Monday, February 9, 2026
Top News
Will Forte Details Grueling Return to "SNL" for Glen Powell's MacGruber Sketch: 'It Really Was like the Old Days'
(2/7, Wesley Stenzel, Entertainment Weekly) ...The Last Man on Earth star tells Entertainment Weekly about the whirlwind saga that led to his signature Saturday Night Live character's return while promoting his Huntington's disease awareness campaign with Teva... Full
Teva Pharma (TEVA) PT Raised to $45 at Goldman Sachs
(2/9, StreetInsider.com) ...Goldman Sachs analyst Matt Dellatorre raised the price target on Teva Pharma to $45.00 (from $36.00) while maintaining a Neutral rating... Sub. Req’d
Teva Price Target Raised to $45 from $36 at Goldman Sachs
(2/9, The Fly) ...[T]he current valuation appears justified and attractive given a fundamentally improved business profile and a de-risked path to above-consensus, double-digit EPS growth driven by revenue growth, margin expansion, and deleveraging, Goldman argues... Sub. Req’d
U.S. Policy & Regulatory News
Senate GOP Stays Cool to Drug Pricing Keyed to Other Nations
(2/6, Victoria Knight, Bloomberg Law) ...The idea behind the policy is to link the prices of US drugs to the lower prices other countries pay for the same medications. Republicans traditionally have been opposed, arguing it represents a form of price controls that can stifle innovation. The early stages of discussion indicate that Trump, who is eager to get Congress to provide the legal authority for his executive order aimed at reducing drug costs, may have difficulty selling it among members of his own party... Sub. Req’d
Medicare's Drug Price Negotiation Choices Risk Increasing Spending
(2/9, Kenneth Thorpe, Las Vegas Sun) ...Employers and half of Americans with employer-sponsored health insurance will be worse off. They already don't receive the government-negotiated Medicare prices. However, they will miss out on the cheaper generics and biosimilars that are never developed... Full
Fearmongering Won't Make Prescription Drugs More Affordable or Accessible
(2/6, Ken McEldowney, The Well News) ...There is no question that the FDA must maintain rigorous oversight of every facility manufacturing drugs for the U.S. market. That includes strengthening unannounced inspections, improving data transparency and ensuring full compliance with FDA safety standards from wherever these firms are located in the world. But implying that drugs from India or China are categorically more dangerous, or that Americans are at immediate and severe risk, is not supported by the data... Full
More Than Half of TrumpRx Drugs Have a Cheaper Alternative
(2/6, Maya Goldman, Axios) ...20 of the 43 drugs listed on TrumpRx as of the website's launch have generic alternatives, according to a tally by Anna Kaltenboeck, a drug pricing expert and president of Verdant Research. Another six contain components that are available as generics or compounded products, or have tentative approvals, meaning consumers will have access to the lower-cost products in the near future... Full
TrumpRx Claims to Offer The Lowest Prices. But Many Drugs Have Cheaper Generics
(2/6, John Wilkerson, J. Emory Parker, Chelsea Cirruzzo, Elaine Chen, Daniel Payne, STAT) ...Pfizer spokesperson Steven Danehy said TrumpRx and the company's own PfizerForAll platform provide patients with simple solutions to lower their costs, and didn't comment specifically on the drugs the company chose to make available. [Mark] Cuban praised the administration for TrumpRx while noting that his company sells many of the same drugs for far less... Full
How Much Will TrumpRx Really Cut Down Your Drug Costs?
