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Aptamer Group Secures Contract with a Global Pharma Company for Vaccine Development
Aptamer Group has signed a contract with a global pharmaceutical company to use Optimers to support innovative vaccine development for neurodegenerative disease.
Idifarma Launches New Service for Accelerated Clinical Pathway
CDMO Idifarma has launched a new service aimed at delivering an accelerated pathway for complex drugs.
PRAC Finds Link to Very Rare Cases of Myocarditis and Pericarditis with Comirnaty and Spikevax
EMA's PRAC has found a possible link to very rare cases of myocarditis and pericarditis after vaccination with Comirnaty and Spikevax COVID-19 vaccines.
EMA Advises Against Using Janssen’s COVID-19 Vaccine in People with Capillary Leak Syndrome
After a review of three cases, EMA's PRAC has advised against the use of Janssen’s COVID-19 vaccine in people who have a history of capillary leak syndrome.
EMA Concludes There is No Link Between Zynteglo and AML
EMA's safety committee, PRAC, has concluded that there is no evidence linking the viral vector in Zynteglo to a blood cancer known as acute myeloid leukemia (AML).
Lilly Acquires Protomer Technologies in Potential $1-Billion Deal
Eli Lilly and Company has announced its acquisition of biotech firm Protomer Technologies, giving it a protein-engineering platform for next-generation protein therapeutics.
Drug Prices Targeted in Biden Competition Initiative
White House proposal includes measure to make drugs more affordable.
Moderna to Deliver 20 Million Doses of COVID-19 Vaccine to Argentina
Moderna announces supply agreement with the Argentina government for 20 million doses of Moderna’s COVID-19 vaccine.
FDA Clears Tevogen Bio’s IND Application for CTL COVID-19 Treatment
The IND for Tevogen Bio's TVGN-489, an allogeneic COVID-19-specific cytotoxic T lymphocyte, received rapid clearance from FDA.
GEA Introduces Pharma Separator Equipment
GEA’s plug-and-produce skids are designed for multi-product pharmaceutical and biopharmaceutical separation.
NewAge Industries Expands Manufacturing Capacity for AdvantaPure Single-Use Tubing and Assemblies
NewAge Industries is adding cleanrooms at its Pennsylvania headquarters.
AMRI Changes Name to Curia and Acquires Integrity Bio and LakePharma
AMRI reinforces positioning as a CDMO with name change and acquires the formulation and fill/finish company, Integrity Bio, and biologics company, LakePharma.
SPI Pharma Introduces Platform for Orally Disintegrating Tablets
UltraBurst has a high disintegration speed, which is for all market segments, from prescriptions to nutraceuticals.
Purisys Adds ISO Certifications
Purisys is now certified for ISO 17025 for testing and calibration laboratories and ISO 17034 for reference material producers
Woodcock Seeks Outside Investigation to Restore FDA Credibility
FDA’s review and approval of Aduhelm triggers controversy and a call for review from within the Agency.
Sparx Therapeutics to Build Commercial Antibody Manufacturing Facility in China
Sparx Therapeutics will build its first commercial manufacturing facility in Yangzhou, China, for antibody drug production.
GSK and Alector Collaborate on Neurodegenerative Disease mAb Candidates
GlaxoSmithKline and Alector have partnered to co-develop two mAbs for a range of neurodegenerative diseases, including Parkinson’s and Alzheimer’s disease.
Custom Viral Vector Manufacturing Protocols to be Produced by Univercells Technologies and VectorBuilder
Univercells Technologies and VectorBuilder to produce custom viral vectors for cell and gene therapies as well as vaccine applications.
FDA Grants Priority Review for AstraZeneca Asthma Biologic
Tezepelumab, being developed by AstraZeneca in collaboration with Amgen, reduced asthma exacerbations in Phase II and III clinical trials.
Gyros Protein Technologies and Cygnus Technologies to Develop Impurity Reagent Sets
The collaboration continues as the companies design bioprocess impurity reagent sets to detect residual HCP from HEK 293 cells.
Thermo Fisher Expands Gene Therapy Portfolio to Support AAV Manufacturing
A new media panel, gene kit, and advanced resins that are now in Thermo Fisher Scientific’s gene therapy portfolio aim to reduce manufacturing costs and increase gene therapy viability.
Exscientia Receives Funding from COVID-19 Therapeutics Accelerator
Exscientia has been given funding from the COVID-19 Therapeutics Accelerator to accelerate the optimization of a new class of COVID-19 drugs created using its AI drug design platform.
MHRA Gives Diurnal the Nod for Efmody
MHRA has granted marketing authorization for Diurnal Group’s Efmody as a treatment of adult and adolescent patients with CAH in Great Britain.
AGC Appoints New CFO
V. Ashok has been appointed as ACG's new group chief financial officer.
Novasep, Exelixis Sign Manufacturing Services Agreement for Next-Gen ADC
Novasep and Exelixis have signed a manufacturing services agreement for the CGMP clinical manufacturing of a next-generation ADC candidate.
Recipharm Signs MOU for Fill/Finish Capacity in Morocco
Recipharm has signed a memorandum of understanding (MOU) with His Majesty the King of Morocco, the Moroccan government, and a consortium of leading banks from the country, for fill/finish capacity in the country.
Industry Body Welcomes UK Government’s Vision for the Future of Life Sciences
The recently published Life Sciences Sector Vision, from the UK government, has been welcomed by the UK BioIndustry Association (BIA).
Teva Recalls Product Due to Particulate Matter
The company is recalling one lot of Topotecan Injection 4 mg/4 mL (1 mg/mL) after a glass particle was found in a vial.
EMA Approves Scale-Up Process for Janssen COVID-19 Vaccine
The approved changes to the API manufacturing plant in Leiden, the Netherlands will enable an increase in API capacity.
LGM Pharma Launches Analytical Services for Drug Developers and Manufacturers
LGM Pharma will offer contract analytical testing and stability services to pharmaceutical developers and manufacturers.