Thursday, May 7, 2026

 

 

Ajovy Wins Korea Approval for Pediatric Episodic Migraine Prevention

(5/7, Kim Ji-hye, Korea Biomedical Review) ...Teva-Handok said Wednesday that Ajovy received approval from the Ministry of Food and Drug Safety (MFDS) on Monday for the preventive treatment of episodic migraine in patients aged 6 to 17 years who weigh at least 45 kg. With the latest approval, Ajovy becomes the first and only anti-CGRP monoclonal antibody approved in Korea for the prevention of episodic migraine in pediatric patients, in addition to its existing indications for chronic and episodic migraine in adults... Full

 

 

Amgen, AbbVie Say IRA Negotiations Impacted Q1 Sales

(5/6, Nicole DeFeudis, Endpoints News) ...AbbVie reported a 25% decline in global sales for its cancer drug Imbruvica, which Chief Commercial Officer Jeffrey Stewart attributed to "IRA pricing and competitive share pressure" on the company's earnings call. AbbVie declined to share more information. The government negotiated a 38% discount to Imbruvica from its list price in the first round of negotiations... Sub. Req'd

 

Trump Promised Cheaper Drugs. Some Prices Dropped. Many Others Shot Up.

(5/7, Elisabeth Rosenthal, Arthur Allen, KFF Health News) ...Aaron Kesselheim, a professor of medicine at Harvard Medical School whose research focuses on drug prices, said the Trump announcements are "one-off agreements made for publicity purposes. They don't change anything about the way drugs are priced." He added: "The agreements are opaque and unenforceable." It was unclear, for example, which drugs would be sold at "most favored nation" prices or how exactly that was defined. But, clearly, not all were... Full

 

Administration Report on Most Favored Nation Drug Pricing Raises New Details - and Questions

(5/7, Daniel Payne, STAT) ...The report, from the administration's own Council of Economic Advisers, lays out the definition of "most-favored nation" pricing. That's the definition pharmaceutical giants agreed to in their confidential deals with the administration, a White House spokesperson told STAT in an email. The most-favored nation pricing calculation represents a key underpinning of one of the White House's top election-year talking points - though many key details of the deals remain private, and their ultimate impacts for consumers uncertain... Sub. Req'd

 

Critical Vulnerability in Drug Supply Chain Puts US at China's Mercy

(5/6, Ronald Piervincenzi, Washington Examiner) ...Blanket approaches to strengthening the supply chain, such as onshoring the finished dose production of a medicine while continuing to source its API from overseas, do not solve the problem and leave U.S. patients at risk. We need a drug-by-drug plan that considers all medicines and their ingredients, identifies areas of overlapping risk, then prioritizes where to intervene and how - using policy, trade, and investment levers across government and the private sector... Full

 

BMS To WH: Reject Combo Drug Policy For Upcoming IRA Rule

(5/6, Gabrielle Wanneh, Inside Health Policy) ...Bristol Myers Squibbs appealed to White House budget officials in a late April meeting to nix any attempt by CMS to make all versions of the same drug eligible for Medicare price negotiation, alleging the agency lacks authority under the Inflation Reduction Act to lump fixed-dose combination and single-active-ingredient medications together for negotiation purposes. CMS had previously punted on the policy shift, but BMS worries it could reappear in a draft IRA drug negotiation rule pending at the White House... Sub. Req'd

 

Most Favored Nation Drug Pricing: Anchoring To A Moving Target

(5/6, Pedro Pita Barros, Giovanni Righetti, Luís Sá, Health Affairs) ...Manufacturers raise prices in reference countries, narrow the set of markets where they launch, and exploit confidential discounts to obscure the benchmarks regulators rely on. Empirical evidence across European markets confirms a pattern of price convergence: Prices in reference countries rise, and the savings in the adopting country are smaller than the initial price gap would suggest... Full

 

Amgen's Retreat: Denmark, Repatha, And The Collision Course Of US MFN Pricing Policy

(5/6, Nathan Jibatand, Jeromie Ballreich, Health Affairs) ...Repatha's withdrawal from Denmark is best understood as an early signal of the impact of Most Favored Nation drug pricing proposals in the US. When low-price foreign markets become linked to large U.S. markets, access disruptions are a predictable risk... Full

 

FDA Rolls Out 1-Day Assessment Pilot in Bid to Refocus Inspection Resources

(5/6, Fraiser Kansteiner, Fierce Pharma) ...The new strategy, which seeks to make the agency's inspectional resources "more targeted and efficient," relies on shorter and more focused screening assessments, according to a May 6 press release. Data gathered via the speedy assessments could be used to pinpoint recurring compliance themes, manufacturing facility-specific risk scores and discrepancies around sites' registered operations, potentially helping tailor future oversight efforts, the FDA said... Full

