Google, Bayer team up to develop new AI products for radiologists
Fierce Healthcare
APRIL 9, 2024
Healthcare company Bayer has tapped Google for its cloud and artificial intelligence capabilities to build new tech products to assist radiologists.
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Daiichi Sankyo Invests Roughly $1.08 Billion to Expand German Production and Development Site for ADCs
BioPharm
FEBRUARY 22, 2024
billion) to expand its Pfaffenhofen an der Ilm, Germany, site for ADC development and production. Daiichi Sankyo is investing approximately €1 billiion (US$1.08
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When passion fuels product development
Drug Store News
JUNE 7, 2023
Meraki is making waves in the beauty space with its hair care products, which are infused with crystals to provide additional benefits.
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eTheRNA Manufacturing Announces New LNP Formulation Development and Production Service
Pharma Mirror
MARCH 29, 2022
NIEL, BELGIUM, eTheRNA Manufacturing, a specialist RNA process developer and manufacturing member of the Belgian eTheRNA group, is introducing a new Lipid Nanoparticle (LNP) formulation development and production service to support the discovery and early pre-clinical development of RNA-based therapeutics and vaccines.
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What the FDA's New Dosage Guidance Means for the Future of Clinical Research
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
Learning Objectives: Dose-response curves and patient treatment: How do pharmacologic and toxicologic principles apply to the dosing of drugs in clinical development? What will the future hold for clinical research? A recent draft from the FDA provides valuable insight.
FDA Creates a New Advisory Committee for Genetic Metabolic Diseases – Could This Be an Opportunity to Support Rare Disease Product Development More Broadly?
The FDA Law Blog
DECEMBER 13, 2023
Drug development for these conditions has unique and complex challenges, therefore few treatments are available to patients.” GeMDAC’s mandate is to advise the Agency on these complicated issues in this challenging area of medical product development.
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Bayer launches unit to develop new precision health consumer products
Drug Store News
JUNE 1, 2023
The group said it will focus on addressing unmet needs in its core categories, delivering new evidence-based precision health products to the market.
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Benefits and Limitations of Strategies Used to Improve Clinical Development Productivity
PharmExec
MARCH 13, 2024
In this Pharmaceutical Executive video interview, Murray Aitken, Executive Director of the IQVIA Institute for Human Data Science, discusses findings from IQVIA's Global Trends in R&D 2024 report including the potential benefits and limitations of novel trial designs and decentralized methodologies.
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How Real-Time Data Helps Business Development Teams with New Product Acquisition Research
InCrowd
AUGUST 2, 2022
Learn why a pharmaceutical company considering acquiring a new product asset in a space with noticeable market movement turned to InCrowd’s global qualitative and quantitative solutions to uncover opportunities in product administration and identify an unmet market need. Get the results in our latest case study.
Strategic CMC Development Partnership Enabling Timely Approval and Launch of a Breakthrough Product
Impact Pharmaceutical Services
NOVEMBER 1, 2023
Download The Case Study The post Strategic CMC Development Partnership Enabling Timely Approval and Launch of a Breakthrough Product appeared first on SYNER-G. Because of the quality of the entire Syner-G team, the client knew it was going to receive the same caliber of service and expertise from everyone they worked with.
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FDA Issues Guidance on CAR-T Cell Product Development
BioPharm
FEBRUARY 1, 2024
The final guidance provides specific recommendations for CMC, pharmacology, toxicology, and clinical study design for CAR-T cell products.
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The race to develop innovative products and supply chain solutions
pharmaphorum
DECEMBER 30, 2023
The topic of discussion centres around considerations and challenges when it comes to launching a biopharmaceutical product in Europe.
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Bio-Rad and Oncocyte partner to develop and commercialise transplant monitoring products
Pharma Times
APRIL 16, 2024
Solid organ transplantation is used to treat end-stage organ failure, including the kidneys
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Wearables, Sensors, and Apps Part 1 – Updates on FDA’s PDUFA VII Goals for the Use of Digital Health Technologies in Drug and Biological Product Development
The FDA Law Blog
AUGUST 23, 2023
This blog provides an update on the DHT-related PDUFA VII goals that were targeted for completion in the first two quarters of FDA’s Fiscal Year (FY) 2023, including: By the end of Q2 FY 2023, FDA will establish a DHT framework document to guide the use of DHT-derived data in regulatory decision-makings for drugs and biological products.
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Wearables, Sensors, and Apps Part 2 – Development and Qualification of Digital Health Technologies in Drug and Biological Product Development
The FDA Law Blog
AUGUST 28, 2023
Lenz, Principal Medical Device Regulation Expert — Following up on our first post discussing Digital Health Technologies (DHTs) ( here ), this post will focus on development and qualification of DHTs for use in clinical trials for drug development.
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LNP Characterization in Product Development
BioPharm
SEPTEMBER 12, 2022
Light scattering quantifies key attributes of lipid nanoparticle gene vectors, such as payload, size, titer, and stability in formulation and physiological media.
