Friday, September 11, 2026

 

 

Arizona Attorney General Says Naloxone Program Seeing Positive Results

(9/1, Daily Independent) ...Arizona Attorney General Kris Mayes said in a release Thursday that more than 500 lives have been saved as part of the statewide naloxone distribution program. The program is funded through opioid settlement agreements with major pharmaceutical distributors and manufacturers. The program began back in 2024. During the first two years, Teva Pharmaceuticals shipped 55,442 units (110,484 doses) of nalopxone to 13 Arizona counties and eight community-based organizations... Sub. Req'd

 

Generic Acetaminophen Pills Recalled Due to Possible 'Foreign Material' Contamination

(9/10, Kevin Maimann, CBC News) ...An over-the-counter pain reliever is being recalled due to the possible presence of "foreign material" that could harm the digestive system. Teva Canada is recalling a lot of 500-milligram Nov-Gesic Forte acetaminophen "due to the potential presence of phenolic resin or epoxy," according to a Thursday news release from Health Canada... Full

 

Teva recalls Novo-Gesic Forte acetaminophen over possible contamination

(9/10, Red FM Canada) ...The recalled product has DIN 00482323, lot number 100083040 and an expiry date of Jan. 31, 2029. It was supplied to pharmacies in 1,000-count bottles and dispensed to patients in smaller quantities. Consumers are advised to immediately stop using the affected product and return it to the pharmacy where it was purchased for replacement and proper disposal... Full

 

 

Cheap Biologic Drug Alternatives Stall, Threatening U.S. Healthcare Savings

(9/10, Xavier Martinez, The Wall Street Journal) ...Ninety percent of the expensive, widely used biologic drugs facing patent expiration by 2034 have no lower-cost alternatives in development, according to a new report by the Association for Accessible Medicines, a trade group representing generic drugmakers. This means Americans could miss out on nearly $200 billion in healthcare savings over the next decade with 118 popular biologic drugs going off patent, according to the association's estimates. These drugs are highly complex medicines manufactured inside living cells and often end up being multibillion-dollar blockbusters for drug companies... Sub. Req'd

 

U.S. Generic & Biosimilar Medicines Save $496B in Just 1 Year

(9/10, AAM) ..."In only ten years, the generics and biosimilars industry saved U.S. patients and taxpayers a combined $3.6 trillion and there's no denying our industry is one of the greatest success stories in healthcare," said John Murphy III, President and CEO of AAM. "But right now, the very forces that make generics and biosimilars so affordable are destabilizing the market. Without intervention, the U.S. is at risk for supply chain disruptions, drug shortages, or worse, U.S. market exit. To move generics forward for America, we must adopt a generics-and-biosimilars-first policy framework... Full

 

Trump Is Right to Investigate Germany — And He Shouldn't Stop There

(9/10, Andrew Spiegel, Washington Examiner) ...The Trump administration just launched a "Section 301" investigation into Germany's pharmaceutical pricing practices. The move begins a process to address foreign free-riding by one of the world's largest economies — and helps advance the broader goal of ensuring wealthy countries pay their fair share for global innovation. Patients in the United States, Germany, and every other country ought to cheer this news. For decades, Germany and other developed nations have underpaid for lifesaving medicines — and obtained low prices by delaying and rationing drug access. These access restrictions have had real impacts on patients... Sub. Req'd

 

AGs Claim PBMs Using Horizontal Price Fixing Scheme In New Suits

(9/10, Lauren Brensel, Inside Health Policy) ...Two Republican attorneys general are separately suing pharmacy benefit manager Express Scripts, claiming the company is illegally interfering with reimbursement rates of local pharmacies by entering a price fixing contract with competitor Prime Therapeutics. Florida Attorney General James Uthmeier and Louisiana Attorney General Liz Murrill say the agreement allows the pharmacy benefit managers (PBMs) to restrict access to medications and steer patients toward PBM-owned pharmacies in each state. They're seeking injunctive relief, civil penalties and damages... Sub. Req'd

 

States Push for New PBM Reporting Rules | PBMI 2026

(9/10, Denise Myshko, Managed Healthcare Executive) ...State proposals are targeting prior authorization, mandated coverage, formularies, biosimilar substitution, point-of-sale rebates, pharmacy reimbursement, and pharmacist scope of practice. These efforts aim to provide oversight and transparency, as well as increased access for patients. These state laws, however, bring compliance, administrative and technology challenges to PBMs to ensure they meet all of the state reporting requirements, said speakers at a session at the annual meeting of the Pharmacy Benefit Management Institute in Orlando... Full

 

