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

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 pharma markets.
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 quality
Read more: https://www.thepharmaletter.com/article/stricter-checks-for-generic-medicines-in-india

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 lower-cost alternatives.
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 medium size 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. The new draft guidance, issued last month by the Center for Drug Evaluation and Research and the Center for Biologics 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

A new drug has been found to reduce the risk of cancer reoccurring by 50 percent and a Richmond hospital is 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 satisfactory 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 under 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/

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 largely identical version of its automated naloxone injector for a retail price of $178 for a kit, which, like the $4,100 brand-name 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/

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 Japan
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