Tuesday, July 15, 2025

BofA Securities Reiterates Buy Rating On Teva Pharma (TEVA)

(7/15, StreetInsider.com) ...BofA Securities analyst Jason Gerberry reiterated a Buy rating and $22.00 price target on Teva Pharma. The analyst comments "In conjunction with a BofA Global Research movement disorder survey (see July 14th Neurocrine Biosciences report), we maintain our Austedo IR/XR (tardive dyskinesia) forecasts calling for ~+10% revenue CAGR ('24-'29). Our Austedo forecasts assumes the drug can absorb '27-impact from Medicare IRA price negotiation and assume Austedo achieves a 50-50 VMAT2 market split. We view the survey as supportive of our Austedo forecasts as physician feedback indicates the VMAT2 category should see meaningful growth over the next 3-years..."... Sub. Req’d

Makary Suggests Lower PDUFA Fees as Reauthorization Process Begins

(7/14, Joanne S. Eglovitch, Regulatory Focus) ...The US Food and Drug Administration (FDA) kicked off the reauthorization process for the eighth iteration the Prescription Drug User Fee Act (PDUFA VIII) on Monday, with FDA Commissioner Marty Makary saying he'd like to see lower fees paid by industry this time around...The Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) – the two lobby groups that will represent industry in the negotiations – praised the success of the user fee program... Full

Consumer Groups Have A ‘Radical Transparency' List For US FDA's PDUFA VIII

(7/15, Sarah Karlin-Smith, Pink Sheet) ...Using the "radical transparency" rhetoric of HHS and FDA leadership, non-industry groups urged FDA to make the PDUFA negotiation process more open to the public. These groups also want FDA to commit to user fee goals that are more aligned with public health needs, not industry needs. Industry is also calling for improved transparency in areas like requirements for innovative therapies or more details on its decision-making... Global Sub. Full

Makary's New Voucher Program Lacks Legal Authority, Expert Alleges

(7/14, Jessica Karins, Inside Health Policy) ...FDA Commissioner Marty Makary may not have the legal authority to implement his new priority review program that will speed up review times for companies that serve U.S. "national interests," including by lowering drug prices, according to a legal expert who formerly worked at FDA, while stakeholders at an FDA user fee meeting Monday (July 14) expressed worries the agency might overlook safety and efficacy concerns as part of the new initiative... Sub. Req’d

Senate Bill Would Boost Oversight Of US FDA User Fee Program Following Trump Reorganization

(7/14, Sarah Karlin-Smith, Pink Sheet) ...Senate appropriators would require FDA to submit regular reports on the current level of staff and other resources devoted to user fee commitments to receive all of the planned funding for the Office of the Commissioner in FY 2026. The new requirements appear to come from concerns that Trump Administration actions may be impacting the user fee program's mission. Senate appropriators also raised concerns about certain meetings held by FDA Commissioner Makary, called for no hiring freezes of certain positions at the FDA and said to expect the rare pediatric PRV program to be reauthorized in 2025... Global Sub. Full

FDA Employees Let Go in April Receive Final Termination Notices

(7/14, Zachary Brennan, Endpoints News) ...The layoffs, first announced on April 1, will take effect for all employees who were originally notified, haven't had their notices rescinded, and who aren't protected under a July 1 court injunction issued by a federal judge in Rhode Island, an HHS spokesperson said. One FDA lawyer who was part of the layoffs shared the HHS termination email with Endpoints. It said a US Supreme Court ruling last week allows HHS to move forward with the terminations... Sub. Req’d

EU Trade Ministers Plan Countermeasures to Trump's 'Unacceptable' 30% Tariffs

(7/14, Sam McNeil, Associated Press) ...Maroš Šefcovic, the EU's trade representative in its talks with the U.S., said after the meeting that it was "very obvious from the discussions today, the 30% is absolutely unacceptable." He said that the commission was sharing proposals with the 27 member countries "for the second list of goods accounting of some 72 billion euros ($84 billion) worth of U.S imports. They will now have a chance to discuss it. This does not exhaust our toolbox and every instrument remains on the table."... Full

