches, GLP-1 Wave Despite Revlimid Headwinds

(5/13, Viswanath Pilla, Moneycontrol) ...Cipla is gearing up for continued growth in fiscal year 2026, banking on a robust pipeline of new launches in the U.S., sustained momentum in its India business, and the burgeoning opportunity in GLP-1 therapies, even as it navigates the impact of generic Revlimid (lenalidomide) losing exclusivity. Managing Director & Global CEO Umang Vohra expressed confidence in the company's ability to expand, driven by a multi-pronged strategy across key markets... Full

Biocon Geared Up to Be Major Supplier of Insulins, GLP-1 Weight Loss Drugs: Kiran Mazumdar-Shaw

(5/13, Viswanath Pilla, Moneycontrol) ...Biocon Group chairperson Kiran Mazumdar-Shaw expects fiscal year 2026 to be an "acceleration year" for the biopharmaceutical major, fuelled by robust growth across its biosimilars, generics, and research services segments. The company anticipates a significant "windfall" in its insulin business and sees a massive opportunity in GLP-1 therapies for diabetes and obesity. Mazumdar-Shaw said she sees Biocon filling the void left by the large pharmaceutical companies who are exiting or reducing their footprint in insulins to focus on high-margin GLP-1 products... Full

Celltrion Ends Kern Pharma Deal and Begins Direct Sales of Oncology Biosimilars in Spain

(5/14, Kim Ji-hye, Korea Biomedical Review) ...The company said Wednesday it finalized the termination of its partnership with Kern Pharma, and began selling its oncology drugs through its Spanish subsidiary this month. The local unit is initially marketing three biosimilars: Truxima (rituximab) for blood cancer, Herzuma (trastuzumab) for breast cancer, and Vegzelma (bevacizumab) for colorectal and breast cancers. Autoimmune treatments such as Remsima (infliximab), Remsima SC (marketed in the U.S. as Zymfentra), Yuflyma (adalimumab), and Steqeyma (ustekinumab) remain under Kern Pharma distribution, though Celltrion said it is in talks to transition those products as well... Full

Roche Spotlights Perjeta's Staying Power with 10-Year Breast Cancer Survival Results

(5/13, Zoey Becker, Fierce Pharma) ...The drugmaker evaluated a post-surgery Herceptin, Perjeta and chemotherapy regimen over ten years in its phase 3 APHINITY study of 4,804 patients. The regimen slashed the risk of death by 17% compared to those who took Herceptin, chemotherapy and placebo without Perjeta. The final overall survival result was statistically significant, according to Roche... Full

Aurobindo Pharma Arm Gets Marketing Authorisation in UK for Zefylti

(5/14, Ruchika Sharma and Dr. Kamal Kant Kohli, Medical Dialogues) ...CuraTeQ Biologics s.r.o., a wholly owned step-down subsidiary of Aurobindo Pharma Ltd, has obtained marketing authorisation from UK's Medicines and Healthcare products Regulatory Agency (MHRA) for Zefylti, its filgrastim biosimilar version... Full

Novo Nordisk Strikes Deal with Septerna to Develop Obesity Pills

(5/14, Elaine Chen, STAT+) ...Novo Nordisk said on Wednesday that it will work with the biotech Septerna to develop oral GLP-1 obesity drugs, as it races to catch up to competitor Eli Lilly's efforts to bring a more convenient weight loss treatment to the market. Under the deal, Septerna, which specializes in making small molecule drugs, is eligible to receive about $2.2 billion from Novo, including more than $200 million in upfront and near-term milestone payments. Septerna, which is based in the San Francisco area, could also receive royalties on global sales of approved products... Sub. Req’d

Weight Loss Drugs Have "No End Game" Amid Lack of Data On Long-Term Use, Former FDA Commissioner Warns

(5/13, Sara Moniuszko, CBS News) ...Weight loss drugs have transformed how Americans lose weight, including former commissioner for the U.S. Food and Drug Administration Dr. David Kessler. But, Kessler warns there are unknowns about long-term use of the drugs and how to get people off them...Currently, there isn't data on how to get off the drugs safely or how to go back on safely. "FDA's going to have to require that data," Kessler said. "We're just running a national experiment because we don't have the data."... Full

