EPM Magazine | June 25, 2020
As the Covid-19 crisis continues to unsettle global economies and business sectors worldwide, pharma companies are facing huge disruption to their supply chains and clinical research.
And while research into potential Covid-19 vaccines and treatments is speeding along, the pandemic has slowed or brought to a halt clinical trials for other diseases, with organisations like Eli Lilly and other big name pharma’s’ putting the brakes on non Covid-19 trial activity. In fact, 50% of respondents in a recent BSI survey said they will be making changes to their supply chain moving forward.
In this climate, with pharmaceutical supply chains under so much pressure, businesses are understandably focused on protecting supplier relationships as different parties are forced to cancel agreements, delay their contractual obligations or renegotiate key terms.
Orsini Specialty Pharmacy | September 28, 2021
Orsini Specialty Pharmacy, the leading independent specialty pharmacy focused on rare diseases and gene therapies, announced that Sanofi has selected it as a limited distribution partner for Nexviazyme® (avalglucosidase alfa-ngpt). Nexviazyme, an enzyme replacement therapy (ERT), is used for treating patients one year of age and older with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency). This progressive and debilitating muscle disorder impairs a person's ability to move and breathe. For more information about Nexviazyme, please see the Full Prescribing Information.
Pompe disease affects an estimated 3,500 people in the United States. It can present as infantile-onset Pompe disease (IOPD), the most severe form of Pompe disease with rapid onset in infancy, and late-onset Pompe disease (LOPD), which progressively damages muscles over time. LOPD symptoms may present at any age. However, due to the broad spectrum of clinical presentations and progressive nature of the disease, it can take seven to nine years before patients receive an accurate diagnosis. As the disease progresses, people with LOPD may require mechanical ventilation to help with breathing or a wheelchair to assist with mobility.
Orsini's dedicated Pompe Disease Care Team's number one priority is providing exceptional care and compassionate support to patients and their families, We are proud to expand our partnership with Sanofi and add Nexviazyme to the growing number of enzyme replacement therapies we dispense to patients with rare diseases.
- Mike Fieri, Orsini's Founder and Chief Executive Officer.
About Orsini Specialty Pharmacy
Providing patients with comprehensive and compassionate care since 1987, Orsini is the leading independent specialty pharmacy focused on rare diseases, gene therapies, and complex conditions. Orsini's high-touch care model centers around experienced, therapy-specific care teams that provide personalized care to patients based on their specific conditions and treatments. The company's comprehensive solutions include medication adherence programs, data analytics, customized manufacturer programs, and nationwide nursing coverage for convenient in-home infusion services. Headquartered in Elk Grove Village, IL, Orsini Specialty Pharmacy holds accreditations with URAC, the Accreditation Commission for Health Care (ACHC), ACHC's Distinction in Rare Diseases and Orphan Drugs, The Joint Commission, and the National Association of Boards of Pharmacy (NABP).
Pfizer | December 03, 2020
The two organizations' BNT162b2 has become the primary COVID-19 immunization permitted in the Western world as medication controllers in the U.K. given out a crisis use approval on Wednesday, in front of choices by the U.S. also, Europe, which are normal soon.
For the more extensive immunization world, the Medicines and Healthcare items Regulatory Agency's choice methods the world currently has the principal mRNA shot approved for far reaching use, opening up a fresh out of the box new part for antibody advancement.
The principal portions will be conveyed to the U.K. quickly, the organizations said. A representative at the U.K's. Department of Health and Social Care said the antibody will be made accessible the nation over from one week from now. The U.K. has requested 40 million portions of the antibody—enough to immunize 20 million individuals—through an arrangement endorsed in July and extended in October.
"As we envision further approvals and endorsements, we are centered around moving with a similar degree of criticalness to securely flexibly an excellent immunization around the globe. With a great many individuals turning out to be tainted, each day matters in the aggregate competition to end this staggering pandemic," Pfizer CEO Albert Bourla, Ph.D., said in an explanation, calling the U.K. gesture a "noteworthy second."
Pfizer has appointed COVID-19 antibody assembling to three destinations in the U.S. also, one in Belgium. BioNTech has offices in Mainz and Idar-Oberstein in Germany, which have been delivering dosages for clinical preliminaries. The German biotech as of late purchased a Novartis plant in Marburg, Germany, to quicken business assembling of the COVID-19 immunization. In general, the two organizations have said they can create up to 50 million dosages in 2020 and up to 1.3 billion portions in 2021.