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application

EU CTR: Final Countdown, What You Need to Know

The end of the transition period is imminent. How can clinical trial sponsors and CROs ease the transition to CTIS? Soon, the one-year transition period …

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approval

Brexit – Impact, Challenges, and Solutions for The Pharmaceutical Industry

Brexit has provided several challenges to the pharmaceutical industry that required robust actions and swift resolution in order to remain in compliance following the end …

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approval

CHMP recommends approval of Cablivi(TM) (caplacizumab)

First therapeutic to receive positive CHMP opinion for treatment of a rare blood disorder called acquired thrombotic thrombocytopenic purpura The European Medicines Agency’s Committee for …

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approval

WuXi STA first CDMO to support the approval of an innovative drug in China through the “MAH” pilot

WuXi STA enables Ascletis to receive NDA Approval from China FDA for Ganovo® STA Pharmaceutical Co., Ltd. (WuXi STA), a subsidiary of WuXi AppTec, announces …

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Applies

GSK Applies in Japan for Approval of a Once-Daily, Single Inhaler Triple Therapy for COPD

First filing made for a triple therapy for chronic obstructive pulmonary disease offered in a single inhaler. Chronic obstructive pulmonary disease (COPD) affects over five …

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announces

Genmab Announces U.S. FDA Approval of DARZALEX® (daratumumab) in Newly Diagnosed Multiple Myeloma

DARZALEX (daratumumab) approved by U.S. FDA in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are …

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application

Invivoscribe Submits Pre-Market Approval Application in Japan and Panel Track Supplement in the US to Screen Acute Myeloid Leukemia (AML) Patients for FLT3 Mutations

Invivoscribe Technologies, Inc. announced today that they have submitted to Japan’s Pharmaceutical and Medical Devices Agency (PMDA) and the US Food and Drug Administration (FDA) …

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approval

FDA approval for Novartis' melanoma combo

The FDA has approved Novartis’ Tafinlar(dabrafenib) in combination with Mekinist (trametinib) for the adjuvant treatment of BRAF V600E or V600K mutation-positive melanoma, as detected by …

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application

Wickham Laboratories Holdings Announces Planning Application Approval

Outline planning permission application for expansion of the Hoeford Point site now approved. Wickham Laboratories Holdings, owner of Wickham Laboratories Ltd, today announces approval of …

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allogeneic

TiGenix announces approval of trade name for lead development candidate Cx601 in Europe

TiGenix NV (Euronext Brussels and NASDAQ: TIG), an advanced biopharmaceutical company focused on exploiting the anti-inflammatory properties of allogeneic, or donor-derived, stem cells to develop …

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