Thursday, July 31, 2025

Teva CEO On Tariffs, Generic Drugs Market, MFN Pricing

(7/30, Bloomberg) ...Teva Pharmaceutical CEO Richard Francis discusses potential tariff pressures, generic drugs market and Most Favored Nation drug pricing. He speaks with Scarlet Fu and Katie Greifeld on "Bloomberg Markets."... Full

Teva CEO: Our Supply Chain Puts Us in a Strong Position

(7/30, CNBC) ...Richard Francis, Teva Pharmaceuticals CEO, joins CNBC's ‘Money Movers' to discuss the company's most recent earnings report... Full

Teva Pharm's Second-Quarter Profit Boosted by Branded Drugs, US Tariff Questions Remain

(7/30, Steven Scheer, Reuters) ...Teva Pharmaceutical Industries reported a better than expected increase in second-quarter profit on Wednesday, helped by a 26% rise in sales of its branded drugs and said it was well positioned to mitigate potential U.S. tariffs. Richard Francis, CEO of Teva, the world's largest generic drugmaker, said there was "big ambiguity" and "so many unanswered questions" in the pharmaceuticals sector regarding potential U.S. import levies. He added, however, that the Israel-based company, had been leveraging its U.S.-based manufacturing facilities and its minimal reliance upon China and India to soften the blow from any eventual tariffs... Full

Teva Pharm CEO Says Drugs Sector Facing 'Big Ambiguity' Over US Tariffs

(7/30, Steven Scheer, Reuters) ...Richard Francis said 70% of Teva's generics business was outside of the United States while most of its branded drugs business was in the U.S., with its largest drug - Huntington's Disease treatment Austedo - manufactured there. He told Reuters after Teva issued second-quarter earnings that it had a favourable supply chain - no reliance on China and very little in India. "Those aspects just set us up in the face of this change, probably a lot better than our competitors," he said. "I feel we have the ability to put ourselves in a good position here, with the caveat - I need to know the details."... Sub. Req’d

Teva Execs Shrug Off Pharmaceutical Tariff Threat as Turnaround Strategy Rolls Forward

(7/30, Fraiser Kansteiner, Fierce Pharma) ...The Israel-based generics and innovative medicines hybrid has "absorbed the already confirmed tariffs into our 2025 guidance," Teva's CFO, Eli Kalif, said on a call with analysts Wednesday...Many unknowns remain around the EU tariffs, including how the U.S.' Section 232 investigation into the national security implications of pharmaceutical imports could influence the current rate, if at all. Further, in a potentially key carveout for Teva, certain generic drugs will be excluded from the tariffs, though it's currently unclear which ones. Teva has "done very comprehensive work to understand how we can mitigate the impact [of tariffs] on our business," the company's CEO, Richard Francis, said on the call... Full

Teva Expects to Make Q3 Decision On Sale of API Unit, CEO Says 

(7/30, Nicole DeFeudis, Endpoints News) ...The unit, called TAPI, was put up for sale last year as the company executed its "pivot to growth" strategy, which has also involved consolidating its manufacturing network and shifting away from some lower-margin generics. Teva initially expected to divest TAPI in the first half of 2025. But during a second-quarter earnings call with investors, CEO Richard Francis said a deal is still "in active and advanced discussions."...A Teva spokesperson told Endpoints News the company could decide not to sell TAPI at all. Teva said in a news release that the sale is ultimately "contingent on reaching a definitive agreement, subject to the approval by Teva's Board of Directors."... Sub. Req’d

Repurposed Generics For Rare Diseases: Janet Woodcock Proposes Shortcut

(7/30, Grace Moser, Pink Sheet) ...Former CDER Director Janet Woodcock suggested the FDA could use the citizen petition process to allow non-commercial entities to propose new treatments for off-patent medicines. But the process would only be a temporary solution, while a new pathway is developed to update labels on older products. Using citizen petitions would help demonstrate the potential success of a new pathway, Woodcock said... Global Sub. Full

Big PBM Dominance Enabled By Affiliated Third Party Administrators Limiting Choices, FTC Told

(7/30, Cathy Kelly, Pink Sheet) ...Third party administrators affiliated with the leading insurer/pharmacy benefit manager conglomerates are blocking PBM market competition and plan sponsor efforts to find alternative solutions to lowering drug costs, Transparency Rx CEO Joseph Shields told the Federal Trade Commission... Global Sub. Full

