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• Breaking News | Trials & Filings
  

  Janssen's UPTRAVI IV FDA-Approved for PAH

  New therapeutic option allows patients to avoid short-term treatment interruptions and stay on UPTRAVI therapy.

  07.30.21
  

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• Breaking News | Trials & Filings
  

  Roche’s Actemra Receives FDA EUA to Treat COVID-19

  Authorization enables emergency use of Actemra in hospitalized adult and pediatric patients.

  06.28.21
  

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• Breaking News | Drug Development
  

  FDA Approves Aducanumab To Treat Alzheimer’s Disease

  First novel therapy approved for AD in nearly 20 years was developed by Biogen and its Japanese partner Eisai.

  Charles Sternberg, Assistant Editor 06.08.21
  

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• Information Technology | QA/QC | Regulatory Affairs
  

  The Importance of Data Integrity Risk Assessment

  Executing Data Integrity Risk Assessments for systems that generate and store both paper (manual)-based systems as well as computer-based and hybrid systems.

  Paul Mason, Ph.D., Lachman Consultants 06.07.21
  

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• Regulatory Affairs
  

  Meeting with the FDA: Valuing the Statistician and Preparation for Review

  A look at the key roles and responsibilities of FDA and biopharmaceutical industry statisticians throughout product lifespan.

  Joshua Baker, VP and LaRee Tracy, PHASTAR 05.27.21
  

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• Breaking News | Collaborations & Alliances | Industry News
  

  Zynrelef Anesthetic Receives FDA Approval

  Lifecore will manufacture the new innovative drug for treatment of postoperative pain.

  Charles Sternberg, Assistant Editor 05.17.21
  

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• Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News
  

  FDA Expands EUA for Pfizer, BioNTech’s Covid-19 Vax

  Expands the authorization to include individuals 12-15 years of age.

  Charles Sternberg, Assistant Editor 05.11.21
  

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• APIs | Breaking News | Collaborations & Alliances | Cytotoxics and High Potency Manufacturing | Industry News
  

  FDA Approves ADC Therapeutics' Zynlonta

  ADC collaborated with CDMO Sterling Pharma Solutions to develop the cancer drug.

  Tim Wright, Editor, Contract Pharma 05.07.21
  

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• Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances
  

  ADC Therapeutics Receives FDA Approval for Zynlonta

  ADC collaborated with Sterling Pharma Solutions to develop Zynlonta.

  Charles Sternberg, Assistant Editor 05.06.21
  

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• Bio News | Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Facilities | Industry News | Validation
  

  ADMA Receives FDA Approval for Increased IVIG Production Scale

  Increases plant manufacturing capacity from 400,000L to 600,000L.

  Tim Wright, Editor, Contract Pharma 04.29.21
  

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• Breaking News | cGMP Manufacture | Industry News
  

  FDA Approves ADMA Biologics Increased IVIG Production

  Expanded manufacturing process enables fractionation and purification of a 4,400-liter plasma pool for the manufacture of Intravenous Immune Globulin.

  Kristin Brooks 04.28.21
  

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• Breaking News | Drug Development | Drug Discovery
  

  KemPharm Receives $10M Milestone for FDA Approval of Azstarys

  Is eligible to receive an additional near-term $10 million milestone payment following DEA scheduling of SDX.

  Charles Sternberg, Assistant Editor 04.22.21
  

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• Breaking News | Clinical Trials | Drug Development | Trials & Filings
  

  FDA Accepts Airway Therapeutics’ IND for COVID Treatment

  To initiate a Phase 1b trial to confirm the feasibility of intratracheal administrations of AT-100 and its beneficial safety and tolerability profile.

  Kristin Brooks 04.12.21
  

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• Aseptic Processing | Fill/Finish | Parenterals | Process Development | Scale-up/Technology Transfer
  

  Vetter Commercial Manufacturing

  Vetter’s decades of experience as a contract manufacturer providing fill & finish for injectable drugs helps deliver results for both large and small companies.

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• Analytical Services | Biologics, Proteins, Vaccines | Drug Development | Microbiology
  

  Vetter Development Service

  With Vetter, you have a partner you can trust to support you throughout drug product development, clinical manufacturing and regulatory approval.

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• Biologics, Proteins, Vaccines | Regulatory Affairs
  

  What Will Change at FDA for 2021?

  (R)evolution of the industry’s data, catalyzed by changes at FDA and what’s the likely impact to the pharmaceutical industry?

  Ben Locwin, Contributing Editor, International COVID-19 Advisor, Healthcare Futurist 04.01.21
  

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• Drug Delivery
  

  The Ever-Evolving World of Combination Products

  Looking at the benefits and challenges of the trend towards combination products.

  Ricki A. Chase, M.S, Lachman Consultants 04.01.21
  

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• Breaking News | Clinical Trials | Drug Development | Trials & Filings
  

  Cytocom Gets FDA Clearance for Phase II Trial of COVID Immune Therapy

  Phase 2 clinical trial to evaluate the safety and efficacy of CYTO-205 as a treatment to slow or halt the progression of SARS-CoV-2.

  Kristin Brooks 03.16.21
  

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• Breaking News | Industry News
  

  FDA Grants Tentative Approval to Generic Version of Symbicort

  Product is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD).

  Charles Sternberg, Assistant Editor 03.09.21
  

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• Bio News | Breaking News | Clinical Trial Materials | Clinical Trials | Collaborations & Alliances | Industry News
  

  Samsung Biologics, National OncoVenture, and Eutilex Obtain IND Approval from FDA

  For EU101(NOV1801), an anti-4-1BB therapeutic monoclonal antibody.

  Tim Wright, Editor, Contract Pharma 02.12.21
  

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• Trials & Filings
  

  FDA Approves BMS CAR-T Cell Therapy

  Breyanzi is a CD19-directed chimeric antigen receptor (CAR) T cell therapy for the treatment of relapsed or refractory large B-cell lymphoma.

  Kristin Brooks 02.08.21
  

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• Solid Dosage/Creams/Ointments
  

  Recent Advances in Solid Dispersion Technologies

  Improving the bioavailability and therapeutic efficiency of poorly soluble drugs.

  José L. Toro, Directory, Lachman Consultants 01.27.21
  

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• Biologics, Proteins, Vaccines | 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, Attorneys - Axinn, Veltrop & Harkrider LLP 01.27.21
  

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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 trials

  Contract 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 review

  Contract Pharma Staff 06.05.20
  

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