Lessons learned from the pandemic can advance future biologic drug development and manufacturing.

The selection of a new FDA commissioner has become a contentious issue in Washington, as the White House delays a decision and interest groups line up behind competing candidates.

FDA sent a warning letter to Allay Pharmaceuticals for inadequate written procedures; inadequate out-of-specification testing; inadequate stability testing; and inadequate quality control oversight.

Representatives of industry organizations discuss crucial business, regulatory, science-based issues facing the industry.

The agency is developing guidance to help manufacturers make changes to existing COVID-19 vaccines to treat new variants in the coronavirus.

Through the agreement, AbbVie will use Caribou’s next-generation Cas12a CRISPR hybrid RNA–DNA genome editing and cell therapy technologies to develop two new CAR-T cell therapies.

The company has divested its specialty ingredients business and operations to Bain Capital and Cinven, two private equity firms.

FDA considers regulatory flexibility to allow the agency and sponsors to adapt and pivot to changes in coronavirus.

Through the agreement, Catalent will manufacture Trizell’s Phase I cell therapy for the treatment of micro- and macroangiopathies at its Belgium facility.

FDA’s Vaccines and Related Biological Products Advisory Committee will meet on Feb. 26, 2021 to discuss the request for emergency use authorization for Janssen Biotech’s COVID-19 vaccine candidate.

The company recently installed a fully validated visual inspection system that uses artificial intelligence in an automated inspection machine.

The CGMP manufacturing agreement will expand production of lenzilumab, a candidate for COVID-19 therapy, to support a potential emergency use authorization filing.

PathoQuest will apply its experience in viral safety testing and quality control of biologics for mitigating the risk of adventitious agent contamination in biopharmaceutical manufacturing.

Catalent will offer materials from its gene therapy facilities in Maryland to support IND-enabling studies and a Phase I/II clinical trial of the product.

Through the acquisition, Jazz will gain access to GW’s novel cannabinoid platform, including Epidiolex, a plant-derived cannabinoid medicine for the treatment of high-growth childhood-onset epilepsy.

Through the acquisition, Element will have access to Avomeen’s expertise in formulation chemistry, product manufacturing, extractables and leachables, and large molecule testing.

As demand for COVID-19 vaccines increases, Big Pharma offers its manufacturing capacity and expertise.

Scientists at the company learned that deagglomeration techniques lose efficacy through equipment wear over time and developed a tactic that makes up for the wear and prepares an ideal sample for each particle size test.

Both companies will provide resources and expertise to research, develop, and manufacture multiple mRNA vaccine candidates, including multi-valent and monovalent approaches.

The companies have entered into a research collaboration and license agreement for the potential treatment of rheumatoid arthritis via Imcyse’s RA program based on its Imotope technology.

More work is needed to educate businesses on the value of innovation and the availability of funding.

FDA puts applications on hold as the agency limits alternative oversight methods.

The EC intends to get tougher on issues such as reliability of drug supplies, particularly essential medicines.

COVID-19 vaccine supplies are breaking news headlines, in both ‘good’ and ‘not so good’ ways.

Viewpoint: Mike Hennessy, Sr., founder and chairman of MJH Life Sciences, commends the leadership of the pharmaceutical industry in combatting the COVID-19 pandemic.

A complicated vaccination rollout and mixed messages may derail the pandemic endgame.

The new board will join the company’s co-founder and chairman, Jay Walker, and company CEO, Franco Negron.

The companies previously entered into a collaboration in November 2020 with the goal of producing more than 100 million doses of the CureVac vaccine per year at Rentschler’s Laupheim, Germany facility.