Wednesday, October 15, 2025

Cold Chain Technologies Validates Ocean Freight for Temp-Sensitive Pharma Shipments

(10/14, Charlie Sternberg, Contract Pharma) ...Cold Chain Technologies (CCT), a provider of temperature-controlled packaging solutions, has completed a project demonstrating the viability of ocean freight for transporting temperature-sensitive pharmaceutical products. The initiative, conducted in collaboration with logistics firm Kuehne + Nagel and drugmaker Teva Pharmaceuticals, tested the shipment of pharmaceuticals from Germany to Australia—one of the most logistically demanding sea routes... Full

Cold Chain Technologies enables sea freight success for Teva and Kuehne+Nagel

(10/14, AJOT) ...The project, which validated the transportation of temperature-sensitive pharmaceuticals on one of the world's most demanding sea routes - from Germany to Australia - has shown that sea freight can offer a viable, cost-effective and more sustainable* alternative to air cargo. Despite facing a series of extreme logistical setbacks, the shipment arrived in perfect condition, thanks in part to Enshield, a high-performance, reusable PCM thermal blanket from Cold Chain Technologies...The ship set out from Germany in November 2023, with an estimated journey time of about 60 days. However, circumstances would determine that the shipment would arrive on land a full 10 days late – but with no impact on the target temperature range of 2-8 degrees C. "Pretty much everything that could go wrong did so, in terms of putting pressure on the integrity of the cargo," confirmed Fabian Reitmeier, Project Manager Logistics Integrity at Teva Logistics... Full

No Trump Drug Pricing Plan for J&J—Yet

(10/14, Annalee Armstrong, BioSpace) ...Johnson & Johnson has not yet secured a drug pricing plan with the White House, as the healthcare giant's peers Pfizer and AstraZeneca have. CEO Joaquin Duato told analysts that discussions are ongoing to find "common ground" on the issue that has dogged the pharmaceutical industry since President Donald Trump took power in January. Speaking on the company's third quarter earnings call Tuesday, Duato said discussions are ongoing and have been "since day one, even before day one."... Full

J&J Chief Duato Expects to Find 'Common Ground' with Trump Administration as Industry's MFN Talks Play Out

(10/14, Fraiser Kansteiner, Fierce Pharma) ...With two Trump administration drug pricing deals in the books and more likely on the way, the U.S. policy environment could soon stabilize for many Big Pharma companies. That put Johnson & Johnson in an interesting position this week, as the drugmaker led the vanguard on the industry's third-quarter earnings reporting but has yet to strike a formal pricing accord with the government... Full

Expert: Tariff Increases May Pressure Pharmacy Margins and Supply Chains

(10/14, Ron Lanton III, Esq and Luke Halpern, Pharmacy Times) ...In an interview with Pharmacy Times®, Ron Lanton, partner at Lanton Law, discusses the potential impact of increased tariffs and trade restrictions on the pharmaceutical industry. Lanton warns that such measures would likely raise costs and disrupt product supply, ultimately squeezing pharmacy margins and operational efficiency... Full

President Trump's Executive Orders On Prescription Drug Prices: What The Evidence Says

(10/14, Jeromie Ballreich Michelle Mello Marissa B. Reitsma, et al., Health Affairs) ...The first, issued on April 15, 2025, announced the objectives of delivering lower drug prices for US patients, creating a fairer prescription drug market, and ending policies that distort incentives for different kinds of innovation. The second, on May 12, 2025, emphasized the need to "get the best deal" on drugs for US patients. Both EOs propose an expansive array of policies, some extending initiatives from the first Trump administration, others building on legislation passed during the Biden Administration, and some are new. Achieving the full policy agenda will require cooperation from Congress, making it important for policy makers to understand the evidence underlying the proposals as well as specific ways in which the ideas could be operationalized... Full

PCMA Announces President & CEO JC Scott to Step Down Before Year End

(10/14, PCMA) ...After more than seven years leading the Pharmaceutical Care Management Association and in the last year of his contract with the organization, PCMA President and CEO Juan Carlos "JC" Scott today announced his decision to step down before the end of the year... Full

