The Veeda Newsletter
Issue 1 JANUARY 2019
2018—A Year in Research
Challenges and opportunities for Indian pharma industry
Looking ahead: FDA priorities for 2019
5 Biopharma Trends to Watch in 2019
Outlook 2019: Pharma looks medically fit for double-digit growth after years of suffering
Healthcare sector may see further consolidation in 2019
At IMARC, we pride ourselves on being trusted advisors. It’s our greatest privilege to support
clinical research sponsors and help them earn approval to bring their devices to market.
Read more: https://www.massdevice.com/the-most-popular-clinical-research-resources-from-2018/
2018 was a banner year for biosimilars, with the number of FDA-aproved biosimilar products nearly
doubling, and with major policy,
business, and regulatory developments that moved the biosimilars marketplace forward.
Read more: https://www.ajmc.com/newsroom/the-key-biosimilars-developments-of-2018
Once again, it’s time to reflect on the preceding 12 months. Despite the 2025 deadline for
effective therapy that has been set by the National Alzheimer’s Plan and the World Dementia
Council, 2018 brought no drug approvals or Phase 3 breakthroughs.
Read more: https://www.alzforum.org/news/search-news/2018-year-research
There were a variety of developments in the biosimilars space in 2018, and our expert contributors
responded to those changes with in-depth insights that reflected the complexity of the biosimilars
Read more: https://www.centerforbiosimilars.com/news/the-mostread-contributor-articles-of-2018
Here are our picks for the top-five most significant U.S. biosimilar market developments in 2018:
Read more: https://www.jdsupra.com/legalnews/year-in-review-the-top-five-u-s-22499/
As we all know, India is the largest provider of generic drugs globally. The Indian pharma industry
supplies over half of the global demand for vaccines, one third of the demand for generics in the
US and one fourth per cent of all medicines in the UK.
Read more: http://www.expressbpd.com/pharma/latest-updates/challenges-and-opportunities-for-indian-pharma-industry/407864/
The techtonic shift of global healthcare from small molecules to biologics is hard to ignore anymore
and considering the imminent problems that biologic drugs bring forth in terms of drug pricing and
affordability, the role of biosimilars has never been more important.
Read more: : http://www.expressbpd.com/pharma/management-pharma/recommendations-and-way-forward-for-indian-biosimilars-industry-road-to-a-sustainable-future/408243/
India is one of the world’s biggest suppliers of generic drugs and complex formulations. It accounts
for 20 per cent of global generics exports volume and ranks among the top five fastest-growing
Read more: http://www.expressbpd.com/pharma/guest-blogs/new-growth-tonic-for-indian-pharma-industry/408280/
To boost public confidence in generic medicines, India’s drug controller is putting stringent
Read more: https://www.thepharmaletter.com/article/stricter-checks-for-generic-medicines-in-india
With around 1.3 billion residents, India is home to just a fraction fewer people than China, the
Read more : https://www.thepharmaletter.com/article/indian-pharma-market-update
The guidance is part of the broader FDA Drug Competition Action Plan that was introduced in June
2017 with the
intent of increasing competition in the drug marketplace and facilitating entry into the market for
Read more: https://www.heartland.org/news-opinion/news/fda-issues-guidance-to-speed-approval-of-complex-transdermal-drugs
A disruptive market of $410 billion until 2023, changes dramatically with the entrance of small and
players, many of them rising up from the startup community.
Read more: https://www.forbes.com/sites/yiannismouratidis/2018/12/09/the-rise-of-use-of-medical-devices-force-fda-to-change-the-rules/#766e061c2101
The FDA has issued an update to its 2015 draft guidance on developing drugs to treat rare diseases.
draft guidance, issued last month by the Center for Drug Evaluation and Research and the Center for
Evaluation and Research within the FDA, contains several updates to the original document
Read more: https://www.ajmc.com/newsroom/fda-revises-draft-guidance-on-developing-drugs-for-rare-diseases
The United States Food and Drug Administration (FDA) set a record this year in new drug approvals,
light to multiple innovative drugs to fight cancers and HIV.
Read more: http://www.china.org.cn/world/Off_the_Wire/2018-12/31/content_74328075.htm
Since becoming Commissioner of the Food and Drug Administration (FDA) in 2017, Dr Scott Gottlieb has
Read more: https://www.thepharmaletter.com/article/looking-ahead-fda-priorities-for-2019
A new drug has been found to reduce the risk of cancer reoccurring by 50 percent and a Richmond
behind a major medical breakthrough for breast cancer patients.