New Study: PBMs and Commercial Insurers Are Quietly Blocking Prescription Access

(7/30, Caroline Dunne, PhRMA) ...Commercial insurers initially denied coverage for three out of four patients' newly prescribed medicines in five chronic disease areas studied by IQVIA in a new white paper...By denying these doctor-prescribed medications, insurers and pharmacy benefit managers (PBMs) are choosing to maximize profits over patients. Initial coverage denials are so common that being approved at the outset for these treatments without encountering barriers was as likely as meeting someone who doesn't own a smartphone or computer. More than 90% of patients faced denials in four of the five therapeutic areas studied... Full

AMA: PBM Markets are at Risk of Harming Patients

(7/31, AMA) ...The findings in the AMA paper highlight whether proposed or consummated mergers among PBMs and between insurers and PBMs should or should have raised antitrust concerns. Low competition may lead to higher prices paid by insurers for PBM services, higher insurance premiums, PBMs not fully passing rebates through, and lower reimbursement to pharmacies. Moreover, given extensive vertical integration of insurers and PBMs, non-affiliated insurers may be losing access to PBMs... Full

FY 2026 BsUFA Fees

(7/30, Rebecca Welton, Lachman Consultants) ...As in FY 2024 to FY 2025, the Biological Product Development (BPD) fees did not change, which is a welcome relief and something we don't experience often! Additionally, application and program fees decreased by 18.4% across the board! This will be a big help for applicants in this space... Full

FY 2026 PDUFA Fees

(7/30, Rebecca Welton, Lachman Consultants) ...The fees increased by 8.6% for applications, which is a larger increase when compared to that from FY 2024 to FY 2025, which was about a 6.5% increase. Program fees increased by 9.5% for FY 2026, which is a significant change when one realizes that they decreased between FY 2024 and FY 2025... Full

After Prasad Controversy, Makary Emphasizes Listening To Industry

(7/30, Jessica Karins, Inside Health Policy) ...After the abrupt departure of top FDA biologics and science official Vinay Prasad, a surprise to industry and other observers, FDA Commissioner Marty Makary announced an additional date for his private meetings with biopharmaceutical CEOs and emphasized in an interview that the agency's new top drug reviewer has a background as a drug developer and industry executive. After the interview, FDA confirmed that drug center chief George Tidmarsh will also serve as acting head of the biologics center... Sub. Req’d

Double Duty At US FDA: Tidmarsh Will Temporarily Lead Both CDER And CBER

(7/30, Sarah Karlin-Smith, Pink Sheet) ...Learning the ropes of these two centers is no feat in normal times. Tidmarsh, however, is dealing with unusually high levels of staff departures and upheaval at both centers. Tidmarsh will get some assistance. Makary announced that Scott Steele and Brittany Goldberg will serve as deputy directors of CBER in his July 30 memo to staff..."With Dr. Prasad's time as director of CBER now over, we wonder if his departure could signal a shift towards the more permissive, patient advocacy centered ‘right to try' wing of the MAHA movement vis-à-vis rare disease indications," Leerink analysts wrote in a July 30 note... Global Sub. Full

Investment in Quality Management Can Reduce Defects and Recalls, FDA Says

(7/30, Joanne S. Eglovitch, Regulatory Focus) ...Companies that invest in quality management initiatives can incur lower costs related to defects, waste, and recalls compared to those that do not make such investments, according to a white paper published by the US Food and Drug Administration's (FDA) Office of Pharmaceutical Quality (OPQ) on Tuesday. Additionally, FDA stated that investing in quality management can lead to public health benefits, such as improved supply chain reliability and a reduction in drug shortages... Full

Novartis Calls Oregon Drug Discount Law Unconstitutional in Suit

(7/30, Ian Lopez, Bloomberg Law) ...Novartis Pharmaceuticals Corp. is suing Oregon over a drug pricing law it says forces drugmakers into providing sprawling discounts. Oregon's H.B. 2385 blocks drugmakers from interfering with pharmacies acquiring drugs discounted through the federal government's 340B drug discount program. Novartis, however, says the law forces companies "to do what the federal courts found Congress intentionally gave manufacturers the power to choose not to do: recognize unlimited contract-pharmacy arrangements" for acquiring steeply discounted drugs... Sub. Req’d