Pharma Tariffs Would Hit Uninsured Americans the Hardest, Experts Warn

(7/15, Niamh Rowe, Quartz) ...Manufacturers of branded drugs enjoy higher margins and therefore have room to absorb tariff-related costs, explains Margaret Kyle, professor at the Center for Industrial Economics. They could, for example, cut back on research and development to offset costs, she says. Cheaper generics lack this buffer. "Since margins are already very thin, the manufacturers would almost certainly pass them on to payers," says Kyle. While some generic manufacturers may absorb some costs in the short term, most will be passed on, agrees Stephen Ezell, vice president of global innovation policy at the Information Technology and Innovation Foundation (ITIF)... Full

First Look: Welch-Hawley "Patent Thicket" Bill

(7/14, Peter Sullivan, Axios Pro) ...The bill would allow drug companies to assert only one patent per thicket in litigation against a generic drugmaker, in order to streamline the process. That goes further than a bipartisan bill from Sens. John Cornyn and Richard Blumenthal, which allowed asserting a small group of patents... Sub. Req’d

Long-Term Effects of Medicare Price Negotiations On Drug Competition

(7/14, AAM) ...According to the report, the government's new role as a price setter will crowd out existing and effective market-based methods of price competition – like generic and biosimilar entry – that have long driven down drug prices...Now, as generic and biosimilar manufacturers make decisions about which drug development areas to pursue, the chance that the drugs they may select will become subject to price negotiation will influence their decision... Full

Medicare Drug Price Negotiation Has Chilling Effect On Generic and Biosimilar Medicines Development and Availability

(7/14, AAM) ...The white paper, by Alex Brill and Christy Robinson, concludes: "A significant unintended consequence of Medicare price negotiations will be a chilling effect on the development and launch of new generic small-molecule drugs and new biosimilars. The threat of a brand drug being selected for price negotiation reduces the willingness of these competitors to undertake the significant risk and expense involved in trying to enter the market. As our analysis demonstrates, there is a quantifiable negative impact on the US healthcare system and patients from a less competitive pharmaceutical marketplace. By our estimate, lost savings from Medicare price negotiations could total billions of dollars annually."... Full

Medicare Inflation Rebates Show Limited Impact On Drug Price Trends

(7/14, Brooke McCormick, AJMC) ...Medicare inflation rebates did not significantly curb price increases for top-selling drugs, despite the Inflation Reduction Act's intentions. Part D drugs showed a slight association between Medicare sales share and price increases in the first year, but not in the second. Researchers suggest further policy measures, such as extending inflation rebates to private insurance or expanding federal price negotiations, to control drug price inflation... Full

Conservatives Must Rally Behind Generic Drugs

(7/16, Scottie Nell Hughes, RealClearHealth) ...Access to cheaper generics aligns closely with core conservative values of free markets, fiscal responsibility, personal freedom, empowering families, and national strength. It's time for Republicans at all levels to unite behind expanding generic drug access. Let's show America that conservatism delivers on both values and results... Full

As Restraints On Drug Middlemen Take Effect in Illinois, Congress Considers Following Suit

(7/14, Jon Asplund, Crain's Chicago Business) ...U.S. Reps. Raja Krishnamoorthi, D-Ill., and Earl "Buddy" Carter, R-Ga., along with nine other representatives, introduced a bipartisan PBM Reform Act, with regulations centered around Medicare and Medicaid. If passed, the bill would ban spread pricing in Medicaid and "move to a transparent system that ensures pharmacies are fairly and adequately reimbursed for serving Medicaid beneficiaries," Krishnamoorthi said in a news release. It also provides for policy to delink PBM compensation from the cost of medications and increase transparency, with semi-annual reporting on drug spending, rebates and formulary determinations... Sub. Req’d

