BioCentury | Jul 24, 2020
Regulation

Data Bytes: CHMP’s July recommendations

Among the 11 new medicines recommended for approval by EMA’s CHMP is the first antibody-drug conjugate, and most advanced BCMA-targeted agent, for multiple myeloma patients: GSK’s Blenrep belantamab mafodotin. FDA’s Oncologic Drugs Advisory Committee unanimously...
BioCentury | Jul 21, 2020
Product Development

Acadia drops major add-on indication for psychosis drug after pivotal miss

Acadia shed nearly $1.7 billion in market cap on Tuesday after saying it would no longer pursue the broader population of major depressive disorder patients for its psychosis drug after a Phase III miss. Pimavanserin...
BioCentury | Jun 11, 2020
Product Development

J&J picks up pace for Warp Speed COVID-19 vaccine

One Operation Warp Speed finalist is advancing its COVID-19 vaccine into the clinic two months earlier than planned as the U.S. initiative looks to a 170-year-old company to produce glass packaging for countermeasures. Meanwhile, a...
BioCentury | Apr 15, 2020
Product Development

AZ targeting cytokine storms as ranks of repurposed agents for COVID-19 grow

AstraZeneca joins the growing list of companies targeting cytokine storms caused by COVID-19 with plans to start a trial of its Btk inhibitor to treat patients with severe disease. The announcement came Tuesday amid another...
BioCentury | Jan 24, 2020
Product Development

The new drug development -- collaborative and people-powered

In recent years, the healthcare ecosystem has been experiencing a paradigm shift in how it engages with the people at its center: patients. Patients are demanding to be viewed first as people, with lives and...
BioCentury | Dec 5, 2019
Clinical News

Dementia-related psychosis data could make Acadia’s pimavanserin a blockbuster

Pivotal data reported late Wednesday support Acadia’s bid for a label expansion that would bring pimavanserin to the broader population of dementia-related psychosis and help allay safety concerns associated with a black box on the...
BioCentury | Nov 23, 2019
Company News

Nov. 22 Company Quick Takes: AZ’s Btk inhibitor gains expanded approval; plus WuXi Vaccines, SK Bio, ViiV, Horizon and Neon

Label expansion for AZ’s Calquence under Project ORBIS FDA approved an sNDA for Calquence acalabrutinib from AstraZeneca plc (LSE:AZN; NYSE:AZN) to treat chronic lymphocytic leukemia and small lymphocytic leukemia under the agency’s Real-Time Oncology Review...
BioCentury | Nov 15, 2019
Company News

BeiGene enters U.S. market with first approval for in-house pipeline

With its first approval for an internally developed drug, BeiGene faces tough competition as it seeks to carve out a niche for Brukinsa. But the third-to-market Btk inhibitor could have an edge on efficacy without...
BioCentury | Sep 9, 2019
Clinical News

Dementia-related psychosis readout could lead to label expansion for Acadia's Nuplazid

A new Phase III readout could speed Acadia's timeline to a potential regulatory submission of pimavanserin to treat dementia-related psychosis, an indication that afflicts a much larger population than the one for which the molecule...
BioCentury | Jul 23, 2019
Clinical News

Acadia looks to next schizophrenia readout after Phase III miss

Acadia shed $3.96 (15%) to $22.01 in after hours trading Monday when it reported after market close that Nuplazid pimavanserin as an adjunct schizophrenia therapy missed the primary endpoint and key secondary endpoint in the...
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