Product Development

Realities of limited manufacturing capacity for COVID-19 vaccines hit Horizon’s Tepezza launch

In a blow to what has been one of the more successful drug launches of the year, Operation Warp Speed has commandeered some of Horizon’s manufacturing slots for thyroid eye disease drug Tepezza to prioritize a COVID-19 vaccine. The...

Next-generation checkpoints acting on NK and T cells: Data Byte

Following the early success of anti-TIGIT mAbs in clinical development this year, interest in next-generation checkpoints has been on the rise, and there’s reason to believe that checkpoints expressed on both T cells and NK...

Two non-amyloid therapies for Alzheimer’s advance to late-stage trials

December has been a busy month for Alzheimer’s therapies testing new hypotheses outside of amyloid, with the latest coming Wednesday from Novo Nordisk, which said it is taking semaglutide into Phase III...

BARDA, DOD backing of I-SPY COVID trial highlights continued need for new therapies

Vaccines are here, but the pandemic is far from over and BARDA and DOD are supporting the search for therapies to help the sickest COVID-19 patients by funding a mechanism that’s proving to be most...

Dec. 14 COVID roundup: Phase III miss for Incyte-Novartis JAK inhibitor; Queensland vaccine program axed; plus Sputnik V final efficacy and Phase II starts for CureVac and Inovio

No benefit in Phase III for Incyte, Novartis JAK inhibitorJakafi ruxolitinib from Incyte Corp. (NASDAQ:INCY) and Novartis AG (NYSE:NVS; SIX:NOVN) plus standard of care vs. SOC alone did not reduce the proportion of patients with severe complications...

Arvinas regains investor confidence with path forward for AR degrader, second proof-of-concept for platform

A better understanding of responder profiles, a path to accelerated approval and proof that its degrader platform is not a one-trick pony were among the factors that nearly doubled Arvinas’ stock after the company presented...

Vaccines march forward & CAR Ts move earlier: a BioCentury podcast

On the latest edition of the BioCentury this Week podcast, BioCentury editors discuss the latest advances and setbacks among COVID-19 vaccines in the wake of FDA’s emergency use authorization on Friday for Pfizer and BioNTech’s...

Setback for Sanofi/GSK COVID-19 vaccine highlights importance of portfolio strategy

A delay in the development of Sanofi and GSK’s COVID-19 vaccine due to a lack of efficacy in older adults reinforces the importance of the portfolio strategy governments are taking in procuring a COVID-19 vaccine. ...

Ipsen is casting a wider BD net under new CEO Loew

With a pipeline heavy on line extensions and its bestseller headed toward a patent cliff, new Ipsen CEO David Loew is doubling down on the mid-cap biopharma’s commitment to external innovation. But...

RNA vaccines still outshine other modalities as two protein-based COVID-19 vaccines yield mixed results

With clinical data available from at least four vaccine modalities, including validated technologies, results from the newest modality — mRNA — remain the strongest.  mRNA vaccine technology,...

Dec. 11 Quick Takes: AZ to run combo trial with Sputnik; plus Phase III hits for Lilly, AbbVie and TG, data from Immutep, NVS, Mycovia, Sarepta and Greenwich

Russian and AZ COVID vaccines in combo trialAstraZeneca plc (LSE:AZN; NASDAQ:AZN) will begin by year-end a clinical trial of its AZD1222, developed with the University of Oxford, in combination with the adenovirus serotype 26 (Ad26)...

More Moderna: U.S. doubles its doses of COVID-19 vaccine ahead of potential emergency authorization

As Moderna’s mRNA-1273 closes in on FDA emergency authorization, the U.S. government has doubled its commitment to the COVID-19 vaccine to 200 million doses. Moderna Inc. (NASDAQ:MRNA) and the U.S. government announced Friday that the U.S. exercised...

AZ and Oxford paper spotlights the swerves on the road to pooled vaccine efficacy readout

The first peer-reviewed paper on pivotal data from a COVID-19 vaccine details the unplanned protocol shifts complicating the pooled efficacy analysis of AstraZeneca and Oxford’s AZD1222. The Lancet study, published Tuesday, contains the efficacy and...

CAR Ts make the move to earlier lines of treatment despite access barriers

CAR T manufacturers and payers are still negotiating access for B cell lymphoma patients without other treatment options, but that hasn’t stopped companies from pressing on into earlier lines of treatment....

Pfizer-BioNTech COVID-19 vaccine endorsed at shambolic advisory committee meeting

Thursday’s FDA advisory committee meeting on the Pfizer-BioNTech COVID-19 vaccine could have been the shining culmination of a historic development program, but it failed to live up to its promise. If...