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Home » Newsletters » BioWorld

BioWorld

Aug. 22, 2022

View Archived Issues
Magnifying glass, FDA concept image

On the rebound: FDA wants a follow-up study of COVID patients from Pfizer

It’s a step forward and a step back at Pfizer Inc. Even as Pfizer and its partner Biontech SE finished filing an emergency use authorization application with the U.S. FDA seeking to field an updated booster dose of their omicron COVID vaccine, the regulator has made a request of its own, for more data on the company's oral antiviral, Paxlovid (nirmatrelvir + ritonavir), for treating COVID-19. An Aug. 5, 2022, letter from the FDA stipulates post-EUA requirements for Paxlovid, including that Pfizer conduct a trial in patients with a relapse of COVID symptoms, longhand for a “rebound,” after an initial Paxlovid treatment course. Read More
NIAID Director Anthony Fauci speaking at a White House briefing

End of an era: Fauci to leave US NIAID leadership role

After nearly four decades as director of the U.S. NIH’s National Institute of Allergy and Infectious Diseases (NIAID), 81-year-old Anthony Fauci will be stepping down in December. He also announced Aug. 22 that he will be handing over the reins as chief of the NIAID Laboratory of Immunoregulation and as chief medical adviser to President Joe Biden. Read More
Adenosine A2A receptor

PD theory by the wayside, Iteos tries A2a-targeting in cancer

Kyowa Kirin Co. Ltd.’s decision, disclosed July 26, to quit development of the adenosine A2a receptor antagonist KW-6356 for Parkinson’s disease (PD) didn’t do much to flatten interest in the target, still under investigation by other firms in cancer. Read More

Pharvaris slumps as oral HAE program delayed by clinical hold

Shares of Pharvaris NV (NASDAQ:PHVS) fell 34% Aug. 22 to close at $12.15 after the company reported the U.S. FDA placed a clinical hold on PHA-121, its oral bradykinin B2-receptor antagonist for hereditary angioedema (HAE), citing a review of nonclinical data. PHA-121, which goes after the same target as well-established injectable HAE drug Firazyr (icatibant, Takeda Pharmaceutical Co. Ltd.), is the active ingredient in Pharvaris’ two lead programs: PHVS-416, a softgel capsule formulation, and PHVS-719, an extended-release tablet formulation. Read More
Ebola-virus

Ebola losing ‘killer’ status to MAbs

Regeneron Pharmaceuticals Inc.’s Inmazeb and Ridgeback Biotherapeutics LP’s Ebanga earned a ringing endorsement from the World Health Organization (WHO) in its first ever guideline on Ebola therapies. In releasing the guideline Aug. 19, WHO officials celebrated the fact that Ebola is no longer “a near certain killer” – provided treatment starts as soon as possible following diagnosis. Read More

US FDA revises guidance on charging for INDs used in trials, expanded access

In the six years since the U.S. FDA issued its final guidance on charging for drugs used under an investigational new drug (IND) application for clinical trials or expanded access, the agency has received several questions about how it is implementing regulations on the matters. To answer those questions, the FDA released a revised draft guidance that, when finalized, will replace the guidance issued in 2016. Read More

ICYMI: Week in review, Aug. 15-19, 2022

A quick look back at top stories.

Read More

Appointments and advancements for Aug. 22, 2022

New hires and promotions in the biopharma industry, including: Biosion, Elevar, Leucadia, Tessa, Turn. Read More

Financings for Aug. 22, 2022

Biopharmas raising money in public or private financings, including: Avelos, Fennec, Hemostemix and Mydecine. Read More

In the clinic for Aug. 22, 2022

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agios, Dermaliq, Jiangsu Recbio, Siranomics. Read More

Other news to note for Aug. 22, 2022

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aarvik, Almac Discovery, Antisense, Avenge, Emerald, Emtora, Innoviva, La Jolla, Larkspur, Lytic Solutions, Moderna, Nighthawk, Nrx, Panther, Relief, Skye, Vaderis, Verve and Zyversa. Read More

Regulatory actions for Aug. 22, 2022

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aeglea, Axsome, Celltrion, Krystal, Kyowa Kirin, Menarini, Stemline, Valneva, Verona, Virfor. Read More

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