Recon: Vertex inks $900M deal with CRISPR Therapeutics; Congress investigates Emergent's contracts
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
Is the US FDA at A Tipping Point? (Pink Sheet )
New report finds COVID-19 pandemic causes dramatic shifts in prescription drug spending (EurekAlert )
Trump administration awarded a firm $1.3 billion to make Covid vaccine syringes. Where are they? (NBC )
U.S. Reaches Another Crucial Juncture In The Fight Against COVID-19 (NPR )
Biden to push for more vaccinations as administration reaches 200 million-dose milestone (CNBC )
U.S. vaccination pace holds above 3 million shots per day for two weeks straight (CNBC )
With vaccines open to 16- to 17-year-olds, high schools set up shop to give the shots (CNBC )
The US spat over the vaccine IP waiver (FT1 ) (FT2 )
In Focus: International
J&J COVID-19 vaccine to resume Europe rollout (Reuters ) (PharmaFile )
GW Pharma’s cannabidiol gains EC approval (PharmaFile ) (PharmaTimes )
UK: RWD at Center of NICE Five-Year Strategy (Pink Sheet )
Chile shifts Covid vaccine drive to second doses amid concerns over first shot's protection (CNBC )
European data protection board to strengthen sharing of health data between EU and UK (Healthcare IT News ) (PMLive )
Germany contained Covid-19. Politics brought it back. (Vox )
Sudden Coronavirus Spike Overwhelms India's Health Care System (NPR )
Brazil cases dropping but relaxing health measures could reverse gains – PAHO (Reuters )
Bharat Biotech announces interim analysis results of Phase 3 trials (Economic Times )
Coronavirus Pandemic
How worried should we be about links of blood clots to AstraZeneca’s vaccine? (Reuters )
Nasal spray works against COVID-19 variants (Pharmaletter )
UK government launches search for at-home COVID-19 treatments (PharmaTimes )
For Vaccine Passports, Less Tech Is Best (NYT )
How a WHO push for global vaccines needled Europe (Reuters )
Thailand sticks with Sinovac vaccine after cases of 'stroke-like' side effects (Reuters )
Sri Lanka reports six cases of blood clots among AstraZeneca vaccine recipients, 3 dead (Reuters )
Fair Shot? Does COVID Vaccine Availability Ensure Equity? (MedPage Today )
Pharma & Biotech
Sanofi Q1 Preview: Building The Pipeline, Improving Business Efficiencies (Scrip )
Roche culls 2 COVID-19 drug hopefuls amid Q1 clear-out (Fierce )
Vertex to pay CRISPR Therapeutics $900M for bigger share of gene-editing alliance (MedCity News )
BioNTech sees scope for further capacity expansion -CFO (Reuters )
Diurnal completes £20 million placing to fund US Phase III clinical trial (Pharmaletter )
Peter Thiel-backed ATAI is preparing to go to Nasdaq, as interest in psychedelics reaches fever pitch (Endpoints )
ALS 'Compassionate Use' Again Hits National Media (MedPage Today )
The Making of a Gene Therapy for an Ultra-Rare Disease (Rare Daily )
Citrine and Sinopharm Enter Strategic Partnership to Broaden Access to Rare Disease Drugs in China (Rare Daily )
Evotec starts work on $240M French companion to its biologics 'facility of the future' in Washington (Fierce )
Aldevron founders back a biotech startup that's looking to end the moral debate over cell lines once and for all (Endpoints )
Versant pulls the wraps off of nearly $1B in 3 new funds out to build the next fleet of biotech startups (Endpoints )
On the hunt for bugs outside the gut, Seed Health snares $40M round to advance pipeline with the help of George Church (Endpoints )
Novo Nordisk to launch PhIII obesity trial for oral semaglutide; EdiGene extends Series B with additional $62M (Endpoints )
Pfizer shareholders are urged to reject political spending that contradicts ‘company values’ (STAT )
As bluebird rejiggers EU rollout of one gene therapy, hope for near-term lifting of all clinical holds (BioCentury )
SparingVision acquires GAMUT Therapeutics; expanding novel ocular disease pipeline (BioPharma Reporter )
Critical risk assessment report: use of UK plasma for the manufacture of immunoglobulins and vCJD risk (MHRA )
Medtech
Abbott misses Wall Street as COVID-19 test sales softer than expected (Medtech Dive )
J&J returns to growth in Q1 as elective care rebounds in US, Asia-Pacific (Medtech Dive )
FDA: make medical apps reliable, not risky (STAT )
SenseTime gets CE mark for its AI-powered chest diagnostic software (MobiHealth News )
FDA Issues EUAs for SARS-CoV-2 Tests From Synergy Diagnostic Laboratory, Celltrion (Genome Web )
Even More Woes for Illumina’s Proposed Acquisition of Grail (MD+DI )
Vietnamese Ministry of Health proposes new decree for medical device regulation (Emergo )
Health funding shatters records in Q1, but medtech a bit of a laggard (Medtech Dive )
Intuitive sees Q1 robot rebound, in turnabout from start of year (Medtech Dive )
Could a 'Placebo' Become the Next Big ED Treatment? (MedPage Today )
Government & Regulatory
Congressional investigation launched into Emergent BioSolutions’ federal vaccine contracts (STAT ) (CNBC )
FDA says it tried—in vain—for years to inspect manufacturer of supplements (Natural Products Insider )
Law professors call for FDA to disclose all safety and efficacy data for drugs (Endpoints )
Federal Circuit Tosses 'Unusual' Appeal On Menopause Drug IP (Law360 )
Facing $50B Trial, Drugmakers Minimize Roles In Opioid Sales (Law360 )
Biden Administration Slammed For Nixing WTO Critical-Drug Proposal (Law360 )
Texas Presumption of Adequacy Precludes Prempro Claims (Drug & Device Law )
Incretin State Court – The Expert Blip (Drug & Device Law )
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.