(2/8, Joseph Choi, The Hill) ..."If you have insurance, your out-of-pocket costs are probably going to be less than the discounted list price that's being advertised on TrumpRX," Juliette Cubanski, deputy director of the Program on Medicare Policy at KFF, told The Hill. "For people who are looking at this website and maybe they recognize a drug that they take, they really need to understand how their out-of-pocket cost under insurance would compare to the TrumpRx price."... Full
Employers Celebrated PBM Reform. The Reality Is More Complicated
(28, Marissa Plescia, MedCity News) ...While it is true that there were major gains made by employers, one of the most significant parts of the law — the delinking of PBM compensation from the price of a drug in Medicare Part D — eluded employer groups. This is a provision in the new law that only applies to Medicare Part D, according to Jesse Dresser, a partner in Frier Levitt's Life Sciences Department... Full
PDUVA VIII: Industry Seeks Automatic Post-Inspection Meetings After Receiving a 483
(2/6, Joanne S. Eglovitch, Regulatory Focus) ...The pharmaceutical industry groups are suggesting that the US [FDA] automatically schedule a post-inspection meeting whenever it issues a Form 483 to manufacturers following a preapproval inspection (PAI). Additionally, industry is requesting that FDA respond within 15 days after receiving companies' responses to the Form 483... Full
More America First Fees: US FDA Proposes GDUFA Facility Fee Waiver For Domestic Construction
(2/6, Derrick Gingery, Generics Bulletin) ...The FDA wants to waive facility fees for three years if a sponsor breaks ground on a US-based manufacturing plant, but industry is concerned the idea will force other sponsors to subsidize competition... Global Sub. Full
Orphan Drug Tweak in US Spending Bill Will Make Life Easier for The FDA
(2/6, Zachary Brennan, Endpoints News) ...The FDA can continue to grant seven years of exclusivity for orphan drugs with new indications, as President Donald Trump this week signed a government funding extension that included a provision that codifies that process and runs counter to a 2021 appeals court decision against the agency... Sub. Req’d
Pharma Expert Discusses Effort to Standardize CMC Quality Information
(2/6, Joanne S. Eglovitch, Regulatory Focus) ...The pharmaceutical industry and the US Food and Drug Administration (FDA) are collaborating on a structured data platform for submitting chemistry, manufacturing, and controls (CMC) information in new drug applications. This initiative is part of Project PRISM, which is the FDA's regulatory cloud submissions platform... Full
Citizen Pazdur: Former US FDA Oncology Head Still Interested In Drug Development
(2/6, Kate Rawson, Pink Sheet) ...The session focused on improving early endpoints in oncology clinical trials. Pazdur discussed some of his favorite topics, including accelerated approval, optimal dosing in cancer trials, the importance of US-centered studies, and the need for faster guidance development... Global Sub. Full
Drug Labels as Evidence of Patent Infringement — A Troubling Legal Trend
(2/7, Paul R. Gugliuzza and jacob S. Sherkow, The New England Journal of Medicine) ...Recent court decisions, however, have treated statements in drug labels as evidence of patent infringement by generic-drug manufacturers. We believe those decisions, which embrace a legal theory we call "infringement by label," are incorrect... Full
Virginia Senate Passes Affordable Medicine Act With Overwhelming Bipartisan Support
(2/6, AARP) ...Senate Bill 271/ House Bill 483, called The Affordable Medicine Act, would extend the Medicare negotiated drug prices on 25 drugs to hundreds of thousands of Virginians not enrolled in Medicare. It would also establish a Prescription Drug Affordability Board that could look at other high-cost drugs and set upper payment limits on those medications that pose an affordability challenge to Virginians who need them... Full
Generics & Biosimilars News
Sandoz Enters Canadian Ophthalmology Market With Eylea Biosimilar
(2/6, Urte Fultinaviciute, Generics Bulletin) ...Marketed under the name Enzeevu, it will be supplied as a 2mg/0.05ml solution for intravitreal injection in a single-use pre-filled syringe. The biosimilar was approved for all indications of the reference biologic, which include neovascular wet age-related macular degeneration and diabetic macular edema, among others... Global Sub. Full
Positive PK Results Put Alvotech's Vedolizumab Biosimilar On Path Toward Filings
(2/6, Dean Rudge, Generics Bulletin) ...The trial evaluated a 108mg/0.68ml subcutaneous injection and was designed to support the demonstration of similarity between the biosimilar and the originator product, which is a monoclonal antibody targeting the a4ß7 integrin used to treat inflammatory bowel disease... Global Sub. Full
