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Home » Newsletters » BioWorld

BioWorld

Jan. 24, 2022

View Archived Issues
Woman coughing

FDA rejects Merck cough drug NDA, briefly weighing on Bellus

Merck & Co Inc. has had a setback with its chronic cough drug gefapixant after the FDA rejected its NDA, a decision that also briefly hit the share price of rival Bellus Health Inc. before it regained market traction late Jan. 24. The FDA had been reviewing gefapixant since March 2021, but the regulator is now asking for additional information related to measurement of efficacy in a dreaded complete response letter. Merck said the response was not related to the safety of gefapixant, a P2X3 receptor antagonist, under development for treatment of refractory chronic cough (RCC) or unexplained chronic cough in adults. Shares in Merck (NYSE:MRK) ticked down 1.4% to $78.86 while Bellus Health shares (NASDAQ:BLU) rose by 1.8% to $5.66. Read More

Opko and Pfizer tagged with a CRL for somatrogon

Despite success in other parts of the world, Opko Health Inc. and Pfizer Inc. are still struggling to gain U.S. FDA approval for the recombinant human growth hormone somatrogon in treating pediatric patients, drawing a complete response letter (CRL) with their BLA. The delay caused by the setback gives Skytrofa (lonapegsomatropin) from Ascendis Pharma A/S a chance to charge even further ahead in the pediatric market. Read More
Multiple myeloma illustration

Despite limited info, investors optimistic as Oncopeptides pulls voluntary FDA withdrawal for myeloma drug

In late February 2021, Oncopeptides AB scored a big win on the FDA’s accelerated approval for the first cancer peptide-drug conjugate, Pepaxto (melphalan flufenamide), in multiple myeloma. Less than eight months later, it was shutting down commercial operations and heading back to the drawing board after safety issues emerging in the confirmatory Ocean study prompted the Stockholm-based firm to pull Pepaxto from the market, just ahead of what was likely to be a negative FDA advisory panel vote. Read More

Sanofi-backed Protas plans new tack on costly trials enterprise

LONDON – A pledge to “bottle” improvements made in setting up and running clinical trials during the pandemic has materialized in the formation of Protas Ltd., a nonprofit promising to stage large-scale phase III clinical trials in common diseases for less than one tenth the current cost. Protas will design and run randomized phase III studies of new and repurposed drugs in conditions including depression, dementia, heart, lung and respiratory conditions, arthritis and cancer. Read More
Remdesivir vial and syringe

With limited options, US FDA aims at omicron by expanding Veklury use

Once again, the U.S. FDA giveth and it taketh away. Just a few days after expanding its approval for Gilead Sciences Inc.’s Veklury (remdesivir) to provide access to more people infected with COVID-19, the FDA essentially shut down the use of two monoclonal antibody (mAb) treatments Jan. 24 that had been authorized to treat mild-to-moderate COVID-19 infections – Regeneron Inc.’s Regen-Cov (Ronapreve in Europe), an antibody cocktail of casirivimab and imdevimab, and Eli Lilly and Co.’s bamlanivimab and etesevimab that are administered together. Read More

GPS locates Xilio, Werewolf, others in cytokine engineering

With data due the first half of this year from the phase III trial testing Opdivo (nivolumab, Bristol Myers Squibb Co.) plus Nektar Therapeutics Inc.’s bempegaldesleukin (bempeg) in metastatic melanoma, the possibilities for engineered cytokines such as the latter remain alluring in many quarters. Read More
ICYMI illustration

ICYMI: Week in review, Jan. 17-21, 2022

A quick look back at top stories. Read More

Appointments and advancements for Jan. 24, 2022

New hires and promotions in the biopharma industry, including: Chinook, Eisai, Idorsia, Macomics, Ocugen, Peptilogics, Reneo. Read More

Financings for Jan. 24, 2022

Biopharmas raising money in public or private financings, including: Revelation. Read More

In the clinic for Jan. 24, 2022

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aslan, Clover, Opiant, Provention, UCB. Read More

Other news to note for Jan. 24, 2022

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Anixa, Arrowhead, Dnovo, GSK, Molgenie, Neoimmunetech, Opthea, Respirerx. Read More

Regulatory actions for Jan. 24, 2022

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arch, Kura, Lannett, Regulus.

Read More

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