Tag: featured

February 27, 2024

The FDA’s decision sets back many years of effort by Minerva to secure approval of its drug for schizophrenia, called roluperidone and designed to treat so-called negative symptoms of the condition. The company, which licensed rights to roluperidone from Mitsubishi […]

February 27, 2024

The round was led by Pfizer’s investment arm Pfizer Ventures, with Columbus Venture Partners and British Patient Capital joining the round along with prior investors Advent Life Sciences and Epidarex Capita. The proceeds will be used to develop Curve’s Microcycle […]

February 26, 2024

Founded in 2007, NGM took a broad approach to its drug research, assembling a pipeline that spans from solid tumors to retinal diseases to liver and metabolic disorders. NGM raised a few hundred million dollars in private funding before going […]

February 22, 2024

In an unusual move, United Therapeutics has filed a lawsuit against the FDA which claims the regulator is sidestepping established norms in allowing rival Liquidia to file for approval of a competitor to its Tyvaso product. The suit claims that […]

February 21, 2024

On Feb. 15, 2024, FDA’s Center for Drug Evaluation and Research (CDER) released its report, Drug Safety Priorities FY23. The report describes the center’s key safety programs and activities involved in promoting and protecting public health and dealing with the […]

February 20, 2024

Analysts have followed Rapt as they view its drug, an oral pill dubbed zelnecirnon, as a possible competitor to Dupixent in conditions like eczema. Dupixent, which was developed by Sanofi and Regeneron, is a multibillion-dollar product approved for a range […]

February 20, 2024

Tagrisso is at the center of AstraZeneca’s oncology resurgence. The drug, which first won approval in the U.S. in 2015, is the company’s second highest selling product, after the diabetes and kidney disease treatment Farxiga. It has become a go-to […]

February 20, 2024

Innovative Trials has announced a new initiative designed to boost clinical trial patient retention in paediatric studies, in partnership with the Oliver Patch Project, a US charity. The Retention Patch Program is designed to engage directly with children and young […]

February 14, 2024

A little over four years ago, biotechnology giant Amgen retreated from neuroscience research, halting much of its work developing treatments for diseases of the brain and trimming associated staff. Amgen’s pivot proved a boon for a small startup that was […]

February 13, 2024

Both companies have entered into a license and option agreement, as well as a securities purchase agreement, in connection with the collaboration. Under the terms of the agreement, BioNTech will purchase $200m of Autolus’ US depositary shares in a private […]

February 12, 2024

Six biotechnology startups are merging into a new skin drug developer called Alys Pharmaceuticals, which launched on Monday with $100 million from European life sciences investment firm Medicxi. Alys was formed out of the merger of a group of biotechs […]

February 12, 2024

Researchers from the Massachusetts Institute of Technology (MIT) and the Singapore-MIT Alliance for Research and Technology have developed a plastic microfluidic chip to improve the safety and effectiveness of cell therapy treatments for patients living with spinal cord injuries. In […]

February 12, 2024

The fast-track designation from the US regulator recognises that bepirovirsen is the only single agent in phase 3 that has shown the potential to achieve a “functional cure” when combined with standard CHB therapies based on oral nucleoside or nucleotide […]

February 7, 2024

AstraZeneca is ramping up in cell therapy after a late entrance to the field. In 2022, it made its first significant acquisition in the area, buying up privately held Neogene Therapeutics. And the follow year, it formed a partnership with […]

February 7, 2024

On Feb. 5, 2024, FDA announced it has published a draft guidance, Notification of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act, to assist applicants and manufacturers in notifying the agency about changes in […]

February 6, 2024

When getting vaccines, switching arms for each dose may produce greater immunity than having the jabs delivered into the same arm. That’s the finding from a new study that looked at the first two doses of COVID vaccines. Those who […]

February 6, 2024

To hear venture capitalist Alex Morgan tell it, investors shouldn’t be in the business of predicting trends. “There’s often a public perception that we’re in the prediction game,” said Morgan, a partner at Khosla Ventures who oversees the firm’s biotechnology […]

February 5, 2024

Biovian, a contract development and manufacturing organization (CDMO), announced on Feb. 1, 2024 that it was combining with CDMO 3P Biopharmaceuticals to form 3PBIOVIAN under the two companies’ common shareholder, Keensight Capital. The new group, 3PBIOVIAN, will offer end-to-end development […]

February 2, 2024

If the biologics license application (BLA) is approved, afami-cel will become the first engineered T-cell therapy for solid tumours and the first effective treatment option for advanced synovial sarcoma in more than a decade, according to the Anglo-American company. Synovial […]

January 31, 2024

Revolo Biotherapeutics announced on Jan. 30, 2024 that FDA has granted Orphan Drug Designation to ‘1104, a first-in-class immune-resetting peptide being developed as a potential treatment for eosinophilic esophagitis (EoE). Revolo focuses on developing therapies that reset the immune system […]