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Breaking News | Trials & Filings
FDA Approves Janssen’s CABENUVA
Becomes first and only once-monthly, long-acting regimen for the treatment of HIV infection.Kristin Brooks 01.22.21
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Drug Development | Industry News | Regulatory Affairs
The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021
A look at EUA standards and approvals, unavoidable pitfalls, Operation Warp Speed, FDA’s use of Real-World Evidence, and a slow return to "normalcy".Chad Landmon, Michelle Divelbiss and Alex Alfano, Axinn, Veltrop & Harkrider LLP's Intellectual Property and Food and Drug Administration Practice Groups 01.05.21
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Breaking News | Industry News | Trials & Filings
Moderna Wins FDA Authorization for COVID-19 Vax
The primary efficacy analysis conducted on 196 cases indicated a vaccine efficacy rate of 94.1%.Contract Pharma Staff 12.21.20
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The Importance of Hypothesis Testing During Investigations
Why it is critical to have controls in place during out-of-specification investigations to provide quality assurance.Paul Mason, PhD, Lachman Consultants 11.17.20
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Breaking News | Drug Development | Trials & Filings
Gilead’s Remdesivir Wins FDA Approval to Treat COVID-19
Veklury is now the first and only approved COVID-19 treatment in the U.S.Contract Pharma Staff 10.23.20
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Biologics, Proteins, Vaccines | Breaking News
FDA Issues Guidance on EUA for COVID-19 Vaccines
Provides further information on the EUA process for investigational vaccines.Contract Pharma Staff 10.07.20
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Bioanalytical Services | Breaking News | cGMP Manufacture | Industry News
FDA Approves First Drug Using AJIPHASE Production Process
AJIPHASE platform is for the development and cGMP manufacture of high quality and purity commercial quantities of oligonucleotides and peptides.Contract Pharma Staff 10.07.20
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Biologics, Proteins, Vaccines | Breaking News | Clinical Trials | Industry News
FDA Clears IND Application for Vaxart Oral COVID-19 Vaccine
Recruitment for the Phase 1 clinical study is expected to start this month.Contract Pharma Staff 09.16.20
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Biologics, Proteins, Vaccines | Regulatory Affairs
Ensuring Manufacturing Continuity for Essential Medicines
Applying the principles of Quality Risk Management to get medicines to market faster.John Darby, M.Sc., Senior Director, Lachman Consultant Services, Inc. 09.09.20
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Biologics, Proteins, Vaccines | Drug Development | Regulatory Affairs
Expediting a COVID-19 Vaccine: FDA Approval Process
The pressures of the pandemic are pushing sponsors and FDA to look at both efficacy and speed in developing a vaccine.Kristin Brooks, Managing Editor 09.09.20
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Clinical Trials | Drug Development
FDA Response to COVID-19
A Discussion on Protocol Amendments and Clinical Study Reports in Affected Ongoing Trials.Jack Modell, M.D., Vice President and Senior Medical Officer, Rho 09.03.20
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Breaking News | Trials & Filings
FDA Clears SPI’s Ebselen for Phase II COVID-19 Trials
SPI-1005 is a novel anti-inflammatory drug which was recently shown to inhibit nCoV2 activity and viral replication.Contract Pharma Staff 08.31.20
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Biologics, Proteins, Vaccines | Drug Development | Regulatory Affairs
Expediting a COVID-19 Vaccine: FDA Approval Process
The pressures of the pandemic are pushing sponsors and FDA to look at both efficacy and speed in developing a vaccine.Online Exclusives Kristin Brooks, Contract Pharma 08.25.20
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Breaking News | Facilities | Industry News | Inspections
FDA Approves Romark Facility in Puerto Rico
The facility is equipped to produce tablets, powders and other oral solid dosage forms.Contract Pharma Staff 08.24.20
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Breaking News | Trials & Filings
FDA Approves Roche’s Tecentriq Combo for Melanoma
Tecentriq with Cotellic and Zelboraf helped people live longer without disease worsening or death compared to placebo.Contract Pharma Staff 07.31.20
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APIs | Breaking News | Industry News
ChemWerth Files its 500th Drug Master File with FDA
