News

Will Decentralized Clinical Trials Become Mainstream?

March 25, 2022

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

FDA Grants Breakthrough Therapy Designation for Pfizer Respiratory Syncytial Virus Vaccine Candidate

March 25, 2022

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

EMA Grants Recommendation for New Gene Therapy to Treat Adult Patients with Multiple Myeloma

March 25, 2022

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 Partner to Provide Formulation Services for Respiratory Products

March 25, 2022

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

FDA and Congress Re-Examine Accelerated Approval Program

March 24, 2022

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 and Mirus Bio to Develop Lipid-Polymer Nanocomplexes

March 24, 2022

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

Roquette Invests €25 million for Polyols at its Site in Lestrem, France

March 24, 2022

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

Recro Announces Name Change to Societal CDMO to Reflect Corporate Expansion and Transformation

March 24, 2022

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

Teva Reaches Agreement with Rhode Island to Settle Opioid-Related Claims

March 24, 2022

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

RINVOQ Receives FDA Approval for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis

March 23, 2022

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.