Monday, July 27, 2026

 

 

Teva's Turnaround Is Working. Here's the 1 Thing That Could Send It Soaring Another 50%.

(7/27, Thomas Niel, The Motley Fool) ...As seen in Teva's first-quarter 2026 financials, generic drugs now barely make up a majority of the company's overall sales. Meanwhile, branded drugs, particularly recent hits like Austedo, Ajovy, and Uzedy, are experiencing mid-double-digit annual sales growth... Full

 

The Generics Bulletin Top 50, Part One: The Big Three No More

(7/27, Dave Wallace, Generics Bulletin) ...Despite the higher overall turnover reported by both Teva and Viatris, Sandoz's pure-play nature with a sole focus on generics and biosimilars means it outranks its peers once Prescription Brands and Other sales are removed from the equation... Global Sub. Full

 

 

Editorial: Trump Tariffs, More Tariffs, and More...

(7/25, The Wall Street Journal) ...Mr. Trump's tariff defenders point to the buoyant stock market as evidence that his border taxes aren't harmful. But last year's tax bill -- especially the business provisions like full investment expensing -- has offset some of the damage from his tariffs. So has the AI investment boom. Imagine how strong the economy would be without the tariffs and their uncertainty for business... Sub. Req'd

 

Axios Live: Biosimilars Face Barriers Beyond Science

(7/24, Julie Bogen, Axios) ...Outdated incentives, patent disputes and gaps in public understanding are getting in the way of patients' use of biosimilars, said government and pharmaceutical industry experts at an Axios roundtable event... Full

 

The Biosimilars Forum Commends Members of the Senate HELP Committee for Supporting Lower-Cost Biosimilars

(7/27, Biosimilars Forum) ..."The HELP Committee rightfully recognizes the importance of developing biosimilars efficiently based on science, rather than being slowed down by bureaucracy. This policy will help empower the FDA's Office of Therapeutic Biologics and Biosimilars (OTBB) with signatory authority on biosimilar reviews and applications. The FDA's OTBB office created the biosimilar industry in the U.S. from the ground up, and its personnel simply know the science best and should be empowered."... Full

 

Bill Aims to Remove 'Repetitive' Clinical Requirements for Biosimilars

(7/24, Tom Latek, Kentucky Today) ..."My bill puts an end to wasteful and repetitive clinical requirements that create unjustified barriers, further delaying competition in the market. Biopharmaceutical researchers have argued that new and advanced methods of determining biosimilar clinical equivalence in early development have eliminated the need for late-stage human studies. When a biosimilar proves it is safe, effective, and similar to the brand-name product in the early stages of its analytical and safety assessment, there's no scientific justification to delay access."... Full

 

 

Sanofi Halts Development of Troubled Immune Drug in Eczema

(7/24, Gwendolyn Wu, BioPharma DIVE) ...Sanofi had said in January that it intended to seek clearance of the drug, amlitelimab, in atopic dermatitis despite mixed late-stage study results and signs of possible safety concerns. On Friday, though, the French pharmaceutical firm said that, during a pipeline review, it found that the "totality of efficacy and safety evidence generated to date" doesn't support further development of amlitelimab in that indication... Full

 

China's Innocare Says Psoriasis Oral Drug Shows 'Consistent Treatment Effect' in Late-Stage Trial

(7/27, Reuters) ...Innocare Pharma said on Monday one of its experimental oral treatments for moderate-to-severe plaque psoriasis showed a "consistent treatment effect" in a late-stage clinical trial, as it seeks to compete with Western rivals in a growing market..."Multiple secondary endpoints were successfully met, demonstrating a consistent treatment effect across efficacy measures," Innocare said in a statement, adding it plans to advance regulatory filing for the drug, fadeucravacitinib, following completion of its Phase III study... Full

 

Gastroenterologists Flag Clinical Remission and its Durability as Unmet Needs in IBD Care: Survey

(7/24, Zoey Becker, Fierce Pharma) ...Despite the size of the ever-growing inflammatory bowel disease (IBD) drug market and its diversity of modalities from JAK inhibitors to IL-23s, unmet needs and treatment gaps remain. That's according to a new paper from Nimbus Therapeutics and Back Bay Life Science Advisors, which surveyed 36 U.S. gastroenterologists to gauge physician perspectives on the current treatment landscape, what's to come and what they want to see next... Full

 

