Tuesday, July 29, 2025

Teva Price Target Lowered to $29 from $30 at Piper Sandler

(7/29, The Fly) ...Piper Sandler lowered the firm's price target on Teva to $29 from $30 and keeps an Overweight rating on the shares ahead of quarterly results. The firm says performance for biopharma in Q2 and into Q3 thus far has seen marked improvement, in part a function of fears surrounding tariff-related dislocation receding into the background, in part a function of fears regarding pricing-related dislocation also receding into the background, and in part a function of an anticipated more favorable rate environment... Full

EU-US Trade Deal Could Add Up to $19 Billion in Pharma Industry Costs, Analysts Say

(7/29, Bhanvi Satija, Reuters) ...The European Union's trade deal with the United States could cost the pharmaceutical industry between $13 billion and $19 billion as branded medicines become subject to a tariff of 15%, analysts said on Monday. The added costs could raise prices for consumers unless pharmaceutical companies take action to mitigate the impact of the tariffs, one of the analysts said...UBS' Weston said that it was not immediately clear which generic drugs were exempted from duties under the deal, but any impact for generic drugmaker Sandoz for this year should mostly be manageable... Full

Tariffs On Medicines From Europe Stand to Cost Drugmakers Billions

(7/29, Rebecca Robbins, The New York Times) ...The 15 percent rate is final and will not be affected by the national-security-related tariffs that Mr. Trump is expected to impose on pharmaceuticals made elsewhere in the world, according to a White House official and senior European Commission officials. This outcome is something of a win for the pharmaceutical industry, which had feared that drugs from Europe would be hit with high levies related to national security. Both sets of pharma tariffs are expected to take effect simultaneously sometime next month, officials said... Sub. Req’d

Drug Prices Likely to Rise with Tariffs On EU

(7/29, Tina Reed, Axios) ..."The big picture is: The cost of imported drugs is about to become more expensive for all Americans," Joe Brusuelas, principal and chief economist for RSM US, told Axios..."I don't see anyone doing anything until we see that these deals are worth the paper that eventually they're going to be written on," Marc Busch, a Georgetown University authority on international trade policy, told Axios. Manufacturers will have to game out whether to take on major one-time expenses of moving their production, as well as whether to pass along future higher costs for certain drugs... Full

EU 15% Tariff Deal Still Leaves Questions For Pharma On Possible Grace Period, Generic Exemption

(7/29, Jessica Merrill, Pink Sheet) ...The European deal appears to supersede pharmaceutical sector tariffs, which the Trump administration has been threatening to announce for several months. Any sector tariffs on imports from other countries that Trump announces will not impact European pharma imports, at least according to European Commission President Ursula von der Leyen, who provided some clarity on the issue in public remarks the same day... Global Sub. Full

Medicare Part B ASP Proposal Sets ‘Guardrails' Around Bona Fide Service Fee Reporting

(7/28, Cathy Kelly, Pink Sheet) ...CMS limits how manufacturers can handle bona fide service fees in calculating average sales prices for Medicare Part B drugs in the Physician Fee Schedule proposed rule. Fees that are calculated as a percentage of drug price should be considered price concessions unless companies can prove they represent fair market value, the agency says. The proposal, which could lead to lower ASPs and reduced Medicare reimbursement, includes a list of examples in which service fees should be considered price concessions... Global Sub. Full

PCMA Supports the Eliminating Thickets to Improve Competition (ETHIC) Act

(7/28, PCMA) ..."We applaud U.S. Senators Peter Welch (D-VT), Josh Hawley (R-MO), and Amy Klobuchar (D-MN) for introducing the Eliminating Thickets to Improve Competition (ETHIC) Act  to support competition in the prescription drug market and address the egregious patent abuse by some drug companies. Patent abuse is anticompetitive, drives up health care costs, and limits access to prescription drugs for patients who need them. Increased competition in the prescription drug marketplace is a proven path to lower drug costs, and this bill would be a step in the right direction toward preventing delays to market entry and promoting more competition..."... Full

7-Year FDA Review Finds Improved GCP Compliance

(7/28, Emily Hayes, Regulatory Focus) ...A study of routine good clinical practice (GCP) inspections between 2017 and 2023 found a declining number of Form 483s flagging violations at clinical trial sites and a very low number requiring official action (0.3%), US Food and Drug Administration (FDA) officials report... Full

