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Tag: drug manufacturing


News

Colorado Blames Biden Team and Drugmakers for Delaying Canadian Imports

December 7, 2023

Via: Kaiser Health News

Colorado 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

Fujifilm to invest $200M in cell therapy production

December 6, 2023

Via: Biopharma Dive

Fujifilm 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

Accelerating Lentivirus Manufacturing: Choosing the Right Plasmid Manufacturing Platform

November 17, 2023

Via: Biopharm International

Plasmid 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, […]


FDA, Regulations

FDA approves new Bristol Myers drug for lung cancer

November 16, 2023

Via: Biopharma Dive

The 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 […]


Industry, Vaccines

New WHO initiative to prioritise endemic pathogens for vaccine development

November 14, 2023

Via: PMLiVE

The 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 […]


News

FTC challenges patents held by nine big drugmakers, citing unfair competition

November 8, 2023

Via: Biopharma Dive

The 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 […]


FDA, Regulations

Lilly weight loss drug approved by FDA

November 8, 2023

Via: Biopharma Dive

The 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

Aragen to Establish $30 Million Biomanufacturing Facility in India

November 2, 2023

Via: Biopharm International

On 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 […]


News

The Challenge of Raw Material Variation in Adopting Continuous Manufacturing (AAPS PharmSci 360)

November 1, 2023

Via: Biopharm International

In 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, […]


Industry, Vaccines

FDA Approves Vaccine for Prevention of the Five Most Common Serogroups Causing Meningococcal Disease in Adolescents

October 30, 2023

Via: Biopharm International

On 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 […]


FDA, Regulations

FDA grants clearance for Endogena’s age-related macular degeneration treatment

October 25, 2023

Via: Pharma Times

The 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 […]


Pricing, Regulations

Biden Pick to Lead NIH Finally Has Her Day, but Still Gets Caught Up in Drug Price Debate

October 19, 2023

Via: Kaiser Health News

A 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 […]


Industry, Pharma

UCB bags FDA approval for second myasthenia gravis drug

October 17, 2023

Via: Pharmaphorum

Zilbrysq (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 […]


FDA, Regulations

Pfizer wins FDA approval for its $7B colitis drug

October 13, 2023

Via: Biopharma Dive

In 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 […]


News

Trump Misplaced Blame When He Said Drug Shortages Were Biden’s Fault

October 6, 2023

Via: Kaiser Health News

In 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 […]


FDA, Regulations

FDA panel finds KRAS drug data unreliable, in blow to Amgen

October 6, 2023

Via: Biopharma Dive

The 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 […]


FDA, Regulations

FDA Gets Its Arms Around Advanced Therapy Medicinal Products Early

October 2, 2023

Via: Biopharm International

It 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 […]


News

Structure boosted by early data for experimental obesity drug

September 29, 2023

Via: Biopharma Dive

Structure’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 […]


News

PTC to lay off more staff following drug setback in Europe

September 29, 2023

Via: Biopharma Dive

Over 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

Innovations and Trends in Aseptic Manufacturing Processes

September 29, 2023

Via: Biopharm International

In 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 […]