Judge Rejects AbbVie's Fight Against Missouri 340B Contract Pharmacy Law

(7/14, Nicole DeFeudis, Endpoints News) ...AbbVie failed to convince a judge to strike down a Missouri law regulating 340B discounts, marking the second setback in two weeks in the drugmaker's fight against alleged abuses in the federal program. Judge Stephen Clark of the US District Court for the Eastern District of Missouri ruled that AbbVie lacked standing to challenge the law, SB 751, because the company "only alleges injuries stemming not from the Missouri law at issue but from violations of federal law — which violations AbbVie does not ask the Court to address."... Sub. Req’d

States Peddle Snake Oil of Cracking Down On PBMs

(7/14, Thomas Savidge, RealClearHealth) ...Beyond cost savings, PBMs also enhance patient safety. They monitor for drug interactions, ensure appropriate dosages, and help prevent opioid misuse and fraud. Stripping away these services in the name of regulation would be a public health setback. The real solution to high drug prices lies in more competition, more flexibility, and more consumer choice. PBMs provide all three. It's time policymakers treated them as part of the solution—not the scapegoat... Full

Mabwell Enters into License and Commercialization Agreement with UNILAB to Launch Denosumab Biosimilars in the Philippines

(7/14, Mabwell) ...Mabwell, an innovative biopharmaceutical company with entire industry chain, announced that it has entered into a license and commercialization agreement with UNILAB, INC., a Philippine company, for its denosumab injections, 9MW0311 (Prolia® biosimilar) and 9MW0321 (Xgeva® biosimilar). Under the agreement, UNILAB will be responsible for the registration and marketing of the products in the Philippines, while Mabwell will be responsible for the development, manufacturing and commercial supply of the products... Full

Aurobindo Pharma to Manufacture, Supply Long Acting HIV Treatment Drug

(7/15, Press Trust Of India) ...The Hyderabad-based drugmaker has been selected as one of the generic manufacturers under the expanded voluntary licensing agreement between the Medicines Patent Pool (MPP) and ViiV Healthcare, the company said in a statement. The agreement allows Aurobindo to manufacture and supply the long-acting injectable HIV treatment across 133 countries, including several low and middle-income markets, it added... Full

6 Drugs in Shortage

(7/14, Alexandra Murphy, Becker's Hospital Review) ...Octreotide intramuscular injection kits: Teva has reported a shortage of 10 mg, 20 mg and 30 mg kits of octreotide acetate intramuscular injection, a drug used in endocrinology and oncology. No reason for the shortage has been provided. Novartis has Sandostatin LAR Depot kits available. Teva estimates resupply of the 10 mg kits in mid-June 2025 and the 20 mg and 30 mg kits in late June... Full

Sun Pharma's Alopecia Med Leqselvi Hits US Market After Incyte Patent Settlement

(7/14, Zoey Becker, Fierce Pharma) ...Sun's Leqselvi is now available for prescription to eligible patients with severe alopecia areata nationwide, the company announced on Monday. The drug is poised to compete with Pfizer's rivaling Litfulo and Eli Lilly and Incyte's first-to-market Olumiant...The launch comes after a legal back-and-forth with Incyte has now ended in a settlement agreement... Full

Post-Hype, Pre-Value: The Real AI-Pharma Shift Starts Now

(7/14, Mati Gill, Pharmaphorum) ...McKinsey estimates that AI could unlock $60 to $110 billion in annual value across the pharma industry, but most of that value is still waiting to be realised. Why? Because drug development is not a sprint. It is a regulated, risk-averse, deeply complex relay that demands rigorous validation, reproducibility and, above all, safety. It is also a vastly different scientific discipline. AI can't yet simulate a full immune response. It can't predict off-target effects with certainty. And it can't, on its own, replace decades of biological insight and clinical trial infrastructure... Full

What Could Lower US Drug Prices Cost the Rest of the World?

