Maryland
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FDA Authorizes Novavax’s Covid-19 Vax, Set to Join Fall Rollout of Updated Shots
Novavax’s updated version of its Covid-19 vaccine is now FDA authorized for use in the U.S., joining the approved shots from Moderna and partners Pfizer and BioNTech. Novavax said its protein-based vaccine will be available in coming days.
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FDA Places Arcellx Cell Therapy Under a Clinical Hold After Patient Death
Arcellx attributes the death to limitations of the treatments that patients receive while their cell therapies are being manufactured. The company is working to expand these so-called bridging therapy options for patients.
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Streamline the Process for Consent Collection and Management
Join us on April 16th and hear executives from DocuSign and Velatura discuss how their partnership modernizes and facilitates the efficient and secure completion of the patient consent form.
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CDMO Startup Vector BioMed Launches to Fill Lentiviral Gap for Cell & Gene Therapies
Vector BioMed has developed a technology platform for designing and manufacturing the lentiviruses used to deliver cell and gene therapies. The startup is launching as the field continues to experience shortages of these viral vectors.
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Gilead Sciences Gets a Shot at Next-Gen Cell Therapy With $325M Arcellx Alliance
In partnering with clinical-stage Arcellx, Gilead Sciences gains the opportunity to develop a cell therapy for multiple myeloma that could offer advantages over currently available therapies for the blood cancer. The deal announced Friday came as Arcellx reported additional data during the annual meeting of the American Society of Hematology that showed continued durability of the cell therapy.
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FDA authorizes Novavax’s Covid-19 booster, a first for a protein-based vaccine
Novavax’s Covid-19 vaccine is now authorized as a booster shot for adults. The regulatory decision, which comes three months after the shot was first granted FDA emergency authorization, introduces a booster shot alternative to messenger RNA vaccines.
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Sanofi’s RNA therapies strategy adds new piece with alliance in muscular dystrophy
Sanofi is collaborating with startup miRecule to develop an RNA therapy for facioscapulohumeral muscular dystrophy. The pharmaceutical giant gets global rights to miRecule’s therapy for this type of muscular dystrophy, which has no FDA-approved treatments.
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Arcellx’s IPO raises $124M to fuel chase of better CAR T-cell therapy for cancer
Clinical-stage Arcellx raised $123.8 million from its IPO, which the company will use to advance to a pivotal test for its lead program, a CAR T-cell therapy for multiple myeloma. Though Arcellx trails its large pharmaceutical rivals, the biotech contends its technology produces cell therapies with key advantages.
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AbbVie makes another gene therapy move, paying $370M to partner with Regenxbio
AbbVie will take the lead on commercializing Regenxbio’s gene therapy in wet AMD and diabetic retinopathy. It’s AbbVie’s second major gene therapy deal this year, coming months after it committed $90 million to preclinical-stage Capsida Biotherapeutics.
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Transforming rural healthcare will require a funding overhaul. Here’s one way to do it.
The answer to rural healthcare’s financial issues could lie in a payment model that pools funds from public and private insurers alike to pay for agreed-upon core services, allowing rural hospitals to provide the care most needed by the communities they serve.
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Do you advise self-insured employers? You Can Help Us!
Take part in this survey and share some of the trends you are seeing among your clients across healthcare, including chronic conditions, behavioral health and navigation.
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Novavax Covid-19 vaccine shows 90% efficacy, protection against variants
Novavax reported that its Covid-19 vaccine was 100% effective at protecting against moderate and severe disease and 90.4% effective overall. The vaccine is seen as an important alternative to messenger RNA vaccines because of its storage and distribution advantages.
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Ellume founds U.S. manufacturing facility as part of $232M contract for at-home Covid tests
Ellume, a startup that won a $232 million contract to manufacture more of its over-the-counter Covid-19 tests in the U.S., has started building a manufacturing facility in Maryland. In the longer term, it plans to use the site to prepare for future outbreaks and pandemics.
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Supernus ADHD drug is FDA approved; first new ‘non-stimulant’ med in a decade
FDA approval of Supernus Pharmaceuticals drug Qelbree gives attention-deficit hyperactivity disorder patients another treatment option that is not classified as a Schedule II substance. It’s a different formulation of a drug that was first approved in Europe decades ago.
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United Therapeutics notches another FDA approval for lung drug
The FDA decision for Tyvaso as a treatment for pulmonary arterial hypertension in patients who have interstitial lung disease is the second approval for the United Therapeutics drug. The additional indication gives the company another way to grow revenue for the drug, which faces generic competition.
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Novavax preps to meet global demand, plans capacity for 2B Covid vaccine doses
Novavax says it’s building up its manufacturing capacity now to be ready to ship Covid-19 vaccine globally as emergency authorizations are granted in coming months. The company expects to seek FDA authorization in the second quarter.
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FDA issues Covid-19 vaccine guidance as White House reportedly relents
The guidance calls for a median two months’ worth of follow-up safety data from well-designed Phase III studies as a precondition for a vaccine receiving an EUA. The Wall Street Journal reported that the White House had backed down in its opposition to the guidance, which pushes the date of an EUA past Election Day.