Drug Filing

19 Dec 2019
- Regulation
- Drug Filing
US FDA accepts and grants priority review to sNDA for BRAFTOVI in combination with ERBITUX to treat BRAFV600E-mutant metastatic colorectal cancer after prior therapy

By PBR Staff Writer

Pfizer announced that the US Food and Drug Administration (FDA) has accepted and granted priority review to the company’s supplemental New Drug Application (sNDA) for BRAFTOVI (encorafenib) in combination with ERBITUX (cetuximab) (BRAFTOVI Doublet) based on results from the Phase 3 BEACON CRC trial, which evaluated the efficacy and safety of BRAFTOVI in combination with ERBITUX with or without MEKTOVI (binimetinib) in patients with advanced BRAFV600E-mutant metastatic colorectal cancer (mCRC), following one or two lines of therapy.
18 Dec 2019
Regulation
Drug Filing
FDA committee recommends approval of Keytruda in high-risk NMIBC

By PBR Staff Writer

Merck said that a committee of the US Food and Drug Administration (FDA) has recommended approval of Keytruda for the treatment of certain patients who are highly prone to non-muscle invasive bladder cancer (NMIBC).
16 Dec 2019
Regulation
Drug Filing
FDA Advisory Committee votes unanimously to support use of teprotumumab to treat thyroid eye disease

By PBR Staff Writer

Horizon Therapeutics announced that the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) of the US Food and Drug Administration (FDA) voted unanimously that the potential benefits of teprotumumab, a fully human monoclonal antibody (mAb), outweigh the potential risks for the treatment of Thyroid Eye Disease (TED).
13 Dec 2019
Regulation
Drug Filing
FDA grants accelerated approval to first targeted treatment for rare DMD mutation

By PBR Staff Writer

The U.S. Food and Drug Administration today granted accelerated approval to Vyondys 53 (golodirsen) injection to treat Duchenne muscular dystrophy (DMD) patients who have a confirmed mutation of the dystrophin gene that is amenable to exon 53 skipping.
11 Dec 2019
Regulation
Drug Filing
Dermira secures FDA fast track status for lebrikizumab in atopic dermatitis

By PBR Staff Writer

Dermira has secured fast track designation from the US Food and Drug Administration (FDA) for lebrikizumab for the treatment of moderate-to-severe atopic dermatitis.
06 Dec 2019
Regulation
Drug Filing
ViiV Healthcare seeks FDA approval for fostemsavir to treat HIV-1 infection

By PBR Staff Writer

ViiV Healthcare is seeking approval from the US Food and Drug Administration (FDA) for its fostemsavir to treat HIV-1 infection.
04 Dec 2019
Regulation
Drug Filing
Bristol-Myers Squibb, Acceleron announce FDA advisory committee will review Reblozyl for use in patients with MDS

By PBR Staff Writer

Bristol-Myers Squibb and Acceleron Pharma said that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee will hold a review of Bristol-Myers Squibb’s supplemental Biologics License Application (sBLA) for the use of Reblozyl (luspatercept-aamt) in patients with myelodysplastic syndromes (MDS) at its meeting on December 18, 2019.
02 Dec 2019
Regulation
Drug Filing
Merck’s Keytruda gets FDA priority review for high-risk NMIBC

By PBR Staff Writer

Merck said that its anti-PD-1 therapy Keytruda has been granted priority review by the US Food and Drug Administration (FDA) in certain patients with high-risk, non-muscle invasive bladder cancer (NMIBC).
29 Nov 2019
Regulation
Drug Filing
AstraZeneca’s Imfinzi gets FDA priority review for extensive-stage SCLC

By PBR Staff Writer

AstraZeneca has secured priority review from the US Food and Drug Administration (FDA) for its cancer drug Imfinzi (durvalumab) for the treatment of extensive-stage small cell lung cancer (SCLC) in previously untreated patients.
28 Nov 2019
Regulation
Drug Filing
Verrica Pharmaceuticals announces FDA filing acceptance of NDA for VP-102 to treat molluscum contagiosum

By PBR Staff Writer

Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a medical dermatology company, announced that its New Drug Application (NDA) for VP-102 (cantharidin 0.7% Topical Solution), a proprietary topical therapy for the treatment of molluscum contagiosum (molluscum), has been accepted for filing by the U.S. Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) goal date assigned by the FDA for this NDA is July 13, 2020.

Drug Discovery

Research & Development

Parvus and Resilience expand partnership to develop IBD drug candidate

Ring Therapeutics signs partnerships to advance R&D in biomedical sciences

Clinical Trials

Patient Enrollment

US FDA approves Avacta Group’s IND application for AVA6000

AM-Pharma enrols first patients in Covid-19 phase III trial

Regulation

Drug Filing

Torii submits NDA for molluscum contagiosum treatment therapy in Japan

Neuvivo files NDA seeking FDA approval for ALS treatment

Production & Sales

Manufacturing

ENCell and Lucy Biotech forge alliance for mesenchymal stem cell therapy

Merck introduces single-use reactor to accelerate ADC manufacturing

Packaging & Supply Chain

Packaging

Gerresheimer

PCI Pharma announces bottling line expansion at Rockford site

Suppliers

No data found

Drug Filing

US FDA accepts and grants priority review to sNDA for BRAFTOVI in combination with ERBITUX to treat BRAFV600E-mutant metastatic colorectal cancer after prior therapy

FDA committee recommends approval of Keytruda in high-risk NMIBC

FDA Advisory Committee votes unanimously to support use of teprotumumab to treat thyroid eye disease

FDA grants accelerated approval to first targeted treatment for rare DMD mutation

Dermira secures FDA fast track status for lebrikizumab in atopic dermatitis

ViiV Healthcare seeks FDA approval for fostemsavir to treat HIV-1 infection

Bristol-Myers Squibb, Acceleron announce FDA advisory committee will review Reblozyl for use in patients with MDS

Merck’s Keytruda gets FDA priority review for high-risk NMIBC

AstraZeneca’s Imfinzi gets FDA priority review for extensive-stage SCLC

Verrica Pharmaceuticals announces FDA filing acceptance of NDA for VP-102 to treat molluscum contagiosum

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Research & Development

Patient Enrollment

Drug Filing

Manufacturing

Packaging

No data found