Connecticut Targets Lower Drug Prices with New Law

(7/30, Connecticut Public) ...The bill includes provisions demanding that Pharmacy Benefit Managers (PBMs) give health plans the option to pay the same price for prescription drugs as the PBM pays pharmacies. It also eliminates a contentious provision that allowed penalization of pharmacists for disclosing the cost of a medication to a patient, among other efforts... Full

Roche Pushes Ahead With Late-Comer Strategy in Obesity

(7/30, Amy Baxter, PharmaVoice) ...After shelling out to get into the race, the Swiss pharma's strategy to enter the market with differentiated assets is becoming clearer as the drugs move through the clinic. Now, the Swiss pharma is revealing more about its long-term pipeline plans and potential move to join the ranks of other Big Pharma companies in the direct-to-patient space...The company plans to announce a phase 3 study in obesity for the drug later this year, according to its most recent earnings presentation. In addition, Roche wants to study CT-388 combined with petrelintide, a mid-stage amylin analog it licensed in its deal with Zealand... Full

Mounjaro Proves More Heart Protective Than Trulicity in Trial of Eli Lilly Diabetes Drugs

(7/31, Patrick Wingrove, Reuters) ...Eli Lilly said on Thursday that its newer diabetes drug Mounjaro outperformed Trulicity, its previously top-selling medication for the disease, in reducing the risk of heart attack and stroke in a large, head-to-head study...Kenneth Custer, president of Lilly's cardiometabolic health division, told Reuters that the new results make Mounjaro an even stronger choice for patients. The new late-stage study, which spanned nearly five years, was the largest and longest trial yet for tirzepatide - the chemical name for Mounjaro - Lilly said. Custer said the company planned to submit its findings to the FDA later this year for an anticipated 2026 expanded approval... Full

Roche Braces For Late 2026 Biosimilar Wave

(7/31, Dean Rudge, Generics Bulletin) ...Roche anticipates the launch of biosimilars for its Perjeta (pertuzumab) and Xolair (omalizumab) brands by the end of 2026. This expectation aligns with recent developments from Shanghai Henlius Biotech and Celltrion, who are leading biosimilar production. Roche's Teresa Graham stated that the first Perjeta biosimilar could lead to a limited initial market launch, paralleling the slow uptake of Actemra's biosimilars...Other sponsors with omalizumab biosimilars currently in development include Teva, which has wrapped up a Phase III clinical trial comparing its TEV-45779 candidate against the reference product in patients with chronic idiopathic urticaria/chronic spontaneous urticaria... Global Sub. Full

Celltrion Unveils 3-Year Clinical Data for Avastin Biosimilar Vegzelma in Metastatic Lung Cancer Treatment

(7/31, Kim Kuk Ju, Hinews) ...Celltrion announced the publication of three-year long-term clinical results for its Avastin biosimilar, Vegzelma (CT-P16), in the international oncology journal Cancer Treatment and Research Communications...A Celltrion representative stated, "This study marks a significant milestone in validating Vegzelma's long-term efficacy and safety," and added, "We plan to ramp up market penetration in key global regions." Vegzelma is currently seeing strong sales in markets like the United States and Europe, where it has overtaken rivals to claim the top spot in bevacizumab prescriptions... Full

Takeda Wades Through More Vyvanse Declines, Muses DTC Model as US Pricing Uncertainty Looms

(7/30, Zoey Becker, Fierce Pharma) ...The company's quarterly revenues from April to June sank 8.4% to 1.1 trillion Japanese yen ($7.3 billion). While the impact of generic erosion on sales of its branded Vyvanse ADHD med was "very significant," the Japanese drugmaker had expected the hit, CFO Milano Furuta commented in its quarterly earnings release...The company has been focusing on preparing for potential Inflation Reduction Act-related price changes to its inflammatory bowel disease (IBD) treatment Entyvio and working on its own "mitigation plans" for a "variety of different scenarios" in which MFN could play out, she said... Full

India's Sun Pharma Reports Higher Adjusted Quarterly Profit On Strong Domestic Demand

(7/31, Rishika Sadam and Kashish Tandon, Reuters) ...The firm has been focusing on strengthening its portfolio of innovative drugs in dermatology, oncology and obesity therapy areas as it targets mid-to-high single-digit percentage revenue growth in the current fiscal year. Sales from its high-margin global innovative segment, which includes drugs used to treat rare and complex chronic conditions such as hair loss and psoriasis, rose 16.9% and accounted for 19.3% of the total... Full

