Bringing Quantum Ideas to the Messy World of Disordered Proteins
Intrinsically disordered proteins (IDRs) make up roughly 79 % of human cancer‑associated proteins and defy traditional structure‑based drug design. Akshay Uttarkar’s team introduced QuPepFold, a Python package that translates short peptide sequences onto a tetrahedral lattice and uses a CVaR‑optimized Variational Quantum Eigensolver to locate low‑energy conformations. The workflow runs on simulators and real quantum hardware such as IonQ’s Aria‑1, achieving over 90 % fidelity in reproducing ground‑state energies. While the method is coarse‑grained and limited to short peptides, it offers a practical bridge between quantum algorithms and biophysical modeling.
What the FDA’s Priority Voucher Decision Means for Psychedelic Drug Development
The FDA’s Commissioner’s National Priority Review Voucher (CNPV) pilot compresses review timelines to one‑to‑two months for qualifying drugs, but its criteria favor applications with mature data packages. Compass Pathways’ synthetic psilocybin (COMP360) was listed as eligible yet did not receive...
SGLT2s Linked to Lower Cardiorenal, Hepatic Risks in Type 2 Diabetes
A Taiwanese retrospective cohort of 24,259 adults with type 2 diabetes and liver cirrhosis found that initiating sodium‑glucose cotransporter‑2 inhibitors (SGLT2is) markedly reduced the risk of end‑stage kidney disease, acute kidney injury, major adverse cardiovascular events, all‑cause mortality, and hepatic decompensation...
Silencing Ghrelin The Hunger Hormone
Recent research reveals that several snake lineages have completely lost the hunger hormone ghrelin and its activating enzyme, yet maintain normal energy balance. Modern anti‑obesity drugs, such as GLP‑1 receptor agonists, achieve weight loss by amplifying satiety signals rather than...
EU Pledges €225m to Develop Next Generation of Flu Vaccines
The European Commission has pledged €225 million through a pre‑commercial procurement model to accelerate the development of next‑generation influenza vaccines. Ten entities, including Sanofi and Bavarian Nordic, will receive eight‑year contracts that cover clinical testing through market authorisation. The funding targets...
Six RNAi Companies to Keep an Eye on in 2026
RNA interference (RNAi) has moved from a scientific curiosity to a fast‑growing therapeutic platform, with the global market projected to reach $1.97 billion by 2032. Six biotech firms—Aerska, ADARx, Alnylam, Arrowhead, City Therapeutics and SanegeneBio—are leading the next wave of innovation...
A New Era in Neuropsychiatry: Dr. Velichka Valcheva on GH Research’s Rapid-Acting Breakthrough, GH001
GH Research’s inhaled mebufotenin (GH001) demonstrated ultra‑rapid, profound antidepressant effects in a Phase 2b trial for treatment‑resistant depression, with 73% of patients in remission after six months versus ~11% for standard oral therapies. Early‑stage studies in postpartum depression and bipolar disorder...
Gilead Shows Belief in Its Partner’s Cancer Treatment with $7.8 Billion Buyout
Gilead Sciences agreed to acquire the remaining shares of Arcellx for an equity value of $7.8 billion, paying $115 per share—a 79.4% premium to the prior close. The deal secures full rights to Arcellx’s BCMA‑directed CAR‑T therapy anito‑cel, which is in...
Novo’s CagriSema Falls to Lilly’s Zepbound in Daring Head-to-Head Test
Novo Nordisk’s experimental obesity drug CagriSema delivered a 23% average weight loss in the 84‑week REDEFINE 4 Phase 3 trial, but fell short of Eli Lilly’s tirzepatide (Zepbound) which achieved 25.5%. The head‑to‑head study failed the primary non‑inferiority endpoint, prompting a 15% drop...
STAT+: Gossamer Lung Disease Drug Fails Late-Stage Study, but Company Will Still Seek FDA Approval
Gossamer Bio announced that its Phase 3 trial of seralutinib for pulmonary arterial hypertension missed its primary endpoint. Patients on seralutinib walked 13 meters farther than placebo over six minutes, but the difference lacked statistical significance. The trial also reported cough...
