Thursday, August 20, 2026

 

 

Teva Says FDA Accepts Ecopipam Application, Grants Priority Review

(8/19, Anvee Bhutani, Dow Jones) ...Teva Pharmaceuticals said the Food and Drug Administration accepted its application for ecopipam and granted the investigational therapy priority review for pediatric patients with Tourette syndrome... Sub. Req'd

 

Ecopipam's D1 Receptor Approach Signals New Pediatric Neuroscience Pathway

(8/19, Zachary Zubulake, PharmTech) ...The application has been granted Priority Review along with Orphan Drug designation, and the agency has set a targeted action date for late in the first quarter of 2027... Full

 

Accepts Ecopipam NDA With Priority Review for Pediatric Tourette Syndrome

(8/19, Morgan Ebert, Contemporary Pediatrics) ..."Ecopipam's NDA acceptance is an important milestone that advances Teva's Pivot to Growth strategy and brings us closer to addressing the unmet needs of children and their families affected by Tourette syndrome," said Eric Hughes, MD, PhD, executive vice president of global research and development and chief medical officer at Teva... Full

 

FDA Accepts NDA for Ecopipam in Pediatric Tourette Syndrome

(8/19, Chelsie Derman, HCP Live) ..."If approved, ecopipam would be the first new therapy for Tourette syndrome in more than 10 years and the first novel mechanism of action in more than 50 years, offering patients and families a long-awaited new treatment option," said Eric Hughes, MD, PhD, executive vice president, Global R&D and chief medical officer, at Teva, in a statement... Full

 

FDA Grants Priority Review to First-in-Class Ecopipam for Pediatric Tourette Syndrome

(8/19, Sydney Jennings, Patient Care) ...The NDA is supported by positive phase 2b and phase 3 data. In the phase 2b D1AMOND study, pediatric patients treated with ecopipam had a statistically significant and clinically meaningful improvement in Yale Global Tic Severity Scale–Total Tic Score (YGTSS-TTS) vs placebo at week 12 (P = .01), according to Teva... Full

 

Teva Receives FDA Acceptance for Ecopipam Tourette Treatment NDA

(8/19, Frank DeMatteo, Investing.com) ...Across clinical trials, ecopipam showed no clinically meaningful changes in body weight, BMI Z-Score, vital signs, laboratory measures, electrocardiogram measurements, or drug-induced movement disorders... Full

 

Teva Gets FDA Priority Review for Tourette Syndrome Therapy

(8/19, Dulan Lokuwithana, Seeking Alpha) ...Characterized by involuntary motor and vocal tics seen initially during childhood, Tourette syndrome affects roughly 100,000 children and adolescents in the U.S. If approved, ecopipam would be the first therapy for Tourette syndrome in over a decade, the company said... Full

 

FDA Accepts NDA, Grants Priority Review to Ecopipam for Pediatric Tourette Syndrome

(8/19, Isabella Ciccone, MPH, Neurology Live) ...Mechanistically, selective D1 antagonism differentiates ecopipam from D2-dominant TS pharmacotherapy, potentially addressing adherence-limiting extrapyramidal, sedating, and metabolic toxicities... Full

 

Ecopipam Sustains Tic Control in Pediatric Tourette Syndrome Responders

(8/20, Eve Bender, Neurology Today) ...Lead author Donald L. Gilbert, MD, MS, of Cincinnati Children's Hospital Medical Center, said the investigational therapy could add an important option to a treatment landscape in which the AAN recommends behavioral therapy as first-line treatment. "If the FDA [U.S. Food and Drug Administration] approves ecopipam for treatment of Tourette syndrome, neurologists will have an important new medication for their toolkit, which currently includes behavioral therapy ... and a variety of medications initially marketed for other conditions, like schizophrenia or high blood pressure," Dr. Gilbert told Neurology Today... Full

 

Aurinia Settles Patent Infringement Lawsuit With Teva

(8/19, Kelly Cloonan, Dow Jones) ...Under the terms of the settlement, Teva stipulated that Aurinia's patents for its flagship drug Lupkynis, which expire in 2037, are enforceable, and would be infringed if Teva sold a generic version of the drug in the U.S., Aurinia said Wednesday. Under the settlement, Teva can't launch its generic voclosporin product earlier than Dec. 7, 2036... Sub. Req'd

 

 

When Drug Pricing Becomes Trade Policy

(8/19, Ron Lanton, Pharmaceutical Executive) ...Drug pricing has entered a new phase. Foreign pharmaceutical prices are now part of more than a domestic affordability debate. International prices appear in federal payment models and manufacturer agreements, while pharmaceutical pricing, manufacturing and market access have become subjects of bilateral trade negotiation and statutory trade enforcement... Full

 

