Sun.Jun 23, 2024

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FDA clears Argenx’ Vyvgart Hytrulo for rare disease CIDP

pharmaphorum

Netherlands biotech Argenx has a second FDA approval for its FcRn inhibitor Vyvgart Hytrulo, adding a new indication in chronic inflammatory demyelinating polyneuropathy (CIDP) for a drug that it hopes could find a use in more than a dozen diseases.

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Estimated Effectiveness of the BNT162b2 XBB Vaccine Against COVID-19

JAMA Internal Medicine

This case-control study estimates the association between receipt of the BNT162b2 XBB vaccine and medically attended COVID-19 outcomes among US adults 18 years and older.

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Vertex islet cell therapy gets type 1 diabetics off insulin

pharmaphorum

Three people with type 1 diabetes who received Vertex Pharma’s islet cell therapy VX-880 were able to come off insulin within a year

Insulin 115
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Altimmune Targets Obesity Market With Weight-Loss Drug That Preserves Lean Muscle Mass

BioSpace

Altimmune Targets Obesity Market With Weight-Loss Drug That Preserves Lean Muscle Mass 6/24/2024

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Severe Acute Liver Injury After Hepatotoxic Medication Initiation

JAMA Internal Medicine

This cohort study identifies the most potentially hepatotoxic medications based on clinical incidence rates of hospitalizations for severe acute liver injury (ALI) and examines how these rates compare with the hepatotoxicity categorization of severe ALI using published case reports.

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New tentative approval for Alembic drug dabigatran etexilate mesylate

Drug Patent Watch

Dabigatran etexilate mesylate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Apotex, Hetero Labs Ltd Iii, and Boehringer Ingelheim and, and is included in five NDAs. There are three patents protecting this compound. Drug patent litigation for DABIGATRAN ETEXILATE MESYLATE. Nine suppliers are listed for this compound.

Drugs 52

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Drug Patent Expirations for the Week of June 23, 2024

Drug Patent Watch

MOVANTIK (naloxegol oxalate) Valinor Patent: 7,056,500 Expiration: Jun 29, 2024 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com or visit www.DrugPatentWatch.

Drugs 52
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Identifying and Measuring Administrative Harms

JAMA Internal Medicine

This qualitative study using a mixed-methods approach examines the identification of and proposed measures to address administrative harms.

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Lilly Sees Path for Zepbound’s Label Expansion With Phase III Sleep Apnea Win

BioSpace

Lilly Sees Path for Zepbound’s Label Expansion With Phase III Sleep Apnea Win 6/24/2024

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Which pharmaceutical companies have the most SPCs in Italy?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most supplementary protection certificates (SPCs) in Italy. SPCs are used in European Union and select others to encourage pharmaceutical innovation by compensating for the long time needed to obtain regulatory approval for drugs.

Drugs 52
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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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G1 Therapeutics Fails Late-Stage Breast Cancer Trial, Plans ‘Targeted’ Headcount Reductions

BioSpace

G1 Therapeutics Fails Late-Stage Breast Cancer Trial, Plans ‘Targeted’ Headcount Reductions 6/24/2024

Trials 51
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DEA’s Expected Guidance: It Should Reduce Current “Pain” at the (Intrathecal Pain) Pump Dispensing Process and Improve Therapeutic Outcomes

FDA Law Blog

By John A. Gilbert & Karla L. Palmer — For more than 50 years, the Drug Enforcement Administration (DEA) has enforced the central mandate of the Controlled Substances Act (CSA) to maintain a closed chain of distribution for drugs with a potential for abuse and diversion. The CSA and regulations promulgated by DEA are intended to reduce the potential for diversion and abuse and ensure that controlled substances are dispensed and delivered to patients for a legitimate medical purpose.

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Alnylam Aces Phase III Cardio Trial, Eyes Label Expansion for RNAi Therapy

BioSpace

Alnylam Aces Phase III Cardio Trial, Eyes Label Expansion for RNAi Therapy 6/24/2024

Trials 51
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Novo’s Wegovy Shows Stronger Weight-Loss Effects in Women Than Men: Study

BioSpace

Novo’s Wegovy Shows Stronger Weight-Loss Effects in Women Than Men: Study 6/24/2024

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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FDA Action Alert: Merck, Verona, AbbVie and Rocket

BioSpace

FDA Action Alert: Merck, Verona, AbbVie and Rocket 6/24/2024

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What Would a Donanemab Approval Mean for Leqembi?

BioSpace

What Would a Donanemab Approval Mean for Leqembi?

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