Pharma Press Releases

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Sigilon Therapeutics Receives Orphan Drug Designation for SIG-007 for the Treatment of Fabry Disease

Saturday, March 06, 2021

Sigilon Therapeutics Inc a biotechnology company that seeks to develop functional cures for chronic diseases through its Shielded Living Therapeutics platform announced that the United States Food and Drug Administration FDA has granted orphan drug d...

Dicerna Announces Roche’s Initiation of GalXC™ RNAi Candidate RG6346 in Phase 2 Combination Trial for Treatment of Chronic Hepatitis B Virus Infection

Friday, March 05, 2021

Dicerna Pharmaceuticals Inc a leading developer of investigational ribonucleic acid interference RNAi therapeutics announced that Roche has initiated RG in a Rochesponsored Phase combination trial for the treatment of chronic hepatitis B virus HBV i...

Enzyre announces strategic partnership with Takeda to accelerate development of pioneering diagnostic technology platform for hemophilia patients

Friday, March 05, 2021

Enzyre which is developing breakthrough ambulant diagnostic technology for blood coagulation testing announced that it has entered into a strategic partnership with Takeda Pharmaceutical Company Limited Takeda to develop assays for the diagnosis and...

Sharp appoints EU Qualified Person

Friday, March 05, 2021

Sharp part of UDG Healthcare plc a global leader in contract packaging and clinical supply services has appointed Ria RhemrevBoom as its new lead EU Qualified Person QP for market release services In her new role Ria will take responsibility for lead...

Roche’s Actemra/RoActemra becomes the first biologic therapy approved by the FDA for slowing the rate of decline in pulmonary function

Friday, March 05, 2021

Roche announced that the US Food and Drug Administration FDA approved ActemraRoActemra tocilizumab subcutaneous injection for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosisassociated interstitial lung dise...

Proxalutamide Phase III Clinical Trial for the Treatment of COVID-19 Patients Approved by FDA

Friday, March 05, 2021

Kintor Pharmaceutical Limited is pleased to announce that the Investigational New Drug IND application of the phase III clinical trial of Proxalutamides treatment of male COVID outpatients has been approved by the United States Food and Drug Administ...

U.S. FDA Approves Yescarta® for Relapsed or Refractory Follicular Lymphoma After Two or More Lines of Systemic Therapy

Friday, March 05, 2021

Kite a Gilead Company announced that the US Food and Drug Administration FDA has granted accelerated approval to Yescarta axicabtagene ciloleucel for the treatment of adult patients with relapsed or refractory follicular lymphoma FL after two or more...

ABclonal Biotechnology Acquires Yurogen Biosystems to Better Serve Diagnostic and Pharmaceutical Researchers Worldwide

Friday, March 05, 2021

ABclonal Biotechnology Co Ltd a global life science tools and services provider acquires Yurogen Biosystems LLC a contract research organization dedicated to monoclonal antibody discovery using singleBcellbased SMabTM platform

Elekta and IBA strengthen partnership to help cancer centers integrate proton therapy

Friday, March 05, 2021

Elekta announced that its latest solution for proton therapy Monaco treatment planning for protons has received k clearance from the US Food and Drug Administration Monaco brings robust functionality for proton therapy

U.S. FDA Expands Approval of Pfizer’s LORBRENA® as First-Line Treatment for ALK-Positive Metastatic Lung Cancer

Thursday, March 04, 2021

The US Food and Drug Administration FDA approved Pfizer Incs NYSE PFE supplemental New Drug Application sNDA for LORBRENA lorlatinib expanding the indication to include firstline treatment of people with anaplastic lymphoma kinase ALKpositive nonsmal...

EXIthera Pharmaceuticals Announces FDA Acceptance of IND Application for Phase 2 Trial of EP-7041 for Thrombosis Prevention in COVID-19 Patients

Thursday, March 04, 2021

EXIthera Pharmaceuticals a clinicalstage biotechnology company focused on addressing bleeding complications associated with currently available antithrombotic agents through the targeted inhibition of coagulation Factor XIa

Novartis signs initial agreement with CureVac to manufacture COVID-19 vaccine candidate

Thursday, March 04, 2021

Novartis announced today that it has signed an initial agreement to manufacture the mRNA and bulk drug product for the COVID vaccine candidate CVnCoV from CureVac to aid in the fight against the COVID pandemic

Gilead Sciences Completes Acquisition of MYR GmbH

Thursday, March 04, 2021

Gilead Sciences Inc today announced the completion of the previously announced transaction to acquire MYR GmbH for up to approximately billion in aggregate cash consideration The acquisition provides Gilead with Hepcludex bulevirtide which was condi...

Tirzepatide achieved superior A1C and body weight reductions across all three doses compared to injectable semaglutide in adults with type 2 diabetes

Thursday, March 04, 2021

Tirzepatide led to superior AC and body weight reductions from baseline across all three doses compared to injectable semaglutide mg in adults with type diabetes in Eli Lilly and Companys week SURPASS clinical trial In topline results from the larg...

Biogen Announces Plans to Build a New, State-of-the-Art Gene Therapy Manufacturing Facility in Research Triangle Park, North Carolina

Thursday, March 04, 2021

Biogen Inctoday announced its plans to build a new gene therapy manufacturing facility at its Research Triangle Park RTP manufacturing campuses in North Carolina to support its growing gene therapy pipeline across multiple therapeutic areas

Foresee Pharmaceuticals Enters Exclusive License Agreement with Intas Pharmaceuticals for Commercialization in the United States

Thursday, March 04, 2021

Foresee Pharmaceuticals announced today that it has entered into an exclusive license agreement with Intas Pharmaceuticals Intas for the US commercialization of Foresees novel FP program Leuprolide Mesylate Injectable Suspension LMIS readytouse subcu...