Maryland PDAB Votes Farxiga, Jardiance As Unaffordable

(7/28, Luke Zarzecki, Inside Health Policy) ...The Maryland Prescription Drug Affordability Board (PDAB) voted Monday (July 28) that AstraZeneca's Farxiga and Boehringer Ingelheim's Jardiance are both unaffordable, a step toward limiting the amount state and local governments can pay for the two popular drugs... Sub. Req’d

Managing Tardive Dyskinesia With VMAT2 Inhibitors in Clinical Practice

(7/28, Kayla Johnson, PharmD, BCPS, BCPP, Pharmacy Times) ...VMAT2 inhibitors, including deutetrabenazine and valbenazine, are recommended for TD treatment, with valbenazine showing superior clinical outcomes...Updated in 2020, American Psychiatric Association Practice Guideline for the Treatment of Patients With Schizophrenia (Third Edition) and A Modified Delphi Consensus Study of the Screening, Diagnosis, and Treatment of Tardive Dyskinesia recommend treatment with a VMAT2 inhibitor for patients with TD.1,5 Additionally, deutetrabenazine (Austedo; Teva Neuroscience, Inc) and valbenazine (Ingrezza; Neurocrine Biosciences, Inc) both carry a level A recommendation using the Scottish Intercollegiate Guidelines Network framework... Full

Lilly's Cancer Drug More Effective Than AbbVie's In Head-To-Head Study

(7/29, Bhanvi Satija, Puyaan Singh and Siddhi Mahatole, Reuters) ...Eli Lilly said on Tuesday its drug, Jaypirca, was more effective in a head-to-head study against AbbVie's Imbruvica when tested in patients with a type of blood cancer. The drug was being tested in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma... Full

INVESTIGATING GENERICS: The Trouble With Generic Vyvanse

(7/28, Emma Tasinski, Med Shadow Foundation) ...Ryan Sultan, M.D., a child and adult psychiatrist in New York City who specializes in treating ADHD, says about 70 percent of his patients who take lisdexamfetamine dimesylate have reported lower efficacy since being switched from name-brand Vyvanse to a generic. For most, he says a slight dose increase helped alleviate their problems, but it's not a great long-term solution... Full

Celltrion Seeks to Acquire US Biologics Plant to Hedge Tariff Risks, Secure US Manufacturing Base

(7/29, Lee Han-soo, Korea Biomedical Review) ...Celltrion said on Tuesday it hopes to acquire a U.S.-based biologics production facility by the end of this year, with an investment of up to 700 billion won ($528.7 million), in a move aimed at neutralizing risks from potential U.S. drug tariffs and strengthening its U.S. manufacturing presence... Full

AstraZeneca Beats Profit Expectations On Robust Drug Sales, US Demand

(7/29, Pushkala Aripaka, Unnamalai L and Maggie Fick, Reuters) ...AstraZeneca is betting on a wave of expected launches of 20 new medicines and its U.S. expansion to reach $80 billion in annual revenue by 2030 and offset generic competition. On Tuesday, it maintained its 2025 outlook and increased its interim dividend by 3%. "Our strong momentum in revenue growth continued through the first half of the year and the delivery from our broad and diverse pipeline has been excellent," CEO Pascal Soriot said... Full

Obesity Drugmaker Novo Nordisk Cuts 2025 Sales Growth, Operating Profit Outlook

(7/29, Stine Jacobsen, Reuters) ...Obesity drugmaker Novo Nordisk warned on Tuesday that full-year sales and operating profit would grow less than previously expected, marking its second forecast cut of 2025..."The lowered sales outlook for 2025 is driven by lower growth expectations for the second half of 2025," the company said in a statement. "This is related to lower growth expectations for Wegovy in the U.S. obesity market, lower growth expectations for Ozempic in the U.S. GLP-1 diabetes market, as well as lower-than-expected penetration for Wegovy in select IO markets," it said... Full

Merck Plans $3 Billion Cost Cuts by End of 2027, Narrows Full-Year Outlook

(7/29, Annika Kim Constantino, CNBC) ...Merck on Tuesday said it will slash $3 billion in costs by the end of 2027 to be fully reinvested to support new product launches and its drug pipeline. The multi-year effort comes as Merck prepares to offset revenue losses from the upcoming patent expiration of its blockbuster cancer drug Keytruda in 2028, and braces for the Trump administration's planned tariffs on pharmaceutical imported into the U.S. Merck also posted second-quarter revenue that missed estimates and narrowed its full-year guidance... Full

