Thursday, July 23, 2026

 

 

Shifting Manufacturing Operations to US Not Practical, Says Dr. Reddy's CEO Amid Trump's Proposed Generic Drug Tariffs

(7/22, Subhojit Sarkar, Fortune India) ...Responding to the announcement during the company's post-earnings interaction with reporters, [CEO Erez] Israeli said Dr. Reddy's would closely monitor policy developments but had no immediate plans to alter its strategy. "If the tariff is increased, we will have to increase prices in the US," Israeli said, adding that the company would "see how this evolves" and was "not going to do anything special because of the announcement."... Full

 

Tariff Threat Surprises Generic Industry After Previous Talks With Trump Admin

(7/22, Inside Health Policy) ...The source told IHP previous dialogues between generic drugmakers and the White House, including the July meeting, have emphasized market-based reforms to the factors the industry says make generic production in the United States difficult, including the low prices for generic medicines and the earlier launch dates for biosimilars available in markets including Canada and the European Union... Sub. Req'd

 

Problems with Trump's Plan for Tariffs on Generic Drugs

(7/22, Public Citizen) ..."This reckless and impetuous move will drive up price, force rationing of key medicines and needlessly create scarcity problems. The sole respite from Trump's reckless pharma tariff plans has been that they so far do not apply to generics, which are vulnerable to supply disruptions that risk people's access to medicine. Now, Trump has erased even that modest protection, and set a destructive course that could cause, rather than prevent, scarcity and rationing," said Peter Maybarduk, Access to Medicines Director at Public Citizen... Full

 

Generic Drug Tariffs Set to Skyrocket in 2028. Consumers Could Feel Impact

(7/22, Ken Alltucker, USA TODAY) ..."Imposing massive tariffs on generic medicines risks making lower-cost generic drugs millions of Americans rely on more expensive and harder to access," said Merith Basey, CEO of Patients for Affordable Drugs. "Tariffs of this magnitude could have enormous consequences - raising costs, worsening shortages and putting access to lifesaving medicines at risk."... Full

 

Editorial: Trump's Generic Drug Tariffs Will Drive Up Pharmaceutical Prices

(7/23, The Washington Post) ...The administration casts the tariffs as an effort to protect the U.S. drug supply from foreign adversaries such as China. But if anything, this invites uncertainty into the market, weakening the U.S. pharmaceutical industry at a moment when China's biotech leaders are making enormous gains... Full

 

Trump's Generic Drug Tariffs: What They Could Mean for Medicine Prices, Manufacturers and Supply

(7/22, Elsa Ohlen, CNBC) ..."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," John Murphy III, president and CEO of the Association for Accessible Medicines, said in a statement to CNBC. Murphy said the industry has expanded its U.S. footprint across the supply chain over the past two years, but argued that problems with purchasing and reimbursement for many generic medicines continue to discourage further domestic manufacturing... Full

 

Senate Panel Advances Legislation Capping Private Insurance Insulin at $35

(7/22, Nathaniel Weixel, The Hill) ...The private-market insulin cap was being pushed by Sen. Susan Collins (R-Maine), who is facing a tough reelection battle this fall. It's unclear if Majority Leader John Thune (R-S.D.) will bring it to the floor, but the legislation would give Collins and others a win on affordability... Full

 

Senate Committee Advances Bipartisan Price Transparency, Workforce Bills

(7/22, Inside Health Policy) ...The bill would require a variety of providers, plans and pharmacy benefit managers (PBMs) to publicly post the prices they charge patients in a machine-readable format... Sub. Req'd

 

Senate HELP Sends Bills On Drug Labels, Biosimilars, Compounding To Floor Vote

(7/22, Lauren Brensel, Inside Health Policy) ...[Sen. Rand] Paul's bill, the Expedited Access to Biosimilars Act, intends to increase access to generic medications by reducing the number of clinical trials for biosimilars and, when that research is warranted, requiring HHS to provide a written justification within 60 days after a licensing application is submitted. The legislation would codify current FDA policy... Sub. Req'd

 

HHS Partners With OSTP To Launch AI Health Care Challenges

(7/22, Cara Smith, Inside Health Policy) ...HHS announced Wednesday (July 22) it will partner with the White House Office of Science and Technology Policy (OSTP) to launch a series of science and technology challenges aimed at facilitating the development of artificial intelligence health care solutions and transforming drug discovery and development... Sub. Req'd

