Monday, July 7, 2025

FDA Will Not Pull Teva And MSN Hetlioz ANDAs, Finds No ‘Serious Discrepancies'

(7/4, Dean Rudge, Generics Bulletin) ...The US Food and Drug Administration will not revoke abbreviated new drug application approvals for generic versions of Vanda Pharmaceuticals' Hetlioz (tasimelteon) 20mg capsules held by Teva and MSN Laboratories, nor will it recall or seize distributed product, after denying a pair of citizen petitions filed by the originator... Global Sub. Full

US Budget Bill Eases IRA Price Controls But Coverage Losses Will Impact Pharma

(7/4, Cathy Kelly, Pink Sheet) ...The Republicans' budget reconciliation mega-bill passed with provisions providing relief from Medicare price negotiation for orphan drugs and tax benefits, including for domestic R&D. The bill includes major cuts to federal spending in Medicaid and Affordable Care Act insurance markets, which could lead to significant coverage losses and access issues for prescription drugs. The bill also threatens reimbursement in Medicare going forward... Global Sub. Full

Kennedy Appears Ill-Informed On Major Pharma Priorities, Creating Unique Lobbying Dynamics

(7/4, Sarah Karlin-Smith, Pink Sheet) ...HHS Secretary Robert F. Kennedy Jr.'s recent congressional testimony highlighted gaps in his awareness of drug industry policy priorities, such as changing the IRA or faster FDA drug reviews. The issue may force industry to grapple with the best way to accomplish its agenda in Washington. Lobbyists and consultants suggested the situation could have some upsides for industry, particularly given Kennedy's general distaste for pharma... Global Sub. Full

Trump's Push to Lure EU Pharma May Clash with Global Supply Reality

(7/7, Sarantis Michalopoulos and Vasiliki Angouridi, Euractiv) ...Last week, Trump signed off on sweeping tax and spending cuts, which for Dr Cinzia Alcidi, a senior research fellow at the centre for European policy studies (CEPS), is a clear sign that the US president is seeking to raise revenue through tariffs. "We have a tax cut which will attract a lot of companies and will be financed through tariffs imposed on the rest of the world," she told Euractiv. In the case of "sensitive" pharmaceutical trade, Alcidi added, Trump may deploy targeted measures aimed at delivering a political win by lowering prices for US consumers – though tariffs could in reality drive those prices up... Full

US-Swiss Trade Deal Likely to Contain Assurances On Pharma Levy

(7/4, Bastian Benrath-Wright and Jenny Leonard, Bloomberg) ...The draft of a trade accord between the US and Switzerland contains a provision that the European country will receive preferred treatment in the ongoing national-security investigations to avoid tariffs on pharma exports, according to people familiar with the matter. The clause doesn't constitute a guarantee that Washington will hold off on putting tariffs on the industry considered vital by the Swiss, the people said, speaking on the condition of anonymity. They said the wording is framed as a pledge for both parties to cooperate to avoid such a move via the so-called Section 232 probe. The people cautioned that details are still being finalized and negotiations remain fluid until an announcement is ready... Full

How Pharmaceutical Tariffs Could Worsen Generic Drug Shortages

(7/6, Joshua P. Cohen, Forbes) ...Generic drugs often rely on active pharmaceutical ingredients from countries such as India and China. But with only a limited number of generic drug ingredients produced domestically. imposing tariffs on API could in the short term heighten already existing shortages or lead to new ones as well as possibly raising prices... Full

Let's Fix Our Own Prescription Drug Policies

(7/3, Mark Merrit, RealClearHealth) ...Europe shows why government price controls backfire. Their governments hold drug prices down so tightly that pharmaceutical companies often cannot afford to launch new treatments. Europeans may pay less for older drugs, but they wait years longer for access to breakthrough therapies. It is no surprise that many European-based drugmakers now conduct their cutting-edge research in the United States...Instead of copying Europe's government-controlled approach, Washington must stop protecting middlemen and favoring those in government programs over those with private health insurance. It's time to focus on what actually matters: reducing pharmacy costs for all Americans, not just expanding government control over healthcare decisions... Full

