Friday, May 23, 2025

Please note: Teva Daily News will not publish Monday, May 26 in observance of the U.S. Memorial Day holiday. Publication will resume on Tuesday, May 27.

Sun Pharma to Ramp Up Specialty Play, Eyes More Acquisitions

(5/23, Ekta Batra, CNBC TV-18) ...Sun Pharma is looking to expand its specialty portfolio through strategic acquisitions. Group CFO CS Muralidharan told CNBC-TV18 that the company is open to deals across oncology, dermatology, and ophthalmology. "We have sufficient resources on the balance sheet. If the product is attractive and we can do well in the market, size is not a constraint at this point," he said... Full

Amgen And Samsung Soliris Biosimilars Skirt UK Infringement On Claim Construction

(5/22, Dean Rudge, Generics Bulletin) ...The UK High Court of Justice's Patents Court has ruled that Amgen's and Samsung Bioepis' biosimilars to Soliris (eculizumab) do not infringe Alexion's European patent 3,167,888. UK High Court justice Richard Meade sided with the biosimilars firms' argument that the patent's claims are limited to "what they literally say," rejecting a purposive reading of the claims put forward by Alexion... Global Sub. Full

GSK Revs Up Launch Plans After Nucala's FDA Approval in COPD, Targeting £500M Opportunity

(5/22, Fraiser Kansteiner, Fierce Pharma) ...The FDA on Thursday approved Nucala as an add-on maintenance treatment for adults with inadequately controlled COPD and an eosinophilic phenotype. The thumbs-up makes Nucala (mepolizumab) the second biologic approved for the disease and the third new COPD therapy to score approval in the U.S. in less than a year... Full

Jazz Outlines Full Survival Data for Lung Cancer Drug Zepzelca

(5/22, Max Gelman, Endpoints News) ...In patients with extensive-stage small cell lung cancer, Jazz's drug Zepzelca combined with Roche's Tecentriq demonstrated a 27% reduction in the risk of death compared to Tecentriq alone. Median follow-up was 15 months, and the result was statistically significant with a p-value of 0.0174... Sub. Req’d

ASCO: Roche Details Itovebi's Survival Benefit in Certain Breast Cancers, Further Backing Blockbuster Plan

(5/22, Zoey Becker, Fierce Pharma) ...Adding Itovebi to Ibrance and Faslodex slashed the risk of death by 33% in patients with PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer that has grown during or after hormone therapy treatment. The data, to be presented at the American Society of Clinical Oncology's (ASCO's) annual meeting, come from Roche's pivotal phase 3 INAVO120 trial... Full

Alembic Pharma Gets USFDA Nod for Generic High Blood Pressure Treatment Drug

(5/23, Press Trust Of India) ...Alembic Pharmaceuticals announced that it has secured final approval from the USFDA for its generic amlodipine and atorvastatin tablets, used for treating hypertension. The approval covers multiple strengths of the tablets, therapeutically equivalent to Pharmacia and Upjohn Co LLC's Caduet. With this approval, Alembic now has a cumulative total of 223 ANDA approvals from the USFDA... Full

Bayer's Eylea Set for Longer Treatment Intervals to Challenge Roche's Vabysmo

(5/23, Robert Barrie, Pharmaceutical Technology) ...A committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion that would allow 8mg of Eylea to be injected in intervals of up to six months...Although Eylea is approved in four indications in Europe, the label extension will only be eligible for two conditions, notably neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular oedema (DME). The European Commission will now mull over CHMP's opinion with a decision "expected within the next weeks", according to Bayer, which licensed the rights to the drug outside the US from manufacturer Regeneron in 2012... Full

Sanofi Opens Doors to $130M 'Flagship' US Office Facility in New Jersey

(5/22, Fraiser Kansteiner, Fierce Pharma) ...In the wake of the COVID-19 pandemic, which acclimated many workers to at-home or hybrid work models, French drugmaker Sanofi concluded that the traditional office paradigm was on its way out. Now, following efforts by the company to modernize its workspaces in France and beyond, nearly 2,000 employees have moved on up to Sanofi's new flagship U.S. offices in New Jersey... Full

PBM WellDyne Teams Up with Waltz Health On Specialty Pharmacy

(5/22, Paige Minemyer, Fierce Healthcare) ...WellDyne is teaming up with Waltz as well as Mark Cuban Cost Plus Drugs as part of its broader member routing strategy, which surfaces real-time alerts and smart prompts that can help its members find the most affordable medication option for them. The PBM's tech stack also uses automated algorithms to adjudicate claims in the background and let members know when they may be able to achieve savings... Full

Makary Signals Support For Biosimilar Interchangeability Reform

(5/22, Maaisha Osman, Inside Health Policy) ...FDA Commissioner Marty Makary signaled his support to streamline the approval and uptake of biosimilar drugs in his first appearance before Congress as commissioner Thursday (May 22), including reconsideration of removing the controversial "interchangeability" designation that industry experts say has hindered competition and kept drug prices high... Sub. Req’d

Trump Admin Seeks Feedback On Price Transparency for Prescription Drugs

(5/22, Paige Minemyer, Fierce Healthcare) ...The Departments of Labor, Treasury and Health and Human Services jointly issued a request for information on Thursday that is looking for public comment on requirements around drug price disclosures, including existing data elements. The agencies are also seeking input on access factors, like how readily health insurers can secure the information necessary for reporting... Full

House Passes Trump Tax Bill with PBM and Orphan Drug Reforms Included

(5/22, Zachary Brennan, Endpoints News) ...The reconciliation package also includes some pro-pharma changes but so far does not include PhRMA-backed reforms related to the price negotiation program's "pill penalty," which Trump has pledged to support. Currently, small molecule pills are eligible for negotiation seven years after FDA approval, while biologics are eligible 11 years following approval. PhRMA and industry are seeking to change the seven-year wait for small molecule drugs to 11 years. The Senate is expected to pass a version of the House bill, and the Wall Street Journal reported that Republicans are aiming to get the package to Trump's desk by July 4... Sub. Req’d