Sanofi Sees 'Manageable' Impact from US Tariffs, Expects Strong Sales Growth

(7/31, Bhanvi Satija, Reuters) ...Drugmaker Sanofi said on Thursday it believes the impact from U.S. tariffs to be manageable as it raised its sales growth expectations for the year, banking on expanded demand for its anti-inflammatory drug Dupixent to treat more conditions...Sanofi has significantly ramped up investments in research and development, and plans to be more active with acquisitions as it looks to build its next wave of products. Investor hopes, meanwhile, remain high for Dupixent - the company's main growth driver used to treat conditions including asthma and eczema - particularly since it gained U.S. approval last year to treat chronic obstructive pulmonary disease, a common lung condition... Full

Bristol Myers Posts Better-Than-Expected Second Quarter Results on Strength of Top Sellers

(7/31, Michael Erman, Reuters) ...Bristol Myers Squibb posted much better-than-expected second-quarter results on Wednesday on strong sales of its most established and best-selling brands, blood thinner Eliquis and cancer treatments Opdivo and Revlimid. Revenue in the quarter, which analysts had expected to fall due to the loss of patent protection on some of its products, including Revlimid, rose 1% to $12.3 billion. Analysts, on average, were looking for revenue of $11.4 billion, according to LSEG data... Full

Biogen Raises Annual Profit Forecast on Strong Demand for Rare Disease Drugs

(7/31, Mariam Sunny, Reuters) ...The company has focused on deals, cost-cutting measures and newer drugs to address investor pressure for growth, amid declining sales of its aging multiple sclerosis drugs and slow take-up of its Alzheimer's treatment Leqembi. Biogen said it does not expect President Donald Trump's tariff threats to have a material impact on its annual outlook, even if the exemption for pharmaceuticals were to be removed, as a significant portion of its U.S. revenue comes through domestic manufacturing... Full

AbbVie in Talks to Acquire Gilgamesh Pharmaceuticals, Bloomberg News Reports

(7/30, Christy Santhosh and Padmanabhan Ananthan, Reuters) ...Drugmaker AbbVie is in talks to acquire privately-held mental health therapeutics company Gilgamesh Pharmaceuticals in a deal worth about $1 billion, Bloomberg News reported on Wednesday, citing people familiar with the matter... Full

Aurobindo Pharma to Acquire U.S.-Based Lannett for $250 Million

(7/31, IIFL Capital) ...The acquisition will be executed by Aurobindo Pharma USA Inc. It will purchase 100% membership interest in Lannett from its parent entity, Lannett Seller Holdco, Inc. The deal is being carried out on a cash-free, debt-free basis, factoring in standardised working capital levels...For Aurobindo, the deal offers much more than just a portfolio expansion. It enables the Indian pharma major to enter the ADHD treatment space, an area where it currently has limited presence. The acquisition also brings a growing contract development and manufacturing (CDMO) business into Aurobindo's fold, while offering significant surplus production capacity to support future scaling... Full

Macron Says the EU-US Trade Deal's Not Yet Done, and Calls for More Negotiation

(7/30, Peggy Corlin, Euronews) ...French President Emmanuel Macron has called on the EU Commission to rebalance EU's trade relationship with the US, particularly in the services sector, just days after a deal was reached between EU Commission President Ursula von der Leyen and US President Donald Trump. "To be free, one must be feared. We haven't been feared enough," Macron said during a meeting of the French council of ministers, French media reported, calling for "relentless efforts to rebalance trade, particularly in the services sector."... Full

Ireland Awakens to the Risk of Relying On US Investment

(7/31, Jude Webber, Financial Times) ...The US-EU deal, struck on Sunday, has put an end to Trump's threat of a much stiffer 30 per cent tariff on goods and eased fears — for now — of separate levies as high as 200 per cent on pharmaceuticals. This is "not good news for Ireland Inc, with its reliance on pharma exports", says Glenn Reynolds, head of indirect tax at KPMG in Ireland, adding that the full picture will only become clear once the US concludes a separate investigation into the pharma sector..."We're being told [by management] ‘we aren't worried about Trump' but drug companies are investing billions in the US to build new plants to keep him happy," says one Pfizer employee who asked not to be named. "These guys won't spend money here when there's uncertainty."... Sub. Req’d

