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Pulnovo Wins Two IDE Approvals for PADN Trials with CMS Coverage
Following the FDA's BDD designation granted in 2021 for Group- I, II and IV, the newly-obtained IDE approvals for Pulnovo Medical’s PADN with CMS coverage will advance clinical studies targeting Groups-I and II into the IDE stage.
Cook Medical, Siemens Healthineers Partner to Develop Radiation-Free iMRI Suite
Cook Medical and Siemens Healthineers have announced a strategic commercial partnership to develop the Interventional MRI (iMRI) Suite, a first-of-its-kind, radiation-free solution designed to transform minimally invasive procedures.
Alkermes appoints Joshua Reed as CFO
The newly-appointed CFO at Alkermes, Joshua Reed, brings over 30 years of financial leadership experience, with a strong focus in the biotechnology and pharmaceutical sectors. Most recently, he served as CFO of Omega Therapeutics.
Dr. Reddy's Biologics Facility in Hyderabad Receives USFDA Form 483 with Five Observations
The USFDA has completed a Pre-Approval Inspection (PAI) at Dr. Reddy's biologics manufacturing facility in Bachupally, Hyderabad, with five observations.
FDA Warns Pharma Companies to Remove Misleading Ads, Issues 100 Cease-and-Desist Notices
The US Food and Drug Administration (FDA) has launched a sweeping crackdown on misleading pharmaceutical advertising, sending thousands of warning letters and issuing about 100 cease-and-desist notices to drugmakers.
NMPA Clears Zhimeng Biopharma's Drug for Phase-II Epilepsy Trial
Zhimeng Biopharma’s drug for Phase II epilepsy trial will be evaluated in a randomized, double-blind, placebo-controlled multinational study to test its efficacy, safety, and tolerability as an adjunct therapy in adults with focal epilepsy.
Indian Pharma Exporters Face Delayed Payments from Cairo-Based API importer, Embassy Cautions
The Embassy of India in Cairo has advised Indian pharmaceutical exporters to exercise caution when dealing with an Egyptian company, citing significant delays in payment settlements.
Avidity Biosciences Announces Pricing of Upsized Public Offering of Common Stock
Avidity Biosciences will use the funds, along with existing reserves, to advance late-stage clinical programmes, prepare for potential launches, expand commercial infrastructure, progress its AOC platform, and for general corporate needs.
MIRA Secures Shareholder Approval to Acquire SKNY
The acquisition strengthens MIRA’s pipeline with SKNY-1, a differentiated oral candidate that has demonstrated up to 30 percent weight loss and nicotine craving reversal in preclinical studies.
Fermenta Biotech Secures Indian Patent for Plant-Based Vitamin D3 Invention
Fermenta Biotech has been granted a patent by the Indian Patent Office for its proprietary process to produce plant-based Vitamin D3.
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