Wednesday, June 24, 2026

 

 

Teva's Shift Beyond Generics Puts Focus on Branded Drug Growth

(6/23, Kinjel Shah, Zacks) ...Global sales of Austedo, one of the major pillars of Teva's branded business, rose 41% to $578 million in the first quarter, backed by strong prescription growth...Teva expects Austedo annual revenues to be more than $2.5 billion by 2027 and exceed $3 billion by 2030... Full

 

 

Germany Sticks to Plan for Cuts in Drug Prices Despite US Probe

(6/24, Naomi Kresge, Bloomberg) ...Germany signaled it will move ahead with plans to impose lower drug prices on pharmaceutical companies, calling a US accusation of unfair trade practices "unfounded."..."The financial stability of the statutory health-insurance system is currently at risk, requiring urgent action from all stakeholders," the ministry said in a written response to emailed questions. "Only in this way can contribution rates - and, by extension, non-wage labor costs - be stabilized."... Full

 

Eli Lilly and Bayer Hit Out at Germany's Spending on New Medicines

(6/23, Mari Novik, Ian Johnston, Andy Bounds and Aanu Adeoye, Financial Times) ...Patrik Jonsson, president of Eli Lilly's international division, told the FT that Germany was "moving in the wrong direction", even as Trump's push to lower US medicine prices has prompted some European governments, including the UK, to increase spending on innovative drugs...Stefan Oelrich, head of Bayer's pharmaceuticals division, also sympathised with the move by the US administration, saying Americans were paying a "disproportionate price...to finance our research and development investment"... Sub. Req'd

 

US Shoulders Disproportionate Cost of New Medications, Report Finds

(6/23, Edward Lawrence, Fox Business) ...The report, obtained by FOX Business, shows Americans account for nearly 80% of the innovative revenue for drugs launched between 2020 and 2025. The report also shows that no other country comes close to the United States' contribution to shouldering the cost of research and development. The next-closest country paying the cost for R&D in that time frame is Japan, which accounts for about 5.5% of innovative revenues for new medications coming online and roughly 5.8% of innovative revenues for all medications... Full

 

MFN Policy Could Become 'Backdoor' Influence On Medicare Negotiated Prices

(6/23, Cathy Kelly, Pink Sheet) ..."For me the way it could" incorporate MFN reference pricing is "assuming MFN is durable and you start to see drugs launch with MFN prices, then you will start to see therapeutic alternatives [to the negotiated drug] that will have MFN based pricing," [Covington and Burling attorney Victoria Corke] said... Global Sub. Full

 

Trump Tells Pa. Truck Workers 'Fat Drug' Prices Coming Down Next Week: 'That Alone Should Win the Midterms'

(6/23, Steven Nelson and Emily Goodin, New York Post) ..."Starting next week, weight loss drugs will be available for just $50 - think of that‚ for seniors who previously had to pay $1,200,$1,300, $1,400," Trump said in the cavernous facility, mere hours after White House officials denied that Trump was himself taking a new weight-loss drug... Full

 

Republicans Debate Insulin Pricing Cap Ahead of Daunting Midterms

(6/24, Robert King, David Lim, Politico) ...The move is a major shift for a party that's long viewed price controls as anathema to free markets. And it's the latest sign that GOP lawmakers are trying to address affordability issues ahead of the midterms... Full

 

Dems Forecast Health Oversight Agenda Should Party Win House

(6/23, Lauren Brensel, Inside Health Policy) ...In the 105-page report based on 80 interviews with government and public health officials, the Democrats, led by Chair Robert Garcia (CA), said Kennedy and the Trump administration have only increased American's health risks since taking office, while reducing data collection and public health alerts to minimize accountability... Sub. Req'd

 

Trump Administration Eyes White House Aide for Top FDA Post

(6/23, Rachel Cohrs Zhang, Bloomberg) ...White House policy aide Heidi Overton is among the final candidates the Trump administration is considering to lead the Food and Drug Administration, according to people familiar with the matter. No final decision has been made, said the people, who asked not to be identified because the discussions are private. It's unclear whether Overton has the support of Health and Human Services Secretary Robert F. Kennedy Jr., some of the people said... Full

 

HHS and FDA Propose Clinical Trial Reforms to Expedite Drug Development

(6/23, Joanne S. Eglovitch, Regulatory Focus) ...The US [FDA] is seeking comments on a pilot program where qualified external institutions will collaborate with sponsors to develop and review protocols for first-in-human (FIH) clinical trials intended for investigational new drug (IND) submissions to FDA. The agency has also issued a draft guidance to clarify the circumstances under which developers can rely on one rigorous, adequate, and well-controlled clinical trial, along with confirmatory evidence, to support drug approvals... Full

