Regulation

01 Jul 2019
- Regulation
- Drug Filing
Sensorion receives EMA agreement on the pediatric investigation plan for Arazasetron in two indications

By PBR Staff Writer

Sensorion (Paris:ALSEN)(FR0012596468 – ALSEN) a pioneering clinical-stage biopharmaceutical company which specializes in the development of novel therapies to restore, treat and prevent inner ear diseases such as hearing loss, tinnitus and vertigo, announces today that the European Medicines Agency (EMA) has accepted its Pediatric Investigation Plan (PIP) for both development in the treatment of severe hearing loss (SSNHL) and for prevention of ototoxicity caused by cisplatin (CIO) in the pediatric population.
01 Jul 2019
Regulation
Drug Filing
CHMP recommends EU approval of Roche’s Tecentriq plus Abraxane for metastatic TNBC

By PBR Staff Writer

Roche announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Tecentriq (atezolizumab) plus chemotherapy (Abraxane; nab-paclitaxel) for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression (≥ 1%) and who have not received prior chemotherapy for metastatic disease.
01 Jul 2019
Regulation
Approvals
Pfizer gets FDA nod for Avastin’s biosimilar Zirabev

By PBR Staff Writer

Pfizer has secured approval from the US Food and Drug Administration (FDA) for its Zirabev (bevacizumab-bvzr), an oncology biosimilar to Roche’s Avastin (bevacizumab).
01 Jul 2019
Regulation
Rejections
CHMP adopts negative opinion over osteoporosis drug Evenity

By PBR Staff Writer

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has refused to recommend approval for Amgen and UCB’s Evenity (romosozumab) for the treatment of severe osteoporosis.
28 Jun 2019
Regulation
Approvals
FDA approves Alexion’s Soliris to treat adults with neuromyelitis optica spectrum disorder

By PBR Staff Writer

Alexion Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for Soliris to treat adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive.
27 Jun 2019
Regulation
Approvals
FDA grants fast track designation to empagliflozin to treat chronic heart failure

By PBR Staff Writer

The US Food and Drug Administration (FDA) has granted fast track designation to empagliflozin for the reduction of the risk of cardiovascular death and hospitalization for heart failure in people with chronic heart failure, Boehringer Ingelheim and Eli Lilly and Company announced.
27 Jun 2019
Regulation
Approvals
Regeneron, Sanofi get FDA nod for Dupixent to treat chronic rhinosinusitis with nasal polyps

By PBR Staff Writer

Regeneron Pharmaceuticals and Sanofi have secured approval from the US Food and Drug Administration (FDA) for Dupixent (dupilumab) to treat adults with nasal polyps accompanied by chronic rhinosinusitis.
25 Jun 2019
Regulation
Drug Filing
Tesaro’s niraparib secures FDA priority review for late stage ovarian cancer

By PBR Staff Writer

Tesaro, a GlaxoSmithKline (GSK) company, has secured priority review designation for its polymerase (PARP) inhibitor ZEJULA (niraparib) from the US Food and Drug Administration (FDA) for the treatment of late stage ovarian cancer.
24 Jun 2019
Regulation
Approvals
Pfizer’s Talzenna gets EC nod for metastatic breast cancer treatment

By PBR Staff Writer

Pfizer has secured approval from the European Commission (EC) for its Talzenna (talazoparib) to treat patients with inherited (germline) BRCA-mutated locally advanced or metastatic breast cancer (MBC).
24 Jun 2019
Regulation
Approvals
Allergan’s Botox secures FDA paediatric approval for upper limb spasticity

By vbandhakavi

The US Food and Drug Administration (FDA) has expanded the approval of Allergan’s Botox (onabotulinumtoxinA) to cover the treatment of paediatric patients with upper limb spasticity.

Drug Discovery

Research & Development

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Clinical Trials

Patient Enrollment

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Regulation

Drug Filing

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Production & Sales

Manufacturing

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Packaging & Supply Chain

Packaging

Uwe Röhrhoff Steps Down as Interim CEO of Gerresheimer AG

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Suppliers

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Regulation

Sensorion receives EMA agreement on the pediatric investigation plan for Arazasetron in two indications

CHMP recommends EU approval of Roche’s Tecentriq plus Abraxane for metastatic TNBC

Pfizer gets FDA nod for Avastin’s biosimilar Zirabev

CHMP adopts negative opinion over osteoporosis drug Evenity

FDA approves Alexion’s Soliris to treat adults with neuromyelitis optica spectrum disorder

FDA grants fast track designation to empagliflozin to treat chronic heart failure

Regeneron, Sanofi get FDA nod for Dupixent to treat chronic rhinosinusitis with nasal polyps

Tesaro’s niraparib secures FDA priority review for late stage ovarian cancer

Pfizer’s Talzenna gets EC nod for metastatic breast cancer treatment

Allergan’s Botox secures FDA paediatric approval for upper limb spasticity

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Research & Development

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Drug Filing

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