Regulation

27 Mar 2019
- Regulation
- Approvals
AbbVie gets Japanese approval for SKYRIZI to treat plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis

By PBR Staff Writer

AbbVie has announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved SKYRIZI (risankizumab), an interleukin-23 (IL-23) inhibitor, for the treatment of plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis in adult patients who have an inadequate response to conventional therapies.
26 Mar 2019
Regulation
Approvals
AstraZeneca’s Forxiga approved in Europe for type-1 diabetes

By PBR Staff Writer

The European Commission (EC) has approved Forxiga (dapagliflozin) for use in type-1 diabetes (T1D) as an adjunct to insulin in patients with a BMI ≥ 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy.
26 Mar 2019
Regulation
Lawsuits
Bayer, Janssen settle litigation over blood thinner Xarelto

By PBR Staff Writer

Bayer has entered into a $775m settlement agreement with Janssen Pharmaceuticals to resolve litigation related with blood thinner medication Xarelto.
25 Mar 2019
Regulation
Drug Filing
Janssen seeks expanded use of Darzalex combination therapy for patients with newly diagnosed ASCT multiple myeloma

By PBR Staff Writer

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a Type II variation application to the European Medicines Agency (EMA) for Darzalex (daratumumab) in combination with lenalidomide and dexamethasone (Rd) for the treatment of patients newly diagnosed with multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).
20 Mar 2019
Regulation
Approvals
Sage Therapeutics gets FDA nod for Zulresso to treat postpartum depression

By PBR Staff Writer

Sage Therapeutics has secured approval from the US Food and Drug Administration (FDA) for its Zulresso (brexanolone) injection to treat postpartum depression (PPD) in adult women.
20 Mar 2019
Regulation
Patents
Novo Nordisk settles US patent litigation case on Victoza (liraglutide) with Teva

By PBR Staff Writer

A settlement between Novo Nordisk and Teva Pharmaceuticals USA (Teva) has been reached on the US patent litigation case for Victoza (liraglutide).
19 Mar 2019
Regulation
Approvals
Genentech gets FDA nod for Tecentriq plus chemotherapy to treat ES-SCLC

By PBR Staff Writer

Roche Group member Genentech has secured approval from the US Food and Drug Administration (FDA) for its Tecentriq (atezolizumab) in combination with chemotherapy for the initial treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).
18 Mar 2019
Regulation
Approvals
European Commission approves Roche’s MabThera for rare autoimmune disease

By PBR Staff Writer

Roche have announced that the European Commission (EC) has approved MabThera (rituximab) for the treatment of adults with moderate to severe pemphigus vulgaris (PV), a rare condition characterised by progressive painful blistering of the skin and/or mucous membranes.
15 Mar 2019
Regulation
Marketing Authorisation
European Commission approves Roche’s Hemlibra for people with severe haemophilia A without factor VIII inhibitors

By PBR Staff Writer

Roche announced that the European Commission has approved Hemlibra (emicizumab) for routine prophylaxis of bleeding episodes in people with severe haemophilia A (congenital factor VIII deficiency, FVIII <1%) without factor VIII inhibitors.
13 Mar 2019
Regulation
Approvals
FDA approves Dupixent for moderate-to-severe atopic dermatitis in adolescents

By PBR Staff Writer

Regeneron Pharmaceuticals and Sanofi announced that the US Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

Drug Discovery

Research & Development

Transcripta Bio, Mayo Clinic join force on ALS therapies

Pfizer partners with Enodia Therapeutics in $500m drug deal

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

Uwe Röhrhoff Steps Down as Interim CEO of Gerresheimer AG

Gerresheimer at CPHI Frankfurt 2025

Suppliers

No data found

Regulation

AbbVie gets Japanese approval for SKYRIZI to treat plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis

AstraZeneca’s Forxiga approved in Europe for type-1 diabetes

Bayer, Janssen settle litigation over blood thinner Xarelto

Janssen seeks expanded use of Darzalex combination therapy for patients with newly diagnosed ASCT multiple myeloma

Sage Therapeutics gets FDA nod for Zulresso to treat postpartum depression

Novo Nordisk settles US patent litigation case on Victoza (liraglutide) with Teva

Genentech gets FDA nod for Tecentriq plus chemotherapy to treat ES-SCLC

European Commission approves Roche’s MabThera for rare autoimmune disease

European Commission approves Roche’s Hemlibra for people with severe haemophilia A without factor VIII inhibitors

FDA approves Dupixent for moderate-to-severe atopic dermatitis in adolescents

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Research & Development

Patient Enrollment

Drug Filing

Manufacturing

Packaging

No data found