Know What's Happening in Pharma
Know What's Happening in Pharma
Eli Lilly’s oral GLP‑1 pill and triple‑agonist trial reshape obesity drug race
The FDA approved Lilly’s oral GLP‑1 weight‑loss tablet Foundayo (orforglipron), which can be taken without food or water restrictions. In a Phase 3 trial, Lilly’s experimental injectable triple‑hormone agonist retatrutide achieved a 28.7% average body‑weight reduction, outpacing Novo Nordisk’s next‑generation candidates.
Also developing:
By the numbers: Lupin Limited acquires VISUfarma
FDA drug‑center head Tracy Beth Høeg used her first staff address to flag two priority areas: the safety of antidepressants taken during pregnancy and the use of monoclonal antibodies that protect infants from RSV. She also signaled a continued interest in vaccine policy after a tenure marked by Covid‑19 shot restrictions. Meanwhile, Roche announced it will seek a buyer for its flagship antibiotic Rocephin and plans to cease its Swiss manufacturing by 2030, citing rising costs and fierce generic competition. The move aligns with the EU’s new Critical Medicines Act aimed at reshoring essential drug production.
In a February 20, 2026 Pharm Exec Podcast, ZS CEO Pratap Khedkar, PhD, outlined three converging trends reshaping pharma: heightened AI integration, evolving ecosystem partnerships, and sweeping US‑driven policy reforms. Drawing on his nine‑year tenure leading ZS’s global pharmaceuticals practice and its advanced data‑science...
The U.S. FDA has accepted Roche’s new drug application for giredestrant combined with everolimus to treat ER‑positive, HER2‑negative, ESR1‑mutated advanced breast cancer. Phase III evERA data show a 44% reduction in disease progression or death overall and a 62% reduction in...
Johnson & Johnson announced a $1 billion investment to build a next‑generation cell‑therapy manufacturing facility in Montgomery County, Pennsylvania, slated to support 500 skilled jobs. The hub is a key element of J&J’s $55 billion U.S. manufacturing, R&D, and technology strategy. Meanwhile,...
U.S. FDA has granted IND clearance for NexEos Bio’s ophthalmic solution NTX-1024, allowing the company to commence a combined Phase II/III clinical trial in vernal keratoconjunctivitis (VKC). The upcoming study will assess safety and efficacy after an open‑label investigator‑initiated trial...
Boehringer Ingelheim India has signed a memorandum of understanding with the National Institute of Pharmaceutical Education and Research (NIPER) in Raebareli to deepen collaboration on pharmaceutical technologies and novel drug delivery systems. The agreement grants NIPER access to Boehringer’s opnMe...
Boehringer Ingelheim received an Emergency Use Authorization (EUA) from the U.S. FDA for its NexGard chewable tablets to treat New World screwworm (NWS) infestations in dogs and puppies, and for NexGard COMBO topical solution to treat NWS in cats and...
Rare Disease Week convenes on Capitol Hill, bringing patients, advocates, regulators, and industry together to shape policy for rare disease therapies. Hyman, Phelps & McNamara will be prominently represented, highlighted by Frank Sasinowski receiving the EveryLife Foundation’s Abbey Lifetime Achievement...
Texas Attorney General Ken Paxton filed a lawsuit alleging Sanofi paid kickbacks to physicians by offering free nursing staff and insurance‑support services. The alleged scheme was designed to steer prescriptions toward Sanofi’s drugs for chronic conditions such as diabetes, multiple...
Amgen reported double‑digit revenue and earnings growth for 2025, driven by strong performance across its oncology, rare‑disease, biosimilar and general‑medicine portfolios. Fourteen products surpassed $1 billion in sales, with Repatha, Evenity and Tespire each posting over 30% year‑over‑year growth. The company...
The FDA announced it will drop the historic requirement for two adequate and well‑controlled studies in certain new‑drug approval pathways, a move that could accelerate timelines and lower development costs. The change is especially relevant for therapies targeting unmet medical...
The Advisory Committee on Immunization Practices (ACIP) cancelled its scheduled February 25‑27, 2026 meeting, and no new date has been announced. The cancellation occurs amid a wave of senior HHS leadership changes, including the departure of Deputy Secretary Jim O’Neill and General...
Eli Lilly reported that its biologic Omvoh (mirikizumab) sustained steroid‑free remission for three years in Crohn’s disease patients in the Phase 3 VIVID‑2 open‑label extension study. More than 90% of participants remained in remission, with 80% experiencing relief from bowel urgency. The...
CoverMyMeds outlines how access and affordability challenges evolve across a biopharma brand’s lifecycle, from launch through loss of exclusivity, and offers actionable, data‑driven strategies to mitigate them. The firm emphasizes real‑time analytics, provider‑focused tools, and tailored patient assistance to reduce...