The FDA and PBMs Are Blocking Cheap Biologics

(10/14, Justin Leventhal, DC Journal) ...Overregulation and a lack of coverage have left the United States with too few biosimilars and too few being developed. Smart reforms can change this. First, the FDA should finalize the decision to drop unnecessary interchangeability tests...Second, Congress should require transparency from PBMs in the form of upfront reporting on the biosimilars they offer and those they don't. Without comparable data, insurers cannot pressure PBMs to compete on access and price. Until biosimilars are given a fair chance to compete, patients will continue to pay more than they should for essential medicines... Full

OMB Reviews FDA Guidance That May Ease Biosimilar Requirements

(10/14, Jessica Karins, Inside Health Policy) ...At that meeting, senior FDA officials said they were weighing when, if at all, to require comparative efficacy studies as part of a broader push to make biosimilars development "as efficient as possible," according to Korea Biomedical Review. Comparative efficacy studies are head-to-head trials aimed at showing a biosimilar works the same in patients as its reference product, and U.S. and European regulators are weighing whether sameness could be shown by analytics and immunogenicity data instead... Sub. Req’d

Wholesalers Sue Connecticut Over Law On Generic Drug Price Hikes

(10/14, Celine Castronuovo, Bloomberg Law) ...A national organization representing prescription drug distributors is taking Connecticut to federal court over a new state law prohibiting excessive price increases on generic drugs. The law, which goes into effect Jan. 1, 2026, unconstitutionally imposes "draconian penalties" on wholesale distributors if generic drug products are sold in Connecticut above the price at which the wholesaler purchased the drug from the manufacturer, the Healthcare Distribution Alliance said in its lawsuit filed Tuesday in the US District Court for the District of Connecticut... Sub. Req’d

Sen. Rick Scott Teases COOL Bill for Pharmaceuticals

(10/14, Inside U.S. Trade) ...Citing safety and national security concerns about foreign-made pharmaceuticals, Florida Sen. Rick Scott (R) is crafting legislation that would require country-of-origin labels on prescription drugs. In opening remarks before an Oct. 8 hearing of the Senate Special Committee on Aging, which he chairs, Scott said U.S. consumers "deserve to know where items they purchase are made." The labels would include "the country where each drug ingredient and the finished drugs are manufactured, processed or compounded," he said, noting a previous attempt to pass legislation to implement origin labels for consumer products... Sub. Req’d

FDA Approves Risperidone Injection for Bipolar I Disorder in Adults

(10/14, Ashley Gallagher, Drug Topics) ..."Adults living with BD-I experience debilitating manic and depressive symptoms, and today's FDA approval of Uzedy provides a new long-acting formulation of risperidone that may help address existing unmet needs and treatment gaps," Chris Fox, executive vice president of US Commercial at Teva, said in a news release. "This expanded indication for Uzedy builds on its success in adults living with schizophrenia and demonstrates Teva's dedication to developing innovative medicines for complex mental health conditions that place a heavy burden on individuals and their caregivers."... Full

Pfizer Scores Again in HER2-Positive Breast Cancer, This Time With Seagen's Tukysa

(10/14, Angus Liu, Fierce Pharma) ...When used as a first-line maintenance therapy in patients with HER2-positive metastatic breast cancer who've responded to standard induction therapy, Tukysa significantly prolonged the time before cancer progression or death compared with placebo, Pfizer said Tuesday. Both Tukysa and placebo were given in combination with the standard maintenance regimen of Roche's Herceptin and Perjeta... Full

Celltrion Gets 1st Stelara Biosimilar OK in New Zealand, Broadening Oceania Footprint

(10/15, Kim Ji-hye, Korea Biomedical Review) ...The clearance covers all of Stelara's approved uses in New Zealand -- plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis -- and allows sales in both vials and prefilled syringes. Celltrion said Steqeyma is the first Stelara look-alike cleared in New Zealand, a country that has encouraged switches to lower-cost alternatives. In 2023, the Kiwi government moved reimbursement for the cancer drug trastuzumab from the brand-name Herceptin to a biosimilar to widen access... Full

Pfizer CEO Says US Pharma Industry Needs to Collaborate with China

(10/14, Michael Erman, Reuters) ...Pfizer Chief Executive Albert Bourla said on Tuesday that the U.S. pharmaceutical industry needs to collaborate with China's, where speedy processes have vaulted it to 30% of global drug development over the past decade. "In biopharma, China's dramatic speed, cost and scale have triggered a shift in the global competitive landscape," Bourla said, speaking at the National Committee on U.S.-China Relations Gala in New York... Full

