Top News
FDA Approves $3.5 Million Hemophilia B Gene Therapy
CSL’s Hemgenix (etranacogene dezaparvovec) will cost approximately $3.5 million, making it the most expensive single-use medicine in the United States.
Merck Announces $1.35 Billion Acquisition of Imago BioSciences
Merck will purchase Imago BioSciences, a biotechnology company focused on bone marrow disorders, for approximately $1.35 billion.
Sanofi and Insilico Medicine Ink $1.2 Billion Drug Development Deal
The deal will see Sanofi use Insilico’s AI drug discovery platform to advance up to six new drug development candidates.
J&J to Acquire Abiomed for $16.6 Billion
Johnson & Johnson’s acquisition of Abiomed, a provider of heart pump technologies, is designed to bolster their position in the medical technology sector.
Gilead and MacroGenics Enter $1.7 Billion Oncology Collaboration
Gilead and MacroGenics will work together on bispecific antibodies for the treatment of blood cancers.
Merck and Moderna Enter $250 Million Cancer Vaccine Partnership
Merck has exercised a $250 million option with Moderna to jointly develop and commercialize cancer vaccine mRNA-4157/V940.
FDA Authorizes Bivalent COVID-19 Boosters for Children Ages Five and Older
FDA amended its authorization for the Moderna and Pfizer-BioNTech bivalent booster vaccines to permit their use in children as young as five years old.
Biogen to Settle Kickbacks Lawsuit for $900 Million
Biogen has agreed to pay $900 million to settle federal and state claims that it paid kickbacks to physicians to encourage them to prescribe its drugs.
Pfizer to Supply up to 6 Million PAXLOVID Treatment Courses for Low-and-Middle-Income Countries
Pfizer is set to supply global fund up to 6 million treatment courses of its COVID-19 oral treatment, PAXLOVID, for low-and-middle-income countries.
Novo Nordisk to Acquire Forma Therapeutics for $1.1 Billion
Novo Nordisk’s $1.1 billion acquisition of Forma Therapeutics is intended to expand its sickle cell and rare blood disorder portfolio.
FDA Authorizes Bivalent COVID-19 Boosters
FDA has issued an emergency use authorization for both the Pfizer-BioNTech and Moderna bivalent COVID-19 boosters.
Revisions to Annex 1 Officially Published
The European Union publishes long-awaited changes to Annex 1.
Moderna Files Suit Against Pfizer and BioNTech
Moderna is suing Pfizer and BioNTech for allegedly infringing on patents the company filed from 2010 to 2016.
Anthony Fauci to Step Down in December
Anthony Fauci announced that he plans to step down as Director of the National Institute of Allergy and Infectious Diseases in December 2022.
UK Approves First Bivalent COVID-19 Booster Vaccine
The United Kingdom has approved Moderna’s bivalent COVID-19 vaccine, which targets the original variant and Omicron.
Pfizer to Acquire Global Blood Therapeutics for $5.4 Billion
Pfizer’s $5.4 billion acquisition of Global Blood Therapeutics is expected to strengthen its sickle cell disease portfolio.
WHO Declares Monkeypox Spread a Global Health Emergency
WHO has determined that monkeypox constitutes a public health emergency of international concern.
Royalty Pharma Acquires Royalty Rights to COPD/Asthma Treatment for $1.6 Billion
Royalty Pharma is paying $1.6 billion for the royalty rights to Trelegy Ellipta, a treatment for COPD and asthma.
FDA Issues Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted
FDA has granted an Emergency Use Authorization to Novavax’s COVID-19 vaccine.
First Successful Efficacy Study Against Omicron With COVID-19 Vaccine
The Sanofi-GSK vaccine is the first candidate to demonstrate efficacy in a placebo-controlled trial with a high-Omicron environment.
Novartis to Invest $250 Million for R&D of Neglected Tropical Diseases
Novartis will endorse the Kigali Declaration on neglected tropical diseases and invest $250 million for R&D.
GSK Announces £1 Billion R&D Investment in Fighting Infectious Diseases in Lower-Income Countries
GSK will invest £1 billion in furthering R&D in malaria, tuberculosis, and HIV, as well as neglected tropical diseases.
FDA Authorizes COVID-19 Vaccines for Individuals Six Months and Older
FDA has issued an Emergency Use Authorization for the Moderna and Pfizer-BioNTech COVID-19 vaccines in children as young as six months old.
EC Approves Lunsumio, Roche’s Bispecific Antibody for Follicular Lymphoma
Roche has received approval from the European Commission for Lunsumio (mosunetuzumab), the first CD20xCD3 T-cell engaging bispecific antibody for treating follicular lymphoma.
Bristol Myers Squibb Acquires Turning Point Therapeutics for $4.1 Billion
The acquisition grants Bristol Myers Squibb access to the company's oncology pipeline and lead candidate, repotrectinib.
Lilly to Invest $2.1 Billion in New Indiana Manufacturing Facilities
Eli Lilly and Company plans to build two new manufacturing sites at Indiana's LEAP Lebanon Innovation and Research District in Boone County.
GSK Acquires Affinivax for $2.1 Billion
GSK’s acquisition of Affinivax will give the company access to their portfolio of next-generation pneumococcal vaccines.
Pfizer and BioNTech Granted EUA for Booster Dose of COVID-19 Vaccine in Young Children
Pfizer and BioNTech’s COVID-19 vaccine has been granted EUA for booster doses in children five through 11 years of age.
Pfizer to Acquire Biohaven Pharmaceuticals for $11.7 Billion
Pfizer will acquire Biohaven Pharmaceuticals, a clinical-stage biopharmaceutical company specializing in migraine treatments, for $11.7 billion.
FDA Launches Accelerated Rare Disease Cures Program
The agency’s Center for Drug Evaluation and Research has launched the new program to increase development of treatment options for patients with rare diseases.