Tuesday, January 7, 2025

Teva Intros Generic Tykerb

(1/6, Sandra Levy, Drug Store News) ...Teva is offering lapatinib tablets, which is the generic of Tykerb. Lapatinib tablets are used with capecitabine to treat people with breast cancer that is advanced or that has spread to other parts of the body (metastatic), and that is HER2-positive (tumors that produce large amounts of a protein called human epidermal growth factor receptor-2), and who have already had certain other breast cancer treatments... Full

Bancel Says Moderna's RSV Strategy Was 'Too Optimistic'

(1/6, Elizabeth S. Eaton, FirstWord Pharma) ...In a letter to shareholders Monday, Moderna CEO Stéphane Bancel acknowledged the underperformance of its respiratory syncytial virus (RSV) jab mResvia — which only brought in $10 million in sales during the third quarter of 2024, well below analyst forecasts of $135 million. Bancel pointed to guidance from a CDC panel as one of the factors behind the vaccine's limited uptake... Full

The Third Time's The Charm? Xbrane Resubmits Ranibizumab In US

(1/6, Dave Wallace, Generics Bulletin) ..."FDA has not requested any additional clinical trials nor any further studies to demonstrate biosimilarity," clarified Xbrane at the time, pledging to assemble a task force of "very experienced team members," both from within the firm and also with "external expertise," to address the agency's feedback. Having indicated in July that the firm was working towards a resubmission by the end of 2024 – eyeing a Q2 2025 approval – Xbrane announced on 31 December that it had resubmitted its filing to the FDA... Sub. Req’d

Aurobindo Ramps Up In Biosimilars With UK Bevacizumab Nod

(1/7, Dave Wallace, Generics Bulletin) ...CuraTeQ's Bevqolva biosimilar has been granted a marketing authorization by the UK's Medicines and Healthcare products Regulatory Agency as a 25mg/ml concentrate for infusion that will be available in 4ml (100mg) and 16ml (400mg) single-use vials for infusion. The product is used in the treatment of multiple cancers, including metastatic colorectal cancer, recurrent or metastatic non-squamous non-small cell lung cancer, advanced and/or metastatic renal cell carcinoma, cervical cancer and epithelial ovarian, fallopian tube and primary peritoneal cancer... Sub. Req’d

Biosimilar Brand Buy to Help Intas Pharma Take on Biggies

(1/6, Vikas Dandekar, The Economic Times) ...MUMBAI: Intas Pharmaceuticals' acquisition of Udenyca for up to $558.4 million (about Rs 4,784 crore) will pit it against other leading biosimilar makers like Biocon, Amgen, Pfizer, Fresenius Kabi and Sandoz in the fast-growing global market for oncology treatment. In one of the biggest deals worldwide for a biosimilar brand, Ahmedabad-based Intas agreed to buy Udenyca-the brand name for medication pegfilgrastim-cbqv-from US-based Coherus BioSciences. Udenyca will be sold in the US by Accord BioPharma, the specialty division of Intas Pharma... Full

Bancel Says Moderna's RSV Strategy Was 'Too Optimistic'

(1/6, Elizabeth S. Eaton, FirstWord Pharma) ...In a letter to shareholders Monday, Moderna CEO Stéphane Bancel acknowledged the underperformance of its respiratory syncytial virus (RSV) jab mResvia — which only brought in $10 million in sales during the third quarter of 2024, well below analyst forecasts of $135 million. Bancel pointed to guidance from a CDC panel as one of the factors behind the vaccine's limited uptake. The Advisory Committee on Immunization Practices (ACIP) voted unanimously in June to limit RSV vaccines to adults 75 and older, representing a much more limited patient population compared with a 2023 recommendation that all adults over the age of 60 "may receive" an RSV jab... Sub. Req’d

FDA Warning Letter Reveals Quality Control, Data Integrity Issues at Viatris Plant in India

(1/6, Fraiser Kansteiner, Fierce Pharma) ...Following Viatris' December announcement that a manufacturing plant in India had been written up by the FDA, a document published by the U.S. regulator reveals the details behind the company's manufacturing infractions. In a warning letter posted online late last month, the FDA scolded Viatris over a range of production slights at the company's Pithampur plant in the Indian state of Madhya Pradesh. The violations include poor quality control, inadequate handling of manufacturing errors and more... Full