 

NIH Joins Trump's $5B AI Mission with Biomedical Research Push

(7/22, Marissa Russo, Fierce Biotech) ...The commitments include efforts to uncover the root causes of chronic disease, unlock treatments for pediatric cancer and accelerate drug discovery and clinical translation. HHS will also contribute to federal projects involving autonomous laboratories and AI models designed to make biological systems more predictable... Full

 

How the FDA Is Unwinding the Makary Era, and Making Way for a New Commissioner

(7/22, Max Bayer, Endpoints News) ...It's not clear when exactly the White House will name a new leader of the FDA. But the erasure of Makary's tenure is coinciding with a period of interim calm for the agency after 14 months of turbulence. It's a tacit recognition from the Trump administration that it feels Makary's time in office is one to forget, and a clearing of the decks for whoever comes next... Sub. Req'd

 

Former Cancer Chief Pazdur Says FDA Has 'Golden Opportunity' to Kill CDER and Restructure

(7/22, Nicole DeFeudis, Endpoints News) ...Richard Pazdur, who spent more than two decades leading the FDA's cancer drug reviews, said the agency has a "golden opportunity" to restructure after being struck last year by the Trump administration's reduction in force... Sub. Req'd

 

 

AstraZeneca Wins EU Approval for Breast-Cancer Drug as U.S. Review Continues

(7/23, Adrià Calatayud, The Wall Street Journal) ...The U.K. drugmaker said Thursday that the medicine, known as camizestrant and marketed as Etcamah, was approved in the EU as part of a drug combination to treat adults with a type of advanced breast cancer. The EU nod follows earlier approvals in Japan, the United Arab Emirates and Saudi Arabia, it added... Sub. Req'd

 

With Nuvalent Takeout Complete, GSK Wins its First FDA OK for a Lung Cancer Drug

(7/22, Elizabeth S. Eaton, FirstWord PHARMA) ...GSK could see speedy returns from its $10.6-billion buy of Nuvalent, thanks to an FDA nod Wednesday for the first programme from the takeout, Jideytro (zidesamtinib). The US regulator approved the ROS1 selective inhibitor for adults with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC) who received a prior ROS1 kinase inhibitor... Full

 

Takeda Gets First OK for Orexin Narcolepsy Drug, in China

(7/23, Phil Taylor, pharmaphorum) ...The National Medical Products Administration (NMPA) has cleared oveporexton under the Orzeyful brand name for the treatment of narcolepsy type 1 in adults and adolescents aged 16 and over, ahead of regulators in the US and Japan, where it is under review. Filings in Europe are due later this year... Full

 

FDA Calls out Sanofi Emails for Giving 'Misleading Impression' of Beyfortus Use in RSV

(7/22, Zoey Becker, Fierce Pharma) ...As the FDA explains in the letter (PDF), Beyfortus' 2023 U.S. approval specifically clears the drug as a defense against RSV lower respiratory tract disease. Sanofi's promotional emails (PDF) regarding Beyfortus, on the other hand, urge healthcare professionals to "help prevent RSV disease in infants," creating what the FDA's Office of Prescription Drug Promotion (OPDP) deems a "misleading impression" about the drug's indication... Full

 

 

Anvisa Approval Opens Latin America to Aurobindo Biosimilars

(7/23, Dean Rudge, Generics Bulletin) ...CuraTeQ received the approval following a good manufacturing practice inspection conducted by Anvisa from May 11-15, 2026, with the inspection covering the production of biological active pharmaceutical ingredients and sterile drug products... Global Sub. Full

 

 

Indian Drugmaker Dr Reddy's Slips on Margin, Semaglutide Supply Woes

(7/23, Reuters) ...The company's weak June-quarter results have reignited concerns about profitability, with analysts warning that the pace of recovery now hinges on the successful restart of semaglutide supplies and the timely approval of biosimilar abatacept... Full

 

Roche Backs Full-Year View as First-Half Sales Rise

(7/23, Adam Whiitaker, The Wall Street Journal) ...The Swiss drugmaker Thursday reported first-half sales of 30.36 billion Swiss francs, equivalent to $37.28 billion. Compared with the same period a year earlier, sales grew 6% on a constant exchange rate basis and exceeded the 30.27 billion Swiss francs analysts had expected, according to a company compiled consensus... Sub. Req'd