The BIG Summit Meets at the Intersection of Patient Advocacy and Venture Investment
At the BIO Investor Growth (BIG) Summit, IBD Ventures’ associate director Nicole Schwerbrock discussed how venture philanthropy and patient advocacy are reshaping investment in inflammatory bowel disease (IBD) research. She explained that patient‑driven funding models complement traditional venture capital by...
STAT+: Gilead to Buy Arcellx in Nearly $8B Deal
Gilead Sciences announced a $7.8 billion acquisition of Arcellx, pricing the deal at $115 per share—a 79% premium to the prior close. The agreement includes an additional $5 per share contingent on future sales milestones. Central to the transaction is anito‑cel,...
Partner Therapeutics Reports P-II (eNRGy) Post-Hoc Results on Zenocutuzumab for NRG1+ NSCLC
Partner Therapeutics presented post‑hoc data from its Phase II eNRGy study of zenocutuzumab (Bizengri) in 27 patients with advanced NRG1‑positive non‑small cell lung cancer who received at least three doses beyond radiographic progression. Eight patients stayed on therapy for six months...
STAT+: Novo Nordisk’s Next-Gen Obesity Drug Stumbles in Comparison Study
Novo Nordisk’s next‑generation obesity drug CagriSema failed to demonstrate non‑inferiority to Eli Lilly’s tirzepatide in the 84‑week REDEFINE 4 study, achieving 20.2% weight loss versus 23.6% for tirzepatide. The open‑label trial showed the two treatments were not statistically equivalent. Following the announcement,...
J&J Reports Long-Term QUASAR Data for Tremfya in Ulcerative Colitis
Johnson & Johnson released long‑term QUASAR extension data for Tremfya (guselkumab) in ulcerative colitis, showing sustained efficacy through week 140. Clinical remission was achieved by 80.8% of patients, with 78.6% attaining histo‑endoscopic improvement and 53.6% reaching endoscopic remission. Approximately 89% of...
Podcast: Which Pharma and Medtech Companies Came Out on Top in 2025 Revenues?
The 2025 earnings season highlighted a clear hierarchy among healthcare giants, with Eli Lilly and AstraZeneca leading pharma revenue growth and Medtronic and Edwards Lifesciences topping medtech sales. The podcast hosted by Robert Barrie and Ross Law breaks down the financial results, noting...
STAT+: Pharma Lobbyists Focus on a Surprising New Target: The FDA
Health Secretary Robert F. Kennedy Jr. has pledged to purge industry influence from the FDA, yet the Trump administration’s injection of political priorities has reshaped the agency’s operating environment. Under the current administration, discussions that once were deemed off‑limits between...
Vanda Pharmaceuticals Reports the US FDA’s Approval of Bysanti (Milsaperidone) for Acute Bipolar I Disorder & Schizophrenia
Vanda Pharmaceuticals announced that the U.S. FDA has approved Bysanti (milsaperidone), an active metabolite of iloperidone, as a first‑line therapy for acute manic or mixed episodes in bipolar I disorder and for schizophrenia. The approval is based on demonstrated bioequivalence...
'It Was Like Buying Groceries' - Woman Calls for Tighter Weight-Loss Jabs Checks
Emma Dyer bought weight‑loss injections online for £115, bypassing any medical assessment, and suffered a severe health collapse within days. Her experience reflects a wider surge, with an estimated 1.6 million UK adults using GLP‑1 drugs such as Mounjaro and Wegovy,...
Summit Therapeutics Inc (SMMT) Q4 2025 Earnings Call Transcript
Summit Therapeutics reported a strong cash position of $713 million with no debt at the end of 2025, while GAAP operating expenses fell to $225 million despite a rise in non‑GAAP R&D spend. The FDA accepted the Biologics License Application for ivonesumab...
