Mizuho Sees Strong Risk-Reward in Corbus Pharmaceuticals Holdings, Inc. (CRBP) Near Cash Value
Mizuho Securities raised its price target on Corbus Pharmaceuticals (CRBP) to $40 from $39 and kept an Outperform rating after the company’s Q4 results. The broker noted the stock is trading close to Corbus’s cash balance, implying limited downside risk. Mizuho highlighted three anticipated clinical data readouts in 2026 as key catalysts. Meanwhile, Corbus announced broad FDA alignment on the registration plan for its CRB‑701 antibody‑drug conjugate targeting head‑neck and cervical cancers, and disclosed a chief medical officer departure in mid‑2026.
STAT+: FDA Eyes Expanding Testosterone Therapy for Libido
The FDA is reviewing data that could broaden testosterone‑replacement therapy to include low libido as an approved indication, a move that would extend the drug’s market beyond hypogonadism. If cleared, the label change could add roughly $1.5 billion in annual U.S....
Lilly’s Foundayo Reaches 1,390 Patients in First Week, Trailing Novo’s Oral Wegovy Launch
Eli Lilly’s newly approved oral obesity drug Foundayo recorded 1,390 prescriptions in its first two days, a modest start compared with Novo Nordisk’s oral Wegovy, which logged over 3,000 patients in its inaugural week. RBC Capital Markets noted the timing difference—Foundayo launched...
MD Pharmaceutical Supply, LLC - 637815 - 04/13/2026
The FDA has finished reviewing MD Pharmaceutical Supply’s corrective actions taken after a warning letter issued in November 2022. The agency concluded that the company appears to have addressed the cited deviations, but it emphasized that future inspections will assess...
Biovac Gets $108M Backing for Vaccine Factory in South Africa
Biovac announced that its new vaccine manufacturing complex in Cape Town has secured $108 million in financing from the European Investment Bank, the European Commission, and the International Finance Corporation. The plant is designed to produce up to 400 million doses per...
Revolution Medicines' Buyout Price Soars After Pancreatic Cancer Win
Revolution Medicines announced positive Phase 3 data for its pancreatic cancer candidate, showing a statistically significant survival benefit. The breakthrough lifted the company’s market value from roughly $30 billion to an estimated $45 billion, reigniting speculation of a mega‑buyout. Investors rushed in, sending...
STAT+: Pharmalittle: We’re Reading About Lilly Weight Loss Pill Trial Results, Slashed U.K. Clinical Trial Times, and More
Researchers led by Richard DiMarchi and Matthias Tschöp reported a novel GIP‑glucagon dual agonist that may achieve weight loss comparable to GLP‑1 drugs without the typical nausea and vomiting. In parallel, Eli Lilly announced that its new obesity pill Foundayo lowered...
MD Pharmaceutical Supply, LLC - 637815 - 11/22/2022
The FDA issued a warning letter to MD Pharmaceutical Supply, LLC after an April‑May 2022 inspection uncovered multiple CGMP violations at its Hanover, PA drug repackaging facility. The agency cited failures to investigate returned API complaints, inadequate temperature and humidity...
Therapy for Brain Injuries in Infants Bags Funding: Is the First HIE Drug on the Way?
ReAlta Life Sciences raised $40 million to finish its phase 2 STAR trial of pegtarazimod, a first‑in‑class drug that blocks both complement C1 and neutrophil pathways to treat hypoxic‑ischemic encephalopathy (HIE) in newborns. HIE affects about 8,000 U.S. infants annually, causing 15‑20%...
Medicare Can Save $4 Billion On Four Cancer Drugs – Can You Guess Which Ones?
The Inflation Reduction Act authorizes Medicare to negotiate drug prices, starting with ten high‑spending products and expanding each year. By targeting four oncology drugs—Pomalyst, Ibrance, Xtandi and Imbruvica—Medicare could save over $4 billion, with Imbruvica alone offering more than $1 billion in...
Stakeholders Urge Labor Department to Finalize PBM Transparency Rule
Employers, lawmakers and patient groups urged the Labor Department to finalize a rule that forces pharmacy benefit managers (PBMs) to disclose detailed compensation data, including rebates and spread‑pricing. The DOL’s proposal, released in January, would require PBMs to share dollar‑level...
Obesity, GLP-1s, and Metabolic Care
In an interview, hVIVO’s Chief Medical Officer Professor Thomas Forst explains how GLP‑1 receptor agonists have reshaped obesity treatment by targeting metabolic dysfunction rather than just weight loss. He highlights that these drugs reduce cardiovascular events, improve renal outcomes and...
