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 […]
Cell and Gene Therapy, Industry
December 6, 2023
Via: Biopharma DiveFujifilm said Tuesday it will invest $200 million in cell therapy manufacturing, earmarking the new funds for an area of drug research it expects to grow considerably in the coming years. The investments will go to two subsidiaries focused on […]
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 16, 2023
Via: Biopharma DiveThe arrival of immunotherapies like Merck & Co.’s Keytruda and Bristol Myers’ Opdivo transformed the treatment of lung cancer. But for patients with uncommon mutations like ROS1, ALK, KRAS and EGFR, targeted drugs are a first choice for physicians. The […]
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 […]
November 8, 2023
Via: Biopharma DiveThe 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 8, 2023
Via: Biopharma DiveThe Food and Drug Administration on Wednesday approved a powerful new medicine for weight loss, clearing Eli Lilly’s Zepbound for adults with obesity or who are overweight and have at least one related health condition. The drug, which was already […]
Manufacturing, Research and Development
November 2, 2023
Via: Biopharm InternationalOn Oct. 30, 2023, Aragen, a contract research development and manufacturing organization (CRDMO), announced that it was setting up a new biologics manufacturing facility in Bangalore, India as part of a $30 million investment. The new 160,000 m2 facility will […]
November 1, 2023
Via: Biopharm InternationalIn 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 30, 2023
Via: Biopharm InternationalOn Oct. 20, 2023 Pfizer announced that PENBRAYA, its vaccine for meningococcal groups A, B, C, W, and Y, has been approved by FDA. According to Pfizer, PENBRAYA is the first and only vaccine to protect against the five most […]
October 25, 2023
Via: Pharma TimesThe US Food and Drug Administration (FDA) has granted clearance for Endogena Therapeutics’ investigational new drug application to treat geographic atrophy (GA), an advanced form of age-related macular degeneration (AMD). The FDA clearance will enable Endogena to progress with the […]
October 19, 2023
Via: Kaiser Health NewsA Senate committee finally held a hearing Wednesday on President Joe Biden’s pick to lead the National Institutes of Health. But the panel’s chair, Sen. Bernie Sanders (I-Vt.), was focused on drug prices — an issue over which the NIH […]
October 17, 2023
Via: PharmaphorumZilbrysq (zilucoplan), billed as the first once-daily subcutaneously-administered complement C5 inhibitor, will launch onto the US market in competition with AstraZeneca’s Soliris (eculizumab) and follow-up Ultomiris (ravulizumab) – both given as intravenous infusions – which were approved for gMG in […]
October 13, 2023
Via: Biopharma DiveIn clinical trials, Velsipity helped 27% of patients taking it go into remission at 12 weeks and 32% at 52 weeks, significantly higher than the 7% of patients who received placebos at both time points. The pill also showed a […]
October 6, 2023
Via: Kaiser Health NewsIn 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 […]
October 6, 2023
Via: Biopharma DiveThe negative panel vote is a setback in Amgen’s efforts to cement Lumakras’ U.S. approval, but doesn’t appear likely to result in the drug’s withdrawal from market. Many of the advisers, in explaining their “no” votes, indicated they were ruling […]
October 2, 2023
Via: Biopharm InternationalIt is common knowledge that messenger RNA (mRNA) advances saved lives and limited the extent of the COVID-19 pandemic. Far less recognized, even in the science and technology community, is the decade-long nurture and support governmental organizations provided the mRNA […]
September 29, 2023
Via: Biopharma DiveStructure’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
Via: Biopharma DiveOver 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 […]
Manufacturing, Research and Development
September 29, 2023
Via: Biopharm InternationalIn 2022, the number of newly approved biologic drugs outpaced that of small molecules for the first time (1). Notably, almost a third of the new approvals comprised novel modalities, such as cell and gene therapies, antibody–drug conjugates, and bispecific […]