Abbreviated Biologics Pathway Could Revive Biosimilar Competition

(8/19, Sabrina McCrear, The Center for Biosimilars) ...An abbreviated biologics license application (ABLA) pathway modeled on the 1984 Hatch-Waxman Act-one that would grant new biosimilars class-level interchangeability with their reference products immediately upon licensure-is needed to revive a stalled US biosimilar market, according to a recent study published in Therapeutic Innovation& Regulatory Science... Full

 

Biologics Lobby Slams Combo Drug Policy In Proposed IRA Rule

(8/19, Jessica Karins, Inside Health Policy) ...The leading biologics lobbying group is objecting to CMS' proposal to consider some fixed-combination drugs the same Qualifying Single Source Drug (QSSD) as an originator product for the purposes of Inflation Reduction Act drug price negotiation, saying the policy would discourage innovation and exceeds CMS' statutory authority by aggregating drugs that FDA considers separate... Sub. Req'd

 

Trump's Pick to Lead The FDA Faces Uphill Senate Battle

(8/19, Lauren Gardner, David Lim, Alice Miranda Ollstein, Cheyenne Haslett, Politico) ...As Trump's deputy assistant for domestic policy, Overton, a physician, has helped bring Trump's health policies to fruition, most recently helping shepherd an executive order last week that spelled out Trump's plan to reduce the number of recommended vaccines for children. Sen. Bill Cassidy (R-La.), proponent of vaccination, occasional Trump critic, and chair of the Health, Education, Labor and Pensions Committee, has already signaled that may cost her his vote... Full

 

What Is The Purpose Of Drug Repurposing?

(8/19, Michael McCaughan, Pink Sheet) ...The goal of repurposing older medicines for unmet needs, [former acting Commissioner Janet Woodcock] said, should not be framed as updating labeling, but instead in terms of driving adoption of new treatments. "Let's be honest: nobody looks at generic labels," Woodcock said. "The treating community doesn't refer to those for treating instructions." The challenge with repurposing drugs, she argued, is "how to get it … into the doctors' and patients' hands, and into clinical guidelines."... Global Sub. Full

 

 

Ono Pharma's Opdivo Intravenous Infusion Wins Additional Approval in Taiwan

(8/20, BioSpectrum Asia) ...Ono Pharmaceutical has announced that Ono Pharma Taiwan, a Taiwanese subsidiary of Ono, has received the additional approval of OPDIVO® Intravenous Infusion, an anti-PD-1 antibody, from the Taiwan Food and Drug Administration (TFDA), for the neoadjuvant treatment of adult patients with resectable (tumours 4 cm or node positive) Non-Small Cell Lung Cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements in combination with platinum-doublet chemotherapy, followed by single-agent OPDIVO as adjuvant treatment after surgery... Full

 

Blenrep Clears 1st Reimbursement Hurdle in Korea for Relapsed Multiple Myeloma

(8/20, Kim Yun-Mi, Korea Biomedical Review) ...The Health Insurance Review and Assessment Service (HIRA) said its Cancer Disease Review Committee (CDRC) approved reimbursement criteria for Blenrep in combination with bortezomib and dexamethasone (BVd) at its seventh meeting of 2026 on Wednesday. The criteria cover adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy. However, the CDRC did not approve reimbursement criteria for another approved regimen: Blenrep with pomalidomide and dexamethasone (Bpd)... Full

 

 

Semaglutide Sole-Supplier Status Brings Both Rewards And Challenges For Apotex In Canada

(8/19, Dave Wallace, Generics Bulletin) ...Dr Reddy's has suffered with active pharmaceutical ingredient supply issues that have forced the company to temporarily withdraw from the market... Global Sub. Full

 

How Celltrion Is Making A Splash In Tenders, Formularies And Pharmacies

(8/19, Dean Rudge, Generics Bulletin) ...Celltrion has strengthened the position of several of its newer biosimilars in Spain and Portugal through a string of tender wins, with Omlyclo (omalizumab) estimated to have captured more than 90% of the Spanish market by June and Avtozma (tocilizumab) approaching a 50% share during the second quarter... Global Sub. Full

 

SK Strikes Settlement With MSN Over Future Xcopri Generic: Reports

(8/19, Kevin Dunleavy, Fierce Pharma) ...For the first time, SK Biopharmaceuticals has struck a settlement with a generics manufacturer that has applied for FDA approval of a copycat version of its epilepsy treatment, Xcopri (cenobamate), several Korean news outlets report... Full

 

Outlook To Expand Ophthalmic Bevacizumab Empire With Pre-Filled Presentation

(8/19, Urte Fultinaviciute, Generics Bulletin) ...The long-awaited approval from the US Food and Drug Administration has filled Outlook Therapeutics with confidence to build on its ophthalmic bevacizumab product Lytenava... Global Sub. Full

 

Ustekinumab Setback Tests Richter's Expanding Biosimilar Business

(8/20, Dean Rudge, Generics Bulletin) ...Gedeon Richter has put the launch of its in-licensed Usymro (ustekinumab) biosimilar on hold after a change in the EU good manufacturing practice compliance status of partner Bio-Thera Solutions' manufacturing site, adding a fresh execution challenge as the Hungarian firm continues to scale up its expanding biosimilars business... Global Sub. Full

