Drug Channels
JANUARY 10, 2022
PCMA Business Forum. February 28 – March 1, 2022 JW Marriott Grande Lakes | Orlando, FL Register Today! www.pcma.com/businessforum. The PCMA Business Forum is PCMA's largest business networking and educational conference. PCMA’s PBM Members send a large number of executives from relevant business units including pharma and trade relations, specialty pharmacy, clinical and patient care services, and the c-suite.
Eye on FDA
JANUARY 12, 2022
Each year we look back to take stock of how the agency has been communicating in the course of the previous year and assess how that might compare to years gone by. In fact from year to year, there is a good deal of change that occurs. When Dr. Scott Gottlieb took the reins of FDA as Commissioner, the amount of communications material put out jumped enormously.
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Drug Patent Watch
JANUARY 14, 2022
Annual Drug Patent Expirations for GOCOVRI Gocovri is a drug marketed by Adamas Pharma and is included in one NDA. It is available from one supplier. There are seventeen patents…. The post New patent for Adamas Pharma drug GOCOVRI appeared first on DrugPatentWatch - Make Better Decisions.
Sygnature Discovery
JANUARY 13, 2022
We’ve appointed the highly experienced pharmaceutical executive Dr Charles Woler as Chairman. In a broad career, Charles has held multiple key roles in the sector, including CEO at Roche France, Executive Chairman for Europe at SmithKline Beecham PLC, and CEO at Cadus Pharmaceutical in the US. He has also worked in numerous biotech-focused venture capital firms, chairing the advisory committee of the public-private Inserm-Transfert Initiative Investment Committee fund and serving as Vice C
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
Drug Channels
JANUARY 14, 2022
Today’s guest post comes from Jeremy Docken, Founder and Chief Strategy Officer at Kalderos. Jeremy describes Kalderos’ 340B rebate model. He discusses an independent research organization’s study of the 340B rebate model’s impact on covered entities’ cash flow. To learn more, download the whitepaper: The Kalderos 340B Rebate Model In Action: Ensuring a Thriving and Sustainable 340B Program.
Eye on FDA
JANUARY 9, 2022
Once again it was a quiet year with respect to the FDA’s Office of Prescription Drug Programs (OPDP). As noted in the past, there are two primary means for understanding the agency’s latest thinking with respect to promotional communications from pharmaceutical companies – the content and pattern of enforcement and the issuance of guidance documents to shed light on the parameters that exist.
Drug Discovery Digest brings together the best content for drug research and development professionals from the widest variety of industry thought leaders.
The Anticancer Fund
JANUARY 12, 2022
13 January 2022 Language EN Drug repurposing is a strategy for identifying new uses for approved drugs, outside the scope of the original indication. It is one of the focus areas of the Anticancer Fund. Below, we have listed recent findings about the repurposing of generic drugs in oncology. Our intention is to help bring these findings to the attention of the broader cancer research community.
Drug Channels
JANUARY 11, 2022
As I have highlighted in previous posts, retail pharmacies are experiencing a period of intense competition that continues to pressure prescription profits. What's more, the pharmacy shakeout is accelerating, as smaller competitors exit and larger companies reduce store count. . In the video below, I provide a brief overview of key challenges facing retail pharmacy this year.
Drug & Device Law
JANUARY 11, 2022
In In re: Onglyza and Kombiglyze XR Products Liability Litigation , MDL 2809, 2022 WL 43244 (E.D. Ken. Jan. 5, 2022), the MDL judge bifurcated discovery into two phases with general causation proceeding first. At the close of expert discovery, plaintiffs move to exclude three defense experts and defendants moved to dismiss one plaintiff expert. Plaintiffs went down swinging and defendants caught it right in the sweet spot.
Drug Patent Watch
JANUARY 10, 2022
Annual Drug Patent Expirations for LASTACAFT Lastacaft is a drug marketed by Allergan and is included in one NDA. It is available from one supplier. There are two patents protecting…. The post New patent for Allergan drug LASTACAFT appeared first on DrugPatentWatch - Make Better Decisions.
