Thursday, May 14, 2026

 

 

Wall Street Thinks Teva Stock Still Has Room to Run After Soaring Over 100%. Here's Why Analysts Are Right.

(5/14, Keith Speights, The Motley Fool) ...There's no question at this point that Teva's turnaround is real. And Wall Street believes the stock has more gas in the tank... Full

 

'Fix Them Without Delay': Supply Shortages Hit Parkinson's Drugs

(5/13, Ben Lee, Chemist & Druggist) ...Parkinson's UK's associate director of policy and health strategy Rowan Wathes told C+D that its helpline has heard from an "increasing number of people" experiencing "difficulties and delays in obtaining co-careldopa". Co-careldopa is manufactured by Teva Pharmaceuticals and is facing supply issues "until early December"... Full

 

 

Exclusive: Sen. Welch Would Back Trump's Most Favored Nation Drug Policy Plan

(5/13, Josephine Walker, Axios) ...Asked by Axios' Peter Sullivan if he'd vote for Trump's plan, Welch said he would "not only vote for it, I would work actively and aggressively to make it happen."...He noted that Trump hasn't introduced any legislation yet and he'd like the president to "do it, not just talk about it."... Full

 

As Trump Arrives in China, Big Pharma CEOs Are Notably Absent

(5/13, Angus Liu, Fierce Pharma) ...The missing pharma voice in Trump's delegation mirrors the topic's relatively lower priority on the President's agenda compared with semiconductors and artificial intelligence, or it could simply reflect the direction of the flow of investment. After all, Trump is apparently keen on wringing more investment in the U.S. from China, and not the other way around, like what many pharmas are doing... Full

 

SCOTUS Weighs Taking Up Six Petitions Challenging IRA Drug Negotiation

(5/13, Jessica Karins, Inside Health Policy) ...The Supreme Court is set to consider at its conference Thursday (May 14) whether to take up petitions from six pharmaceutical companies to consider the legality of the Inflation Reduction Act's Medicare drug negotiation program, after industry has suffered numerous losses with lower courts ruling the program is constitutional... Sub. Req'd

 

Lawmakers Want to Break Up Some Pharmacy Companies. Here's Why

(5/13, Ken Alltucker, USA TODAY) ...On May 13, Sens. Elizabeth Warren, D-Massachusetts, and Josh Hawley, R-Missouri, reintroduced the Patients Before Monopolies Act. Under the legislation, companies that own a pharmacy benefit manager or an insurance company would be forbidden from owning a pharmacy... Full

 

Harshbarger, Colleagues Renew Bipartisan Push to Put Patients Before Monopolies, Cut Drug Costs

(5/13, Congresswoman Diana Harshbarger) ...Congresswoman Diana Harshbarger (R-TN) and Congressman Jake Auchincloss (D-MA) today reintroduced the Patients Before Monopolies (PBM) Act with expanded bipartisan support. The legislation would prohibit the joint ownership of Pharmacy Benefit Managers (PBMs) and pharmacies-a glaring conflict of interest that has allowed these shadowy middlemen to manipulate the system, pad their own pockets, and squeeze patients and independent community pharmacies dry in the process... Full

 

The Trillion-Dollar Blind Spot - How Influential Wholesalers Have Stayed in the Shadows

(5/13, Amanda Frost, PCMA) ...Despite the rather mundane description of wholesalers painting them as largely drug movers, their positioning in the middle of the supply chain means they exert significant influence over drug availability and pricing, especially generic drugs. Over 90% of the prescriptions filled in the U.S. every year are generic drugs, and wholesalers dominate nearly every aspect of their pricing between manufacturer and patient... Full

 

FDA Faces User Fee, Drug Approval Tests Under Acting Leadership

(5/13, Jessica Karins, Inside Health Policy) ...Steve Grossman, a longtime FDA observer and author of the FDA Matters blog, said Diamantas has earned a high level of respect during his short time at FDA and may be able to bring a more stable footing to the agency. "The biggest issue for drug and biologics sponsors, FDA reviewers, and patient advocates is the apparent discrepancy between agreed-upon review standards and decisions about individual products. If, as I suspect, Kyle Diamantis brings a more orderly approach to FDA issues and decisions, then I would think there would be diminished concern about reliability and consistency in reviews," Grossman said... Sub. Req'd

