Pharma Press Releases

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Sanofi provides update on Aubagio® (teriflunomide) submission for children and adolescents with relapsing-remitting multiple sclerosis in the U.S.

Friday, June 11, 2021

The US Food and Drug Administration FDA issued a Complete Response Letter regarding the supplemental New Drug Application for Aubagio teriflunomide for children and adolescents to years of age with relapsing forms of multiple sclerosis The FDA deem...

Novartis Entresto® indicated for treatment of hypertension in China

Thursday, June 10, 2021

Novartis today announced that Entresto sacubitrilvalsartan has received a new indication in China for the treatment of patients with essential hypertension a disease affecting approximately million adults in the country This National Medical Product...

U.S. Food and Drug Administration Approves New Formulation of Epclusa®, Expanding Pediatric Indication to Treat Children Ages 3 and Older With Chronic Hepatitis C

Thursday, June 10, 2021

Gilead Sciences Inc announced today that the US Food and Drug Administration FDA has approved an expansion of the pediatric indication of Epclusa sofosbuvirvelpatasvir for the treatment of chronic hepatitis C virus HCV to now include children as youn...

Veru Enrolls First Patient in Phase 2 Clinical Trial of VERU-100, Novel Long-acting GnRH Antagonist Decapeptide Injection Formulation, for the Treatment of Hormone

Thursday, June 10, 2021

Veru Inc an oncology biopharmaceutical company with a focus on developing novel medicines for the management of prostate and breast cancer today announced that it has enrolled the first patient in its Phase clinical trial of VERU a novel proprietary...

Revolo Biotherapeutics Enters into Partnership Agreement with Northway Biotech to Manufacture its Novel Binding Immunoglobulin Protein, ‘1805, to Support Phase 2 Trials

Thursday, June 10, 2021

Revolo Biotherapeutics a company developing therapies that reset the immune system to achieve superior longterm remission for patients with autoimmune and allergic diseases announced today that it has entered into a partnership with Northway Biotech...

Merck Announces Supply Agreement with U.S. Government for Molnupiravir, an Investigational Oral Antiviral Candidate for Treatment of Mild to Moderate COVID-19

Wednesday, June 09, 2021

Merck known as MSD outside the United States and Canada today announced it has entered into a procurement agreement with the United States government for molnupiravir MK Molnupiravir is currently being evaluated in a Phase clinical trial the MOVeOUT...

Verona Pharma and Nuance Pharma Announce $219 Million Strategic Collaboration to Develop and Commercialize Ensifentrine in Greater China

Wednesday, June 09, 2021

Verona Pharma plc and Nuance Pharma Limited today announce that the companies have entered into an agreement granting Nuance Pharma a Shanghaibased specialty pharmaceutical company the rights to develop and commercialize ensifentrine in Greater China...

Hummingbird Bioscience and Novogene enter into strategic partnership to expand precision medicine testing for individuals with NRG1-fusion driven cancers in China

Wednesday, June 09, 2021

Hummingbird Bioscience an innovative clinicalstage biotech company focused on developing precision therapies against hardtodrug targets today announced a strategic partnership with Asian genomic sequencing and bioinformatics company Novogene Co Ltd N...

Indo-Irish Biotech Startup CyGenica Secures Funding from SOSV to Accelerate Cancer and Rare Genetic Disease Therapy

Tuesday, June 08, 2021

CyGenica has announced that it has raised USD million in a seed fund investment round led by global venture capital investor SOSV The funding round will accelerate validation of CyGenicas proprietary technology which enables safe targeted and afford...

Syntegon’s GKF 60 sets new standards in capsule filling for laboratories

Tuesday, June 08, 2021

With the new GKF Syntegon Technologysets new standards in labscale capsule filling under the motto GKF takes your molecule to productionResearching pharmacists and laboratories need to bring their new drugs to regulatory approval quickly and in a...

