Friday, April 5, 2024

Teva, Forging Ahead with New Strategy, Inks Biosimilar Deal with Spain's mAbxience

(4/4, Fraiser Kansteiner, Fierce Pharma) ...As Teva advances its Pivot to Growth strategy under CEO Richard Francis, the company is making good on its pledge to beef up its biosimilar pipeline through outside deals. The Israeli-American drugmaker has unveiled a fresh in-licensing accord with Spain's mAbxience to chip in on an investigational biosimilar spanning "multiple oncology indications," according to a Thursday release... Full

Teva And mAbxience Join Forces On Unnamed Oncology Biosimilar

(4/5, Dean Rudge, Generics Bulletin) ...The collaboration reflects Teva's "ideal strategic partnership model to optimize development costs, mitigate risk and leverage our extensive commercial capabilities," Teva believes..."We have all the reasons to be successful in biosimilars. We have great commercial presence in all the markets. We have good experience at it. We have good manufacturing," noted Teva's CEO, Richard Francis. But, he stressed, "the partnership model is the one we favour."... Global Sub. Full

Teva, mAbxience Strike Licensing Deal for Biosimilar Candidate Focused on Multiple Oncology Indications

(4/4, Don Tracy, PharmExec.com) ..."The approval of Simlandi marks the first high-concentration, citrate-free biosimilar to Humira with IC status," said Eric Hughes, MD, PhD, EVP, global R&D, chief medical officer, Teva, in a press release. "Biosimilars create opportunities for cost savings across the healthcare system and introduce additional treatment options for patients. This approval marks an important milestone for Teva and Alvotech's partnership to collaborate on seven biosimilars and expand the availability, access, and uptake of biosimilars in the US."... Full

Teva Links Up with mAbxience On Oncology Biosimilar Candidate

(4/5, The Pharma Letter) ..."Teva is pleased to form this strategic alliance with mAbxience, who share our commitment to accelerate the delivery of impactful medicines to patients worldwide," says Angus Grant, executive vice president of business development at Teva. "This collaboration reflects Teva's ideal strategic partnership model to optimize development costs, mitigate risk and leverage our extensive commercial capabilities," he noted... Sub. Req'd

Teva and mAbxience Sign Global Licensing Agreement for Oncology Biosimilar Candidate

(4/4, Nilanjana Basu, Seeking Alpha) ...Teva Pharmaceuticals International GmbH, unit Teva Pharmaceutical and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, entered a strategic licensing agreement for a biosimilar candidate currently in development for the treatment of multiple oncology indications. The licensing agreement covers multiple global markets, including in Europe and the United States... Full

Teva and mAbxience Enter Strategic Licensing Agreement for Biosimilar Candidate

(4/4, Contract Pharma) ...Signals a step in mAbxience's global expansion strategy and advances Teva's goal to expand its biosimilar pipeline through business development...Under the terms of the agreement, mAbxience will leverage its expertise in biosimilar development and its current Good Manufacturing Practice-approved facilities in Spain and Argentina, to develop and produce the biosimilar product. Teva will lead the regulatory processes and commercialization in the designated regions, to ensure access to a broader patient population... Full

Teva Pushes For Progress On Asthma Rescue Inhaler

(4/4, David Wallace, Generics Bulletin) ...Teva has struck a $150m strategic development funding agreement with Abingworth and a clinical collaboration agreement with Launch Therapeutics to accelerate development of a dual-action asthma rescue inhaler...The proposed product – codenamed ICS-SABA/TEV-'248 – will benefit from "Launch Therapeutics' innovative late-stage drug development model" as well as development funding to offset program costs thanks to the two agreements. Teva said the program was in line with its "Pivot To Growth" strategy to "step up innovation and advance its innovative pipeline.”... Global Sub. Full

Boehringer to Lay Off Salespeople as Humira Biosimilar Sales Lag

(4/4, Patrick Wingrove, Reuters) ...The German drugmaker said it planned to reduce its customer-facing teams in favor of a hybrid in-person and virtual sales model by June 30, in large part because pharmacy benefit managers had kept branded Humira on their lists of medicines for reimbursement. That choice has led to less uptake of biosimilar versions of Humira in the United States, including Boehringer's Cyltezo, it said... Full

Boehringer Ingelheim Layoffs are a Sign of Dysfunctional Humira Biosimilar Market

(4/4, John Wilkerson, STAT Plus) ...Boehringer Ingelheim is laying off or relocating its sales staff for its Humira biosimilar Cyltezo in a sign of how difficult it's been to get drug middlemen to adopt less-expensive versions of the blockbuster, the company confirmed. Some employees may find positions elsewhere in the company, but they are mostly being pulled from the field...The drug industry blames drug middlemen for the slow uptake of Humira biosimilars... Sub. Req'd

