Friday, December 5, 2025

Teva Initiated with an Outperform at Scotiabank

(12/4, The Fly) ...Scotiabank initiated coverage of Teva with an Outperform rating and $35 price target... Sub. Req’d

Scotiabank Starts Teva Pharma (TEVA) at Sector Outperform

(12/5, StreetInsider.com) ...Scotiabank analyst Louise Chen initiates coverage on Teva Pharma (NYSE: TEVA) with a Sector Outperform rating... Sub. Req’d

Exclusive: Trump Administration Pushes End-of-Term Deadline for ‘Most Favored Nation' Promises

(12/4, Anna Brown, Endpoints News) ...Large pharma companies that have made "most favored nation" deals with the White House will have until the end of President Donald Trump's current term to fulfill some of their commitments to invest in the US, according to a framework of the agreements reviewed by Endpoints News. The document, titled a "letter of agreement," is a template that appears to formalize agreements between companies and the US Department of Commerce....The exact amounts companies will have to invest in the US are being negotiated individually, according to two drugmakers involved in talks. At least one expects to fulfill the entirety of its multibillion-dollar pledge by the Jan. 1, 2029 deadline... Sub. Req’d

New Senate Finance Bill Aims To Bring PBM Reform Closer To Passage

(12/4, Gabrielle Wanneh, Inside Health Policy) ...The new bill would delink the rebates PBMs negotiate with companies for prescription drugs from the compensation PBMs receive for their overall drug benefit management services and require PBMs report various data to Medicare Part D plan sponsors and HHS, as well as empower plan sponsors to audit the PBMs they contract with for contract compliance. It also would bar PBMs from implementing spread pricing practices in the contract they hold with Medicaid managed care organizations and require PBMs to fully pass on the cost of a prescription drug and all associated rebates, discounts and other fees to the pharmacy or provider dispensing the drug... Sub. Req’d

NCPA Urges Congress to Pass Crapo-Wyden PBM Reforms

(12/4, NCPA) ...The PBM Price Transparency and Accountability Act, which is also sponsored by Senate Majority Leader John Thune (R-S.D.), contains the same key reforms that nearly passed last December but were stripped out at the last minute when spending negotiations broke down. One key reform would ensure that independent pharmacies receive a fair and transparent reimbursement under state Medicaid managed care programs. Another would require the Centers for Medicare & Medicaid Services to define and enforce "reasonable and relevant" Medicare Part D contract terms, including those related to reimbursements... Full

Senate Finance Leaders Introduce Bipartisan PBM Reform, NACDS Hails Move and Calls for Swift Passage

(12/4, NACDS) ...The policies contained within the PBM Price Transparency and Accountability Act closely mirror language that House and Senate leaders negotiated at the end of 2024. It aims to bring transparency and fairness to the prescription drug system. The bill would open Medicare Prescription Drug Plan networks to any pharmacy willing to accepts fair terms, ban spread pricing where PBMs keep the gap between plan charges and pharmacy reimbursement for drugs, and enforce strict transparency rules. It also gives federal agencies tools to hold PBMs to account and to shield pharmacies from retaliation... Full

Lankford Eyes Attaching Drug Policies to Government Funding Bill

(12/4, Benjamin Guggenheim, Politico) ...The Oklahoma Republican said in an interview Thursday he is actively looking to insert a health care bill targeting PBMs into the fiscal 2026 appropriations bill funding the Departments of Labor, Health and Human Services and Education. Lankford acknowledged it would be unusual for legislation under the jurisdiction of the Senate Finance Committee to be included in an appropriations measure, but that "it's also appropriations, and strange things ride there if all the different players all agree."... Full

Attorney General Tong Announces Development in Generic Drug Price-Fixing Case

(12/4, Connecticut Office of the Attorney General) ...Attorney General William Tong today announced a significant development in one of the ongoing generic drug price-fixing cases, sharing that U.S. District Judge Shea Michael P. Shea dismissed a motion for summary judgment filed by the drugmakers seeking to toss key elements of the case... Full

Exclusive: FDA to Lower Number of Trials Required for Approval of Drugs, Other Medical Products