 

Updated US FDA Master Protocols Guidance Includes Specific Communication Plans

(6/23, Derrick Gingery, Pink Sheet) ...Updated master protocol guidance from the US [FDA] makes minor changes on informed consent and other topics, but also includes a detailed plan for communications between the agency and study sponsors... Global Sub. Full

 

The FDA's Industry-Friendly About-Face

(6/24, Caitlin Owens, Axios) ..."The changes appear to be in the right direction but I think it hasn't been long enough to see a trajectory and know whether we can count on consistency," said RA Capital managing partner Peter Kolchinsky... Full

 

DIA: Regulators Tout International Efforts to Set AI Policies

(6/23, Joanne S. Eglovitch, Regulatory Focus) ...Officials from the US [FDA] and the European Medicines Agency (EMA) said that increased international collaboration is influencing the development of policies about artificial intelligence during the Drug Information Association's (DIA) Global Annual Meeting last week... Full

 

Want High-Quality Generic Drugs? One Expert Has Ideas on How Consumers Can Trust Their Supply

(6/23, Ed Silverman, STAT+) ...Kevin Schulman, a professor and deputy director of the Clinical Excellence Research Center at the Stanford University School of Medicine, believes a solution is within reach. Schulman - who has also worked with an independent lab called Valisure that found impurities in some widely used medicines - argues the FDA should encourage testing by independent, accredited laboratories... Sub. Req'd

 

LTC Pharmacies Double Down On Call For PBM Contract Negotiation Reform

(6/23, Lauren Brensel, Inside Health Policy) ...A source close to the issue told Inside Health Policy that, starting July, a group of LTC pharmacies are now considered out-of-network after the PBM Optum Rx canceled its contract mid-term with its Pharmacy Services Administrative Organization, which negotiates on behalf of independent or smaller pharmacies... Sub. Req'd

 

How a $0 Co-Pay Saves Billions

(6/24, Ezekiel J. Emanuel, Miriam J. Paramore, The Washington Post) ...By getting rid of co-pays and the complicated bureaucracy behind prescribing generic drugs, the health system could save billions on administrative costs... Full

 

Drug Patents Are a Financing Mechanism, Not an End in Themselves

(6/23, Tom Krause, Tom Krause) ...Congress should not assume that years of supermonopoly pricing - and successive patents that help preserve it - are necessarily the best way to decide which medicines are developed, which improvements are pursued, or who can afford the resulting treatments... Full

 

Colorado Won Federal Approval for Its Plan to Import Prescription Drugs From Canada. Now Comes the Hard Part.

(6/24, John Ingold, The Colorado Sun) ...Now comes the much tougher task: persuading pharmaceutical manufacturers to work with the program when they could just say no and continue to sell higher-priced drugs to Coloradans and their insurance companies... Full

 

 

Lundbeck Presents New Vyepti® (Eptinezumab) and Bocunebart Migraine Portfolio Data at EAN 2026

(6/24, Lundbeck) ...Eptinezumab data highlight patient-centered measures of migraine prevention Lundbeck will also present new analyses from the Phase III SUNRISE and Phase IV RESOLUTION trials on eptinezumab, exploring treatment outcomes that reflect the wider clinical, functional and psychological burden of migraine... Full

 

Sanofi's Multiple Sclerosis Drug Gets EU Approval

(6/24, Adria Calatayud, The Wall Street Journal) ...Sanofi said Tuesday that the drug, Cenrifki, was approved by the European Commission -- the bloc's executive arm -- for the treatment of secondary progressive MS -- a stage of the disease at which patients' disability steadily worsens -- without relapses in the previous two years... Sub. Req'd

 

 

J&J Widens Golimumab Patent Fight With Alvotech Lawsuit

(6/23, Dean Rudge, Generics Bulletin) ...The case targets both forms of AVT05: a subcutaneous version, AVT05 SC, referencing Simponi; and an intravenous version, AVT05 IV, referencing Simponi Aria. Teva, Alvotech's US commercialization partner, is not named as a defendant, but is referenced in Janssen's requested injunctive relief... Global Sub. Full

 

Sunshine Lake Pharma and Lanexa Biologics Get Their First FDA Biosimilar Approval

(6/23, Stanton Mehr, Biosimilars Review & Report) ...A new, lesser-known manufacturer from China has received its first FDA approval, joining the ranks of insulin glargine competitors in the US. The product, Langlara (insulin glargine-aldy) was approved by the FDA in late April. Langlara is manufactured by Guandong, China-based Sunshine Lake Pharma Co, Ltd (we think-see below)... Full

 

