Monday, January 27, 2025

Is Teva-Amneal Inhaler Case A Double-Edged Sword For The Generics Industry?

(1/27, Urte Fultinaviciute, Generics Bulletin) ...The Teva v. Amneal battle over inhaler patents in the FDA's Orange Book has become a noteworthy case that will impact both branded and generic drug companies. Yet, the clarity over patent listings might be overshadowed by possible future litigations, discussed law firm Polsinelli's chair Chad Landmon with Generics Bulletin... Global Sub. Full

Alvotech: FDA To Review BLA For AVT05 - Quick Facts

(1/27, RTT News) ...Alvotech and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., announced that the FDA has accepted for review Biologics License Applications for AVT05, Alvotechs proposed biosimilar to Simponi and Simponi Aria, or golimumab, which are prescribed to treat a variety of inflammatory conditions...The FDA review process is anticipated to be completed in the fourth quarter of 2025... Full

Teva Pharma (TEVA) PT Raised to $21 at JPMorgan

(1/27, StreetInsider.com) ...JPMorgan analyst Chris Schott raised the price target on Teva Pharma to $21.00 (from $18.00) while maintaining a Neutral rating... Sub. Req’d

Eye On Pharma: Teva, Formycon, Celltrion Biosimilar Updates in Global Markets

(1/26, Skylar Jeremias, The Center For Biosimilars) ...The European Commission granted marketing authorization a new aflibercept biosimilar that will be marketed as Ahzantive and Baiama (FYB203) across major parts of Europe. The biosimilar was developed by Formycon and will be commercialized by Teva Pharmaceuticals as part of a January 2025 licensing agreement for semi-exclusive commercialization of FYB203, which concerned major European markets and Israel... Full

Torrent Pharma Eyes 5-7 US Launches in FY26 to Drive Revenue Growth

(1/27, Nigel D'Souza, Prashant Nair and Surabhi Upadhyay, CNBC TV-18) ...Torrent Pharmaceuticals plans to launch 5-7 products in the US market in 2025-26 (FY26), which is expected to drive a 10-15% revenue growth, according to , Executive Director and CFO Sudhir Menon. The company's US operation, which is currently unprofitable, is projected to turn around within the next two to three years... Full

Pfizer Offers $60M to Settle Prescriber Kickback Claims

(1/27, Phil Taylor, Pharma Phorum) ...Pfizer has agreed to pay $60 million to resolve allegations brought by the US government that its Biohaven Pharma subsidiary made improper payments to physicians to boost sales of its migraine drug Nurtec ODT. The Department of Justice (DoJ) claims that Biohaven – before being acquired by Pfizer – paid "improper remuneration" to some Nurtec ODT (rimegepant) prescribers in the form of speaker fees and meals at high-end restaurants, which violated the US anti-kickback statute... Full

Vanda Loses US Trade Secrets Battle Over Fanapt And Hetlioz Generics

(1/24, Dean Rudge, Pink Sheet) ...A federal court said the FDA did not improperly disclose trade secrets about Vanda's Fanapt and Hetlioz to generics manufacturers. Vanda claimed dissolution specifications, as well as impurities testing and micronization information, were given to generics manufacturers during ANDA reviews. The court determined that Vanda did not develop the specifications at issue... Global Sub. Full

Bio-Thera Keeps Partnership Streak With Turkish Stelara Deal

(1/24, Adam Zamecnik, Generics Bulletin) ...Bio-Thera Solutions appears to be extending its streak of partnerships secured in 2024 into the new year, having announced a new deal with World Medicine that will license out Bio-Thera's Stelara (ustekinumab) biosimilar BAT2206 to World Medicine for commercialization in its domestic Turkish market... Global Sub. Full

Takeda Discontinues US Supply of Gout Drug Uloric Over Generic Competition 

(1/24, Anna Brown, Endpoints News) ...Takeda has ended the manufacturing and supply of its gout drug Uloric in the US market as more patients turn to generic versions, the company confirmed to Endpoints News. "We have taken this decision to help streamline our operational efficiencies and better dedicate our resources where they can provide the most value to patients," a Takeda spokesperson said. The two doses of Uloric, 40 mg and 80 mg, were listed as "discontinued" on the FDA's drug shortage list on Tuesday... Full

