Thursday, May 1, 2025

UK Forxiga SPCs Wiped Out As Trio Succeed With Plausibility Attack

(5/1, Dean Rudge, Generics Bulletin) ...A pair of key supplementary protection certificates and their underlying compound patent shielding AstraZeneca's Forxiga (dapagliflozin) blockbuster treatment for diabetes have been invalidated by the UK High Court, handing a major victory to claimants Glenmark, Teva and Viatris' Generics UK subsidiary that could open up a path to market worth hundreds of millions of dollars... Global Sub. Full

First New PBS Listing for ALS Drug in 20 Yrs

(5/1, Pharmacy Daily) ...RADICAVA IV infusion (edaravone, Teva Pharma) is now listed on the Pharmaceutical Benefits Scheme (PBS) for eligible adults with amyotrophic lateral sclerosis (ALS), representing the first new PBS-listed molecule for the treatment of ALS in over 20 years. Teva noted that pharmacists will play a key role in counselling patients and caregivers about Radicava's administration schedule, monitoring for potential side effects, and supporting adherence to treatment, particularly as part of a multidisciplinary approach to ALS care... Full

Children Bearing the Brunt of ADHD Medicine Shortage

(5/1, William Ton, AAP) ...A shortage of medications used to treat ADHD could leave more than one million Australians paying more for substitutes. The nation's health regulator says certain drugs used to treat attention deficit hyperactivity disorder are in short supply, and the shortage could last until the end of 2025...Several brands, including Janssen-Cilag and Teva Pharma's Concerta and Teva-XR products and Novartis and AFT Pharmaceuticals' Ritalin LA and Rubifen LA products were impacted, the TGA said...The shortages of Concerta and Ritalin LA products are put down to manufacturing issues, while the shortage of Teva-XR and Rubifen LA products is due to increased demand caused by the unavailability of other methylphenidate products... Full

GSK's Supply Chain 'Reset' After Haleon Spinoff to Ease Tariff Impact, CEO Says

(4/30, Reynald Castañeda, Endpoints News) ...When the drugmaker went through its "demerger" with the consumer health business in 2022, there were "very intentional, deliberate choices to reset" its supply chain for "regional resilience" as well as "double sourcing" to allow for flexibility, CEO Emma Walmsley said. It has "mitigation options" that it could execute across its manufacturing networks once pharma levies are in place, the UK company said in a statement. "We're watching it very carefully … we are well-prepared," Walmsley said during GSK's first-quarter earnings call with the media... Sub. Req’d

GSK Turns to AI to Offset Potential US Tariff Hit

(4/30, Hannah Kuchler, Financial Times) ...GSK has identified "productivity initiatives" that could save money, such as using technology to improve procurement processes and AI to find efficiencies, according to a person familiar with the matter... Sub. Req’d

Europeans Must Do More to Boost Pharma or Risk Losing Jobs and Investment to the US, Warns GSK Boss

(4/30, Calum Muirhead, This is Money) ...The pharma giant's chief executive Emma Walmsley said European nations faced ‘tough choices' on investment'. But she ‘absolutely agreed' that backing the creation of new drugs and vaccines was ‘one of the best investments' a country could make. Walmsley added: ‘It is key that the business environment stays competitive. Europe and the UK could do more in that regard.'... Full

Discounted Ustekinumab Biosimilars Further Dent J&J's Q1 Stelara Sales

(4/30, Urte Fultinaviciute, Generics Bulletin) ...Johnson & Johnson continues to see revenue loss for its once-blockbuster Stelara (ustekinumab), as biosimilar rivals entered the US market with steep discounts during the first quarter. US Stelara sales dropped to $981m in Q1 2025, marking a 29.8% decrease from $1.4bn generated in the same quarter last year...The first wave of biosimilar entrants "has played a pivotal role in fostering market competition and encouraging more dynamic pricing strategies," commented Thomas Newcomer, vice president and head of US commercial operations at Samsung Bioepis... Global Sub. Full

Dong-A ST Profit Soars as Stelara Biosimilar Launch Drives Q1 Gains at Dong-A Socio

(4/30, Kim Ji-hye, Korea Biomedical Review) ...Dong-A Socio Holdings posted a 31 percent jump in first-quarter operating profit, powered by an 854 percent surge at drugmaker Dong-A ST and a 556 percent spike at CDMO affiliate STgen Bio following the launch of a Stelara biosimilar... Full

