March 1, 2024
Via: Biopharm InternationalThe number of contractors and subcontractors involved in the supply chain for finished goods can be high, and their relationships very complex, particularly when goods are shipped by air or sea. Depending on the scope of the activity (e.g., whether […]
February 2, 2024
Via: Biopharma DiveArch Venture Partners, one of the biotechnology sector’s most prolific company creators, is raising a new $3 billion fund, according to a regulatory filing. The fund, which would be Arch’s 13th, is being put together less than two years after […]
January 31, 2024
Via: Biopharm InternationalRevolo 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 […]
January 4, 2024
Via: Biopharma DiveBiotechnology is often described as an “innovation” industry, dependent on companies’ ability to invent and develop new medicines. By that metric, 2023 was a good year. The FDA’s main review office approved 55 novel drugs, the most since 2018, while […]
Cell and Gene Therapy, Industry
January 2, 2024
Via: Biopharma DiveNovartis is a leading gene therapy developer. In 2019, its SMA treatment Zolgensma became one of the first genetic medicines cleared for use in the U.S., and so far has been the field’s most lucrative product. Since then, gene therapy […]
July 6, 2023
Via: Biopharma DiveInitial public offerings in the biotechnology sector have been occuring at a snail’s pace in 2023, prolonging a downturn that’s now lasted nearly two years. Since January, only nine biotech companies have gone public, putting new stock offerings in the […]
May 10, 2022
Via: Biopharma DiveOver 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 […]
May 3, 2022
Via: FiercePharmaZosano 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 […]
October 6, 2021
Via: FiercePharmaWith Democrats in Washington debating the specifics of the president’s infrastructure program, the pharmaceutical industry may be able to squeak out a much-desired drug pricing win. As the negotiations unfold, Politico reports that the party leadership may have to abandon […]
August 12, 2021
Via: FiercePharmaPfizer and Moderna are getting used to readjusting their projected COVID-19 vaccine sales. Now another recalibration may be in order. The FDA is set to authorize a third dose of their COVID-19 shots for those with weakened immune systems, NBC […]
Clinical Trials, Research and Development
July 19, 2021
Via: Biopharma DiveEfficient execution of clinical trials requires the provision of medicines and all other critical materials to be carefully delivered on time to clinical sites or patient’s homes. Undertaking this level of detail at scale requires a considerable range of resources, […]
Manufacturing, Research and Development
June 8, 2021
Via: FiercePharmaAfter investigating America’s supply chains, including those for drugs and pharmaceutical ingredients, the Biden administration has revelations to share—and it’s proposing a sweeping strategy to boost domestic drug production. Under the plan, the White House is establishing a public-private partnership […]
June 4, 2021
Via: FiercePharmaMost people don’t normally think about the intricacies of the pharma supply chain, but the COVID-19 pandemic suddenly pushed the topic front and center. Now a new ad campaign from the Healthcare Distribution Alliance celebrates the critical work of healthcare […]
April 12, 2021
Via: BioSpaceAngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology today announced that on April 9, 2021, it submitted a 510(k) application to the United States Food and Drug […]
Manufacturing, News, Research and Development
April 8, 2021
Via: BioSpaceThe rising popularity of outsourcing implementations across the healthcare industry due to the benefits such as affordability and less-time consumption will serve as a vital growth prospect for the pharmaceutical contract development and manufacturing market during the forecast period of […]
March 10, 2021
Via: BioSpaceAgena Bioscience, the global manufacturer of the MassARRAY System for targeted genetic analysis, announced an exclusive distribution agreement with Alliance Global, the AGBL Group of companies, to bring the MassARRAY technology to many emerging markets across the Middle East, Africa, […]
January 12, 2021
Via: BioSpaceThe U.S. Food and Drug Administration (FDA) is experiencing abrupt and noticeable personnel changes as it continues to clash with the Health and Human Services (HHS), the department that oversees the agency and its operations. As reported in POLITCO, the […]
December 24, 2020
Via: BioSpaceAlgernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (the “Company” or “Algernon”) a clinical stage pharmaceutical development company announces that the Company has elected to exercise its acceleration right under the warrant indenture (the “Indenture”) governing the common share […]
Clinical Trials, Industry, Manufacturing, Research and Development, Vaccines
December 4, 2020
Via: Biopharma DiveWith Pfizer’s and Moderna’s vaccines proving highly protective against COVID-19 in large clinical trials, planning to roll out and distribute the two shots throughout the U.S. has kicked into high gear. The vaccines are expected to be authorized shortly after […]
September 29, 2020
Via: Biopharma DiveThe next three months will be among the most consequential in the Food and Drug Administration’s modern history. This fall, at least two of the leading coronavirus vaccine makers could seek emergency approvals, setting up what will be a series […]