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Among PMEC exhibitors are ACG, Accupack Engineering, Ace Technologies, Avish Machines, Bowman & Archer Pharma Machines, Cadmach Machinery, CAM PAK India, Fette India, IMA Industria Macchine, Parle Global Technologies, Snowbell Machines, and Truking Technology, showcasing cutting-edge equipment for pharmaceuticalmanufacturing.
Integrating IT with pharmaceuticals will further strengthen its role, paving the way for dominance in biologics and biosimilars. With exports nearing $27.84 billion and innovative advancements like nanoparticles and improved drug delivery systems, India continues to lead.
announced that it has partnered with Tabuk PharmaceuticalManufacturing Company to commercialize BAT2206, a proposed ustekinumab biosimilar to Jansen’s STELARA, in Saudi Arabia. Stay up to date on biosimilar news, applications and approvals in the Greater China by following our Big Molecule Watch China blog.
International Federation of PharmaceuticalManufacturers and Associations (IFPMA), the global trade body for the biopharmaceutical industry , has announced its new CEO leadership team for the next two years. The site holds the world’s largest manufacturing capacity at a single site.
2) limiting the scope and number of patents asserted in litigation against proposed biosimilar entrants. 3) policing anticompetitive settlements between competing drug manufacturers. 4) prohibiting ‘product hopping’ and interference with generic and biosimilar substitutions. 5) monitoring access to biosimilars.
Richardson, who focuses her practice on state and federal regulatory strategy and compliance, primarily for pharmaceuticalmanufacturers and wholesale distributors, has been with the firm 7 years and has proven herself invaluable to colleagues and clients alike. Kalie is the quintessential HPM lawyer.
I am pleased to announce our new 2021–22 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors , available for purchase and immediate download. pharmaceutical distribution industry. analyzes how marketplace dynamics of provider-administered biosimilars affect wholesalers’ gross margins. Section 4.4.
Drug Distribution Industry Expands as COVID-19 Disruption Fades and Biosimilars Boom (press release) We’re offering special discounted pricing if you order before October 21, 2022! pharmaceutical distribution industry. If you would like to pay by corporate purchase order or check, please email Tamra Feldman.
Data integrity is a paramount concern for pharmaceuticalmanufacturers, particularly as they navigate the complexities of modern production with legacy equipment.
It’s time for Drug Channels ’ annual update on pricing at the largest pharmaceuticalmanufacturers. Insulin has been the first to deflate—and the Humira biosimilar market may be next. You can find links to each company’s data below. See the second chart below.
The event, titled “New and Improved – AMCP Format for Formulary Submissions v5.0,” aims to educate pharmaceuticalmanufacturers and other healthcare stakeholders on the latest updates and best practices in dossier development.
The PMEC segment will highlight companies such as ACG, Cadmach Machinery, Fette India, and Parle Global Technologies, showcasing pharmaceuticalmanufacturing equipment. The event will feature prominent exhibitors, including Dr Reddy’s Laboratories, Biocon, Glenmark Lifesciences, Hetero Labs Limited, and Lupin, among others.
Mr. Karst, a co-author of the FDA Law Blog, provides regulatory counsel to pharmaceuticalmanufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. This is an achievement that only around 5% of WWL-listed practitioners were accorded in 2023.
Gaulkin — Enacted in 2022, the Inflation Reduction Act (IRA) amended the Medicare provisions of the Social Security Act to impose several discount requirements on pharmaceuticalmanufacturers.
Drug Distribution Industry Gaining from Anti-Obesity Drugs and Provider-Administered Biosimilars (press release) We’re offering special discounted pricing if you order before October 20, 2023! pharmaceutical distribution industry. and Section 6.4.3. A new Section 6.2.2.
Advanced manufacturing technologies The legislation also calls for HHS to support development and implementation of advanced and continuous pharmaceuticalmanufacturing technologies through creation of national centers of excellence. Such products include small molecule medicines, biologics and biosimilars.
Sustainability in the pharmaceutical sector is becoming increasingly critical. With growing awareness of the environmental impact of pharmaceuticalmanufacturing—such as pollution from toxic discharges—companies must adopt more sustainable practices. billion green loan to fund its purchase of Viatris’ biosimilars business.
She also provides consulting services for state licenses, as well as regulatory due diligence concerning licensing requirements, primarily for pharmaceuticalmanufacturers, wholesale distributers, and pharmacies. Sara is conveniently able to be a client’s one-stop point of contact for licensing needs.
Kurt provides regulatory counsel to pharmaceuticalmanufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. He helps clients develop strategies for product lifecycle management, obtaining approval, managing post-marketing issues, and defining periods of exclusivity.
Kirschenbaum — Last week, the United States Court of Appeals for the District of Columbia ruled that Section 340B of the Public Health Service Act does not prohibit pharmaceuticalmanufacturers from imposing conditions on the distribution of discounted drugs to covered entities in the program. In United Therapeutics Corporation v.
Gaulkin — On April 10, the Fourth Circuit unanimously affirmed a summary judgment ruling for the Centers for Medicare & Medicaid Services (CMS) regarding the agency’s definitions of “line-extension drug” and “new formulation” for purposes of determining rebates that drug manufacturers may owe the Medicaid Drug Rebate Program (MDRP).
The court did not make much of Plaintiff’s argument that a manufacturer cannot terminate its participation in Medicare for close to two years, see Motion at 8; Complaint at 27-28, potentially dismissing it as a mere administrative matter. Standing The Defendants questioned, and the court reviewed, Plaintiffs’ standing.
FDA issued 72 CGMP-related warning letters to pharmaceuticalmanufacturing sites, and over two-thirds of those went to makers of non-application products. Again, the effects of the PHE lingered in this area, as FDA targeted hand sanitizer manufacturers with 31 of those 72 letters.
Addepalli Veeranjaneyulu and Shubhadeep Debabrata Sinha introduced the session by describing the function of PV in the safety profiles of biosimilars. There was also discussion of the PV difficulties related to structure, nomenclature/ product name, manufacturing, and manufacturing variation challenges.
Dr. Christina Beato: Lowering Interchangeable Biosimilar Standards Risks Patient Health, Physician Confidence On January 17th, the Albuquerque Journal published an op-ed by Dr. Christina Beato, former Assistant Secretary for Health and Human Services (HHS) on the topic of interchangeable biosimilar standards.
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