Biogen Beats Quarterly Profit Estimates On Strong Demand for Rare Disease Drugs

(5/1, Christy Santhosh and Mariam Sunny, Reuters) ...Biogen beat first-quarter profit and revenue expectations on Thursday, as strong demand for its rare disease drugs helped offset declining sales of its multiple sclerosis drugs. The drugmaker has been counting on newer launches such as genetic disorder drug Skyclarys as demand falls for its once top-selling multiple sclerosis medicines in the face of stiff competition in a crowded treatment market... Full

Moderna Beats Wall Street Estimates for First-Quarter Profit and Sales

(5/1, Patrick Wingrove, Reuters) ...Moderna's cost-cutting drives better-than-expected results. Combination COVID and flu shot approval not expected until 2026. Tariffs have minimal impact on Moderna's U.S.-manufactured drugs... Full

Lilly Meets Sales Expectations, But Novo Gains On PBM Win

(5/1, Kyle LaHucik, Endpoints News) ...On Thursday morning, Eli Lilly posted $12.73 billion in revenue in the first quarter, a 45% jump from the prior year, matching the percentage spike it experienced last quarter. But minutes before Lilly made its quarterly sales announcement, Novo said CVS Caremark — the US' largest pharmacy benefit manager — has chosen Wegovy as the preferred GLP-1 on its template formularies, effective July 1. This move will essentially improve access to the Danish company's weight loss product and could hamper rollout of Lilly's Zepbound... Sub. Req’d

CVS Drops Lilly's Zepbound from Preferred Coverage in Novo Win

(5/1, Madison Muller and Ike Swetlitz, Bloomberg) ...Starting July 1, Zepbound will no longer be preferred on CVS Caremark's standard formulary, while Wegovy and other anti-obesity medicines will be, according to the company. The change means that Lilly's drug may cost more to insurers or employers that opt to pay for weight-loss drugs and who use CVS Caremark to manage their prescription drug plans... Sub. Req’d

Speranza Starts Generics Offshoot In Response To Wider US Pharma Manufacturing Drive

(4/30, Adam Zamecnik, Generics Bulletin) ...The drug and medical device company Speranza Therapeutics is starting a new generics division, Lotus Therapeutics, in response to ongoing developments in regulatory demands and increased interest in reshoring pharmaceutical manufacturing to the US. According to Speranza, there has been an increase in pressure from regulators, be it with the removal of the Medicaid AMP Cap, and new changes to Best Price rules, which has in turn led to pharmaceutical players reflecting on their portfolios... Global Sub. Full

Sandoz And Henlius Join Forces With $300M Ipilimumab Deal

(4/30, Dave Wallace, Generics Bulletin) ...Targeting originator sales of $2.5bn achieved by Bristol Myers Squibb for the oncology brand across a variety of cancer indications, Sandoz said the deal with Henlius would involve an upfront payment of $31m, with further milestones of up to $270m taking the value to a total consideration of up to $301m. The deal – which covers the US along with 42 European countries and regions, as well as Japan, Canada and Australia – will see Henlius develop and manufacture the biosimilar, with Sandoz set to register and commercialize the product after patents expire... Global Sub. Full

GSK's Nucala Shows Promise in COPD Ahead of US Decision

(5/1, The Pharma Letter) ...The data, published in the New England Journal of Medicine, showed that Nucala cut the annual rate of moderate or severe flare-ups by 21% compared to placebo. For patients identified with chronic bronchitis, the figure rose to 31%. The study followed patients for up to two years. GSK said the results underscore the potential of Nucala in a difficult-to-treat population and highlighted a 35% drop in exacerbations that resulted in emergency department visits or hospital stays — a secondary finding from the trial that was statistically significant but described as "nominal" due to how the data was analyzed... Sub. Req’d

Strides Pharma Science Gets USFDA Approval for Celecoxib Capsules

(4/30, The Hindu) ...The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Celebrex Capsules, 100 mg, 200 mg, and 400 mg, of Upjohn US 2 LLC, and would be manufactured at the company's facility in Puducherry, according to a company statement... Full

US FDA Approves J&J's Immune Disorder Drug

(4/30, Christy Santhosh, Reuters) ...The drug will compete with other approved treatments for the condition, such as those by Argenx SE, AstraZeneca and UCB. J&J expects the drug to bring in over $5 billion in peak sales and is also testing it for other immune disorders, including Sjögren's disease and chronic inflammatory demyelinating polyneuropathy. Leerink analysts estimate Imaavy to generate $2.3 billion in sales by 2032... Full