CVS Officially Rolls Out CostVantage Model for Commercial Prescriptions

(1/6, Paige Minemyer, Fierce Healthcare) ...All of the commercial prescriptions dispensed at CVS pharmacies will be processed through its CostVantage reimbursement model beginning this year, the healthcare giant announced on Monday. Under the model, prescriptions are priced based on the underlying cost with a delineated markup and dispensing fee to cover the services provided by CVS in the transaction. The company says that this model makes it less necessary to raise the cost for certain prescriptions to cover losses on other drugs... Full

Trump Denies Report That His Team Is Eyeing Pared-Back Tariffs

(1/6, Reuters) ...U.S. President-elect Donald Trump on Monday denied a newspaper report that said his aides were exploring tariff plans that would only cover critical imports, deepening uncertainty among business leaders about future U.S. trade policies. Trump responded on his Truth Social platform after the Washington Post cited three sources familiar with the matter as saying that Trump aides were exploring a narrower approach to tariffs, focused on certain critical sectors... Full

Generic Drug Group Revives Ask for Pause on Illinois Pricing Law

(1/6, Celine Castronuovo, Bloomberg Law) ...The national group representing generic drug and biosimilar manufacturers is looking to replicate its success challenging state pricing limits with a motion filed Friday requesting a federal judge pause enforcement of an Illinois anti-price gouging law. Members of the Association for Accessible Medicines face a high risk of penalties under the state statute prohibiting excessive price gouging on generic and other off-patent drugs, the organization wrote in its brief filed in the US District Court for the Northern District of Illinois... Sub. Req’d

Reforms Can Improve Competition and Generate More Savings

(1/7, Wayne Winegarden, Pacific Research Institute) ...Given biosimilars' demonstrated ability to reduce the costs of medicines, removing policy obstacles and improving the functioning of the competitive market can be expected to generate additional savings in the near- and longer-term. Three high priority reforms/changes include reforming (ideally repealing) the price negotiation authority granted to the Health and Human Services (HHS) by the Inflation Reduction Act (IRA), improving the buy-and-bill purchase system including delinking a clinic's reimbursement from the price of drugs, and reforming the malfunctioning rebate system... Full

MA-PD Deductibles Up, PDP Options Down Amid Big Policy Changes in 2025

(1/6, Jinghong Chen, Pink Sheet) ...Medicare Part D benefit policy changes included in the Inflation Reduction Act, namely a $2,000 out-of-pocket drug costs cap, will lead to lower out-of-pocket spending for some Part D enrollees, but higher costs for Part D plans overall in 2025, according to a KFF analysis. Six in 10 enrollees in Medicare Advantage Prescription Drug (MA-PD) plans will be charged a deductible for drug coverage if they stay in their current plan, compared to just 21% in 2024. The average drug deductible for MA-PD plans will increase four-fold from $59 in 2024 to $225 in 2025... Sub. Req’d

Novo Petition Argues FDA's 503B Bulks List Violates Law, GLP-1 Should Be Removed

(1/6, Jessica Karins, Inside Health Policy) ...Novo Nordisk is joining fellow GLP-1 drug manufacturer Eli Lilly in alleging FDA is violating the law by allowing compounding of GLP-1 drugs, even when the brand-name versions are in shortage, arguing in a new communication with FDA that the 503B Bulks List of drugs allowed to be compounded during times of shortage is invalid. Even if the list stands, Novo says that its GLP-1 liraglutide should not be compounded because of what it says are heightened risks to patients... Sub. Req’d

PBMs Have Evaded Lawmakers' Reform Attempts So Far. Could 2025 Turn The Tide?

(1/6, Amy Baxter, PharmaVoice) ...Pharmacy benefit managers are facing an uphill battle to maintain their status quo in the healthcare arena. Known as the middlemen of the pharma industry, PBMs play an intermediary role between health insurers, pharmacies and patients, negotiating drug prices and designing formulary plans while mediating cost efficiency for their clients. Or so they claim. According to critics, PBMs drive up drug costs through an opaque rebate system, and their joint ownership structure with pharmacies and health insurers creates an unfair and anticompetitive business model... Full