Read more: : https://www.mystateline.com/news/researchers-testing-drug-that-reduces-breast-cancer-by-50-percent/1712197030
There are around 7,000 rare or ‘orphan’ diseases for which there currently exists no authorized or
method of treatment. Many are life-threatening or debilitating, and they particularly affect the
very young, who
often do not survive beyond adolescence.
Read more: http://www.pharmatimes.com/web_exclusives/orphan_drug_development_and_the_urgent_need_for_a_new_approach_1271944
Two years later, when you ask pharma people for their overarching thoughts about their fate so far
President Donald Trump, their responses are peppered with disbelieving giggles
Read more : https://www.mmm-online.com/home/channel/regulatory/how-the-pharma-industry-may-be-impacted-by-drug-pricing-and-other-policies-in-2019/
PCI Synthesis, Inc., a pharmaceutical manufacturer of new chemical entities (NCEs), generic active
pharmaceutical ingredients (APIs), and other specialty chemical products, issued its annual list of
will affect the emerging biotech and generic drug sectors
Read more: https://www.rdmag.com/news/2018/12/cdmo-identifies-trends-affecting-generic-drugs-sector-2019
Biopharma industry watchers, executives, and especially investors often display that same desire as
a year comes
to a close, which explains why there’s typically a wave of news articles and commentaries
attempting to divine
events of the coming year based on the 12 months that are coming to a close.
Read more: https://www.genengnews.com/lists/5-biopharma-trends-to-watch-in-2019/
The domestic pharmaceutical industry bounced back to a nearly double-digit year-on-year growth in
2018 (9.4 per
cent), after falling to an eight-year low (5.5 per cent) in the previous year.
Read more: https://www.business-standard.com/article/companies/indian-pharma-industry-records-9-4-growth-in-2018-dispels-gst-gloom-119011000018_1.html
The company announced Wednesday it has authorized its subsidiary IJ Therapeutics to produce a
version of its automated naloxone injector for a retail price of $178 for a kit, which, like the
version, contains two doses.
Read more :https://www.statnews.com/2018/12/12/kaleo-evzio-overdose-antidote-generic/
Vedanta’s experimental treatments are compositions of live bacteria that the Cambridge, MA, company
says trigger a targeted immune response.
Read more : https://xconomy.com/boston/2018/12/24/gates-foundation-bristol-myers-join-27m-funding-for-vedanta-bio/
Indian pharma companies have been going through a tough phase for the past couple of years due to
competitive intensity and pricing pressure in the US (the largest market) and regulatory hurdles in
India in terms
of demonetization, GST implementation and lower prices.
Read more: http://economictimes.indiatimes.com/articleshow/67297361.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst
The rapidly changing global pharmaceutical landscape reached another milestone Tuesday as Takeda
Co. completed its $62 billion acquisition of Shire Plc.
Read more : https://www.bloomberg.com/news/articles/2019-01-07/how-takeda-s-62-billion-shire-deal-reshapes-the-pharma-world
Investors are excited about GlaxoSmithKline Plc’s (GSK) plan to split the firm into two
entities—pharmaceuticals and consumer healthcare.
Read more: https://www.livemint.com/Money/XVEWDuE2v9R1cYPNrW4qTI/What-the-GSK-Pfizer-merger-means-for-their-Indian-units.html
The acquisition comes less than 2 months after the companies announced that they had entered into a
partnership agreement for the commercialization of Alvotech’s entire pipeline of biosimilars in
Read more :https://www.centerforbiosimilars.com/news/fuji-pharma-acquires-42-stake-in-biosimilar-developer-alvotech
Taiwan's major biotech manufacturing service provider Mycenax Biotech plans to buy some new drug
testing platforms and a small cell strain supplier primarily in the US and Japan in 2019.
Read more : https://www.thepharmaletter.com/in-brief/brief-taiwan-s-mycenax-looking-for-acquisitions-updates-on-biosimilar
Healthcare sector may see further consolidation in 2019 with tightening of regulatory environment
set to make it difficult for small players to stay afloat in a highly competitive market.
Read more: http://economictimes.indiatimes.com/articleshow/67319829.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst
Activity in the pharma sector is rife in India, with mergers and acquisition deal values doubling
Read more : https://www.thepharmaletter.com/article/indian-drugmakers-hit-record-year-for-m-a-and-deal-values
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