 

Sanofi Asks to Pull Diabetes Drug Out of FDA Voucher Program after Political Appointee Interfered with Review

(5/7, Lizzy Lawrence, STAT+) ...The move comes after acting Center for Drug Evaluation and Research Director Tracy Beth Høeg disagreed with a staff decision to approve the drug, according to sources familiar with the dispute who requested anonymity due to fear of reprisal. The agency has missed its goal date of April 21 to deliver a decision to Sanofi... Sub. Req'd

 

Makary May Face Tough Questions At Senate Approps Hearing

(5/6, Jessica Karins, Inside Health Policy) ...Embattled FDA Commissioner Marty Makary is testifying before the Senate Appropriations Committee next Wednesday (May 13), where he's likely to face questions about how drug approval processes have been impacted by FDA's leadership turnover, decline in staffing levels and controversial Commissioner's National Priority Review Voucher program... Sub. Req'd

 

What Was Lost at the FDA

(5/7, Lizzy Lawrence, STAT) ...STAT asked six of these former officials to recount their most challenging responsibilities and experiences at the agency, to more intimately illustrate the expertise the agency has lost... Sub. Req'd

 

 

CellCentric Lands $220M Series D to Propel Myeloma Drug Through Pivotal Studies

(5/6, Pavan Kamat, FirstWord PHARMA) ...CellCentric announced Wednesday the closure of an oversubscribed $220 million series D financing to advance its oral p300/CBP inhibitor inobrodib through pivotal trials for relapsed or refractory multiple myeloma (RRMM)....CellCentric noted that the megaround's proceeds will fund continued enrolment in the recently commenced Phase II DOMMINO-1 study of inobrodib, as well as initiation of the global Phase III DOMMINO-2 trial in the second half of the year... Full

 

BeOne Culls Five Cancer Programs and an Autoimmune Phase 2

(5/6, Kyle LaHucik, Endpoints News) ...In the past quarter, BeOne canned five cancer projects and one of its leading forays into autoimmune diseases, according to Wednesday's first-quarter pipeline update. The company, formerly known as BeiGene, has spent most of its history on cancer with the marketed medicines Brukinsa and Tevimbra, but in recent years has broadened its efforts into the autoimmune arena... Sub. Req'd

 

 

Catalyst Pharmaceuticals Announces Settlement of FIRDAPSE® (amifampridine) Patent Litigation with Hetero Labs Ltd.

(5/7, Catalyst Pharmaceuticals) ...Pursuant to the terms of the Agreement, Hetero will not market its generic version of FIRDAPSE in the United States any earlier than a specified date in January 2035, if approved by the U.S. Food and Drug Administration, unless certain limited circumstances customarily included in these types of agreements occur... Full

 

Xbrane Looks At Its Opdivo Biosimilar Partner Intas For Cash

(5/6, Urte Fultinaviciute, Generics Bulletin) ...The pair announced a revision to their 2024 licensing agreement, extending the financial aid from Intas, which was originally responsible for the clinical development and global commercialization of the Opdivo rival. Now, the Indian firm will also assume responsibility for financing certain CMC-related development activities performed by Xbrane's contract manufacturing partner... Global Sub. Full

 

Novo Sees Generic Ozempic Delayed in China Until Next Year

(5/6, Naomi Kresge, Amber Tong, Bloomberg) ...The delay helps Novo push back, at least for now, against a growing wave of Ozempic generics outside the US. "Everyone thought there were a bunch of companies - nine, 10 companies - waiting" to introduce generics, said Zhao Heng, founder of Latitude Health, a Shanghai-based consultancy. "Nobody expected this." The setback should be a lesson for Chinese drugmakers to strengthen their legal departments, he said... Full

 

Semaglutide Scaling Continues In Canada With Apotex Approval

(5/6, Anabel Costa-Ferreira, Generics Bulletin) ...The authorization given to the generic covers two pre-filled pen formats: a pen delivering 0.25mg or 0.5mg doses (containing 2mg of semaglutide at a 0.68mg/ml concentration) and a 1mg pen (containing 4mg of semaglutide at a 1.34mg/ml concentration)... Global Sub. Full

 

 