 

You Can Teach an Old Drug New Tricks

(5/13, Christopher Snyder, Sarrin Chethik, The Wall Street Journal) ...[N]ew research by University of Chicago economist Eric Budish and coauthors suggests that a lack of stronger market incentives has left hundreds of opportunities for generic drug repurposing on the shelf... Sub. Req'd

 

PhRMA CEO Backs Parts Of Makary's US FDA Agenda As Diamantas' Onboarding Continues

(5/13, Maaisha Osman, Sue Sutter, Pink Sheet) ...Pharmaceutical Research and Manufacturers of America CEO Stephen Ubl said during the Axios Future of Health Summit on May 13 that industry supports several initiatives that Makary pursued, including efforts to expand the use of single-arm trials, reduce reliance on animal testing, streamline inspections and explore novel regulatory pathways for rare diseases... Global Sub. Full

 

Exclusive: Pharma Leaders Hope Next FDA Head Calms Waters

(5/14, Peter Sullivan, Axios) ..."What we really need from the next leader of the FDA is to calm the waters and reestablish that certainty and predictability," PhRMA CEO Steve Ubl said at Axios' Future of Health Summit. Bristol Myers Squibb CEO Chris Boerner sounded a similar theme, pointing to the years of work that go into developing a drug. "What we need right now is we need predictability," he said. "Our time horizons are 10 to 15 years. We spend billions of dollars to bring one new medicine to market. And in that environment, we need to know that we've got a very stable FDA that sets consistent rules."... Full

 

Klomp: Search For Makary Successor Underway, Shortlist Expected In Coming Weeks

(5/13, James Jarvis, Christian Robles, Inside Health Policy) ...Senior HHS advisor Chris Klomp told Inside Health Policy Wednesday (May 13) he is leading the search for a new FDA commissioner, which is already underway, and a list of candidates will be presented to the president within weeks..."We don't plan to dilly dally; we'll get moving pretty fast," Klomp, the director of Medicare and HHS chief counselor, said in an exclusive interview. Klomp said there is no short list yet for the commissioner's role and the agency is still in the early stages of putting together a hiring committee to vet potential nominees... Sub. Req'd

 

Editorial: A Desperately Needed Reset at the FDA

(5/14, The Washington Post) ...MARTY MAKARY'S resignation as commissioner of the Food and Drug Administration creates a much-needed opportunity to reset the critical agency. It's not an exaggeration to say that developing a more constructive relationship with medical innovators could benefit billions of people... Full

 

What Does Declining Average Commissioner Term Length Say About US FDA's Future?

(5/13, Derrick Gingery, Pink Sheet) ...The relatively frequent turnover in the commissioner's office recently would seem to place more responsibility on senior career civil servants to help maintain agency stability. But the FDA does not have permanent leaders at the top of several centers, including the Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research. The turmoil has raised concerns about morale, staff recruitment and retention, and agency direction... Global Sub. Full

 

With Governor's Signature, Healthcare Affordability Bills Become Law

(5/14, Charlotte Rene Woods, Virginia Mercury) ...Most of the legislation was sponsored by lawmakers representing that part of the state and met success following years of efforts under previous gubernatorial administrations. About a dozen of those legislators joined Spanberger for the signing at the Inova Schar Cancer Institute in Fairfax County. The measures reflect Spanberger's focus on affordability, which she called "the cornerstone of my legislative agenda."... Full

 

Legislature Unanimously Approves Prescription Drug Discount Card Proposal

(5/13, Vermont Business Magazine) ...Under H.577, Vermont would join ArrayRx-a coalition of states pooling their buying power to negotiate more affordable drug prices. Vermonters could sign up for an ArrayRx discount card free of charge, offering up to 80% off generic drugs and up to 20% off name-brand medications. The card is accepted at most pharmacies nationwide and can be used for any FDA-approved medication. All Vermonters, insured and uninsured, could enroll for free... Full

 

Price Protection Legislation Passes New York Senate

(5/12, Alex Gault, Watertown Daily Times) ...And a "Manufacture Disclosure Transparency Act" would address agreements between pharmaceutical companies that delay the production of cheaper or generic versions of new and more expensive name-brand drugs. It would force companies to alert the state attorney general's office for when they enter into certain agreements that delay the introduction of generic drugs... Full