Mark Cuban Says This is Why He Started Cost Plus Drugs

(5/14, Kwan Wei and Kevin Tan, Business Insider) ..."Going back to 2018 or 2017, being here in Texas, I had some Republican friends who were asking me questions like, 'Do you have any ideas how the Republicans can replace the ACA, Obamacare?'" Cuban said in an episode of the "Hims House" podcast, which aired on Tuesday...Cuban said his interest led him to pay for studies to find out why healthcare costs more in the US compared with countries such as Canada. "It became very obvious the more I dug in, that there was zero transparency, no transparency, and that there were a lot of vested interests that wanted opacity. They want it to be as opaque as possible so that people can't make good decisions when it comes to their healthcare," Cuban said on the podcast... Full

Trump's Push to Boost Drug Imports Met With Doubt On Feasibility

(5/13, Celine Castronuovo, Bloomberg Law) ...President Donald Trump's push to lower pharmaceutical prices by buying more drugs from abroad likely won't work and may not even be legal, according to policy analysts and researchers...The directive, a continuation of one of the first Trump administration's policy priorities, appears to go beyond the statutory authority granted to FDA to approve state-run programs to import prescription drugs from Canada, but not other countries. The FDA has so far only approved one state importation program, in Florida, which has yet to import any drugs from Canada... Sub. Req’d

Trump Wants Europe to Pay Up for Drugs to Help Lower Prices for Americans. It Won't Be Easy

(5/13, Andrew Joseph, STAT+) ...No longer, he and other administration officials said, would the U.S. subsidize drugmakers' research projects that resulted in medicines that benefited the whole world. "With this new order, Europe will share the burden of that," said Jay Bhattacharya, the director of the National Institutes of Health. "And in fact, you may think of it as somehow going after drug companies — actually it's helping drug companies."... Sub. Req’d

Cutting Out The Middlemen? Trump's Pricing Order Offers Opportunity On PBMs

(5/13, Dave Wallace, Generics Bulletin) ..."Encouraging competition from generics and biosimilars is the tested and proven method to reducing prescription drug spending," John Murphy, president and CEO of the AAM, told Generics Bulletin. "In fact, according to HHS, the US leads the world in reducing prescription drug costs through generics, with prices significantly less than many other countries."..."We encourage the administration and congress to stop brand patent games that delay generic and biosimilar competition," Murphy urged, "and to stop PBM rebate games that block patient access to new generics and biosimilars."... Global Sub. Full

Biosimilars Forum Applauds House of Representatives Committee on Energy and Commerce for Including PBM Reform in Reconciliation Package

(5/13, Biosimilars Forum) ..."Biosimilars Forum applauds the House of Representatives Committee on Energy and Commerce for including PBM reform in its first draft of the reconciliation package. Reforming the PBM Monopoly is critical to lowering prescription drug prices for Americans and providing more lower-cost drug options, like biosimilars. PBM middlemen also create waste and bureaucracy in the U.S. health care system. The Forum applauds the House Committee on Energy and Commerce for including reform provisions in its initial reconciliation package."... Full

CSRxP Statement On President Trump's Most Favored Nation Executive Order

(5/13, The Campaign for Sustainable Rx Pricing) ..."CSRxP looks forward to reviewing the full details of the policy initiatives outlined by the recent executive order and encourages the Administration to build on its commitment to lowering drug prices for patients now, by lending its strong support to bipartisan, bicameral work on Capitol Hill to hold Big Pharma accountable for egregious abuse of the U.S. patent system that costs American patients and taxpayers billions of dollars each year."... Full

The Biosimilars Forum Submits Comments Highlighting Biosimilars as Safe and Effective Lower-Cost Medicines for Americans that Need Them

(5/13, Biosimilars Forum) ..."The Biosimilars Forum submitted comments to the Department of Commerce and Secretary Lutnick that highlight the importance of safe and effective biosimilars to lower prescription drug costs for Americans. Biosimilars are integral to the overall integrity of the American pharmaceutical supply chain and should be free from any tariffs so these medicines can continue to provide significant cost-savings to Americans battling disease. Biosimilars are a commonsense solution to skyrocketing drug costs for Americans, but tariffs on the biosimilar industry could end the promise of lower-cost prescription drugs forever."... Full

