Category: News

December 1, 2023

The agency is due to deliver a verdict on the combination by 9th May next year and, if approved, it could be an alternative to first-line chemotherapy for all patients with this form of cancer. Nectin-4-targeting antibody-drug conjugate Padcev (enfortumab […]

November 8, 2023

The drugs targeted by FTC are largely older products that have retained some market power because competitors can’t easily duplicate their effectiveness when combined with a specialized delivery device. “Wrongfully listed patents can significantly drive up the prices Americans must […]

November 1, 2023

In an exclusive interview with BioPharm International at AAPS PharmSci 360, Sara Fathollahi, PhD, product application specialist, DFE Pharma, discusses one of the major challenges in the adoption of continuous manufacturing: variation in raw materials. There is variation in raw materials, […]

October 31, 2023

Launched in 2012 under the US Food and Drug Administration’s (FDA) Safety and Innovation Act, Rare Pediatric Disease PRV’s specifically target and support the development of new drugs and biological products for certain, rare paediatric diseases. Upon approval, the rare […]

October 31, 2023

The deal also includes an option for an exclusive licence for its Claudin-18.2 antibody drug conjugate (ADC), SHR-A1904. Compared to first-generation PARP inhibitors, HRS-1167 has higher selectivity and affinity for PARP1 and induces DNA trapping, Merck said, adding that the […]

October 17, 2023

Biotechnology company Rain Oncology disclosed Monday that it has received a buyout offer from Concentra Biosciences, via Concentra’s owner Tang Capital. Concentra’s bid, filed Friday, proposes to acquire all outstanding shares from Rain for $1.25 per share, plus a type […]

October 12, 2023

AstronauTx has announced the completion of a £48m Series A financing to create new treatments for Alzheimer’s disease (AD). As part of the investment led by the Novartis Venture Fund, the financing was supported by several global venture investors, including […]

October 6, 2023

In a recent campaign video, former President Donald Trump blasted President Joe Biden for “a catastrophic increase” in drug shortages. “It’s a mess,” Trump said in the video, adding that new drug shortages were up last year by 30%, with […]

September 29, 2023

Structure’s stock jump Friday — shares were up by more than 40% at one point — reflects investor enthusiasm for GLP-1 drugs, which promise to upend how obesity is treated. Already, demand for Novo Nordisk’s Ozempic and Wegovy as well […]

September 29, 2023

Over the past year, PTC has replaced its CEO, fired its CFO and rolled out two restructuring plans. The initial round of layoffs was expected to impact about 8% of its workers, and came after the study failure of an […]

September 27, 2023

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 […]

September 20, 2023

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 […]

September 8, 2023

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 […]

August 29, 2023

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 […]

August 23, 2023

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 […]

August 14, 2023

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 […]

August 2, 2023

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 […]

July 25, 2023

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 […]

July 25, 2023

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 […]

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 […]