Friday, October 10, 2025

Teva Price Target Raised to $24 from $22 at BofA

(10/9, The Fly) ...BofA raised the firm's price target on Teva to $24 from $22 and keeps a Buy rating on the shares. Based on Q3 pricing and volume trends for key drugs as well as relevant company commentary, the firm previewed Q3 EPS updates for its commercial-stage biopharma coverage, telling investors that it does not expect any major Q3 beats/misses and no big 2026 revisions among the group... Full

Exclusive: US Pharmacies, Drug Discounters Are Discussing TrumpRx Role With Administration

(10/10, Deena Beasley, Reuters) ...Retail pharmacies and prescription drug savings site GoodRx (GDRX.O) are talking with the Trump administration about joining its TrumpRx website, they told Reuters, suggesting an expansion beyond the early description of it as a link to pharmaceutical companies' direct discounts...The National Community Pharmacists Association and the National Association of Chain Drug Stores, which represent companies like Walgreens and Costco, said they were also talking with administration officials. "As long as drugmakers deliver cost savings for American patients through TrumpRx, how they do so is irrelevant," White House spokesman Kush Desai said in a statement... Full

Editorial: Pfizer's Deal On Drug Prices Gets Closer to the Right Idea

(10/10, Bloomberg) ...American taxpayers spend billions of dollars annually supporting pharmaceutical development. Yet the US continues to pay more for medicine than any other country in the world. This discrepancy so disturbed the president that top health officials say he routinely called them on nights and weekends, urging a solution... Sub. Req’d

Senate Aging Chair Seeks Immediate Tariffs On Generics, Experts Float Compromises

(10/9, Jessica Karins, Inside Health Policy) ...Senate Aging Committee Chair Rick Scott (R-FL) is pressing the Trump administration to immediately impose tariffs on what he says are poor-quality and unsafe imported generic drugs, but Democrats and a pharmaceutical expert at a hearing Wednesday (Oct. 8) called for a stepwise-approach they said would ensure quality while also avoiding drug shortages... Sub. Req’d

CPA Economist Leads Rare Bipartisan Push to Fix America's Generic Drug Crisis

(10/9, Kenneth Rapoza, CPA) ...Wednesday's Senate Special Committee on Aging hearing smashed the Washington stereotype of a hotly divided government. There was not a single member of the committee that blamed the other side for America's generic drug crisis, and everyone agreed on at least some key measures required to reshore a sector of the pharma business that is almost entirely dominated by imports. CPA Economist Andrew Rechenberg gave his testimony and answered questions in a four- panelist hearing. It was arguably the most agreeable hearing in years. A bipartisan consensus on America's generic drug supply chain is nearly fully formed now... Full

Tuberville Discusses National Security Importance of Producing Pharmaceuticals in the U.S.

(10/9, U.S. Senator Tommy Tuberville) ...Yesterday, U.S. Senator Tommy Tuberville (R-AL) spoke with Andrew Rechenberg, Economist at Coalition for a Prosperous America, and Tony Paquin, President and Chief Executive Officer at iRemedy Healthcare, Inc., during a Senate Special Committee on Aging hearing. They discussed the importance of bringing pharmaceutical manufacturing back to the United States... Full

Three Things to Know About Bayh-Dole: Innovation That Pays Off for Taxpayers

(10/9, Andrew Powaleny, PhRMA) ...The Bayh-Dole Act has proven to be one of the most successful pieces of innovation policy in American history. Policymakers should remember that Bayh-Dole is not just about patents and licenses—it is about jobs and the inventions people depend on. Preserving this landmark law is essential to keeping America at the forefront of global innovation... Full

Americans Should Copy Italians' Recipes, Not Our Healthcare System

(10/9, Pietro Paganini, Real Clear Health) ...The damage to American citizens would be twofold. On the one hand, slower and less personalized care. On the other, fewer skilled workers and fewer investments: the pharmaceutical sector employs millions of people, funds university research, and supports the local economy in many states. Stifling innovation also means increasing dependence on China for both drug production and development. That's hardly in keeping with President Trump's America First rhetoric. But the real mistake is strategic: America would be giving up what makes it different: speed, innovation, and freedom of choice in medical treatment. Copying Europe on pharmaceutical policy wouldn't strengthen America: it'd profoundly weaken it and allow China to become the world's biotech leader. America cannot afford to become Europe. And Europe can no longer afford to stay as it is... Full

Pharma R&D Set to Endure Despite Rising MFN Costs

(10/10, Abigail Beaney, Clinical Trails Arena) ...[Ambassador Jeffrey Gerrish, deputy US Trade Representative for Asia, Europe, the Middle East] "If there are stronger actions taken by the administration to get other countries to pay their fair share of R&D, it's going to spread out, potentially providing even more funding. I think it could turbocharge investments into R&D. That's a benefit of working with other countries to get them to pay more and to really pay their fair share." Gerrish states that companies, including Eli Lilly, BMS and AbbVie, are already speaking with other nations, such as the UK, about matching their drug prices to the US list price, explaining the importance of this in funding R&D. This will be no easy feat, with Gerrish noting that the US Government may need to negotiate with countries alongside pharma companies to ensure governments align on how they can balance the books... Full