Strides Pharma Q1 Results: US Sales Improve 7%, Gross Margins Expand

(7/29, Hormaz Fatakia, CNBC TV-18) ...Strides Pharma's Earnings Before Interest, Tax, Depreciation and Amortisation (EBITDA) for the quarter increased by 14.7% from the year-ago quarter to ?217.9 crore, while margins expanded by 150 basis points to 19.5% from 18% last year..."Our focus on cost management and diligent execution has enabled us to deliver robust results," said Badree Komandur, MD & Group CEO of Strides Pharma. He added that the company will enhance its R&D efforts during the year to drive sustainable, long-term growth... Full

Torrent Pharmaceuticals Sees 20% Jump in Q1 Net Profit Amid Strong Global Growth

(7/29, Niyati Parikh, The Times of India) ...Torrent Pharmaceuticals reported a robust 20% increase in net profit, reaching Rs 548 crore for Q1 FY26, fueled by strong performances in India, the US, and Brazil. Consolidated revenue grew by 11% to Rs 3,178 crore, with operating EBITDA rising 14% to Rs 1,032 crore. The India business saw an 11% revenue increase, driven by chronic therapies... Full

Torrent Pharmaceuticals Plans Semaglutide Rollout Post Patent Expiry

(7/29, The Economic Times) ...Torrent Pharmaceuticals is gearing up to launch both oral and injectable versions of semaglutide, the weight loss drug, following the expiration of Novo Nordisk's patent. The company is currently in Phase 3 clinical trials for oral products and has partnered for injectables, anticipating a launch within the next 1-2 years... Full

Gateway To Africa: Natco Bids For 35.75% Of Adcock Ingram

(7/28, Anju Ghangurde, Generics Bulletin) ...Natco to buy out Adcock Ingram's minority shareholders with a cash offer of ZAR75 per share which if accepted translates into a 35.75% stake. Natco's CEO says deal done at "very reasonable valuation", marking the firm's biggest M&A investment. Natco expects to leverage R&D strength for "cross-pollination" of ideas across Africa. Deal not entirely unexpected, with experts having signaled potential M&A opportunities in Adcock... Global Sub. Full

Bristol Myers, Bain Capital Form New Company to Develop Immunology Drugs

(7/28, Padmanabhan Ananthan, Reuters) ...The new company will work on five experimental drugs licensed from Bristol Myers, including a late-stage lupus treatment and a mid-stage psoriasis drug that has shown promise in trials. Bristol Myers will retain nearly 20% equity in the venture and is set to receive royalties and milestone payments based on the drugs' success...Daniel Lynch, a seasoned pharmaceutical executive, will take on the roles of executive chairman and interim CEO of the new company, while Bristol Myers' chief research officer Robert Plenge is set to join the board alongside Bain Capital partners... Full

Big Pharma Aggregate Revenue Up 7.9% in 2024

(7/29, The Pharma Letter) ...As many as 19 of the top 20 publicly-traded global biopharma companies reported revenue growth in 2024, with an overall 7.9% year-on-year (YoY) increase in aggregate revenue to $880.4 billion, reveals GlobalData. The findings reflect a positive year for industry in 2024, with obesity drug developers continuing to witness success... Sub. Req’d

Access Denied: Can Pharma Close the Global Health Gap?

(7/28, The Pharma Letter) ...The 2024 Access to Medicine Index paints a stark picture. It concluded that the largest drugmakers are "falling short" in meeting the healthcare needs of underserved populations. Progress on access is not keeping up with rising demand, leaving a widening gap between innovation and delivery. The report found that just 43% of clinical trials conducted by the companies studied were held in the 113 countries that are home to 80% of the world's population. This lack of representation means delayed access to medicines and data that do not always reflect diverse patient needs... Sub. Req’d

Vizient Projects Continued Cost Pressures Across the Healthcare Supply Chain in 2026

(7/29, Vizient) ...Vizient® released its Summer 2025 Spend Management Outlook forecasting a 3.35% increase in pharmaceutical prices in 2026 with healthcare providers seeing increased usage in GLP-1 therapies, specialty medications and high-cost cell and gene therapies. Supply chain prices in products, materials and services are projected to rise 2.41%, led by IT services, capital equipment and surgical supplies. Read the Summer 2025 Spend Management Outlook... Full

The Generics Bulletin Top 50, Part Two: Leading Players Leapfrog The Competition

(7/29, Dave Wallace, Generics Bulletin) ...With the players featured in our rundown of the top 10 generics and biosimilars companies this year remaining a fairly consistent group – albeit with a couple of German leaders rising up the rankings this year – our middle table covering positions 11-30 in our ranking reflects considerably more movement, in the second part of this year's Generics Bulletin Top 50. Hikma holds on to its position at the top of our second table this year – after last year moving above Intas – with the firm enjoying 9% growth to break the $3bn barrier in annual turnover in 2024, ahead of a mooted $1bn investment in US manufacturing over the next five years... Global Sub. Full

