Pfizer recently announced that its selective sphingosine 1-phosphate (S1P) receptor modulator to treat moderate to severely active ulcerative colitis (UC) significantly improved the primary endpoint of...
Digital healthcare solutions company, Vivalink, will provide its Biometric Data Platform to help detect neutropenic fever events in oncology patients.
Vivalink is at the forefront of...
Moderna will expand its mRNA vaccine pipeline through two new development programs, including a combination respiratory vaccine candidate and a program against four endemic human coronaviruses...
Sandoz, a Novartis division, recently acquired a UK-based medical and drug delivery device company, Coalesce Product Development Limited.
Through the terms of the agreement, Sandoz...
Merck and the European Thoracic Oncology Platform (ETOP) recently announced that Keytruda significantly improved disease-free survival (DFS) in patients with stage IB to IIA non-small cell lung cancer...
AstraZeneca recently launched a global research and development Postdoctoral Challenge to help advance drug discovery for some of the world’s most complex diseases.
The challenge invites...
Boehringer Ingelheim recently announced that the Phase 3 clinical trial studying empagliflozin in adults with chronic kidney disease (CKD) will stop early based on a recommendation from the trial's...
Moderna recently dosed the first participant in an HIV trimer mRNA vaccine (mRNA-1574) clinical trial.
The open-label Phase 1 trial will evaluate the safety and immunogenicity of...
Civica recently announced plans to manufacture and distribute insulin to diabetes patients at significantly lower prices than insulins currently on the market.
Civica, CivicaScript, and the...
FDA recently approved Boehringer Ingelheim's Jardiance to reduce the risk of cardiovascular death and hospitalization in heart failure in adults.
The agency based its approval on the safety and...
Moderna recently announced its global public health strategy through four initiatives to advance mRNA vaccines for infectious diseases.
In the first strategy, Moderna will expand its global public...
Gilead recently announced that the Phase 3 clinical trial of Trodelvy in patients with HR/HER2-metastatic breast cancer met its primary endpoint.
The Phase 3 TROPiCS-02 study evaluated Trodelvy versus...
FDA recently issued three final guidance documents to the industry regarding cancer clinical trials that parallel the goals of President Biden’s effort to renew and rebuild upon his 2016 Cancer...
FDA recently issued a complete response letter (CRL) to Gilead rejecting its New Drug Application (NDA) for HIV-1 treatment, lenacapavir.
The agency cited Chemistry Manufacturing and Controls (CMC)...
The US Patent and Trademark Office (PTAB) recently ruled that CRISPR gene-editing technology belongs to the Broad Institute of Harvard and MIT, according to multiple news sources.
After an...
AstraZeneca Rare Disease and Alexion group recently closed a global collaboration and license agreement with Neurimmune AG for the investigational human monoclonal antibody, NI006.
NI006 is a...
FDA recently accepted Bristol Myers Squibb’s supplemental Biologics License Application (sBLA) for its non-small cell lung cancer (NSCLC) drug, Opdivo, plus chemotherapy.
The agency based its...
FDA recently accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for Pfizer’s interchangeable biosimilar to Humira, Abrilada.
Abrilada is a...
Half of all Medicare Part D covered drugs and nearly half of all Medicare Part B covered drugs (48%) had price increases greater than inflation between July 2019 and July 2020, according to...
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recently adopted a positive opinion for Pfizer and Biohaven’s generic drug to treat migraine...
