Medical Devices

Biopharma Money on the Move

Biopharma, Business, Cells, Gene Editing, Liver Disease, Medical Devices, Precision Medicine, R&D, Series A, Series B Preferred Stock, Series E, Venture Funding

BioSpace reviews whose wallets got thicker in the biopharma industry, from largest to smallest, during the Nov. 11-17 period

November 18, 2020/by BioSpace

FDA Places Partial Clinical Hold on Inovio’s Planned Phase II/III COVID-19 Vaccine

Clinical Trials, COVID-19 Vaccines, FDA, FDA/Regulatory, Interim Data, Medical Devices, Partial Clinical Hold, R&D

Shares of Inovio Pharmaceuticals plunged in trading after the company reported the U.S. Food and Drug Administration placed a partial clinical hold on the planned Phase II/III study of the Covid-19 vaccine candidate INO-4800.

September 28, 2020/by Andrew Humphreys

Eli Lilly Reports Positive Results in Phase III Migraine Attack Study

Acute Migraine, Clinical Trial Endpoints, Clinical Trials, Drug Safety, Efficacy, Medical Devices, Migraine Attacks, R&D

Eli Lilly and Company announced positive results from CENTURION, the company’s Phase III study looking into Reyvow (lasmiditan) for migraine attacks.

September 11, 2020/by Andrew Humphreys

FDA Approves New Asthma Indication for Trelegy Ellipta

"Closed Triple" Therapies, Approvals, Asthma, Chronic Obstructive Pulmonary Disease (COPD), Data, FDA, FDA/Regulatory, Inhalers, New Indications, Supplemental New Drug Application (sNDA)

The U.S. Food and Drug Administration approved a new indication for GlaxoSmithKline plc and Innoviva Inc.’s Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’) for the treatment of asthma in patients aged 18 years and older adding to the product’s current license for use in patients with chronic obstructive pulmonary disease (COPD).

September 9, 2020/by Andrew Humphreys

EVERSANA acquires Alkemy Partners

Acquisitions, Business, Digital, Life Sciences, Market Access, Medical Devices, New Hampshire

EVERSANA™ expands pharmaceutical training and digital engagement capabilities with acquisition of Alkemy Partners CHICAGO, Sept. 9, 2020 /PRNewswire/ — EVERSANA™, the leading provider of commercial services to the life science industry, today announced the acquisition of Alkemy Partners, a full-service field learning and development company committed to solving market access, sales and clinical engagement through training, […]

September 9, 2020/by Andrew Humphreys

Foundation Medicine Wins Approval of Comprehensive Pan-Tumor Liquid Biopsy Test

Approvals, BRCA mutation, Companion Diagnostics, FDA, FDA/Regulatory, Liquid Biopsies, Metastatic Castration-Resistant Prostate Cancer (mCRPC), Non-Small Cell Lung Cancer, PARP Inhibitors, Precision Therapies

The U.S. Food and Drug Administration approved FoundationOne Liquid CDx, a new pan-tumor liquid biopsy test that is indicated for use as a companion diagnostic for four FDA-approved precision therapies.

August 27, 2020/by Andrew Humphreys

Bayer to pay $1.6 billion to resolve U.S. claims for Essure birth-control device

Birth Control Devices, Business, Cancer, Lawsuits, Plaintiffs, Settlements, United States, Women

German drugs and pesticides group Bayer will pay around $1.6 billion to settle the majority of U.S. claims involving the Essure birth-control device.

August 20, 2020/by Andrew Humphreys

U.S. House of Representatives Sends $3.2 Billion FDA Budget to the Senate

Congress, FDA, FDA/Regulatory, Food, Foodborne Illnesses, House of Representatives, Medical Devices, Medicines, Outbreaks, Senate

The U.S. House of Representatives approved a $3.2 billion budget proposal for the U.S. Food and Drug Administration that will boost the regulatory agency’s abilities to approve new medicines and medical devices, as well as protect the nation’s food supplies.

July 28, 2020/by BioSpace

Glympse Bio Secures $46.7 Million to Advance NASH Biosensor Program

Biosensors, Doctors, Fibrotic Diseases, Financing, Infectious Diseases, Nonalcoholic Steatohepatitis (NASH), Oncology, Series B

Glympse Bio secured $46.7 million in a Series B fundraising round that will be used to support continued development of the company’s novel biosensor platform in fibrotic diseases such as non-alcoholic steatohepatitis (NASH), oncology and infectious diseases.

July 15, 2020/by BioSpace

3M, MIT partner to make rapid COVID-19 antigen test

Antigen Tests, Business, Massachusetts Institute of Technology (MIT), National Institutes of Health, Partnerships, Point-Of-Care Devices, Proteins

U.S. industrial conglomerate 3M Co. has partnered with the Massachusetts Institute of Technology to develop a rapid antigen test for COVID-19.

July 14, 2020/by Reuters Health