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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David Wallace 18 Jan 2022
WaveData’s compilation of the fastest-rising UK generics prices in December showed several products across multiple presentations more than doubling their average trade prices to independent pharmacists.
02 Nov 2021
Following a recent settlement in Louisiana, Teva has been told by a court in California it is not liable for the state’s opioid crisis, avoiding for now the potential for significant damages.
Pink Sheet
12 Oct 2021
The company behind the CVnCOV COVID-19 vaccine candidate says the decision to withdraw from regulatory review is strategic. The EMA says outstanding issues affecting the benefit-risk balance remained to be answered at the time of withdrawal.
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.
21 Sep 2021
Against a backdrop of unprecedented disruption, the biopharma and medtech industries reached incredible heights for deal-making activity during 2020.
Akriti Seth 14 Sep 2021
India’s Alkem has delivered a strong quarter with a boost in its domestic business on the back of “strong volume-led growth in the acute therapies and faster than market growth in chronic therapies.” However, the company saw a slight YoY decline in the US.
David Ridley 13 Sep 2021
Amazon is becoming an increasingly important retail channel for the German wellness market. An analysis of best-selling categories, Omega 3, vitamin B and probiotic supplements, by Sempora Consulting suggests a mixture of exclusive and hybrid selling strategies can deliver results.
Akriti Seth 01 Jul 2021
Major Indian pharmaceutical companies including Cipla, Dr Reddy’s, Emcure, Sun and Torrent have entered into a first-of-its-kind collaboration to jointly sponsor, supervise and monitor the clinical trial of the investigational oral anti-viral drug molnupiravir to fight against COVID-19 in India.
Pink Sheet
By Sarah Karlin-Smith 16 Jun 2021
CDER Director Cavazzoni also wants to loosen conflict of interest rules and improve technology for remote meetings. Given FDA’s approval of Aduhelm, her comments, made in a prerecorded interview for the BIO Digital annual meeting, may raise some eyebrows. Industry is also working on recommendations for the agency on the topic.
Pink Sheet
By Sue Sutter 08 Jun 2021
Biogen/Eisai Alzheimer’s drug wins agency nod on basis of amyloid plaque reduction, a surprising use of the accelerated approval pathway that was not considered by an FDA advisory committee; approval raises feasibility questions about confirmatory trial and daunting prospect of market withdrawal if studies fail to verify clinical benefit.
Vibha Sharma 22 Apr 2021
A simplified process for registering and evaluating clinical trials promised by the EU Clinical Trial Regulation is finally set to become a reality.
27 Jan 2021
Companies seeking marketing authorizations in the UK or Great Britain will be able to make use of two new “reliance” procedures offering regulatory assessment times of 67 days or less if their products have already gone through the EU centralized or decentralized approval systems.
Generics Bulletin
08 Dec 2020
Reforms set out by the European Commission to better prepare the EU for future health crises must heed key lessons learned from experiences of the COVID-19 pandemic, such as the benefits of digitalization, Medicines for Europe has urged
29 Nov 2020
Warp Speed’s Slaoui predicts vaccinations starting within days of the 10 December advisory committee for Pfizer’s coronavirus vaccine. Regeneron’s monoclonal cocktail follows Lilly’s antibody product with an EUA.
29 Nov 2020
A nasal spray formulated using compounds already approved by regulatory bodies in Europe and the US can “prevent and slow” transmission of COVID-19, according to UK researchers who are now seeking a partner to commercialize the product.
Generics Bulletin
28 Jun 2022
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24 Jun 2022
Pink Sheet
23 Jun 2022
23 Jun 2022
HBW Insight
22 Jun 2022
Pink Sheet
22 Jun 2022
Generics Bulletin
22 Jun 2022
21 Jun 2022
20 Jun 2022
20 Jun 2022
Generics Bulletin
20 Jun 2022
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