AstraZeneca's Trixeo Recommended by CHMP for Approval in EU for Asthma

(7/24, PMLiVE) ...AstraZeneca's fixed-dose triple-combination Trixeo Aerosphere (Trixeo) has been recommended for approval in the EU for the maintenance treatment of asthma in patients 12 years of age and older... Full

 

Moving From Symptom Management to Disease Modification in Parkinson's Research: Q&A with Dr. Jan Stoehr

(7/27, Mike Hollan, Dr. Jan Stoehr, PharmExec.com) ...Dr. Stoehr, neuroscience researcher at AbbVie discusses how biomarkers are opening a new window into Parkinson's disease... Full

 

Merck Licenses Experimental HIV Pill to Generic Makers in 129 Countries

(7/24, Christy Santhosh, Reuters) ...Merck said the agreements are with three sub-Saharan Africa manufacturers - Aspen Pharmacare, Quality Chemical Industries and UCL - and four Indian companies, which are Aurobindo, Cipla, Emcure and Viatris... Full

 

 

Par Health Launches First and Only Generic Version of Janumet® XR (sitagliptin and metformin HCl extended-release) Tablets in the United States

(7/24, Par Health) ...Par Health's sitagliptin metformin XR is the first and currently the only FDA-approved generic of Janumet® XR available in the US... Full

 

Roche Sees No Biosimilar Spillover Threatening Vabysmo Demand

(7/24, Dean Rudge, Generics Bulletin) ...Speaking to investors during the company's second-quarter earnings call, Teresa Graham, CEO of Roche Pharmaceuticals, said that the ophthalmology market is showing distinct competitive dynamics. "Where we are seeing biosimilar impact happen, it is impacting directly the molecule that it's replacing. So a biosimilar to Lucentis (ranibizumab) [is taking] Lucentis share," Graham said, adding that biosimilars to other retinal medicines are similarly affecting their respective originators... Global Sub. Full

 

EMA Backs Three Generics Targeting Blockbuster Franchises

(7/24, Dean Rudge, Generics Bulletin) ...European regulators have backed generics to the blockbusters tafamidis and ruxolitinib, alongside riociguat, but patent and exclusivity barriers mean meaningful market entry may remain several years away... Global Sub. Full

 

European Filing Moves Celltrion Closer To Cosentyx Market

(7/24, Dean Rudge, Generics Bulletin) ...The Incheon-based company submitted its marketing authorization application to the European Medicines Agency today (July 24), seeking approval across the adult and pediatric indications covered by the reference product in Europe. Celltrion is seeking authorization in adults with plaque psoriasis, hidradenitis suppurativa, psoriatic arthritis and axial spondyloarthritis, including ankylosing spondylitis and non-radiographic axial spondyloarthritis... Global Sub. Full

 

What Real-World Data Show About Moving Patients From Humira to Biosimilars

(7/24, Justin Arzt, Agata Siwak, Marnie Wickizer, Ryan Schmidt, Matt Hustad and Robert Topp, Pharmacy Times) ...Within three months, 472/504 members converted to biosimilars, with only three maintained on Humira via exceptions and 16 discontinuing before switch...Nationwide, uptake of adalimumab biosimilars has started low, at 23%, but has now grown to 60%, according to Samsung Bioepis... Full

 

FSS Scrutinizes Samchundang as FDA Path Hinges on BE Claims and Factory Checks

(7/27, Park Su-hyeon, Chosun Biz) ...Sam Chun Dang Pharm said it received a reply from the U.S. Food and Drug Administration (FDA) regarding procedures for generic approval and began heavily promoting that there is "absolutely no clinical risk." Sam Chun Dang Pharm has pursued pre-ANDA procedures with the FDA, aiming to develop the first generic of Novo Nordisk's oral diabetes drug "Rybelsus." The company said it viewed the reply as a turning point that "significantly eased regulatory uncertainty."... Full

 

Celltrion's Q2 Profit Jumps 86% on Biosimilar Growth, Stronger Margins

(7/27, Lee Han-soo, Korea Biomedical Review) ...According to a regulatory filing on Monday, second-quarter revenue rose 45 percent year over year, and operating profit surged 86.3 percent, marking the company's second consecutive quarter of record-high sales. The operating margin improved to 32.4 percent, up 7.2 percentage points from a year earlier, reflecting both robust top-line growth and enhanced profitability... Full

 

 