Trump Order On Drug Pricing Appears to Issue Subtle Threat to Pharma

(5/13, Ed Silverman, STAT+) ...For these reasons, the order is troubling, because it suggests administration officials will look for reasons unrelated to safety or effectiveness to inappropriately achieve a policy goal, said Reshma Ramachandran, an assistant professor at the Yale School of Medicine and co-director of the Yale Collaboration for Regulatory Rigor, Integrity, and Transparency... Sub. Req’d

HHS Focuses On 'Transparency' in Third-Round IRA Negotiation Guidance

(5/13, Alexis Kramer, Endpoints News) ...For round three, CMS will select up to 15 eligible drugs covered under Medicare Part D and/or payable under Part B for negotiations, with negotiated prices taking effect in 2028. The draft guidance issued Monday outlines how CMS will identify eligible Part B drugs and how drugmakers should make the negotiated prices available...Under the IRA, drugs typically aren't eligible for negotiation if there's a generic version that's "approved and marketed." CMS has said that it will consider a generic drug marketed if the manufacturer is engaged in "bona fide marketing." Several drugmakers, including AstraZeneca and Teva, have challenged the CMS' bona fide marketing standard in their lawsuits... Sub. Req’d

Rejection Of AstraZeneca Lawsuit May Have Considerable Impact On Remaining Cases

(5/13, Gabrielle Wanneh, Inside Health Policy) ...Michael Lieberman, an attorney at Fairmark Partners who has helped the advocacy group Patients for Affordable Drugs file amicus briefs supporting the IRA against legal challenges, told Inside Health Policy that a positive sign for the government regarding how the Third Circuit might rule in other cases is the court's rejection of AstraZeneca's claim that drug price negotiations deprive the company of procedural due process... Sub. Req’d

Big Pharma Counted On a Price Negotiation Loophole. It May Be Closing.

(5/13, Josh Nathan-Kazis, Barron's) ...Buried in a 200-page technical document released by the Centers for Medicare and Medicaid Services late Monday was a short, convoluted paragraph that could translate to big problems for Johnson & Johnson, Merck, Bristol Myers Squibb, and a handful of their big pharma peers. The paragraph could spell the end of a strategy the drugmakers had believed would allow them to put off the impact of Medicare price cuts for some of their top-earning cancer drugs... Sub. Req’d

Editorial: How to Cut US Drug Prices Without Hurting Innovation

(5/13, Bloomberg) ...For decades, Americans have been overpaying for prescriptions and subsidizing innovation for the rest of the world. The White House is rightly fixated on getting Americans a better deal. Bold ideas that address such disparities should be welcome... Full

Trump's Drug Price Controls Could Ground Innovation To a Halt

(5/14, Fred Roeder, RealClearMarkets) ...Americans are notoriously unhappy with healthcare. As of last December, Americans' perception of the quality of US healthcare hit a new low, with 54% of the population reporting to Gallup that quality is either fair or poor. Coverage is viewed even more poorly than quality, and it has slowly brought the Republican Party of President Trump to a position where their message is identical to that of socialist Senator Bernie Sanders. President Trump began the week by tearing into American pharmaceutical firms, accusing them of "profiteering and price gouging"... Full

Cassidy Set to Ask RFK Jr. to Explain His Health Department Overhaul

(5/14, Daniel Payne, STAT+) ...Sen. Bill Cassidy (R-La.) will ask Kennedy to address worries that the overhaul across the Department of Health and Human Services is impeding its critical duties, according to excerpts of his opening remarks reviewed by STAT... Sub. Req’d

Gavin Newsom Says These Middlemen Drive Up Drug Prices. He's Got a New Plan to Fix It

(5/13, Alexei Koseff and Kristen Hwang, CalMatters) ...The plan — part of a revised state budget proposal that Newsom will unveil in full on Wednesday — calls for licensing pharmacy benefit managers through California's Department of Managed Health Care and requiring them to report their operational and financial details... Full

Iowa Lawmakers Send Sweeping 'PBM' Bill to Kim Reynolds, Seeking to Halt Pharmacy Closures

(5/13, Stephen Gruber-Miller, Des Moines Register) ...Iowa lawmakers have passed sweeping regulations governing pharmacy benefit managers that supporters say are desperately needed to keep pharmacies from closing, but opponents argue will impose a costly mandate on businesses and patients...They say the bill will help prevent more pharmacies from closing their doors thanks to provisions requiring pharmacy benefit managers to reimburse pharmacies for the cost of the drugs they buy and pay pharmacies a baseline $10.68 dispensing fee for each drug. But business groups say those provisions will cost Iowans millions in higher prescription drug costs... Full

