Wednesday, July 22, 2026

 

 

Trump Pledges New Tariffs on Generic Drugs Not Made in the US

(7/21, Zachary Brennan, Endpoints News) ...A White House spokesperson told Endpoints News the new fees will be Section 232 tariffs, which allow Trump to adjust duties on imports that threaten national security. But generic companies likely won't need to sign deals with the administration, as pharmaceutical companies did on the branded side under the "most favored nation" (MFN) pricing deals, the spokesperson said... Sub. Req'd

 

Trump Says He Will Impose Tariffs on Generic Drugs Starting in August 2028

(7/22, Ari Hawkins and Oliver Ward, Politico) ...The Association for Accessible Medicines, which represents generic drugmakers, said it needed more details and urged the administration to address broader barriers to expanding domestic production. "We need to understand more the specifics of the policy, but the generics industry is committed to pursuing policies that support and stabilize both the industry and the access necessary to ensure patients have reliable options for affordable medicines," said president and CEO John Murphy III in a statement. "Our industry has several legislative and regulatory solutions to address the market deficiencies and we look forward to dialogue with the Administration and with Congress to pursue solutions that restore the generics industry to growth and to prioritize its place as a critical national security asset here in the U.S."... Full

 

Trump's 100% Generic Drug Duty Threatens US Low-Cost Supply

(7/22, Amber Tong, Laura Curtis, Bloomberg) ...[S]hifting production to the US would remove the cost advantage foreign generic producers have against branded drugmakers, forcing them to either raise prices or withdraw from the market, said Nathan Gray, senior research fellow at the Institute for International Trade at Adelaide University in Australia. "This decision will lead to reduced access to generic medicines in the US because they won't be able to make them as affordable," Gray said. "It'll push them into higher pricing. It's likely to reduce competition and lead to consumers having to choose the name-brand medicines and not have the alternative for generics in the US market."... Sub. Req'd

 

Trump Sets Course for 100%, Then 200%, Tariffs on Generics

(7/22, Phil Taylor, pharmaphorum) ...It is also unclear what legal authority Trump will use to impose the planned tariffs on generic drugs, particularly the projected 200% tariff, which would take effect in August 2029, several months after the end of what should be his final term in office... Full

 

Sandoz to Engage With U.S. Policymakers After Trump's Tariff Plan

(7/22, Dow Jones) ...Sandoz said Wednesday that further details on the scope and implementation of the measure are still required before it can assess its potential implications. "We share the goal of improving affordability and access to medicines in the United States," a Sandoz spokesman said. "We look forward to continuing our dialogue with policymakers on how best to achieve these shared objectives."... Sub. Req'd

 

As US Threatens A Tariff Bomb On Generic Drugs, Will Exemptions Be Negotiated?

(7/22, Vibha Ravi, Pink Sheet) ...In February 2026, Teva Pharma discontinued global supplies of 100mg and 300mg tablets of allopurinol - its generic to GSK's Zyloprim/Zyloric that prevents uric acid buildup - due to low margins and there have been many such instances of product discontinuations by companies over the years... Global Sub. Full

 

Lawmakers Advance Key Biosimilar Access Reforms To House Floor

(7/21, Inside Health Policy) ...The committee passed measures that would reduce the number of clinical trials manufacturers must complete to obtain FDA approval for biosimilars and codify the agency's new policy to automatically deem FDA-approved biosimilars as interchangeable with brand biological drugs. The policies stem from separate bills -- the Expedited Access to Biosimilars Act and the Biosimilar Red Tape Elimination Act -- but were included in an amended version of the Lower Costs, More Transparency Act among other several provisions to make transparent and lower health care costs in United States... Sub. Req'd

 

House Panel Passes Large, Bipartisan Health Transparency Bill

(7/21, Erin Durkin and Victoria Knight, Bloomberg Government) ...The bill, sponsored by Chair Brett Guthrie (R-Ky.) and top Democrat Rep. Frank Pallone (D-N.J.), and sailed through the full committee, 45-0. Guthrie said the package was a result of "many months of work," including hearings with insurance CEOs, members of the drug supply chain, and hospitals. He added the package "creates a comprehensive health care package that will strengthen healthcare price transparency, hold insurers accountable to their patients, lower drug prices and expand access to care."... Sub. Req'd

