Monday, August 24, 2026

 

 

Teva Reaches its Highest Level Since 2017 as Investors Embrace its Transformation

(8/24, CTech) ...The rally extends a remarkable turnaround for a company that was once synonymous with the global generic-drug business and had fallen deeply out of favor with investors. Teva's shares have now gained more than 100% over the past year, although the company is still in the process of proving that its transformation can deliver sustained growth... Full

 

Teva Share Price Hits Nearly 10-Year High

(8/24, Shiri Habib-Valdhorn, Globes) ...The dual traded company, led by CEO Richard Francis, has issued several positive reports in recent weeks, helping the stock recover from a period of weakness and leading to a rise of about 20% in the past month... Full

 

Teva Share Price Hits Nearly 10-Year High

(8/23, FirstWord PHARMA) ...In late July, the company released positive second-quarter financial results and raised its annual revenue guidance, while this month, it reported that Moody's had upgraded its debt rating to investment grade, after Fitch had done so earlier this year... Full

 

Teva Secures A 2036 US Launch Date For Its Generic To Aurinia's Lupkynis

(8/24, Urte Fultinaviciute, Generics Bulletin) ...Unless certain undisclosed contingencies occur earlier, Teva will be able to enter the market with the generic voclosporin from Dec. 7, 2036. The launch is also contingent on Teva receiving approval from the US Food and Drug Administration... Global Sub. Full

 

US FDA Accepts Teva's New Drug Application for Ecopipam

(8/24, John Pinching, PharmaTimes) ...Ecopipam is a selective D1 dopamine receptor antagonist with Orphan Drug designation. Teva said the milestone advances its Pivot to Growth strategy by using its neuroscience expertise to support patients in areas of high unmet need... Full

 

FDA Accepts Ecopipam NDA for Tourette Syndrome, Remlifanserin Receives Fast Track Designation for AD Psychosis, Alterity Reaches FDA Alignment on ATH434

(8/22, NeurologyLive) ...Eric Hughes, MD, PhD, executive vice president, global R&D and chief medical officer at Teva, told NeurologyLive® this, "We are encouraged by the FDA's acceptance of the ecopipam application and grant of Priority Review. Tourette syndrome is an area where innovation has been limited for far too long, with patients and clinicians often relying on treatments developed for other conditions."... Full

 

 

Price Transparency, Insulin Top Lawmakers' Health To-Do Lists

(8/24, Erin Durkin, Victoria Knight, Bloomberg) ...If one or both chambers of Congress changes hands, there will be urgency for Republicans to push through partisan policies before losing their governing trifecta. But that reality may not lead to action, said Chris Meekins, a health policy analyst and managing director at Raymond James. "Political dynamics likely will lead to limited actions focused on what must be handled not what people might like to get done," said Meekins, who previously worked for Rep. Andy Harris (R-Md.) and in the first Trump administration. "Congress will handle the expiring health provisions, but bigger actions around transparency, PBMs, physician payment reforms, or others seem like heavy lifts."... Sub. Req'd

 

Dr. Oz: 1 in 3 Americans Leave Pharmacy Empty-Handed Over Drug Costs

(8/23, Kiara Moore, Washington Examiner) ...Oz emphasized that the cost of healthcare remains a major concern for Americans, particularly when expenses come directly out of their pockets. He also noted that patients are frequently forced to leave pharmacies without their prescriptions because they cannot afford them... Full

 

PBMs Urged To Ensure New TrumpRx Prices Count Toward OOP Insurance Obligations

(8/21, Gabrielle Wanneh, Inside Health Policy) ...Anna Hyde, vice president of Advocacy and Access at the Arthritis Foundation, and HIV+HEP Policy Institute Executive Director Carl Schmid requested clarity on the matter in a letter sent Friday (Aug. 21) to David Marin, president and CEO of the Pharmaceutical Care Management Association that lobbies on behalf of the country's traditionally modeled PBMs... Sub. Req'd

 

As Trump 2.0 Continues its Assault on Federally Funded Research, a New Study Highlights What's at Stake

