Pharmaceutical Technology ePT Weekly
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PharmTech
August 08, 2019
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In this issue:

Blending Trace Ingredients

FDA Issues Statement on Compounding Decision

Iontas, Teva Enter New Antibody Optimization Agreement


Top Stories

FDA Assessing Data Accuracy in Zolgensma Approval

The agency is keeping Zolgensma on the market as it evaluates the accuracy of data submitted with the product's biologics license application.
/ read more /


FDA Approves Nine Generic Versions of Lyrica

The first generics of Lyrica have been approved by the FDA for neuropathic pain management and adjunctive therapy.
/ read more /

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Industry News

CHMP, CMDh Recommend a Change in Names of Liposomal Medicines to Avoid Errors

CHMP and CMDh have recommended that all marketing authorization holders (MAHs) of medicines containing liposomal drug delivery systems change the medicine name to avoid medication errors.
/ read more /


NIIMBL and FDA Partner in Biopharmaceutical Manufacturing

NIIMBL announced it is partnering with FDA through the University of Delaware to improve biopharmaceutical manufacturing.
/ read more /


More Industry News
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Supplier News

Fujifilm Extends Regional Presence Through Danish Acquisition

Fujifilm has bought Biogen ApS' Copenhagen facility for US$890 million.
/ read more /


Cambrex to be Acquired by Permira Funds

An affiliate of the Permira funds has signed an agreement to purchase Cambrex in an approximately $2.4-billion transaction.
/ read more /


More Supplier News

Bio/Pharma News

Alizé Pharma 3 Completes €67 Million Series A Financing Round for Boost in Portfolio

Alizé Pharma 3 completed a €67 million Series A financing round led by LSP to boost its product portfolio in rare endocrine and metabolic diseases.
/ read more /


Iontas, Teva Enter New Antibody Optimization Agreement

Iontas and Teva Pharmaceuticals have entered into an agreement for the application of technologies and know-how into the optimization of human antibodies to be used as biotherapeutics.
/ read more /


More Bio/Pharma News

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Webinar Alert: B. cepacia complex (Bcc) Testing for Non-Sterile Water-Based Drug Products
Watch Eurofins BioPharma Product Testing’s on-demand webinar on B. cepacia complex (Bcc) testing, the absence of Bcc and FDA’s guidance on prevention and detection. Our expert will also cover the history, health risks, recalls and lessons learned, as well as a glimpse of the USP <60> draft for Bcc testing.
Register now



Regulatory News

FDA Issues Statement on Compounding Decision

A US District Court in Washington, DC upheld FDA's interpretation of clinical need when choosing which substances are approved to use for drug compounding.
/ read more /



Bayer Recalls Product Due to Mislabeling

Bayer is voluntarily recalling two lots of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials because they contain the incorrect product.
/ read more /


More Regulatory News

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Exclusive Video from BIO:
Contract Development and Manufacturing Organization for Your Injectable
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FEATURED TOPICS

REGULATORY/GMP COMPLIANCE

FDA Maps Strategies to Advance Cell and Gene Therapies

New tools and policies aim to support more complex manufacturing processes.
/ read more /

MANUFACTURING

Blending Trace Ingredients

Homogeneity of the powder blend is crucial for solid-dosage drug manufacturing.
/ read more /

ANALYTICS

Combo Drugs Require a Complex Design Approach

A design strategy can ensure conflicting properties are managed appropriately for multi-API controlled-release formulations.
/ read more /

OUTSOURCING

Balancing CMC Priorities

A risk-based approach to CMC enables drug sponsors to focus on clinical and manufacturing development paths.
/ read more /


UPCOMING WEBCAST

Method Development for Moisture Analysis in Lyophilized Products
Wednesday, August 14, 2019 at 1pm EDT | 12pm CDT | 10am PDT
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ON DEMAND WEBCASTS

Innovative Approaches to Tailoring Particle Size Distribution
On Demand
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Expanded Access and Commercial Packaging Strategies for Orphan, Niche, and Low-Volume Drugs
On Demand
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Science or Hype? Navigating the Questions about Titanium Dioxide Safety
On Demand
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Events

5th Annual Bio/Pharmaceutical Product Launch Summit

September 10–11, 2019

PDA/FDA Joint Regulatory Conference

September 16–18, 2019

PDA Data Integrity Workshop

September 18–20, 2019

more events

eBOOKS

Biologics and Sterile Drug Manufacturing 2019

The editors explore novel technologies for the formulation, manufacture, purification, and delivery of sterile small- and large-molecule drugs including single-use systems, facilities and equipment, contamination issues, and process analytics.


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