Researchers used Mendelian randomization to demonstrate that the inflammatory cytokine IL6 directly increases all‑cause mortality, while its soluble receptor IL6R has the opposite effect. Elevated circulating IL6R was linked to lower risk of lung cancer, diabetes, stroke and coronary artery...
Valneva reported a 3.3% decline in product sales to €157.9 million in 2025, driven primarily by regulatory suspensions of its chikungunya vaccine Ixchiq in the US and UK. Despite the sales dip, total revenue rose to €174.7 million, buoyed by a licensing...
DHL Group announced a €2 billion strategic investment to expand its Life Sciences & Healthcare air‑freight cold‑chain network. The rollout adds more than 30 GDP‑compliant aviation hubs and a dedicated Boeing 777F route between Brussels and Cincinnati, linking Europe’s life‑science cluster...
The FDA, under Commissioner Marty Makary, is pushing to expand over‑the‑counter (OTC) availability for safe prescription drugs such as nausea treatments and vaginal estrogen. Simultaneously, the agency proposes dropping the long‑standing requirement for two pivotal clinical trials, moving to a...
ViiV Healthcare presented results from the Phase III LATITUDE trial evaluating Cabenuva, a long‑acting injectable of cabotegravir and rilpivirine, in 453 adults with adherence challenges. Among 306 virally suppressed participants, the quarterly injection reduced cumulative regimen failure to 22.8% versus...
The Centers for Medicare & Medicaid Services announced a third round of drug price negotiations that for the first time includes Part B physician‑administered therapies. By extending the Inflation Reduction Act’s pricing provisions to infused medicines, the move pulls doctors into...
The FDA has reversed its earlier refusal-to-file and will review Moderna’s seasonal mRNA influenza vaccine, with a decision slated for August 5, 2026. Moderna now seeks full approval for adults aged 50‑64 and accelerated approval for those 65 and older. Meanwhile, Eli Lilly...
Covetrus and Cencora have signed a definitive agreement to merge Covetrus with MWI Animal Health, creating a unified animal‑health platform valued at $3.5 billion. Cencora will receive $1.25 billion in cash, $800 million of preferred equity and $1.45 billion of common equity, securing a...
A preclinical study published in Reproductive and Developmental Medicine found that combining melatonin with zinc oxide nanoparticles mitigates cyclophosphamide‑induced reproductive toxicity in male rats. The antioxidant duo restored testosterone and luteinizing hormone levels, lowered oxidative stress markers, and preserved spermatogenic...
Merck & Co (MSD) and Mayo Clinic have launched a research partnership that leverages AI, advanced analytics, and multimodal clinical‑genomic data to accelerate drug discovery and precision medicine. The collaboration merges Mayo’s Platform architecture and de‑identified datasets—including imaging, labs, molecular...
GLP‑1 agonists have moved from scarcity to abundance, reshaping weight‑management practice. In 2023, shortages forced clinicians to ration these drugs, often off‑label for obesity. Today, the surplus creates a new dilemma: patients seeking extreme, unsustainable weight loss and refusing to...
Researchers at the Technical University of Munich have created a bio‑hybrid coating that visibly signals UV‑A exposure by turning from green to red. The sensor embeds dry Escherichia coli cells loaded with the photoconvertible protein mEosFP, which undergoes an irreversible...
Genentech’s oral BTK inhibitor fenebrutinib met its primary endpoint in the Phase III FENtrepid trial for primary progressive multiple sclerosis, showing non‑inferiority to Ocrevus and a 12% risk reduction in confirmed disability progression. The drug also delivered a 26% lower risk...
The FDA’s Center for Veterinary Medicine issued new guidance urging drugmakers to add explicit duration limits to medically important antibiotics used in food‑producing animals. Currently, about 28% of these drugs are administered continuously for approved indications, but the guidance seeks...
The Xtalks Life Science Podcast featured Joseph Sinkule, CEO of Klotho Neurosciences, discussing the company’s secreted α‑Klotho gene therapy platform aimed at age‑related neurodegenerative diseases such as Alzheimer’s, ALS and Parkinson’s. Klotho leverages a patented anti‑aging gene to develop cell‑ and...
The FDA has reversed its earlier refusal and will now evaluate Moderna’s mRNA‑1010 seasonal flu vaccine using a two‑track approach: a full Biologics License Application review for adults 50‑64 and an accelerated approval pathway for those 65 and older, contingent...
The National University of Singapore Academy for Healthy Longevity is hosting the Geromedicine Conference on February 26-27, 2026, bringing together geroscience researchers, clinicians, and industry leaders. The event emphasizes clinical translation of molecules such as NAD+ precursors, urolithin A, and ergothioneine,...
Cryogenic electron microscopy enabled researchers to solve five structures of Vibrio cholerae transcription activation complexes, revealing how the bacterium initiates virulence in the human gut. The study shows ToxR and TcpP transcription factors bind the RNA polymerase α‑C‑terminal domain via...