Pharma Marshalling Legal Challenges Of Medicare Negotiation Fixed Combo Policy

(9/10, Cathy Kelly, Pink Sheet) ...The pharmaceutical industry may be building a legal case against the US Centers for Medicare and Medicaid Services' proposal to designate fixed combination products, including ingredients enabling alternative routes of administration, as eligible for Medicare price negotiation along with older products containing the same active moiety. In recent comments to CMS, the Pharmaceutical Research and Manufacturers of America and Biotechnology Innovation Organization strongly oppose the policy... Global Sub. Full

 

Pharma's Patent Games Are Costing Patients. Congress Must Act

(9/11, Dr. Eric Wargotz, The Daily Record) ...The patent system is supposed to reward genuine innovation. Drug discovery is difficult, expensive work and companies that develop lifesaving treatments deserve a reasonable period to recoup their investment and profit from their success. But a patent is not a blank check, and innovation is not the same as manipulation. Too often, brand-name drug companies build dense webs of secondary patents around a single medicine, covering dosage, delivery methods, formulations, packaging or other incremental changes... Full

 

 

CGRP-Therapy Atogepant Meets Primary and Secondary End Points in Phase 3 LUNA Trial for Menstrual Migraine

(9/10, Isabella Ciccone, Neurology Live) ..."Menstrual migraine attacks are generally more severe and more difficult to treat, making timely intervention particularly important," Cristina Tassorelli, MD, PhD, professor of neurology and director of the Headache Science Centre at IRCCS Mondino Foundation, University of Pavia, Italy, said in a statement.1 "LUNA is the first study of a CGRP-targeted treatment to report positive results specifically in menstrual migraine and meets an important unmet need for women."... Full

 

 

California to Provide Free Inhalers for Every Public School, Sparing Families Extra Costs

(9/10, Marie Perez, The Cool Down) ...the initiative will provide public schools with free supplies of the fast-acting medicine for when someone suddenly has trouble breathing. Albuterol inhalers, commonly known as rescue inhalers, treat asthma attacks and other respiratory emergencies by relaxing the muscles around the airways. Under the program, state officials said each public school will receive two metered-dose inhalers and 25 single-use inhalers every year for three years... Full

 

Sandoz's Biosimilar Revolution Sets Stage For 100 Products By 2040

(9/10, Dave Wallace, Generics Bulletin) ...Delving into the strategy underpinning these targets, however, provides insights into how Sandoz is evolving as a company, how the firm perceives the landscape for a broadening range of biosimilars that will encompass more limited-competition assets as well as rivals to big blockbusters, how vertical integration will boost profitability, and how the small-molecule generics business will continue to remain significant for the company despite the potential for it to be overshadowed by Sandoz's biosimilars growth... Global Sub. Full

 

As Radiopharma Comes Of Age, Generics Pose A New Kind Of Test

(9/10, Dean Rudge, Generics Bulletin) ...Novartis is betting that complex manufacturing and supply requirements will blunt generic erosion of Lutathera, even as Lantheus and Curium press closer to potential US competition after a sweeping patent defeat... Global Sub. Full

 

Renova Pharmaceuticals Announces First Three U.S. Generic Product Launches, Marking a Major Company Milestone

(9/10, Renova Pharmaceuticals LLC) ..."This is a very proud moment for all of us at Renova. Launching our first three products represents the beginning of an exciting new phase in our journey," said Seshu Akula, CEO, Renova USA. "Our vision is to build Renova into a differentiated and trusted U.S. generics company focused on technically challenging products, reliable supply and meaningful market opportunities. I am extremely grateful to our teams, partners, customers and stakeholders whose commitment has helped us reach this milestone."... Full

 

Sandoz's Spravato Generic Blocked From US Market Until 2035

(9/11, Dean Rudge, Generics Bulletin) ...Sandoz has been blocked from launching its proposed generic version of Johnson & Johnson's Spravato (esketamine) blockbuster nasal spray in the US before September 2035, after a New Jersey federal judge found 10 claims across four Janssen patents infringed and not invalid following a five-day bench trial... Global Sub. Full

 

Ipsen Weighs U.S. Manufacturing Investment

(9/11, Adrià Calatayud, The Wall Street Journal) ...France's Ipsen is considering building a production site in the U.S., joining other European drugmakers looking across the pond when planning new investments. "Discussions are ongoing," Ipsen Chief Executive David Loew said in an interview. "No decision has been reached yet on exactly when, but this is certainly something that we are taking into consideration."... Sub. Req'd

 

