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 […]
Clinical Trials, Manufacturing, Research and Development
September 3, 2020
Via: BioSpaceCNS PHARMACEUTICALS AG, Inc. (NASDAQ: CNSP) (“CNS” or the “Company”), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the central nervous system, today provides an update on progress for the U.S. manufacturing […]
August 28, 2020
Via: FiercePharmaAstraZeneca has been on roll lately, inking COVID-19 vaccine supply deals left and right with countries worldwide. One of its highest-profile pacts—a purchase deal with the European Union—was made official earlier this month, and now, the trading bloc has floated […]
July 28, 2020
Via: Biopharma DiveWith just over three months before the U.S. elections in November, President Donald Trump is making a last-ditch effort to stamp his name on a drug pricing deal that has eluded him over his first three years in office. A […]
July 14, 2020
Via: BioSpaceIn hopes of a late-stage COVID-19 vaccine candidate hitting the 50% efficacy threshold set by the U.S. Food and Drug Administration, U.S. drugmakers who have partnered with the U.S. government could begin to manufacture doses of a preventative treatment by […]
June 17, 2020
Via: Biopharma DiveVaccines normally take years to test and mass produce; the European Union, like the U.S., is trying to shrink that timeframe to 12 to 18 months. In addition to providing financial help to companies who are ramping up production before […]
June 15, 2020
Via: Biopharm InternationalFDA has revoked the emergency use authorization (EUA) for hydroxychloroquine sulfate (HCQ) and chloroquine phosphate (CQ) as treatments for COVID-19, according to a June 15, 2020 announcement. In a statement on its website, the agency noted that it “has determined […]