top of page
Business Meeting


January 2023 - February 2023

J&J’s Latest Data for Nipocalimab in Fetal Disorder Suggests Momenta Acquisition May Still Pay Off

When Johnson & Johnson acquired nipocalimab as part of the $6.5 billion takeover of Momenta Pharmaceuticals, the hype surrounding the therapy was focused on its potential as a treatment for the hot disease area of myasthenia gravis. But a top-line phase 2 readout for the drug in a fetal disorder is a reminder that nipocalimab could have a far broader reach. Nipocalimab is the only therapy in clinical development for the treatment of alloimmunized pregnant adults at risk of severe hemolytic disease of the fetus and newborn. Over the roughly 20-week treatment period, nipocalimab’s safety profile supported further development of the drug in this fetal indication, J&J said in a release Monday morning.

Boarding Priority Review Track, Biogen and Sage get August Decision Date for Depression Drug Approval

Add Aug. 5 to your diaries. That is the FDA's decision date for the approval of Biogen and Sage Therapeutics' zuranolone, which the agency has accepted for priority review as an oral treatment of major depressive disorder (MDD) and postpartum depression (PPD). The FDA’s acceptance of the submission is the latest milestone in Sage’s bid to recover from the failure of a phase 3 clinical trial of zuranolone in MDD in 2019. Biogen came on board in 2020, and, together, the pair executed a three-pronged R&D program that was originally designed to get the molecule to market in 2022. While the partners missed that target, they now have the finish line in sight.

FDA Approves Gilead’s Trodelvy for Expanded Use in Breast Cancer

Gilead has secured an expanded U.S. approval for its breast cancer medicine Trodelvy, announcing Friday the Food and Drug Administration cleared the antibody treatment for the most commonly occurring form of the tumor type. Previously approved only for rarer, “triple-negative” breast tumors, Trodelvy can now be used to treat patients with metastatic breast cancer that’s hormone receptor, or HR, positive, but negative for a protein called HER2. This type of breast cancer accounts for an estimated 70% of all new cases, according to Gilead. The FDA’s decision is a win for Gilead, which gained Trodelvy when it paid $21 billion to acquire Immunomedics in 2020. But clinical trial results showed the drug’s benefit was modest, and Gilead will face competition from a rival drug sold by AstraZeneca and Daiichi Sankyo. 

How CAR-T Therapies are Revolutionizing Cancer Treatments

One of the most significant advancements made in treating disease in recent years is the development and commercialization of CAR-T therapy, which weaponizes a patient’s own white blood cells to attack certain types of blood cancer cells. For some cancer patients, CAR-T therapy hope holds the promise of a cure. Something that could open more options for CAR-T treatments is a shift from autologous (unique to a single patient) to allogeneic CAR-T treatments, which are off-the-shelf options that can be used by many patients.

Baxter Links Up With Miromatrix to Test Bioengineered Liver Replacement Therapy 

Baxter has teamed up with the xenotransplant developer Miromatrix Medical to help advance bioengineered replacement organs for patients suffering from acute liver failure.The medtech signed on while Miromatrix’s work is currently in a holding pattern. The company is awaiting a green light from the FDA to launch a phase 1 human study after the agency delivered a clinical hold and requested additional data before participants could be treated.

N.Y.U. Langone Withdraws From Type 1 Diabetes Vaccine Trial in Adolescents

The B.C.G. vaccine, more than a century old, has shown some promise against diabetes. The university’s move left parents and outside investigators concerned. Researchers at N.Y.U. Langone Health have pulled out of a trial investigating the use of an old tuberculosis vaccine to treat children with Type 1 diabetes only months after they began enrolling participants on Long Island.The lead investigators of the pediatric trial, who are at Massachusetts General Hospital in Boston, are proceeding with the study, but N.Y.U. Langone’s abrupt withdrawal could potentially jeopardize its viability if they are unable to collect data on the children at the N.Y.U. site. 

AAHI Awarded a $9.9 Million Project to Develop Prototype Intranasal Bivalent Influenza RNA Vaccine Candidate 

The Access to Advanced Health Institute (AAHI) announced today that it has been awarded a project agreement worth up to $9.9 million through the Medical CBRN Defense Consortium (MCDC) Other Transaction Authority (OTA) to develop a prototype intranasal bivalent influenza RNA vaccine candidate based on AAHI's self-amplifying RNA (saRNA) platform that targets both pandemic A(H5N1) and A(H7N9) influenza virus pathogens.This prototype project was awarded on behalf of the U.S. Department of Defense's (DoD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services. AAHI's innovative RNA platform, which delivers saRNA bound to the exterior of a nanostructured lipid carrier (NLC), entered first-in-human clinical trials in May 2022 with Phase 1/2 clinical trials of the "AAHI-SC2" COVID-19 vaccine candidate (NCT05370040).