Rep. Auchincloss to Newsmax: Pharmacy Benefit Managers Drive Up Costs

(1/6, Mark Swanson, Newsmax) ...Auchincloss joined "The Record With Greta Van Susteren" to say the 119th Congress needs to rein in Cigna's Express Scripts, CVS Caremark, and Optum Rx of UnitedHealthcare Group. While the names are known, many Americans don't know what they do, and that's intentional, he said. PBMs "like being in the middle of a complicated supply chain, and they are shielded from public scrutiny and congressional scrutiny. They can be rent-seekers, and they are taking about $300 billion from the U.S. healthcare system every year," Auchincloss said... Full

Batch Uniformity: FDA Details Testing Approaches for Continuous Manufacturing, 3D Printing

(1/6, Joanne S. Eglovitch, Regulatory Focus) ...The US Food and Drug Administration (FDA) has issued draft guidance to assist manufacturers in complying with its good manufacturing practice (GMP) regulations under 21 CFR 211.110 governing batch uniformity for drug and biological products. The guidance specifically addresses methods for ensuring blend uniformity for products made through advanced manufacturing techniques, such as continuous manufacturing and 3D printing... Full

US FDA's Inspections Reorg: Changes In Form 483 Responses, Faster Engagement With Product Centers

(1/6, Sue Sutter, Pink Sheet) ...Product sponsors are seeing some early changes from the US Food and Drug Administration's reorganized inspection operations, including the need to send FDA-483 responses to different offices, but also faster engagement by product centers after inspections. The FDA's product center compliance directors also discussed their expectations for greater inspection and compliance review efficiencies and more unified decision-making during the Food and Drug Law Institute's recent Enforcement, Litigation and Compliance Conference... Sub. Req’d

Common Drugs Could Be Releasing 'Forever Chemicals'

(1/7, Amudalat Ajasa, The Washington Post) ...The widespread use of pharmaceuticals in America is introducing even more toxic "forever chemicals" into the environment through wastewater, according to a study released Monday, and large municipal wastewater treatment plants are not capable of fully filtering them out. The plants' inability to remove compounds known as organofluorines from wastewater before it enters drinking water supplies becomes even more pronounced during droughts and could affect up to 23 million people, scientists wrote in an article published Monday in Proceedings of the National Academy of SciencesHealth Care Is Newsom's Biggest Unfinished Project. Trump Complicates That Task... Full

Angela Hart and Christine Mai-Duc

(1/6, California Healthline) ...some of Newsom's signature health initiatives, which could shape his profile on the national stage, are in peril as Donald Trump returns to the White House. According to national health policy experts, California stands to lose billions of dollars in health care funding should the Trump administration alter Medicaid programs as Republicans have indicated is likely. Such a move could force the state to dramatically slash benefits or eligibility... Full

Poll: Marylanders Unconvinced Lower Drug Costs Would Hinder Research for New Treatments

(1/6, Danielle J. Brown, Maryland Matters) ...New poll results say that Marylanders believe prescription drug prices can be reduced without cutting into funding for drug researc and development. Photo by Angela Breck. A new poll says an overhwhelming majority of Marylanders believe drug manufacturers could reduce costs for prescription drugs without cutting into funds going to research and development of new drugs, a key argument of the pharmaceutical industry... Full

India Poised to Be Healthcare Custodian of World, Says Torrent's Samir Mehta

(1/7, Press Trust of India) ..."The journey of Indian pharma is a testament to how key policy reforms coupled with entrepreneurial spirit have nurtured the sector's growth," Mehta wrote in an article on the occasion of IPA completing 25 years. "The Indian pharmaceutical sector stands at a critical juncture as India heads toward 2047. From job creation to global trade and innovation to public health, the industry's contributions will be central to realising the goals of 'Viksit Bharat."... Full

Japan's 2025 ‘Off-Year' Price Cut Stirs Deeper Concerns

(1/7, Lisa Takagi, Pink Sheet) ...A 25 December announcement from the Ministry of Health, Labour and Welfare (MHLW) indicated the broad re-pricing under the country's National Health Insurance (NHI) scheme aims to save JPY246.6bn ($1.57bn) in overall drug spending and JPY64.8bn in government costs, with several new features directed at the financial sustainability of the NHI program. Japan has long implemented such reductions - aimed at bringing reimbursement into line with actual market prices - every two years. But in-between revisions started in 2021 to further control rising healthcare costs, in a decision which has stirred criticism from the industry and some other groups... Sub. Req’d

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