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Drug Patent Watch
JANUARY 10, 2022
Annual Drug Patent Expirations for KISQALI Kisqali is a drug marketed by Novartis and is included in two NDAs. It is available from one supplier. There are eight patents protecting…. The post New patent for Novartis drug KISQALI appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
JANUARY 10, 2022
Annual Drug Patent Expirations for LEVOLET Levolet is a drug marketed by Genus Lifesciences and is included in one NDA. The generic ingredient in LEVOLET is levothyroxine sodium. Additional details…. The post New patent for Genus Lifesciences drug LEVOLET appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
JANUARY 10, 2022
Annual Drug Patent Expirations for KISQALI+FEMARA+CO-PACK+%28COPACKAGED%29 Kisqali Femara Co-pack (copackaged) is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are…. The post New patent for Novartis drug KISQALI FEMARA CO-PACK (COPACKAGED) appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
JANUARY 9, 2022
Annual Drug Patent Expirations for ALPHAGAN+P Alphagan P is a drug marketed by Allergan and is included in two NDAs. It is available from one supplier. There are eight patents…. The post New patent expiration for Allergan drug ALPHAGAN P appeared first on DrugPatentWatch - Make Better Decisions.
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Drug Patent Watch
JANUARY 8, 2022
Annual Drug Patent Expirations for GIVLAARI Givlaari is a drug marketed by Alnylam Pharms Inc and is included in one NDA. There are twelve patents protecting this drug. This drug…. The post New patent expiration for Alnylam Pharms drug GIVLAARI appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
JANUARY 10, 2022
ALPHAGAN P (brimonidine tartrate) Allergan Patent: 9,295,641 Expiration: Jan 10, 2022 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com…. The post Drug Patent Expirations for the Week of January 9, 2022 appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
JANUARY 14, 2022
This chart shows the pharmaceutical companies with the most cream dosed drugs. For a different perspective, see the most popular dosage types. The companies with the most cream dosed drugs…. The post Which pharmaceutical companies have the most cream dosed drugs? appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
JANUARY 12, 2022
This chart shows the pharmaceutical companies with the most patents in Mexico. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is…. The post Which pharmaceutical companies have the most drug patents in Mexico? appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
JANUARY 8, 2022
This chart shows the drugs with the most supplementary protection certificates (SPCs). SPCs are used in European Union and select others to encourage pharmaceutical innovation by compensating for the long…. The post Which drugs have the most supplementary protection certificates? appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
JANUARY 13, 2022
This chart shows the pharmaceutical companies with the most patents in Portugal. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is…. The post Which pharmaceutical companies have the most drug patents in Portugal? appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
JANUARY 11, 2022
This chart shows the pharmaceutical companies with the most patents in Lithuania. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is…. The post Which pharmaceutical companies have the most drug patents in Lithuania? appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
JANUARY 10, 2022
This chart shows the drug companies with the most supplementary protection certificates (SPCs). SPCs are used in European Union and select others to encourage pharmaceutical innovation by compensating for the…. The post Which pharmaceutical companies have supplementary protection certificates in the most countries? appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
JANUARY 9, 2022
This chart shows the pharmaceutical companies with the most patents in Malaysia. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is…. The post Which pharmaceutical companies have the most drug patents in Malaysia? appeared first on DrugPatentWatch - Make Better Decisions.
Drug & Device Law
JANUARY 13, 2022
Last year we reported on Plourde v. Sorin Group USA, Inc. , 2021 WL 736153 (D. Mass. 2021), which held that the plaintiff’s failure-to-warn claims were expressly preempted by 21 U.S.C. § 360k(a) because those claims were based on an alleged failure to report adverse events to the FDA and the plaintiff had not shown that Massachusetts recognizes a duty to submit such reports.
Drug & Device Law
JANUARY 14, 2022
We heard the other day from attorneys involved in the MDL direct filing, choice-of-law case that we wrote about a couple of weeks ago , Looper v. Cook Inc. Engaging in this kind of dialogue is one of the joys of blogging, even when our friends and colleagues write to tell us we got something wrong. To err is human, to blog is divine. or something like that.
Drug & Device Law
JANUARY 12, 2022
Some of our posts about challenges to Covid-19 vaccines or treatments might have been a bit … strident. It is hard to be otherwise when the cases involve such high stakes and so little merit. But this time we will try to take our cue from the court in Frey v. Trinity Health-Michigan , 2021 Mich. App. LEXIS 6988 (Mich. Ct. App. Dec. 17, 2021). In that case, the court rejected a plaintiff’s request for a preliminary injunction requiring a hospital to administer ivermectin to a Covid-19 patient.
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