Eisai and Biogen Win Approval for Once-Monthly Leqembi Maintenance Dosing

(1/26, Nicole DeFeudis, Endpoints News) ...Eisai and Biogen scored an approval for once-monthly IV maintenance dosing of their Alzheimer's drug Leqembi, as part of what they've said is an ongoing effort to make treatment more flexible for patients and physicians..."One of the reasons Leqembi business is a little bit slower than we expected is infusion capacities," Katsuya Haruna, executive VP of business operations at Eisai, told Endpoints News ahead of the approval. He said less frequent IV maintenance dosing "helps physicians and other staff to reduce their workload."... Full

Bankrupt Purdue Buys Time to Advance $7.4 Billion Opioid Deal

(1/24, Dietrich Knauth, Reuters) ...Purdue Pharma said on Friday it needs more time to build support for a new $7.4 billion settlement that could complete the company's years-long effort to resolve thousands of lawsuits over its addictive pain medication OxyContin. The company still needs to hammer out remaining details and seek buy-in from states, local governments, and other creditors that have sued the company and its Sackler family owners over their roles in the deadly U.S. opioid epidemic... Full

Trump's Tariff Plan Could Deepen U.S. Drug Shortages, AAM CEO Warns

(1/24, Maaisha Osman, Inside Health Policy) ...AAM CEO John Murphy told Inside Health Policy that tariffs' increased costs for importers would hit hard for generics makers in a market that is highly consolidated and dominated by three group purchasing organizations (GPOs), which limits manufacturers' profit margins. Murphy emphasized that the United States depends on global supply chains for essential medicines, particularly generics used to treat chronic diseases. "There are many production facilities outside the United States that serve U.S. patients, just like U.S. facilities serve patients abroad," he said, arguing that tariffs would disrupt this delicate balance without boosting domestic production... Sub. Req’d

MACPAC Warns Weight-Loss Rule Initially Shifts Costs To Medicaid

(1/24, Luke Zarzecki, Inside Health Policy) ...Congress' Medicaid payment advisers are cautioning CMS that its proposed rule to cover weight-loss medications would temporarily shift the cost of the medications from Medicare to Medicaid, with different start dates meaning dually eligible beneficiaries could receive coverage first through Medicaid. The advisers urge CMS to remedy the issue and to send states guidance on prior authorization... Sub. Req’d

Experts: Trump Executive Orders Create Foundation for What's to Come

(1/24, Ferdous Al-Faruque, Regulatory Focus) ...President Donald Trump wasted no time this week launching his agenda for the federal government, issuing scores of executive orders and directives from the White House, including some that affect how US health agencies communicate with the public, conduct hiring, and address public health issues...Philip Desjardins, a partner at Arnold & Porter and a former policy director at FDA Center for Devices and Radiological Health (CDRH), told Focus that the agency has significantly ramped up its workforce over the past 15 years and intentionally hired people for fully remote positions outside of the Washington metropolitan area to meet its needs. Requiring staff to work from FDA's White Oak headquarters, or even regional offices or duty stations, creates significant logistical challenges, he said... Full

Congress Can't Wait—Reform Pharmacy Benefit Managers and Deliver Lower-Cost Drugs for Patients | Opinion

(1/27, Juliana Reed, Newsweek) ...Congress must build on the reforms drafted in 2024 that require PBM transparency, delink the PBM monopoly's business practices from the Medicare program, and allow all patients to have access to lower-cost medicines like biosimilars. A robust reform package can even save the U.S. billions of dollars from biosimilars through the end of next year and bring forward fiscal responsibility in health care... Full

Trump Says He May Consider Rejoining World Health Organization

(1/26, Nandita Bose, Kanishka Singh, Reuters) ...President Donald Trump said on Saturday he may consider rejoining the World Health Organization, days after ordering a U.S. exit from the global health agency over what he described as a mishandling of the COVID-19 pandemic and other international health crises. "Maybe we would consider doing it again, I don't know. Maybe we would. They would have to clean it up," Trump said at a rally in Las Vegas... Full

