Friday, February 20, 2026

Teva Beats Corcept in Appeals Fight Over Generic Cushing's Syndrome Drug

(2/19, Alexis Kramer, Endpoints News) ...Teva scored a win after a federal appeals court held that its generic Cushing’s syndrome drug doesn’t infringe Corcept Therapeutics’ patents. The US Court of Appeals for the Federal Circuit said Thursday there was “no clear error” in the lower court’s ruling, which found Corcept failed to prove direct or induced infringement... Sub. Req’d

Corcept Loses Patent-Infringement Appeal Against Teva

(2/19, Katherine Hamilton, Dow Jones Newswires) ...The ruling from the U.S. Court of Appeals for the Federal Circuit upheld a previous finding against Corcept's claims that Teva was infringing on its patent for the drug Korlym... Full

Corcept Loses Patent Appeal Against Teva over Generic Korlym

(2/19, StreetInsider.com) ..."We are disappointed in the Court's ruling," said Joseph K. Belanoff, Corcept's Chief Executive Officer. "The patents we asserted in this case cover methods of safely treating patients with Cushing's syndrome that physicians rely on every day. We will vigorously defend our rights and are currently considering the best way to pursue judicial review of this decision."... Full

Trump Says Tariffs Pushed Novartis to Expand Operations in US

(2/20, Fabienne Kinzelmann, Bloomberg) ...Speaking to workers at a steel plant in Rome, Georgia, on Thursday, Trump said [Vas] Narasimhan told him the company was building new US plants as a result of the president's tariff policies. "We appreciate the opportunity to update the US government on our progress, including recent groundbreakings for manufacturing and research facilities in North Carolina and California and plans to expand our radioligand therapy manufacturing network with a new site in Florida," a spokesperson for Novartis said in an emailed statement. The statement didn't include any figures... Sub. Req’d

Health Advocates Demand US Trade Policy Prioritize Global Affordability Over Aggression

(2/19, Gabrielle Wanneh, Inside Health Policy) ..."Trump's tariff threats lead only to worsening medicine scarcity and rationing. His dishonest alliance with Big Pharma to raise medicine prices abroad risks peoples' lives while distracting from the real change and pharma accountability we need in the United States to make medicine affordable. Instead of raising costs and making threats, governments should be investing to expand medicine production everywhere, and learning from each other's best practices to lower prices at home," Public Citizen Access to Medicines Director Peter Maybarduk said in a statement... Sub. Req’d

The Eliquis Paradox: US Price Caps Trigger Double-Digit Growth

(2/19, Michael McCaughan, Pink Sheet) ...Eliquis is set for strong growth despite a 56% price cut in Medicare. The poster child for the negotiation program may instead be the poster child for the value manufacturers can find by resetting list-to-net pricing differences... Global Sub. Full

CMS Broadens Drug Price Negotiations to Part B Therapies

(2/19, Nicholas Saraceno, Pharmaceutical Commerce) ...In the first part of his Pharma Commerce video interview, John Stanford, Incubate's executive director, explains how third round of CMS drug selections brings physician-administered medicines under price controls for the first time, intensifying debate over provider reimbursement and investment in small-molecule therapies... Full

Success of TrumpRx, Other Discount Drug Websites, Depends on Consumer "Homework"

(2/19, Logan Lutton, Managed Healthcare Executive) ...In this video interview, Joseph Kleiman, president of Buzz Health, says that patients should always "do their homework" to see if they are paying the lowest possible price for their prescription, whether that's through TrumpRx or another website..."I can't really say I'd change anything at this point, except for maybe adding more drugs," Kleiman said... Full

End Of US FDA's ‘Two-Trial Dogma' Places Faith In Modern Science Of Evidence

(2/19, Bridget Silverman, Pink Sheet) ...The FDA's history of regulatory flexibility suggests that applications based on one trial often receive complete response letters calling for a second trial, a scenario repeated multiple times in the past year...While embracing the shift toward flexibility, the FDA still will require two studies when mechanisms, endpoints, or trial designs raise uncertainty about a therapy's true effect... Global Sub. Full

In First Speech to her FDA Staff, Høeg Says She'll Scrutinize RSV Shots and SSRIs in Pregnancy

(2/20, Lizzy Lawrence, STAT) ..."I've been interested to learn we really haven't been doing sort of thorough safety monitoring of these products during pregnancy, and so I think we could do a better job," Høeg said. "I actually think that there's agreement about that, and among the CDER staff that I've been working with on this issue, so I'm excited to see that."... Full

Generic Industry Against Giving Fee Breaks to Firms Setting Up Operations in the US