(8/21, John Carroll, Endpoints News) ...Biopharma now recruits close to 10 adult cancer patients for every one that goes into a federally sponsored trial, according to a 2024 study led by Joe Unger, a biostatistician at the Fred Hutch Cancer Center. That's twice the comparable rate of a decade earlier. And with the Trump administration continuing its assault on federally sponsored research, Unger and a group of researchers are back with a new study in JAMA Oncology aimed at offering lawmakers some added ammunition in their defense of the work undertaken by the National Cancer Institute... Sub. Req'd

 

FDA Publishes New Product-Specific Guidances to Support Generic Drug Development, Including Targeted Oncology Therapies

(8/23, OncoDaily) ...The latest publication includes a total of 55 PSGs, consisting of 24 new guidances and 31 revised guidances. More than 30 of the guidances address products with no currently approved ANDAs, including several complex drug products... Full

 

FTC Files Amicus Brief to Protect Competition in Biologic Drug Markets

(8/21, Federal Trade Commission) ...As part of its efforts to ensure Americans have greater access to low-cost prescription drugs, the FTC argues in the brief that acquisitions of patent applications, like Amgen's acquisition, are subject to antitrust scrutiny... Full

 

Patent Application Buyouts Are Fair Game For Antitrust Scrutiny, FTC Says In Enbrel Dispute

(8/21, Sue Sutter, Pink Sheet) ...Amgen's exclusive licensing of patent applications also is not shielded from antitrust review simply because the applications were subsequently prosecuted before the Patent and Trademark Office and the resulting patents enforced through litigation, the FTC said in an amicus brief filed with the Fourth Circuit US Court of Appeals... Global Sub. Full

 

AstraZeneca Loses Second Suit Against Medicare Drug Price Cuts

(8/21, Ganny Belloni, Nyah Phengsitthy, Bloomberg Law) ...Judge Matthew J. Maddox of the US District Court for the District of Maryland on Aug. 19 granted the government's motion for summary judgment against AstraZeneca's lawsuit challenging the government's determination of drugs eligible for Medicare price negotiations... Full

 

Trump Offered State Medicaid Programs Lower Prices on Weight-Loss Drugs. Most Are Rejecting The Deal.

(8/22, Kelly Hooper, Politico) ...President Donald Trump's pledge to make new but pricey weight-loss drugs widely available for low-income Americans isn't panning out as planned. Trump promised last year that obese Americans on Medicaid would soon gain access to drugs known as GLP-1s, like Wegovy and Zepbound, if the states where they live signed on with his administration to negotiate prices directly with manufacturers...Only Indiana has publicly signed on with the administration. Some states have stopped covering the medications for Medicaid patients who need them for weight loss. Others are considering ending coverage. Most states told POLITICO they will not participate... Full

 

 

AbbVie to Present New Data at WCLC 2026 Showcasing Innovation Across Lung Cancer Pipeline

(8/24, AbbVie) ...AbbVie today announced new data highlighting research programs across its lung cancer portfolio being presented at the 2026 World Conference on Lung Cancer (WCLC), including non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). The presentations span clinical, translational and real-world data across next-generation immunotherapies and targeted antibody-drug conjugates (ADCs), designed to generate insights into treatment burden, patient experience and biomarker identification that may help inform future research... Full

 

 

Upsher-Smith Joins Crowded Copaxone Generic Market

(8/24, Dean Rudge, Generics Bulletin) ...The Bora Pharmaceuticals subsidiary has launched glatiramer acetate injection in 20mg/ml and 40mg/ml strengths, with both products carrying an AP therapeutic equivalence code to their respective reference-listed versions of Copaxone... Global Sub. Full

 

Alvotech Announces Licensing and Commercialization Agreement With Lotus Pharmaceutical for Proposed Biosimilars to Durvalumab and Emicizumab in the U.S. and Selected Asian Markets

(8/21, Alvotech) ...Under a semi-exclusive agreement in the United States, Alvotech retains the right to commercialize both products directly alongside Lotus, while Lotus will commercialize the products through Alvogen, its U.S.-based wholly owned subsidiary. Alvotech will retain responsibility for product development, and for obtaining and maintaining marketing authorizations in the United States, and will serve as the exclusive supplier of the products for all markets... Full

 

