Regulation

18 Jul 2019
- Regulation
- Lawsuits
AHF calls on Gilead to set up fund for victims harmed by its TDF-based drugs

By PBR Staff Writer

AIDS Healthcare Foundation (AHF) is calling on Gilead Sciences Inc., one of the largest manufacturers of HIV/AIDS drugs, to set up a $10 billion victim compensation fund for patients harmed after taking the drug maker’s TDF-based (tenofovir disoproxil fumarate) drugs as part of their treatment for HIV or AIDS or taken by uninfected individuals as part of the HIV prevention strategy known as pre-exposure prophylaxis or PrEP.
18 Jul 2019
Regulation
Approvals
FDA approves Merck’s Recarbrio to treat complicated infections

By PBR Staff Writer

Merck has secured approval from the US Food and Drug Administration (FDA) for its Recarbrio (imipenem, cilastatin and relebactam) to treat adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).
17 Jul 2019
Regulation
Drug Filing
Novartis’ crizanlizumab secures FDA priority review for sickle cell disease

By PBR Staff Writer

Novartis has secured priority review status from the US Food and Drug Administration (FDA) for its humanized anti-P-selectin monoclonal antibody crizanlizumab (SEG101) for the prevention of vaso-occlusive crises (VOCs) in patients with sickle cell disease (SCD).
16 Jul 2019
Regulation
Drug Filing
AstraZeneca’s Imfinzi gets FDA orphan drug status for small cell lung cancer

By PBR Staff Writer

AstraZeneca’s oncology immunotherapy Imfinzi (durvalumab) has been granted orphan drug designation (ODD) for the treatment of small cell lung cancer (SCLC).
16 Jul 2019
Regulation
Approvals
Dicerna gets breakthrough therapy designation for DCR-PHXC to treat primary hyperoxaluria type 1

By PBR Staff Writer

Dicerna Pharmaceuticals announced that the US Food and Drug Administration (FDA) has granted a breakthrough Therapy Designation (BTD) to DCR-PHXC for the treatment of patients with primary hyperoxaluria type 1 (PH1).
15 Jul 2019
Regulation
Approvals
Sensorion receives FDA IND approval for Arazasetron

By PBR Staff Writer

Sensorion has received the investigational new drug (IND) clearance from the US Food and Drug Administration (FDA) to proceed with SENS-401, based on preclinical data and clinical development plan.
11 Jul 2019
Regulation
Drug Filing
FDA accepts to review Sanofi’s multiple myeloma candidate isatuximab

By PBR Staff Writer

Sanofi said that its biologics license application (BLA) for isatuximab for the treatment of relapsed/refractory multiple myeloma (RRMM) has been accepted for review by the US Food and Drug Administration (FDA).
05 Jul 2019
Regulation
Approvals
FDA approves Grifols’ Xembify to treat primary immunodeficiencies

By PBR Staff Writer

Plasma-derived medicines producer Grifols has secured approval from the US Food and Drug Administration (FDA) for its Xembify, a new 20% subcutaneous immunoglobulin solution, to treat primary immunodeficiencies.
04 Jul 2019
Regulation
Marketing Authorisation
EC approves ViiV Healthcare’s Dovato to treat HIV-1 infection

By PBR Staff Writer

ViiV Healthcare has secured marketing authorisation from the European Commission (EC) for its Dovato (dolutegravir/lamivudine) to treat HIV-1 infection.
04 Jul 2019
$FDA approves new treatment for refractory multiple myeloma$
Regulation
Approvals
FDA approves new treatment for refractory multiple myeloma

By PBR Staff Writer

The US Food and Drug Administration granted accelerated approval to Xpovio (selinexor) tablets in combination with the corticosteroid dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is resistant to several other forms of treatment, including at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.

Drug Discovery

Research & Development

FDA grants traditional approval to Novartis’ Fabhalta for IgAN

Novartis and Chai Discovery collaborate on antibody identification

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

Viatris files applications in Japan for approval of Effexor to treat GAD

Scholar Rock submits application of SMA therapy to FDA

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 at CPHI Frankfurt 2025

Gerresheimer

Suppliers

No data found

Regulation

AHF calls on Gilead to set up fund for victims harmed by its TDF-based drugs

FDA approves Merck’s Recarbrio to treat complicated infections

Novartis’ crizanlizumab secures FDA priority review for sickle cell disease

AstraZeneca’s Imfinzi gets FDA orphan drug status for small cell lung cancer

Dicerna gets breakthrough therapy designation for DCR-PHXC to treat primary hyperoxaluria type 1

Sensorion receives FDA IND approval for Arazasetron

FDA accepts to review Sanofi’s multiple myeloma candidate isatuximab

FDA approves Grifols’ Xembify to treat primary immunodeficiencies

EC approves ViiV Healthcare’s Dovato to treat HIV-1 infection

FDA approves new treatment for refractory multiple myeloma

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Research & Development

Patient Enrollment

Drug Filing

Manufacturing

Packaging

No data found