Agilent Technologies Inc., of Santa Clara, Calif.

PD-L1 IHC 22C3

PharmaDx assay

Locally advanced or metastatic non-small-cell lung cancers

Approved by China's NMPA as a companion diagnostic to identify patients whose tumors express PD-L1 for first-line treatment with single-agent Keytruda (pembrolizumab, Merck & Co. Inc.)

Cytodyn Inc., of Vancouver, Wash.

Leronlimab (PRO-140)

CCR5 antagonist

Nonalcoholic steatohepatitis

FDA cleared the firm to start phase II trial

Durect Corp., of Cupertino, Calif.


Bupivacaine extended-release solution

Postoperative pain

FDA notified firm the class 2 NDA resubmission will be discussed at Anesthetic and Analgesic Drug Products Advisory Committee meeting set for Jan. 16, 2020; FDA previously assigned a PDUFA date of Dec. 27, 2019, and a new date has not yet been set

Glaxosmithkline plc, of London, and Innoviva Inc., of Brisbane, Calif.

Trelegy Ellipta

Once-daily, single-inhaler comprising fluticasone furoate, umeclidinium and vilanterol


Submitted supplemental NDA to FDA seeking additional indication

Iaso Biotherapeutics Co. Ltd., of Nanjing, China, and Innovent Biologics Inc., of Suzhou, China


Lentiviral vector containing CAR with fully human scFv, CD8a hinger and transmembrane, 4-1BB co-stimulatory and CD3z activation domains

Relapsed/refractory multiple myeloma

China's NMPA cleared an IND for a phase Ib/II study

Medicago Inc., of Quebec City

Plant-based quadrivalent virus-like particle influenza recombinant vaccine



Health Canada accepted new drug submission for scientific review

Merck & Co. Inc., of Kenilworth, N.J.

Dificid (fidaxomicin)

Macrolide antibacterial medicine

Clostridioides difficile infections

FDA accepted for review both an NDA for oral suspension and supplemental NDS for tablets and oral suspension to treat infections in children 6 months or older; both applications have priority review, with PDUFA dates of Jan. 24, 2020

Merck & Co. Inc., of Kenilworth, N.J.

Keytruda (pembrolizumab)

Anti-PD-1 antibody

Locally advanced or metastatic non-small-cell lung cancer

Approved by China's NMPA for use as a monotherapy in first-line treatment of patients whose tumors express PD-L1 as determined by NMPA-approved test, with no EGFR or ALK genomic tumor aberrations

Savara Inc., of Austin, Texas


Inhaled formulation of recombinant human GM-CSF

Autoimmune pulmonary alveolar proteinosis

In written response from FDA following type C meeting, agency indicated data in briefing package do not provide sufficient evidence of efficacy and safety and recommended company not submit a BLA; Savara is working to determine next steps; shares of the company (NASDAQ:SVRA) sank 58% on the news


For more information about individual companies and/or products, see Cortellis.


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