 

Competing Bills Aim for Elusive Changes to Drug Discount Program

(7/21, Jessie Hellmann, Roll Call) ...Lawmakers in both chambers have rolled out, or are planning to soon introduce, fresh proposals to alter the 340B program, which requires drug manufacturers sell deeply discounted drugs to safety net providers, including some hospitals and community health centers that serve large numbers of low-income patients... Full

 

Drugmakers Lose Appeal in Fight of HHS Oversight in Rebate Plans

(7/21, Nyah Phengsitthy, Bloomberg Law) ..."Like the district court, we disagree," Judge Bradley Garcia wrote for the court. "Based on the statutory text and structure, we conclude that Section 340B requires the Secretary to provide for a rebate mechanism before manufacturers may implement one," Garcia added. "And because it is undisputed that the Secretary has never authorized a mechanism encompassing the manufacturers' rebate models, the Secretary properly required the manufacturers to await his approval while he further studied their proposals."... Full

 

FDA Plans to Name Permanent CBER, CDER Heads with New Commissioner Nomination

(7/21, Max Bayer and Zachary Brennan, Endpoints News) ...The FDA is planning to announce a slate of senior personnel announcements when a new commissioner is named, including permanent heads of CBER and CDER, according to three sources familiar with the planning. One of the sources said the agency hopes to cement as many top officials as it can, while another said that the plan was part of an effort to stabilize leadership at the FDA during the Senate confirmation process... Sub. Req'd

 

Biotech Experts Want FDA Drug Reviews Based on Science, Not Politics

(7/22, Reuters) ..."Regulatory predictability is ultimately what keeps promising science from being abandoned before it reaches patients," said John Guy, policy director at the Incubate Coalition, a venture capital advocacy group. "The agency's current priority should be rebuilding durable scientific expertise."...Emily Hilliard, a Department of Health and Human Services spokesperson, said in an email that "suggesting that the agency's regulatory actions reflect politics rather than science misrepresents the FDA's review process and the hard work of its dedicated career scientists, physicians and other experts."... Full

 

 

J&J's Tremfya Remains on Top in Q2 Pharma Ad Spending League as Overall Outlay Drops

(7/21, Ben Adams, Fierce Pharma) ...The only pharma that charted a spending increase for the period was Teva with its Huntington's disease chorea or tardive dyskinesia drug Austedo, though the boost was a scant $1 million quarter over quarter. This saw the medication reach the top 10 rankings, an achievement Teva could not claim back in Q1... Full

 

Helus Pharma Completes Enrollment in Phase 3 APPROACH Study of HLP003 in Adjunctive Treatment of Major Depressive Disorder Ahead of Schedule

(7/21, Helus Pharma) ...APPROACH enrolled adults with moderate to severe MDD, who experience inadequate response despite a stable antidepressant regimen. Completion of enrollment represents an important milestone for Helus Pharma and advances the Company toward the expected release of topline data in the fourth quarter of 2026... Full

 

Global Clinical Trial Testing Huntington's Pill to Open in 3 New Countries

(7/21, Marisa Horak, MS, Huntington's Disease News) ..."We are excited to now begin enrolling patients in our pivotal trial for Huntington's in the United States, the United Kingdom and Canada," Sergey Paushkin, Skyhawk's head of research and development, said in a company press release...Another portion of this study (004-ANZ; NCT06873334) is being conducted at sites in New Zealand and Australia, and has completed recruitment - of a total 144 participants - ahead of schedule, per the developer... Full

 

 

Dr Reddy's Bottleneck Stalls Aspen's Canadian Semaglutide Ambitions

(7/21, Dean Rudge, Generics Bulletin) ...Aspen said on July 20 that it had received regulatory approval from Health Canada for its self-named Aspen-Semaglutide version, which is indicated, alongside diet and exercise, to improve glycemic control in adults with type 2 diabetes. However, the approval does not translate into an immediate commercial launch, with Aspen explaining: "The timing of commercialization remains dependent on the availability of semaglutide active pharmaceutical ingredient supply from Dr Reddy's Laboratories Limited."... Global Sub. Full

