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Home » Authors » Lee Landenberger

Articles by Lee Landenberger

Ebola virus vaccine vial and syringe

FDA’s approval of Ebola vaccine will be felt around the world

Dec. 20, 2019
By Lee Landenberger
While Ebola virus disease in the U.S. is a rare occurrence, the FDA approval of Merck & Co. Inc.’s Ervebo, the agency’s first for preventing Ebola Zaire virus in people age 18 and older, will have a ripple effect across the world, especially Africa where its effects have been devastating for decades. Stockpiling such a vaccine is crucial to world safety as Ebola has long been a potential bioterrorism threat, especially after 9/11. In the world of theoretical biological warfare, where the virus could be weaponized and disseminated by aerosol, Ebola virus is considered the most dangerous, with fatality rates estimated between 25% to 90%.
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FDA approves the first vaccine to prevent Zaire Ebola virus

Dec. 20, 2019
By Lee Landenberger
FDA Approved stamp

FDA grants accelerated approval for Padcev to treat urothelial cancer

Dec. 19, 2019
By Lee Landenberger
A mere 26 months after the first patient was enrolled in its pivotal phase II study and about three months ahead of its PDUFA date, the FDA granted accelerated approval for Padcev (enfortumab vedotin-ejfv) to treat adults with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery or in a locally advanced or metastatic setting.
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FDA grants accelerated approval for Padcev to treat bladder cancer

Dec. 19, 2019
By Lee Landenberger

Syros, GBT in multimillion-dollar deal to treat sickle cell, beta-thalassemia

Dec. 18, 2019
By Lee Landenberger
Syros Pharmaceuticals Inc. and Global Blood Therapeutics Inc. (GBT) agreed to a discovery, development and commercialization deal to treat sickle cell disease (SCD) and beta-thalassemia. GBT, of South San Francisco, Calif., will pay Syros $20 million up front and fund up to $40 million in preclinical research for at least three years, with the goal of identifying targets and discovering drugs to induce fetal hemoglobin.
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Adamas’ MS therapy hits primary endpoint, and yet it …

Dec. 17, 2019
By Lee Landenberger
While the market gave Adamas Pharmaceuticals Inc. shares a thrashing Tuesday, newly installed CEO Neil McFarlane wouldn’t call it quits on the data generated from the phase III of ADS-5102, the Inroads study for treating multiple sclerosis patients with walking impairment.
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Mirum, FDA meetings more than double the company’s stock value

Dec. 16, 2019
By Lee Landenberger
With two FDA meetings in its hip pocket to discuss maralixibat for treating pruritus associated with Alagille syndrome, Mirum Pharmaceuticals Inc. got a resounding boost from the market Monday as its stock (NASDAQ:MIRM) closed up 111%, at $17.28.
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FDA’s change of heart

Sarepta’s Vyondys 53 wins a surprise accelerated approval

Dec. 13, 2019
By Lee Landenberger
In August the FDA was skeptical about Sarepta Therapeutics Inc.’s injectable Vyondys 53 (golodirsen), but that changed swiftly Friday with the agency’s accelerated approval for the Duchenne muscular dystrophy (DMD) follow-on therapy, the first treatment specifically for this subtype.
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FDA’s change of heart: Sarepta’s Vyondys 53 wins surprise accelerated approval

Dec. 13, 2019
By Lee Landenberger
Brain, illustrating pain/injury

Neurotrauma Sciences exercises an option with Emory University

Dec. 12, 2019
By Lee Landenberger
Neurotrauma Sciences LLC and Emory University’s Institute for Drug Development entered a license agreement for patents and technology invented at the school, enlarging a deal the two cut about a year ago.
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