Industry News
Sun Pharma to Stay Disciplined on M&A, Says Dilip Shanghvi
(2/8, PTI) ..."I think the US continues to be an important part of our focus, specifically for innovative medicines," Shanghvi said when asked about the company's M&A strategy in an analyst call... "For emerging markets, we are looking at what you call tuck-ins or smaller acquisitions, which we can look at integrating with our existing business to get scale in the emerging markets," he added... Full
Aurobindo Pharma Says US FDA Inspection at Subsidiary Ends With 11 Procedural Observations
(2/6, Jomy Jos Pullokaran, CNBC-TV18) ...Aurobindo Pharma Ltd on Friday (February 6) said the United States Food and Drug Administration (US FDA) has completed an inspection at Unit-III of Eugia Pharma Specialities Ltd, its wholly owned subsidiary...According to the company's filing, the inspection concluded with 11 observations. Aurobindo Pharma said the observations are procedural in nature and will be responded to within the stipulated time. The company stated that there is no impact on its financials or operations due to the inspection outcome... Full
Novo Nordisk Faces More Gloom From Price Cuts in Crowded Anti-Obesity Drugs Market
(2/9, Aanu Adeoye and Alan Livsey, Financial Times) ...In addition to competition in an increasingly crowded obesity market, Novo is facing price cuts in the US that Doustdar has described as "painful" as well as expiring patents in some key markets... Sub. Req’d
Hims Says It Will Stop Selling GLP-1 Pill, After Legal Pressure From US
(2/7, Drew Armstrong, Endpoints News) ...Hims didn't say if it plans to make changes to its business selling compounded semaglutide for injection, and HHS didn't say if it would continue to pursue action against the company now that it is pulling back from its plans for the compounded pill... Sub. Req’d
Women Are One Patch Away From Menopause Relief—If Only They Could Find It
(2/6, Sara Ashley O'Brien, The Wall Street Journal) ...Eleven estradiol patch products are currently in shortage, according to data from the University of Utah's Drug Information Service. The products in shortage come from three manufacturers, Amneal, Sandoz and Viatris, which are aware of the issues and working to address them. Meanwhile, women are going from pharmacy to pharmacy—and tapping their personal networks—to track down supply... Sub. Req’d
Editor's Corner: Pharma's Slack Tightening Across Pipelines, Trust
(2/9, Ayla Ellison, Fierce Pharma) ...Declining satisfaction and perceptions of value, along with shifts in how younger people consume health information, have left the pharmaceutical industry facing a trust deficit. Combined with ongoing concerns about pricing and corporate motives, that gap suggests the pandemic-era boost to pharma's reputation is fading and will require greater transparency and engagement to rebuild... Full
International News
'Access Is A Right, Not A Privilege' - Medicines For Europe's Saltofte Sets Out Priorities
(2/6, Dave Wallace, Generics Bulletin) ...Zentiva CEO Steffen Saltofte talks to Generics Bulletin about his priorities as the new president of industry association Medicines for Europe... Global Sub. Full
Swiss Medicine Revenues Pegged Back by Price Reductions
(2/7, Swissinfo.ch) ...Generics sales rose to CHF1.1 billion (+6.4%), exceeding the CHF1bn mark for a syecond year running. Even more pronounced was the growth of biosimilars, whose turnover rose by 13.7% to CHF255 million. This above-average growth came at the expense of original products: sales of chemical preparations fell by 1.2%, while those of biologics declined by 7.8%... Full
India Can Emerge as Biologics Hub With Right Execution, Says Wockhardt Chairman
(2/9, Ekta Batra, CNBC-TV18) ...Habil F Khorakiwala, Founder and Chairman of Wockhardt Group believes biologics will play a decisive role in the future of drug discovery, making capacity building in this segment critical for India's pharmaceutical ambitions...He said that under the current trade agreement, Indian pharma exports to the US do not attract any tariff or duty, and this has largely remained the case even in earlier phases of trade discussions... Full
US-India Trade Deal: Generics Dance Goes On, Oil Prices To Be Watched
(2/9, Vibha Ravi, Pink Sheet) ...The joint statement also makes it clear that the exemption is contingent on the findings of the US Section 232 investigation of pharmaceuticals and pharmaceutical ingredients. "India will receive negotiated outcomes with respect to generic pharmaceuticals and ingredients," it said, implying that the danger of some tariff being imposed on these categories cannot be dismissed yet... Global Sub. Full
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