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Dec
4
Sandeep Singh Dhillon
Brexit impact on UK pharma industry to be investigated – BBC News
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By Bill Wilson
Business reporter, BBC News

Brexit may affect the cost of medicines and hit UK pharmaceutical investment, a Commons committee head has warned.
Rachel Reeves, who chairs the Business, Energy and Industrial Strategy (BEIS) committee, says access to new medical products may also be at risk.
She said the uncertainty around Brexit was “very concerning”, as MPs prepare to examine its effects on the industry.
They include the sector’s access to highly skilled workers after the UK leaves the European Union.
Ms Reeves said the evidence MPs had received suggested Brexit could threaten “the cost of medicines, investment in the UK and access to new and innovative research and products”.
“There are serious concerns raised around the future regulation of pharmaceuticals, mutual recognition of medicines, and the prospect of damaging disruption to cross-EU drug supply chains,” she said.
“This is very concerning, with uncertainty risking the UK becoming a less desirable place for investment and development in a growing, productive industry.
“We are keen to examine the detail of these concerns and to hear from the industry what it wants from the government to ensure the smoothest possible transition as we leave the EU.”
Brexit will mean the relocation of the European Medicines Agency from London to Amsterdam.
The MPs’ inquiry comes despite the announcement last week of two big deals in the UK’s pharma sector.
The government said then that the decisions by MSD, known as Merck in North America, and Germany’s Qiagen illustrated confidence in its recently announced industrial strategy for when the UK leaves the EU.
The industrial strategy white paper outlines the government’s plans to support more research and development, encourage firms to embrace new technology and boost the economy.
A report in the Sunday Times said more major investment for the sector is due to be announced soon, with GlaxoSmithKline expected to reveal a new research partnership.
The Business committee has been seeking views from across the sector and has received written submissions from big pharmaceutical companies, trade unions, industry bodies and the government.
The submissions have been published ahead of a public evidence session on Tuesday when the committee will question witnesses from the industry on the impact of Brexit.
It will consider different outcomes relating to future cross-border customs and trading arrangements, and consider what the government should aim to achieve in negotiations.
Those appearing before the committee will include the Association of the British Pharmaceutical Industry (APBI) and Belgian-headquartered Janssen Pharmaceutical, part of US giant Johnson & Johnson.
The ABPI said the inquiry was important.
“The written evidence received by the committee highlights how regulatory cooperation, a frictionless system for trade and access to research funding, collaboration and talent, underpin the successful development and delivery of medicines,” a spokesperson said.
“Evidence also shows that 45 million packs of medicines go from Britain to the EU every month and 37 million come the other way. With this whole system at stake, clarity on medicines regulation and trade is urgently required for all patients across Europe.”

Full article at http://www.bbc.com/news/business-42213937

Jul
5
Sandeep Singh Dhillon
US Pharma Looks at Blockchain Tech to Track Prescription Drugs – Cryptocoinsnews.com
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U.S. Pharmaceutical companies and the Food and Drug Administration (FDA) could soon track prescription drugs over an interoperable blockchain as a means to detect and put an end to counterfeit medicines in the market.

The solution comes from San Francisco-based blockchain startup Chronicled and its partnership with LInkLab, a life sciences supply chain. The two companies have launched a blockchain “track and trace” pilot at a recent one-day event in San Francisco. Developed for the pharmaceutical industry, the solution could prove a viable means to curbing counterfeit drug distribution and sales in the United States and beyond.

Attended by representatives from global pharma manufacturers, wholesalers and hospitals, the blockchain pilot event also saw participation from enterprise IT giants and blockchain tech companies. The event, according to Chronicled, marks the first phase of a pilot to develop an interoperable blockchain platform for the pharmaceutical industry.

Chronicled co-founder and chief performance officer Samantha Radocchia stated in a release:
We will be working closely with teams at leading enterprise blockchain projects over the coming months to identify the most suitable enterprise blockchain to serve as a data utility for the pharmaceutical industry.

The blockchain platform will adhere and satisfy the FDA’s Drug Supply Chain Security Act, signed into effect by former US President Obama in November 2013. The act was and signed to ‘develop an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.’

With this in mind, the blockchain solution will developed to support and comply with DSCSA protocols. Further, the pilot solution will focus on data privacy while adhering to GS1 standards, a global standardized system for traceability that can be implemented by all participants in a supply chain across borders globally.

Altogether, the blockchain tech solution aims to standardize a less expensive, less cumbersome and more efficient and secure approach to facilitate prescription drug distribution.

“The first phase of this project is to prove that one global pharmaceutical manufacturer can comply with their DSCSA regulatory obligations and meet the 2017 and 2023 requirements,” stated Susanne Somerville, co-founder of the LinkLab. “We are excited to be partnering with a major pharmaceutical player in this first phase.”

Future phases will foster the involvement of other participants in a typical pharma supply chain process, straight from the manufacturer to the pharmacy and hospitals.

