Thursday, April 9, 2026

Top Drug Lobbyist to Depart PhRMA at Year End

(4/9, Amanda Chu, David Lim and Lauren Gardner, Politico) ...A pharmaceutical industry consultant granted anonymity to discuss the news said it was disclosed at a PhRMA board call Wednesday morning that was scheduled on Monday evening. "There was an unplanned board call for Steve [Ubl] where he talked about staying on until the end of the year, but this will be his last year as CEO," the pharmaceutical industry consultant said. "No successor was mentioned."...In an interview with the Washington Post, Ubl said he planned to transition to teaching, consulting, and board service... Full

Pharma Fallout from Iran War Won't End with Ceasefire

(4/9, Peter Sullivan, Axios) ...Even if the ceasefire holds, disruptions to air cargo and the Strait of Hormuz bring the threat of higher prices for generic drugs and spot shortages, especially in developing countries. The conflict is also disrupting clinical trials of experimental cancer, heart and other treatments in countries like Turkey, Israel and Egypt, according to data science company Phesi...Pharmaceuticals and drug ingredients also had to compete with fertilizer and other commodities held up by the bottleneck, creating a logistics nightmare... Full

How War in the Middle East Is Disrupting Medical Supply Chains

(4/9, Sarah Evans, PharmaPhorum) ...It is worth noting that most countries in the Middle East are not major producers of pharmaceuticals. One important exception is Israel, where Teva Pharmaceuticals, headquartered in Tel Aviv, is the world's largest manufacturer of generic medicines. However, they still place a crucial role in global healthcare delivery, for several reasons... Full

Tariffs Are Trump's Perpetual Leverage Machine

(4/9, Sam Lowe, Financial Times) ...Via its conditional exemptions, what the US has created is a mechanism for continuous pressure on companies to make more in the US, sell their medicines for less, and get paid more by foreign health providers. And if that doesn't happen? Well, tariffs. Obviously. So this isn't really a tariff regime. It's a perpetual leverage machine with tariffs as the enforcement mechanism. And I think it's going to stick around, long after Trump. Or to put it another way: once you've built that machine - and felt its benefits - it's going to be hard to give it up... Sub. Req'd

The Revived Medicare Generics Push

(4/8, Kelly Hooper, Sophie Gardner, Politico) ...Bipartisan lawmakers have revived efforts to require Medicare to cover generic drugs - and at least two biosimilars - with patients paying lower costs than for brand-name drugs, POLITICO's Alec Snyder reports. The bill would require that cheaper generics and biosimilars be covered and listed prominently next to their brand-name versions. It would also seek to stop plans from using prior authorization or step therapy to restrict access to generic or biosimilar options... Full

Exclusive: AbbVie Sues to Narrow Drug Discount Patient Definition

(4/9, Maya Goldman, Axios) ...AbbVie's lawsuit filed in U.S. District Court for the District of Columbia on Wednesday says that definition is "overly inclusive, capturing individuals who may have had only a cursory encounter with the covered entity a long time ago."... Full

PDUFA VIII: FDA, Industry Make Significant Progress Toward Agreement

(4/8, Ferdous Al-Faruque, Regulatory Focus) ...Two major issues were discussed during the latest FDA and industry steering committee meetings, as reflected in the minutes posted in early March. They include America First fee incentives and a non-orphan indication supplement fee proposal... Full

The Much-Feared FDA Form 483, Part 3

(4/8, Robert Califf, Clinical Leader) ...This final installment offers an example of how the misperception of the 483 as a surrogate for overall quality of a firm can lead to policy errors in attempting to mitigate pricing problems with generic drugs. I hope the example reinforces the key points of the first two segments in a different context... Full

Long-Acting Injectable Antipsychotics Linked to Reduced Rehospitalization in BD

(4/8, Hibah Khaja, PharmD, Psychiatry Advisor) ...Use of long-acting injectable antipsychotics (LAIs) vs oral antipsychotics may be associated with reduced short-term rehospitalization among patients with bipolar I disorder (BD-I), according to study findings published in the Journal of Clinical Psychiatry... Full