Upcoming PDUFA Dates May Be Ensnared by Trump's Pause at HHS, Analyst Says

(1/24, Zachary Brennan, Endpoints News) ...President Donald Trump's communications pause for HHS, FDA and other health-related agencies could push some drug approval decisions to later dates, a Raymond James analyst told investors on Thursday. While an HHS spokesperson said the pause until Feb. 1 is for "communications and public appearances that are not directly related to emergencies or critical to preserving health," the new administration has pushed back NIH grant reviews and some meetings, like one for the National Vaccine Advisory Committee... Full

HHS Freezes Travel, Public Appearances, Other Activities

(1/24, Jessica Karins, Inside Health Policy) ...The Trump administration has put on hold public appearances by health agency officials and most employee travel as part of its temporary freeze on the agencies' communications with the public. The moves come on top of President Donald Trump's day one executive orders pausing rulemaking, halting diversity, equity and inclusion efforts, mandating federal workers return to offices, and more... Sub. Req’d

Editorial: Why RFK Jr. Is Dangerous to Public Health

(1/26, The Wall Street Journal) ...The risk is high that Mr. Kennedy will use his power and pulpit at HHS to enrich his trial-lawyer friends at the expense of public health and medical innovation. It's telling that Mr. Kennedy hasn't agreed to stop taking payments from these allies in the Gardasil lawsuit. Senators would be wise to believe RFK Jr.'s career of spreading falsehoods rather than his confirmation conversions... Sub. Req’d

Sen. Dick Durbin: Big Pharma Should Disclose Prices On Drug Advertisements

(1/27, Dick Durbin, Chicago Tribune) ...It's shameful that Big Pharma spends billions in targeted advertisements, often bombarding patients with gibberish, while keeping them in the dark about one crucial factor — the price. With the DTC Act, we will require Big Pharma to end the secrecy and shine light on the real costs of medications — saving Americans from excessive health care costs... Full

Sara Brenner Serves As Acting Head At FDA, Jeff Wu At CMS

(1/24, Jessica Karins, Inside Health Policy) ...Sara Brenner, an FDA official who previously served as associate director for medical affairs and chief medical officer for in vitro diagnostics, has officially been named acting commissioner of the agency, with FDA updating its website to reflect the change Friday (Dec. 24)...Other health agencies' websites were also updated Friday to confirm their acting leadership... Sub. Req’d

FDA Transition: New Acting Commissioner, Disappearing Docs, Scientific Publication Freeze

(1/25, Sarah Karlin-Smith and Sue Sutter, Pink Sheet) ...CDRH's Sara Brenner officially became the FDA's acting commissioner on January 24, but confusion remains at the agency due in large part to a communications freeze. FDA webpages continue to go missing, raising concerns about how the agency is applying a new Trump administration order targeting diversity, equity and inclusion work. The freeze extends to unpublished FDA staff-authored scientific articles and abstracts in journals, potentially impacting submissions for several large scientific conferences in the spring, as well as drug approval communications... Global Sub. Full

Illinois Disputes Generic Drugmakers' Bid for Pricing Law Pause

(1/24, Celine Castronuovo, Bloomberg Law) ...The generic drug and biosimilar industry group failed to establish that the financial penalties its members could face under the Illinois law prohibiting excessive price gouging on generic and other off-patent drugs outweighs the state's interest in "preventing activity that will directly impact the health of its residents," Illinois Attorney General Kwame Raoul (D) wrote in his brief filed in the US District Court for the Northern District of Illinois... Sub. Req’d

Inflated Drug Costs Hurt Pennsylvanians

(1/27, Jennifer Riley, Pennsylvania Capital-Star) ...Last year, Pennsylvania lawmakers from both parties, along with Gov. Josh Shapiro, came together to pass comprehensive legislation aimed at regulating PBMs. However, it is widely accepted that federal law preempts state law in regulating pharmacy benefit managers. This, coupled with the new FTC investigation, is a stark reminder that there is still work to be done to hold PBMs accountable. With the use of specialty medications expected to increase 3-5% per year over the next decade, we need to protect and ensure fair pricing for the millions of Americans—and Pennsylvanians—who depend on these drugs to survive... Full

The Impact of Biosimilar Competition in Europe 2024

(1/24, IQVIA) ...Biosimilars remain a critical part of the European healthcare system and are able to balance pharmaceutical spending by generating savings for payers, creating headroom for innovation, and expanding access to biologic therapy for patients. Since the first biosimilar was launched in 2006, biosimilar medicines have become a core component of an effective healthcare system, but latest information on the biosimilar pipeline signals future headwinds that were highlighted in previous reports and remain steadfast... Full

