Tuesday, December 9, 2025

Barclays Starts Teva Pharma (TEVA) at Overweight

(12/8, StreetInsider.com) ...Barclays analyst Glen Santangelo initiates coverage on Teva Pharma with a Overweight rating and a price target of $35.00... Sub. Req’d

Teva Initiated with an Overweight at Barclays

(12/8, The Fly) ...The firm rolled out coverage on the specialty pharmaceuticals industry with a neutral view, saying investor sentiment is improving as companies shift focus to innovation, margin expansion and de-leveraging. The group's pricing headwinds are easing while debt leverage is coming down, the analyst tells investors in a research note. Barclays sees "plenty of opportunity" as the sector "remains in a transition phase."... Full

Biosecure Makes Annual Defense Bill, With Less 'Bite' for Drugmakers

(12/8, Jared Whitlock, Endpoints News) ...On Sunday, House and Senate leadership released the text of the National Defense Authorization Act, an annual bill that would, among other things, block certain Chinese biotech suppliers from federal contracts. The House is expected to vote this week in what's typically considered a must-pass bill. Biosecure's inclusion marks a milestone, after its failure last year to make the legislative package... Sub. Req’d

Cline Introduces Bipartisan Bill to Protect Skinny Labels, Lower Drug Costs

(12/8, Congressman Ben Cline) ...Rep. Ben Cline (R-VA), alongside Rep. Zoe Lofgren (D-CA), introduced the Skinny Labels, Big Savings Act, a bipartisan bill to help lower prescription drug costs by protecting generic drug makers from abusive lawsuits and preserving patient access to affordable medications...The legislation strengthens protections for the use of "skinny labels," a critical regulatory tool that allows generic and biosimilar manufacturers to seek FDA approval for uses of a drug that are no longer protected by patents. This pathway accelerates access to more affordable alternatives while respecting valid intellectual property rights... Full

AAM Applauds House Introduction of Skinny Labeling Bill

(12/8, AAM) ..."Since the passage of Hatch-Waxman 40 years ago, skinny labeling has saved patients and the health care system billions of dollars annually," said John Murphy III, President and CEO for the Association of Accessible Medicines. "Without hesitation, AAM applauds and supports legislation that will provide a safe harbor for skinny labeling, accelerating patient access to lower-cost generic medications and protecting our health care system. Thank you to Representatives Cline and Lofgren for their hard work on behalf of patients."... Full

Bipartisan House Group Pushes To Ban Copay Accumulators, Patient Group Separately Lobbies OMB

(12/8, Luke Zarzecki, Inside Health Policy) ...A bipartisan group of House lawmakers introduced a counterpart to a Senate bill that would require copay assistance to count towards cost-sharing requirements and ensure any prescription drugs are defined as "essential." A key HIV patient advocacy group separately pressed the White House budget office last week to include the policy in the 2026 health exchange ruling undergoing review, with the Trump administration so far not taking a public stance on the issue... Sub. Req’d

PDUFA VIII: US FDA Proposes Closing Orphan Drug User Fee Loophole

(12/8, Derrick Gingery, Pink Sheet) ...A prescription drug user fee program loophole could be closed in the next reauthorization, requiring orphan drug sponsors to pay user fees for the review of non-orphan indications. At the same time the US [FDA] is trying to ensure more fees are paid, industry is looking for PDUFA VIII changes that would cut the amount due... Global Sub. Full

GDUFA Costs ‘Destroy Economics' Of Onshoring Generics, Cuban Warns

(12/8, Dean Rudge, Generics Bulletin) ...Under the US [FDA's] Generic Drug User Fee Amendments (GDUFA), companies that wish to file an abbreviated new drug application pay fees for their submissions, which in part helps the FDA fund its drug-review operations. Cuban put this figure at around $360,000 per application. These fees, he said, made broad domestic production uneconomical, especially when paired with annual fees for each facility that produces either the active pharmaceutical ingredient (API) or the finished dosage form... Global Sub. Full

Sponsor Inspection Readiness Issues Emerge In Complete Response Letter Deficiencies

(12/8, Sue Sutter, Pink Sheet) ...Facilities that are not ready for an inspection can lead to delays in the FDA's site assessment and leave little time to resolve deficiencies ahead of a user fee goal, CBER compliance office Director Melissa Mendoza said... Global Sub. Full

