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• Trials & Filings
  

  Pfizer, BioNTech Conclude Phase III COVID-19 Vax Study

  Meets all primary efficacy endpoints, demonstrates BNT162b2 to be 95% effective against COVID-19.

  Contract Pharma Staff 11.18.20
  

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• Biologics, Proteins, Vaccines | Breaking News | Industry News
  

  Pfizer, BioNTech COVID-19 Vax Candidate Successful in Phase III Interim Analysis

  mRNA-based vaccine candidate BNT162b2 found to be more than 90% effective in preventing COVID-19.

  Contract Pharma Staff 11.09.20
  

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• Biologics, Proteins, Vaccines | Breaking News | Clinical Trials | Industry News
  

  Moderna Completes Enrollment in Phase III COVID-19 Vax Study

  COVE study designed in collaboration with the FDA and NIH to evaluate Americans at the highest risk of severe COVID-19 disease in 30,000 participants.

  Contract Pharma Staff 10.22.20
  

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• Biologics, Proteins, Vaccines | Breaking News | Clinical Trials | Industry News
  

  J&J Initiates Phase III ENSEMBLE Trial for COVID-19 Vax

  Will enroll up to 60,000 volunteers across three continents to study the safety and efficacy of a single vaccine dose of JNJ-78436735 versus placebo.

  Contract Pharma Staff 09.23.20
  

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• Breaking News | Clinical Trials | Industry News
  

  Roche’s Phase III Trial of Actemra in COVID-19 Misses Primary Endpoint

  COVACTA trial did not meet primary endpoint of improved clinical status in patients with COVID-19 associated pneumonia, or the key secondary endpoints.

  Contract Pharma Staff 07.30.20
  

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• Clinical Trials | CRO News | Trials & Filings
  

  Lipidor, Cadila Sign Agreement for Phase III Trial of AKP-02

  Cadila Pharmaceuticals to conduct a Phase III study for Lipidor's anti-psoriasis candidate AKP-02.

  Contract Pharma Staff 07.07.20
  

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• Breaking News | Clinical Trials | Drug Development | Industry News
  

  Lilly Begins Phase III Baricitinib Trial in COVID-19

  To evaluate the efficacy and safety of baricitinib, an oral JAK1/JAK2 inhibitor, in hospitalized COVID-19 patients.

  Contract Pharma Staff 06.15.20
  

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

  Roche Initiates Phase III Trial in COVID-19 Pneumonia

  To evaluate Actemra/RoActemra plus remdesivir in hospitalized patients with severe Pneumonia.

  Contract Pharma Staff 05.28.20
  

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

  Glenmark Begins Phase III Trial of Anti-Viral Combo in COVID-19

  To test the combined efficacy of two antiviral drugs Favipiravir and Umifenovir as a potential COVID-19 treatment.

  Contract Pharma Staff 05.26.20
  

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• Breaking News | cGMP Manufacture | Clinical Trial Materials | Industry News | Trials & Filings
  

  Humanigen Initiates Phase III Lenzilumab Study in COVID-19

  Catalent provides clinical supply support to Humanigen and its partners from its Philadelphia facility

  Contract Pharma Staff 05.07.20
  

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• Breaking News | Drug Development | Trials & Filings
  

  CTI BioPharma Initiates Phase III Pacritinib Trial in COVID-19

  Will compare pacritinib plus standard of care versus placebo plus standard of care in 358 patients with severe COVID-19.

  Contract Pharma Staff 04.27.20
  

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• Breaking News | Collaborations & Alliances | Industry News
  

  CMIC Supports Avigan Production for Potential COVID-19 Treatment

  Includes clinical trials and manufacturing of influenza antiviral drug for COVID-19 patients

  Contract Pharma Staff 04.24.20
  

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• Breaking News | Drug Development | Industry News
  

  Roche Accelerates Phase III Actemra Trial in COVID-19

  Receives $25 million in support from BARDA to evaluate safety and efficacy in severe COVID-19 pneumonia

  Contract Pharma Staff 04.08.20
  

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• Breaking News | Drug Development | Industry News
  

  Izana Initiates Namilumab Study in Worsening COVID-19

  Compassionate use study of monoclonal antibody therapy will be evaluated in rapidly worsening COVID-19 patients in Italy

