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May 19, 2021
by Michael Mezher

Recon: Emergent execs face grilling on the Hill; Bristol-Myers enters $1.2B AI pact

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Emergent was aware of vaccine manufacturing issues even as it collected $27 million a month from US (STAT) (The Hill) (Politico) (CNBC) (Washington Post)
  • Troubled Vaccine Maker and Its Founder Gave $2 Million in Political Donations (NYTimes 1, 2)
  • Bristol-Myers pays up to $1.2bn to enter artificial-intelligence pact (FT) (Endpoints)
  • Democrats call on FTC to investigate AbbVie’s Humira pricing strategy (STAT) (BioPharmaDive) (The Hill)
  • HHS cracks down on AstraZeneca, Eli Lilly, Novartis, Novo Nordisk and Sanofi for limiting access to discounted drugs under the 340B program (Endpoints)
  • Sarepta touts clean data for commercial grade Duchenne gene therapy, clearing key hurdle to PhIII (Endpoints) (BioPharmaDive) (Press)
  • US will donate substantial portion of vaccines through COVAX -US official (Reuters)
  • CDC says 600,000 kids ages 12 to 15 have received Covid vaccine shots in last week (CNBC)
  • Top FDA official says fully vaccinated people could need Covid booster shots within a year (CNBC)
In Focus: International
  • UK increasingly confident that vaccines work against Indian variant (Reuters)
  • Pfizer to produce COVID-19 vaccine component in Ireland (Reuters)
  • Under pressure EU presents WTO plan to boost vaccine output (Reuters) (FT)
  • UAE, Bahrain to offer Sinopharm COVID-19 booster shots (Reuters)
  • GAVI hopeful COVID-19 vaccine exports from India can resume in Q3 (Reuters)
  • ‘Slavery’ found at a Malaysian glove factory. Why didn’t the auditor see it? (Reuters)
Coronavirus Pandemic
  • China cuts COVID-19 vaccine ingredient shipment to Brazil (Reuters)
  • DOJ, HHS Watchdog Warn COVID Vaccines Must Be Free (Law360)
  • Spain approves Pfizer shots for under-60s who got AstraZeneca first dose -El Pais (Reuters)
  • BerGenBio fails COVID-19 trial, makes post hoc case for program (Fierce)
  • Indian vaccine maker extends freeze on export of Covid jabs (FT)
  • Dr Reddy's in talks with RDIF on Sputnik V for other countries (Economic Times)
  • Covaxin trials in children between 2-18 years to begin in 10-12 Days: Govt (Economic Times)
  • India's Biological E. to produce Johnson & Johnson's COVID-19 vaccine (Economic Times)
Pharma & Biotech
  • Biopharma R&D 'surged' in 2020, but trial productivity levels a mixed bag: report (Fierce)
  • Your money or else: Some drug makers could be ‘highly’ susceptible to ransomware attacks (STAT)
  • Lilly and Innovent look to bring their anti-PD-1 from China to the US; Merck KGaA names new EMD Serono president (Endpoints)
  • Pediatric Cancer Dataset Gaps, FDA ‘High Bar’ Make Use Of External Control Arms Difficult (Pink Sheet)
  • Cures 2.0 Leaders Sees Biden ‘Advanced Research’ Project As Ticket To Bill’s Success (Pink Sheet)
  • Janssen inks inflammatory disease collaboration with Mestag Therapeutics (PharmaTimes)
  • Decades after a tragic failure, gene therapy successfully treats a rare liver disease (Science)
  • Drug Pricing Shake Up Likely In Germany (Pink Sheet)
  • Companies Brace For ‘Oral Explanations’ On EU Filings (Pink Sheet)
  • Fujifilm, BlueRock Form Strategic Alliance to Develop iPSC Therapies for Ocular Diseases (PharmaJapan)
  • Legacies: 60 biopharma pioneers over 60 who helped birth a tech revolution in the making (Endpoints)
  • CMC holdup delays Iovance filing again — to 2022 — as FDA seeks more assay data for TIL therapy (Endpoints)
  • Months after Novartis buyout, the old Vedere Bio team is back at it with a new pipeline and a fresh $77M (Endpoints)
  • Novartis loses another NIBR exec as neuro expert Shanker joins a gene therapy biotech (Fierce)
  • There’s a new team occupying the executive suite at Merck. And they’ve got a new game plan (Endpoints)
  • Acceleron uncorks more mid-stage data for PAH drug sotatercept as part of the drug's resurrection campaign (Endpoints)
  • Looking to reshape the metastatic cancer landscape, HiberCell fills the tank with a slate of mid-stage tests queued up (Endpoints)
  • Thermo Fisher partners with UCSF to provide a one-stop shop for early biotech manufacturing (Endpoints)
  • Advances in targeting ‘undruggable’ transcription factors with small molecules (Nature)
Medtech
  • US panel trims colorectal cancer screening age, opens door to annual Cologuard use (MedtechDive)
  • BD blueprints $200M delivery device plant in Spain, plans to add 600 jobs by 2030 (Fierce)
  • Laser-sensor startup Atonarp nets $50M to chase chemistry-free point-of-care diagnostics (Fierce)
  • Ascensia unveils online platform that connects to glucose meters for diabetes management, analytics (Fierce)
  • PathAI finds its way to $165M series C for diagnostic and drug development software (Fierce)
  • New Thai medical device regulations increase technical data requirements (Emergo)
  • Rand Paul Reintroduces Bill Aimed at Blocking FDA Regulation of LDTs (360dx)
Government, Regulatory & Legal
  • Bayer seeks approval of $2 bln plan to limit Roundup claims (Reuters)
  • Takeda Unit Inks Deal To End IP Suit After Bayer's $173M Win (Law360)
  • Opening Args In NY Opioid Trial Set For End Of June (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.
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