EPP Says Von der Leyen Not Mandated to Pledge EU Pharma Investment in US

(7/29, Thomas Mangin, Euractiv) ...MEPs from across the political spectrum have accused European Commission President Ursula von der Leyen of giving in to US pharma interests and overstepping her mandate after striking a trade deal with President Donald Trump. The Commission announced on Monday that pharmaceutical products will not be subject to tariffs for now, though a maximum rate of 15% could apply depending on the outcome of a US investigation into reliance on EU pharmaceutical imports... Full

Uncertainty Is Far From Over, Says Belgium's Pharma Sector

(7/28, Nicole Verbeeck, Euractiv) ..."President Trump stated that medicines are excluded from the agreement. However, the official statement from the European Union refers to a ‘clear ceiling' of 15% on tariffs on pharmaceutical products," pharma.be told Euractiv...Belgian Prime Minister Bart De Wever responded cautiously to the announcement on social media platform X. "As we await full details of the new EU–US trade agreement, one thing is clear: this is a moment of relief but not of celebration. Tariffs will increase in several areas, and some key questions remain unresolved."... Full

Italy To Reward Locally Conducted R&D In Innovative Medicines Fund Revamp

(7/28, Francesca Bruce, Pink Sheet) ...Italy has updated criteria for evaluating whether a medicine should enter the innovative medicines fund, which allows reimbursement for 36 months. The changes mean certain antibiotics are automatically entered into the fund without an assessment. Innovation assessments can now take into account whether a product has been developed in Italy... Global Sub. Full

Hungary Shows Why Trump's Cap on Drug Prices Won't Work

(7/28, Máté Hajba, RealClearHealth) ...MFN would make the prices Americans pay for drugs dependent on the policy decisions of European governments and regulators. That's a terrible idea. Artificially lowering prices will cause shortages, just like it did here in Hungary. The U.S. should consider allowing more medicine to be sold over the counter instead. That would achieve what Trump wants without choking up the supply chain. High drug prices are a serious problem — but drug shortages are even worse. Hungarians experience this issue frequently. Hungary has one of the highest instances of shortages in the EU. Sometimes, consumers like me can find viable alternative drugs when the one we need is out of stock, but often, we can't. That means the sick and wounded have to go abroad to secure their medications... Full

Where Does China Stand After US Trade Deal with EU Seen as ‘More Rhetoric Than Substance'?

(7/29, Ji Siqi, South China Morning Post) ...On Monday, China and the US began their third round of trade negotiations in Stockholm, one day after Washington and Brussels announced a trade deal framework that included a 15 per cent tariff on most EU goods entering the US. "The US may believe that, after essentially securing the EU, it will have greater negotiating leverage when dealing with China," said Cui Hongjian, the head of EU studies at Beijing Foreign Studies University... Sub. Req’d

Expedited Reviews For China-Originated Drugs Shift Back Home

(7/29, Xu Hu, Pink Sheet) ...The proportion of China-originated drugs granted expedited review programs by China's regulator has doubled in the first half of this year. There was a notable shift in such designations to China away from the US - the other main awarder of such status - in the first half, likely driven by multiple factors including China's emergence as a global R&D powerhouse and domestic regulatory reforms. ADCs was the leading modality among Chinese-origin biologics that received expedited review designations or were filed for INDs in both years... Global Sub. Full

US-Japan Trade Deal Guarantees Lowest Tariff Rates for Chips, Pharma, Japanese Official Says

(7/29, Makiko Yamazaki, Reuters) ...Japan's leading trade negotiator said on Tuesday that the trade deal Tokyo agreed with the United States last week guarantees Japan will always receive the lowest tariff rate on chips and pharmaceuticals of all the pacts negotiated by Washington. "If a third country agrees with the United States on lower rates on chips and pharmaceuticals, those lower rates would apply to Japan," Ryosei Akazawa told a news conference... Full

Centre to Rope in States to Enforce Drug Quality Norms

(7/28, Priyanka Sharma, Mint) ...A recent revision of Schedule M GMP rules seeks to align India's quality standards with global benchmarks in a bid to boost the country's reputation as a reliable drug producer. All large companies, with revenues exceeding 250 crore, are implementing GMP while smaller firms received an extension until December 31, to make the necessary upgrades... Full

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