  Contract Pharma Staff 04.06.20
  

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• Trials & Filings
  

  Gilead Requests Retraction of Orphan Designation for Remdesivir

  Seeks to waive all benefits amid growing concerns the specialty status could impact pricing and availability of competitor products

  03.25.20
  

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• Breaking News | Fill/Finish | Industry News
  

  Argonaut’s Advanced Facility Readies to Combat COVID-19

  Offers immediate COVID-19 vaccine and therapeutic fill/finish production availability

  03.24.20
  

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

  Roche Trial to Assess Actemra/RoActemra in COVID-19 Pneumonia

  First Phase III global study of Actemra/RoActemra in this setting to evaluate the safety and efficacy in collaboration with BARDA

  03.19.20
  

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• Breaking News | Drug Development | Industry News
  

  Gilead's Remdesivir Shows Promise in COVID-19

  Antiviral drug being evaluated in two Phase III trials in patients with severe and moderate manifestations

  03.13.20
  

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• Biologics, Proteins, Vaccines | Breaking News | Clinical Trials | Drug Development
  

  COVID-19 Clinical Trials

  The vaccines in development for COVID-19, who's developing them, and where they stand in the development process

  Online Exclusives Kristin Brooks, Contract Pharma 03.10.20
  

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  Research and Markets Releases COVID 19 Clinical Trials Insight

  More than 30 clinical trials are being conducted at the global level, with hundreds of patients enrolled

  03.06.20
  

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• Breaking News | Financial Reports
  

  Cryoport Reports Record Revenue

  Revenue from commercial therapies increased 295% to $8.3 million in 2019

  03.06.20
  

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• Breaking News | Industry News | Trials & Filings
  

  Research and Markets Releases COVID 19 Clinical Trials Insight

  More than 30 clinical trials are being conducted at the global level, with hundreds of patients enrolled

  03.06.20
  

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  Gilead Initiates Phase III Studies of Remdesivir in COVID-19

  Studies follow the U.S. FDA rapid review and acceptance of Gilead’s investigational new drug filing for remdesivir for the treatment of COVID-19

  03.04.20
  

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• APIs
  

  Drug Substance Cost: A Non-Issue?

  Insight and implications of drug substance cost analysis.

  Dr. Michele Jermini and Dr. Enrico Polastro 03.04.20
  

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• Logistics
  

  Creating a Secondary Packaging Strategy

  When is the ideal time to start?

  Ingo Schraut, Product & Service Manager, Vetter Pharma International GmbH 03.04.20
  

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• Breaking News | Industry News | Trials & Filings
  

  Gilead Initiates Phase III Studies of Remdesivir in COVID-19

  Studies follow the U.S. FDA rapid review and acceptance of Gilead’s investigational new drug filing for remdesivir for the treatment of COVID-19

  03.04.20
  

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• Drug Development
  

  Major Drug Approvals of 2019

  Abbvie, Novartis, Pfizer and J&J score big wins with blockbuster potential

  Online Exclusives Kristin Brooks, Contract Pharma 02.24.20
  

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  Realizing the Full Potential of Precision Medicine in Oncology

  Innovation in oncology drug development is being driven by “precision medicine"

  Peter Larson, Executive Medical Director, Hematology-Oncology, Premier Research 01.28.20
  

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• Drug Development | Industry News
  

  Oncologie Receives Exclusive Navicixizumab License

  To develop and commercialize navicixizumab in advanced heavily pretreated ovarian cancer

  01.14.20
  

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• Breaking News | Drug Development | Industry News
  

  Lilly to Acquire Dermira

  Expands Lilly's immunology pipeline with the addition of lebrikizumab, a Phase III monoclonal antibody to treat atopic dermatitis

  01.10.20
  

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• Drug Development | R&D
  

  Top Pharma M&A Deals of 2019

  Drug manufacturers spent a record $342 billion on Mergers & Acquisitions

  Online Exclusives Kristin Brooks, Contract Pharma 12.23.19
  

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• Breaking News | Drug Development | Trials & Filings
  

  VistaGen Gains Fast Track for SAD Drug

  PH94B neuroactive nasal spray for on-demand treatment of social anxiety disorder completes successful Phase II development

  12.10.19
  

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• Breaking News | Drug Development | Trials & Filings
  

  UCB Trial Achieves Endpoints

  Phase III study met its co-primary and secondary endpoints demonstrating superiority of bimekizumab to Abbvie’s Humira in plaque psoriasis

  12.06.19
  

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• Breaking News | Clinical Trials | CRO News | Drug Development
  

  PPD Expands Early Development Research Capabilities

  Adds neuroscience and ethno-bridging expertise, broadening capabilities to provide increased access to patients and special populations at its CRUs

  12.03.19
  

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• Bio News | Biologics, Proteins, Vaccines | Breaking News | Clinical Trials | Industry News
  

  Novartis to Acquire The Medicines Company for $9.7B

  Adds cardiovascular drug inclisiran to portfolio, a potentially transformational investigational cholesterol-lowering therapy.