Biogenerics After All? US FDA Wants Biosimilar Process To Mirror Generics

(10/9, Ramsey Baghdadi, Pink Sheet) ...US FDA will take a "streamlined" approach to biosimilar assessment, thanks to a "analytical revolution" that "brings biosimilars very, very close to generic drugs," CDER Director Tidmarsh said. Timelines for a revised pathway are unclear, but one already-pending guidance could make meaning changes. An "all-interchangeable" biosimilars approach has garnered support as part of the Trump Administration's larger drug pricing and competition agenda... Global Sub. Full

Some Missouri and Kansas Pharmacists Join Effort to Get Drug Prices Under Control

(10/9, Suzanne King, Kansas City) ...As health insurance premiums are expected to climb 9% for commercial plans next year, there are growing calls for state and federal lawmakers to rein in the complicated drug supply chain. Independent pharmacists are leading the push for the Kansas and Missouri legislatures to regulate pharmacy benefit managers, the middlemen that pharmacists claim are squeezing their profits and driving them out of business. But the $650 billion prescription drug business will likely need other reforms as well, some experts said... Full

Xspray Must Wait For CMO Fix Before FDA Greenlights Dasatinib Hybrid

(10/10, Dean Rudge, Generics Bulletin) ...Xspray Pharma has received a second FDA complete response letter for its 505(b)(2) dasatinib tablet, Dasynoc, after manufacturing observations at a contract facility delayed approval despite no issues with the drug's data package...The contract manufacturer has initiated a remediation plan, and a meeting with the FDA is scheduled for December. Xspray aims to resubmit its application after correcting these issues while continuing to develop other candidates... Global Sub. Full

Celltrion Launches A Third Tocilizumab Biosimilar To Actemra In US

(10/9, Dave Wallace, Generics Bulletin) ...Celltrion has become the third company to launch a biosimilar rival to Actemra (tocilizumab) in the US, introducing an intravenous formulation of its Avtozma (tocilizumab-anoh) version...However, being third to market may not disadvantage Celltrion too severely. Roche late last year indicated that biosimilar rivals to Actemra had been slow to gain a foothold in the US market, with launches "slower than expected," and biosimilar penetration "still weak" as of the third quarter... Global Sub. Full

Celltrion Wins FDA Nod for Eylea Biosimilar

(10/10, Kim Ji-hye, Korea Biomedical Review) ...Celltrion said Friday that the U.S. FDA approved Eydenzelt (CT-P42), an ophthalmology biosimilar to Regeneron's Eylea (aflibercept). The decision covers both vial and prefilled-syringe versions...With Eydenzelt (aflibercept), Celltrion's U.S. lineup now includes 11 biologics, among them the autoimmune therapy Avtozma (adalimumab), bone-disease biosimilar Stoboclo-Osenvelt (denosumab), and allergy treatment Omlyclo (omalizumab)... Full

NATCO Wins Legal Battle to Launch Generic Drug Treating Severe Muscle Disorder in Infants

(10/9, Megha Rani, CNBC TV-18) ...NATCO Pharma Ltd has been cleared by the Delhi High Court to launch its generic version of Risdiplam, a critical treatment for a rare genetic disorder that causes severe muscle weakness and is a leading cause of infant death. The court dismissed Swiss pharmaceutical giant Roche's appeal on Thursday, October 9, removing the legal hurdle for NATCO to make the drug available in India... Full

AstraZeneca Breaks Ground at $4.5 Billion Virginia Plant as Drugmakers Court Trump

(10/9, Maggie Fick, Reuters) ...AstraZeneca broke ground on a new plant in Virginia on Thursday and said it would spend $4.5 billion on the facility as drugmakers look to respond to President Donald Trump's call for more medicines to be made in the U.S. and at lower costs. The site in Albemarle County, about 120 miles (193 km) southwest of Washington, will be the Anglo-Swedish company's largest manufacturing facility worldwide... Full

Ypsomed Spends $248M to Gain its First US Manufacturing Site 

(10/10, Anna Brown, Endpoints News) ...The Swiss company Ypsomed is buying a 15,000-square-meter factory in Holly Springs, NC, as President Donald Trump continues to pressure drugmakers to move manufacturing to the US...The facility is expected to be operational by the end of 2027 and will supply products solely for the US market...Ypsomed packages GLP-1 drugs for companies, including Novo Nordisk, and has been working to narrow its business to injectables. Earlier this year, Ypsomed divested its diabetes care business, which consisted of devices like insulin pumps, for up to CHF 420 million ($508 million) to focus on self-injected products... Sub. Req’d

