BioCentury | Apr 3, 2020
Product Development

COVID-19: manufacturing mAbs in patients

The urgency and scale of the coronavirus outbreak could drive progress in an emerging therapeutic strategy suited to rapid development and distribution -- encoding of antibodies in RNA or DNA. Neutralizing mAbs against SARS-CoV-2 have...
BioCentury | Apr 1, 2020
Distillery Therapeutics

FLNA identified as a target for epilepsy associated with focal cortical dysplasia type II

DISEASE CATEGORY: Neurology INDICATION: Epilepsy Inhibiting the actin-binding protein FLNA could prevent or treat epilepsy associated with focal cortical dysplasia type II, a cerebral developmental malformation. Levels of FLNA protein in cortical tissue from 12...
BioCentury | Mar 30, 2020
Product Development

As part of $1B initiative with HHS, J&J looks to dramatically scale up vaccine manufacturing

Johnson & Johnson is moving to rapidly scale up its manufacturing capacity via a partnership with HHS, with the goal of supplying globally over a billion doses of a vaccine. The initiative is part of...
BioCentury | Mar 27, 2020
Regulation

CHMP decisions set stage for approval of Novartis’ SMA gene therapy, Celgene’s Zeposia for MS, Sanofi’s comeback cancer drug

EMA’s CHMP backed conditional approval of an MAA for Zolgensma to treat spinal muscular atrophy in its March set of recommendations, which were made via a virtual meeting because of the COVID-19 outbreak. The agency...
BioCentury | Mar 27, 2020
Product Development

March 26 Quick Takes: Pear’s digital therapeutic approved for insomnia; plus Medimetriks-Otsuka, Merck KGaA, Jazz, Roche, EpiVax

FDA approves Pear’s cognitive behavioral insomnia therapy  FDA approved Somryst from Pear Therapeutics Inc. to treat chronic insomnia. The prescription digital therapeutic is the first to be approved via simultaneous review under the standard 510(k)...
BioCentury | Mar 24, 2020
Product Development

Positive data for intrathecally delivered Zolgensma could broaden its patient population

The latest data on Novartis’ Zolgensma could help solidify and possibly expand the gene therapy’s position in the SMA market as the company prepares for a potential new entrant in the coming months. During a...
BioCentury | Mar 23, 2020
Product Development

March 23 Quick Takes: Venclexta combo hits in AML; plus Jardiance rebuffed, Zolgensma approved in Japan and Zealand-Boehringer

Venclexta combo shows survival benefit in AML  Partners Roche (SIX:ROG; OTCQX:RHHBY) and AbbVie Inc. (NYSE:ABBV) said Venclexta venetoclax plus azacitidine significantly improved overall survival and composite complete remission rate among acute myelogenous leukemia (AML) patients...
BioCentury | Mar 21, 2020
Product Development

Under duress, biotechs will have to make hard decisions for patients and themselves about which trials to run

While COVID-19’s risk to clinical trials was initially a function of geography, the fallout for companies is now less a matter of where the studies are being run, and more about which patient population is...
BioCentury | Mar 18, 2020
Regulation

FDA’s clinical trial guidance stresses patient safety, studies’ integrity amid outbreak

As disruptions begin to mount among biopharmas’ planned or ongoing clinical trials during the COVID-19 outbreak, newly issued FDA guidance clarified the agency’s thinking on how sponsors can ensure participants’ safety and implement modifications to...
BioCentury | Mar 14, 2020
Politics, Policy & Law

Patient access to new Alzheimer’s drugs will depend on diagnostic innovation and payment reform

If Biogen’s Alzheimer’s disease therapy aducanumab gets approved this year, it will set off a payment time bomb given the huge patient population, and the fact it almost exclusively falls in the Medicare age group....
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