Tag: Pharmaceuticals

Biotech, Industry

Bora Pharmaceuticals Adds Roller Compaction Capabilities

April 9, 2021

Via: Contract Pharma

Bora Pharmaceutical Laboratories, a division of Bora Pharmaceuticals, has added roller compaction technology to its solid dose capability offerings at its Zhunan, Taiwan contract manufacturing and packaging facility. The Zhunan facility manufacturers complex oral solid dose (OSD) formulations with expertise […]

FDA, Regulations

FDA May be Getting Tougher, but Gives Trodelvy Nod for Triple-Negative Breast Cancer

April 9, 2021

Via: BioSpace

There has been discussion that the U.S. Food and Drug Administration (FDA) is getting tougher, and they are running an industry-wide evaluation of accelerated approvals. However, today the agency granted full approval to Gilead Sciences’ Trodelvy (Sacituzumab govitecan-hziy) for adults […]

Industry, News, Vaccines

Biden moves deadline for states to open Covid vaccines to all U.S. adults to April 19

April 6, 2021


President Joe Biden announced Tuesday that states should open Covid-19 vaccine appointments to all U.S. adults by April 19, moving up his original deadline by nearly two weeks. Biden announced the new deadline after he visited a vaccination site in […]

Biotech, FDA, Industry, Regulations

FDA Provides Positive Feedback on Tetra Bio-Pharma’s Application for ARDS-003 Clinical Development in COVID-19 Patients

April 5, 2021

Via: BioSpace

Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSX:TBP)(OTCQB:TBPMF)(FRA:JAM1), a biopharmaceutical pioneer in immunomodulator drug discovery and development is pleased to announce that the U.S. Food and Drug Administration (FDA) has favorably reviewed the preclinical data package and clinical development plan […]

Clinical Trials, News, Research and Development

Study identifies possible COVID-19 drugs — including several that are FDA-approved

April 2, 2021

Via: ScienceDaily

A team led by scientists in the Perelman School of Medicine at the University of Pennsylvania has identified nine potential new COVID-19 treatments, including three that are already approved by the Food and Drug Administration (FDA) for treating other diseases. […]

Industry, News, Vaccines

European Union countries clash over unequal vaccine distribution

March 15, 2021


Six members of the European Union have raised concerns over how the bloc is distributing Covid-19 vaccines, after AstraZeneca cut its delivery targets once again. Austria, Latvia, the Czech Republic, Bulgaria, Croatia and Slovenia wrote to the European Commission on […]

Industry, News, Vaccines

Britain denies ‘completely false’ EU claims as a new vaccine dispute boils over

March 10, 2021


The European Union and the United Kingdom have clashed over the export of coronavirus vaccines, with Britain fiercely denying it has blocked any shipments to other nations. The latest battle emerged after European Council President Charles Michel accused the U.K. […]

FDA, News, Regulations

Don’t Use Veterinary Drug Ivermectin Against COVID, FDA Warns

March 9, 2021


Desperate for a treatment against COVID-19, some Americans have reached for an anti-parasitic drug aimed at animals, with serious consequences, the U.S. Food and Drug Administration warns. “Never use medications intended for animals on yourself. Ivermectin preparations for animals are […]


Biotech’s deal refusals led to pricey buyout by Merck

March 5, 2021

Via: Biopharma Dive

Merck, under outgoing CEO Ken Frazier and now retired research chief Roger Perlmutter, has stayed away from large-scale dealmaking. But the pharma has proven an enthusiastic acquirer of early-stage, smaller companies, buying up seven private and public biotechs over the […]

FDA, Regulations

FDA Accepts Dupixent (dupilumab) for Review in Children with Moderate-to-severe Asthma

March 4, 2021

Via: BioSpace

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) as an add-on treatment for children aged 6 to 11 […]


Everest Medicines Announces Selection as a Constituent of Certain Indexes of Hang Seng Indexes Company Limited

March 1, 2021

Via: BioSpace

Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, today announced that the company has been selected as […]

FDA, Regulations

GC Pharma Submits Biologics License Application to US FDA for Immune Globulin ‘GC5107’

February 26, 2021

Via: BioSpace

GC Pharma (006280.KS) today announced that it had submitted its Biologics License Application (BLA) for ‘GC5107’ (Immune Globulin Intravenous (Human),10% Liquid) to the United States Food and Drug Administration (FDA). GC Pharma demonstrated positive results in a Phase III study […]