Product Development

BMS heeds BIO’s call to ‘walk the talk’

A week after BIO unveiled its BIOEquality initiative, BMS said it is preparing to invest $300 million to increase diversity in clinical trials of its therapies and the representation of Blacks and Latinos at all...

GigaGen aims to overcome supply limits, boost potency with recombinant convalescent sera substitute

GigaGen is developing polyclonal antibodies for COVID-19 and other infectious diseases that could be more potent and easier to supply than convalescent plasma.  GigaGen Inc. plans to submit an IND for its COVID-19 treatment, GIGA-2050, by...

Data Bytes: Regeneron leads COVID-19 antiviral antibody pack

The earliest efficacy signal among the eight SARS-CoV-2 neutralizing mAb therapies in the clinic could come from Regeneron, which expects to report early data for its REGN-COV2 antibody cocktail this summer. Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) is...

Aug. 11 Quick Takes: BMS hits, Genentech misses; plus JW-Lyell, CStone, Big Health

Opdivo clears Phase III hurdles in gastric, esophageal cancers Opdivo nivolumab from Bristol Myers Squibb Co. (NYSE:BMY) plus chemotherapy led to a survival benefit compared with chemotherapy alone in the Phase III CheckMate -649 trial as first-line...

U.S. commits $2.5B total to Moderna’s COVID-19 vaccine as biotech closes 100M dose deal

Moderna’s $2.48 billion across two COVID-19 vaccine deals with the U.S. government imply a price per dose of $24.80 for mRNA-1273 -- in line with those for the vaccines in the two other largest Operation Warp...

Phase II learnings set up microbiome play Seres for Phase III success

Seres parlayed lessons learned from the failed Phase II trial of SER-109 to treat recurrent C. difficile infection into a Phase III win through improved patient selection and higher dosing. Seres Therapeutics Inc. (NASDAQ:MCRB) added...

Charting a path to COVID-19 testing that supports a return to normalcy

A panel of diagnostics leaders points to open questions and infrastructure gaps limiting what society is getting out of COVID-19 testing, and how the lessons learned could reach beyond the pandemic. In an Aug. 5 webinar,...

BIOEquality, data sharing and deals: a BioCentury podcast

BIO is calling on biopharmaceutical companies to put their pledges on social justice into practice as the trade group launches an initiative that aims to diversify the biotech workforce and ensure that clinical trials reflect...

Remdesivir heads for FDA review as Gilead continues to build manufacturing pipeline

As Gilead continues to expand its manufacturing capabilities for Veklury, the company has moved a step closer to gaining full approval of the therapy in the U.S. for COVID-19. The company announced its NDA submission for...

Data Bytes: the COVID-19 pipeline grows to 737 programs

New entrants to BioCentury’s COVID-19 Resource Center keep trickling in, with the total number of therapies and vaccines in development for the indication up to at least 737. ...

Data sharing in and after COVID, with Takeda’s Anne Heatherington: a BioCentury podcast

Among the barriers broken by biopharmas during COVID-19 is the concept of data sharing, an idea far from standard practice in the industry, gaining life due to the gravity and urgency of the pandemic. Proponents...

Asymptomatic COVID-19 testing pushes forward, with lessons from cancer

The growing demand for asymptomatic COVID-19 testing is shifting the conversation from one-time diagnosis to ongoing screening, and from single results to population outcomes. Companies moving the ball forward for early detection of cancer, some...

Novavax secures multicountry access to COVID-19 vaccine

Building on its commitment to make its COVID-19 vaccine globally accessible, Novavax closed two partnerships this week to supply Japan, India and lower income countries with doses of NVX-CoV2373. The biotech plans to start a...

First oral SMA therapy will be delivered to patients’ homes, well placed for virtual launch

FDA’s early approval on Friday of the first oral spinal muscular atrophy treatment, Evrysdi risdiplam, leaves Genentech and PTC well positioned for a virtual launch amidst COVID-19. The Roche (SIX:ROG; OTCQX:RHHBY) unit will begin to...

Bringing COVID-19 vaccines to authorization faster through data sharing

Developers of leading COVID-19 vaccines won’t be able to meet global demand on their own, but they do have the power to accelerate global coverage by helping each other reach authorization and streamlining development for...