Another Regeneron CRL Prompts Regulatory Operations Questions

(4/30, Alaric DeArment, Pink Sheet) ...Regeneron reported that it received a CRL for the pre-filled syringe version of Eylea HD, apparently due to third-party supplier issues. CEO Len Schleifer defended the company's regulatory team amid analyst questions about its performance. Schleifer said during the company's earnings call that he hoped the Health and Human Services Department would continue to follow science, adding that Secretary Robert F. Kennedy Jr. "needs assistance" in that area... Global Sub. Full

Lack of Access to Antibiotics for Drug-Resistant Infections Often Blamed On Poor Care, Study Says

(4/30, Ed Silverman, STAT+) ...Only 6.9% of people with drug-resistant infections in eight large, low- and middle-income countries received an appropriate antibiotic in 2019 and the lack of access was largely attributed to insufficient care, according to a new analysis...The findings, which were published in The Lancet, underscored potentially significant gaps in care that may otherwise have made it possible to access the available antibiotics, according to Jennifer Cohn, a senior author of the study and the global access director at the Global Antibiotic Research & Development Partnership, a nonprofit health organization... Sub. Req’d

Trump Warns of a 'Tariff Wall' for Pharmaceutical Companies, Raising Cost Concerns

(5/1, Trevor Hunnicutt, Reuters) ...US President Donald Trump said on Wednesday that there will be a tariff "wall" for pharmaceutical companies operating in the United States after a certain amount of time. A 25% US tariff on pharmaceutical imports would increase US drug costs by nearly $51 billion annually, boosting US prices by as much as 12.9% if passed on, a report commissioned by the industry's US trade group and reviewed by Reuters shows... Full

Tariffs Threaten a Pharmaceuticals Shortage, As 95% of Ibuprofen Comes from China

(4/30, Sasha Rogelberg, Fortune) ...The U.S. gets nearly all of its supply of common over-the-counter pain medications from China, meaning President Donald Trump's 145% tariffs on the country could have an outsize impact on the U.S.'s method of sourcing key drugs, Apollo chief economist Torsten Sløk said in a Wednesday blog post...Key players in the pharmaceutical industry fear tariffs will pile onto the factors driving the scarcity. Profit margins for generic drugs are incredibly thin to keep them affordable, meaning some manufacturers could stop producing drugs that are too expensive to make as a result of the increased cost of raw materials, according to John Murphy, president and CEO of trade group Association of Accessible Medicines (AAM). To make matters worse, Murphy said, any hiccups in the supply chain will also likely mean an increase in drug prices for consumers... Full

How Trump's Pharma Tariffs Will Hurt Industry and Patients Alike

(4/30, Jonah Comstock, PharmaPhorum) ...A number of pharma companies, including Eli Lilly, Novartis, Roche, and Johnson & Johnson, have already announced major investments in US manufacturing either to get ahead of the tariffs or curry favour with the administration. But, as a matter of policy, there are a number of problems with using tariffs as a lever to encourage domestic manufacturing. Stephen Farrelly, global lead of healthcare and pharma at ING research, spoke with Deep Dive about the impact of the tariffs... Full

"Pill Penalty" Fix Eyed for Reconciliation

(4/30, Victoria Knight, Axios Pro) ...Drugmakers are pushing for a legislative fix in reconciliation that would sync the length of time that small molecule drugs and biologics are exempt from negotiations. The vehicle would be the EPIC Act, sponsored by Rep. Greg Murphy and Sen. Thom Tillis, which would change the law to make small molecules eligible for negotiation 11 years after they're approved by FDA...Murphy told Axios on Tuesday that he was "absolutely" pushing for the EPIC Act to be in the budget package...The pharmaceutical industry is facing significant headwinds, so passing the EPIC Act would be a coup... Sub. Req’d

Updated Comprehensive Analysis from Leading Economists Confirms PBMs Deliver Value for Plan Sponsors, Support Pharmacies

(4/30, PCMA) ...The report examines several important PBM issues including finding that reimbursement to PBM-affiliated pharmacies, on average, is below the National Drug Acquisition Cost (NADAC), while reimbursements to non-affiliated pharmacies are higher than NADAC on average — meaning PBMs are on average reimbursing pharmacies that are not affiliated with a PBM at a higher rate than affiliated pharmacies. Importantly, the report also finds that, contrary to accusations, PBMs are not driving non-PBM-affiliated pharmacies out of business... Full

PBMs No Longer Profit From Rebates But Plans Benefit; Should Sponsors Push More For Reform?

