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FDA Continues to Warn Companies Marketing Products to Treat COVID-19
The agency sent warning letters to three more companies for selling unapproved products claiming to treat COVID-19.
ISPE Announces FOYA Category Winners
ISPE’s Facility of the Year Awards for 2020 go to bio/pharma companies in eight award categories, including two winners in the new Social Impact category.
Orgenesis to Acquire Tamir Biotechnology for Broad Spectrum Antiviral Platform
With the acquisition, Orgenesis will combine TamirBio’s ranpirnase antiviral platform with its Bioxome technology.
Buy American Proposals Rile Manufacturers and Trading Partners
Drug manufacturers, distributors, and dispensers oppose Buy American policies as likely to reduce reliable supplies and raise product costs.
Alnylam Pharmaceuticals and Blackstone Life Sciences Enter into Collaboration for up to $2 Billion
The companies announced they are entering into a strategic collaboration under which Blackstone will provide up to $2 billion to fund Alnylam’s RNAi drugs to treat a range of diseases.
EMA Sets Up COVID-19 Task Force
The task force will assist in the developing, authorizing, and monitoring of treatments of COVID-19.
EMA Publishes COVID-19 Q&A Guidance
The guidance answers questions on changes made to the regulatory framework to address challenges during the COVID-19 pandemic.
Theravance Biopharma to Advance its Janus Kinase Inhibitor to Treat Acute Lung Injury
The company is advancing its lung-selective nebulized Janus kinase inhibitor into clinical development to determine its ability to prevent acute lung injury in patients with COVID-19.
Orgenesis, RevaTis Partner on Cell Therapy Production
The partners have formed a joint venture to produce muscle-derived mesenchymal stem cells as a source of exosomes and other cellular products to develop related therapies and advance clinical trials.
Horizon Discovery Expands Screening Services
Horizon Discovery has announced that it has expanded its cell-based clustered regularly interspaced short palindromic repeats (CRISPR) screening services to include primary human B cells, which complements the T cell screening service.
UCB Successfully Completes Acquisition of Ra Pharmaceuticals
Belgian biopharmaceutical company, UCB, has successfully completed its acquisition of Ra Pharmaceuticals, which is now a wholly-owned subsidiary of the company.
EMA Recommends Compassionate Use of Remdesivir for COVID-19
EMA's CHMP has recommended the use of remdesivir, an investigational antiviral medicine, in compassionate use programs across the European Union.
Applied Biology, Brown University Collaborate on COVID-19 Drug Discovery Platform
The drug discovery platform was developed to rapidly predict blocking of COVID-19 pneumocyte cellular entry.
EMA Takes Measures to Ensure Supply of Medicines
The agency has been tasked with coordinating efforts to mitigate shortages of medicines within Europe during the COVID-19 pandemic.
Gilead and Second Genome Enter into $338 Million Biomarker and Drug Discovery Collaboration
Second Genome will use its Microbiome Analytics Platform throughout the collaboration to identify novel biomarkers associated with clinical response to Gilead’s investigational medicines.
Key Considerations for Negotiating Strategic Partnering Transactions
Successful negotiation of life-sciences collaboration agreements involves careful planning.
Global Plasma Providers Partner to Develop Potential COVID-19 Hyperimmune Therapy
The partnership, led by Takeda and CSL Behring, will focus on developing a hyperimmune immunoglobulin against COVID-19.
2020 BIO International Convention Transitions to Online-Only Conference Due to COVID-19
The digital event, called Bio Digital 2020, will now take place from June 8–12, 2020.
GSK and Vir Team Up for $250 Million COVID-19 Solutions Collaboration
The companies will collaborate on research and development solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19.
Arch Venture Partners to Invest $1.46 Billion in Early Stage Biotechnology Companies
The company closed two new funds, ARCH Venture Fund X and ARCH Venture Fund X Overage, for a total of $1.46 billion combined.
Merck, Pfizer, and Eli Lilly to Launch Medical Service Volunteer Programs for Company Employees
The medical service volunteer programs will allow their employees who are licensed medical professionals to help fight against COVID-19 while maintaining their base pay.
MJH Life Sciences to Acquire the Pharmacy Benefit Management Institute
The acquisition will include PBMI’s trademarks, conference, website, education, and membership assets.
N4 Pharma Undertakes Research Project Using a COVID-19 DNA Plasmid
N4 Pharma will be undertaking a proof-of-concept research project using a COVID-19 DNA plasmid to demonstrate the ability of its delivery system, Nuvec, to collaborative partners developing DNA or RNA vaccines.
Amgen and Adaptive Team up for Neutralizing Antibody COVID-19 Treatment
The companies are entering into a partnership to develop fully human neutralizing antibodies targeting SARS-CoV-2 to prevent or treat COVID-19.
CMIC group Announces Integration of Chinese Subsidiaries
CPS will be integrated into CB, who will proceed as the operating company while CMIC group continues to expand its business in China.
Excipient World 2020 Canceled Due to COVID-19 Concerns
The event, which was originally scheduled for May 11–13, 2020 at the Gaylord Palms Resort and Convention Center in Kissimmee, FL, will be canceled due to concerns regarding the spread of COVID-19.
GE Healthcare Life Sciences is Now Cytiva
GE biopharma brands are now part of Cytiva, a Danaher Corporation Life Sciences company.
FDA Removes Ranitidine Products from Market
With new tests showing NDMA levels increase under normal storage conditions, FDA calls for removal of ranitidine products from the market.
Orgenesis, ExcellaBio Announce Breakthrough Manufacturing Process for Bioxomes
The new patented process results in uniform, scalable production and the ability to deliver cell cargo similar to natural exosomes/extracellular vesicles.
FibroGenesis Announces Provisional Patent for a Fibroblast Therapy for COVID-19 Treatment
The patent includes the use of fibroblast cells and adjuvants such as peptides and hydroxychloroquine, which fuels the assembly of natural interferon to overpower the virus.