Danish Medicines Agency Wants Companies To Use "Better Data Format" To Submit Bioequivalence Studies

(7/30, Anabel Costa-Ferreira, Pink Sheet) ...The Danish Medicines Agency is requesting that data from bioequivalence studies to be submitted in the CDISC format in addition to the current eCTD format. It believes the move will make it easier for the agency claims to access and analyze data and will reduce the burden for applicants... Global Sub. Full

Tariffed or Not? Uneasy Calm Prevails Over Pharma Industry as It Looks for Clarity from the US

(7/31, PT Jyothi Datta, The Hindu BusinessLine) ...While the heads of pharma companies have indicated that some of these directives were directed at innovator drugmakers, an uneasy calm continues to prevail over the pharmaceutical industry that exports about $9 billion worth of medicines to the US. India's ability to provide quality and affordable medicines to the US - as it has in previous years - will be their trump card, they say. Public health advocates caution that Intellectual Property (IP) issues could play a significant role in trade discussions. Industry, meanwhile, is pinning its hopes on the bilateral trade talks... Full

Trump's Tariffs Hike US Drug Costs

(7/31, Press Trust Of India) ...Pharmaceuticals Export Promotion Council of India (Pharmexcil) on Thursday said President Donald Trump's imposition of a 25 per cent tariff plus unspecified penalty on all goods coming from India starting August 1, will result in increased costs for essential drugs in the US, ultimately harming consumers and healthcare systems in the country in the long term. The US market, heavily reliant on India for Active Pharmaceutical Ingredients (APIs) and low-cost generics, faces a daunting challenge in finding alternative sources that can match the scale, quality, and affordability that India offers, Pharmexcil Chairman Namit Joshi said in a statement... Full

Who's Most at Risk from Trump's 25% India Tariffs and Penalty

(7/30, Satviki Sanjay, Bloomberg) ...India is the largest exporter of non-patented drugs to the US at an approximate annual value of $8 billion. Shares of some of the country's biggest companies, including Sun Pharmaceutical Industries Ltd., Dr. Reddy's Laboratories Ltd. and Cipla Ltd., fell Thursday as they receive at least 30% of their revenue from the US. India's drugmakers, however, are still hoping for a lower rate on these items. "Tariff on Indian generic pharmaceuticals would pose huge challenges for US pharma supply chain," Namit Joshi, chairman of Pharmaceuticals Export Promotion Council of India, told Bloomberg News. "May be it will attract only a base tariff of 10%."... Full

Trump's Tariff Move On India May Backfire, Pharma Industry Leaders Say

(7/31, ANI) ...Indian pharmaceutical industry leaders strongly criticize U.S. President Trump's tariff announcement, arguing it will harm the American healthcare system more than India's economy. They emphasize India's crucial role in supplying affordable medicines, particularly generics, to the U.S., warning that tariffs will lead to drug shortages and price increases for American citizens... Full

U.S. Trade Deal Has Pharma Firms On Edge Despite 'Most Favored Nation' Status

(7/31, Korea JoongAng Daily) ...Following the Korea-U.S. tariff negotiations on Wednesday, the Korean government said Washington has promised most-favored-nation (MFN) treatment under its upcoming pharmaceutical tariff policy — a development that brought cautious relief to the local pharmaceutical and biotech industry. With the bio sector included in the government's planned $200 billion U.S.-bound investment fund, more companies are expected to build local production facilities. However, since details remain unclear on how tariffs will be applied to specific items such as active pharmaceutical ingredients and finished drugs, many firms are adopting a wait-and-see approach... Full

Note: Article links may expire over time or require a free registration. All news articles are the property of their respective publishers and copyright holders. [contextual emphasis added].

Teva global subscription access: registration is required to access FirstWord Pharma+ News and The Generics Bulletin. Please note you must be on the Teva Network (in a Teva location or connected via VPN) to access Teva's InfoNOW news resources. If you have any questions or issues, please email InfoNOW@tevapharm.com.

 

•      FirstWord Pharma+ News registration: first-time users, register here with your Teva email address. You will automatically receive a daily FirstWord Pharma+ newsletter; click on any news item to access your account.

•      Generics Bulletin, Pink Sheet, Scrip (Citeline) registration: go to the Generics Bulletin site and choose "Sign In" in the upper right-hand corner. First-time users, choose "Sign Up Here" and enter your Teva email address.