Symbiosis Affirms Commitment to Growth with New Business Development Manager for The Nordics and Germany

Tuesday, June 08, 2021

Symbiosis Pharmaceutical Services Symbiosis a fastgrowing contract manufacturing organisation CMO specialising in sterile manufacture of vaccines pharmaceuticals and biopharmaceuticals and headquartered in Stirling UK has appointed Jette Cowan as Bus...

Scipher Medicine and Leading Medical Researchers in Network and Data Science Compress Time to Identify Covid-19 Treatments from Years to Months

Tuesday, June 08, 2021

Scipher Medicine a precision immunology company matching patients with the most effective therapy in collaboration with Northeastern University Brigham and Womens Hospital Harvard Medical School and Boston Universitys National Emerging Infectious Dis...

BerGenBio Receives FDA Fast Track Designation For Bemcentinib / Anti-PD-(L)1 Combination In NSCLC

Tuesday, June 08, 2021

BerGenBio ASA a clinicalstage biopharmaceutical company developing novel selective AXL kinase inhibitors for severe unmet medical need today announces that the US Food and Drug Administration FDA has granted Fast Track designation for Bemcentinib in...

Roche obtains CE mark for the SARS-CoV-2 Antigen Self Test Nasal allowing for rapid self testing of COVID-19 at home

Tuesday, June 08, 2021

Roche announced it has received CE mark for its SARSCoV Antigen Self Test Nasal for athome testing The test will be available in countries accepting the CE mark through pharmacies and other locations in packs of five tests An early version of the tes...

Bayer to advance two first-of-its-kind cell and gene therapies for Parkinson’s disease

Tuesday, June 08, 2021

Bayer AG announced today that BlueRock Therapeutics BlueRock a clinical stage biopharmaceutical company and whollyowned subsidiary of Bayer AG successfully administered the first dose of its pluripotent stem cellderived dopaminergic neurons named DA...

Rockwell Medical and Drogsan Pharmaceuticals Enter into Exclusive License Agreement for the Rights to Commercialize Triferic® in Turkey

Tuesday, June 08, 2021

Rockwell Medical Inc a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management and improving outcomes for patients around the world and Drogsan Pharmaceuticals a leading pharmaceutical company in Tur...

Innovent and AnHeart Release Preliminary Results from the Phase II TRUST Trial of Taletrectinib in ROS1 Fusion Positive NSCLC at the ASCO 2021 Annual Meeting

Monday, June 07, 2021

Innovent Biologics Inc a worldclass biopharmaceutical company that develops manufactures and commercializes highquality medicines for the treatment of cancer metabolic autoimmune and other major diseases together with AnHeart Therapeutics Co Ltd AnHe...

SpringWorks Therapeutics Announces Clinical Collaboration with Seagen to Evaluate Nirogacestat in Combination with SEA-BCMA in Patients with Relapsed or Refractory Multiple Myeloma

Monday, June 07, 2021

SpringWorks Therapeutics Inc a clinicalstage biopharmaceutical company focused on developing lifechanging medicines for patients with severe rare diseases and cancer today announced that the company has entered into a clinical trial collaboration agr...

Janssen Affiliate Cilag GmbH International Discontinues Collaboration and License Agreement with argenx for Cusatuzumab

Monday, June 07, 2021

Cilag GmbH International one of the Janssen Pharmaceutical Companies of Johnson Johnson announced today its decision not to continue the collaboration and license agreement with argenx for cusatuzumab an investigational therapeutic antibody that tar...

FDA grants accelerated approval for ADUHELM™ as the first and only Alzheimer’s disease treatment to address a defining pathology of the disease

Monday, June 07, 2021

Biogen and Eisai Co Ltd today announced that the US Food and Drug Administration FDA has granted accelerated approval for ADUHELM aducanumabavwa as the first and only Alzheimers disease treatment to address a defining pathology of the disease by redu...