 

 

FDA Hands Down Approvals to Blood Cancer Drugs from BeOne and Taiho

(5/13, Elizabeth S. Eaton, FirstWord PHARMA) ...The approval for Beqalzi marks the next-generation BCL2 inhibitor's first regulatory clearance. Its approval, following priority review, was based on data from a Phase I/II trial involving 125 adults with MCL whose disease had progressed following treatment with anti-CD20 therapy and a BTK inhibitor... Full

 

Woman Diagnosed with Huntington's Disease at 18 Speaks Out About Living with a Fatal Illness: 'I Am Going to Die' (Exclusive)

(5/13, Jordan Greene, People) ...Despite the uncertainty surrounding her future, [Jenna] Cotromano says there is still immense joy within the Huntington's disease community - something she hopes people outside the community can better understand. "We are not just existing," she says. "We live while we can and refuse to let HD take us before our time."... Full

 

Ryan Reynolds on His Father's Parkinson's Disease and the Symptoms No One Talks About

(5/14, Brain & Life) ...In August 2024, Reynolds, who also serves on the board of the Michael J. Fox Foundation, partnered with Acadia Pharmaceuticals to launch More to Parkinson's, a national awareness campaign focused on the hallucinations and delusions that affected his father. Acadia is the manufacturer of pimavanserin (Nuplazid), currently the only FDA-approved treatment for Parkinson's-related hallucinations and delusions... Full

 

 

Dr Reddy's Sets Out Details Of Imminent Semaglutide Launch In Canada

(5/13, Dave Wallace, Generics Bulletin) ...And in terms of pricing, "our list price will be, give or take, about half of what Novo Nordisk will be," [Dr. Reddy's CEO, Erez Israeli, revealed. "This can be shared because it will be listed. Obviously, the rest is arrangements that we have with the customer that we will not be able to disclose. But let's say it will be the normal arrangements that you normally have."... Global Sub. Full

 

Viatris Targets US GLP-1s With Auto-Injector Strategy

(5/13, Dean Rudge, Generics Bulletin) ...While acknowledging that the strategy is "more in the 2030 and beyond timeframe," chief executive officer Scott Smith described GLP-1s as "important to our future and long-term strategy" - pointing to a complex market shaped by multiple molecules, indications and dosage forms - as he addressed investors during the company's recent first-quarter earnings call... Global Sub. Full

 

Cheaper Generic Ozempic Is Coming Soon - But Not for Americans

(5/13, Berkeley Lovelace Jr., NBC News) ...Thanks largely to loopholes in the U.S. patent system, Americans aren't expected to get generic forms of semaglutide, the drug in Novo Nordisk's Ozempic and Wegovy, until at least the end of 2031. Even that timing is uncertain, said Arti K. Rai, a professor at the Duke University School of Law and former senior official in the United States Patent and Trademark Office. "It could take much, much longer than that."... Full

 

Gifrer Acquisition To Boost Celltrion's French Reach, Portfolio

(5/13, Jung Won Shin, Generics Bulletin) ...After completion, Celltrion intends to continue operating Gifrer as an independent entity to fully leverage its local brand recognition, while seeking to maximize product and sales synergies. All of Vaulx-en-Velin-based Gifrer's roughly 70 employees will be retained... Global Sub. Full

 

Lupin Gets FDA Nod for Famotidine Injection to Treat Ulcers, GERD

(5/13, Jomy Jos Pullokaran, CNBC-TV18) ...Drug firm Lupin Ltd on Wednesday (May 13) said it has received approval from the United States Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for famotidine injection USP, 20 mg/2 mL (10 mg/mL), single-dose vials... Full

 

IQVIA and Kexing Biopharm Expand Strategic Collaboration to Accelerate Global Biosimilar Development Using AI-Enabled Capabilities

(5/13, IQVIA) ...The collaboration is designed to support Kexing's global expansion by bringing together IQVIA's end-to-end capabilities across the development lifecycle. By aligning clinical development, regulatory strategy, advanced analytics and commercialization under a coordinated global approach, the program aims to accelerate biosimilar development for international markets while upholding rigorous standards for quality and scientific integrity... Full

