Monday, December 8, 2025

Teva Price Target Raised to $31 from $28 at Goldman Sachs

(12/8, The Fly) ...Goldman Sachs analyst Matt Dellatorre raised the firm's price target on Teva to $31 from $28 and keeps a Buy rating on the shares. The recently published IRA-negotiated price for Austedo, which will go into effect in 2027, was better than expected, and management has reiterated their FY27+ guidance for the product, the analyst tells investors in a research note... Full

Estimated Savings From Year Two of the IRA Prescription Drug Negotiation Program

(12/5, Anna Anderson-Cook, Richard G. Frank, Brookings) ...Like CMS, we also take into account the coverage gap discount program. Our estimate is that the discount program reduced 2024 net spending on the 15 negotiated drugs by $3.4 billion. That implies that savings under the negotiated prices (MFP) relative to prices negotiated by Part D plans are estimated at $12.5 billion and $9.1 billion after accounting for the coverage gap discounts... Full

Arrington Leads Bipartisan Charge to Lower Prescription Drug Costs

(12/5, Congressman Jodey Arrington) ...To complement the Trump Administration's commitment to strengthening domestic manufacturing and reducing artificial barriers in health care, Arrington and his colleagues encourage Secretary Lutnick to support the bipartisan Eliminating Thickets to Increase Competition (ETHIC) Act as a targeted, market-based solution to promote fair competition and expand patient access to affordable medicines... Full

Trump's Trade Shift Reshaping Our Medicine Supply Chain | Opinion

(12/8, Andrew Rechenberg, Florida Today) ...Essentially, Washington is signaling that the era of America's unlimited drug imports is ending. And that's good news because the United States long ago surrendered control of its pharmaceutical supplies to overseas factories with weak oversight and chronic safety failures... Full

FDA Announces Major Deregulatory Push to Speed up Cures and Expose Hidden Vaccine Risks

(12/5, Fox News) ...FDA Commissioner Dr. Marty Makary joins 'Mornings with Maria' to unveil the push to slash red tape, accelerate life-saving drug approvals, expose hidden COVID vaccine data and cut soaring prescription costs... Full

FDA Plans Dereg Push To Speed Cures To Market After Criticism Over Increased Approval Hurdles

(12/5, Inside Health Policy) ...In an interview with Makary Friday (Dec. 5), Fox News host Maria Bartiromo said FDA is issuing a request for information (RFI) asking stakeholders for feedback on which regulations should be cut. It wasn't clear if Bartiromo was referencing the new OTC drug RFI, one issued in May or a new effort. Suggestions for regulations to cut can still be submitted through a dedicated website. Makary told Fox News the push to get rid of outdated regulations is an attempt to get more cures and treatments to the public faster... Sub. Req’d

Is FDA Streamlining Regulations in the Biosimilar Space?

(12/8, Mike Hollan, Gillian Woollett, PharmExec.com) ...Gillian Woollett: FDA's approach to streamlining has been in the works for a while. We're seeing it portrayed as if we're seeing something sudden happening, but this has been gained through the experience either of 30 years of comparability or 20 years of biosimilars. FDA is ultimately aiming to be science-based and consistent. The experience with biosimilars has been good, they've done exactly what they were expected to do... Full

Lowering FDA Fees Would Spur Generics Manufacturing in US, Mark Cuban Says

(12/5, Kevin Dunleavy, Fierce Pharma) ...Cuban said Thursday that he is looking to manufacture 100 generic treatments in the U.S. and eventually work up to 1,000. Cost Plus also is eyeing biosimilars, Cuban said. "If we're able to get that support from the FDA, and I can't say whether we will or not, but I know they're at least discussing it, then you will see most generics from us made here in the USA," Cuban said... Full

Why Mark Cuban's Drug Cost Message Resonates: It's Simple

(12/7, Bruce Japsen, Forbes) ..."We need more CEOs of large employers to basically say ‘Hey, we're going to demand a different model. One that is transparent, one that bypasses the system that's been in place now for decades,'" [Humana CEO Jim] Rechtin told the Forbes Healthcare Summit audience. "And look, there are alternatives, but those alternatives can't be fully built without the demand that we need from employers, and that really is going to require CEOs to step into the benefit process."... Full

Appointment of Controversial FDA Official Rocking Agency like "An Atom Bomb," Scientists There Say

(12/7, Michael Kaplan, Margaret Brennan, Caitlin Yilek, CBS News) ..."Putting Tracy Beth in charge is like dropping an atom bomb," one agency source said, adding that multiple top-level officials are preparing resignations. "It's an extinction level event. Tracy Beth Høeg has never supervised a drug review, never has conducted a clinical trial. She doesn't understand laws and regulations."... Full

FDA Instability, Alarm Over Agency's Direction Escalate After Top Regulator Exits

(12/5, Rachel Roubein, Dan Diamond, The Washington Post) ..."I think we need a tiny bit of stability," Paul Hudson, the chief executive of Sanofi and board chair-elect of the drug lobby, Pharmaceutical Research and Manufacturers of America, said at an investor conference. "We have all of this drama with vaccines. We have all of this drama now with CDER. Do we really know what the new FDA looks like and how they operate?"... Sub. Req’d

Owners of Small, California Pharmacies Fought for PBM Legislation. What Now?