Stakeholders Weigh In On Potential Price Transparency Rule Hinted By Oz

(7/3, Gabrielle Wanneh, Inside Health Policy) ...CMS may have plans to release a rule by the end of this year that would demand health care companies, potentially including insurers and pharmacy benefit managers, disclose prescription drug prices. But if that's the case, leadership for Transparency-Rx, a coalition of small PBMs that already operate under a transparent business model with their clients, is urging the Trump administration to pursue policies that will not only crack down on the opacity of traditional PBMs, but will also prevent them from exploiting any loopholes or using off-shore business tactics to avoid adhering to the administration's regulations... Sub. Req’d

Inside The Staff Exodus and Tanking Morale That Threaten Makary's FDA

(7/7, Lizzy Lawrence, STAT+) ...STAT spoke with 15 employees across the agency's drug, device, biologics, and food centers on how the FDA has functioned since the April 1 layoffs, which coincided with the start of FDA Commissioner Marty Makary's tenure. All requested anonymity due to fear of retaliation from leadership. They told STAT that morale is incredibly low as departures mount and distrust of leaders grows among the staff that remain... Sub. Req’d

Biocon Biologics Gets UK Drug Regulator Nod for Denosumab Biosimilars — Vevzuo and Evfraxy

(7/7, CNBC TV-18) ...Biocon Ltd. on Monday, July 7, said its subsidiary Biocon Biologics Ltd has secured marketing authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA), UK, for its Denosumab biosimilars — Vevzuo and Evfraxy...Clinical studies have demonstrated that both biosimilars are comparable in safety and efficacy to the reference product, the company stated... Full

Bio Usawa To Market Formycon's Lucentis Biosimilar In Sub-Saharan Africa

(7/3, Urte Fultinaviciute, Generics Bulletin) ...Bio Usawa and Bioeq, a partnership between Formycon and Polpharma Biologics, have entered an exclusive agreement to market FYB201 in sub-Saharan Africa. This collaboration aims to improve access to treatment for millions suffering from preventable blindness related to diabetes, which is a growing health threat on the continent. Bio Usawa also recently announced an agreement with construction firm Pacific Environmental Technologies to build local manufacturing capabilities. The first unit is expected to be operational in Rwanda by the end of the year... Global Sub. Full

US Federal Circuit Says It Will Not Rehear Viatris Invega Trinza Infringement Ruling

(7/4, Dean Rudge, Generics Bulletin) ...The US Federal Circuit has decided not to rehear Viatris' infringement case regarding Janssen's sole Orange Book-listed Invega Trinza patent. The court's ruling from March 2025, which upheld a lower court's finding of induced infringement and non-obviousness related to US patent 10,143,693, will remain unchanged. The patent, expiring in April 2036, details a method for restarting treatment with Invega Trinza after a missed dose... Global Sub. Full

CivicaScript Offers Generic Tecfidera To US Pharmacies For $47 Per Bottle

(7/3, Urte Fultinaviciute, Generics Bulletin) ...CivicaScript will sell its generic Tecfidera for $47 per bottle to pharmacies, recommending a $68 price tag for patients. The nonprofit estimated monthly savings of around $4,300 compared to traditional PBM-affiliated pharmacies. However, concerns remain about the coverage of newly launched generics and systemic barriers in the healthcare system that hinder access, the AAM argues in a recently published white paper... Global Sub. Full

6 Drugs in Shortage

(7/3, Alexandra Murphy, Becker's Hospital Review) ...Mefloquine hydrochloride tablet: Chartwell Molecular Holdings and Teva Pharmaceuticals have reported a shortage of mefloquine hydrochloride 250 mg tablets, an anti-infective medication used to prevent and treat malaria... Full