Cancer Drug Shortages Persist Into Fourth Year, NCCN Data Show

(9/10, Mary Caffrey, AJMC) ...Generic drug shortages have become an entrenched part of the cancer care landscape, even as tariffs loom, according to new survey data released today by the National Comprehensive Cancer Network (NCCN). New data show that every responding cancer center reported a current shortage of at least 1 anticancer agent, and more than 20% were managing shortages of 5 or more different medications... Full

 

Alembic Pharma Clears USFDA Inspection at Vadodara Bioequivalence Facility

(9/11, The Economic Times) ...Alembic Pharmaceuticals on Friday said the US health regulator has completed an unannounced inspection at its bioequivalence facility in Vadodara, Gujarat, with zero observation. In a regulatory filing, the company said the United States Food and Drug Administration (USFDA) carried out the onsite bioequivalence inspection from August 31, 2026, to September 10, 2026... Full

 

Lannett Launches Generic Advair Diskus

(9/10, Sandra Levy, Drug Store News) ..."This launch marks the first product from our inhalation pipeline to be commercialized in the United States, reflecting our continued focus on expanding our portfolio of complex and differentiated inhalation products," the company said... Full

 

Jordan Enacts Updated Regulations for Biosimilar Drug Registration

(9/10, Petra) ...The Official Gazette published the updated "Biosimilar Drug Registration Instructions of 2026" on Thursday, bringing the new regulations into effect immediately under the Drug and Pharmacy Law and the Food and Drug Administration Law. The rules apply to biosimilar medicines containing well-characterized protein active substances produced using modern biotechnology, such as recombinant DNA techniques... Full

 

 

Novartis, Novo Nordisk Drug Failures Will Likely 'Pop a Hole in the Balloon' of the Field

(9/11, Allison DeAngelis and Adam Feuerstein, STAT) ...The back-to-back failures of cardiovascular drugs from Novartis and Novo Nordisk made headlines earlier this month. They could also have a chilling effect across the industry. Just before Labor Day, Novartis reported that its cardiac therapy, pelacarsen, failed in a widely watched, seven-year clinical trial. The drug was designed to reduce the rates of heart attack or stroke by lowering lipoprotein a, or Lp(a), a type of lipid that, at elevated concentrations, increases the likelihood of severe heart problems. An estimated 20% of people have abnormally high levels... Full

 

Major Novartis Shareholder Calls for Board Shake-up after Drug Trial Setbacks

(9/10, Oliver Hirt and Marleen Kaesebier, Reuters) ...A major shareholder in Novartis has called for a shake-up of the Swiss drugmaker's board to improve corporate governance after its shares suffered a record fall this week following back-to-back trial setbacks. David Samra, managing director at top 20 investor Artisan Partners and founding partner of International Value Group, said the board needed to strengthen its oversight of acquisitions, calling for action from board chairman Giovanni Caforio... Full

 

 

Medicines For Europe Presses EU To Toughen Procurement Reform

(9/10, Dean Rudge, Generics Bulletin) ...Medicines for Europe has called for the EU's proposed overhaul of public procurement rules to go further in protecting medicine supply and supporting manufacturing investment, pressing for mandatory quality criteria, multi-winner tenders and tougher scrutiny of "abnormally low" bids. Responding to the European Commission's newly proposed Public Procurement Act, the off-patent association said procurement should support competition while promoting "resilience, sustainability, competitiveness and security of supply" for medicines... Global Sub. Full

 

Mounjaro Survives Generic Ozempic Shock as India's Obesity Drug Market Splits

(9/11, Sumi Sukanya Dutta, India Today) ...When cheaper generic versions of semaglutide – originally developed by Danish drugmaker Novo Nordisk and runaway success under the brand names Ozempic and Wegovy globally – hit the Indian market this March, its rival Mounjaro's extraordinary run in the country faced its biggest test. Why would patients continue paying over Rs 13,000 to Rs 26,000 for a premium obesity drug when versions of a rival GLP-1 medicine were suddenly available at a fraction of the cost?... Full

 

The Race for the Next Big Weight-Loss Drug Is On—and China Wants In

(9/10, Katrina Northrop, The Wall Street Journal) ...Chinese biotech companies, rapidly evolving from manufacturers of low-end generic drugs to serious competitors to American pharma giants, are training their sights on one of the most lucrative medicines: GLP-1s. Today Eli Lilly and Novo Nordisk, with drugs like Mounjaro and Ozempic, are the undisputed leaders of the $80-billion global GLP-1 market, which is dominated by U.S. sales. But Chinese biotechs are pouring in, hoping to steal a slice of the weight-loss drug market... Sub. Req'd

 

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