RFK Jr. Defends Makary, Claims Pharma ‘Owns’ Congress and Media
Health Secretary Robert F. Kennedy Jr. defended FDA Commissioner Marty Makary during a Ways and Means Committee hearing, praising the agency’s recent drug‑approval record and rejecting criticism from the pharmaceutical industry. He highlighted the FDA’s decision to reject Replimune’s oncolytic...
NIH Researchers Discover Pain-Relieving Drug with Minimal Addictive Properties
NIH scientists have identified a novel nitazene‑derived opioid, DFNZ, that delivers potent, two‑hour pain relief in rats without causing respiratory depression, tolerance or significant withdrawal. The compound briefly enters the brain yet sustains analgesia, and unlike traditional opioids it fails...
LEO Pharma’s Enstilar Receives the NMPA Approval for Plaque Psoriasis
LEO Pharma’s topical aerosol foam Enstilar, combining calcipotriene and betamethasone dipropionate, received approval from China’s National Medical Products Administration for adult plaque psoriasis. The approval follows a Phase III trial of 604 Chinese patients that demonstrated superior efficacy and safety versus...
Novo May Have Muscle Advantage over Lilly in Weight-Loss Race: Preprint
A new medRxiv pre‑print analyzing nearly 8,000 GLP‑1 patients finds Novo Nordisk’s semaglutide preserves lean body mass better than Eli Lilly’s tirzepatide, despite the latter delivering greater overall weight loss. In the first year, 6.7% of semaglutide users fell into a...
Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers
The FDA issued a final Level 1 guidance titled “Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers,” originally released in June 2016 and updated in October 2017. The document consolidates frequently asked questions about the 2009‑enacted expanded‑access regulations under 21 CFR part 312...
Policy Watch: FDA Issues Draft Guidance on Genome-Editing Safety
The FDA released a draft guidance urging sponsors to use next‑generation sequencing to evaluate off‑target effects of CRISPR‑Cas9 and other gene‑editing therapies, recommending short‑read or long‑read approaches based on the type of DNA alteration. The guidance dovetails with a February...
Can an LSD Candidate Do for Anxiety What Spravato Did for Depression?
Johnson & Johnson’s 2019 Spravato approval unlocked the pharmaceutical market for psychedelics, proving they can become blockbuster drugs. Definium Therapeutics is now advancing DT120, an LSD‑based candidate for generalized anxiety disorder, after phase 2 data showed a 78% clinical response and...
New Bioengineered Patch Makes Its Own Oxygen to Heal Wounds and Grow Tissue
Researchers at UC Riverside and Rowan University unveiled a self‑oxygenating tissue patch, the Smart Self‑Oxygenating Tissue (SSOT) system, that creates oxygen on‑demand via low‑voltage electrolysis in a conductive hydrogel called BioGel. The BioGel incorporates a choline‑based ionic liquid, boosting stiffness...
Replimune Cries Foul on Regulatory Flexibility. But Many Americans Want a Stricter FDA
The FDA rejected Replimune’s RP1 melanoma combination therapy twice, citing patient‑population heterogeneity that it says undermines efficacy interpretation. The biotech’s CEO decried the agency’s lack of regulatory flexibility, while a Politico poll revealed most Americans prefer a slower, more rigorous...
Piramal Pharma Solutions Partners with Ajinomoto Bio-Pharma Services to Advance ADC Development and Manufacturing
Piramal Pharma Solutions and Ajinomoto Bio‑Pharma Services have signed a strategic collaboration to accelerate antibody‑drug conjugate (ADC) development and manufacturing. Piramal will refer its customers to Ajinomoto’s AJICAP platform for site‑specific ADC conjugation, while Ajinomoto will direct clients to Piramal...
Lilly’s Tirzepatide Sheds Lean Muscle Harder than Novo’s Semaglutide, Study Suggests
A new, pending‑peer‑review study compares Eli Lilly’s tirzepatide with Novo Nordisk’s semaglutide, confirming tirzepatide delivers greater overall weight loss but also leads to a larger reduction in lean body mass. Researchers used dual‑energy X‑ray absorptiometry to quantify fat‑free mass loss, finding up...
Helsinki’s Algorithmiq Wins €1.7 Million Prize for Quantum-Enabled Light-Sensitive Cancer Drug Discovery
Algorithmiq, a Helsinki‑based quantum software firm, secured the €1.7 million ($2 million) Wellcome Leap prize for demonstrating a practical quantum advantage in drug discovery. The team built an end‑to‑end quantum‑classical workflow that ran on up to 100 qubits to simulate a photosensitiser...