One of blockchain technology’s core offerings that make it a no-brainer for supply chains across industries is its immutable, time-stamped, tamper-proof ledger, accessible by its all or pre-approved participants. Last week, Australia Post, the country’s postal service operator announced a partnership with Alibaba to curb the rise of counterfeit food exports from Australia to China, using blockchain technology to improve traceability.

Nov
11
Sandeep Singh Dhillon
Is a Donald Trump Presidency a Black Swan Event for Pharma Stocks? – The Motley Fool
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Pharma stocks, so far, are reacting positively to the news the Donald Trump has upended Hillary Clinton to become the 45th President of the United States of America. However, a Donald Trump presidency may, in fact, be a black swan for this multi-billion industry. Here are 3 reasons why.

Reason No. 1: The Trans-Pacific Partnership would be beneficial to American pharma giants
Donald Trump is a champion of the bold idea of withdrawing from the Trans-Pacific Partnership (TPP). While this dramatic shift in trade policy may sound pro-American, it would unquestionably cause serious damage to the growth prospects of big pharma companies like Pfizer (NYSE:PFE) and Gilead Sciences (NASDAQ:GILD) that are based inside the United States.

The heart of the matter is that the TPP was set up in part to help U.S. drugmakers improve their profit margins abroad by increasing the patent life of top-selling medications and making drug prices more uniform across the globe. Although the evergreening of patents and modestly higher drug prices worldwide are two issues that have drawn the ire of global healthcare advocates, these core tenets of the TPP are without a doubt a huge benefit for U.S. pharmaceutical companies.

Reason No. 2: A pivot toward isolationist trade policies will negatively impact foreign exchange rates
A Trump presidency is almost certainly going to drive the U.S. dollar upwards against major world currencies, whereby negatively impacting foreign exchange rates. After all, a key part of his trade platform centered around new tariffs, renegotiating long-standing trade deals like NAFTA, and an attempt to label China a currency manipulator. The point is that capital is probably going to get sucked out of top emerging markets like China, driving unfavorable exchange rates for U.S. pharma companies moving forward.

How does this issue directly impact pharma companies? One of the few bright spots in Pfizer’s Q3 earnings report was the company’s continued strength in emerging markets. The drugmaker’s Essential Health revenues, for instance, rose by 9% year over year in the third-quarter in emerging markets.

Turning to Gilead, this blue-chip biotech derives around 7% of its total antiviral sales from global markets outside of Europe and Japan. That number could grow substantially if foreign exchange rates remained stable and the TPP was ratified. However, that rosy growth scenario now appears to be off the table.

The big picture issue is that a rising dollar stemming from isolationist trade policies is going to be detrimental to the profit margins of U.S. pharma companies.

Reason No. 3: Obamacare is now in jeopardy
With the Republicans taking control of both houses of Congress, Trump now has the political firepower — and arguably, the mandate — to dismantle the Affordable Care Act, or Obamacare. Whether you agreed with Obamacare or not, this crown jewel of Obama’s presidency coincided with an unprecedented rally among biopharmaceutical stocks as a whole, shown by the 200% rise in the iShares Nasdaq Biotechnology ETF (NASDAQ:IBB). To put this dramatic rise into context, the iShares Nasdaq Biotechnology ETF was actually down by more than 6% since its inception until the ACA become law on March 23, 2010.

Take-home message

A Donald Trump presidency, along with a Republican Congress, may spell disaster for U.S. pharmaceutical companies that have benefited from favorable exchanges rates and from wider insurance coverage that was part and parcel of Obamacare over the last six years. Say what you want about Obama, but there’s no doubt that the pharmaceutical industry flourished under his administration, thanks in no small part to Obamacare.

To be fair, a Trump administration may attempt to deal with the outstanding tax issues that drove companies like Pfizer to seek asylum abroad of late. Even so, these tax headaches are minor issues compared to the potential headwinds that could be stirred up by nixing the TPP and a strong dollar. That’s why I plan to remain cautious with this industry for the time being — that is, until Trump’s actual policies take shape.

Jul
7
sandeepsd
BBC News ‘Obamacare’ boost to Indian pharmaceutical industry
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Jul
7
sandeepsd
A Guide to Effectively Sourcing and Purchasing Liquid Filling Systems
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Jul
7
sandeepsd
Is Helium Leak Testing Worth the Cost?
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Jul
7
sandeepsd
Quality Assurance and Quality Control – Differences in FDA vs. EU Regulations
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Jun
22
sandeepsd
Drug firms bank on faster US approvals
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Mumbai, June 21: Domestic pharmaceutical companies are pinning their hopes on faster clearances from the US Food and Drug Administration (USFDA) amid challenges such as compliance issues and customer consolidation. Read more …

Jun
15
sandeepsd
Mylan introduces generic version of GSK’s asthma therapy in UK
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Generic and specialty pharmaceuticals Mylan has introduced its pressurised metered-dose inhaler (pMDI), Sirdupla, in the UK. Read more …

Jun
15
sandeepsd
Novartis announces new one-year results demonstrating sustained secukinumab efficacy in ankylosing spondylitis patients
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Novartis announced today new one-year study results from the MEASURE 2 pivotal Phase III study of secukinumab in ankylosing spondylitis (AS). Read more …