Industry News

WuXi STA served as the marketing authorization holder (MAH) and offered end-to-end support, including drug substance, amorphous solid dispersion, tablet, and packaging for the product.

The company is recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) because of nitrosamine impurities.

The draft guidance document offers developers of these treatments information regarding product development, preclinical testing, and clinical trial design.

The vetting and authorizing of important new therapies remained productive in 2020, despite the need to devote considerable resources to dealing with COVID-19 related approvals and policies.

EMA has chosen Panalgo's Instant Health Data (IHD) platform to enable rapid analyses of real-world data.

Intravacc and Cristal Therapeutics have entered into a strategic collaboration for the development of novel vaccine programs against human diseases.

The European Commission has granted a conditional marketing authorization to Moderna for its COVID-19 vaccine.

Evonik has closed its acquisition of the Lactel Absorbable Polymers product line from DURECT Corporation on Dec. 31, 2020.

Part of Operation Warp Speed, the trial will enroll 30,000 people ages 18 to 64 and 65 and older at 115 sites.

Despite the COVID-19 pandemic disruptions, with continued support and industry resilience, the European bio/pharma outlook for 2021 is positive.

The recently published European pharmaceutical strategy is being seen as an opportunity to strengthen medicines regulation in the region.

The outlook for the European pharma industry is appearing to be favourable overall.

Commissioner Stephen Hahn evaluates the agency’s response to COVID-19 and how it affected non-COVID related initiatives in 2020.

FDA sent a warning letter to Clientele for CGMP violations at the company’s Sunrise, FL facility that included a lack of an adequate quality unit.

A report in the New England Journal of Medicine states preliminary results from a Phase III clinical trial shows the vaccine is 94.1% effective.

Sunstar Americas is expanding its voluntary recall of Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12% products because of Burkholderia lata contamination.

President Trump signed the COVID-19 package, which appropriates $2.3 trillion to finance the federal government through September 2021 and provides support for individuals and entities suffering from the economic crisis wrought by the pandemic.

The agency is targeting websites that market untested CBD products as medical treatments.

Customceutical Compounding was sent a warning letter by FDA after investigators found deficiencies in the production of sterile drug products.

The agency is organizing a second public meeting on January 8, 2021 to discuss the assessment, approval, and roll-out of new COVID-19 vaccines.

The guidance provides information on review timelines during the COVID-19 pandemic.

The new guidance provides information on how sponsors should interact with the agency regarding complex innovative trial design proposals.

The agency is answering frequently asked questions about the Pfizer–BioNTech COVID-19 vaccine on its website.

FDA is expected to issue Emergency Use Authorization for Moderna’s vaccine, enabling immediate distribution.

The product represents a first-of-its-kind intentional genomic alteration in a line of domestic pigs that may be used for human therapeutics.

Due to a packaging error, the company is voluntarily recalling one lot of sildenafil 100 mg tablets for the treatment of erectile dysfunction and one lot of trazodone 100mg tablets for the treatment of major depressive disorder.

The ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System is the first in a four-part series that will address refining pharmaceutical quality and guaranteeing sustainable compliance within organizations.

Trixeo Aerosphere—AstraZeneca’s triple-combination COPD therapy—has been approved for use in the European Union (EU).

A report, launched by Takeda UK, has shown that despite the increase in media attention, COVID-19 has had little positive impact on the perception of pharmaceutical companies.

EUA marks a milestone in COVID-19 vaccine development and is hailed as a turning point in pandemic fight.