FDA's Drug Price Push in Biosimilar Plan Hinges on Other Reforms

(12/9, Nyah Phengsitthy, Bloomberg Law) ...The [FDA] is seeking to lower drug costs by simplifying the development of biosimilars, products that are highly similar to FDA-approved biologics, have no clinically meaningful differences, and can treat patients the same way...The FDA action, however, might not immediately yield patient access to the cheaper medicines without reforming other policies that seek to make biosimilars available upon approval, drug pricing experts say. Biosimilars often face hurdles before hitting the market, frequently due to patent litigation, agreements between drug companies to defer entry, and how they're treated in health insurers' prescription drug plans... Sub. Req’d

FDA to Require CAR-T Developers Conduct Randomised Controlled Trials

(12/9, Elizabeth S. Eaton, FirstWord PHARMA) ...The FDA is looking to raise the bar for clinical trials of CAR-T cell therapies for cancer. Vinay Prasad, director of the agency's Center for Biologics Evaluation and Research (CBER), penned a piece for the Journal of the American Medical Association (JAMA) on Monday outlining how randomised controlled trials (RCTs) will be the standard moving forward... Full

EpiVax and FDA Scientists Publish New Insights on Immunogenicity Risks of Peptide-Related Impurities in Generic Teriparatide

(12/8, EpiVax) ...The study uses a series of different tools to evaluate whether peptide-related impurities may influence unwanted immune responses in generic teriparatide (TPT)—an important consideration for ensuring the safety and comparability of generic peptide drugs... Full

US FDA Drug Center Director To Be ‘Dual-Encumbered' During Pazdur, Høeg Transition

(12/8, Derrick Gingery, Pink Sheet) ...FDA Commissioner Martin Makary sent a memo to staff Dec. 8 stating that Høeg's appointment as acting CDER director would not be official until Dec. 15. Makary added that Pazdur "will work to transition the role through the end of the year."..."This role will be dual-encumbered to ensure a smooth and strong transition," Makary wrote. "This is an HR flexibility that is sometimes used to facilitate knowledge transfer and transition."... Global Sub. Full

AAM Comments on Pazdur Retirement and FDA Transition

(12/8, AAM) ...As the agency navigates this transition, AAM remains confident in the FDA's deep bench of scientific and regulatory expertise. The strength of the FDA has always come from its people; dedicated public servants that uphold the highest standards of safety, quality, and integrity. We are grateful for their continued commitment and for the stability they provide to patients and to America's healthcare system... Full

Missouri Aims to Address Medication Pricing by Reforming Pharmacy Benefit Manager System

(12/8, Cameron Montemayor, St. Joseph News-Press) ...Dual legislation introduced in both the Missouri House and Senate by Sen. Jill Carter (R-32) and Rep. John Hewkin (R-120) would modify definitions and regulations to address transparency and pricing disparities tied to pharmacy benefit managers, or PBMs... Full

GSK Ends Five-Year Partnership with IDEAYA

(12/8, Elizabeth S. Eaton, FirstWord PHARMA) ...The reasoning behind the breakup wasn't given in the brief update, though IDEAYA noted the British pharma will return IDE275 and IDE705, clinical programmes that target Werner Helicase and Pol Theta, respectively. The biotech said that next year, it will "evaluate its strategic options" for the two inhibitors... Full

BioNTech, OncoC4's Antibody More than Halves Risk of Death in Phase 3 Lung Cancer Trial

(12/9, Ayisha Sharma, Endpoints News) ...The biotech's treatment, called gotistobart, slashed the risk of death by 54% compared with standard-of-care docetaxel chemotherapy in a Phase 3 trial called PRESERVE-003. The data came from the non-pivotal part of the study, which enrolled 87 patients with metastatic squamous non-small cell lung cancer (NSCLC) who had progressed after treatment with an anti-PD-(L)1 drug and platinum-based chemotherapy... Sub. Req’d

BioNTech, BMS Unwrap Phase 2 Data for PD-L1xVEGF Bispecific in Breast Cancer

(12/9, Ayisha Sharma, Endpoints News) ...The drug, called pumitamig, combined with nab-paclitaxel chemotherapy, achieved a 62% confirmed overall response rate in a cohort of patients with triple-negative breast cancer (TNBC). The Phase 2 data from 39 patients with first- or second-line locally advanced or metastatic disease will be presented on Tuesday at the San Antonio Breast Cancer Symposium... Sub. Req’d

Will a Biotech's Pivot Away from Obesity Let it Compete with Novartis in Leukemia?