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FDA Publishes New Product-Specific Guidelines for Generic Drug Development
BioPharm
FEBRUARY 17, 2023
Some noteworthy PSGs include dihydroergotamine mesylate nasal spray, glucagon nasal powder, afamelanotide subcutaneous implant, and triamcinolone acetonide injectable suspension.
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Adragos Pharma - poised to make a lasting impact in the pharmaceutical industry
Outsourcing Pharma
APRIL 11, 2024
Adragos Pharma is a contract development and manufacturing organization (CDMO) that provides development and manufacturing services for drug products. It concentrates on small molecule dosage forms including sterile and non-sterile liquids, solids, and semi-solids products.
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Comparison Of Rebyota Versus Vowst: A Study Table To Help You Compare Fecal Microbiota Therapies
IDStewardship
APRIL 14, 2024
Gut dysbiosis has been the subject of several clinical research studies aiming to better understand its role in rCDI and to ultimately apply that understanding towards the development of preventative treatments. Rebyota, a solution delivered via enema, was the first FMT product to be FDA-approved.
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Shinobi strikes deal with electronics powerhouse Panasonic to create new cell therapy manufacturing platform
Fierce Pharma
APRIL 18, 2024
History is coming full circle as induced pluripotent stem (iPS) cell-derived cell therapy maker Shinobi Therapeutics links up with Panasonic and Japan’s Kyoto University, where the first mouse iPS | Shinobi Therapeutics has entered an accord with electronics powerhouse Panasonic and Kyoto University in a bid to develop a new closed-system manufacturing (..)
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Daiichi Sankyo plots €1B expansion to beef up antibody-drug conjugate production in Germany
Fierce Pharma
FEBRUARY 20, 2024
After laying out plans to absorb a pair of production subsidiaries in October, Japan’s Daiichi Sankyo is doubling down on its quest to dominate the red-hot antibody-drug conjugate (ADC) field. Aiming to beef up development and manufacturing of antibody-drug conjugates, Daiichi Sankyo is plugging roughly €1 billion ($1.08
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STAT+: As Humira biosimilars take over the market, CVS has created a new ploy: the drug ‘rebate credit’
STAT
MARCH 18, 2024
So when new market developments threaten to diminish or wipe away that revenue stream, PBMs find crafty ways to keep as much of those dollars as possible — often at the expense of employers. Continue to STAT+ to read the full story…
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Teva UK partners Closed Loop on personalised medicine
pharmaphorum
MARCH 27, 2024
Teva UK has joined forces with techbio company Closed Loop Medicine to develop digital companions for pharma products that could provide personalised medicine
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Accelerating High-Concentration Protein Drug Product Development Via the High-Throughput, and High-Quality WuXiHighTM Platform
BioPharm
JANUARY 25, 2024
Webinar Date/Time: Thu, Feb 22, 2024 11:00 AM EST
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Patent expiration to drive biosimilars market expansion to 2032
European Pharmaceutical Review
APRIL 11, 2024
Over the past few years, the biosimilar market has expanded “rapidly” due to these medicines offering a cost-effective alternative to the reference product. Because there are so many biosimilars in various stages of development, the report predicted that expansion of the biologics market will likely “slow down soon”.
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Catching up with LGM Pharma ahead of CPhI North America to find out about its pipeline
Outsourcing Pharma
APRIL 19, 2024
LGM Pharma is a leading CDMO provider of comprehensive API sourcing and drug product contract development and manufacturing solutions to the pharmaceutical, biotechnology, and compounding pharmacy industries.
Teva enters into oncology biosimilar licensing agreement
European Pharmaceutical Review
APRIL 16, 2024
A new global licensing agreement is set to advance development of an oncology biosimilar candidate. and Spain-based biopharmaceutical company mAbxience, have entered into a strategic deal for a drug candidate that is in development for treating multiple indications in the oncology space.
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STAT+: Amy Abernethy to step down as Verily’s chief medical officer in latest departure from company
STAT
DECEMBER 19, 2023
Amy Abernethy, the president of product development and chief medical officer at Verily, a health care spinout of search giant Alphabet, will leave the company at the end of the first quarter to start a nonprofit aimed at changing the way the health care system collects data. Continue to STAT+ to read the full story…
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FDA Issues Fast Track Designation to ADP101 for Mono-, Multi-Food Allergies
Pharmacy Times
NOVEMBER 22, 2023
The designation allows expedited development of ADP101 as a treatment for food allergy in children ages 4 to 17 with confirmed allergy to 1 or more of the 15 foods in the drug product.
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Opinion: For national security, the U.S. must maintain its biotech dominance
STAT
APRIL 4, 2024
researchers discovered new antibiotics that turned once-fatal infections into minor ailments, and developed antiretroviral cocktails that transformed HIV from a death sentence into a manageable, chronic disease. The development of new biofuels could transform global politics as countries grow less reliant on oil-rich nations.