(12/4, Lizzy Lawrence, STAT+) ... "You can achieve the same statistical power with one trial as you would with two trials when it's designed and controlled appropriately," Makary told STAT by phone. The agency will publish a press release soon, a spokesperson told STAT. Makary said the agency will also start updating policies to reflect the change, which could take three to six months. The change will take effect once the guidance is updated. STAT obtained a draft press release that laid out the plans, but it's not clear if it was the final version... Sub. Req’d

FDA Eyes Higher User Fees for Companies Holding Phase I Studies Abroad

(12/4, Tristan Manalac, BioSpace) ...Industry groups—including the Biotechnology Innovation Organization, Pharmaceutical Research and Manufacturers of America and Consumer Healthcare Products Association—asked why the FDA chose to change the user fee structure instead of "leveraging efficiencies" to speed up drug reviews. The regulator said that that approach is also "of interest," though it falls "outside of scope of the PDUFA negotiations." FDA officials were also unable to provide specifics about how it plans to implement these fee changes, noting that those details will be determined in future negotiation meetings... Full

Updated: US FDA Sending Pazdur Back To Oncology Office

(12/4, Derrick Gingery, Pink Sheet) ...In a memo to staff sent the afternoon of Dec. 4 and obtained by the Pink Sheet, FDA Commissioner Martin Makary said "Høeg will assume the role in the coming weeks" as Pazdur "transitions into retirement." He also congratulated Pazdur on his 26 years of distinguished service... Global Sub. Full

Frequent FDA Leadership Shakeups Put Industry at ‘Tipping Point'

(12/4, Nyah Phengsitthy, Bloomberg Law) ..."It gums up the works when there isn't consistency at the top," said Eva Temkin, a former FDA acting policy director at CDER. "The regulated industry wants to play by the rules, but they need to know what those rules are," said Temkin, now a partner at Arnold & Porter Kaye Scholer LLP representing pharmaceutical companies. "The need for a fixed playing field is critical and a lot of that comes from center leadership."... Sub. Req’d

And Then There's the FDA

(12/5, Axios) ...My thought bubble: There is certainly a huge difference between changing federal vaccine recommendations — which has a real-world effect but a comparably limited one — and making decisions that would keep vaccines from people who want them. That difference has enormous political ramifications given vaccines' overall popularity among Americans. But it's not yet clear what Kennedy's and the White House's red lines are, or what are his ultimate goals... Full

Former F.D.A. Leaders Alarmed by Changes to Vaccine Policy

(12/5, Rylee Kirk, The New York Times) ...A spokeswoman for the Department of Health and Human Services, which oversees the F.D.A., said in an emailed statement that ''Americans deserve evidence-based science'' and that Dr. Prasad's memo ''lays out a philosophical framework that points us toward that higher standard.''....''The fact these criticisms are coming from former F.D.A. officials who opposed raising the bar for vaccine science confirms we are on the right track,'' the spokeswoman, Emily G. Hilliard, said... Full

Parexel Exec On How CROs Should Prepare For Biosimilar Pathway, AI-Led Changes

(12/4, Vibha Ravi, Pink Sheet) ...The US Food and Drug Administration (FDA)'s earnest effort to simplify its regulatory pathway for biosimilar approvals and registration is a mixed blessing for contract research organizations, Parexel International Corp's India head tells the Pink Sheet in an interview... Global Sub. Full

FDA Official: CDER Warning Letters Up 50% in FY 2025

(12/4, Joanne S. Eglovitch, Regulatory Focus) ...The US Food and Drug Administration's (FDA) Jill Furman, director of the Center for Drug Evaluation and Research's (CDER) Office of Compliance (OC), reported that there has been a 50% increase in warning letters issued by CDER in FY 2025. She noted that a significant portion of this increase is due to letters sent to telehealth platforms that are making false claims about compounded drug products... Full

The Talk Of The Town: Biosimilars Developers React To FDA Streamlining

(12/4, Dave Wallace, Generics Bulletin) ...Perhaps the most succinct summary of the significance of the guidance was provided by Amneal co-CEO Chirag Patel. During the firm's third-quarter earnings call, he declared that it was "awesome" to see the FDA's draft guidance come in, suggesting it demonstrated that the regulator was "in agreement to push for more biosimilar approvals," allowing developers to "cut down the cost and time by half."... Global Sub. Full

Sandoz Chief Scientific Officer: What Is Truly Necessary to Establish Biosimilarity?