European Governments Scramble to Interpret Trump's New Drug Pricing Order

(5/14, Maggie Fick, Reuters) ...Denmark's industry and business minister Morten Bodskov plans to meet with drugmakers based in his country to discuss the order. He did not give details about the meeting. "The uncertainty (caused) by the U.S. is bad for the world," he told Reuters. "Danish pharmaceutical companies are among the best in the world and are of great importance to Denmark. The message from Trump does not change that."... Full

UK-India FTA Could Offer ‘Significant Benefits' For Generics And Biosimilars

(5/14, Dave Wallace, Generics Bulletin) ...Medicines UK - formerly known as the British Generic Manufacturers Association - said the deal represented "very welcome news and could have significant benefits for the generic and biosimilar sectors."... Global Sub. Full

Expect a 'Soft-Landing' for Indian Pharma: Biocon's Kiran Mazumdar-Shaw On Trump's Drug Order

(5/13, Moneycontrol) ...Speaking to CNBC TV18 on May 13, Kiran Shaw said Trump had brought up the issue of reference pricing during his first term as US President and has now questioned the policy of dual pricing by companies which leads to different prices in US and Europe...Biocon's Kiran Shaw said generics and biosimilars are being scrutinised but these are not the target, as they do not fall under the big pharma bracket which comprises 80 percent of the US pharma sector... Full

Trump's Drug Pricing Order Boosts Case for Generics and Biosimilars: Kiran Mazumdar-Shaw

(5/13, Financial Express) ...US President Donald Trump's recent executive order to reduce prescription drug prices aims to address the significant price disparity of innovator drugs between the US and other developed markets like Europe and Australia. According to Biocon executive chairperson Kiran Mazumdar-Shaw, the order encourages greater use of generics and biosimilars, areas where India has proven strengths. In an interview with FE, she discusses what this means for the industry, as well as Biocon's latest performance, biosimilars growth, and expansion in the US market... Full

Australia Says it Will Not Compromise On Drug Subsidies as Trump Reviews US Prices

(5/14, Andrew Silver, Reuters) ...Australia will "not compromise" on its policy to subsidise the cost of some medicines, the government said on Wednesday, after U.S. President Donald Trump's executive order to lower domestic drug prices roiled the global pharmaceutical industry...In Australia, pharmaceutical companies are able to freely set medicine prices on the private market but the government subsidises the cost of some medicines used in community and outpatient settings through the PBS. A recent analysis by the Australia Institute, a public policy think tank, found that some medicines in the U.S. were more expensive than in Australia... Full

Trump Wants Lower Drug Prices and Pharmaceutical Tariffs — What Does that Mean for Australia?

(5/13, Paige Cockburn, Australian Broadcasting Corporation) ...Pharmaceutical imports into Australia exceed what we send to the US by around $US1 billion ($1.6 billion) so if we were to go down the path of reciprocal tariffs — where we put a tariff on US pharmaceuticals coming in — there would be major repercussions. "If we retaliated, that would mean the US products that come here would go up in price," Director of Health at the Grattan Institute, Peter Breadon, said. That would be dangerous because Australia imports around 21 per cent of total pharmaceuticals from the US, making it the largest single supplier... Full

Austria To Fine Companies For Violating New Drug Stockpiling Rule

(5/13, Neena Brizmohun, Pink Sheet) ...Ordinance BGBLA_2024_II_161 introduces a new rule on stockpiling certain medicines in Austria to tackle drug shortages. Non-compliance can result in a fine of up to €25,000, rising to €50,000 for repeat violations. The ordinance affects around 700 high-turnover pack sizes of drugs that are important for ensuring the medical care of patients. The products concerned include painkillers, antibiotics, medicines for cold symptoms and preparations for cardiovascular or pulmonary diseases... Global Sub. Full

Russian Authorities Plan for Reduction in Share of Imported Drugs

(5/13, The Pharma Letter) ...The Russian authorities are preparing for a further reduction of the share of imported drugs in the domestic public healthcare system. According to recent statements of Russia's Prime Minister Mikhail Mishustin 90% of drugs from the list of vital and essential should be of domestic origin already in the middle term, reports The Pharma Letter's local correspondent... Sub. Req’d

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