  11.28.19
  

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• Breaking News | cGMP Manufacture | Industry News
  

  WuXi STA, Impact Therapeutics Enter Strategic Pact

  WuXi STA will serve as Impact’s preferred contract development and manufacturing partner for its pipeline.

  11.21.19
  

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• Biologics, Proteins, Vaccines | cGMP Manufacture | Drug Development | Industry News
  

  Takeda to Open New Plant in Germany

  Will manufacture the company's dengue vaccine candidate TAK-003

  11.08.19
  

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• Breaking News | Collaborations & Alliances | Drug Delivery | Industry News
  

  Phillips-Medisize Inks Combination Drug Deal

  Wins contract to manufacture first electronic-enabled combination drug delivery product.

  10.23.19
  

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  How Can a Contract Development and Manufacturing Organization Advance a Cell & Gene Therapy Product?

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• Breaking News | Industry News
  

  UCB to Acquire Ra Pharmaceuticals in $2.5B Transaction

  Acquisition will add zilucoplan, a Phase III candidate to potentially compete with Alexion’s Soliris

  10.18.19
  

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• Breaking News | GMPs/GCPs | Industry News | Inspections
  

  ASIT biotech Receives GMP Certification

  Site in Liège, Belgium to manufacture in-house the active pharmaceutical ingredient of its leading product for grass pollen allergies

  10.07.19
  

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• Breaking News | Collaborations & Alliances | Industry News
  

  Mayne, Mithra Sign 20-Year License and Supply Agreement in the US

  For Mayne’s novel oral contraceptive E4/DRSP; launch is expected in 1H of 2021

  10.02.19
  

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• Breaking News | cGMP Manufacture | Fill/Finish | Industry News
  

  Minerva, Catalent Enter Long-Term Commercial Supply Pact

  Catalent will manufacture and package the finished dose form of Roluperidone at its facility in Schorndorf, Germany

  09.24.19
  

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• Biologics, Proteins, Vaccines | cGMP Manufacture | Drug Development
  

  Continued and Consistent Investment in Manufacturing Facilities

  As companies move their cell and gene therapies through the development process, supporting larger Phase III trials and commercial launches will be a challenge

  Ryan Carpentier, Executive Director of Business Development, Cryoport 09.23.19
  

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• Drug Development | Trials & Filings
  

  Eisai, Biogen Discontinue Phase III Alzheimer's Trials

  Data Safety Monitoring Board recommended to discontinue trials due to unfavorable risk-benefit ratio

  09.13.19
  

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• Biologics, Proteins, Vaccines | Cold Chain Management | Drug Development | Supply Chain
  

  CAR T for Large Tumors: The Next Frontier?

  Ryan Carpentier of Cryoport discusses the successes and the challenges these exciting new therapies present

  Ryan Carpentier, Executive Director of Business Development at Cryoport 09.10.19
  

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• Breaking News | Drug Development | Trials & Filings
  

  FDA Approves Boehringer’s Ofev

  Becomes the first and only therapy to slow the rate of decline in pulmonary function in systemic sclerosis-associated ILD

  09.09.19
  

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  Roche’s Tecentriq/Abraxane Combo for TNBC Approved by EU

  The Tecentriq combination marks the first cancer immunotherapy regimen to be available in Europe for triple-negative breast cancer

  08.29.19
  

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• Formulation Development | Industry News
  

  Enteris, Cara Therapeutics Enter Peptelligence Pact

  Cara has a non-exclusive, royalty-bearing license to the Peptelligence technology to develop, manufacture and commercialize Oral KORSUVA

  08.26.19
  

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• Promotions & Moves
  

  Provention Bio Appoints Clinical Development SVP

  Dr. Kell will lead the PRV-031 program, including the oversight of the Phase III PROTECT study and support of regulatory submissions

  08.20.19
  

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