Top News
AstraZeneca Signs Blockbuster Deal With Ionis for TTR Amyloidosis Treatment
AstraZeneca struck a deal worth up to more than $3.5 billion with Ionis Pharmaceuticals for the rights to develop and commercialize their transthyretin (TTR) amyloidosis treatment.
Recordati Acquires EUSA Pharma for $845 Million
Recordati’s blockbuster acquisition of EUSA Pharma gives them access to a portfolio of four drugs that treat rare cancers.
EMA Recommends Pfizer and BioNTech’s COVID-19 Vaccine for Children
The Comirnaty vaccine received a positive opinion from the EMA’s CHMP for children five to under 12 years of age.
FDA Authorizes COVID-19 Boosters for All Adults
FDA has amended its EUA for Pfizer-BioNTech’s and Moderna’s COVID-19 booster to include all individuals aged 18 or older.
Novo Nordisk Acquires Dicerna for $3.3 Billion
Novo Nordisk’s 3.3 billion acquisition of Dicerna gives them access to their RNAi technology.
Pfizer Submits COVID-19 Oral Antiviral Candidate to FDA for Emergency Use Authorization
Pfizer’s PAXLOVID oral solid-dosage treatment is designed to combat SARS-CoV-2 in high-risk patients at the first sign of infection.
Califf Named to Head FDA
The White House has nominated Robert Califf to head FDA, ending months of uncertainty about the future path for the high-profile agency.
FDA Grants EUA for Pfizer-BioNTech COVID-19 Vaccine Use in Children
The Pfizer-BioNTech COVID-19 vaccine is the first to receive FDA Emergency Use Authorization for use in children ages five to 11.
Moderna Announces Positive Results in Study On COVID-19 Vaccine in Children
Moderna’s KidCOVE study showed a robust neutralizing antibody response in children aged six to under 12.
Pfizer and BioNTech Release Phase III Trial Data Supporting Efficacy of Booster Doses
Pfizer and BioNTech’s Phase III trial demonstrated 95.6% booster efficacy relative to participants who received placebo.
FDA Amends EUA to Allow Booster Shots for Moderna, J&J COVID-19 Vaccines
In addition to allowing booster shots of the Moderna and J&J vaccines, FDA approved heterologous booster shots.
FDA Advisory Council Unanimously Supports Johnson & Johnson COVID-19 Booster EUA
The council voted 19-0 to recommend that FDA authorize booster doses of the J&J COVID-19 vaccine just one day after granting Moderna a similar recommendation.
FDA Advisory Council Unanimously Supports Moderna COVID-19 Booster EUA
The council voted 19–0 to recommend that FDA authorize booster doses of the Moderna COVID-19 vaccine for certain populations.
AstraZeneca, Merck KGaA, Pfizer, and Teva Team up with Tech and Investment Leaders to Launch New Biotech Innovation Lab
AION Labs will be a first-of-its-kind AI/pharma and computational biology innovation lab aimed at spearheading the adoption of AI technologies and computational science.
Pfizer, BioNTech Request EUA for COVID-19 Vaccine in Children Aged 5-11
Pfizer and BioNTech’s request would make them the first vaccine accessible to individuals under the age of 12.
Selecta Biosciences and Takeda Announce Gene Therapy Platform Licensing Agreement
Takeda will use Selecta Bioscience’s ImmTOR platform to develop gene therapies for lysosomal storage disorders.
Merck Acquires Acceleron for $11.5 Billion
Merck’s 11.5 billion acquisition of Acceleron gives them access to their lead therapeutic candidate, sotatercept.
FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations
The FDA has amended the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine to allow a single booster dose to several high-risk populations.
Moderna Releases New Clinical Data on COVID-19 Vaccine
Moderna’s newest insights include an overall efficacy review, a study on breakthrough infections, and a study on long-term immunity.
Moderna to Develop Combined COVID-19/Flu Vaccine
Moderna’s new single-dose vaccine will be a booster for both COVID-19 and the flu.
Two Dead After Receiving Contaminated Moderna COVID-19 Vaccines & Japan Pulls Another 1-Million Doses From Circulation
After receiving the COVID-19 vaccine from a batch of Moderna vaccines that were suspected to have contaminants, two people in Japan died. Meanwhile, another one million doses have been temporarily suspended in Japan.
Pfizer to Acquire Trillium Therapeutics in $2.26-Billion Deal
Pfizer’s proposed $2.26-billion acquisition of Trillium Therapeutics will add next-generation hematology-targeted immuno-therapeutics to its oncology pipeline.
HHS Public Health Makes Statement on COVID-19 Booster Shots
HHS Public Health and a team of medical experts recommend that COVID-19 vaccine booster shots will soon be necessary.
FDA Approves First COVID-19 Vaccine from Pfizer-BioNTech
FDA approved the Pfizer-BioNTech COVID-19 vaccine, which will be marketed as Comirnaty.
FDA Authorizes Additional COVID-19 Vaccine Dose for Certain Individuals
The agency has amended the emergency use authorizations for the Pfizer-BioNTech and Moderna vaccines to allow certain immunocompromised people to receive an additional dose of the vaccine.
Sanofi Acquires Translate Bio for $3.2 Billion
Sanofi has acquired Translate Bio in a bid to further their mRNA research.
Pfizer and BioNTech Announce Collaboration with Biovac to Manufacture and Distribute COVID-19 Vaccine Doses Within Africa
Pfizer Inc. and BioNTech SE announced the signing of a letter of intent with The Biovac Institute Ltd to manufacture the Pfizer-BioNTech COVID-19 vaccine for distribution within the African Union.
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.
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.
FDA Adds Warning to mRNA Vaccine Fact Sheets
Reports of myocarditis and pericarditis following Pfizer-BioNTech and Moderna vaccinations prompts warnings.