Trump Predicts Drug Prices Will ‘Drop Like a Rock' After New Executive Order

(5/22, Joseph Choi, The Hill) ...President Trump on Thursday claimed his recent "most favored nation" executive order could cause U.S. drug prices to "drop like a rock" in just a matter of weeks, saying the savings will be "incalculable."...Trump shifted much of the blame for sky-high drug prices to other countries, saying they're "a lot more vicious than us in terms of their representatives," and he claimed the U.S. has been subsidizing the low cost of drugs in other nations. "We are going to now get a reduction in drug costs of up to 89 percent in some cases, but 50 percent would be a low, a bad number," Trump said... Full

MAHA Report Blames 'Overmedicalization,' Pharma's Influence for Children's Poor Health

(5/22, Dave Muoio, Fierce Healthcare) ...Likely of immediate interest to the healthcare industry is the section on "The Overmedicalization of Our Kids." It outlines increased utilization of prescription treatments with "proven harms," such as psychiatric drugs that could have short-term adverse effects like seizures, or antibiotics that could bring allergic reactions and contribute to antibiotic resistance development. It also describes unnecessary treatments or those without benefit over placebo as a net harm, which the report said is the case when treatments are given for a misdiagnosis of conditions like ADHD or depression that "are diagnosed disproportionately in children relatively young for their school grade."... Full

Biosimilars Forum Submits Comments to Accelerate Safe and Effective Biosimilar Development by Modernizing the FDA and Eliminating Bureaucratic Inefficiencies

(5/22, Biosimilars Forum) ..."The Biosimilars Forum submitted comments to OMB Director Vought on commonsense, necessary steps to optimize the FDA and eliminate inefficiencies in its biosimilars approval program. These recommendations are critical to achieving the Trump Administration's priorities of accelerating the approval of biosimilars and eliminating unnecessary bureaucracy at federal health agencies..."... Full

Drug Companies: Lower the List Price

(5/22, JC Scott, DC Journal) ...Every policymaker in America, on both sides of the aisle, wants to lower prescription drug costs. There is a basic understanding that drug costs are too high for some patients. How to lower drug costs is equally basic: the drug companies that set the prices should lower those prices. Unfortunately, drug companies have succeeded at muddying the path to achieving this universally shared objective... Full

Meet the ‘First Sale' Rule: A Customs Loophole Pharma Companies Could Use to Ease Tariff Impact

(5/22, Anna Brown, Endpoints News) ...Called the "first sale" rule, this allows companies to reduce the value of a drug declared at US customs, substantially lowering the tariff duty they would have to pay...Two lawyers who work directly with pharma companies spoke with Endpoints News on the condition of anonymity and said they've had increased inquiries from their clients looking to use the first sale rule. Endpoints reached out to the top 10 pharma companies for comment, but all either declined to comment or didn't respond in time for publication... Sub. Req’d

FDA Chief to Senators: 3,000+ Staff Departures Won't Delay User Fee Targets

(5/22, Zachary Brennan, Endpoints News) ...Makary said that in total, about 1,900 FDA employees have been let go under the Trump administration, and another 1,200 employees retired early from the agency. He later added that no scientific reviewer or inspector was cut as part of the reduction in force, but that there have been cuts to scientific researchers. He stressed several times throughout the hearing that drug approvals would not be delayed because of the cuts... Sub. Req’d

Non-User Fee Dollars Increased In US FDA's Updated FY 2026 Budget Request

(5/22, Derrick Gingery, Pink Sheet) ...FDA Commissioner Martin Makary gave an apparently updated FY 2026 budget request for the agency that increased the non-user fee total about 9% from the amount in an April OMB "passback" document. The budget authority total still would be lower than previous years and about in line with the FY 2021 total. Makary also said the agency continues to hire scientists and defended the recent RIF during a Senate appropriations subcommittee hearing... Global Sub. Full

Florida, Michigan Lawmakers Lead Charge To Secure America's Medicine Cabinet, Cut China Reliance

(5/22, Leslie Bolden, Tampa Free Press) ...A bipartisan group of senators, including Florida's Rick Scott and Michigan's Gary Peters, has introduced the Mapping America's Pharmaceutical Supply (MAPS) Act, a legislative effort aimed at strengthening the nation's access to essential medicines and reducing dependence on foreign sources, particularly China. The bill seeks to codify and build upon a Trump administration Executive Order designed to secure the U.S. pharmaceutical supply chain... Full

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

(5/22, Vibha Sharma, Pink Sheet) ...Among the four new harmonized guidelines that the International Council for Harmonisation plans to develop, one will explain how to use real-world evidence for drug effectiveness, and another will deal with how to leverage registry and natural history data for rare diseases. Draft guidelines on including pregnant and breastfeeding women in clinical trials (ICH E21), and revising the quality section of the Common Technical Document (ICH M4Q(R2)) have progressed to the public consultation phase... Global Sub. Full

US ‘Most Favored Nation' Pricing Could be Game Changer for Drug Access In Germany

(5/22, Francesca Bruce, Pink Sheet) ...Access to medicines in Europe could be at stake if pharmaceutical companies delay or decide against launching there because of fears that lower prices may be adopted in the US in light of President Trump's "most favored nations" (MNF) policy, warned Alexander Natz, secretary general of EUCOPE, which represent small and medium sized companies in Europe. The risk of such decisions is greater in Europe's biggest pharmaceutical market, Germany, because net prices there are widely available, unlike in other European countries where they are kept confidential, he said... Global Sub. Full

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