Friday, February 13, 2026

Please note: Teva Daily News will observe the U.S. Presidents' day holiday and resume publication on Tuesday, February 17.

Teva And GSK Settle Skinny-Label Dispute

(2/13, Dave Wallace, Generics Bulletin) ...A Delaware district court filing indicates that the pair have "resolved their disputes" and entered into a confidential settlement to bring the litigation to an end...[A] GSK spokesperson told Generics Bulletin that "GSK can confirm that a settlement has been reached to the satisfaction of the parties."... Global Sub. Full

AbbVie Mounts Fresh IRA Legal Challenge Over Botox's Inclusion in Latest Drug Pricing Negotiations List

(2/12, Zoey Becker, Fierce Pharma) ...While AbbVie's lawsuit contends that the CMS pricing negotiations mandated for Botox step on the company's constitutional rights—a common thread woven into much of the industry's legal complaints about the program—the Illinois-based drugmaker also takes a unique position that specifically relates to the formulation of its offering... Full

More Than 50 Conservative Leaders Sign Letter Against Trump Drug Pricing Policy Codification

(2/12, Emily Brooks, The Hill) ...The letter, which argues an MFN pricing law would "import socialist price controls and values into our country," highlights the growing tension between Trump and a portion of the conservative movement. "In addition to doing nothing to address foreign freeloading, MFN would reduce access to new cures and reduce U.S. global competitiveness, ceding ground to China," the leaders wrote... Full

New Report From Democrats: ‘TrumpRx' Drugs Could Cost Thousands More Than Generics

(2/13, Kevin Frey, MS NOW) ...In a new report shared first with MS NOW, Democrats on the Joint Economic Committee analyzed the prices of 15 common medications, comparing the discounted prices on the TrumpRx website to the cost of generics purchased using a GoodRx coupon... Full

Lowering Drug Costs Is on Republicans' Minds. Democrats Say GOP Policies Don't Help.

(2/12, Emily Olsen, Healthcare Dive) ...Meanwhile, one of the administration's latest efforts to bring down the cost of drugs, TrumpRx, likely won't help much, Democrats say. The online portal allows consumers to buy around 40 drugs directly from manufacturers that reached pricing deals with the White House. However, many of the included medications are already heavily rebated or wouldn't be more affordable than accessing them through insurance... Full

Cassidy Bill Seeks to Ban a Customs Loophole on Pharma's Radar

(2/12, Anna Brown, Endpoints News) ...The measure by Sen. Bill Cassidy (R-LA) seeks to stop use of a little-known trade principle called the "first sale rule." That rule allows companies to reduce the value of a product declared at US customs, substantially lowering the tariff duty they would have to pay. The bipartisan bill would ensure importers pay duties based on the actual commercial value of the imported product, according to a Wednesday press release... Sub. Req’d

They Said It! Lawmakers and Experts Call Out Big Pharma's Anti-Competitive Playbook, Urge Congress to Boost Generic and Biosimilar Competition

(2/12, CSRxP) ...Ranking Member Diana DeGette (D-CO) expressed frustration with PhRMA's lack of meaningful answers to how the pharmaceutical industry was trying to deliver lower prescription drug prices for American patients... Full

New HHS Petition Calls on the Trump Administration to Authorize Affordable Generic GLP-1 Drugs for Americans

(2/12, Public Citizen) ...Today, Public Citizen filed a petition requesting that the United States Department of Health and Human Services (HHS) authorize generic competition for Novo Nordisk's semaglutide and Eli Lilly's tirzepatide, overcoming the drugmakers' patent barriers to improve access to expensive GLP-1s for weight loss, type 2 diabetes, and other conditions... Full

White House Pushes Shake-Up at HHS Ahead of Midterms

(2/12, Liz Essley Whyte, The Wall Street Journal) ...Kennedy and White House officials tapped Chris Klomp, the head of Medicare and a former healthcare executive, to lead the department as its No. 2 under Kennedy, administration officials said. Klomp will have responsibility for operations and messaging, and he will be aided by at least three other agency lieutenants to take senior counselor roles under him, the officials said... Sub. Req’d

FDA Issues REMS Guidance for Hypocalcemia Risk Associated With 2 Denosumab Biosimilars

(2/12, Ashling Wahner, Onc Live) ...The REMS updates for both biosimilars emphasize the increased risk for severe hypocalcemia following administration in patients with advanced chronic kidney disease, defined as those with estimated glomerular filtration rate levels below 30 mL/min/1.73 m2, including patients dependent on dialysis. The updates note that cases of severe hypocalcemia resulting in life-threatening events, hospitalization, and death have been reported... Full

Study: Price, Therapeutic Value Impact International Submission Times for New Drugs

(2/11, Jeff Craven, Regulatory Focus) ...The US tends to receive regulatory submissions earlier and more often than other major international regulators, but there was a similar rate of submissions across regulators for oncology drugs and those deemed by authorities of having moderate-to-high therapeutic value, according to recent research published in Health Affairs... Full

A Bill to Create a Prescription Drug Affordability Board Is Again Advancing in The Va. Legislature

(2/13, Charlotte Rene Woods, Virginia Mercury) ...Now often referred to by lawmakers and advocates as the "Affordable Medicine Act" — a clearcut sign of its goals — House Bill 483 sponsor Del. Karrie Delaney, D-Fairfax, told her colleagues Thursday that she is "continuing to work with stakeholders and the administration" to refine the bill... Full