(12/8, Max Gelman, Endpoints News) ...In an interview with Endpoints News at ASH, Terns CEO Amy Burroughs said that trying to move forward in obesity would have required a partnership, and the company was more confident — and had better data — in chronic myeloid leukemia... Sub. Req’d

Eli Lilly's Jaypirca Makes First-Line Case in Chronic Lymphocytic Leukemia, but Ceiling May Be Capped

(12/9, Max Gelman, Endpoints News) ...The results, revealed at the American Society of Hematology's annual meeting, expand on last month's abstract and come in patients with previously untreated chronic lymphocytic leukemia (CLL), a slow-progressing form of blood cancer. Jaypirca cut the risk of cancer progression or death by 80% compared with chemotherapy plus rituximab... Sub. Req’d

Lilly Will Be 'Aggressive' in Spending GLP-1 Money, Top Dealmaker Van Naarden Says

(12/9, Max Gelman, Endpoints News) ...In an interview with Endpoints News, Van Naarden said the company is looking at everything that could help beef up its pipeline as it pulls in unprecedented revenue from Mounjaro and Zepbound, its diabetes and weight loss drugs. The GLP-1 revenue, which recently surpassed Merck's cancer drug Keytruda as the best-selling therapy in the world, puts Lilly "in a unique position to do really aggressive things," Van Naarden said. "It's an unusually large amount of capital, so we have to responsibly deploy that."... Sub. Req’d

At ASH, GSK's Top Cancer Exec Discusses the FDA's Different Take on Multiple Myeloma Drug Blenrep

(12/8, Frank Vinluan, MedCity News) ...Comeback stories are often the stuff of movies, but GSK is showing they can also happen in pharmaceuticals. The multiple myeloma medicine Blenrep has returned to the market three years after GSK voluntarily withdrew the product following the failure of the confirmatory study required of its accelerated FDA approval... Full

High Court Should Hear Skinny Label Drug Patent Case, US Says

(12/8, Michael Shapiro, Bloomberg Law) ...Hikma shouldn't be punished for its use of a so-called skinny label that "accurately described their drug as the generic version" of Amarin Pharma Inc.'s Vascepa, US Solicitor General D. John Sauer said in an amicus brief... Sub. Req’d

Stelara Purchasers Get Partial Class Status in J&J Antitrust Row

(12/8, Katie Arcieri, Bloomberg Law) ...Judge Jamar K. Walker granted class status to the buyers on federal and state antitrust claims, saying plaintiff Carefirst of Maryland Inc. demonstrated that facts common to class members predominated. Walker denied class status for Carefirst's state-law consumer protection and unjust enrichment claims, but said Carefirst demonstrated that 90 to 95% of class members were readily identifiable as to the antitrust claims... Sub. Req’d

Formycon and Zydus Partner for Exclusive Licensing and Supply Agreement of FYB206, a Biosimilar to Keytruda® (Pembrolizumab), in the U.S. and Canada

(12/9, Formycon) ...Under the terms of this agreement, Formycon AG will finalize development, prepare and file the regulatory dossier, and supply the product, while Zydus will be responsible for the commercialization of FYB206 in the U.S. and Canada... Full

Hopewell Told Delay Is ‘Of Its Own Making' As Cladribine Stay-Lifting Bid Fails

(12/9, Dean Rudge, Generics Bulletin) ...Delaware district judge Gregory Williams rejected Hopewell's arguments that Merck had unfairly stalled proceedings and that the stay no longer served its intended purpose, concluding that there was no legal basis to intervene under the Hatch-Waxman framework... Global Sub. Full

Biocon-BBL Integration: Can It Unmask The Biosimilars Arm's Intrinsic Worth?