Samsung Bioepis Initiates Global Phase 3 Study for Keytruda Biosimilar

(4/5, Lee Han-soo, Korea Biomedical Review) ...Samsung Bioepis said it has commenced global phase 3 clinical trials for its biosimilar, SB27, a biosimilar referencing Keytruda, a blockbuster cancer treatment developed by MSD. SB27 marks the company's eleventh biosimilar pipeline, illustrating its ongoing commitment to expanding its portfolio in the biopharmaceutical industry...In a strategic move to accelerate the clinical development process, Samsung Bioepis has also been conducting phase 1 clinical trials of SB27 in Korea and three other countries since January... Full

NURTEC ODT® is Now Available in Canada for the Treatment of Acute Migraine

(4/4, Pfizer) ...NURTEC ODT® (rimegepant) is now available in Canada for use in the acute treatment of migraine, with or without aura in adults older than 18 years of age.iii NURTEC is an orally disintegrating calcitonin gene-related peptide receptor antagonist tablet. It was approved by Health Canada on December 1, 2023... Full

UK Watchdog Says Theramex-Viatris Deal Raises Competition Concerns

(4/4, Prerna Bedi, Reuters) ...Britain's competition watchdog said Theramex's purchase of European rights to two of Viatris' women's healthcare products ranges could lead to higher prices and fewer options for hormone replacement therapies. The Competition and Markets Authority said its phase 1 probe found the deal could reduce options in an already concentrated HRT market, lead to price hikes and pose a threat to entry of new products... Full

Cipla Patalganga Facility Gets 6 USFDA Observations

(4/5, Business Standard) ...In a regulatory filing, Cipla said, On conclusion of the inspection, the company has received 6 inspectional observations in Form 483. The company will work closely with the USFDA and is committed to address these comprehensively within stipulated time... Full

New Cephalosporin Class Antibiotic Approved by FDA for Three Uses

(4/4, Bob Pollock, Lachman Consultants) ...The rise in "Antimicrobial resistance—the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the effects of a drug—is a serious, complex and costly public health problem. According to the Centers for Disease Control and Prevention, each year in the United States at least 2.8 million antibiotic-resistant infections occur, and more than 35,000 people die as a result." Yesterday, the FDA announced the addition of a new tool to combat AMR with the approval of "Zevtera (ceftobiprole medocaril sodium for injection) for the treatment of adults with Staphylococcus aureus bloodstream infections (bacteremia)...The hunt is on for more new antibiotics to keep ahead of microorganisms' ability to mutate. Let's hope this new drug is used responsibly in medical practice to slow down the chance for the development of AMR... Full

'Nothing Rivaled This': Navigating the Oncology Drug Shortage

(4/4, Sharon Worcester, MA, Medscape) ...Cancer centers have grappled with intermittent drug shortages for several decades but "nothing rivaled this," said Elizabeth A. Guancial, MD, a medical oncologist at Florida Cancer Specialists & Research Institute, Sarasota, Florida. Although the major shortage issues have eased since August 2023, anxiety surrounding the crisis has not. This drug shortage is not the first — and experts warn that it won't be the last...Successfully navigating future shortages will require a multipronged approach, including timely notification of impending shortages, said Guancial, who outlined how the crisis unfolded for Florida Cancer Specialists and how the center managed... Full

‘Patience Young Grasshopper': Former Phlow Exec Admits Securities Fraud Over US Kodak Loan

(4/4, Dean Rudge, Generics Bulletin) ...A former executive at the US-based public benefit manufacturer Phlow and his cousin have both pleaded guilty to US charges of security fraud, after being accused of buying ten of thousands of shares in Eastman Kodak using insider knowledge that the film photography firm was due to receive a massive loan from the US government at the height of the COVID-19 pandemic... Global Sub. Full

Local Pharma Company Phlow Kicks Off Drug Ingredient Production in Petersburg

(4/5, Jack Jacobs, Richmond BizSense) ...In a recent interview with BizSense, [Robby Demeria, Phlow’s Affairs CCO] said the company intends to expand its capabilities to include sterilization and packaging of finished medicine (a process known as fill finish) as well as production of key starting materials, which are the raw building blocks of API. "We are definitely focused on the end-to-end manufacturing of essential medicines. Right now we have a lot of partnerships, fill-finish partners," Demeria said. "We're focused on, at least in the short term, getting a fully domestic manufactured drug product."... Full

Cost-Based Pricing: The Real Threat Hiding In Latest US Drug Price Headlines

(4/4, Michael McCaughan, Pink Sheet) ...Bernie Sanders is back at it, getting headlines for demanding immediate price cuts to Novo's blockbuster GLP-1 brands. But behind the familiar rhetoric is a newer threat: academic research on cost-based pricing that could one day feed into the emerging Medicare ‘negotiation' system...The rhetoric is as predictable as it is effective in making headlines: call on an individual company to lower the price of a prominent, widely used brand. Tie it to some new (or repackaged) research, and make sure to include comparisons to cheaper prices in other countries... Sub. Req'd

