Tuesday, March 3, 2026

Amid Unfolding Middle East War, Pharma Giants Keep Close Eye on Employee Safety, Supply Chains

(3/2, Frasier Kansteiner, Fierce Pharma ) ..."As a global company, we are closely monitoring the situation and are working hard to make sure our colleagues, affiliates, partners, and their families in the region are safe," a Boehringer Ingelheim spokesperson said in an emailed statement. "At the same time, we will work hard to ensure that human and animal patients continue to have access to the medicines they need." The company is "saddened to see the humanitarian consequences of this conflict," the spokesperson added...Swiss drugmaker Roche is taking a similar approach, with a spokesperson telling Fierce that the company's employees in affected countries "are accounted for" and have Roche's support... Full

US Asks Smaller Drugmakers to Discuss Lowering Prices for Medicaid

(3/2, Reuters) ...CMS said on Monday it extended the application deadline for drugmakers to join the payment model, which aims to offer comparable drug prices to those paid in other developed countries. It said it will hold meetings with interested small and mid-sized manufacturers beginning on April 1... Sub. Req’d

Drugmakers Pressure Trump to Withdraw Foreign Pricing Frameworks

(3/3, Nyah Phensitthy, Bloomberg Law) ...The requests come despite the various deals manufacturers have struck with Trump to slash drug prices. Those agreements, which were voluntary, are primarily focused on Medicaid and direct-to-consumer drug purchasing platforms. Some drugmakers have wondered if they would be exempt from the pricing models if they made a deal with Trump. A CMS spokesperson said in an email that if the proposals are finalized, the agency would outline how the models would interact with existing pricing arrangements... Sub. Req’d

Trump's Drive to Get Europe to Pay More for Drugs Creates Uncertainty for Countries, Patients

(3/3, Andrew Joseph, STAT+) ...Only time will tell if drugmakers actually tame their launch prices in the U.S. But they are already leveraging the pressure from the U.S. to try to get European countries to pay more... Sub. Req’d

CMS Extends Deadline for MFN Pricing Pilot Scheme

(3/3, Phil Taylor, pharmaphorum) ...[CMS] in the US has extended the deadline for companies to take part in its GENEROUS pilot programme, designed to implement most-favoured-nation (MFN) pricing for outpatient drugs reimbursed by Medicaid...In an update, CMS said the extension will "provide interested drug manufacturers more opportunity to join the model," adding that it will hold meetings with interested manufacturers from the start of April and plans to hold a town hall meeting to discuss the operational and methodological details of the model later this spring... Full

HHS Bans Claude AI Tool as Trump Seeks Full Government Blacklisting of Anthropic

(3/2, Darren Incorvaia, Fierce Biotech) ...While Claude is now off-limits, similar tools like OpenAI's ChatGPT Enterprise and Google Gemini "remain available for authorized mission-related use," HHS spokesperson Emily Hilliard confirmed to Fierce Biotech... Full

How Can HHS Drive Clinical AI Adoption? The Industry Wish List Is Starting to Take Shape

(3/3, Mario Anguilar, STAT) ...At the time of publication, just a fraction of the 7,300 comments submitted to the health department have been posted to the docket. Still, they offer a comprehensive industry wishlist for AI, including reforms to health data privacy rules to account for AI training and calls for reliable AI reimbursement... Full

Pfizer CEO Flags Concerns with US FDA's Vaccine Leadership

(3/2, Mariam Sunny, Reuters) ...Pfizer CEO Albert Bourla said the company "has a problem" with the U.S. Food and Drug Administration's biologics and vaccines chief, Vinay Prasad, in response to a question about the drugmaker's recent communications with the regulator. Bourla said on Monday, at the TD Cowen healthcare conference, that Prasad was disregarding the advice of the agency's career scientists..."I think the current director is not following the recommendations of his staff...and that's a problem," Bourla said... Full

FDA Seeks Feedback on Overhaul of Its SUPAC Guidelines

(3/2, Joanne S. Eglovitch, Regulatory Focus) ...The notice concerns five guidance documents: immediate-release dosage forms (IR), modified-release (MR) dosage forms, and non-sterile semi-solid dosage forms. It also covers a manufacturing equipment addendum (SUPAC-MEA) as well as a question-and-answer guidance on the IR guidance... Full

DOJ Sides With Big Pharma in Fight Over Rhode Island Drug Discount Law

(3/2, Mary Serreze, Providence Business First) ...Rhode Island Attorney General Peter Neronha is in a legal fight with Big Pharma over state involvement in a federal drug discount program — and now Washington has stepped in, on the pharmaceutical industry's side, with a friend-of-the-court brief... Full