 

 

Cipla Looks to Ensure Consistent Drug Supplies, as Costs Increase Due to West Asia War, Says MD & Global CEO

(5/13, The Hindu Businessline) ...As the war prolongs, [Achin Gupta, Cipla's Managing Director and Global Chief Executive Officer,] said, there is an increase across raw materials, across fuel, across solvents. "We try and maintain enough inventory of, all the input materials that we can, and then we will work with....whatever guidance we receive from the government. There is an active dialogue," said Gupta, as pharmaceuticals is a critical industry. "We are trying to ensure as much of supply security as possible, and absorbing some of the cost, but, ...at some point, there is a dialogue to be had with customers and with all the payers on the cost side as well," said Gupta, who took charge as MD, last month... Full

 

Cipla Focuses on Respiratory Therapies, Specialty Drugs and Complex Generics

(5/13, Neetu Chandra Sharma, Business Today) ..."Going ahead, the focus will be on growing our key markets, further building our flagship brands, investing in future pipeline as well as focusing on resolutions on the regulatory front," said Achin Gupta, CEO, Cipla. The strategy reflects the changing mix of Cipla's business over the past few years. India now contributes nearly 45% of consolidated revenue, with the domestic business increasingly driven by chronic therapies, consumer health products and trade generics rather than acute products alone... Full

 

Owkin, AstraZeneca Expand Collaboration on AI-Driven Drug Research Tools

(5/13, Nathan Eddy, MobiHealthNews) ...As part of the agreement, Owkin will develop AI agents for AstraZeneca teams that will operate through the K Pro platform and integrate into the company's existing IT infrastructure and workflows. The agents are designed to help analyze and forecast competitive intelligence related to pharmaceutical targets, drug assets and clinical trials... Full

 

Aiming for The Sun: How The $11.75 Billion Organon Buy Is Cementing Dilip Shanghvi's Legacy

(5/24, Neetu Chandra Sharma, Business Today Magazine) ...A man who has spent over four decades being almost pathologically cautious is now writing the largest cheque of his life, a contrast that traces back to a wholesale medicine shop in the dust and din of Kolkata's bustling Dawa Bazar. It is also the first time he is stepping into businesses and geographies where Sun has limited prior operating experience... Full

 

 

Euro Convergence: Regulators Discuss New Pharma Legislation, AI, and More

(5/13, Ferdous Al-Faruque, Regulatory Focus) ...A panel of European regulators answered questions during a town panel discussion at RAPS Euro Convergence 2026 on the implementation of the new EU Pharmaceutical Legislation and the use of artificial intelligence (AI) in regulatory and drug development... Full

 

EU Member States To Gain Power to Mandate Medicine Supply From December 2027

(5/13, Eliza Slawther, Pink Sheet) ...The new legislation, which will comprise a regulation and a directive, is expected to enter into force this December. While most of its provisions will not apply for two years, provisions relating to the supply of medicines will apply 12 months after the legislation comes into force... Global Sub. Full

 

EMA Offers Scientific Advice For 'High Impact' Modeling And Simulation Strategies

(5/13, Vibha Sharma, Pink Sheet) ...The pilot, launched in May, enables sponsors to request scientific advice or protocol assistance (which is the equivalent scientific advice procedure for orphan medicines) on their proposed model informed drug development (MIDD) strategies... Global Sub. Full

 

Regulatory Recap: UK's Dormant License Rival Project To Close Applications In June

(5/13, Urte Fultinaviciute, Generics Bulletin) ...Project Revive is a collaborative initiative set up by the UK's off-patent drug trade group Medicines UK, NHS England, and the Medicines and Healthcare products Regulatory Agency. It aims to resolve critical medicines shortages by encouraging drug makers to relaunch dormant but already approved licenses... Global Sub. Full

 

India's Pharma Industry Is Going Global. But Can It Catch up to China?

(5/13, Kelly Bilodeau, PharmaVoice) ...Probably not anytime soon, according to Subin Baral, EY-Parthenon global life sciences deals leader. "In our view, [India is] a long time away from actually competing as a serious innovation hub for biopharma," he said. Gaps in infrastructure and capital are among the biggest barriers on the path forward... Full

 

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