‘We Beat Big Pharma': President Biden, Bernie Sanders Tout Drug Pricing Reform

(4/4, Lecia Bushak, MM+M) ...Following Sanders' comments, Biden proceeded to claim victory over Big Pharma, noting that he was proud his administration has taken on the pharma industry "in the most significant ways ever."...While total victory over the pharma industry may be an exaggeration, the Biden administration was responsible for what was arguably the most significant drug pricing reform in years — the Inflation Reduction Act (IRA) — in 2022... Full

Victory Over Big Pharma Will Take More Than the IRA

(4/4, Omar Qureshi and Reshma Ramachandran, MD, MPP, MHS, MedPage Today) ...The IRA represents a good starting point in driving down America's spending on prescription drugs, but leaves room for drug manufacturers to maintain high drug prices if not supplemented by additional policies. The need for policies that increase drug accessibility and affordability for Americans has never been higher... Full

This Fix to the Inflation Reduction Act Will Make a Big Difference for American Seniors

(4/4, Michael Ward, RealClearHealth) ...President Biden's signature legislative accomplishment, the Inflation Reduction Act, included a number of provisions good for the health and well-being of older adults, starting with the new $2,000 cap on out-of-pocket expenses for prescription drugs under Medicare...A notable misstep was the IRA's unequal treatment of small-molecule drugs and large-molecule biologics. This policy mistake is already distorting new drug development in ways that will result in less value for the aging population... Full

Drug Shortage Could Be Addressed By ‘Resilience Rating' From Private Entity Under HHS Plan

(4/4, Laura Helbling, Pink Sheet) ...White paper is HHS' latest attempt to create a rating system that would incentivize the purchase of pharmaceuticals from more reliable producers. The public-private partnership may help overcome the industry and political objections that have so far blocked similar proposals in the past. Increased costs from such a system (which could reach $5.1 billion over 10 years for the federal government) are as much a concern as philosophical objections to the concept of a ratings system... Sub. Req'd

Opinion | No, Big Pharma's High Prices Don't Drive Innovation

(4/4, Avik Roy, Gregg Girvan, The Washington Post) ...The real barrier to innovation in drug development isn't manufacturers' ability to charge extortionate prices; it's the ever-increasing cost of navigating the FDA's approval process. In the rest of the economy, innovation drives lower prices for valuable goods and services. The pharmaceutical industry - and its regulator - should follow suit... Sub. Req'd

Do Voters Care About Policy Even a Little?

(4/4, Rogé Karma, The Atlantic) ...In that respect, drug pricing is a microcosm of Biden's predicament—and a challenge to conventional theories of politics, in which voters reward politicians for successful legislation. Practically nothing is more popular than lowering drug prices, and yet the popularity hasn't materialized. Which raises an uncomfortable question: Politically speaking, does policy matter at all... Full

Increasing Legislative Changes May Mark Turning Point in US Biosimilar Adoption

(4/4, Lana Pine, HCPLive) ...Looking ahead, Reed and her team predict ongoing developments in biosimilar approvals and discussions on scientific advancements, with legislative actions and market reforms driving change. Collaboration among stakeholders, including patient groups, healthcare providers, and regulatory agencies, may be crucial factor in addressing these issues and ensuring widespread access to biosimilars... Full

US-China Tensions Threaten to Ensnare Additional Chinese Biopharma Contractors

(4/4, Max Gelman, Endpoints News) ...The Biosecure Act threatens to blacklist WuXi AppTec and other "companies of concern" from doing business in the US. But less known is that the bill could expand to target additional Chinese firms, including contractors like Beijing-headquartered Pharmaron, which is the second-biggest contract research organization after WuXi; and synthetic DNA company GenScript, whose custom manufacturing services are based in Nanjing, China... Full

Data Integrity: US FDA Guidance Seeks To Head Off Bioavailability/Bioequivalence Study Problems

(4/4, Sue Sutter, Pink Sheet) ...FDA's new draft guidance is aimed at heading off the types of data integrity concerns with BA/BE studies seen during inspections and drug application assessments. The guidance makes clear that the ultimate responsibility for data integrity rests with the applicant, even if the study is contracted out. Testing site management should build and implement a culture of quality to ensure the integrity of study data... Sub. Req'd

Agency Chief Seeks Help from Pharmacos with Medicines Shortages

(4/4, Gerardo Fortuna, Euronews) ..."We have to encourage greater transparency because the only way to help mitigate [shortages] is if we understand. And we can only understand if we know," EMA boss Cooke said..."Honestly, I don't even believe these are competitive issues. There is more of a perception that companies need to not share them," she pointed out. Cooperation with pharmaceutical companies helped the EMA to understand better what is really under the control of private entities during a shortage, Cooke said... Full

Pharma Dubs EU HTA Proposal ‘Unworkable,' But Patient Groups Support The Plan

(4/4, Eliza Slawther, Pink Sheet) ...The European Commission's proposed implementing act for EU-level joint clinical assessments, a key element of the upcoming Health Technology Assessment Regulation( (EU) 2021/2282), has been described as "unworkable" by the pharma industry... Sub. Req'd

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