Sawai Launches Four First-Time Generics As Revenue Rises But Profit Falls In Q1

(8/21, Anabel Costa-Ferreira, Generics Bulletin) ...A raft of new launches is on the horizon for Sawai Pharmaceuticals after the Japanese firm achieved a revenue increase of 4.3% in its financial first quarter, despite the cost of multiple product launches and continuously rising operational costs leading to a fall in operating profit... Global Sub. Full

 

'We Expect To Be First To Market For That' – Organon's Azzinaro On Taking Pole Position In Pertuzuma

(8/24, Dave Wallace, Generics Bulletin) ...In the competitive biosimilars space, "it's not often that you have the opportunity to be first to market," pointed out Joe Azzinaro, vice president and global commercial lead for biosimilars at Organon, in an exclusive interview with Generics Bulletin. However, the firm's Henlius-partnered Poherdy (pertuzumab) biosimilar to Perjeta offers Organon the opportunity to do just that, with the company eyeing a lead position in both Europe and the US, following recent approvals... Global Sub. Full

 

Glenmark Builds On US Respiratory Portfolio With Generic Flonase Nasal Spray Approval

(8/21, Urte Fultinaviciute, Generics Bulletin) ...Glenmark Pharmaceuticals is continuing the momentum on its respiratory product portfolio in the US, following the US [FDA] approval for a generic rival to Haleon's Flonase 0.05 mg (fluticasone propionate) nasal spray... Global Sub. Full

 

 

Lundbeck Continues Neuroscience Evolution as CEO Keeps Company 'Punching Above its Weight'

(8/21, Fraiser Kansteiner, Fierce Pharma) ...By the numbers, Rexulti, approved in major depressive disorder (MDD) and Alzheimer's disease-associated agitation, continued to lead the pack for the earnings period, growing 17% at constant currencies over the first six months of the year to 3.3 billion Danish kroner (nearly $515 million), while migraine prevention med Vyepti climbed an impressive 46% to reach 2026 first-half sales of 2.9 billion kroner ($447 million)... Full

 

Richter Sees GenMed Recovery Stretching Into 2027

(8/21, Dean Rudge, Generics Bulletin) ...Richter expects its General Medicines business to return to mid-single-digit growth from 2027, with newer generics helping offset legacy-product erosion, distributor changes and market-specific setbacks that weighed on first-half performance... Global Sub. Full

 

AI, Genomics Expert Leaves Pathos AI, Will Advise Pfizer

(8/21, Jonah Comstock, pharmaphorum) ...Eric Schadt, a serial entrepreneur and expert in computational biology, is leaving his post as chief scientist at Pathos AI to start a new, stealthy venture - and signing on as Pfizer's first AI Scholar in the process. "I'm excited to help Pfizer think ambitiously about what an AI-native R&D organisation can become, and particularly about how advanced AI models can deepen our understanding of disease and improve how we discover and develop medicines and vaccines," Schadt wrote in a post on LinkedIn... Full

 

Drugmakers Still Struggling to Keep Up With Spiking Estrogen Patch Demand

(8/21, Joseph Choi, The Hill) ...The ASHP noted that Amneal, Viatris and Zydus did not provide a reason for their shortages. Like Sandoz, Noven blamed an increase in demand. Other estradiol patch products from Viatris, Amneal and Bayer continue to be available... Full

 

 

EMA Pilot Cuts Approval Times For Global Post-Marketing Changes By More Than Half

(8/21, Vibha Sharma, Pink Sheet) ...Around 80% of changes were approved in non-EU markets in less than half the time typically required under standard national procedures. The faster reviews by the regulators were enabled by companies making near-concurrent submissions across participating NRAs, which relied on the EMA's assessment reports for their reviews, avoiding questions already resolved during the EU review process... Global Sub. Full

 

Indian Pharma Firms Have Little Reason to Fear Trump's Tariff Threat

(8/23, Juliana Liu, Bloomberg) ...Instead of rushing to fire up new manufacturing facilities, the likes of Sun Pharmaceutical Industries Ltd. and Dr. Reddy's Laboratories Ltd. would be better off biding their time. The duties may never fully materialize... Sub. Req'd

 

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