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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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• 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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• Bio News | Breaking News | Facilities | Industry News
  

  NW Bio Accelerating Sawston Plant Phase I Buildout

  Construction crews working double shifts to accelerate completion despite COVID effects.

  Contract Pharma Staff 09.01.20
  

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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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• Breaking News | Trials & Filings
  

  Laurent Pharma Initiates Phase II Trial of LAU-7b in COVID-19 Disease

  LAU-7b has shown potent antiviral effects against SARS-CoV-2 and MERS-CoV coronaviruses, and is also being developed for its anti-inflammatory properties.

  Contract Pharma Staff 08.27.20
  

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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 | Trials & Filings
  

  PTC Begins Phase II/III Trial of PTC299 in COVID-19

  PTC299 has a novel dual-mechanism of action that has the potential to address high viral replication and uncontrolled inflammatory response.

  Contract Pharma Staff 06.17.20
  

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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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• Clinical Trials | Drug Development | Industry News
  

  Lilly and Junshi Biosciences Initiate Phase I COVID-19 Trials

  Studies will evaluate the safety, tolerability, pharmacokinetics and immunogenicity of JS016 in healthy participants who have not been diagnosed with COVID-19.

  Contract Pharma Staff 06.09.20
  

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

  FSD Pharma Gets Go Ahead for Phase IIa COVID-19 Trial

  To evaluate FSD-201 to treat COVID-19; anti-inflammatory properties aim to avoid the cytokine storm.

  Contract Pharma Staff 06.03.20
  

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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 | Trials & Filings
  

  Moderna’s Phase I Interim Data of mRNA-1273 Shows Promise

  Dose dependent increases in immunogenicity against SARS-CoV-2 were seen across the three dose levels.

  Contract Pharma Staff 05.26.20
  

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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 | Clinical Trials | R&D
  

  Enlivex Initiates Phase II Trial of Allocetra in COVID-19

  Will assess Allocetra in combination with therapy in patients with lung dysfunction.

  Contact Pharma Staff 05.07.20
  

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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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• Biologics, Proteins, Vaccines | Breaking News | Drug Development | Trials & Filings
  

  Regeneron, Sanofi Release Preliminary Phase II Kevzara Results in COVID-19

  Kevzara rapidly lowered C-reactive protein (CRP), a key marker of inflammation, meeting the primary endpoint.

  Contract Pharma Staff 04.27.20
  

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

  Cytovance and Akshaya Enter Vaccine Collaboration

  Partnership to focus on therapeutics for treatment of coronavirus and hepatitis B virus infections

  Contract Pharma Staff 04.24.20
  

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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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• 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 | Clinical Trials | Drug Development | Trials & Filings
  

  Theravance Initiates Study in ALI caused by COVID-19

  TD-0903 has potential to inhibit cytokine storm associated with ALI and prevent progression to Acute Respiratory Distress Syndrome

  04.23.20
  

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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 lymphoma

  Contract Pharma Staff 04.22.20
  

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

  panCELLa, CCRM Collaborate to Benefit Academia and Industry

  New iPSC master cell banks to accelerate development of novel cell therapies

  Contract Pharma Staff 04.21.20
  

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• New iPSC Master Cell Banks to Accelerate Development of Novel Cell Therapies

  panCELLa and CCRM collaborate to benefit academia and industry

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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-19

  Contract Pharma Staff 04.20.20
  

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• Breaking News | Trials & Filings
  

  4D Pharma Begins Phase II COVID-19 Study

  MRx-4DP0004, an immunomodulatory therapy, has shown potential to down-regulate hyper-inflammatory response while maintaining anti-viral response

  Contract Pharma Staff 04.20.20
  

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• Breaking News | Drug Development | Industry News
  

  Orgenesis to Acquire Tamir Bio Assets

  Aims to combine ranpirnase antiviral platform with Bioxome technology for enhanced payload delivery directly to cells.

  04.14.20
  

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

  Lilly, NIAID to Study Baricitinib in COVID-19

  Baricitinib's anti-inflammatory activity has been hypothesized to have a potential benefit in COVID-19

  Contract Pharma Staff 04.13.20
  

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• Bio News | Breaking News | Facilities | Industry News
  

  Seneca Completes Stem Cell Manufacturing Facility

  Will be used to manufacture the company's lead stem cell therapy for clinical trials within China

  Contract Pharma Staff 04.13.20
  

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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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• Collaborations & Alliances | Drug Development
  

  Regeneron, Zai Lab Enter Strategic REGN1979 Alliance

  Regeneron will receive $30 million upfront and is eligible to receive up to $160 million in additional regulatory and sales milestones.

  Contract Pharma Staff 04.08.20
  

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

  Hope Bio Gets FDA Nod to Start First Stem Cell COVID-19 Clinical Trial

  Autologous mesenchymal stem cells to provide immune support against COVID-19

  Contract Pharma Staff 04.07.20
  

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• Bio News | Biologics, Proteins, Vaccines | Breaking News | Clinical Trials | Collaborations & Alliances | Drug Development | Industry News
  

  GSK, Vir Biotechnology Enter Coronavirus Collaboration

  Antibody candidates for SARS-CoV-2 to be accelerated into Phase II trials in the next 3-5 months; GSK to invest $250 million in Vir

  Contract Pharma Staff 04.07.20
  

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• Clinical Trials
  

  COVID-19: Keeping Clinical Trials Moving

  How DTP and virtual services keep clinical trials moving during pandemic and beyond

  Ariette van Strien, President, Marken 04.06.20
  

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

  BioSig Acquires Anti-viral Agent to Treat COVID-19

  Laboratory results demonstrate high level of activity against COVID-19 in cell culture

  Contract Pharma Staff 04.06.20
  

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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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• Breaking News | cGMP Manufacture | Clinical Trial Materials | Collaborations & Alliances | Drug Development | Process Development
  

  Samsung Biologics, PharmAbcine Enter Antibody Pact

  To develop and manufacture PMC-402, a next-gen therapeutic antibody candidate to treat oncology and neovascular disorders

  Contract Pharma Staff 04.06.20
  

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

  APEIRON Biologics Initiates Phase II COVID-19 Trial

  APN01 has potential to block infection of cells by COVID-19 virus and reduce lung injury

  04.02.20
  

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• Drug Delivery
  

  CEO Spotlight: Will Downie

  Vectura’s chief executive talks trends in the inhaled-drug market, and the company’s transition into a CDMO

  Tim Wright, Editor, Contract Pharma 04.01.20
  

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

  Cobra Bio, Karolinska Inst. to Develop COVID-19 Vaccine

  OPENCORONA consortium awarded €3 million funding by Horizon 2020 to support emergency research and development against the COVID-19 outbreak

  03.30.20
  

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• Breaking News | Trials & Filings
  

  Altasciences Completes Phase I Study in COVID-19 Patients

  Gimsilumab, a monoclonal antibody, is being evaluated in patients with or at risk of developing acute respiratory distress syndrome

  03.27.20
  

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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 | Collaborations & Alliances | Drug Development
  

  CNS, WPD Pharma to Develop Coronavirus Candidates

  To develop several preclinical drug candidates including WP1122, which is being tested on a range of viruses including coronavirus

  03.23.20
  

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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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