FDA Holds Line On uniQure Filing for Huntington's Gene Therapy

(3/2, Anna Bratulic, FirstWord PHARMA) ...According to Monday's company update, the FDA "strongly recommended" that uniQure conduct a prospective, randomised, double-blind, sham surgery-controlled study. "While we did not reach alignment on a submission pathway based on the Phase I/II data, we believe the totality and durability of our data warrant continued substantive dialogue regarding how the FDA's stated commitment to regulatory flexibility may be appropriately applied in this setting," [CEO Matt] Kapusta said... Full

Updated: Caught in FDA's Rare Disease Crackdown, uniQure Seeks Ethical Path Forward for Huntington's Treatment

(3/2, Max Gelman, Endpoints News) ...These decisions are raising ethical issues about potential placebo-controlled studies and scrambling some biotechs' plans, confusing executives and analysts alike...A senior FDA official later Monday disputed any characterization that the agency isn't being flexible in rare disease, pointing to an approval from last August as evidence... Sub. Req’d

First EU Pertuzumab Leads Latest EMA Biosimilar Nods

(3/2, Dave Wallace, Generics Bulletin) ...Poherdy – formerly known as HLX11 – was already approved in the US in November, where Henlius and Organon have struck a settlement deal ending patent litigation with Roche. The originator recently indicated that "we don't expect a biosimilar for Perjeta until 2028 in the US, and 2027 in the EU."... Global Sub. Full

SamChunDang Seals Semaglutide Oral Generics Deal Across European Markets

(3/2, Dean Rudge, Generics Bulletin) ...SamChunDang Pharmaceutical has signed an exclusive licensing and commercialization agreement covering generic versions of oral semaglutide products in the UK and 10 additional European markets, in a deal valued initially at €30m ($35m). The agreement spans generic versions of Rybelsus for type 2 diabetes and Wegovy for obesity, both based on earlier injectable version of Novo Nordisk's semaglutide brand... Global Sub. Full

NATCO Pharma Launches Generic Blood Cancer Treatment Medicine in US

(3/3, The Economic Times) ...The product is available in 1mg, 2mg, 3mg, and 4mg strengths and is distributed primarily through specialty pharmacies and clinics, NATCO Pharma said in a regulatory filing... Full

Geopolitics Now Play Key Role in Boardrooms, Fresenius CEO Says

(3/3, Sonja Wind and Ashleigh Furlong, Bloomberg) ...The conflict in the Middle East is highlighting the importance of alternative supply routes, with geopolitics now playing a vital role in the boardroom, according to Fresenius SE's chief executive officer. The health industry must analyze and navigate "a new world order" in which exchanges have become transactional and national interests the priority, CEO Michael Sen said in an interview with Bloomberg TV... Full

Cipla, Kemwell Form Biologics JV to Tap Fast-Growing Biosimilars Market

(3/2, Anjali Singh, Business Standard) ...The two companies signed the joint venture agreement on March 2, 2026, and will incorporate a new JV company in India. Cipla will hold a 60 per cent stake in the venture, while Kemwell will own the remaining 40 per cent... Full

Nearly Half of Colorectal Cancers Now Occur in Younger Patients, Study Shows

(3/2, Nina Agrawal, The New York Times) ...The distinct location of the cancers and the rising rates suggest that there may be unique drivers of the disease in younger generations. For example, scientists suspect environmental exposures that began around the 1950s may be partially responsible. Much of the ongoing research is focused on changes to the gut biome and inflammation associated with modern products like ultraprocessed foods, microplastics and antibiotics, the study said... Sub. Req’d

How Pharma Marketers Are Capturing the Power of Podcasts to Connect with Consumers

(3/2, John Newton, Fierce Pharma) ...Several Big Pharmas have introduced their own podcasts to advance corporate branding efforts, like Pfizer's award-winning "Science Will Win" series and AbbVie's newly launched "The Persistence Lab."... Full

Trump's Ambassador to UK Rebukes Head of Medicines Watchdog Over Drug Pricing

(3/3, Chris Smyth and Aanu Adeoye, Financial Times) ...Ambassador Warren Stephens called in Jonathan Benger, chief executive of the National Institute for Health and Care Excellence (Nice), to criticise Britain's "anti-growth policies" and express displeasure at his defence of the UK cost control system, according to people briefed on the meeting. US diplomats are said to have been angered by an interview with the FT in January in which Benger warned that giving in to Trump's demands for higher drug payments by weakening the role of Nice would be a "huge backwards step"... Sub. Req’d

Nordic Countries Press For Wider Adoption Of Joint HTA Pathway

(3/2, Francesca Bruce, Pink Sheet) ...So far, the JHNB has delivered four joint assessments. "However, as of early 2026, only one joint assessment is expected, and none are currently underway," said the initiative in a statement. "That is truly a shame, because it means that much of the countries' valuable expertise is still tied up in parallel national processes," said Birgitte Klindt Poulsen, Chair of the Danish Medicines Council... Global Sub. Full

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