Tarsus Pharmaceuticals Inc (TARS) Q4 2025 Earnings Call Transcript
Tarsus Pharmaceuticals reported record 2025 net product sales of $451.4 million, driven by XDEMVY adoption, and issued its first full‑year 2026 guidance forecasting $670‑$700 million, implying over 50% revenue growth. The company highlighted a 44% gross‑to‑net discount, a robust DTC campaign that...
Immunitybio Inc (IBRX) Q4 2025 Earnings Call Transcript
AbbVie reported a record $61.2 billion in net revenue for 2025, an 8.6% increase that beat guidance despite a $16 billion HUMIRA erosion. Adjusted EPS reached $10, $0.54 above the midpoint, while SKYRIZI and RINVOQ together generated $7.4 billion in Q4, delivering double‑digit...
Axsome Therapeutics Inc (AXSM) Q4 2025 Earnings Call Transcript
Axsome Therapeutics reported a 66% revenue surge to $639 million in 2025, driven by strong growth in Auvelity, Sunosi and the newly launched Cymbravo. Net loss narrowed to $183 million, a 35% improvement year‑over‑year, while cash rose to $323 million. The company secured...
BioMarin Pharmaceutical Inc (BMRN) Q4 2025 Earnings Call Transcript
BioMarin Pharmaceutical raised its fiscal 2025 total revenue guidance, now starting at $3.15 billion, and reaffirmed Voxzogo revenue between $900 million and $935 million. The company lifted non‑GAAP operating margin guidance to 26‑27% and lifted diluted EPS guidance to $3.50‑$3.60. A $221 million IPR&D...
First-of-a-Kind Stem Cell Therapies Set for Approval in Japan
Japan’s health ministry is set to grant conditional approval to two first‑of‑a‑kind regenerative medicines – Amchepry for Parkinson’s disease and ReHeart for severe heart failure – after tiny phase I/II trials involving seven and eight patients respectively. Both drugs are derived...
It Seems Bad That Temu Is Selling Peptides
A recent Futurism report reveals that the low‑cost e‑commerce platform Temu is selling a variety of peptide products, including BPC‑157 and GLP‑1‑like compounds, at prices as low as $4. These peptides, marketed as muscle, skin, or cognitive boosters, are often...
STAT+: Pharmalittle: We’re Reading About an FDA Official’s Speech, a Grail Cancer Blood Test, and Much More
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...
The US FDA Accepts Roche’s Giredestrant NDA for ESR1-Mutated, ER-Positive Advanced Breast Cancer
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...
NexEos Bio Receives US FDA IND Clearance to Advance NTX-1024 Into P-II/III Study for Vernal Keratoconjunctivitis
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 and NIPER Sign MoU on Pharmaceutical Research
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 Secures US FDA’s EUA for NexGard and NexGard COMBO to Treat NWS
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...
STAT+: Texas Attorney General Sues Sanofi for Allegedly Providing Kickbacks to Doctors to Prescribe Its Drugs
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...
Amicus Therapeutics Inc (FOLD) Q4 2025 Earnings Call Transcript
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...
Valneva’s Lyme Disease Vaccine Offers Beacon of Hope Amid 2025 Sales Dip
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 Invests €2bn in Healthcare Logistics Push
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...
STAT+: Pharmalittle: We’re Reading About the FDA Pushing OTC Meds, Its New Trial Standards, and Much More
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 Reports P-III (LATITUDE) Trial of Cabenuva in Adherence-Challenged HIV Patients
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...
Covetrus to Merge with Cencora’s MWI Animal Health in a $3.5B Deal
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...
MSD and Mayo Clinic Team up to Advance AI in Drug Development
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...
Opinion: My Biggest GLP-1 Ethical Problem: Patients Who Don’t Want to Stop
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...
STAT+: New FDA Guidance for Antibiotic Use in Food-Producing Animals Prompts Criticism over Antibiotic Resistance
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...
FDA to Review Moderna’s Flu Jab on Agency Pivot
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...
Opinion: I Was a Moderna Exec when the Covid Vaccine Rolled Out. That Spirit of Possibility Is No More
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...
STAT+: At Drugmakers’ Forum, Oz Gets a Friendly Embrace, While Makary Faces Tough Questions
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...