Gene editing startup Metagenomi files for an IPO
Bio Pharma Dive
JANUARY 6, 2024
The Emeryville, California- based gene therapy developer has several preclinical programs in development with Moderna, Ionis and Affini-T.
Sat.Jan 06, 2024
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Cell therapy bigwigs endorse CAR-T in Nature Medicine article amid FDA safety probe
Fierce Pharma
JANUARY 6, 2024
A group of cell therapy experts, including CAR-T pioneers Drs. Bruce Levine and Carl June, wrote in support of continued use of CAR-T therapy.
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Daiichi Sankyo Wins $47M in ADC Patent Arbitration With Seagen, Pfizer Dispute Looms
BioSpace
JANUARY 6, 2024
Daiichi Sankyo has secured a victory in its patent arbitration with Seagen, nabbing a $47 million award for attorneys’ fees and other costs, plus interest. However, a larger patent battle with Pfizer remains.
FDA's authorization of Florida drug importation plan draws heat from US, Canadian trade groups
Fierce Pharma
JANUARY 6, 2024
Florida has secured a major win in its yearslong quest to import cheaper drugs from Canada—though the backlash from pharma trade groups on both sides of the border has been swift and fierce. | The FDA on Friday authorized Florida’s drug importation program, which will be valid for two years after it officially begins. The program quickly drew fire from pharma trade groups in both Canada and the United States.
CDC Backs Merck’s Capvaxive, Tees Up Pneumococcal Competition With Pfizer
BioSpace
JANUARY 6, 2024
In a potential challenge to Pfizer’s Prevnar 20, Merck’s Capvaxive has been recommended by the Centers for Disease Control and Protection for use in preventing invasive pneumococcal disease in adults.
Which pharmaceutical drugs have the most drug patents in Philippines?
Drug Patent Watch
JANUARY 6, 2024
This chart shows the drugs with the most patents in Philippines. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.… The post Which pharmaceutical drugs have the most drug patents in Philippines? appeared first on DrugPatentWatch - Make Better Decisions.
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Eisai Assumes Sole Responsibility for ADC After Collaboration With BMS Ends
BioSpace
JANUARY 6, 2024
Due to Bristol Myers Squibb’s ongoing portfolio reprioritization, Eisai is taking over the development and commercialization of farletuzumab ecteribulin, an investigational antibody-drug conjugate targeting solid tumors.
Gilead’s Trodelvy Stumbles in Late-Stage Trials But Remains Prized Cancer Asset
BioSpace
JANUARY 6, 2024
Gilead Sciences’ blockbuster antibody-drug conjugate Trodelvy has encountered some clinical speed bumps in 2024 in bladder and lung cancer. Still, analysts remain bullish on its prospects in the oncology space.
Psychiatric Drug Developers Make Recommendations Following Lykos Adcomm
BioSpace
JANUARY 6, 2024
Industry experts provide clinical trial design and protocol suggestions for psychedelic drug developers after an advisory committee voted against approving Lykos’ MDMA-assisted PTSD therapy.
Depression Is Notoriously Difficult to Treat. Can Psychedelic Therapies Help?
BioSpace
JANUARY 6, 2024
Psychedelic drug developers are homing in on the potential $16 billion depression treatment market, with a particular focus on treatment-resistant depression.
The New Age of Decentralized Clinical Trials
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
FDA Action Alert: Arcutis, Orexo, Phantom and More
BioSpace
JANUARY 6, 2024
The FDA’s calendar is relatively light in July, with only five major deadlines, including one for a PD-1 blocker and another for an opioid overdose drug.
Samsung Bioepis Gets FDA Approval for Biosimilar of J&J’s Stelara
BioSpace
JANUARY 6, 2024
Pyzchiva, developed by Samsung Bioepis, will be commercialized in the U.S. by Sandoz with the license period beginning on Feb. 22, 2025, according to a settlement and licensing agreement with Johnson & Johnson.
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