Lundbeck Preps Phase 3 for Migraine Prevention Drug

(2/13, Phil Taylor, pharmaphorum) ...Results from the phase 2b PROCEED trial of intravenous bocunebart (also known as Lu AG09222) showed that the drug was able to cut the number of monthly migraine days (MMD) compared to placebo, with a dose-response relationship, in a group of patients who had failed earlier treatments...Lundbeck hasn't revealed the data behind its update, but said it was sufficiently encouraged to seek discussions with regulators about the design of a phase 3 programme that could support regulatory filings for bocunebart as a potential first-in-class option for migraine prevention... Full

MedImpact Offers Low-Cost Humira Biosimilar

(2/12, Sandra Levy, Drug Store News) ...MedImpact Holding is launching an unbranded biosimilar to Humira (adalimumab) priced at 95% below the brand-name cost. MedImpact is offering this biosimilar (Adalumymab-ryvk), manufactured by Anda, an affiliate of Teva Pharmaceuticals USA... Full

As US Relies on Foreign-Made Generics, One Factory Stands Apart

(2/12, Lisa Fletcher, Andrea Nejman, Bill Castle, Nathan Aaron, Spotlight on America) ...At Oxford Pharmaceuticals in Birmingham, Alabama, pills move down production lines in a process that has become increasingly uncommon in the United States... Full

STADA and Bio-Thera Receive European Marketing Authorization for Gotenfia, a Biosimilar to Simponi

(2/13, Bio-Thera Solutions) ...STADA and Bio-Thera Solutions...have received a marketing authorization from the European Commission[1] for their Gotenfia® (golimumab) biosimilar referencing Simponi®... Full

Samsung Bioepis Secures US Launch Date For Eylea Biosimilar – Though Later Than Others

(2/12, Urte Fultinaviciute, Generics Bulletin) ...The Korean firm announced a settlement and license agreement with the originator Regeneron, enabling the launch of Opuviz (aflibercept-yszy) in the US from January 2027, adding that other terms of the agreement remain confidential... Global Sub. Full

Prices, Pipelines and Patent Cliffs: Inside Pharma's Big Reset

(2/13, Elsa Ohlen, CNBC) ..."2025 was about understanding kind of the rules of the future of the game… what's still to be seen in [2026] is how those companies actually implement what they agreed to, particularly in the deals that you saw with the Trump administration," McKinsey Senior Partner Greg Graves told CNBC...While drugmakers are always to some extent touting their pipelines, they're now putting them even more on display as they seek to reassure investors that their pipeline holds enough promise to offset upcoming patent expiries. "With the scale of the patent losses that are coming up over the next few years, you probably are hearing a bigger focus on the optimism for the future, as opposed to near-term delivery," Graves said... Full

Sanofi's New CEO Belén Garijo Gets Frosty Reception as Dupixent Challenge Awaits

(2/12, Ayisha Sharma and Elizabeth Cairns, Endpoints News) ...Investors are concerned Garijo doesn't have a track record of delivering R&D productivity at Merck KGaA, Jefferies managing director Michael Leuchten told Endpoints News in an interview. He considers that criticism "a little unfair" because the German conglomerate focused its capital allocation on areas other than pharma... Sub. Req’d

Lupin Raises FY26 Margin Guidance to 27-28%

(2/13, Ekta Batra, CNBC-TV18) ...Vinita Gupta, Chief Executive Officer of Lupin, said the exclusivity benefits in products such as Tolvaptan and Mirabegron, along with steady traction in base generics and seasonal flu therapies, have driven US growth. Gupta is confident that the company will not only achieve its $1 billion US sales target in FY26 but also sustain the billion-plus run rate into FY27, supported by a growing injectable and biosimilar portfolio... Full

Biocon in Q3 Clocks Revenue of Rs. 4,290 Crore, Up 11%, Net Profit at Rs. 144 Crore Up 475%

(2/13, Pharmabiz.com) ...Biocon for the fiscal third quarter ended December 31, 2025 clocks revenue of Rs. 4,290 crore compared to the corresponding quarter last year where it registered Rs. 3,856 crore which is up 11%, net profit at Rs. 144 crore up 475% as compared to the parallel quarter last year which was at Rs. 25 crore... Full

Even Europeans Don't See a Future in Euro Biopharma Anymore: Endpoints Signal

(2/13, Tom Randall, Endpoints News) ...The data come from the Q1 Biopharma Sentiment Index, Endpoints Signal's quarterly survey of industry insiders. The BPSI showed a general lack of confidence coming out of Europe. Respondents there registered a headline sentiment score of 88, below North America's 90 and far from China's optimism at 110. Europe's scores were dragged down by assessments of current business conditions (85 vs. 101 in North America) and hiring (82 vs. 99)... Sub. Req’d

Denmark Creates MFN Task Force As Companies Decide Against Danish Drug Launches

(2/12, Francesca Bruce, Pink Sheet) ...The US Most Favored Nations pricing policy that references Danish drug prices is making companies think twice about investing in R&D in the country and risks Denmark's status as an important "life sciences nation," according to Lif, the Danish pharmaceutical industry association... Global Sub. Full

Nitrosamine Fallout: EMA Pushes For Stricter Active Substance Manufacturing Controls

(2/12, Vibha Sharma, Pink Sheet) ...In light of these learnings, the EMA on Feb. 9 proposed extending the scope of Annex 15 of the EU Good Manufacturing Practice (GMP) guideline (ie, EudraLex Volume 4), which currently applies to the qualification and validation of finished products, to also cover the manufacturing of active substances... Global Sub. Full

Medicine Shortages in the UK Have Become a 'New Normal,' Report Finds

(2/13, Lisa Lock, Medical Xpress) ...The committee found that medicine shortages in the U.K. have become a "new normal" of rising shortages, a vicious cycle of high manufacturing costs and global supply chain disruptions and generic drugs at risk because profit margins are so thin that companies simply stop making them if costs rise... Full

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