Category: News

July 24, 2023

Tornado damage to a Pfizer drug-making plant in North Carolina is unlikely to trigger drug shortages across the country, the U.S. Food and Drug Administration says. “We do not expect there to be any immediate significant impacts on supply, given […]

July 21, 2023

The U.S. Food and Drug Administration is working closely with Pfizer to assess the impact of the damage at Pfizer’s Rocky Mount, North Carolina, facility. Over the next few days, we will complete a more extensive assessment of the products […]

July 3, 2023

Artificial intelligence can predict on- and off-target activity of CRISPR tools that target RNA instead of DNA, according to new research published in Nature Biotechnology. The study by researchers at New York University, Columbia Engineering, and the New York Genome […]

June 26, 2023

Affecting almost seven million people in the US and approximately 147 million people globally, alopecia areata is an autoimmune disease characterised by patchy or complete hair loss on the scalp, face, or body. The condition can develop at any age, […]

June 15, 2023

Thaerapy BV, a pharmaceutical drug product development company, and Resyca BV a joint venture of Medspray Pharma BV and Recipharm AB, that develops soft mist inhalers, signed an exclusive license agreement for Resyca’s soft mist inhaler for the development of […]

June 8, 2023

On June 8th, at the Bio conference in Boston, Samsung Biologics announced a long-term agreement with Pfizer that enlarges and extends a March $183M manufacturing deal between the two. This strategic collaboration will focus on long-term biosimilars manufacturing, and more […]

June 2, 2023

Medicare will soon cover a new class of Alzheimer’s drugs if they receive full approval from the U.S. Food and Drug Administration, with some key limits. Along with being full approved, drug makers will also have to gather and keep […]

May 17, 2023

Gilead Sciences on Tuesday named former Roche executive Cindy Perettie as the next head of its cell therapy business Kite Pharma, moving quickly to fill the vacancy left by Christi Shaw, who stepped down from the role at the end […]

May 11, 2023

NewBiologix SA launched as a technology innovation company developing a proprietary and breakthrough platform for the advanced engineering of cell lines used to manufacture gene and cell therapies. The launch also includes the completion of a custom built 19,000 square-foot […]

May 10, 2023

Food and Drug Administration scientists evaluating what could be the first gene therapy for Duchenne muscular dystrophy appear skeptical of the treatment’s benefit, adding to questions about its approval prospects days before a crucial regulatory meeting. On Friday, the FDA […]

May 8, 2023

Through quantitative structure-activity relationship (QSAR) models, predictions can be made for a drug substance itself, intermediates, prioritizing experimental inquiries into the potential effects of newly identified drugs of abuse, and more. FDA’s Division of Applied Regulatory Science’s (DARS) computational toxicology […]

April 27, 2023

Lilly rival Novo Nordisk has a several year head start in selling insulin-modulating drugs for weight loss, first with a daily shot called Saxenda and, more recently, with a weekly shot named Wegovy. They both stimulate a hormone called GLP-1, […]

April 25, 2023

Biogen has stopped or paused several drug programs as part of a larger effort to cut costs and prioritize certain research. The decision, disclosed Tuesday in the company’s latest earnings report, comes as sales of its marketed medicines for brain […]

April 21, 2023

The Supreme Court on Friday allowed the abortion pill mifepristone to remain on the market for the time being, suspending a lower court order that would have curtailed its availability in the U.S. The 7-2 ruling stays a verdict earlier […]

April 13, 2023

The new drug looked so promising — except for that one warning sign. At the American College of Rheumatology’s annual meeting in 2008, Duke University’s Dr. John Sundy proudly announced that pegloticase, a drug he’d helped develop, was astoundingly effective […]

April 11, 2023

Curevo Vaccine, a privately held clinical-stage biotechnology company dedicated to reducing the burden of infectious disease by developing safe and highly effective vaccines, announced Guy De La Rosa has joined the company as its new chief medical officer. “The Curevo […]

April 4, 2023

Despite the headwinds young biotechs now face in raising capital, money is still flowing into venture firms. Data from the National Venture Capital Association shows that investment firms across industries raised about $163 billion last year and deployed nearly $31 […]

March 30, 2023

RoslinCT and Lykan Bioscience, companies involved in contract development and manufacturing for cell therapies, have been granted a Manufacturer’s Authorization License (MIA) for commercial manufacturing of cell therapy products from the Medicines and Healthcare products Regulatory Agency (MHRA), following a […]

March 30, 2023

In 2011, Jeffrey Motts was executed in South Carolina. More than a decade later, the state hasn’t carried out another execution because officials have struggled to obtain the drugs needed for lethal injection. Now, to resume executions, lawmakers are debating […]

March 29, 2023

The results are compelling when compared with approved drugs known as GLP-1 agonists that showed a reduction of between 0.5% and 0.8% in A1C after four weeks of treatment, Jefferies analysts wrote in a note to clients. Biomea also has […]