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Key questions (and answers) about the historic approval of a CRISPR-based medicine
STAT
NOVEMBER 16, 2023
The regulator is the United Kingdom’s Medicines and Healthcare products Regulatory Agency. The product is Casgevy, a treatment for sickle cell disease and beta thalassemia, two blood disorders. For the first time, a regulator has cleared a treatment using CRISPR , the gene-editing technology, for patients.
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Opinion: STAT+: A California court is setting a dangerous precedent over drug development (or lack thereof) liability
STAT
FEBRUARY 13, 2024
The assault on the development of new lifesaving therapies continues apace. Recently, the First Appellate Division of California Appeals held that companies not only have to defend products they have developed and marketed, but also those they have not. Now, the California court has agreed to let the suit proceed.
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Making new product planning for life science more effective with human-centred design
pharmaphorum
OCTOBER 28, 2022
The sooner a human-centred perspective is applied to the development of either a drug or device product, the more likely the product will be adopted and used because it’s been designed around what the end consumer wants and needs. This will ensure that you are developing a product these audiences will use.
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Appeals court allows unique argument in Gilead's legal battle over HIV meds
Fierce Pharma
JANUARY 12, 2024
When a plaintiff raises allegations of negligence against a company, the claims typically center on defective products that can cause harm. | Now, Gilead will have to prove that a manufacturer can't be held liable for its development timeline of an upgraded product.
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Novo Nordisk to expand French production facilities
European Pharmaceutical Review
NOVEMBER 24, 2023
billion (16 billion Danish kroner) to expand its production site in Chartres, France, supporting manufacture of its products for serious chronic diseases. Aseptic production and finished production processes will be added to the site, as well as an extension of the current Quality Control Laboratory.
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Teva, forging ahead with new strategy, inks biosimilar deal with Spain's mAbxience
Fierce Pharma
APRIL 4, 2024
Under the deal, Teva will oversee regulatory duties and marketing for the biosimilar, while mAbxience is on the hook to continue developing and manufacturing the drug at its production sites in Spain and Argentina.
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STAT+: Can gene therapies make for a profitable business? Keep your eye on Bluebird Bio
STAT
FEBRUARY 1, 2024
Bluebird and the case for gene therapy profits Genetic treatments that are potential cures for inherited diseases are a huge medical advance, but can these transformational (and expensive) products become a profitable business? The other products are Zynteglo for beta thalassemia ($2.8 million), Bluebird sells three gene therapies.
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Navigating the unique CMC challenges of oral anaerobic live biotherapeutics
European Pharmaceutical Review
FEBRUARY 14, 2024
The development of drug products containing live anaerobic bacterial strains as the active pharmaceutical ingredient and where potency and shelf-life is typically associated with viable cell quantification, poses unique challenges when compared to both small and large molecule development therapeutics.
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High-flying Fujifilm splashes $200M to beef up cell therapy capacity
Fierce Pharma
DECEMBER 4, 2023
Fujifilm Corporation is spreading the wealth across two production units as the contract development and manufacturing organization (CDMO) juggernaut works through a cell therapy expansion. Fujifilm is dividing $200 million between a pair of subsidiaries.
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STAT+: Novo Holdings to purchase drug manufacturer Catalent for $16.5 billion, a deal that could expand Wegovy production
STAT
FEBRUARY 5, 2024
billion deal, an acquisition that will give Novo additional sites as it builds up production of its booming obesity and diabetes drugs. Under the deal, Novo Holdings is purchasing Catalent, a major contract development and manufacturing company with more than 50 sites globally.
Ascendis Pharma’s Yorvipath approved by MHRA for hypoparathyroidism treatment
Pharmafile
APRIL 25, 2024
Ascendis Pharma has announced that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation for Yorvipath (palopegteriparatide; developed as TransCon PTH) in Great Britain as a parathyroid hormone (PTH) replacement therapy for the treatment of adult patients with chronic hypoparathyroidism.
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Analytical technique may advance medical cannabis quality control
European Pharmaceutical Review
MARCH 15, 2024
Researchers have proposed an advanced analytical technology that can rapidly classify medical cannabis plants at production sites. Hurdles in medical cannabis development “Medical cannabis must be produced in a very controlled way and there is as yet no clear regulation in this regard,” San Nicolas added.
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Ultragenyx Pharmaceutical gets grant for method of developing stable cell line for producing RAAV
Pharmaceutical Technology
APRIL 22, 2024
Develop a stable cell line for high-titer rAAV production with Ultragenyx's patented method involving HDAC inhibitors and AAV rep proteins. Explore the groundbreaking patent now!
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Alkermes to sell Irish manufacturing facility to Novo Nordisk
European Pharmaceutical Review
DECEMBER 15, 2023
Alkermes has agreed to sell its pharmaceutical development and manufacturing facility in Athlone, Ireland to Novo Nordisk for $92.5 Hummel Bøgebjerg, Senior Vice President, Product Supply Emerging Technologies, Novo Nordisk. The deal also includes around 400 staff employed by Alkermes in drug development and manufacturing.
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