news

Bluebird bio may finally get a gene therapy approved in the US Bluebird bio may get gene therapy approved in the US. The Cambridge, MA biotech declared that the FDA had accepted and given priority review for Zynteglo, its gene therapy for the rare blood disorder beta-thalassemia. The announcement sets up an expe...

J&J intends to split into two companies, separating consumer products and pharmaceutical businesses  On November 12, 2021, Johnson & Johnson announced its plans to split the Company’s Consumer Health business, forming a new publicly traded company. This will help the company create two global leaders tha...

AstraZeneca, Moderna announces positive data of mRNA potential in heart failure patients  Moderna, Inc., a biotechnology company is pioneering messenger RNA (mRNA) therapeutics and vaccines, declared positive data from the AstraZeneca-led Phase 2 (EPICCURE) study assessing the use of an mRNA therapeutic, wh...

TecTraum’s pro2cool® receives FDA Breakthrough Device Designation for the Concussions treatment   On November 03, 2021, TecTraum Inc., working to develop the world’s first point-of-care treatment for concussions, announced that the US Food and Drug Administration (FDA) has provided a Breakthrough Device to its f...

Alcon to acquire Ivantis for USD 475 Million  Alcon announced that it intends to buy glaucoma surgery device maker Ivantis for USD 475 million upfront. Geneva, Switzerland-based Alcon aims to support its portfolio across cataract, refractive, retina and glaucoma offerings by taking over Ivantis and its n...

ReValve Solutions, Inc. declares successful first human use of the Transeptal Mitral Valve Replacement  On November 01, 2021, ReValve Solutions, Inc., a company operating in the field of transcatheter structural heart replacement and repair, announced the successful first human use of its transcatheter, Palmetto...

Magnus Medical’s neurostimulation technology gets FDA breakthrough status to treat MDD Magnus Medical has secured a breakthrough device designation from the US Food and Drug Administration (FDA) for its neurostimulation technology for major depressive disorder (MDD) treatment. The individualised, rapid-acting...

Naviswiss secures FDA 510k clearance for Naviplan, an advanced planning solution for hip replacement surgery  On October 21, 2021, Naviswiss, a Swiss-based medical technology company, received approval from the FDA to commercialise Naviplan in the United States. Naviplan is a digital pre-operative planning ...

Ocular Therapeutix’s dry eye disease insert fails in phase 2 trial Ocular Therapeutix declared that its OTX-CSI (cyclosporine intracanalicular insert) for dry eye disease (DED) has flunked to reach the primary endpoint in the phase 2 clinical trial. The company has conducted the US-based, randomised, double-m...

Hologic to acquire Bolder Surgical for USD160 Million, expanding its Surgical Franchise  On October 14, 2021, Hologic, Inc., a global player in women's health, signed a definitive agreement to acquire Bolder Surgical. This US-based company offers advanced energy vessel sealing surgical devices for approxima...