Tag: drug manufacturing

September 14, 2021

AGC Biologics, a global biopharmaceutical contract development and manufacturing organization (CDMO), unveiled expansion plans for the company’s Heidelberg facility to increase manufacturing capacities for plasmid-DNA (pDNA) and messenger RNA (mRNA) projects. With this expansion, AGC Biologics is boosting its current […]

September 8, 2021

The spread of the delta variant across the U.S. and the world has driven case numbers among unvaccinated people, including children under 12, sharply higher. Global vaccine supply, therefore, remains a top priority for Moderna and its mRNA counterparts, Pfizer […]

September 8, 2021

The deal with see Adaptimmune receive $150m upfront, another $150m over the next five years and then milestone payments potentially exceeding $3bn in aggregate sales, as well as royalties. Unlike other leaders in next-generation cell therapies, the partners will use […]

August 20, 2021

The White House has ruled out acting Food and Drug Administration Commissioner Janet Woodcock as a nominee for the agency’s permanent chief, Bloomberg news reported, leaving the role unfilled seven months into President Joe Biden’s term as the regulator prepares […]

August 19, 2021

The expanded approval offers a significant boost for Jardiance, sales of which are already on track to top $1 billion this year. In the second quarter, revenue from the drug jumped 36% to about $357 million. Lilly and Boehringer next […]

August 16, 2021

The drug is part of Merck’s efforts to expand its oncology portfolio and reduce its reliance on big-selling cancer immunotherapy Keytruda (pembrolizumab), which is patent protected in the US and Europe until 2028. Welireg (belzutifan), an oral HIF-2 alpha inhibitor, […]

August 13, 2021

On Aug. 12, 2021, Rentschler Biopharma announced that it has broken ground at its new production site, adjacent to its existing Milford, Mass., site where it will build the Rentschler Biopharma Manufacturing Center US, a new facility that will add […]

August 12, 2021

On Aug. 10, 2021, Moderna announced that it plans to build a messenger RNA (mRNA) vaccine manufacturing facility in Canada that will include access to the company’s mRNA development technology. The company signed a memorandum of understanding (MoU) with the […]

August 12, 2021

Pfizer and Moderna are getting used to readjusting their projected COVID-19 vaccine sales. Now another recalibration may be in order. The FDA is set to authorize a third dose of their COVID-19 shots for those with weakened immune systems, NBC […]

August 6, 2021

The reasons behind this problem, however, are rarely studied or understood. Despite this, new strategies devised over the last five years are beginning to reverse the trend, and both reduce stigma and increase awareness to funnel new patients into these […]

August 3, 2021

The FDA has expanded the use of Regeneron’s antibody cocktail, REGEN-COV, updating its emergency use authorisation (EUA) to include those at high risk of developing severe COVID-19 who have been exposed to the virus. The therapy – a combination of […]

July 30, 2021

The FDA’s decision wasn’t surprising to analysts, as “deficiencies” in an approval application have become somewhat of a prelude to rejection. This year alone saw two other drugmakers, Provention Bio and Acadia Pharmaceuticals, receive negative feedback about their applications shortly […]