Novartis announces new interim analysis Phase II data for iptacopan in rare kidney disease C3 glomerulopathy (C3G)

Monday, June 07, 2021

Novartis today announced positive new interim Phase II data showing investigational iptacopan LNP a firstinclass oral targeted factor B inhibitor improved estimated glomerular filtration rate eGFR slope and stabilized kidney function in patients wi...

Thermo Fisher Scientific Launches Ion AmpliSeq SARS-CoV-2 Insight Research Assay for SARS-CoV-2 Surveillance

Monday, June 07, 2021

Thermo Fisher Scientific today introduced the Ion AmpliSeq SARSCoV Insight Research Assay to improve SARSCoV surveillance The assay is designed to enable early identification of new and known variants from samples that have lower viral loads By seque...

Cullinan Oncology Receives Investigational New Drug (IND) Clearance from the FDA for CLN-049, a FLT3 x CD3 Bispecific Antibody for the Treatment of Relapsed/Refractory AML

Monday, June 07, 2021

Cullinan Oncology Inc an oncology company seeking to drive shareholder returns by focusing on the patient today announced that the US Food and Drug Administration FDA has cleared Cullinan Florentines IND application for CLN a FLT x CD bispecific anti...

Aragen (formerly GVK BIO) to partner with global biopharma with a renewed brand promise

Saturday, June 05, 2021

Aragen Life Sciences Aragen formerly known as GVK Biosciences and a leading contract research development and manufacturing organization officially marked its transition to a new brand identity With a legacy of over years of partnering with innovato...

Sihuan Pharmaceutical (0460.HK) Obtained the Exclusive Distribution Right for LipiVage(R) Fat Collection System in Greater China and South Korea

Friday, June 04, 2021

Sihuan Pharmaceutical Holdings Group Ltd the Company or Sihuan Pharmaceutical together with its subsidiaries collectively referred to as the Group Hong Kong Stock Exchange stock code is pleased to announce that Meiyen Laboratory Inc an American subs...

Liminal BioSciences Announces FDA Approval for its Biologics License Application for Ryplazim® (plasminogen, human-tvmh)

Friday, June 04, 2021

Liminal BioSciences Inc announced today that the US Food Drug Administration FDA has approved Ryplazim plasminogen humantvmh Ryplazim for the treatment of patients with plasminogen deficiency type hypoplasminogenia through its subsidiary Prometic B...

Surface Oncology to Collaborate with Roche on Immuno-Oncology Study Evaluating SRF388, Targeting IL-27, as Part of a Novel Combination in Patients

Friday, June 04, 2021

Surface Oncology a clinicalstage immunooncology company developing nextgeneration immunotherapies that target the tumor microenvironment today announced a clinical trial collaboration with Roche to evaluate SRF Surfaces investigational antiIL antibod...

Novartis Kymriah® pivotal trial demonstrates strong response rates and a remarkable safety profile in relapsed or refractory follicular lymphoma

Thursday, June 03, 2021

Novartis today announced robust data from the primary analysis of the pivotal Phase II ELARA trial of Kymriah tisagenlecleucel in patients with relapsed or refractory rr follicular lymphoma FL Data will be presented as an oral presentation during the...

Novartis 177Lu-PSMA-617 significantly improves overall survival and radiographic progression-free survival for men with metastatic castration-resistant prostate cancer

Thursday, June 03, 2021

Novartis today announced that results of the Phase III VISION study evaluating LuPSMA a targeted radioligand therapy plus best standard of care SOC demonstrated significant improvement in overall survival OS compared to SOC alone in patients with pro...

Samsung Biologics and KAHR Medical Announce Development and Manufacturing Agreement for Cancer Immunotherapy Drug Candidate

Wednesday, June 02, 2021

Samsung Biologics the worlds leading contract development and manufacturing organization signed a strategic partnership with KAHR Medical Ltd a cancer immunotherapy company developing novel multifunctional immunerecruitment proteins Under the terms o...

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