API supplier supports both large and small finished dosage companies worldwide.Contract Pharma Staff 07.23.20
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Breaking News | Collaborations & Alliances | Industry News
Patheon to Manufacture FDA-Approved Nasal Spray
Evoke Pharma initiates commercial manufacturing of Gimoti with the CDMO.Contract Pharma Staff 07.17.20
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Biologics, Proteins, Vaccines
Pharma’s Fight Against the Coronavirus Pandemic
A look at the pharma industry’s concerted effort to develop vaccines against the SARS-CoV-2 virus and therapeutics to treat COVID-19.Keith O. Webber, Lachman Consultant Services, Inc. 07.15.20
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Drug Development | Trials & Filings
FDA Approves Expanded Use for BOTOX
For the treatment of spasticity in pediatric patients 2 years of age and older, including those with lower limb spasticity caused by cerebral palsy.Contract Pharma Staff 07.10.20
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Pii Gets Registered as a Part of the FDA’s 503B Solution
Added to the list of organizations officially registered as human drug outsourcing facilities.Contract Pharma Staff 07.06.20
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EMD Serono, Pfizer Win FDA Approval for sBLA for BAVENCIO
For the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma.Contract Pharma Staff 07.01.20
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FDA COVID-19 Update
FDA has authorized 141 tests under EUAs; these include 120 molecular tests, 20 antibody tests, and 1 antigen test.Contract Pharma Staff 06.19.20
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Breaking News | Industry News
FDA Issues EUA to HymonSARS-CoV-2 Test Kit for Detection of COVID-19
SpectronRx and HymonBio expect to produce 10 million tests per month for labs around the world.Contract Pharma Staff 06.18.20
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Breaking News
FDA Authorizes Next-Gen Sequence Test for Diagnosing COVID-19
Illumina’s COVIDSeq can determine the genetic sequence of a virus.Contract Pharma Staff 06.11.20
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Breaking News | Drug Development
FDA Grants Orphan Drug Designation for Brain Cancer Drug Berubicin
Accelerates its development to treat malignant gliomas and provides CNS with the potential for market exclusivity.Contract Pharma Staff 06.11.20
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Breaking News | Clinical Trial Materials | Collaborations & Alliances | Industry News
Aspargo Laboratories Completes Pre-IND Meeting with FDA
Collaborating with the CDMO Pii to develop and manufacture Sildenafil Oral Spray for clinical trialsContract Pharma Staff 06.08.20
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Industry News
COVID-19 Update: FDA Shares Antibody Test Performance Data
Independently evaluates certain antibody tests, including antibody tests that were not the subject of an EUA or pre-EUA, and those that were under FDA reviewContract Pharma Staff 06.05.20
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Breaking News | Drug Development | Trials & Filings
Merck’s sNDA for RECARBRIO Wins FDA Approval
For the treatment of hospital-acquired and ventilator-associated bacterial pneumonia caused by Gram-negative microorganisms.Contract Pharma Staff 06.05.20
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Breaking News | Drug Development | Industry News
Lilly's CYRAMZA Gains Sixth FDA Approval
CYRAMZA plus erlotinib is the first FDA-approved anti-VEGFR/EGFR TKI combination therapy for metastatic EGFR-mutated NSCLC.Contract Pharma Staff 06.01.20
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Bio News | Breaking News | Collaborations & Alliances | Drug Delivery | Industry News
Virpax Completes pre-IND Meeting with FDA
Epoladerm spray being developed with contract service company MedPharmContract Pharma Staff 05.22.20
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Aetion Launches Research Collaboration with FDA
Aims to advance understanding of COVID-19.Contract Pharma Staff 05.20.20
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Virpax Completes Pre-IND Meeting with FDA on Epoladerm
To pursue a 505(b)(2) New Drug Application for Epoladerm in osteoarthritis of the knee.Contract Pharma Staff 05.20.20
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Industry News
FDA COVID-19 Update
To date, the FDA has authorized 98 tests under EUAs, which include 85 molecular tests, 12 antibody tests, and 1 antigen test.Contract Pharma Staff 05.15.20
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Breaking News | Industry News