(2/19, Joanne S. Eglovitch, Regulatory Focus) ...[A]ccording to the January 21 meeting minutes, "Industry indicated that they support incentivizing onshoring of generic drug and API manufacturing but that they believe this proposal would not be an effective incentive because, among other things, it could result in increased fees for existing U.S. facilities in order to make up for the lost revenue, thereby potentially undermining existing domestic manufacturing operations."... Full

Chairman Rick Scott Sends Letter to Secretary Hegseth on Securing Generic Drug Supply for Service Members and Veterans

(2/19, United States Senate Special Committee on Aging) ...Chairman Rick Scott and Ranking Member Kirsten Gillibrand sent a letter to Department of War Secretary Pete Hegseth requesting information on efforts to identify and address vulnerabilities in America's pharmaceutical supply chain that may threaten military readiness and national security. The senators expressed concern over the United States' heavy reliance on foreign sources, particularly those from Communist China and India, for key starting materials, active pharmaceutical ingredients, and generic drugs essential to supporting our service members and veterans... Full

No Hassle, Hidden Markups or Fees: AmericasMedicines.com

(2/19, PhRMA Blog) ...Too often, middlemen and insurers drive up costs and restrict access to medicines. To alleviate the pain of rising out-of-pocket costs and the growing burden of complex insurance requirements, direct purchase programs create clear, affordable pathways to care, helping patients overcome these barriers... Full

Virginia Lawmakers Push Bipartisan Legislation to Lower Prescription Drug Costs

(2/19, Cameron Thompson, WTVR) ...A bipartisan group of Virginia lawmakers is advancing legislation through this year's General Assembly aimed at reducing prescription drug prices by targeting pharmacy benefit managers (PBMs)..."It bans the practice of PBMs, requiring patients to use only specific pharmacies. It requires disclosures of fees and costs to patients, and it mandates pass through rebates to us," said Del. Katrina Callsen (D-Albemarle)... Full

Eli Lilly Announces Positive Results for Treating Crohn's Disease with Omvoh

(2/19, Mike Hollan, PharmExec.com) ...Eli Lilly executive vice president and president of Lilly Immunology Adrienne Brown said, "Too many people with inflammatory bowel disease never achieve lasting remission, leaving them vulnerable to cumulative damage from poorly controlled inflammation that can result in emergency hospitalizations or surgery. Omvoh is redefining what durable disease control can look like, with long-term data showing patients treated with Omvoh stayed in remission and experienced fewer serious complications over three years, underscoring its potential to alter the course of the disease."... Full

AbbVie Wins FDA Approval for Venclexta-Acalabrutinib Combo in First-Line Chronic Lymphocytic l

Leukemia

(2/20, Arundhati Sarkar, Seeking Alpha) ...This milestone updates the treatment of CLL in the first-line setting, establishing the Venclexta and acalabrutinib combination as the first and only all-oral, fixed-duration regimen for previously untreated patients, the company said... Full

Merck to Seek 2nd-Season RSV Nod for Enflonsia in Hot Pursuit of Sanofi, AZ's Beyfortus

(2/19, Fraiser Kansteiner, Fierce Pharma) ...In new results from the late-stage Smart trial—which helped win Enflonsia its initial green light based on interim data last June—Merck's immunizing antibody appeared safe in kids under 2 years old who remained at risk for severe RSV through their second RSV season and who received Enflonsia at the start of that second season, Merck said in a Feb. 19 release... Full

Sumitomo Pharma Shares Plunge Nearly 16% Despite Greenlight for Parkinson's Treatment

(2/19, Lee Ying Shan, CNBC) ..."While the treatment could potentially see widespread use and become a blockbuster in Japan and the US over the long term, we expect almost no profit contribution near term," said Citigroup Global Markets Japan's analyst Hidemaru Yamaguchi. Sumitomo's stock has been overheated, and recent gains have been "excessive," he added... Full

J&J Pauses Patient Recruitment in Mid-Stage Trial of AC Immune's Alzheimer's Drug

(2/20, Elizabeth Cairns, Endpoints News) ...The asset is an anti-pTau therapeutic vaccine known as ACI-35.030, or JNJ-2056. Patient sign-up in the mid-stage study was temporarily halted to allow J&J to assess aspects of the trial, including recruitment, a Tuesday SEC filing shows. The trial itself continues. The pause was not related to new safety findings, and the trial's prespecified interim immunogenicity threshold was met, AC Immune said... Sub. Req’d

Roche to End Manufacturing of Key Antibiotic Amid EU's Generic Woes

(2/19, Emma Pirnay, Euractiv) ...Roche said it is seeking a buyer for one of its key antibiotics and plans to shut down local manufacturing operations by 2030, according to local media. The company's site manager, Jürg Erismann, told AWP Financial News on Wednesday that the decision to end production of Rocephin in Kaiseraugst reflects rising manufacturing costs, falling prices and intensifying generic competition... Full