How Clinical Trials Validate New Peptide Therapies
Clinical trials are essential for turning promising peptide molecules into reliable therapeutics by confirming that their effects are consistent, measurable, and reproducible across diverse populations. The article outlines how preclinical research defines mechanisms and safety, while Phase I focuses on human...
Multiple Myeloma Drug Blenrep Backed for Wider NHS Use
The UK’s health technology regulator NICE has broadened the approved use of GSK’s BCMA‑targeting drug Blenrep, allowing it to be combined with Takeda’s Velcade and dexamethasone for a larger second‑line multiple myeloma population. The new guidance lifts the restriction that...
Lilly’s Obesity Pill Foundayo Gets 1,390 Prescriptions in Debut Week
Eli Lilly's newly launched oral obesity drug Foundayo filled 1,390 prescriptions in the United States during its debut week ending April 10, according to IQVIA data. By comparison, Novo Nordisk's oral Wegovy recorded 3,071 prescriptions in its first four days...
This Sam Altman-Backed $1.8 Billion Startup Bets AI Can Get Drugs Through Clinical Trials Faster
Formation Bio, backed by Sam Altman and top VCs, has raised $615 million at a $1.8 billion valuation to use AI for faster, cheaper clinical trials. The New York‑based firm plans to acquire a portfolio of about ten early‑stage drug candidates, many stalled...
3 Ways to Invest in the Growing GLP-1 Weight Loss Market
The global GLP‑1 receptor agonist market is set to nearly triple, reaching roughly $185 billion by 2033 with a 12.4% compound annual growth rate. Investors can tap the surge through a direct play in Structure Therapeutics, whose aleniglipron candidate posted a...
Karnataka Approves AI Centre of Excellence in Bengalurus Electronics City
The Karnataka government approved a four‑year AI‑Biotechnology Centre of Excellence at the Institute of Bioinformatics and Applied Biotechnology in Bengaluru’s Electronics City, allocating roughly $2.4 million. The project partners the institute with the Centre for Cellular and Molecular Platforms (C‑CAMP) and...
The Innovators Working to Make in Vivo Cell Therapy a Reality
First‑in‑human trials of in‑vivo CAR‑T therapies are now underway, delivering therapeutic genes directly inside patients via viral or lipid‑nanoparticle vectors. Big‑pharma interest is evident after AstraZeneca’s $1 bn purchase of EsoBiotec and Eli Lilly’s $2.4 bn acquisition of Orna Therapeutics, despite limited clinical...
Anavex Withdraws EU Application for Alzheimer’s Drug Blarcamesine
Anavex Life Sciences has withdrawn its European marketing authorisation application for blarcamesine, a small‑molecule therapy aimed at early Alzheimer’s disease, after the EMA’s Committee for Medicinal Products for Human Use concluded in December 2025 that the drug’s benefits did not...
First Patient Receives JANX014 Dose in Janux’s Trial for mCRPC
Janux Therapeutics announced the dosing of its first patient in a Phase I trial of JANX014, a prostate‑specific membrane antigen (PSMA)‑directed T‑cell engager for metastatic castration‑resistant prostate cancer (mCRPC). The multicenter, open‑label study will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics and early...
Bavarian Nordic Reports Swissmedic’s Approval of Vimkunya to Prevent Chikungunya
Swissmedic has granted approval to Bavarian Nordic’s Vimkunya, a single‑dose, virus‑like particle vaccine for chikungunya, targeting individuals 12 years and older. The vaccine is designed to elicit protective immunity as early as one week after injection. Bavarian Nordic has also...
Argobio: The Venture Model Building Europe’s Next Biotech Champions
Argobio, led by Thierry Laugel, raised roughly $54.5 million in 2021 to launch a venture‑builder focused on European biotech. The model has already spun out three companies—Enodia, Laigo Bio and Elkedonia—that together secured over $46.9 million in seed funding for platforms in protein degradation...
Radiopharm Completes Final Patient Dosing of RAD 101 for Diagnosis of Brain Metastases in the US
Radiopharm Theranostics announced the final patient dosing in its U.S. Phase IIb trial of the 18F‑RAD101 PET imaging agent for recurrent brain metastases. The study enrolled 30 patients and interim results demonstrated 90% concordance with MRI, meeting the predefined efficacy...
Stockholm’s BioLamina Secures €20 Million EIB Loan to Scale Cell Therapies for Chronic Diseases
Swedish biotech scale‑up BioLamina secured a €20 million (≈$22 million) venture‑debt loan from the European Investment Bank to accelerate its laminin‑based cell‑culture platform. The financing will fund expansion of manufacturing capacity, broaden the product portfolio and reinforce the company’s technology base for...