 

Henlius Advances Darzalex And Opdivo Biosimilar Trials

(7/21, Urte Fultinaviciute, Generics Bulletin) ...The multi-center, randomized, double-blind Phase I trial will evaluate the pharmacokinetic similarity between the biosimilar and originator after single and multiple SC injections in the target patient population. The secondary objective is to compare the PK characteristics, safety, tolerability, immunogenicity, and efficacy of HLX15... Global Sub. Full

 

Opdivo's Biosimilar Challenge Spreads From India To Russia

(7/22, Dean Rudge, Generics Bulletin) ...Russia's Ministry of Health has approved Biocad's Nivocad (nivolumab) biosimilar version of Bristol Myers Squibb's PD-1 inhibitor Opdivo, according to an entry in the country's State Register of Medicines. The marketing authorization was granted earlier this month and is valid until July 8, 2031. It has been awarded to PK-137, a Biocad-affiliated manufacturing company based in Zelenograd, Moscow... Global Sub. Full

 

Aurobindo Pharma Subsidiary Gets Brazil Regulator Nod for Hyderabad Biosimilars Facility

(7/21, Jomy Jos Pullokaran, CNBC TV18) ...The facility underwent a Good Manufacturing Practices (GMP) inspection by ANVISA from May 11 to May 15, 2026. The approval was granted after the successful completion of the inspection for biological API and sterile products... Full

 

 

2025 Gross-to-Net Realities at Eight Top Drugmakers: The Net Pricing Drug Channel Emerges

(7/21, Adam J. Fein, Ph.D., Drug Channels) ...We review the following eight companies: Bristol Myers Squibb, Eli Lilly and Company, Genentech, GlaxoSmithKline, Sanofi, Takeda, Teva, and UCB...Net prices declined at nearly every manufacturer. The unweighted average net price change was -1.8%. By comparison, U.S. consumer price inflation was +2.6%, meaning every manufacturer except Teva recorded net price growth at or below the inflation rate. Teva was the sole exception, with a +5.1% increase... Full

 

Indian Drugmaker Dr Reddy ' S Posts Quarterly Profit Slump

(7/22, Reuters) ...Dr Reddy's reported a smaller-than-expected quarterly profit on Wednesday, as muted sales of a key generic oncology drug and pricing pressure weighed on the competitive U.S. market. Consolidated net profit tanked 68.7% to 4.44 billion rupees ($45.98 million) in the first quarter ending June 30... Full

 

For Novartis' CEO, China Deals Aren't a Strategy Shift - Just Where the Science Is

(7/21, Ayisha Sharma, Endpoints News) ...Novartis isn't making deals in China just for the sake of buying there. That's the word from CEO Vas Narasimhan, who told reporters on a second-quarter earnings call that the Swiss pharma is "agnostic" to the geography of a deal and "will go wherever the science takes us." Any pickup in transactions the drugmaker is doing in the region is because of the "increase in innovative science coming out of China," he said... Sub. Req'd

 

Glenmark Sees Innovative Products Driving 70% Revenue in 5-6 Years: CMD Glenn Saldanha

(7/22, Rica Bhattacharyya, Vikas Dandekar, The Economic Times) ...Glenmark expects innovative products to account for nearly 70% of its revenue over the next five-six years, marking a sharp shift from its traditional generics-led model as decades of investment in drug discovery begins to pay off, chairman and managing director Glenn Saldanha told Rica Bhattacharyya & Vikas Dandekar... Full

 

Indian Generics Maker Lupin Seeds US Spinout Kaveri With Cash, Clinical-Phase Cancer Assets

(7/21, Nick Paul Taylor, Fierce Biotech) ...India-based Lupin has spun out two clinical-phase cancer drug candidates to create Kaveri Therapeutics, a U.S.-based startup that plans to raise cash for further development. Kaveri's programs hit targets pursued by major drugmakers including AstraZeneca, Bayer and Bristol Myers Squibb... Full

 

'We've Been Looking for a Novel Approach': Why Novartis CEO Ended ADC Holdout for $1.5B Myricx Deal

