Pharmaceutical Technology ePT Weekly
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PharmTech
February 09, 2017
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In this issue

Survey Points to Supply Chain Weaknesses

Catalent Predicts More Demand than Capacity

FDA Warns Facta Farmaceutici

Top Stories

Pfizer Reacts to Trump's Comments and Discusses Pipeline in Its Q4 Earnings Call

A change in the tax code could help the company create more jobs in the United States, while fewer FDA regulations could help reduce drug prices, according to Pfizer CEO Ian Read.
/ read more /


Does Pharma Really Want to Overhaul FDA?

In promising to expedite and simplify the FDA approval process, President Donald Trump fails to take account of industry's appreciation of an efficient, rigorous FDA regulatory system.
/ read more /

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PODCAST

Jonathan Knight, vice-president of New Product Development at Cambrex Corp., discusses the environmentally friendly, economical process route that won CPhI's 2016 award for innovation in APIs and intermediates.

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2017 PDA Annual Meeting
The 2017 Annual Meeting, the theme of which is Manufacturing Innovation: The Next Wave of Sterile and Biopharmaceutical Science, Technologies & Processing, will look ahead to the future of bio/pharmaceutical science and technology. Explore current and future trends in advanced therapeutic strategies, immunotherapy, gene-based personalized medicine and cell-based therapies, next-generation processing and facilities and big data applications for process design and optimization.
Check it out today!


Industry News

Inadequate Cleaning Validation Cited in FDA Warning Letter

FDA's Warning Letter to an Indian API manufacturer alleges cGMP violations and improper cleaning and validation.
/ read more /


Drug Shortage Survey Points to Pharma's Supply Chain Management Weaknesses

Research by Pew Charitable Trust and ISPE suggests that inability to forecast internal demand, and poor partner alignment are among the reasons for drug shortages.
/ read more /


More Industry News

Supplier News

Danaher Reports Revenue Increases of 17% in 2016

Operational improvements at Pall contributed to the overall growth in the Danaher life-sciences sector.
/ read more /


Catalent Predicts More Demand than Capacity in the Next Five Years

On a recent call, Catalent revealed that it has reached more than 90% of its current capacity and discussed how tax policy changes could affect the outsourcing industry.
/ read more /


More Supplier News

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See machinery in action. Discover packaging innovations. Learn about breakthroughs and best practices. For pharma and medical device manufacturing professionals, PACK EXPO East and the Healthcare Packaging and Processing Conference have it all! Head to Philadelphia next month for solutions from 400+ exhibitors—including 200+ pharma industry suppliers—and get answers to critical issues from 30 education sessions. Register today at packexpoeast.com!


Bio/Pharma News

Nemaura Pharma Receives Funding to Develop Biologic Micropatch System

The investment will be used to advance Nemaura's R&D programs, which include liquid vaccines that have been reformulated for administration through the skin using its micropatch drug delivery technology.
/ read more /


Amgen's PCSK9 mAb Shown to Protect Against Heart Attack and Stroke

According to results from the FOURIER trial, Repatha significantly reduced the risk of cardiovascular events and death in patients with atherosclerotic cardiovascular disease.
/ read more /


More Bio/Pharma News

Regulatory News

FDA Issues Warning Letter to Facta Farmaceutici S.p.A.

The warning letter cited GMP violations for finished drug products.
/ read more /


FDA Warns Pharmco Laboratories of CGMP Violations and Misbranding

Pharmco Laboratories received an FDA warning letter for significant violations of CGMP for finished drugs and APIs at its Florida, US facility as well as misbranding of over-the-counter (OTC) acne and sunscreen drug products.
/ read more /


More Regulatory News

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Pharmaceutical Technology's PharmaMarketplace
Your Connection to Global Pharmaceutical Manufacturing Suppliers
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FEATURED TOPICS

STANDARDS & REGULATIONS

Staffing and Preparation for Audits

Siegfried Schmitt, PhD, principal consultant, PAREXEL, discusses how to handle audits and inspections during business expansion.
/ read more /

VIEWPOINTS

Beyond Distractions, Pharma Moves On

Translating campaign promises to predictions for bio/pharma is difficult, but optimism prevails.
/ read more /

PACKAGING

Blister Packaging Moves Forward

Advances in materials and equipment for pharmaceutical blister packaging protect quality and enhance shelf life.
/ read more /

FILL/FINISH

Taking a Closer Look at Parenteral Contaminants

Visual inspection of parenteral vials is the first step in a root cause investigation.
/ read more /


UPCOMING WEBCAST

Around the World in Clinical Trials: New Regulations and Country Specific Challenges
Live Webinar: Tuesday, February 28 at 11:00am EST
Register now


On Demand WEBCASTS

From Bench to Clinic: Preclinical and First-in-Man Development Strategies
On Demand
Learn more


Orally Disintegrating Tablets: A Patient-centric Dosage Form
On Demand
Learn more


Events

IFPAC Annual Meeting

February 27–March 2, 2017

Pittcon 2017

March 5–9, 2017

3rd FDA/PQRI Conference on Advancing Product Quality

March 22–24, 2017

more events

REFERENCE BOOKS

Pharmaceutical Technology presents its Process Analytical Technology resource guide combo

A compilation of informative, useful articles designed to help you meet the challenges of process analytical technology, be more efficient in testing, reduce over-processing, enhance consistency, and minimize rejects.
/ Click here /

More Reference Library

eBOOKS

Quality Throughout the Supply Chain

Quality issues can appear at any stage of the bio/pharmaceutical development and manufacturing supply chain. Drug companies must monitor raw materials, suppliers, contract service providers, facilities, manufacturing processes, and production workers. In this e-book, the editors examine current quality issues, and how the industry is addressing quality challenges throughout the supply chain.


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