Biotech News

Despite sliding stock prices, biotechs aren't "on sale," J&J CFO Joe Wolk said Tuesday. "It's really hard to say whether there's been a capitulation, or a recognition, that values have come down."

The trial, which will enroll nearly 1,500 people, could help determine whether a variant-specific shot is more effective than an additional booster of Pfizer's original vaccine.

Pfizer, BioNTech launch trial for potential omicron-busting vaccine aarmstrong Tue, 01/25/2022 - 09:29

Sierra's bet on Gilead castoff pays off, teeing up FDA filing for rival to Incyte-Novartis cancer drug ntaylor Tue, 01/25/2022 - 08:10

The biotech raised the Series B round during "probably one of the worst biotech markets" emerging drugmakers have faced in some time, a Metagenomi executive told BioPharma Dive.

The biotech said it plans to soon submit the drug, which it acquired for cheap from Gilead three years ago, to the Food and Drug Administration for approval.

AstraZeneca success torpedoes PCI's pivotal plan, crushing stock ntaylor Tue, 01/25/2022 - 06:23

89bio, trying to rise from ashes of NASH failures, posts gains in disease severity, cardiovascular health in small data set aarmstrong Mon, 01/24/2022 - 14:51

According to the drugmaker, the FDA asked in a complete response letter for more information related to how the drug's efficacy was measured.

New clinical trial organization launches with promise to conduct randomized trials at fraction of the cost aarmstrong Mon, 01/24/2022 - 10:36

With other COVID treatments ineffective against the variant or in short supply, the FDA is expanding its approval of Veklury to include outpatient use. 

1b, or not 1b: FDA hits Viking with clinical hold over mix-up in phase of rare disease trial ntaylor Mon, 01/24/2022 - 08:26

MaaT wraps up cancer microbiome trial early to power into phase 2/3 this year ntaylor Mon, 01/24/2022 - 07:13

Learn more about Iowa's efforts in the ongoing fight against pandemics and other threats to human and animal health.

Manage, maintain and optimize all the tasks, duties and goals that fall under the umbrella of your workplace.

Academics with a drive to turn their research into commercial products often end up in the position of Chief Scientific Officer at a biotech company. Kees Melief shares his own personal experience transitioning from academia to industry. After his retirement as an academic researcher at Leiden University, Cornelis ‘Kees’ Melief founded and became the Chief Scientific Officer (CSO) of ISA Pharmaceuticals in 2004. This Dutch biotech company develops therapeutic vaccines for cancer and infectious diseases, including Covid-19.  Melief, who has received several awards for his discoveries and lifetime contribution to cancer immunology, got into immunology almost by chance, through a student project. After building a career in academia, he decided to delve into the startup world and confronted the transition of becoming a CSO. What were the main differences you noticed between academia and a CSO position? The Chief Scientific Officer basically is still very much close to academic work because the CSO has to weigh different concepts against each other; The post Transitioning from Academia to Chief Scientific Officer in the Biotech Industry appeared first on Labiotech.eu. © Labiotech UG and Labiotech.eu. Unauthorized use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Labiotech UG and Labiotech.eu with appropriate and specific direction to the original content.

New research on tau's role in neurodegenerative diseases like Alzheimer's could inform new treatments klahucik Fri, 01/21/2022 - 13:51

After halting a Phase 3 trial of the drug last year, Roche went digging for more data. What it found led to plans for another trial, but the pharma's hypothesis may rest on shaky ground.

New results show the effects of its next drug for transthyretin amyloidosis appear to hold up for a year and a half. But it's unclear whether treatment will help those with heart problems, a much larger market opportunity.  

Alnylam touts data replication for next-generation Onpattro in ATTR trial, but analysts pour some cold water aarmstrong Fri, 01/21/2022 - 10:40

MD Anderson inks deal to put Chinese cancer drugs through trials, starting with a PI3K inhibitor ntaylor Fri, 01/21/2022 - 08:00

Kura exits FDA clinical hold after agreeing to mitigation measures, enabling resumption of blood cancer trial  ntaylor Fri, 01/21/2022 - 06:37

After a drought of more than a year, the European gene therapy sector saw initial public offerings from Genenta Science and Genflow Biosciences. The firms aim to shine as biotech stocks elsewhere perform poorly. Until recently, European gene therapy companies were going through a dry spell in terms of launching initial public offerings (IPO). The last major European gene therapy IPO came from the UK firm Freeline Therapeutics in late 2020. Another UK player, Gyroscope Therapeutics, came close in 2021 but the event was canceled and the company was instead acquired by Novartis. The Italian firm Genenta Science and the UK company Genflow Biosciences make up a fresh wave of European gene therapy players going public. Genenta bagged €31.4M ($36M) in its Nasdaq debut in December 2021 and Genflow Biosciences listed on the London Stock Exchange this week, raising around €4.4M (£3.7M) in the process. One factor driving the general reluctance to go public is the continuing volatility of biotech stock markets around the world. The post Two Gene Therapy Players Launch IPOs on Stormy Stock Market appeared first on Labiotech.eu. © Labiotech UG and Labiotech.eu. Unauthorized use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Labiotech UG and Labiotech.eu with appropriate and specific direction to the original content.

CROs embracing tech to decentralize trials and speed enrollment as regulators show support 'with their feet' aarmstrong Thu, 01/20/2022 - 08:54

Fresh from $86M series A, Metis poaches Kala CSO to support move into the clinic ntaylor Thu, 01/20/2022 - 08:18