
Boehringer Ingelheim announced Empagliflozin Phase III EMPA_KIDNEY trial will stop early due to clear positive efficacy in people with chronic kidney disease.

Boehringer Ingelheim announced Empagliflozin Phase III EMPA_KIDNEY trial will stop early due to clear positive efficacy in people with chronic kidney disease.

Huma has acquired AstraZeneca’s digital health platform, and AstraZeneca has become a shareholder of Huma in a partnership to accelerate digital-first patient care.

Pharma’s interest in decentralized clinical trials (DCTs) increases as it helps to expand their geographical reach and racial diversity

Pfizer’s respiratory syncytial virus vaccine candidate has received Breakthrough Therapy Designation from FDA for the prevention of RS in older adults.

EMA has recommended a conditional marketing authorization for a new gene therapy to treat adult patients with multiple myeloma.

DFE Pharma, Harro Höfliger, and Sterling have announced a partnership called Inhalation Together to provide formulation services for respiratory products.

Congress is considering revising and improving policies related to drug development and regulation for possible inclusion in broader legislation to reauthorize FDA user fees.

Gamma Biosciences has announced an initiative through its subsidiary, Mirus Bio, to develop lipid-polymer nanocomplexes for improve mRNA delivery solutions.

Roquette is investing €25 million at its site in Lestrem, France to strengthen its position in the polyols market.

Recro Pharma changed its name to Societal CDMO to reflect the company’s expansion as a result of the acquisition of IriSys.

Teva has reached an agreement with the Attorney General of Rhode Island to settle opioid-related claims.

FDA has approved RINVOQ as a treatment for adults with moderately to severely active ulcerative colitis who have not had an adequate response to existing treatments.

FDA has approved Opdualag for adults and pediatric patients 12 years of age and older with unresectable or metastatic melanoma.

FDA has approved ZTALMY as a treatment for seizures associated with CDKL5 deficiency disorder (CDD).

AstraZeneca’s antibody combination has been authorized for use in Great Britain to prevent COVID-19 in high-risk populations and people for whom vaccination may not be effective.

Moderna has reached an agreement with the Ministry of Health, Labor, and Welfare of Japan (MHLW) to supply Japan with an additional 70 million doses of its COVID-19 Booster Vaccine.

Olympia Pharmacy is voluntarily recalling eleven lots of seven compounded products due to out-of-specification results.

Moderna, Pfizer, and BioNTech are seeking FDA approval for a fourth dose of their respective COVID-19 vaccines.

physIQ and CellCarta are conducting a study to evaluate individual patient response to vaccination using wearable biosensors.

New report released by USP offers a look into API supply-chain vulnerabilities.

Sanofi is collaborating with Blackstone Life Sciences to accelerate the development of a treatment for multiple myeloma.

Emmes has acquired Casimir, marking its fourth major acquisition.

Sanofi and Seagen have entered an agreement to investigate three cancer targets.

Catalent has announced the completion of a $30 million project at its facility in Limoges, France focused on biopharmaceutical development and drug product manufacturing.

Viatris’ new drug-device is the first FDA-approved generic version of AstraZeneca’s Symbicort.

BioMed X and Merck KGaA, Darmstadt, Germany announced their collaboration on a research project to study T-cells and autoimmunity.

Envirotainer and Swiss WorldCargo have successfully completed the first commercial shipment using a new temperature-controlled air freight solution.

Novasep increases its production capacity for HPAPIs with an investment in its site in Le Mans, France.

EMA has recommended that possible side effects of Spikevax and Janssen COVID-19 vaccines be added to product information.

Spectrum Chemical is adding twelve products to its bioCERTIFIED product line.