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Tag: drug manufacturing


Manufacturing, Research and Development

Alnylam wins FDA approval of rare disease drug in step toward profitability

June 14, 2022

Via: Biopharma Dive

Alnylam, a pioneer in the drugmaking method known as RNA interference, has climbed the biotech industry ranks over the last two decades. After solving challenges associated with delivering these treatments into the body, Alnylam has become one of the sector’s […]


Manufacturing, Research and Development

Resilience, a well-funded manufacturing startup, joins with the Parker Institute to make cancer drugs

June 9, 2022

Via: Biopharma Dive

While recent years have seen scientists make major advances in cutting-edge treatments such as gene and cell therapies, manufacturing remains a significant hurdle. The complex, multi-step processes required are beyond the capabilities of a traditional pharmaceutical plant. That’s where Resilience […]


Cell and Gene Therapy, Industry, Manufacturing, Research and Development

Regenxbio Opens Gene Therapy Manufacturing Facility

June 9, 2022

Via: Contract Pharma

Regenxbio recently celebrated the opening of its new Manufacturing Innovation Center gene therapy manufacturing facility. “Launching operations at our Manufacturing Innovation Center is an important milestone in the evolution of REGENXBIO,” said Kenneth T. Mills, president and CEO of REGENXBIO. […]


Biotech, Industry

Yumanity’s days as an independent biotech come to a close

June 6, 2022

Via: Biopharma Dive

After nearly eight years, Yumanity’s time as an independent company appears close to an end. The biotech was established in late 2014 — the creation of Tony Coles, Susan Lindquist and Ken Rhodes, each well-known in the pharmaceutical industry for […]


News

Roche gambles $125M on a sliding biotech’s cancer drug

June 2, 2022

Via: Biopharma Dive

The most immediate effect of the deal is a much-needed infusion of funds for Repare, which went public in 2020 at a price of $20 a share. The company’s stock soared above $42 in early 2021, only to plummet as […]


Pricing, Regulations

FDA Moves Forward with State Drug Import Plans

May 31, 2022

Via: Biopharm International

Despite a long history of difficulties in this area, FDA once again is taking steps to facilitate the import of less costly prescription drugs from Canada by states, Indian Tribes, and other entities. The Canadian government has objected to the […]


FDA, Regulations

FDA urges drug manufacturers to develop risk management plans to promote a dtronger, resilient drug supply chain

May 19, 2022

Via: World Pharma News

Drug shortages pose a significant public health threat as they can delay, and in some cases, even deny critically needed care for patients. Over the past decade, the FDA’s efforts have contributed to fewer new drug shortages and reduced the […]


FDA, Regulations

FDA Expands Baby Formula Market to Foreign Suppliers, Moves to Reopen Abbot Plant

May 16, 2022

Via: Drugs.com

Dealing with a crippling shortage of infant formula that has many U.S. parents desperate, the Food and Drug Administration on Monday announced ‘Increased flexibilities” in allowing foreign manufacturers to help boost American supply of the vital product. Also on Monday, […]


News

Bora Pharmaceuticals Acquires Eden Biologics

May 12, 2022

Via: Contract Pharma

Taiwan-based contract development and manufacturing organization (CDMO) Bora Pharmaceuticals recently announced the establishment of Bora Biologics Co., Ltd., to focus on the development of bio-pharmaceuticals. Bora Biologics has investors Taishin Healthcare Limited Partnership and Dr. Allen Chao, founder of Tanvex […]


FDA, Regulations

With spotlight on FDA, Congress weighs reforms to accelerated drug approvals

May 10, 2022

Via: Biopharma Dive

Over the past few years, the Food and Drug Administration has come increasingly under scrutiny for its program to grant speedy approvals to drugs that show early signs of benefiting patients with life-threatening diseases. These so-called accelerated approvals have ushered […]


FDA, Regulations

FDA spurns Coherus and Junshi’s China-made PD-1 cancer drug

May 3, 2022

Via: FiercePharma

The next China-developed immuno-oncology therapy to cross the FDA’s desk has been hit with bad news. Still, it will be half a year at least before Coherus BioScience and Junshi Bioscience get another crack at U.S. approval of their cancer […]


FDA, Regulations

No go for Zosano as FDA knockback triggers suspension of transdermal migraine patch program

May 3, 2022

Via: FiercePharma

Zosano Pharma’s headaches are intensifying. With the FDA again knocking back its transdermal migraine patch, the biotech has suspended its M207 program and made more layoffs to preserve its dwindling cash reserves. The patch uses microneedles to deliver zolmitriptan, a […]