Drug Filing

01 Oct 2020
- Regulation
- Drug Filing
Baylx receives US FDA clearance of Covid-19 IND application for umbilical cord tissue mesenchymal stem cells product

By PBR Staff Writer

Baylx, a clinical-stage stem cell biopharmaceutical company focused on developing living stem cell products to address unmet medical needs, announced that the US Food and Drug Administration (FDA) has cleared Baylx's Investigational New Drug (IND) application for BX-U001, a fresh, non-frozen human umbilical cord tissue mesenchymal stem cells (hUC-MSC) product in patients with COVID-19.
25 Sep 2020
Regulation
Drug Filing
Anokion announces FDA clearance of IND application for ANK-700 to treat multiple sclerosis

By PBR Staff Writer

Anokion SA, a Swiss biotechnology company focused on treating autoimmune disease by restoring normal immune tolerance, announced that the U.S. Food and Drug Administration (FDA) has accepted its investigational new drug (IND) application for ANK-700, an antigen-specific drug candidate for the treatment of multiple sclerosis (MS).
23 Sep 2020
Regulation
Drug Filing
BMS, bluebird get FDA priority review for ide-cel in multiple myeloma

By PBR Staff Writer

Bristol Myers Squibb (BMS) and bluebird bio have secured priority review from the US Food and Drug Administration (FDA) for their co-developed investigational cell therapy idecabtagene vicleucel (ide-cel; bb2121) for the treatment of multiple myeloma.
16 Sep 2020
Regulation
Drug Filing
Gilead gets FDA breakthrough therapy status for magrolimab in MDS

By PBR Staff Writer

Gilead Sciences has been given breakthrough therapy designation for magrolimab from the US Food and Drug Administration (FDA) for the treatment of myelodysplastic syndrome (MDS) in newly diagnosed patients.
01 Sep 2020
Regulation
Drug Filing
Omeros’ investigational new drug application for OMS906 cleared by FDA

By PBR Staff Writer

Omeros Corporation today announced that its Investigational New Drug Application (IND) to begin clinical trials with OMS906 has been cleared by the U.S. Food and Drug Administration (FDA).
27 Aug 2020
Regulation
Drug Filing
HiFiBiO submits IND application for SARS-CoV-2 neutralising antibody to treat Covid-19 patients

By PBR Staff Writer

HiFiBiO Therapeutics, a multinational biotherapeutics company focused on the development of novel antibodies for immunomodulation, announced today the submission of an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for a novel SARS-CoV-2 neutralizing antibody for the treatment of Covid-19 patients.
25 Aug 2020
Regulation
Drug Filing
Exelixis announces submission of sNDA to FDA for CABOMETYX plus Opdivo for advanced RCC

By PBR Staff Writer

Exelixis announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for CABOMETYX (cabozantinib) in combination with Opdivo® (nivolumab) for patients with advanced renal cell carcinoma (RCC).
19 Aug 2020
Regulation
Drug Filing
Imfinzi granted FDA priority review for less-frequent, fixed-dose use

By PBR Staff Writer

AstraZeneca's Imfinzi (durvalumab) has received acceptance for its supplemental Biologics License Application (sBLA) and has also been granted Priority Review in the US for a new four-week, fixed-dose regimen for treatment in the approved indications of non-small cell lung cancer (NSCLC) and bladder cancer.
11 Aug 2020
Regulation
Drug Filing
Gilead seeks FDA approval for Veklury in Covid-19 treatment

By PBR Staff Writer

Gilead Sciences has filed a new drug application (NDA) with the US Food and Drug Administration (FDA) for its investigational antiviral Veklury (remdesivir) seeking its approval for the treatment of Covid-19.
04 Aug 2020
Regulation
Drug Filing
FDA approves IND for PSC’s stem cell therapy candidate for Covid-19

By PBR Staff Writer

Calidi Biotherapeutics said that the Investigational New Drug (IND) application submitted by its partner, Personalized Stem Cells, Inc. (PSC), has received FDA approval for the treatment of COVID-19 and pneumonia patients using stem cell therapy.

Drug Discovery

Research & Development

Pfizer to acquire minority stake in CStone Pharmaceuticals for $200m

Orgenesis to acquire regenerative medicine company Koligo Therapeutics

Clinical Trials

Patient Enrollment

Pfizer and BioNTech propose expansion of pivotal Covid-19 vaccine trial

Ampio announces enrolment completion for intravenous Covid-19 clinical trial

Regulation

Drug Filing

Baylx receives US FDA clearance of Covid-19 IND application for umbilical cord tissue mesenchymal stem cells product

Anokion announces FDA clearance of IND application for ANK-700 to treat multiple sclerosis

Production & Sales

Manufacturing

J&J, GRAM collaborate on manufacturing of Covid-19 vaccine candidate

Santen and US ophthalmic company Eyevance enter into share purchase agreement

Packaging & Supply Chain

Packaging

Gerresheimer

PCI Pharma announces bottling line expansion at Rockford site

Suppliers

No data found

Drug Filing

Baylx receives US FDA clearance of Covid-19 IND application for umbilical cord tissue mesenchymal stem cells product

Anokion announces FDA clearance of IND application for ANK-700 to treat multiple sclerosis

BMS, bluebird get FDA priority review for ide-cel in multiple myeloma

Gilead gets FDA breakthrough therapy status for magrolimab in MDS

Omeros’ investigational new drug application for OMS906 cleared by FDA

HiFiBiO submits IND application for SARS-CoV-2 neutralising antibody to treat Covid-19 patients

Exelixis announces submission of sNDA to FDA for CABOMETYX plus Opdivo for advanced RCC

Imfinzi granted FDA priority review for less-frequent, fixed-dose use

Gilead seeks FDA approval for Veklury in Covid-19 treatment

FDA approves IND for PSC’s stem cell therapy candidate for Covid-19

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Research & Development

Patient Enrollment

Drug Filing

Manufacturing

Packaging

No data found