Alvotech Q1 2026 Financial Results

(5/6, Alvotech) ...Management anticipates total revenues to be in the range of $650-$700 million and adjusted EBITDA to be in the range of $180-220 million in 2026. The lower end of the revenue range assumes no revenues from new launches into the U.S. market in 2026... Full

 

Roche to Buy PathAI for Up to $1.05 Billion to Bolster AI Diagnostics Tools

(5/7, Adria Calatayud, The Wall Street Journal) ...The Swiss pharmaceutical group said Thursday that the acquisition of U.S.-based PathAI would build on a partnership between the two companies formed in 2021 and take in-house an AI platform that aims to facilitate diagnostic workflows and help accelerate clinical-therapy development. Under the deal, Roche agreed to pay $750 million upfront, with up to $300 million in additional payments subject to targets, it said. The deal is expected to close in the second half of the year... Sub. Req'd

 

Bayer to Buy Perfuse for Up to $2.45B, Bolstering Eye Drug Pipeline

(5/6, Delilah Alvarado, BioPharma Dive) ...The German company said Wednesday it will shell out $300 million upfront for the San Francisco-based biotech, with the bulk of the additional deal payouts only coming if certain unspecified development, regulatory and commercial benchmarks are met. The acquisition will close once approved by Perfuse's stockholders and cleared by antitrust regulators... Full

 

Eli Lilly Sells $9 Billion of Bonds to Fund Acquisitions

(5/7, Brian Smith and Gerson Freitas Jr., Bloomberg) ...Eli Lilly was seeking to raise about $8 billion, Bloomberg News reported earlier Wednesday. "We are encouraged about the interest from investors," a spokesperson said by email, citing last week's credit rating upgrade by S&P Global Ratings and Wednesday's "favorable market backdrop."... Full

 

Lilly Pledges $4.5 Billion More to Indiana Manufacturing Campus

(5/6, Elizabeth S. Eaton, FirstWord PHARMA) ...Wednesday's pledge adds to the initial $2.1 billion that Lilly earmarked for the two sites when they were announced in 2022, bringing the pharma's total commitments to its Indiana-based infrastructure to more than $21 billion since 2020... Full

 

Lilly's Mounjaro Overtakes 'King Keytruda' as World's Top-Selling Drug

(5/6, Annika Inampudi, Bloomberg) ...Mounjaro generated $8.7 billion for Lilly in the first quarter of 2026, outperforming Merck's Keytruda, which posted sales of $7.9 billion. Keytruda has been the world's top-selling drug since the first quarter of 2023, when it displaced AbbVie Inc.'s autoimmune disorder drug Humira... Full

 

Kaiser Permanente Pharmacy Demonstrates Significant Cost Savings

(5/6, Kaiser Permanente) ...Kaiser Permanente commissioned Milliman, a global actuarial and professional services consulting firm, to conduct a study comparing Kaiser Permanente's 2023 prescription drug costs for mid-to-large commercial employer groups in Washington to a matched market benchmark... Full

 

Qatar Airways - Pharma's Flexible Friend

(5/6, Chris Lewis, Freight Business Journal) ...Qatar Airways Cargo has introduced a Pharma Passive FlexTemp solution to manage dual-temperature requirements within shipment journeys... Full

 

 

US-UK Pharma Trade Deal 'Damage Limitation' For UK, Says Former Ambassador

(5/6, Eliza Slawther, Pink Sheet) ...The UK was "very smart" to strike a trade deal with the US that has avoided tariffs of 100% on patented drugs entering the US, according to Lord Kim Darroch..."I think tariffs are here to stay," Darroch commented, although he said that eventually the "pendulum will swing back" and barriers to trade will be removed... Global Sub. Full

 

The Biosimilar Advantage: Powering Patient Access and Industrial Resilience

(5/7, Medicines for Europe) ...Marking the 20th anniversary of the world's first biosimilar launch (somatropin) in Europe, global pharma and healthcare leaders are gathering today for the BIOS26 conference. The message is clear: the EU Biotech Act should foster stronger European resilience to translate proven value into broader access and better outcomes for patients... Full

 

Biosimilar Sustainability Scorecards for Europe 2026

(5/7, IQVIA Institute) ...This report highlights the value of biosimilars and evaluates the structural determinants of biosimilar market sustainability across a diverse set of European countries through a standardized, multi-dimensional assessment framework. It examines sixteen metrics across eight categories-including pricing rules and dynamics, incentives, purchasing mechanisms, dispensing and supply, clinical guidelines and prescribing practices, competitive structure, and healthcare system performance-to identify the policy configurations that support or hinder long-term biosimilar viability... Full

 

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