(12/5, Claire D'Abreu-Hayling, STAT+) ...We are on the cusp of a harmonized global regulatory environment — one that could unlock timely, affordable access to these essential treatments if regulators, industry, clinicians, and patient advocates come together and commit to a shared regulatory language rooted in the latest science. By embracing a streamlined development pathway, Sandoz estimates that we can reduce development costs by about 40%, reduce development timelines by one to two years, accelerate innovation, increase competition, and enable these essential medicines to reach more patients worldwide... Sub. Req’d

HHS Releases ‘OneHHS' Plan To Expand AI Within Health Agencies

(12/4, Cara Smith, Inside Health Policy) ..."For the first time in the Department's history, this Strategy's "OneHHS" approach invites all HHS divisions -- including the Centers for Disease Control and Prevention (CDC), the Centers for Medicare & Medicaid Services (CMS), the Food and Drug Administration (FDA), the National Institutes of Health (NIH), and others -- to collaborate in the development of one robust Department-wide AI infrastructure, streamlining workflows and enhancing cybersecurity," the program announcement says... Sub. Req’d

US Medicare Agency Drops Plan To Redefine ‘Bona Fide Service Fees' For Now

(12/4, Michael McCaughan, Pink Sheet) ...In the draft annual update rule for the PFS released in July, CMS proposed a new definition for "bona fide service fees" (BFSFs) that would have reduced manufacturers' discretion to determine the "fair market value" for those fees. A manufacturer paying more than fair market value must be considered a price concession that reduces the Average Sale Price, which is the benchmark for Part B drug and biologic reimbursement... Global Sub. Full

PhRMA Started Cutting Them Checks, Then They Started Attacking Its Enemies

(12/4, Robert Schmad, Washington Examiner) ..."We engage with different groups who have a wide array of different policy opinions and priorities," PhRMA Senior Vice President of Public Affairs Alex Schriver told the Washington Examiner. "We may not agree on every issue, but we believe engagement and dialogue [are] important to promoting a healthcare policy environment that supports innovation, a highly-skilled workforce, and access to life-saving medicines."... Full

Teva Announces Positive Results from Trial of AJOVY for Migraine

(12/5, Esme Needham, Pharmafile) ...Results from the study showed that primary and secondary endpoints had been met: over 66% of EM patients achieved a 50% reduction in monthly migraine days (MMD) during the first six months of treatment, as did 51.6% of CM patients. AJOVY also demonstrated sustained migraine prevention over the course of the 24 months... Full

Bristol Myers Squibb Wins Fifth US Approval for CAR T Cell Therapy Breyanzi

(12/5, European Pharmaceutical Review) ...Authorised for a total of five cancer types in the US, Breyanzi's latest indication is for MZL patients who have failed treatment or relapsed following two or more prior lines of therapy. Lynelle Hoch, President, Cell Therapy Organization at Bristol Myers Squibb, said the FDA's approval "further solidifies it as the leading CD19-directed CAR T cell therapy covering the broadest range of B-cell malignancies. This approval in a fifth cancer type reflects our bold vision to bring the transformational potential of cell therapy to more patients"... Full

Merck Suffers a Setback over its New Keytruda Formulation in Germany

(12/4, Ed Silverman, STAT) ...The Munich Regional Court decided that Merck's formulation would infringe on a patent held by Halozyme in Europe and so Merck is required to halt its launch for Keytruda SC in Germany. Patients requiring Keytruda will still have access to the existing intravenous version, which is not affected by the patent dispute or court order... Full

Lupin Gets USFDA Nod for Multiple Sclerosis Drug

(12/5, PTI) ...The company has received tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application for Siponimod Tablets in strengths of 0.25 mg, 1 mg and 2 mg, the Mumbai-based drugmaker said in a statement. The new product would be manufactured at the company's Pithampur-based manufacturing facility... Full

Granules' Packaging Facility in US Completes FDA Inspection with Zero Observations

(12/5, India Pharma Post) ...Granules India Limited announced that its US step-down subsidiary, Granules Consumer Health, a wholly-owned subsidiary of Granules Pharmaceuticals, successfully completed a GMP inspection by the U.S. Food and Drug Administration (FDA) with zero observations. This was the facility's second FDA inspection, following the March 2023 audit that resulted in a No Action Indicated (NAI) classification... Full