India's Generic Copies Dent Eli Lilly's Sales

(4/9, Satviki Sanjay, Bloomberg) ...Within days of dozens of generics hitting the Indian market after Novo's patent expired locally, semaglutide's share in the country's GLP-1 segment jumped to 33% in March from 25% a month earlier, according to researcher Pharmarack. That gain came at the expense of tirzepatide — the active ingredient in Lilly's Mounjaro, which is still under patent protection in India — whose share fell to 64% from 71%, Pharmarack said... Full

Inventia Enters the U.S. Market With FDA Approved Dapagliflozin Tablets

(4/8, Express Pharma) ...Inventia Healthcare Limited announced that the U.S. Food and Drug Administration has approved its Abbreviated New Drug Application (ANDA) for Dapagliflozin tablets, 5 mg and 10 mg. The company has commenced Day-One commercialisation in the United States... Full

With 3 Acquisitions to Digest, Gilead Shifts Focus from M&A to Pipeline That Has 'Never Been Stronger'

(4/8, Darren Incorvaia, Fierce Biotech) ..."Recognizing the pace of business development activity over the last few months, we expect to take some time now to focus on integration activities and more ordinary course business development transactions," Gilead CEO Daniel O'Day explained in a call with investors yesterday afternoon..."The quality of Gilead's pipeline has never been stronger," O'Day agreed on the April 7 call, which bookended a day that began with the announcement of the Arcellx buyout... Full

This Pharma Company Makes a Miracle HIV Drug, But Is Blocking Access for Millions of Low-Income People

(4/9, Michael Hiltzik, Los Angeles Times) ..."Lenacapavir could be transformative," says Peter Maybarduk, director of the access to medicines program at the nonprofit organization Public Citizen, "if people can get it." What's the main obstacle? It's the drug company that developed and owns lenacapavir, Foster City, Cal.-based Gilead Sciences. Gilead has so tightly limited access to the drug that millions of people at risk from HIV might not get it, according to Public Citizen... Full

Shionogi Lands US Contract Worth up to $482M to Tackle Superbugs, Onshore Production

(4/8, Anna Bratulic, FirstWord PHARMA) ...The contract, initially funded at $119 million with multi-year options that could bring the total to $482 million, supports multiple efforts, including building a US-based drug product manufacturing site for Fetroja; procuring supply for national stockpiles; and advancing the antibiotic for infections tied to pathogens including Burkholderia pseudomallei, which causes melioidosis, and Yersinia pestis, a Gram-negative bacterium responsible for deadly plague... Full

Patients Scramble to Find Estrogen Patches as Shortage Worsens After US FDA Champions Use

(4/9, Reuters) ..."When the FDA removed the safety warning in November, it created unprecedented demand that cannot fully be met at present," said a spokesperson for Swiss generics manufacturer Sandoz, which has shipped additional supplies to the U.S. to help ease shortages...Major makers of the patches, including Amneal, Zydus, Sandoz, Noven, and Viatris, all have some doses in shortage, according to the American Society of Health-System Pharmacists. Amneal and Viatris said they were trying to boost patch supply to meet demand... Sub. Req’d

As Opioid Use Declines, Gabapentinoid Co-Prescribing Rises

(4/8, Judy George, Medpage Today) ...Meanwhile, co-prescribing of opioids with gabapentinoids (e.g., gabapentin and pregabalin) rose substantially, from 47% in 2015 to 58.7% in 2023. Stimulant co-prescriptions increased from 5.9% to 6.7%, while benzodiazepine co-prescribing decreased from 43.8% to 33.5%... Sub. Req’d

Exclusive: Indian Pharmacopoeia Recognised by 22 Countries, Boosting Pharma Exports

(4/9, Timsy Jaipuria, CNBC TV18) ...In a significant development, the Indian Pharmacopoeia — India's official book of drug standards — has now been recognised by 22 countries for regulatory purposes, including drug registration, testing, and quality control, the sources said. This expanding footprint signals rising global confidence in India's pharmaceutical standards and regulatory systems... Full

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