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Recon: US pulls funding for Inovio COVID vaccine study; EU seeks 1.8 billion more doses of Pfizer-BioNTech vaccine
Recon: US pulls funding for Inovio COVID vaccine study; EU seeks 1.8 billion more doses of Pfizer-BioNTech vaccine
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
With Few New Clotting Cases, J&J Pause Could Be Lifted Soon (NYTimes ) (WSJ ) (Reuters ) (FT )
White House writes off Johnson & Johnson vaccine after string of production failures (Politico )
US CDC probes new death, hospitalization after J&J vaccine shots – officials (Reuters )
US stops funding for late-stage study of Inovio's COVID-19 vaccine (Reuters ) (Endpoints )
CDC reassigns official who drew spotlight for pandemic warning (Politico )
New data point to benefits of Bristol’s novel psoriasis pill, but safety issues will be scrutinized (STAT )
FDA Authorizes Marketing of Device to Facilitate Muscle Rehabilitation in Stroke Patients (FDA )
‘There are no alternatives’: As Pfizer discontinues an old glaucoma drug, a small group of patients struggles to cope (STAT )
In Focus: International
EU to strike world's largest vaccine deal with Pfizer (Reuters )
EU approves ramp-up of Pfizer vaccine manufacturing site in Belgium (Reuters )
EU Commission sees potential in protein-based COVID-19 vaccines (Reuters )
Moderna CEO says world faces 2022 COVID vaccine production surplus (Reuters )
WHO, Macron denounce vaccine inequity as COVAX scheme marks first year (Reuters )
India's Cadila Healthcare starts producing COVID-19 vaccine candidate (Reuters )
MHRA authorises Amarin’s heart drug Vazkepa (PharmaTimes )
Malaria vaccine trial raises hopes of beating disease (FT )
Final Opinion On The Safety Of Breast Implants In Relation To ALCL (EC )
ACT-Accelerator one year on (WHO )
Coronavirus Pandemic
As At-Home Coronavirus Tests Hit Pharmacies, What Role Can They Play In The Pandemic? (NPR )
Patients With Long Covid Face Lingering Worrisome Health Risks, Study Finds (NYTimes )
Vaccines Are Effective Against the New York Variant, Studies Find (NYTimes )
British regulator says AstraZeneca COVID shot clots rise to 168 (Reuters )
Brazil's COVID-19 vaccination program at risk due to 2nd dose no-shows (Reuters )
Norway offers mRNA COVID-19 vaccines to those who first got AstraZeneca's (Reuters )
Swedish health agency extends pause on J&J vaccine (Reuters )
Germany sets no limits on use of J&J COVID-19 shot (Reuters )
Olumiant Snags Japan Approval for COVID-19 (PharmaJapan )
J&J COVID-19 vaccine expected to be imported to India by July – report (Economic Times )
Pharma & Biotech
J&J shareholders approve CEO Gorsky's near-$30 mln pay plan (Reuters )
Vertex eyes controllable genetic drugs with $1.3bn Obsidian alliance (PharmaPhorum )
Why GSK will struggle to mount AstraZeneca-style revival (FT )
With new PhIII data in hand, Dermavant lines up topical psoriasis contender for a sprint to the finish line (Endpoints )
Regeneron looks to inject another $330M into long-running manufacturing expansion plan: report (Fierce )
With 7 PD-1s on the market, price competition hasn't been a factor. Will Regeneron be the first to ask for less? (Endpoints )
Lonza to invest over £150 million on new molecule complex (Pharmafile )
China Cancer Drug Off-Label Use: A Crossed Line? (Pink Sheet )
GlaxoSmithKline hustles the 7th PD-1 past the finish line with Jemperli. But how big will uptake be? (Endpoints )
April showers bring more biotechs to Nasdaq, as Rain and Impel bump 2021's total raise above $6B (Endpoints )
Bayer plots a major facelift at Berkeley campus, uncorking a 30-year, $1.2B plan to drive cell and gene therapies (Endpoints )
A pair of Bayer execs land promotions in the US; Energized by lenzilumab data, Humanigen taps AstraZeneca alum as CMO (Endpoints )
The ICH Q3C(R8) Guideline reaches Step 4 of the ICH Process (ICH )
Pricing Reform in Japan: How Must Life Science Companies Evolve? (PharmaJapan )
Takeda Teams Up with IT Startup for AI-Driven Early HAE Detection (PharmaJapan )
Medtech
Medtech earnings show early signs of electives return, lingering testing uncertainty (MedtechDive )
Quest Q1 revenue jumps 49% even as COVID-19 test demand wanes (MedtechDive )
Roche nets companion diagnostic approval for GlaxoSmithKline's Jemperli in MMR-deficient endometrial cancer (Fierce )
UK Device Regulatory System Off To Good Start Under ‘Supportive’ MHRA (MedtechInsight )
Endeavour Vision raises $375M to fund post-COVID medtech ambitions (Fierce )
FDA Presses Domestic Manufacturers To Engage In Remote Regulatory Assessments In Lieu Of Inspections (MedtechInsight )
Can real-world remote monitoring help doctors treat heart failure? Amgen and Datos aim to find out (Fierce )
Government, Regulatory & Legal
Senators to NIH: Do more to protect US biomedical research from foreign influence (Endpoints )
GenMark Sued by Holder Eyeing $1.8 Billion Roche Deal Challenge (Bloomberg )
How the SCOTUS decision to gut the FTC could help biopharma companies (Endpoints )
Amgen Petitions Federal Circuit to Reconsider Decision Invalidating Praluent Patents (Big Molecule Watch )
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.