Want to Get the Pill without Seeing a GP? Here’s What You Need to Know
Australian states are expanding pharmacy access to oral contraceptives, with New South Wales set to let eligible pharmacists prescribe the pill to women 18 and older from June 2026. Victoria already permits first‑time users to obtain the pill at pharmacies...
Merck’s PD-1/VEGF Data Star in Stacked Lineup of AACR ‘26 Data Reveals
Merck will unveil early clinical data on MK‑2010, a PD‑1/VEGF bispecific antibody it licensed from LaNova for $588 million, at the AACR 2026 meeting. The readout will test Merck’s ability to compete with ivonescimab and other emerging bispecifics from Pfizer/BioNTech and BMS....
Cough Drops From Several Brands Being Recalled, FDA Says
On March 20, the FDA initiated a Class II recall of 15 cough‑drop products sold under five private‑label brands after an inspection of the Chinese manufacturer Xiamen Kang Zhongyuan Biotechnology revealed unspecified concerns. The affected items, many bearing lot 20241030 and expiring...
Stem Cell Editing Programs the Immune System to Make Own Therapeutic Proteins
Researchers at Rockefeller University used CRISPR to edit hematopoietic stem and progenitor cells (HSPCs), programming them to produce therapeutic antibodies or other proteins after vaccination. In mice, as few as 7,000 edited HSPCs generated durable, high‑titer antibody responses that protected...
Biotech Insights - Spring 2026
The FDA’s post‑approval change framework now spotlights GLP‑1 products, exemplified by Wegovy’s tablet approval, and mandates reporting based on the change’s impact—major and moderate changes require supplemental NDAs, while minor changes go in the annual report. In parallel, the Federal...
Will Retatrutide Help Me Lose Weight or Look ‘Shredded’?
Retatrutide, an experimental triple‑hormone peptide, has shown more than 20% body‑weight loss in a 48‑week clinical trial, outperforming existing GLP‑1 drugs like Ozempic and Wegovy. Researchers say it works by modulating GLP‑1, GIP and glucagon pathways to suppress appetite and...
From Lockdown to the Lab: Researcher Develops 'Decoy Molecule' To Slow Down Coronavirus
During the COVID‑19 lockdown, Ph.D. candidate Koen Rijpkema engineered decoy molecules that bind tightly to the coronavirus Mac1 enzyme, which normally dampens immune signaling. By mimicking the enzyme’s natural substrate, the decoys keep Mac1 occupied, allowing the immune system to detect...
Weight Loss, Obesity Drugs Bring Potential New MASLD, MASH Treatment Strategies
A new review in *Diabetes, Obesity and Metabolism* shows that GLP‑1, GIP and glucagon‑based drugs, originally approved for obesity and diabetes, also improve liver outcomes in metabolic dysfunction‑associated steatotic liver disease (MASLD) and its progressive form MASH. A recent meta‑analysis...
Kennedy: 90% Of FDA Reviewers Are Using AI For Faster Drug Approvals
U.S. Health and Human Services Secretary Robert F. Kennedy Jr. told the House Ways & Means Committee that more than 90% of FDA reviewers are now using artificial‑intelligence tools to speed drug approvals. The AI applications are also being rolled...
Re: Managing Resistant Hypertension . . . And Other Research
A retired physician, David Levine, wrote to BMJ questioning the reported cardiovascular event numbers in a recent LDL‑lowering study, noting that the intensive‑therapy arm was listed with 147 events versus 100 in the conventional arm. He suggests the figures may...
UK Says It Has Hit Target on Commercial Trial Set-Up Times
The UK’s National Institute for Health and Care Research (NIHR) reported that average clinical‑trial set‑up time fell to 122 days in the six months to March, beating its 150‑day target set for March 2026. The reduction follows a suite of reforms,...
RFK Jr. Defends FDA, Makary Following Republican Questions
HHS Secretary Robert F. Kennedy Jr. took the podium before the House Energy & Commerce Committee on April 16, 2026 to defend the Food and Drug Administration and its commissioner, Marty Makary, after a line of Republican inquiries. Kennedy asserted that the FDA’s approval processes remain...
OpenAI Debuts GPT-Rosalind, a New Limited Access Model for Life Sciences, and Broader Codex Plugin on Github
OpenAI unveiled GPT‑Rosalind, a domain‑specific reasoning model built to accelerate life‑science research, alongside a Codex plugin that links the model to over 50 public multi‑omics databases. The model demonstrated top‑tier performance on benchmarks such as BixBench and LABBench2, surpassing GPT‑5.4...