(7/15, Blake Forman, Technology Networks) ...A downward pressure on global drug prices could take place as a result of a "reference pricing cascade," Alexander Seyf, co-founder and CEO of Autolomous, told Technology Networks. This could have a significant impact on drug affordability in lower-income countries: "Significant US price drops could force pharmaceutical companies worldwide to lower prices to maintain market access, impacting their global pricing strategies. This also threatens tiered pricing models for essential medicines in lower-income countries, potentially eroding affordable access if manufacturers are reluctant to offer deep discounts that trigger US price reductions," explained Seyf... Full

‘Seize the Moment:' European Drug Regulators Called To Act On Changes In US

(7/14, Francesca Bruce, Pink Sheet) ...Fragile trust in science and regulators is one of the biggest disruptors facing European regulators, said speakers at a recent European Medicines Agency event. Moves to replace members of the US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices were concerning, but could mean opportunities for Europe, said speakers. European regulators must continue to strive for excellence and keep the experimenting of new technologies like artificial intelligence to sandboxes... Global Sub. Full

Europe's Factories Boosted by Tariff Frontrunning as August Deadline Looms

(7/15, Joshua Kirby, The Wall Street Journal) ...The EU's top politician, Ursula von der Leyen, said the bloc would continue to work toward a deal with Washington, but that it is "ready to safeguard EU interests on the basis of proportionate countermeasures." Ahead of the threatened tariffs, front-running of orders looks to have been particularly steep in the pharmaceutical sector. Factory output recorded a strong rebound in May in Ireland, where pharma titans like Allergan and Pfizer manufacture popular drugs from Botox to Viagra... Sub. Req’d

EU Ups Ante On Stockpiling For Crises

(7/14, Pink Sheet) ...The European Commission has published two new strategies aimed at improving drug stockpiling in the EU to better deal with crises. The strategies include proposals to create a European stockpiling network and plans for drawing up a list of medical countermeasures that could be stockpiled. The twin strategies draw on the cross-sectorial "rescEU" reserve program, which was created in 2019 to reinforce and strengthen components of the EU's disaster risk management... Global Sub. Full

Room For Improvement? EU Industry Prepares Feedback For SPC Manufacturing Waiver Review

(7/15, Dave Wallace, Generics Bulletin) ...The European Commission is about to embark on a review of the SPC manufacturing waiver, which allows for manufacturing within SPC terms. At Medicines for Europe's legal affairs conference, Denis Dambois from DG GROW set out the next steps for re-evaluating the regulation. Insud's Beatriz Díaz de Escauriaza presented industry's feelings on the SPC manufacturing waiver, calling for urgent improvements... Global Sub. Full

The Politics Of Divisionals: How European Patentees Are Still Gaming The System

(7/14, Dave Wallace, Generics Bulletin) ...Divisional patent games remain a significant source of frustration for the generics and biosimilars industry in Europe, delaying launches and restricting access. Medicines for Europe's legal affairs conference last month heard fresh details illustrating the scale of the issue from Sandoz global IP head Julia Pike. Despite a landmark decision and fine from the European Commission over Teva's Copaxone last year, divisional games from originators persist... Global Sub. Full

Trump's Economic Nationalism and its Ripple Effects On India and BRICS

(7/15, Vipin Benny, The Hindu) ...U.S. President Donald Trump's latest announcement to impose a 10% tariff on BRICS nations, alongside a potential 200% levy on pharmaceutical imports, signals a dramatic shift in how the world's largest economy seeks to wield its influence. For India, which recently submitted a comprehensive trade offer covering goods worth $150-200 billion to the U.S., this rhetoric threatens not only the flow of exports but also the trust underpinning one of its most important economic partnerships. As global trade teeters on the edge of uncertainty, Mr. Trump's strategy to "weaponise" tariffs is poised to reshape not only bilateral deals but also the foundational dynamics of multilateral blocs, such as BRICS... Sub. Req’d

Beijing City Releases AI Action Plan Including Drug Regulation

(7/15, Xu Hu, Pink Sheet) ...The city of Beijing on July 3 released a three-year (2025-27) action plan to apply AI tools across a wide range of scenarios in the pharma and health sectors, including drug regulation. China's national regulator, the NMPA, also plans to release its own national AI action plan for the same period, it was noted in early June. Potential initial national applications of AI include reviews of regulatory submission completeness, evaluation of generic/supplementary filings and communications between the regulator and applicants, one expert suggested at recent congress in Suzhou... Global Sub. Full

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