January 11, 2024
Via: Biopharma DiveThe J.P. Morgan Healthcare Conference, a yearly temperature taker for the biotechnology industry, had a different feel in 2024. For the first time in awhile, young drugmakers and their backers were optimistic the sector’s downturn might finally be over. An […]
January 10, 2024
Via: Pharma TimesBarinthus Biotherapeutics has announced a new partnership with the Coalition for Epidemic Preparedness Innovations (CEPI) and the University of Oxford to advance a vaccine against Middle East respiratory syndrome (MERS). The partnership aims to fast-track the development of Barinthus Bios’ […]
January 5, 2024
Via: Drugs.comThe U.S. Food and Drug Administration on Friday gave the nod to a Florida plan to import drugs from Canada at much lower prices than in the United States. The approval could prove to be a major turning point for […]
January 2, 2024
Via: Biopharma DiveThe Food and Drug Administration closed out 2023 with rejections of three drugmaker applications for first approval or expanded use, handing Amgen, Zealand Pharma and Merck & Co. complete response letters for medicines to treat cancer, low blood sugar and […]
December 29, 2023
Via: Drugs.comResearchers appear to have discovered a new weapon in the war on a particularly difficult foe. They have identified a previously unrecognized class of antibodies that seem to be capable of neutralizing multiple strains of the flu virus. Their findings, […]
Clinical Trials, Research and Development
December 28, 2023
Via: PharmaphorumTreatment with the cardiac myosin inhibitor significantly improved exercise capacity in patients with obstructive hypertrophic cardiomyopathy (HCM), an inherited disorder in which the heart muscle becomes thickened and can obstruct blood flow. It is one of the most common reasons […]
December 26, 2023
Via: PharmaphorumThe agreement is the latest in a series of acquisitions and licensing deals aimed at bolstering AZ’s position in cell therapy, an area where it has lagged behind other companies like Novartis, Bristol-Myers Squibb, and Gilead Sciences, and also continues […]
December 20, 2023
Via: PharmaphorumThe validity of the patent is at the heart of patent litigation between CureVac and fellow German biotech BioNTech and its partner Pfizer, claiming infringement by their Comirnaty coronavirus shot. CureVac – which is developing mRNA-based vaccines for COVID-19 and […]
December 18, 2023
Via: Camila MendesWith a $1.2 billion dollar acquisition of Gracell Biotechnologies, pharmaceutical giant AstraZeneca has firmly entrenched itself in the Asian market. The company is not only expanding its footprint, but also broadening its scope with its foray into cell therapy—Gracell’s specialized […]
December 12, 2023
Via: PharmaphorumThe $15-per-share deal is a 43% premium to Icosavax’s closing share price yesterday and values the company at around $1.1 billion, of which $800 million is payable near-term, with the remainder tied to certain future achievements. It is due to […]
December 7, 2023
Via: Kaiser Health NewsColorado officials say their plan to import cheaper medicines from Canada has been stymied by opposition from drugmakers and inaction by the Biden administration, according to a state report obtained by KFF Health News. The Dec. 1 report, prepared for […]
November 28, 2023
Via: Drugs.comCOVID vaccines saved the lives and health of countless babies by preventing their premature births, a new study shows. COVID-19 initially caused an alarming surge in premature birth rates, but those returned to pre-pandemic levels following the introduction of vaccines, […]
November 22, 2023
Via: PharmaphorumModerna has lawsuits on the go against BioNTech in several jurisdictions, including the US, Germany, the UK, the Netherlands, Belgium, and Ireland, claiming that its Comirnaty vaccine infringes patents covering its own Spikevax shot, including EU patents EP3590949 (the ‘949 […]
Manufacturing, Research and Development
November 17, 2023
Via: Biopharm InternationalPlasmid DNA is a critical raw material that is required for the manufacturing of virus-based gene therapy and gene-modified cell therapies. The current challenges with the supply of plasmid DNA varies depending on its end use, but usually production capacity, […]
November 15, 2023
Via: PharmaphorumAliqopa (copanlisib) was given accelerated approval by the FDA in 2017 as a third-line treatment for adults with relapsed FL, a form of non-Hodgkin lymphoma (NHL), based on response rate data from the phase 2 CHRONOS-1 study. The CHRONOS-4 trial […]
November 14, 2023
Via: PMLiVEThe VVPs are a result of collaboration between several pathogen and vaccine experts. Led by the Product Development and Research (PDR) team in WHO’s immunisation, vaccines and biologicals department, the aim of the VVPs is to advance the development of […]
Clinical Trials, Research and Development
November 13, 2023
Via: Biopharma DivePandemic-era changes may have permanently altered the clinical trial landscape as decentralized clinical trials gain broader acceptance. During COVID-19, more than three-quarters (76%) of pharmaceutical companies, device manufacturers and contract research organizations conducted off-site clinical trials. These types of trials […]
November 10, 2023
Via: Drugs.comIn a sign that suggests many American parents have become dubious about the safety of childhood vaccines, new government data shows that immunization exemptions for kindergartners have reached their highest levels ever. The latest statistics continue a decline in routine […]
November 10, 2023
Via: Drugs.comThe first vaccine to prevent infection with the chikungunya virus was approved by the U.S. Food and Drug Administration on Thursday. The single-dose shot, known as Ixchiq, is approved for adults who are at increased risk of exposure to the […]
November 3, 2023
Via: Biopharm InternationalOn Oct 31, 2023, Novartis announced FDA’s approval of Cosentyx (secukinumab) as a treatment for adults with moderate to severe hidradenitis suppurativa (HS). As reported by Novartis, Cosentyx is the only FDA-approved fully human biologic that directly inhibits interleukin-17A (IL17A), […]