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Tag: drug manufacturing


Manufacturing, Research and Development

AGC Biologics Expands pDNA and mRNA Manufacturing Capacity

September 14, 2021

Via: Contract Pharma

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 […]


Industry, Vaccines

Moderna expands mRNA vaccine supply in deal with new biotech producer

September 8, 2021

Via: Biopharma Dive

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 […]


Mergers and Acquisitions

Roche bets on T-cell therapies with Adaptimmune deal

September 8, 2021

Via: PMLiVE

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 […]


FDA, Regulations

Biden said to rule out Woodcock as permanent FDA chief

August 20, 2021

Via: Biopharma Dive

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 […]


FDA, Regulations

FDA approves Lilly, Boehringer diabetes drug for heart failure

August 19, 2021

Via: Biopharma Dive

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 […]


News

Merck’s Welireg becomes first drug for rare VHL tumours in US

August 16, 2021

Via: Pharmaphorum

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, […]


Manufacturing, Research and Development

Rentschler Biopharma to Begin Construction of New Multi-Product Commercial Manufacturing Facility

August 13, 2021

Via: Biopharm International

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 […]


Manufacturing, Research and Development

Moderna Plans to Build mRNA Vaccine Manufacturing Facility in Canada

August 12, 2021

Via: Biopharm International

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 […]


Industry, Vaccines

With FDA verging on its first COVID booster approval, Pfizer and Moderna will have to recalibrate revenues—again

August 12, 2021

Via: FiercePharma

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 […]


Clinical Trials, Research and Development

Predicting and improving clinical trial enrolment: A problem for psychiatry

August 6, 2021

Via: Pharmaphorum

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 […]


FDA, Regulations

FDA expands use of COVID-19 antibody cocktail

August 3, 2021

Via: PMLiVE

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 […]


FDA, Regulations

FDA rejects a biotech’s kidney drug, but some analysts still see a ‘sliver of hope’

July 30, 2021

Via: Biopharma Dive

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 […]