(4/30, Cathy Kelly, Pink Sheet) ...PBMs are changing their business model to help evade legislative reforms targeting rebating practices, meaning current policies may not have much impact, Drug Channels Institute President Adam Fein predicted. Employers and other health plan sponsors are not pushing for rebate reforms in favor of the existing system, which also undercuts chances for impactful change. Plan sponsors should become more engaged in developing approaches to lower cost sharing for patients at the point of sale, Fein said... Global Sub. Full

Key E&C Dems Vote Against Bipartisan SUPPORT Act Reauth, Citing Uncertainty With HHS Reorg, Cuts

(4/30, Dorothy Mills-Gregg, Inside Health Policy) ...The House Energy & Commerce Committee voted to reauthorize the landmark law to address the opioid crisis, along with an assortment of other health care bills, during a markup Tuesday (April 29), but many Democrats refused to back the reauthorization and other typically bipartisan issues, instead critiquing their colleagues for ignoring the Trump administration's large-scale staffing cuts and planned reorganization for HHS... Sub. Req’d

FDA Must Make Biosimilar Development More Efficient to Lower Drug Costs

(4/30, Juliana M. Reed, RealClearHealth) ...The Biosimilars Forum recently submitted a Citizen Petition to the FDA recommending that the FDA should eliminate regulatory hurdles like their request for routine 3-way pharmacokinetic ("PK") studies that compare U.S. and non-U.S. versions of a drug. Another simple step the FDA can take is to eliminate the biosimilar 'suffix.' Our analysis demonstrates that the suffix adds no value and is not used in reporting... Full

FDA Seeks Feedback On Drug Compounding Hurdles, Opportunities

(4/30, Nyah Phengsitthy, Bloomberg Law) ...The agency said Wednesday in the Federal Register that it submitted to the Office of Management and Budget a proposed collection of information to support the Food and Drug Administration's research about challenges pertaining to human prescription drug compounding by outsourcing facilities... Sub. Req’d

Exits Continue at FDA, As More Staff in Drug Office Follow Fired Colleagues Out the Door

(4/30, Zachary Brennan, Endpoints News) ..."The core review staff seems to be in place, but the drain of leadership and attrition will have a large impact on the efficiency and quality of product reviews," Gideon Blumenthal, VP of oncology clinical development at Merck and a former deputy director at the FDA's Oncology Center of Excellence, told Endpoints in a message... Sub. Req’d

Exclusive: WHO Set to Back Use of Weight-Loss Drugs for Adults Globally, Raises Cost Issue

(5/1, Jennifer Rigby, Reuters) ...The World Health Organization plans to officially back the use of weight-loss drugs to treat obesity in adults for the first time, a memo reviewed by Reuters on Thursday shows, marking a shift in its approach to treating the global health problem. The UN agency also called for strategies to improve access to the treatment in low- and middle-income countries... Full

EU Commission Slams First US Step Towards Pharmaceutical Tariffs

(4/30, Marta Iraola Iribarren & Gerardo Fortuna, Euronews) ...A European Commission official has criticised a recent US investigation into pharmaceutical imports, calling it an unjustified step toward potential tariffs that could harm both European and American healthcare systems..."We do not agree with this investigation," Elena Kamilarova, a trade official at the European Commission, said at an event in Brussels. "[We do not agree with] the tool nor the concept of it, namely, looking at it as if imports of pharmaceuticals can pose national security risks."... Full

BGMA Becomes Medicines UK

(5/1, Dave Wallace, Generics Bulletin) ...The British Generic Manufacturers Association has changed its name to Medicines UK. The change is intended to "better reflect the essential and intrinsic role generic and biosimilars play in fulfilling four out of five NHS prescriptions". The association is continuing to push for a dedicated UK government strategy for the off-patent pharmaceutical sector... Global Sub. Full

AstraZeneca Continues Legal Battles Over Forxiga in Russia

(5/1, The Pharma Letter) ...The Russian drugmaker Akrikhin has filed a lawsuit against UK pharma major AstraZeneca (LSE: AZN) to the Moscow Intellectual Property Court asking to recognize its right to use formulas from two patents of Astra Zeneca for production of Forxiga (dapagliflozin), a drug for the treatment of diabetes and cardiovascular diseases, The Pharma Letter's local correspondent reports... Sub. Req’d

Russian Pharma Market Showing Positive Dynamics this Year

(4/30, The Pharma Letter) ...The Russian pharmaceutical market grew up to 814 billion roubles ($10 billion) in the first quarter of 2025, 11% higher compared to the same period in 2024, according to latest data, provided by experts of the Russian research agency in the field of pharmaceutics DSM-Group and some local media reports, reports The Pharma Letter's local correspondent... Sub. Req’d

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