FDA COVID-19 Update
Authorizes the first diagnostic test with the option of using home-collected saliva samples for COVID-19 testingContract Pharma Staff 05.11.20
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Information Technology | Regulatory Affairs
Data Integrity: Beyond Electronic Records
Get your Data Integrity house in orderTim Rhines, Ph.D., Director, Lachman Consultant Services, Inc. 05.05.20
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FDA cGMP Inspections Amid COVID-19 Pandemic
Despite FDA’s postponement of most facility inspections, the pharma manufacturing industry should be prepared for heightened scrutiny as this crisis developsJohn J. Carney, Lee H. Rosebush, Susrut A. Carpenter & Andrew M. Serrao, BakerHostetler 05.05.20
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Industry News | Regulatory Affairs
FDA COVID-19 Update
Issues guidance highlighting flexibility under the Drug Supply Chain Security ActContract Pharma Staff 05.01.20
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Breaking News | Industry News
FDA COVID-19 Update
FDA issues a Drug Safety Communication regarding known side effects of hydroxychloroquine and chloroquineContract Pharma Staff 04.27.20
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Bio News | Breaking News | Clinical Trials | Collaborations & Alliances | Industry News
Samsung Biologics, ImmuneOncia Reach Regulatory Milestone
Development and manufacturing agreement accomplishes IND clearance of IMC-002 (anti-CD47 antibody)Contract Pharma Staff 04.24.20
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Biologics, Proteins, Vaccines | Breaking News | Drug Development | Trials & Filings
Novartis’ Kymriah Gets RMAT Designation
Investigational new indication to treat patients with relapsed or refractory follicular lymphomaContract Pharma Staff 04.22.20
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cGMP Manufacture | GMPs/GCPs | Inspections | Regulatory Affairs
FDA cGMP Inspections Amid COVID-19 Pandemic
Despite FDA's postponement of most facility inspections, the pharma manufacturing industry should be prepared for heightened scrutiny as this crisis develops.John J. Carney, Lee H. Rosebush, Susrut A. Carpenter, Andrew M. Serrao, BakerHostetler 04.22.20
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Breaking News | Industry News
Bio-Rad Begins Shipping COVID-19 Antibody Test
Offers more than 99 percent specificity and 98 percent sensitivityContract Pharma Staff 04.21.20
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Breaking News | Industry News
CPL Launches Production of Hand-Sanitizer to Meet Critical Shortages
The first approved product is a hand sanitizer solution containing 80% alcohol in 60mL and 200mL bottlesContract Pharma Staff 04.21.20
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Drug Development | GMPs/GCPs | Regulatory Affairs
FDA’s Emergency Use Authorizations
Aggressive Action Taken to Combat COVID-19Chad Landmon and Drew Hillier, Axinn, Veltrop & Harkrider LLP 04.20.20
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Breaking News | Trials & Filings
Oral Anti-Viral for Covid-19 Filed under FDA’s CTAP
BioSig’s Vicromax is an orally administered drug that could be delivered to patients during all stages of Covid-19Contract Pharma Staff 04.20.20
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Breaking News | Industry News
FDA COVID-19 Update
Public-private partnership with the FDA and others aims to speed the development of COVID-19 vaccine and treatment options.Contract Pharma Staff 04.20.20
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Breaking News | Industry News
COVID-19 Update: Serological Test Efforts
Stephen M. Hahn addresses FDA's approach to expanding access to Serology TestsContract Pharma Staff 04.20.20
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News
Moderna Gets $483M BARDA Deal for COVID-19 Vaccine
Award will fund manufacturing process scale-up to enable large-scale production in 2020 for pandemic responseContract Pharma Staff 04.17.20
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Breaking News | Industry News
Eagle Pharma’s Drug Shows Antiviral Activity Against COVID-19
IND submitted to FDA for clinical study at Hackensack University Medical Center to evaluate Ryanodex for treatment of COVID-19 patientsContract Pharma Staff 04.17.20
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Breaking News | Clinical Trials | CRO News | Drug Development
PPD’s AES Biz Launches Patient-Transfer Program
Supports clinical trial continuity for biopharma companies during COVID-19 pandemic by transferring clinical trial patients to AES’ dedicated research sitesContract Pharma Staff 04.16.20