(12/6, Annika Merrilees, Sacramento Bee) ..."Overall, what we got is a major win for Californians and for pharmacies," said Clint Hopkins, CEO and pharmacist at Pucci's Pharmacy on Folsom Boulevard in East Sacramento. The prohibition of spread pricing, he added, is "huge for all of us."..."We are extremely happy," said Susan Bonilla, CEO of the California Pharmacists Association, who described the legislation as a "landmark bill."... Full

Boehringer Ingelheim Prepares Schizophrenia App for FDA Submission After Trial Results

(12/8, Mario Aguilar, STAT) ...Developed with Click Therapeutics, the app, CT-155, is a 16-week treatment that adapts key elements of established face-to-face psychosocial treatments for schizophrenia as an adjunct to antipsychotic drug treatment... Full

Amneal Reports Positive Interim Results for Parkinson's Drug CREXONT

(12/5, StreetInsider.com) ...The study evaluated 55 patients after six weeks of treatment. Results showed increases in daily "Good On" time of 3.13 hours for patients switching from immediate-release carbidopa/levodopa, 2.31 hours from immediate-release with COMT inhibitor, and 1.80 hours from RYTARY. Corresponding reductions in daily "Off" time were 2.83, 2.36, and 2.57 hours respectively... Sub. Req’d

India's Dr Reddy's Signs Licensing Pact to Sell Immutep's Cancer Drug

(12/8, Reuters) ...As part of the agreement, Immutep will receive about $20 million upfront from Dr Reddy's as well as potential regulatory development and commercial milestones payments of up to $349.5 million. Immutep will also get double-digit royalties on commercial sales, the companies added... Sub. Req’d

Sandoz, Pfizer Denied Bid to End Generic Drug Price-Fixing Case

(12/5, Katie Arcieri, Bloomberg Law) ...Judge Michael P. Shea of the US District Court for the District of Connecticut denied the defendant drugmakers' bid for a judgment on an important threshold issue: whether an overarching conspiracy was properly alleged. The state plaintiffs have "raised a genuine dispute" about whether the companies colluded to stabilize and avoid disruption of the markets for the generic drugs at issue, Shea said... Sub. Req’d

Formycon Delivers On Keytruda Biosimilar Partnership Promise With MS Pharma Deal

(12/5, Urte Fultinaviciute, Generics Bulletin) ...Formycon announced an agreement with its long-standing partner MS Pharma, carving out commercial rights for FYB206 biosimilar rival to Merck's Keytruda in the Middle East and North Africa region. Upon signature of the agreement, which also includes an option for future technology transfer, Formycon will receive an undisclosed amount of upfront remuneration... Global Sub. Full

High Blood Pressure Medication Voluntarily Recalled: FDA

(12/6, Michael Ramsey, The Hill) ...The recall covers more than 11,100 bottles of bisoprolol fumarate and hydrochlorothiazide tablets under the brand name Ziac. Testing of reserve samples showed presence of ezetimibe, a drug used for high cholesterol, FDA officials said in a report published online... Full

Biocon Fully Integrates Biocon Biologics in $5.5 Billion Deal

(12/6, Rishabh Jaiswal, Rishika Sadam, Reuters) ...Biocon said it will acquire the remaining stakes in Biocon Biologics from Serum Institute Life Sciences, Tata Capital Growth Fund II and Activ Pine LLP through a share swap of 70.28 Biocon shares for every 100 Biocon Biologics shares, at a price of 405.78 Indian rupees ($4.51) per Biocon share. The deal values Biocon Biologics at $5.5 billion... Sub. Req’d

Sandoz Completes Strategic Acquisition of Just-Evotec Biologics EU SAS, Asserting Biosimilars Leadership

(12/8, Sandoz) ...This milestone fully aligns with the Sandoz biosimilar strategy, expanding in-house drug substance development and manufacturing capabilities and leveraging continuous-manufacturing technology to boost efficiency and scalability. It further positions Sandoz to capitalize on the projected >USD 300 billion global biosimilars LoE market over the next decade... Full

Driven By GLP-1s, Prescription Drug Spending Explodes at Major Health Insurers

(12/8, Bob Herman, STAT+) ...Some insurers spent more on drugs in the first nine months of this year than they did in all of 2024, financial documents analyzed by STAT show. For many, drug expenses are up more than 20% in 2025... Sub. Req’d

The ‘Pharm-To-Table' Movement For Prescription Drugs: Promising Or Performative?

(12/5, Brian Reid, Peter J. Neumann, Health Affairs) ...While the phrase ‘pharm-to-table' is a lighthearted play on words, the ambition of cash-pay, direct-to-patient portals is similar to those of restaurants that seek to source their meats and vegetables directly from farmers: In both cases, eliminating the middleman creates different economics -- and forges a different kind of relationship -- between producer and end user. A template is emerging among companies that have launched such efforts...Despite the attention such efforts are receiving, they are unlikely to fundamentally change the drug pricing dynamics in the United States, at least in the short term, for several reasons... Full

David And Goliath: How A Parent-Led Buyers' Club Challenged Cystic Fibrosis Giant Vertex

(12/8, Urte Fultinaviciute, Generics Bulletin) ...Threatened by a series of battles and campaigns, which included the establishment of a buyer's club and a license to purchase generic Orkambi from Argentina, the UK government reached a deal with Vertex... Sub. Req’d

Price Controls Erode US Margins of Indian Drugmakers

(12/8, Manu Kaushik, Financial Express) ...Sun Pharma, Dr Reddy's Labs and Aurobindo Pharma have been reporting flat-to-negative growth in their US revenues over the past few quarters. In the case of Sun Pharma, the US revenues, accounting for 32.6% of overall revenues, remained flat in the second quarter of FY26 due to weakness in the generics segment. Dr Reddy's US performance in Q2 was impacted by price erosion in key products, notably gRevlimid, a generic cancer drug. Aurobindo Pharma too reported flattish US growth in Q2 as a result of weak generics segment... Full

Mint Explainer: Does India Need Special Courts for Complex Drug Patent Wars?

(12/6, Jessica Jani, Mint) ...Given the order has significant implications for India's domestic pharma landscape, dotted with patent litigations between the country's generic players and innovators, Mint explains how Indian courts rule on complex patent disputes... Full

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