Price Pressures to Intensify for Drugmakers: Sun Pharma

(7/5, Anjali Singh, Business Standard) ...In a letter to shareholders, Chairman and Managing Director Dilip Shanghvi said the company is focused on maintaining competitiveness by continuously offering value to patients, prescribers, and buyers across its markets. "Reliable supply of safe medicines has become a priority for nations, leading to rising demand for on-shoring or near-shoring of pharma manufacturing. It is likely that price pressures on drug manufacturers may further increase," Shanghvi noted. He added that Sun Pharma is responding to these developments by strengthening its branded portfolio and staying cost-competitive in the generics space... Full

Demand for Obesity Drugs Shoots Up in India as Lilly, Novo Jostle for Market Share

(7/7, Rishika Sadam, Reuters) ...Demand for weight-loss drugs is rising at a fast clip in India where rivals Eli Lilly and Novo Nordisk are competing for market share, data from research firm Pharmarack showed on Monday...Affordability and willingness to try new drugs for obesity have propelled the growth of the market, Pharmarack's Vice President (Commercial) Sheetal Sapale said... Full

Obesity Drug Prices Are Dropping, But Getting a Steady Supply Remains a Challenge

(7/7, Tom Murphy, Associated Press) ...The medications still amount to around $500 per month for those without insurance — out of reach for many patients. And even for people with insurance, coverage remains uneven. "The medications should be available, the question is at what price and can people sustain that," said Matt Maciejewski, a Duke University professor who studies obesity treatment coverage. Doctors say the situation forces them to get creative in treating patients, but there's hope that prices may fall more in the future... Full

European Industry Calls For Support As It Juggles Multiple Challenges

(7/4, Dave Wallace, Generics Bulletin) ...Medicines for Europe's legal and annual conferences took place across four days in Brussels in late June. Key topics of interest for industry discussed at the events included tackling divisional patents, the threat posed by the European Urban Waste Water Treatment Directive, EU pharma legislation reform, the Critical Medicines Act and the SPC manufacturing waiver. Polpharma CEO Markus Sieger addressed the Medicines for Europe conferences as the association's new interim president... Global Sub. Full

EFPIA Position On The Critical Medicines Act

(7/4, EFPIA) ...The Critical Medicines Act (CMA) reflects growing political momentum to address medicine shortages and access across Europe. Its core objectives of strengthening supply chain resilience and ensuring timely, equitable patient access are fully supported by the European research-based pharmaceutical industry. In this position paper and feedback to the Commission, EFPIA sets out recommendations to ensure the successful implementation of the Act... Full

Pharma Welcomes EU Push to Restore Life Sciences Sector

(7/4, Phil Taylor, Pharmaphorum) ...The new Life Sciences Strategy from the European Commission aims to make the EU the most attractive place in the world for life sciences by 2030 and is backed by almost €10 billion ($11.8 billion) in funding. The wide-ranging document sets out three overarching themes for the new strategy; namely, improving the ecosystem for R&D and – in a nod to the concerns of the pharma industry – ensuring that new medicines reach the market quickly and can be accessed promptly by patients... Full

UK Pharma Has Concerns About the New NHS 10-Year Plan

(7/4, Phil Taylor, Pharmaphorum) ...The Association of the British Pharmaceutical Industry (ABPI) has said that the new 10-year plan for the NHS has underplayed the role that innovative medicines can play in driving advances in healthcare. In particular, the trade group is concerned that there is no commitment to increase the government's investment in medicines and reverse "decades of disinvestment in innovative medicines," as well as a "worrying signal about limiting patient and doctor choices around the best treatment for them."... Full

Trump's Tariff Threat Reignites Union Push in Ireland's Billion-Euro Pharma Sector

(7/5, Emer Walsh, Irish Examiner) ...Historically, Ireland's pharmaceutical sector has been defined by stable demand and high-paying salaries, particularly within the industry's epicentre in Cork, which hosts pharma giants Merck, AbbVie, Gilead Sciences, Pfizer, Johnson and Johnson, Thermo Fischer Scientific, Eli Lilly and GE Healthcare, among others...Despite this economic strength, collective bargaining in the sector has remained relatively limited. However, with rising uncertainty and looming tariff fears, momentum for unionisation is growing... Full