(7/21, Angus Liu, Fierce Biotech) ...Asked by Fierce during Novartis' second-quarter earnings call what prompted the apparent shift in strategy, Narasimhan said that while the company's commitment to radiopharmaceuticals "remains completely unchanged," the evolving oncology landscape called for a complementary approach. "We know that there are certain cancer types that […] could be better served by ADCs, or served in different ways than they could be by RLTs," [CEO Vas] Narasimhan explained on the call. "We've been looking for years for a novel approach to ADCs, knowing that it's a competitive space," he continued. "I think we were looking for that differentiated entry point, and Myricx provided us that."... Full

 

J&J's Tremfya Remains on Top in Q2 Pharma Ad Spending League as Overall Outlay Drops

(7/21, Ben Adams, Fierce Pharma) ...J&J's immunology med Tremfya saw spend for Q2 hit $115.3 million, beating out AbbVie's rival Skyrizi at $108.7 million. This kept Tremfya in its number one spot for the second quarter in a row. Skyrizi, however, moved up one spot quarter over quarter, displacing AbbVie's sibling immunology therapy Rinvoq, which dropped down to third position... Full

 

Why Novo Nordisk Sued Eli Lilly Over Zepbound, Mounjaro Ads

(7/21, Susan Haigney, Pharmaceutical Commerce) ...According to the Novo, one campaign compares the maximum tolerated dose of Zepbound (10 mg/15 mg) against a lower dose range of Wegovy, 1.7 mg/2.4 mg. The ads do not reference the 7.2 mg dose of injectable Wegovy, which the FDA approved in March 2026... Full

 

Sanofi Continues Tweaks to Executive Roster as New CEO Garijo Settles In

(7/21, Frasier Kansteiner, Fierce Pharma) ...On Tuesday, Sanofi unveiled a firmed-up executive roster, to be effective Sept. 1, that confirms previously disclosed shakeups in the roles of R&D chief and EVP of specialty care, while the remits of several other company veterans, like vaccine chief Thomas Triomphe, have been expanded. Triomphe, in addition to maintaining his longstanding role as Sanofi's EVP of vaccines, will now assume responsibility for China, too, the company said in a July 21 release... Full

 

Inspection Findings Highlight Hurdles Facing Alvotech's Launch Plans

(7/21, Dean Rudge, Generics Bulletin) ...The US [FDA] has cited Alvotech's Reykjavik biological drug substance and product manufacturing facility for deficiencies spanning complaint investigations, aseptic-process validation, laboratory controls, microbial-excursion reviews and environmental-monitoring oversight, according to a newly released Form 483... Global Sub. Full

 

Indian Generic Drugmaker Gets FDA Warning Over Clinical Study Consent

(7/21, Anna Brown, Endpoints News) ...In a breakaway from typical FDA warning letters, Alembic was criticized for its failure to label a clinical bioequivalence study as "experimental," meaning patients were unable to provide true consent to be enrolled in the study, according to the letter that was dated July 10 and published Tuesday... Sub. Req'd

 

 

Indian Drugmakers Rattled by Trump's 100% Levy on Generic Drugs

(7/22, Satviki Sanjay, Bloomberg) ..."This is a very surprising news for the industry," said Mahesh Doshi, an executive committee member at the Indian Drug Manufacturers Association, or IDMA, that represents over a thousand drugmakers. "None of us were expecting this."..."Two years is not a window you can create a generic drug ecosystem in," said Namit Joshi, chairman at the Pharmaceutical Exports Council of India. He cited concerns around manpower availability and backward integrated ecosystems that includes the availability of active pharmaceutical ingredients - the building blocks in drug manufacturing... Sub. Req'd

 

UK MHRA Licensing Speed Compliance Jumps From 8% To 98% In Single Year

(7/21, Eliza Slawther, Pink Sheet) ...The report, published this month, revealed that the proportion of national medicines license applications for which the MHRA reached a decision within the statutory 210-day window jumped from just 8% in the financial year 2024-25 to 98% in FY 2025-2026, which ran from April 1, 2025 to March 31, 2025. In March, this figure hit 100%... Global Sub. Full

 

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