Argenx to Buy Forte Bio for $2.2b in Immunology Push

(7/27, Pavan Kamat, FirstWord PHARMA) ...In a move to strengthen its autoimmune disease portfolio, argenx said Monday it will acquire Forte Biosciences for $77 per share in cash, or approximately $2.2 billion. The transaction — expected to close this quarter — centres on Forte Bio's lead asset FB102, an anti-CD122 antibody being developed for vitiligo and coeliac disease... Full

 

AstraZeneca Profit Beat, Bullish Tone Ease Worries over Drug Pipeline

(7/27, Pushkala Aripaka and Maggie Fick, Reuters) ...AstraZeneca stood by its annual and long-term forecasts on Monday, expressing confidence that recent trial setbacks had not undermined its long-term prospects as second-quarter profit beat market expectations. Strong demand for cancer and rare disease drugs continues to drive growth, but investors are keen for signs that the pharmaceutical giant's 2030 revenue target is not under threat after an unexpected trial failure this month. AstraZeneca aims to reach $80 billion in annual revenue by 2030, a target JPMorgan analysts said remains achievable after second-quarter profit topped analysts' predictions and sales were as expected... Full

 

The Scientist With 1,000 Patents Fueling a Drug Powerhouse

(7/24, The Wall Street Journal) ...Many drug companies in Regeneron's position would go shopping for a smaller biotech's late-stage drug. Regeneron is in a stronger position than many other companies to do deals, with more than $18 billion of cash on its balance sheet. [Regeneron Pharmaceuticals co-founder and chief scientific officer George Yancopoulos] is betting on Regeneron's science instead. The company has the broadest pipeline in its history with about 60 drugs under development in hopes that the more shots on goal, the better... Sub. Req'd

 

Why Controversial Products Claiming to Help Insomnia and Migraines Just Got a Big Boost

(7/25, Daniel Wu, The Washington Post) ...The votes are not "a green light to compound with these peptides," Ilisa Bernstein, a former deputy director of the FDA's drug compliance office, told The Washington Post on Thursday. "FDA must keep their eye on the science, data, and patient safety as they consider their options and next steps."... Full

 

 

John Whelan: Trump's Generic Drug Tariff Plan Raises Irish Concerns

(7/27, The Irish Examiner) ...The European Commission said Wednesday that it expects European generic medicines to be exempt from Mr Trump's latest tariffs, arguing that Washington committed to a zero-tariff rate with last year's transatlantic trade deal, struck at Turnberry in Scotland last year. The sector in Ireland will hope that this remains the case... Full

 

Germany Figured Out How to Cut Healthcare Costs: Make Americans Pay the Bill

(7/24, Wolfgang Klietmann, Washington Examiner) ...German patients deserve better than a system that restricts access to cutting-edge treatments simply to keep government spending down. The U.S. is the world's leading engine of medical innovation. Trump should use America's economic leverage to ensure wealthy countries such as Germany finally begin paying their share... Full

 

US Tariff Proposal Wake-Up Call for Indian Pharma to Diversify, Innovate: Experts

(7/26, PTI) ...Nikhil K Masurkar, CEO, ENTOD Pharmaceuticals, described the proposed tariffs as an opportunity for long-term strategic transformation, rather than merely a trade challenge. "The finer details of the proposed US tariffs on generic drugs are still unclear, but one thing is certain - Indian pharma can no longer afford to be overly dependent on a single market," he said. This is the right time to diversify, strengthen the domestic innovation ecosystem and position India as the healthcare leader of the Global South, Masurkar said... Full

 

Mint Explainer: How Can Indian Drugmakers Blunt the Impact of Trump's Generic Tariffs?

(7/26, Jessica Jani, Mint) ...Ultimately, pharmaceutical firms will have to pass these additional expenses along to US buyers, executives said. The sector continues to await clearer guidance alongside bilateral talks with the US, anticipating a negotiated fix instead of actual tariff enforcement... Full

 

Chinese Biotech Overtakes AI as Emerging-Market Growth Trade

(7/26, Srinivasan Sivabalan, Bloomberg) ...Rather than retreating to traditional defensive sectors, investors are hunting for the next innovation-led growth story, according to Nelson Yu, the New York-based head of equities at AllianceBernstein. Chinese biotech fits the bill as the nation's drugmakers expand globally through licensing deals with multinational giants... Sub. Req'd

 

Why Korea Faces Another US Tariff Fight

(7/27, Jo He-rim, The Investor) ...Korean trade experts say the second probe could push tariffs back toward the 15 percent ceiling agreed by Seoul and Washington last year - or give the US leverage to demand faster implementation of Korea's $350 billion investment commitments... Full

 

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