Ireland Could Follow France And Italy With Mandated Pharma Payment Disclosure

(7/3, Francesca Bruce, Pink Sheet) ...Ireland could be set to follow other European markets, including France and Italy, in mandating that pharmaceutical companies disclose the payments they make to health care professionals and organizations thanks to a bill that is slowly passing through the legislative process. The current voluntary process overseen by industry "has many flaws" and fails to adequately address conflicts of interest, among other things, Darren O'Rourke, who helped draft the bill, told the Pink Sheet. O'Rourke is a member of the Dáil Éireann, which is the lower house of the Oireachtas, the Irish parliament... Global Sub. Full

Sweden Launches Medicines Inquiry to Prevent Drug Shortages, Prepare for Crises

(7/3, Monica Kleja, Euractiv) ...The Swedish government recently issued directives for a new inquiry into how to strengthen the national drug supply system, both in peacetime and in times of crisis. "In general, we have a stable supply of medicines in Sweden. However, residual and shortage situations of various kinds arise, which can be manageable in everyday situations but devastating in a crisis situation, for example. We need to do more in this area," the Minister for Health, Acko Ankarberg Johansson (EPP), told journalists at a press conference... Full

Here At Last: Canada's Long-Contested Guidelines For Curbing Excessive Drug Prices

(7/4, Neena Brizmohun, Pink Sheet) ...Final guidelines have now been published to explain the new two-step screening process that staff at Canada's Patented Medicine Prices Review Board (PMPRB) should use to identify drugs that could be considered for an excessive price hearing. Step one will involve comparing Canadian prices to the highest international price of the same drug sold in 11 countries. If step one raises concerns, or if a complaint is received from an approved individual or organization, the PMPRB will then move to step two and start a more in-depth review... Global Sub. Full

Lifesciences Industry Adopts a Wait-and-Watch Approach Amid US Tariff Uncertainty: Aditya Sharma

(7/4, Nandita Vijayasimha, Pharmabiz.com) ...Lifesciences industry globally and in India remain in a wait-and-watch mode amid uncertainty surrounding the status of reciprocal tariffs, adding an additional layer of complexity to an already cautious market environment, said Aditya Sharma, head of process solutions, India Region, Merck Life Science. The current situation remains fluid. There is a clear reluctance to act hastily, as companies are wary of making moves that may not align with the evolving landscape, he added... Full

PM Modi Meets Cuban President; Discuss Ties in Pharma, UPI On Sidelines of BRICS

(7/7, Press Trust Of India) ...Prime Minister Narendra Modi and Cuban President Miguel Diaz-Canel Bermudez met during the 17th BRICS Summit to explore strengthening bilateral relations. Discussions encompassed pharmaceuticals, biotechnology, traditional medicine, and digital public infrastructure. Both leaders also considered collaboration on Ayurveda, UPI, disaster management, and capacity building, addressing global South concerns like health and climate change... Full

Niti to Review Concerns Over Pharma Quality

(7/4, Teena Thacker, The Economic Times) ...Niti Aayog is addressing growing quality concerns in India's pharmaceutical industry by convening industry experts for discussions. The aim is to analyze the current state, understand challenges, and improve the quality of Indian pharmaceutical products to meet global standards. A meeting chaired by VK Paul will propose recommendations to ensure alignment with international regulations and patient safety... Full

Note: Article links may expire over time or require a free registration. All news articles are the property of their respective publishers and copyright holders. [contextual emphasis added].

Teva global subscription access: registration is required to access FirstWord Pharma+ News and The Generics Bulletin. Please note you must be on the Teva Network (in a Teva location or connected via VPN) to access Teva's InfoNOW news resources. If you have any questions or issues, please email InfoNOW@tevapharm.com.

 

•      FirstWord Pharma+ News registration: first-time users, register here with your Teva email address. You will automatically receive a daily FirstWord Pharma+ newsletter; click on any news item to access your account.

•      Generics Bulletin, Pink Sheet, Scrip (Citeline) registration: go to the Generics Bulletin site and choose "Sign In" in the upper right-hand corner. First-time users, choose "Sign Up Here" and enter your Teva email address.