 

Celon Pharma's Generic Semaglutide Drug Matches Ozempic in Early Study, Shares Jump

(8/20, Reuters) ...The data will allow Celon Pharma to extend the demonstrated bioequivalence to other doses of the drug candidate, according to clinical guidelines...It said the trial marks a significant step in its strategy to launch the semaglutide equivalent in global markets... Full

 

Glenmark Gets USFDA Nod for Generic Fluticasone Propionate Nasal Spray

(8/20, PTI) ...The approval by the US Food and Drug Administration (USFDA) is for fluticasone propionate nasal spray of strength 0.05 mg/spray, Glenmark Pharmaceuticals said in a regulatory filing... Full

 

EXCLUSIVE: Sunshine Biopharma Secures Canadian Approval for Generic Hypertension Drug

(8/19, Vandana Singh, Benzinga) ...The newly approved medication, the generic equivalent of the well-known brand Vasotec, will be available to patients in multiple dosage strengths: 2.5mg, 5mg, 10mg, and 20mg tablets... Full

 

Joshua Salsi – Head of North America, Biocon Biologics

(8/19, Pharma Boardroom) ...Joshua Salsi, Head of North America, Biocon Biologics explains the company's evolution into an integrated, global biosimilars company following the 2022 Viatris portfolio reacquisition. He highlights the company's growing US leadership, expanding pipeline, vertical integration, and focus on patient access. Salsi goes on to stresses that long-term biosimilar growth depends on sustainable economics, regulatory modernisation, competition and stronger stakeholder collaboration... Full

 

 

Amgen Abandoning $500M+ Crohn's Collab Won't Derail TScan's Pipeline Strategy

(8/19, Darren Incorvaia, Fierce Biotech) ...Amgen has now walked away from the deal, TScan revealed in an Aug. 18 filing with the Securities and Exchange Commission, noting that the partnership will officially end on Nov. 10. A spokesperson for the Big Pharma told Fierce that it had called time on the collaboration "following a strategic review of our portfolio and research priorities."... Full

 

China's Top Drugmaker Hengrui Sees Profit Growth Squeezed by Bulk-Buying Programs

(8/20, Reuters) ...Jiangsu Hengrui Pharmaceuticals...reported a 0.34% rise in first-half net profit on Wednesday, as its generics business remained under pressure from bulk-procurement programs designed to lower healthcare costs... Full

 

Bristol Myers Squibb to Build $2.3B Manufacturing Campus in Houston

(8/19, Nathan Owens, Manufacturing Dive) ...The 600,000-square-foot campus will allow Bristol Myers Squibb to produce small molecules, biologics and antibody-drug conjugates for a range of diseases, and enough flexibility to reconfigure capacity in the future, according to a news release. It also will create about 500 jobs, such as technicians, production specialists, quality control and site leadership... Full

 

The Operational Reality of Reshoring Pharma Manufacturing: Q&A with Rohit Tripathi

(8/20, Nicholas Jacobus, Rohit Tripathi, Pharmaceutical Executive) ...Rohit Tripathi, VP of Industry Strategy at RELEX, talks with Pharmaceutical Executive about the impact new phased tariffs will have on reshoring pharma manufacturing... Full

 

The Most Interesting Takeaway from Anthropic's Design Study Has Nothing to Do with Proteins

(8/19, Andrew Dunn, Endpoints News) ...Those documents give an instructive, and fairly entertaining, look at how some of the world's most talented AI researchers construct prompts for large language models like Claude... Sub. Req'd

 

Dr Reddy's Labs Receives 4 Observations From US FDA for Formulations Facility in Hyderabad

(8/20, PharmaBiz.com) ...Dr. Reddy's Laboratories Ltd has received four observations from United States Food & Drug Administration (FDA) formulations manufacturing facility (FTO-3) in Bachupally, Hyderabad... Full

 

 

Why Indian Exports to US Are Holding up Despite Tariffs — and What Could Threaten That Resilience

(8/19, Ashmit Kumar, CNBC TV18) ...Meera Shankar, former Indian Ambassador to the US, said products such as electronics and pharmaceuticals, including generic drugs, were not covered by the initial tariffs imposed on India. 'The products which continue to go to the US market are broadly those which were not covered in the initial tariffs,' Shankar told CNBC-TV18. Labour-intensive products, however, have faced greater pressure... Full

 

Industry Could Recoup Fees If UK MHRA Misses Deadlines Under New Proposal

(8/19, Vibha Sharma, Pink Sheet) ...The MHRA says industry values reliable and predictable timelines more than financial compensation, but argues that the rebate mechanism demonstrates a clear commitment to delivery and accountability. It says its goal would be to meet the guaranteed timelines, rather than pay rebates... Global Sub. Full

 

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