(12/9, Anju Ghangurde, Generics Bulletin) ...Nimish Mehta Founder Research Delta Advisors told Scrip that an integration is a better option as it hedges Biocon against the "vagaries" of the biosimilar business and at the same time offers BBL investors the hedge of Biocon's traditional generic business, "which is viable and cashflow generating."... Global Sub. Full

Saya-Enze Partnership Signals Growing Momentum For Biosimilars In Mexico

(12/8, Dean Rudge, Generics Bulletin) ...The collaboration will see Saya Biologics register, commercialize and distribute two biosimilars locally, while Enzene Biosciences will lead development and manufacturing, in a partnership designed to accelerate market entry and reduce cost barriers for patients seeking biologic care... Global Sub. Full

Drugmakers Abandon Middlemen, Sell Directly To Patients

(12/9, Peter Loftus, The Wall Street Journal) ..."For the first time, pharma is actually looking end-to-end at the full patient journey," said Pratap Khedkar, chief executive of pharmaceutical consulting firm ZS. "That is a very different mindset than has been the case for the last 50 years."... Sub. Req’d

Merck Outbid Three Competitors in $9.2B Acquisition of Cidara

(12/9, Kyle LaHucik, Endpoints News) ...Unlike the deal for Verona, Merck had competition for Cidara. But Merck was willing to play ball, particularly as it searches for ways to fill billions of dollars in expected revenue loss from Keytruda's patent cliff later this decade... Sub. Req’d

Dr. Reddy's Siddique on Driving Efficiency, Delivering Value

(12/8, Chain Drug Review) ...Chain Drug Review spoke recently with Amber Hussain Siddique, director of finance at Dr. Reddy's Laboratories North America. Siddique leads the North America Controlling function, where he oversees expenditure evaluation, cross-functional collaboration on cost-saving initiatives, inventory operations, accounts payable, treasury, budgeting, forecasting and business reviews... Full

Slow Mail Delivery Hurts Medication Access: Study

(12/9, Maya Goldman, Axios) ...About 6% of Americans — including 3.7 million Medicare enrollees — face the triple-whammy of living far away from a pharmacy, relying heavily on mail-order prescriptions and residing in areas affected by the USPS consolidation plan...The bottom line: The postal system is a key, but sometimes overlooked, part of the country's public health infrastructure... Full

UK-US Trade Deal: How New Value Set For HTAs Will Impact UK Drug Pricing

(12/8, Francesca Bruce, Pink Sheet) ...The work to create a new value set that is to be used by NICE, the health technology appraisal body for England and Wales, in its evaluations should be complete within the first six month of 2026, according to the body. The value set is important because it is expected to accommodate higher-prices for drugs used on the National Health Service... Sub. Req’d

EU Targets Faster, Predictable Multinational Clinical Trial Reviews

(12/8, Vibha Sharma, Pink Sheet) ...Several EU member states have joined forces to pilot a coordinated fast-track procedure, starting in January 2026, to review the regulatory and ethical aspects of multinational clinical trial applications. The initiative, called FAST-EU (Facilitating and Accelerating Strategic Trials), is part of broader efforts to attract more clinical research across the bloc. It will also support the EU's upcoming Biotech Act, which is scheduled for publication on Dec. 16 and is expected to include provisions aimed at simplifying procedures for multinational clinical trials... Sub. Req’d

UK: NICE Threshold Increase Must Not Hit Generics Market, Lords Told

(12/8, Corrinne Burns, The Pharmaceutical Journal) ...The generic medicines market in the UK must not be hit by a decision to increase thresholds for drug recommendations by the National Institute for Health and Clinical Excellence (NICE), pharmacy stakeholders have said. The call comes in a letter sent to Baroness Morris, chair of the House of Lords Public Services Committee, on December 5, 2025. It was co-signed by the Company Chemists' Association, Community Pharmacy England, the Healthcare Distribution Association and Medicines UK... Full

Pharmacy Leaders Call for ‘Urgent' Investment in Generic Medicines

(12/8, Emily Warner, The Pharmacist) ...The UK-US agreement, and the commitment to increase prices for new branded medicines, must not be funded by ‘further pressure on the generic medicines market', urged the letter from the Company Chemists' Association (CCA), Community Pharmacy England (CPE), the Healthcare Distribution Agency (HDA), and Medicines UK... Full

Former Chief of China's Food and Drug Watchdog Ousted From Communist Party

(12/9, Phoebe Zhang, South China Morning Post) ...Bi Jingquan, China's former top food and drug regulator who received an international accolade for promoting innovation, has been expelled from the Communist Party and removed from public office on corruption charges. An investigation found that Bi had accepted gifts, money, trips and banquets and borrowed vehicles from private business owners, a statement from the Central Commission for Discipline Inspection (CCDI) said on Monday... Full

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