Industry Involvement in Key European Research Project Could Keep It Sustainable

(1/24, Anabel Costa-Ferreira, Pink Sheet) ...Pharmaceutical industry involvement in the European Reference Networks (ERNs), which generate data on rare diseases and connect experts across Europe, may become a reality following a European Commission report recommending that the private sector could help generate funds to sustain the networks. However, before these public-private partnerships move forward, a legal framework on what that participation would look like must be in place, said Ines Hernando, ERN & Healthcare Director at EURORDIS in an interview with the Pink Sheet... Global Sub. Full

Danish Industry Demands Vision for Advanced Therapies

(1/27, The Pharma Letter) ...Lif, Denmark's life sciences association, has published an opinion piece urging the government to adopt a stronger political vision for advanced therapies. The group highlights the challenge facing Denmark: while the healthcare system aspires to deliver cutting-edge treatments, many advanced therapies are not reaching patients, a fact attributed in part to the complexities of regulation... Sub. Req’d

Drugmakers Warn NHS Clawback Tax is Putting UK at a Disadvantage

(1/25, Hannah Kuchler and Anna Gross, Financial Times) ...Drugmakers are growing frustrated with the NHS after a clawback tax unexpectedly soared, with pharmaceutical companies warning that investment in the UK may be at risk...Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry, said he would like to review the deal, as the UK lags behind other European countries in what it pays for drugs, putting it in a "very very difficult position" if it wants to grow its life sciences industry... Sub. Req’d

Panel Asks DoP to Fix Issues Related to Implementation of PRIP

(1/24, Pharmabiz.com) ...Identifying that the Promotion of Research and Innovation in Pharma Med-Tech (PRIP) Scheme to support industry-academia linkage in pharma and med-tech research and development (R&D) has been facing challenges in initiation, a Parliamentary Panel has sought the Department of Pharmaceuticals (DoP) to fix all the issues related to the scheme at the earliest... Full

China Investigates Generic Drugs Over Safety Concerns

(1/27, Cheng Leng, Joe Leahy and Tina Hu, Financial Times) ...Chinese regulators are investigating the quality of domestic generic drugs after a rare public backlash against a cost-cutting campaign that prioritised their use in the national healthcare system but has led to doctors complaining about their effectiveness. The probe comes amid increasing concerns among foreign pharmaceutical companies that China's drug procurement system, in which producers bid for bulk tenders to supply public hospitals, in effect discriminates against international competition... Sub. Req’d

China+1 Opens Larger Share for India in Global Pharma Manufacturing Beyond Generics: BCG Report

(1/27, ANI) ...India is set to capture a larger share of the global pharmaceutical market beyond generics, driven by the "China+1" strategy as companies diversify from China. Investments are pouring into India's affordable pharma services and growing infrastructure. India and Singapore are leading hubs for healthcare innovation, with Asia's healthcare market projected to reach USD 5 trillion by 2030... Full

In China, Government Data On Drugs Blocked From Public After Backlash

(1/27, Alexandra Stevenson and Zixu Wang, The New York Times) ...The criticism in China over how the government buys drugs for its public health care system, which most people use, has ignited frustration over the most basic of concerns: the effectiveness of medicine. Two separate groups of medical experts and political advisers in Shanghai and Beijing are sounding the alarm over the country's centralized drug procurement system and the drugs on a list of medications for public hospitals... Sub. Req’d

In China, Rare Dissent Over a Program to Save On Drug Costs

(1/25, Alexandra Stevenson and Zixu Wang, The New York Times) ...A prominent Shanghai surgeon pointed to anesthetics that do not put patients to sleep. A respected Beijing cardiologist questioned blood pressure medication that failed to regulate. A former editor at a leading online health platform went as far as to accuse domestic drugmakers of fraud. The concerns spilled out into public discussions this week when some top doctors and hospital leaders called on the government to change how it buys drugs for its public hospitals. The outburst of scrutiny, unusual in a country where the authorities keep a tight grip on public criticism of the government, was a rebuke of Beijing's campaign to lower medical costs... Full

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