Support for fast pharmaceutical regulatory approval
Our intelligence on approved and pipeline drugs, plus regulatory information on devices/diagnostics help you plan your route to commercial success.
To achieve commercial success, you need to connect successful approved drugs and mid-to-late stage pipeline drugs to the underlying trial information. You’ll also want to focus in on the best trial designs and comparator arms that have met with success across target markets.
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Real-time tracking and analysis of the drug development pipeline
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Unparalleled access to global pharma regulatory and compliance intelligence and expertise.
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The single most comprehensive consumer healthcare information source covering regulatory, legislative, legal and commercial news across the over the counter medicines, vitamins and dietary supplements, and cosmetics industries.
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19 Jan 2022
US FDA’s accelerated approvals hit a contemporary high in 2021, accounting for one-third of novel US approvals, but the big story was the agency’s crackdown on delinquent confirmatory trials for oncology AA indications.
Generics Bulletin
01 Dec 2021
Bio-Thera Solutions had been hoping to become the first Chinese biosimilars developer to win an FDA approval, for its BAT1706 bevacizumab candidate. However, the announced FDA action date for the application has come and gone with no word from the company or regulator.
08 Oct 2021
At NAD 2021, Adam Waheed, an award-winning content creator with more than 17m social media followers, addressed challenges and legal risks that have escalated in recent years as influencer marketing opportunity exploded in the US and abroad.
M. Nielsen Hobbs 23 Jun 2021
US FDA’s approval after a near-unanimous advisory committee vote against Biogen’s Alzheimer’s drug is central to many critics’ arguments, but the acting commissioner says that panel did not vote on the issue of accelerated approval, and that airing of internal agency disagreements could have influenced committee members.
Ryan Nelson 16 Mar 2021
The specialty retailer, entering Target stores in the fall, is aiming for net sales of $7.2bn to $7.3bn in fiscal 2021, compared with $6.15bn in 2020 and $7.4bn in 2019. President Dave Kimbell will be taking the helm in June while CEO Mary Dillon stays on for one year as executive chair of the board.
04 Jan 2021
The UK regulator, the MHRA, has published guidance on its new integrated pathway for innovative drug approvals, which it says is intended to bring together partners including health technology assessment agencies, health care bodies and patient organizations to offer “sustained collaboration” with drug developers.
03 Feb 2020
The 38th Annual J.P. Morgan Healthcare Conference has concluded, and Biomedtracker and Meddevicetracker were there to bring you the important outcomes from the largest and most informative annual healthcare investment symposium in the industry.
Ramsey Baghdadi 27 Jan 2018
Second go-round for oral testosterone could have marked new boundary on how far FDA is willing to go...
26 Nov 2017
BioMarin's sale of voucher earned with approval of rare pediatric disease drug Brineura the fourth publicly disclosed voucher sale.
16 Nov 2017
Concerns with promoting competition and reducing consumers' 'pain in the pocketbook' are key tenets of the Trump Administration's approach.
21 Aug 2017
Reforms proposed in the draft South African policy on intellectual property and public health that has just been put out for consultation have been welcomed.
Michael Cipriano 30 May 2017
New FDA commissioner passes on defending president's budget proposal during House appropriations subcommittee hearing.
Brenda Sandburg 04 May 2017
US Trade Representative also highlights restrictive patentability criteria in Canada, India and Indonesia in its annual Special 301 report.
31 Mar 2017
New report finds increase in use of deductibles and coinsurance charging members list prices. Cost sharing for more than one-third of specialty drug prescriptions filled in 2015 by members of commercial insurance plans was based on undiscounted list pricing, according to an analysis released by the Pharmaceutical Research and Manufactures of America March 29.
01 Mar 2017
The leader of Denmark’s bid to host the European Medicines Agency after the UK leaves the EU says that a rapid decision-making process on the agency’s new location is needed in order to avoid entanglements with the wider Brexit negotiations, and that a decision could be taken sometime in the second half of this year.
Generics Bulletin
28 Jun 2022
28 Jun 2022
Pink Sheet
27 Jun 2022
HBW Insight
26 Jun 2022
Generics Bulletin
24 Jun 2022
23 Jun 2022
23 Jun 2022
22 Jun 2022
22 Jun 2022
20 Jun 2022
20 Jun 2022
Pink Sheet
20 Jun 2022
HBW Insight
18 Jun 2022
Generics Bulletin
16 Jun 2022
Generics Bulletin
16 Jun 2022
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