Q2 2019 Newsletter
Welcome to the Health Delegates Newsletter for 2nd Quarter 2019! In this edition, Industry news include areas of interest within the biologics, as well as changes to the FDA website:
- The FDA launched a revamped FDA.gov website
- Bristol-Myers Squibb to Sell Otezla for Celgene Merger
- AbbVie Settles Humira Patent Litigation
The Clinical updates include a list of FDA approval, as well as expanded approval. There is also a short list of MedWatch updates.
Among “the first approved” products include:
- A first-in-class kinase inhibitor that targets fibroblast growth factor receptors (FGFR)
- The first prescription product to be approved for use in adults with a BMI as low as 25kg/m2, with or without comorbidities
- A new HIV-1 drug
- The first generic version of Narcan
- The first drugs approved in the U.S. to treat cardiomyopathy
Medwatch updates regarding:
- Addyi
- Truvada
- Edsivo
Please let us know if we can provide additional information that you would like to see – we welcome your feedback. As always, everyone at Health Delegates thanks you for your business and we stand at the ready to assist you and your members in any way possible.
Best regards,
The Health Delegates Team
Q1 2019 Newsletter
Welcome to the Health Delegates Newsletter for 1st Quarter 2019! The New Year has brought a great deal of excitement with a lengthy list of top drugs losing exclusivity.
In this edition, Industry news includes:
- ICER Announces New Drug Pricing Report
- Acquisitions – Lilly acquiring Loxo Oncology, and Bristol-Myers Squibb to acquire Celgene
- List of drugs losing Exclusivity in 2019
The Clinical updates include a list of FDA approval, as well as expanded approval. There is also a short list of MedWatch updates and warnings.
Among approved products:
- The first AP rated generic version of Remodulin
- Zulresso, the first drug specifically indicated to treat postpartum depression
- The first A-rated generic to GlaxoSmithKline’s Advair Diskus®
Clinical setbacks:
- Top Alzheimer’s Prospect Fails
- Johnson & Johnson’s Erleada Trial Ends Early
Medwatch Updates/Warnings:
- Chantix
- Uloric
- Xeljanz
Please let us know if we can provide additional information that you would like to see – we welcome your feedback. As always, everyone at Health Delegates thanks you for your business and we stand at the ready to assist you and your members in any way possible.
Regards,
The Health Delegates Team
Q4 2018 Newsletter
Welcome to the Health Delegates Newsletter for 4rd Quarter! As the year winds down, excitement continues to grow within the healthcare sector and pharmaceutical industry.
In this edition, Industry news includes:
- DOJ gives preliminary approval to CVS/Aetna merger, while the Cigna and ESI merger is finalized
- Major decisions in patent litigation in favor of Pfizer and Mylan
- 28 manufacturers announcing their intent to raise prices of their medicines in the new year
The Clinical updates include a list of FDA approval, as well as expanded approval. There is also a short list of FDA Alerts/Warnings/ Recalls.
Among approved products:
- A third Humira biosimilar receives approval
- Pfizer launches Retacrit (epoetin alfa-epbx) injection, the first available biosimilar to Procrit and Epogen
- FDA approves the first Digital Inhaler
- First bio-identical hormone therapy combining estradiol and progesterone in a single capsule is now available
- The first biosimilar to Genentech’s Rituxan
Alerts/Warnings/Recalls:
- ScieGen recalled certain lots of the angiotensin II receptor blocker (ARB) irbesartan
- Teva announces limited doses of the generic version of EpiPen
- Fluoroquinolone antibiotics found to increase the risk of aortic aneurysm or dissection
Please let us know if we can provide additional information that you would like to see – we welcome your feedback. As always, everyone at Health Delegates thanks you for your business and we stand at the ready to assist you and your members in any way possible. Best wishes for a Great and Prosperous 2019!
Regards,
The Health Delegates Team
Q3 2018 Newsletter
Welcome to the Health Delegates Newsletter for 3rd Quarter!
This edition includes Industry news such as:
- Price roll back from Pfizer and Price freezing from Novartis.
- Updates on mergers and acquisition between Albertsons grocery and Rite Aid, CVS Pharmacy and Aetna, and Cigna and Express Scripts PBM.
- Novo Nordisk introduces an online Chatbot.
- GW Pharmaceuticals announces Epidiolex (cannabidiol) oral solution is moved from Schedule I to Schedule V which is the DEA’s lowest restriction Schedule.
- Teva announces launch of generic Cialis.
The Clinical updates include a long list of FDA approval, as well as expanded approval. There is also a short list of FDA Alerts, Warnings and Recalls between July through September.
Among the approved products:
- The FDA approves a Neupogen biosimilar – Nivestym.
- 2 CGRP (Calcitonin gene-related peptide) agents are approved for migraine headaches, which makes 3 available on the market.
- 3 new additional agents for HIV-1 infection receives FDA approval.
The FDA Issues Alert
- SGLT2 Diabetes Drugs.
- Stronger Warnings for Fluoroquinolone Antibiotics.
- Valsartan Recall.
Please let us know if we can provide additional information that you would like to see – we welcome your feedback. As always, everyone at Health Delegates thanks you for your business and we stand at the ready to assist you and your members in any way possible.
Regards,
The Health Delegates Team
Q2 2018 Newsletter
In this edition please see the updates on pipelines and patent expirations; you will also see some interesting news regarding Novo Nordisk’s oral version of GLP-1 agonist semaglutide (currently in clinical phase 3 clinical trials) reported positive results versus Merck’s DPP-4 Inhibitor Januvia. Making Headlines, President Trump signed the controversial “right-to-try” bill allowing terminally ill patients access to experimental medical treatments not yet approved by the FDA. Also, Takeda announced that it had reached a $62 billion deal to buy Ireland-based Shire in the world’s biggest takeover this year. Takeda’s current top selling drugs include Entyvio, used to treat ulcerative colitis, and cancer drug Leuprorelin. Shire focuses on rare diseases, and it sells Adderall, which is used for ADHD.
Also, we are very excited to announce a few new additions to the Health Delegates team including Anne Nguyen Bradshaw; Director of Clinical Programs, Brian Tackett; Director of Finance and Accounting, and Matthew Kupferberg; General Counsel and Chief Compliance Officer. Please view more about them on the About Us page.
As always, everyone at Health Delegates thanks you for your business and we stand at the ready to assist you and your members in any way possible. Enjoy the Summer Sunshine!
Q1 2018 Newsletter
In this edition please see the updates on pipelines and patent expirations; you will also see some interesting news regarding PCSK9 inhibitors, Sanofi to lower the drug’s net price to within ICER’s range. Making Headlines, Biogen and Abbvie announced that Zinbryta (daclizumab), will be withdrawn from the market worldwide. The decision to discontinue marketing was made following reports of brain inflammation, known as inflammatory encephalitis and meningoencephalitis, in patients taking the drug. Although a removal timeline has not been established, Biogen and AbbVie will work collaboratively with FDA and healthcare providers in the management of Zinbryta patients. We also take a look at Cigna to Buy Express Scripts and CVS Health’s pending $68 billion acquisition of insurer Aetna. As always, everyone at Health Delegates thanks you for your business and we stand at the ready to assist you and your members in any way possible. Happy Spring!
The Archives
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