Industry News

Takeda Pharmaceutical Company Limited announced a strategic collaboration with NuBiyota LLC for the development of Microbial Ecosystem Therapeutic products for gastroenterology (GI) indications with a high unmet medical need.

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Roche announced the CE-IVD launch of the cobas® Liat® PCR System with four assays including first 20 minute real-time PCR nucleic acid test to detect Clostridium difficile (C. diff). Countries accepting CE mark are the first to receive access to the cobas® Cdiff test, which detects C. diff in stool specimens from symptomatic patients1 and provides rapid and definitive results in under 20 minutes. Timely and accurate diagnosis of this infection is important because it can quickly become life threatening, especially to high-risk patients such as the elderly, immuno-compromised and those undergoing antibiotic treatment.

Cipla Ltd, a global pharmaceutical company, announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Abacavir and Lamivudine Tablets USP, 600 mg/300 mg, from the United States Food and Drug Administration (USFDA).

Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Meropenem Injection 500 mg/vial and 1 g/vial. Aurobindo’s Meropenem injection is a generic equivalent of AstraZeneca Pharmaceuticals’ Merrem® Injection. The product will be launched immediately.

“Sun Pharma” and includes its subsidiaries or associate companies) was informed by the US FDA , that it will lift the Import Alert imposed on the Mohali (Punjab) manufacturing facility and remove the facility from the Official Action Initiated (OAI) status. This proposed action will clear the path for Sun Pharma to supply approved products from the Mohali facility to the US market, subject to normal US FDA regulatory requirements.

Aurobindo Pharma USA Inc. recalls 47,040 bottles of Venlafaxine hydrochloride prolonged-release capsules in the 37.5 mg strength in a national recall in the US, the latest USFDA enforcement report said. The drug was manufactured by Aurobindo Pharma Ltd, Hyderabad

UK biotech company Nemaura Pharma has announced a commitment from private investors of up to £5m for the development of a hormone Biologic using its Micro-Patch™ solid dose delivery platform. The fast-growing company has made significant progress in the reformulation of liquid vaccines administered through the skin using its solid dose delivery system. The funding is being used to accelerate Nemaura’s commercial research and development of clinical programmes to prepare the drug-device combination for market.

Hundreds of scientists and academics from around the world are offering laboratory and office space to researchers stranded by the U.S. travel ban.