Latest FDA Biosimilar Nod Pushes Accord Towards 2030 Target

(2/19, Dave Wallace, Generics Bulletin) ...Accord said it was "rapidly expanding its US portfolio with a strategic goal to launch 20 biosimilar products by 2030, solidifying its position as a reliable partner delivering more affordable, high-quality biologic alternatives." This would include both in-house and partnered assets, the firm indicated, spelling out that "in addition to developing and marketing their own biosimilar products, the company is strategically collaborating with select partners around the world to bring more biosimilars to the US market as swiftly as possible."... Global Sub. Full

Can Outlook Break The Cycle With Fresh FDA Meeting On Ophthalmic Bevacizumab?

(2/19, Dave Wallace, Generics Bulletin) ..."Unexpected" and "inconsistent" are two of the labels that Outlook Therapeutics has applied to its latest complete response letter from the US [FDA] over its Lytenava ophthalmic formulation of bevacizumab. However, despite having received multiple CRL knockbacks from the FDA for Lytenava - also known as ONS-5010 - the company says it remains committed to bringing the product to the US market, and has submitted a Type A meeting request to the agency to attempt to resolve the issues around its biologics license application... Global Sub. Full

Biocon Biologics Sees Strong FY27 as New Biosimilars Gain Traction

(2/20, CNBC-TV18) ...Biocon Biologics expects the upcoming 12 months to be far more exciting than the recent past, led by a series of new biosimilar launches, including Aspart, Aflibercept and Denosumab. Shreehas Tambe, Managing Director and Chief Executive Officer, Biocon Biologics, said the financial impact of these recently launched products will begin to reflect significantly in the company's full-year numbers for fiscal year 2027... Full

Novartis to Exit Indian Unit With $159 Million Stake Sale

(2/19, Akriti Sharma, Bloomberg) ...Novartis AG has agreed to sell a majority stake in its listed Indian unit, marking the culmination of a strategic review announced two years ago. The Swiss drugmaker will sell its 70.68% stake in Novartis India Ltd. to a consortium of WaveRise Investments, ChrysCapital Fund X and Two Infinity Partners for 14.46 billion rupees ($159 million), according to a statement to the exchanges... Sub. Req'd

Obesity Biotech Verdiva Gears Up for a Big Year of Data - And Maybe Deals Too

(2/19, Elizabeth Cairns, Endpoints News) ...If Verdiva's candidate can show comparable weight loss to Novo's marketed pill and Eli Lilly's imminent oral competitor orforglipron, the less frequent administration could allow it to compete effectively, Farooq said. "My own personal view is that similar weight loss is sufficient," he said. "The differentiation around weekly is very significant, and I also do believe that if we can develop a good profile around tolerability and safety, I think that serves physicians and patients extremely well."... Sub. Req'd

Switzerland Mulls Discounts on Top-Selling Drugs to Cut Health Costs

(2/19, Swissinfo.ch) ...The Swiss parliament is considering limiting the steady rise of healthcare costs by granting discounts on best-selling medicines in the country. The government is now submitting this measure to a consultation process... Full

Jay Goldberg: Canada Must Deal With Trump's Plan to Cap U.S. Drug Prices

(2/19, Jay Goldberg, Toronto Sun) ...Canadian patients already wait an average of 450 more days than Americans to get access to new drugs, because of slower submissions and approvals. If there is less innovation in the U.S. because of Trump's MFN pricing rules, fewer drugs will be developed, and the wait times for Canadians to access new drugs will only worsen. Some drugs might not even become available to the Canadian market at all. It's also likely that prices in Canada will rise. If Canada becomes a reference point for the U.S. in MFN benchmarks, pharmaceutical companies could hike prices here in Canada to help protect U.S. revenues... Full

Health Ministry Postpones Generic Drug Price Reduction Plan

2/20, Park Su-hyeon, The Chosun Daily) ...The Ministry of Health and Welfare decided not to submit a pharmaceutical pricing system improvement plan, including generic (generic drugs) price reductions, to the subcommittee of the Health Insurance Policy Deliberation Committee scheduled for the 20th. This effectively halts the previously announced timeline for a "July implementation."... Full

Drugmakers May Face Muted US Mkt Growth

(2/20, Sanket Koul, Business Standard) ...Firms such as Dr Reddy's, Cipla and Sun Pharma have reported a muted growth in the US market due to expiry of gRevlimid's patent in January 2026, increased market competition and volume-restricted settlements... Full

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