Swiss Analysis Shows Biosimilars Cut Costs but Longer-Interval Options Lead Savings

(12/4, Skylar Jeremias, The Center for Biosimilars) ...A new cost-minimization analysis offers insight into this question by quantifying how ranibizumab biosimilars stack up financially against their reference product and against both doses of aflibercept for neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME)... Full

Mark Cuban's Cost Plus Drugs, Humana Exploring Partnership to Tackle Employer Drug Costs

(12/4, Heather Landi, Fierce Healthcare) ...Mark Cuban's Cost Plus Drugs and Humana are exploring a potential partnership to help lower the cost of prescription drugs for employers. Cuban, an entrepreneur, businessman and TV personality who co-founded Cost Plus Drugs, said the company is in discussions with Humana to work with its CenterWell healthcare services business to provide a better pharmacy experience for consumers and a direct-to-employer model for prescription drugs... Full

Clinical Trials Tech Startup Paradigm Raises $78M, Acquires Part of Roche's Flatiron

(12/4, Kyle LaHucik, Endpoints News) ...Paradigm is ARCH Venture Partners' main bet on shaking up the speed and diversity of oncology clinical trials. Paradigm helps healthcare systems and small oncology practices, mostly in the US, find patients for studies and help drugmakers digitize their protocols. Other Series B investors include DFJ Growth as a new investor and existing backers like the American Cancer Society's BrightEdge Fund, F-Prime, Mubadala Capital, Lux Capital, General Catalyst and GV... Sub. Req’d

How Impoverished People Selling Their Blood Fuels Drug Profits

(12/4, Paul Tullis, Bloomberg) ...In the five years to 2027, the market for plasma-derived medicinal products will climb 38%, to almost $46 billion, according to market analysis firm BCC Research. But the industry's growth poses a problem: The only source for plasma is people who agree to sit in a chair for 90 minutes with a needle in their arm to extract the substance. Most of the world bars paying for this service, so producers of the medications must either rely on voluntary donors or—more likely—buy it from the US, where it's legal to sell your blood... Sub. Req’d

Wegovy's Prices Are Going Down, But They Are 'Wildly Different' - And Confusing

(12/4, Jaimy Lee, MarketWatch) ...There are now a handful of publicly available prices for a month's supply of Wegovy, all of which are different and none of which take into account the prices negotiated by commercial health insurers... Full

Biosimilars 2025: A Turning Point for Equitable Access and EU Competitiveness

(12/4, Medicines for Europe) ...At the 9th European Commission Multistakeholder Event on Biosimilar Medicines, the Biosimilar Medicines Group urges coordinated EU and national action to fully unlock the value of biosimilar medicines for patients and healthcare systems... Full

Single Global Development of Generic and Biosimilar Medicines: A Cornerstone of Patient Access December 2025

(12/5, IGBA) ...A research report resulting from a collaboration between the University of Maryland and University of Michigan (USA) delivers a critical set of recommendations emphasizing the urgent need for policies that foster single global development of off patent medicines... Full

UK Industry Clinical Trials Rise, But Enrollment Crisis Deepens

(12/4, Vibha Sharma, Pink Sheet) ...Association of the British Pharmaceutical Industry said the continued decline in participant recruitment is not only inefficient and costly for sites and sponsors, but is also "selling patients short" of the opportunity to take part in studies. The industry body is calling for "dramatic improvements" in site-level performance, higher and more ambitious recruitment targets, faster setup times, executive-level accountability across the NHS, and clear evidence of impact from the VPAG investment program... Global Sub. Full

Note: Article links may expire over time or require a free registration. All news articles are the property of their respective publishers and copyright holders. [contextual emphasis added].

Teva global subscription access: registration is required to access FirstWord Pharma+ News and The Generics Bulletin. Please note you must be on the Teva Network (in a Teva location or connected via VPN) to access Teva's InfoNOW news resources. If you have any questions or issues, please email InfoNOW@tevapharm.com.

 

•      FirstWord Pharma+ News registration: first-time users, register here with your Teva email address. You will automatically receive a daily FirstWord Pharma+ newsletter; click on any news item to access your account.

•      Generics Bulletin, Pink Sheet, Scrip (Citeline) registration: go to the Generics Bulletin site and choose "Sign In" in the upper right-hand corner. First-time users, choose "Sign Up Here" and enter your Teva email address.