First Patients Treated With Beximco's Generic Version Of Trikafta

(6/23, Urte Fultinaviciute, Generics Bulletin) ...Beximco Pharma has announced that the first doses of its generic version of Vertex's cystic fibrosis drug Trikafta/Kaftrio (elexacaftor/tezacaftor/ivacaftor) have been collected...Triko, the generic drug, is 96% cheaper than the originator drug's US list price and will cost $12,750 per year for adults and $6,375 per year for children. For comparison, Vertex sells a year's supply of Trikafta at around $370,000... Global Sub. Full

 

Adalvo Adds HIV Asset To Expanding Day-One Pipeline

(6/23, Dean Rudge, Generics Bulletin) ...Adalvo has submitted a European decentralized procedure dossier for generic dolutegravir film-coated tablets, extending a recent run of complex generic, off-patent and 'day-one' programs across Europe and international markets. The filing covers 10mg, 25mg and 50mg strengths of dolutegravir, developed as a generic version of ViiV Healthcare's Tivicay... Global Sub. Full

 

 

Eli Lilly Says Trump Pricing Policy Will Affect Obesity Drug Launches in Europe

(6/23, Maggie Fick, Reuters) ...Lilly plans to launch the drug for weight-loss as soon as it gets regulatory approvals but will partner with telehealth companies because most obesity treatment outside the U.S. is paid for directly by patients rather than public health systems, he said... Full

 

Samsung Biologics Establishes European Hub in Netherlands

(6/24, Park Su-hyeon, The Chosun Daily) ...Samsung Biologics CEO John Rim held a briefing for domestic reporters on the 23rd (local time) during his attendance at 'BIO USA' in San Diego, California, stating, "We plan to open an office in the Netherlands in the third quarter of this year," and added, "It will serve as a hub responsible for all European sales."... Full

 

Pharma Giant Roche Seeks Buyer for Former Manufacturing Site in Co Clare

(6/24, RTE) ...Roche is looking to sell its former manufacturing site in Co Clare where it has spent more than €150m in "one of the largest remediation projects of its type in Europe"... Full

 

Lilly Offers Up to $1.9b in New Drug Discovery Deal with Abbisko

(6/24, Elizabeth Cairns, Endpoints News) ...The Shanghai-based company did not say how much of the $1.9 billion would be paid upfront, although Lilly is becoming increasingly secretive about the terms of the deals it cuts. The total value includes upfront and milestone payments, with tiered royalties on top, if any of the discovered compounds gain approval... Sub. Req'd

 

 

Europe Must Rethink Medicine Pricing or Risk Losing Investments, Pharma Lobby Chief Says

(6/23, Maggie Fick, Reuters) ...Stefan Oelrich, president of the European Federation of Pharmaceutical Industries and Associations (EFPIA), said in an interview that the industry faced a new reality as U.S. President Donald Trump's "most-favoured-nation" pricing policy seeks to tie some U.S. medicine prices to those paid in other wealthy countries, including in Europe... Full

 

'It's A Question Of How This New Game Will Be Played' - Adapting To The EU Pharma Package

(6/24, Dave Wallace, Generics Bulletin) ...While the revised EU pharma legislation package has been broadly well-received by the off-patent industry - particularly the clarification around the scope of the Bolar provision - other aspects, such as the new modular approach to innovator exclusivities, may introduce fresh challenges for generics and biosimilars, heard attendees at Medicines for Europe's legal affairs conference in Athens earlier this month... Global Sub. Full

 

EU's Off-Patent Medicines Industry Calls for Industrial Strategy at Athens Summit

(6/24, Brian Maguire, Euractiv) ...Europe must decide whether it wants to remain a pharmaceutical producer or become increasingly dependent on imports, political leaders and industry representatives warned at the recent Medicines for Europe Annual Conference in Athens, as discussions on strategic autonomy, supply security and industrial competitiveness have moved to the centre of the EU health agenda... Full

 

US Cancer Drug Supply Reinforces Role of Indian Drugmakers, Say Industry Insiders

(6/24, PT Jyothi Datta, The Hindu businessline) ...The latest request for a cancer drug from Indian drugmakers by the United States [FDA] points to the reliability of domestic companies in supplying affordable medicine, say industry insiders, at a time when governments across the world are caught up in talks involving trade, tariffs and wars in different parts of the world... Full

 

China's Biotech Surge Sparks US Security Concerns as Drug Trials Break Records in 2025

(6/24, Julie Zhang, South China Morning Post) ...The total number of clinical drug trials reached 5,215 in 2025, more than double the figure recorded in 2020, according to a report released by the National Medical Products Administration on Monday. Of those, 57.5 per cent were trials for new drugs, an 18 per cent year-on-year increase, while the remainder were bioequivalence studies, which test whether a generic drug performs identically to its branded counterpart in the body... Full

 

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