BeiGene Wins Expanded Approval for Leukemia Drug, Intensifying Battle with AbbVie, AstraZeneca

The Food and Drug Administration has approved BeiGene’s targeted cancer drug Brukinsa for use in a type of leukemia, the company said Thursday. The decision expands the treatment’s market and puts it in a battle with AbbVie and Johnson & Johnson’s Imbruvica and AstraZeneca’s Calquence in the most common form of the disease. BeiGene hopes data from a clinical trial testing Brukinsa head to head against Imbruvica will give it an edge in chronic lymphocytic leukemia, a condition in which Brukinsa outperformed the AbbVie and J&J drug in delaying disease progression or death in the ALPINE trial.

An FDA Committee Votes to Roll Out a New COVID Vaccination Strategy

A committee of advisers to the Food and Drug Administration voted unanimously on a proposal to simplify the nation's strategy for vaccinating people against COVID-19. The recommendation is that future COVID-19 vaccines should be interchangeable: no matter whether you're getting your first dose or a booster, the vaccines would all have the same formulation targeting the same viral strain or strains, regardless of the manufacturer. In addition, the committee considered (but didn't vote on) proposals to have an annual COVID vaccination schedule, much like the U.S. has for the flu. The ultimate goal would be to get more people vaccinated.

Fledgling Digital Health Companies Take Complex Fertility Process Out of the Clinic and Into the Home.

The time-sensitive process of getting pregnant through in vitro fertilization (IVF) could not wait for stay-at-home orders to end. As the pandemic wanes, health tech companies are bringing the IVF process into the home while providing support to the patients who largely coordinate the process themselves. Women's health company Proov provides an at-home ovulation testing kit and boasts the only FDA-cleared and CE-marked at-home ovulation diagnostic platform. The startup nabbed $9.7 million in series A funding in December 2021 to continue building out its product pipeline in women's health.

LymeX Diagnostics Prize Launches Phase 2 with a Virtual Accelerator 

The U.S. Department of Health and Human Services (HHS) and the Steven & Alexandra Cohen Foundation (the Foundation) have launched Phase 2 of the LymeX Diagnostics Prize , inviting the ten Phase 1 winners to participate in a virtual accelerator. Through September 2023, the virtual accelerator cohort will refine their concepts for detecting active Lyme disease infections in people.The goal of the multiphase LymeX Diagnostic Prize (LymeX) competition is to nurture the development of diagnostics toward Food and Drug Administration review.

EzriCare Eye Drops Recalled After CDC Linked to Infections, One Death

Federal health officials urged people to stop using a brand of nonprescription eye drops that they said could be responsible for a spate of infections and at least one death. At least 55 patients in 12 states have been diagnosed with multidrug-resistant bacterial infections possibly linked to EzriCare Artificial Tears, the Centers for Disease Control and Prevention said. The infections have caused one death, permanent vision loss and hospitalization, the CDC said in a health alert on its website. At least five patients have experienced vision loss, the CDC said Thursday.

Amazon Doubles Down on Generic Drugs with New RxPass Subscription

Amazon is launching a generic drug discount program for Prime members, beefing up its pharmacy offering as the ecommerce giant continues its push into healthcare. The subscription service, called RxPass, is $5 per month for customers with Prime to fill as many prescriptions as needed from a list of about 50 generic medications, including delivery to their doorstep.RxPass does not accept insurance, including Medicare and Medicaid coverage. It is available in 42 states.

What to Know About Paxlovid, the COVID Antiviral that Keeps People Out of the Hospital

The antiviral Paxlovid has changed the battle against COVID-19. It's so effective that more than 85% of people at risk for severe disease can avoid a bad outcome with a five-day course of the prescription medication given within five days of symptoms starting. But word of its effectiveness has been slow to catch on. Only about 7.6 million Americans have taken the medication, with nearly 1.6 million doses currently available nationwide.

Gilead’s Trodelvy Snags Vital Breast Cancer Nod. But AZ , Daiichi’s Enhertu Casts Long Shadow 

Thanks to a new FDA approval, Gilead Sciences’ Trodelvy has entered a breast cancer arena that’s crucial to the drug’s commercial success—as well as the company’s larger oncology ambitions. The FDA has approved Trodelvy for previously treated HR-positive, HER2-negative breast cancer, Gilead said Friday. To be eligible for the therapy, patients must have tried endocrine therapy and at least two additional therapies in the metastatic setting. Meaningful penetration in HR-positive, HER-2 negative breast cancer could give Trodelvy a major sales boost. But a recent market shift, pioneered by AstraZeneca and Daiichi Sankyo’s Enhertu, casts a layer of uncertainty over the opportunity.


bottom of page