Halozyme CEO Targets M&A and New Deals as IRA Uncertainty On Pharma Subsides

(10/14, Angus Liu, Fierce Pharma) ...Halozyme Therapeutics has been busy. While fighting a patent dispute with Merck & Co. and navigating the impact of the Inflation Reduction Act (IRA), the company has penned an acquisition of fellow drug delivery biotech Elektrofi. Halozyme scoured very broadly for potential acquisitions in the drug delivery field before landing on Elektrofi, Halozyme CEO Helen Torley said during an interview on the sidelines of Fierce Biotech Week in Boston... Full

Which Big Pharma Has The Busiest BD Team? You Might Be Surprised

(10/15, John Carroll, Endpoints News) ...Looking at which of the big pharma business development teams were busiest striking licensing deals, Merck and Bristol Myers get lots of attention for writing big checks for buzzy acquisitions. But they don't come close to cracking the top five in terms of overall licensing deal numbers. Here's what DealForma's Chris Dokomajilar sussed out after crunching the past 21 months of deal data for the second part of our Q3 analysis... Full

EU Decision Time For Insmed's Brensocatib And Sanofi's Belumosudil

(10/14, Eliza Slawther, Pink Sheet) ...Teva's Austedo (deutetrabenazine), which the CHMP already in June said should receive EU marketing authorization for treating adults with moderate-to-severe tardive dyskinesia is also listed on the committee's October meeting agenda as being up for a CHMP opinion (see EMA Nod For First MASH Drug Rezdiffra, Cell Therapy Zemcelpro And 11 Others). Teva is set to appear before the CHMP for an oral explanation meeting on Oct. 15 relating to its request for a re-examination of the CHMP's June positive opinion. It is not yet clear why Teva requested the re-examination – the Pink Sheet contacted the company but had yet to hear back by the time this article was published... Global Sub. Full

Swiss Corporates Pursue Outbound M&A to Boost Pharma Pipelines, Mitigate Tariffs – Dealspeak EMEA

(10/14, Aurelia Seidlhofer, Rupert Cocke and Anahita Sawhney, ION Analytics) ...Outbound M&A deal volume, at EUR 29bn in the year through October 8, has exceeded inbound and domestic activity in Switzerland so far this year, and also did so in the same period last year, according to Mergermarket data. "2025 is shaping up to be a strong year for Swiss M&A and the pipeline of potential deals remains very robust," said Reinout Boettcher, senior country officer for Switzerland and head of Swiss Investment Banking at J.P. Morgan. "Cross-border M&A continues to define the Swiss market, with domestic firms – particularly in the healthcare and industrial sectors – actively seeking acquisitions abroad," Boettcher said... Full

Alumnus Pharmacist of MMC from New York Urges 'One Nation, One Regulator' to Fix India's Drug Safety Flaws

(10/15, Pharmabiz.com) ...In the wake of the recent cough syrup tragedy linked to Sresan Pharmaceuticals in Tamil Nadu which resulted in the death of more than 20 children, an Indian-American pharmacist and alumnus of Madurai Pharmacy College (MMC), A Manoharan has called for an urgent overhaul of India's drug regulatory system... Full

China NMPA Accelerates Market Access For Imported Medicines

(10/14, Xu Hu, Pink Sheet) ...China's NMPA releases new measures to speed up domestic access to selected imported medicines already approved abroad ahead of their formal final approval in China. The changes are designed to enable earlier patient access to high-need drugs. New steps form part of broader policies outlined earlier this year aimed at smoothing and speeding up regulatory pathways... Global Sub. Full

Surge in Out-Licensing Deals Drive China's International Pharma Collaborations

(10/14, The Pharma Letter) ...China's out-licensing deals have significantly increased over the last five years, showcasing the country as a source of innovative drugs. The licensing agreements provide global recognition as well as validation for China's advancements in drug development. With China-origin innovations becoming must-watch opportunities for global pharma, collaborations with the US and EU are reaching record scale and value, says pharma analytics company GlobalData... Full

China's Drugs Offer Lifeline for Global Pharma as It Peers Over the Patent Cliff

(10/14, Frankie Fattorini, Pharmaceutical Technology) ..."The continued flow of deals with US and EU global pharmaceutical companies continues to validate the strength and maturity of China's innovation landscape," said George El-Helou, Pharma Strategic Intelligence analyst at GlobalData. While once notorious for cases of fabricated clinical data, El-Helou said China is now globally recognised as a leader for best-in-class therapies... Full

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