Aptamer Group extends collaboration with leading biopharmaceutical company to explore next-generation drug delivery approaches

Thursday, March 04, 2021

Aptamer Group the developer of Optimer reagents and therapeutics today announced the extension of their current agreement with AstraZeneca a global biopharmaceutical company This agreement will build upon the existing collaboration to evaluate the po...

Sorrento Receives FDA Clearance to Start Clinical Trial of Anti-CD47 Antibody, Discovered from Fully Human G-MAB Library, for Treatment of Multiple Malignancies

Wednesday, March 03, 2021

Sorrento Therapeutics Inc announced that the FDA has cleared Sorrentos internally developed antiCD monoclonal antibody STI which was discovered from Sorrentos GMAB library for an initial clinical trial

Eyenovia Announces FDA Acceptance of the MydCombi NDA

Wednesday, March 03, 2021

Eyenovia Inc a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print MAP therapeutics today announced that the US Food and Drug Administration FDA has accepted the Companys New Drug Application NDA for Myd...

MedAlliance Receives Fourth FDA Breakthrough Device Designation for Sirolimus Drug-Eluting Balloon in Treatment of De Novo Coronary Lesions

Wednesday, March 03, 2021

MedAlliance the first drugeluting balloon DEB company in the world to receive US Food and Drug Administration FDA Breakthrough Device Designation Status for a sirolimus DEB has now been awarded breakthrough status for SELUTION SLR

U.S. Food and Drug Administration Approves Novel Once-Daily CapsuleAZSTARYSTM (serdexmethylphenidate and dexmethylphenidate)

Wednesday, March 03, 2021

Corium Inc a commercialstage biopharmaceutical company leading the development and commercialization of novel central nervous system CNS therapies announced the US Food and Drug Administration FDA approval of oncedaily oral capsule AZSTARYSTM serdexm...

Takeda Secures Global Rights from Ovid Therapeutics to Develop and Commercialize Soticlestat for the Treatment of Children and Adults with Dravet Syndrome and Lennox-Gastaut Syndrome

Wednesday, March 03, 2021

Takeda Pharmaceutical Company Limited and Ovid Therapeutics Inc a biopharmaceutical company committed to developing medicines that transform the lives of people with rare neurological diseases

Junshi Biosciences and Coherus BioSciences Announce Initiation of Rolling Submission of BLA for Toripalimab to the U.S. FDA for the Treatment of Nasopharyngeal Carcinoma

Wednesday, March 03, 2021

Shanghai Junshi Biosciences Co Ltd and Coherus Biosciences Incannounced the initiation of the rolling submission of the Biologics License Application BLA for toripalimab to the US Food and Drug Administration FDA for the treatment of recurrent or met...

ADMA Biologics Expands Global Regulatory Approval Presence and Announces FDA Approval to Commence Hepatitis B Plasma Collections

Wednesday, March 03, 2021

ADMA Biologics Inc an endtoend commercial biopharmaceutical company dedicated to manufacturing marketing and developing specialty plasmaderived biologics today announced that its plasma collection center located in Kennesaw

Partner Therapeutics Announces Partnership with SIRS Therapeutics and F4 Pharma to Explore Potential Uses for FX06 in Biodefense Applications

Wednesday, March 03, 2021

Partner Therapeutics Inc PTx a commercial biotech company announces a licensing and collaboration agreement with Munichbased SIRS Therapeutics and Viennabased F Pharma to support the development of FX a synthetic peptide that has a broad spectrum of...

Arcline Investment Management acquires ChargePoint Technology to fuel increased global presence

Tuesday, March 02, 2021

Sterile and contained pharmaceutical product transfer specialist ChargePoint Technology ChargePoint or the Company has today announced that it has been acquired by Arcline Investment Management Arcline The deal will see ChargePoint Technology headqua...

Flexion Therapeutics Announces FDA Clearance of Investigational New Drug Application for FX301, a Novel Formulation of a Locally Administered NaV1.7 Inhibitor for Post-Operative Pain

Tuesday, March 02, 2021

Flexion Therapeutics Inc announced the US Food and Drug Administration FDA cleared the Investigational New Drug IND application for FX a locally administered NaV inhibitor known as funapide formulated for extendedrelease in a thermosensitive hydrogel

New Drug Approval for in-House Developed Anti-Insomnia Drug Dayvigo (Lemborexant) in Hong Kong

Tuesday, March 02, 2021

Eisai Co Ltd announced that its Hong Kong subsidiary Eisai Hong Kong Co Ltd has obtained approval for the inhousediscovered and developed orexin receptor antagonist DAYVIGO generic name lemborexant for the treatment of adults with insomnia characteri...

Riots under vacuum: Conti-TDS in Practice - Free Webinar

Tuesday, March 02, 2021

After more than registrations for our first live seminar from the series Riots under vacuum we warmly invite you to our next seminar On the March our process engineer Dr HansJoachim Jacob will talk on the subject of Riots under vacuum ContiTDS in P...

KemPharm Announces FDA Approval of AZSTARYS™ (serdexmethylphenidate and dexmethylphenidate capsules, for oral use, CII), A New Once-Daily Treatment for ADHD

Tuesday, March 02, 2021

KemPharm Inc a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs today announced that the US Food and Drug Administration FDA has approved the New Drug Application for NDA AZSTARYS formerly referred to...

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