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Novartis aims to beat rivals to novel $10bn cancer treatment market (FT)
Drugmaker Sobi profit tops forecasts, sees markets recovering (Reuters)
Catalent plans $100 mln expansion at vaccine plant in Italy (Reuters)
EU rejects UK demand for new post-Brexit deal on Northern Ireland (Reuters)
Coronavirus Pandemic
Global quest underway to speed COVID-19 vaccine trials (Reuters)
WHO chief warns that the world is going into the ‘early stages of another wave’ (CNBC)
US life expectancy falls to lowest level in almost 20 years due to COVID-19 -CDC (Reuters)
Takeda agrees to supply additional 50 mln Moderna COVID-19 vaccines to Japan (Reuters)
Vietnam produces first batch of Russian COVID-19 vaccine (Reuters)
Leaked letters show AstraZeneca vaccine commitment not as Thailand claimed (Reuters)
Taiwan bumps BioNTech vaccine order to 15 mln with Buddhist donation (Reuters)
Pharma & Biotech
How cozy is too cozy? FDA and Biogen offer up a test case (Endpoints)
FDA plans to study whether pharma reps at conference exhibit booths are telling the truth (STAT)
Accelerated approval, the path used to greenlight Biogen Alzheimer’s drug, has a checkered track record, critics say (STAT)
Philip Morris CEO defends the company’s intentions to buy inhaler maker Vectura (CNBC)
Sanofi's sleeping sickness drug wins FDA OK and a lucrative priority review voucher too (Endpoints)
Myovant, Gedeon Richter’s uterine fibroids med Ryeqo bags EU approval (PharmaTimes)
AstraZeneca, Alexion close massive $39B merger; bluebird bio earns EU nod for Lenti-D as big split approaches (Endpoints)
Statin Label Change May Signal Broader US FDA Shift On Drug Use During Pregnancy (Pink Sheet)
Novartis discards one of its ‘wild card’ drugs after it flops in key study. But it takes one more for the hand (Endpoints)
A Novartis castoff with a troubled past headlines Chinese biotech's Hong Kong IPO quest (Endpoints)
Albireo caps a big week with back-to-back approvals in the US/EU for the first drug to treat a severe liver disease (Endpoints)
FDA levels clinical hold on Magenta's second lead drug, asking for an additional bioassay before it gets to humans (Endpoints)
Can a next-gen take on a deadly weight loss pill conquer cardiometabolic diseases? A Medicxi-backed startup thinks so (Endpoints)
PacBio engineers $800M buyout of sequencing rival Omniome as analysts fret over FTC action (Endpoints)
As healthcare heats up on HKEX, Qiming sets up $500M fund dedicated to public companies (Endpoints)
The pivot: Turnstone Biologics opens a new chapter with a switch to clinical development and a new venture round to pay for it (Endpoints)
New study shows smaller biopharma companies struggle more than larger ones with clinical trial transparency (Endpoints)
On a mission to treat patients not covered by Luxturna, Horama refuels with a Series B expansion and a new name (Endpoints)
FDA grants Breakthrough Therapy Designation for Venclexta in combination with azacitidine for the treatment of patients with myelodysplastic syndromes (Press)
Medtech
Medtech M&A expected to be robust in second half after 2021 began with a flurry (MedtechDive)
‘One FDA’: US Agency’s New Inspectional Affairs Council Takes Shape (Medtech Insight)
BD acquires needle-free blood draw company Velano Vascular for ‘one-stick’ hospital stays (Fierce)
Radiation therapy 'under attack' from CMS cuts, professional body warns (MedtechDive)
First Expert Panel Opinion Offers Valuable Learning Opportunities (MedtechInsight)
CMS pitches stiffening price transparency fines, halting end of inpatient-only list (MedtechDive)
Nevro gets FDA nod for diabetic neuropathy treatment but misses Q2 sales target (MedtechDive)
Neuspera Medical scores $65M for nerve-stimulating implant to treat overactive bladder (Fierce)
Government, Regulatory & Legal
Examiner Clears Sacklers Of Influencing Purdue's Board (Law360)
Opana Sales Calls Didn't Cause Rx Rise, Economist Testifies (Law360)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
Three major pharmaceutical industry groups—two in the US and one in India—have called for changes to the US Food and Drug Administration's (FDA) Scale-Up and Post-Approval Changes (SUPAC) guidelines. They believe these guidelines should be updated to reflect more modern manufacturing methods and better align with International Council for Harmonisation (ICH) standards.
Patients with breast cancer said faster approval times for oncology products, as a trade-off for evidentiary certainty, is most permissible in situations where there are no treatment alternatives, the results from a recent qualitative study suggest.