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Category: News


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FDA Inspections Face Overhaul

September 27, 2023

Via: Biopharm International

As part of agency initiatives to strengthen its oversight of human food and food products, FDA is revising inspection and compliance programs for all regulated products, at home and abroad. While an overriding aim is to improve FDA’s capability for […]


News

FDA Wants More Data on Neffy, First Needle-Free Antidote for Severe Allergic Reactions

September 20, 2023

Via: Drugs.com

In a surprising move, the U.S. Food and Drug Administration (FDA) has opted not to approve a needle-free alternative to the EpiPen for emergency treatment of severe allergic reactions. Approval of the Neffy nasal spray was widely anticipated. An FDA […]


News

AstraZeneca, seeking new drug targets, taps a genomics biotech and its AI technology

September 8, 2023

Via: Biopharma Dive

Artificial intelligence tools have drawn the interest of many drugmakers hoping to use it to unearth new therapeutic targets. Launched in 2015, Verge has raised over $100 million from a variety of investors, including the asset management firm Blackrock and […]


News

FDA grants Orphan Drug Designation to Faron’s bexmarilimab in AML

August 29, 2023

Via: Pharma Times

The ODD will offer clinical development and commercialisation benefits that will strengthen the drug programme Faron Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its bexmarilimab for acute myeloid leukaemia […]


News

J&J-backed startup raises another $150M for brain drug development

August 23, 2023

Via: Biopharma Dive

Rapport’s work revolves around “RAPs,” or receptor-associated proteins. These proteins, unlike other kinds, are local to specific areas of the brain and central nervous system. By targeting RAPs, Rapport believes it can create precision drugs that are either more effective […]


News

United Kingdom Biotech Report Finds 29% Uptick in Funding

August 14, 2023

Via: Biopharm International

The United Kingdom Bioindustry Association recently released new data surrounding UK biotech funding in the second quarter. According to the report, venture capital investments rose from £258 million in the first quarter to £338 million in the second, whereas public […]


News

Karyopharm cuts staff amid push to broaden use of blood cancer drug

August 2, 2023

Via: Biopharma Dive

Cancer drug developer Karyopharm Therapeutics is reducing its workforce and streamlining its clinical development plan, joining a list of nearly 100 other drugmakers to turn to layoffs in 2023. Alongside second quarter earnings on Wednesday, Karyopharm announced plans to lay […]


News

FibroGen CEO resigns amid latest round of layoffs

July 25, 2023

Via: Biopharma Dive

In what’s already been a tough year for biotechnology companies, FibroGen’s has been particularly difficult. Following a yearslong struggle to win U.S. approval of roxadustat as a treatment for chronic kidney disease patients, the company had been looking to a […]


Industry, News, Pharma

Teva Pharmaceuticals, Alvotech Expand Strategic Biosimilars Pact

July 25, 2023

Via: Contract Pharma

Teva Pharmaceuticals, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and Alvotech, a global biotech company specializing in the development and manufacture of biosimilars, expanded their existing strategic partnership agreement. Teva will also acquire subordinated convertible bonds to be […]


News

Major Drug Shortages Not Likely After Tornado Damages Pfizer Plant, FDA says

July 24, 2023

Via: Drugs.com

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 […]


News

FDA Provides Update Regarding Storm Damage at Pfizer Facility in North Carolina

July 21, 2023

Via: Drugs.com

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 […]


News

AI and CRISPR precisely control gene expression

July 3, 2023

Via: World Pharma News

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 […]


News

Pfizer’s Litfulo approved by FDA as first treatment for adolescents with severe alopecia areata

June 26, 2023

Via: PMLiVE

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, […]


News

Thaerapy, Resyca Ink License Agreement for Soft Mist Inhaler Technology

June 15, 2023

Via: Contract Pharma

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 […]


News

Biosimilar CDMO Capacity Increased in Samsung Biologics – Pfizer’s New Arrangement

June 8, 2023

Via: Biopharm International

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 […]


News

Medicare Will Cover New Class of Alzheimer’s Drugs if Fully Approved by FDA, With Limits

June 2, 2023

Via: Drugs.com

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 […]


News

Gilead picks former Roche executive to run cell therapy unit Kite

May 17, 2023

Via: Biopharma Dive

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 […]


News

NewBiologix Launches with $50M to Advance Novel Technology Platform

May 11, 2023

Via: Contract Pharma

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 […]


Cell and Gene Therapy, Industry, News

FDA staff skeptical of Sarepta’s Duchenne gene therapy, documents show

May 10, 2023

Via: Biopharma Dive

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 […]


News

New QSAR Model for Predicting Blood Brain Barrier Permeability

May 8, 2023

Via: Biopharm International

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 […]