Novo CEO Says Risk-Taking, Deals Are Needed to Win Obesity Race

(10/9, Naomi Kresge, Bloomberg) ...Novo Nordisk A/S needs to be ready to take calculated risks on deals in order to win, Chief Executive Officer Mike Doustdar said, sketching out the Ozempic maker's strategy as it seeks to regain lost ground in the increasingly competitive obesity market..."We should not have a ‘not invented here' syndrome, and be quite open to other people's science," Doustdar said in an interview. "You need to be able to have an eye on who else is out there, who has possibly invented something above and beyond what we could do."... Sub. Req’d

Samsung Biologics Secures Half of Japan's Top 10 Pharmas as Clients

(10/10, Wang Hae-na and Minu Kim, Pulse) ...Samsung Biologics Co. is accelerating its expansion in Japan, the world's third-largest pharmaceutical market. The South Korean company has signed contracts with half of Japan's top 10 pharmaceutical and biotech companies, rapidly strengthening its presence in the region. "We have signed contracts with four of Japan's top 10 pharma companies and are in final talks with one more," said Samsung Biologics CEO John Rim at BioJapan 2025 held in Yokohama on Thursday... Full

Regulatory, Policy Disruptions Are Causing Consternation Among Biopharma Leaders: Report

(10/8, Fraiser Kansteiner, Fierce Pharma) ...On the occasion of life sciences supplier and partner Cytiva's third global biopharma index, many of the more than 1,200 executives surveyed concurred that uncertain government policy and inconsistent regulatory approaches—both in the U.S. and abroad—are creating significant obstacles for the industry. Effective policy and regulation are key to the biopharma industry's success, setting the "rules of engagement" for investment, innovation and market access, Cytiva noted in the index, which it released Monday. But among the 1,250 industry executives Cytiva surveyed, many are grappling with "fragmented, unpredictable policy environments," even in markets that have traditionally remained stable, according to the report... Full

UMich Deepens Pharma Partnerships Amid AstraZeneca Lawsuit

(10/9, Anjali Budhram and Emma Spring, The Michigan Daily) ...As pharmaceutical companies face increased national scrutiny over transparency and corporate oversight, universities partnered with the industry are paying closer attention to how research is funded and commercialized. The University of Michigan has expanded its work with pharmaceutical companies in recent years, even as it currently pursues legal action against AstraZeneca for allegedly commercializing University-developed research without a finalized agreement...In an interview with The Daily, Peter Toogood, research associate professor of medicinal chemistry and director of Michigan Drug Discovery, said the University's work with industry is long-term and foundational... Full

A Telehealth Startup Had a Plan for ADHD Drugs. Now Two Executives Face a Criminal Trial

(10/10, Jenna Greene, Reuters) ...The founder and the top doctor of self-proclaimed "digital health company" Done are currently on trial in San Francisco federal court for running an alleged $100 million pill mill prescribing Adderall and other stimulants to treat ADHD...Prosecutors allege the "vast majority" of Done patients got a stimulant prescription after completing a few online screening questions plus a 30-minute telehealth appointment with one of the company's network of practitioners. The medication could then allegedly be automatically refilled without follow-up visits, provided the patient paid Done a monthly subscription fee of $79... Full

UK Confirms ‘Landmark' Partnership With US Amid Drug Pricing Increase Rumors

(10/9, Eliza Slawther, Pink Sheet) ...A government spokesperson declined to comment specifically on plans to increase the thresholds, but told the Pink Sheet: "We've secured a landmark economic partnership with the US that includes working together on pharmaceutical exports from the UK whilst improving conditions for pharmaceutical companies here."... Global Sub. Full

EU Pharma Package: ‘Give Patients Top EMA Committee Voting Rights'

(10/9, Francesca Bruce, Pink Sheet) ...Revamped EU pharmaceutical legislation is an opportunity to secure the appropriate involvement of patients in regulatory decision making, according to patient advocates. The European Commission proposed that new legislation would give patients the right to vote on a key European Medicines Agency committee, the CHMP. However, the Council of the EU has removed patient voting rights in its version of a new regulation. The European Medicines Agency says it is committed to involving patients in its decision making... Global Sub. Full

New Zealand's Pharma Growth Complements Ongoing FTA Negotiations with India to Boost Pharma Trade

(10/10, Shardul Nautiyal, Pharmabiz.com) ..New Zealand's pharma growth, which is complemented with the ongoing free trade agreement (FTA) negotiations with India, will boost pharma trade in the near future, according to trade experts. Following the third round of FTA talks concluding in September, 2025, both sides have identified pharmaceuticals as a priority sector for collaboration. A major area for cooperation involves speeding up regulatory processes and assessing the quality of manufacturing facilities. This would make it easier for Indian generic drugs to enter the New Zealand market... Full

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