 

Roche Drops TCE for Lupus, but Hasn't Given up on Autoimmune Cell Therapies

(7/23, James Waldron, Fierce Biotech) ...As part of a wider pipeline clearout disclosed during Roche's second-quarter earnings results released July 23, the Swiss pharma revealed that it had stopped work on RG6382, a T-cell-engaging bispecific antibody targeting CD19 and CD3. The company had been evaluating the therapy in an ongoing phase 1 open-label study of patients with systemic lupus erythematosus (SLE)... Full

 

Roche Says it Is Thoughtful on Token Use for AI, Shelves a Drug from Carmot Buy

(7/23, Elizabeth Cairns, Endpoints News) ...Schinecker said Thursday. The company is "using AI to speed up drug development, increase [probability of success], and increase the volume of drug development," he said during a media call covering its earnings in the first half of 2026. In terms of output, Schinecker said that the growing number of molecules in the early-stage pipeline is "already strongly driven by AI." Roche has 43 Phase 1-stage assets... Sub. Req'd

 

Pfizer's Talzenna Plus Xtandi Gets FDA Priority Review for Metastatic Prostate Cancer

(7/23, PMLiVE) ...A supplemental New Drug Application (sNDA) for Pfizer's Talzenna (talazoparib) in combination with Xtandi (enzalutamide) has been accepted for Priority Review by the US FDA. The application is to treat men with homologous recombination repair (HRR) gene-altered metastatic castration-sensitive prostate cancer (mCSPC), also known as metastatic hormone-sensitive prostate cancer (mHSPC)... Full

 

Eli Lilly Says it Will File for Approval of Next-Generation Obesity Drug in 2027 as it Clears Two More Trials

(7/23, Annika Kim Constantino, CNBC) ...In a statement to CNBC, Lilly said it needs more time to gather and verify the manufacturing and quality-control data required by regulators before it can seek approval... Full

 

AI Shortens Drug Discovery to Around 1 Year in China, Insilico CEO Says

(7/23, Reuters) ..."It usually takes about 4.5 years to get to a drug developmental candidate using the traditional approach. But if a pharma company has a research lab in China... they cut two years of time," Insilico CEO Alex Zhavoronkov told Reuters in an interview at its Shanghai R&D facility. "When you combine frontier AI that is proven to work experimentally with the power of China, you can significantly accelerate that. Now our record is nine months to a developmental candidate, with a typical timeline of 13 months."... Full

 

 

China's Rise in Pharma Sector Now Tariff-Proof, Analysts Say

(7/22, Alice Li, Julie Zhang, South China Morning Post) ...Despite Washington's move to tighten policy on pharmaceutical trade with a fresh threat of 100 per cent tariffs on generic drug imports, analysts say China's pharmaceutical rise is now tariff-proof, making its ascent in the global supply chain look irreversible... Full

 

Trump Threatens Tariffs on Generic Drugs, Complicating Canada's On-Shoring Efforts

(7/22, Chris Hannay, The Globe and Mail) ...Jim Keon, president of the Canadian Generic Pharmaceutical Association, said Canada and the U.S. have spent decades building an integrated pharmaceutical supply chain. "Trade barriers on essential medicines are not in the interests of patients, health care systems or either country's longterm health security," he said... Sub. Req'd

 

EU Shrugs Off Trump's Latest Tariff Threat on Generics

(7/22, Emma Pirnay, Euractiv) ...The move comes despite the EU and US agreeing clear exemptions for cheaper, off-patent generic drugs under the trade deal struck in April, keeping them at the current 0% tariff rate. Innovative branded pharmaceuticals, meanwhile, are capped at 15%. "We expect the US will continue to uphold this commitment," an EU spokesperson told Euractiv... Full

 

Europe Looks To Formalize Leaner Biosimilar Development

(7/23, Dean Rudge, Generics Bulletin) ...The EMA's Biosimilar Medicinal Products Working Party aims to publish a draft revised guideline for consultation in the second quarter of 2027 and adopt the final document in 2028... Global Sub. Full

 

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