The looming patent cliff, projected to strip up to $300 billion in annual drug sales by 2032, is keeping large pharma firms focused on strategic acquisitions rather than triggering a sudden surge in deal volume. Dan Chancellor of Norstella notes that...
Professor Segun Fatumo highlights the stark under‑representation of African genomes in global research, where over 86% of GWAS participants are of European ancestry despite Africa housing the greatest genetic diversity. He explains how this gap limits the accuracy of polygenic...
Carterra unveiled Vega, the industry’s first 48‑channel high‑throughput SPR platform, delivering roughly 12‑fold higher screening capacity for small‑ and large‑molecule drug candidates. Covaris introduced the truCOVER® Total RNA Library Prep Kit, enabling robust RNA‑seq libraries from as little as 10 ng...
Former Moderna executive Richard Hughes IV reflects on the exhilaration of the COVID‑19 vaccine launch, describing a once‑vibrant "spirit of possibility" that drove rapid innovation. He recounts his personal journey from unknown outsider to key player in a global health...
At a PhRMA‑hosted forum, CMS Administrator Mehmet Oz engaged warmly with Pfizer CEO Albert Bourla, championing vaccines and proposing closed‑door policy talks and even suggesting industry executives consider government jobs. In contrast, FDA Commissioner Marty Makary was sharply questioned by...
ArgenTag, now a PacBio Compatible Partner, has launched a grant that provides free access to its Single‑Cell RNA Library Kit for Long‑Read Sequencing. The kit uses a gravity‑based microfluidic chip to isolate individual cells, capture full‑length mRNA, and prepare barcoded...
In this 16‑minute DDW Highlights episode, host Bruno Quinney recaps five major drug‑discovery stories from the past week, focusing on a breakthrough study linking specific biomarkers to improved cancer survival rates and the launch of a multinational consortium tackling chronic...
Congress renewed the Rare Pediatric Disease Priority Review Voucher (RPD PRV) program, extending it to September 30 2029 and eliminating the dual sunset dates. The FDA released its Rare Disease Innovation Hub’s 2026 Strategic Agenda, allocating $1 million in funding and outlining plans...
Researchers engineered mice lacking growth hormone receptors specifically in adipose tissue (Ad‑GHRKO) and observed striking brain benefits in aged males. Compared with control mice, the Ad‑GHRKO group showed increased neuronal activity, reduced neuroinflammation, lower tau phosphorylation, and fewer senescence markers....
The FDA has opened submissions for its PreCheck Pilot Program, targeting new U.S. drug‑manufacturing facilities that will begin construction by the March 1 2026 deadline. Eligible sites must be stand‑alone plants, located in the United States or its territories, and commit to...
In the inaugural episode, host Alex discusses the GLP‑1 business model with obesity expert Prof. Alex Miras, who emphasizes that the drug itself drives the bulk of weight loss—about 20% versus 2.5% from behavioral support—making extensive multidisciplinary care unnecessary for...
Longevity Global is launching the inaugural Longevity Innovation Forum in San Diego on March 11‑12, 2026, gathering leading scientists, clinicians, biotech founders and investors to accelerate healthy‑aging research. The two‑day summit features high‑profile speakers such as Mike Snyder, Eric Verdin,...
Scientists at EPFL applied a three‑factor (OSK) partial reprogramming cocktail to memory‑encoding engram neurons in 9‑10‑month‑old mice and Alzheimer’s‑model strains. Using a dual‑AAV system gated by doxycycline, OSK expression was limited to neurons active during a learning event, preserving cell...
Researchers engineered CD4+ T cells with chimeric antigen receptors (CARs) derived from FDA‑approved Alzheimer’s antibodies aducanumab and lecanemab. The lecanemab‑based CAR (Lec28z) selectively bound fibrillar amyloid‑beta and reduced plaque burden in mouse brains, especially when delivered via transient mRNA transfection....
The Southern District of Florida held that a denial of a citizen petition transforms the underlying FDA warning letters into final agency action, allowing judicial review. Hybrid Pharma sued after the FDA refused to rescind two warning letters and the...
Researchers performed heterochronic fecal microbiota transplants, moving gut microbes from young to aged mice, which reactivated canonical Wnt signaling and enhanced intestinal stem cell regeneration. Aged mice receiving young microbiota showed increased expression of Wnt3, Ascl2, Lgr5 and improved epithelial...
The American Conference Institute will host its 22nd Annual Paragraph IV Disputes Conference on April 21‑22, 2026 in New York’s Times Center. The two‑day forum gathers brand‑name and generic drug stakeholders to discuss Hatch‑Waxman litigation strategies, recent case law, and evolving PTAB practices. Featured...
In this 15‑minute episode, DDW host Bruno Quinney recaps five major stories from the past week, highlighting breakthrough cancer therapies that promise greater efficacy and safety, and new research aimed at enhancing brain function in Alzheimer’s patients. He also touches...
