Regulatory Focus™ > News Articles > 2020 > 7 > Recon: Takeda in for $900M on gene therapy R&D; Vertex gets quick win in England for CF triple thera

Recon: Takeda in for $900M on gene therapy R&D; Vertex gets quick win in England for CF triple therapy

Posted 02 July 2020 | By Kari Oakes 

Recon: Takeda in for $900M on gene therapy R&D; Vertex gets quick win in England for CF triple therapy

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Gottlieb says worst of outbreak will pass by January; Pence sees no need for a mask mandate (CNBC)
  • Coronavirus Update: Spooked By America’s COVID-19 Vaccine Skepticism, FDA Promises Not To Lower Standards (Scrip)
  • AHA: Hospital losses could top $323B in 2020 (HealthLeaders)
  • 2020 Fortune/IBM Watson Health 100 Top Hospitals List (HITConsultant)
  • EUSA Pharma gets FDA green light to evaluate IL-6 inhibitor siltuximab in COVID-19 patients (Pharmafile)
  • Mnuchin: White House 'absolutely' does not regret pushing states to reopen (The Hill)
  • Drugmakers Raised Drug Prices Throughout COVID-19 Pandemic, Analysis Finds (FDA News)
  • Some Government Contracts for COVID-19 Products Dodge Affordable Pricing Laws, Report Says (FDA News)
  • AI drug discovery startup strikes partnership with LEO Pharma (MedCity News)
  • Tesla chief Elon Musk teams up with Covid-19 player CureVac to build 'RNA microfactories' (Endpoints)
In Focus: International
  • Vertex Secures Rapid Deal In England For CF Triple Therapy (Scrip)
  • RDIF and ChemRar exceed target production of Avifavir (Pharmaletter)
  • Avadel sells sterile injectables portfolio; will focus on narcolepsy (Pharmaletter)
  • Notified body poll finds multi-month waits for COVID-19 conformity assessments (MedTech Dive)
  • South Korean biotech IPO fuels concerns of bubble in sector (Financial Times)
  • Brussels in talks with Gilead to secure doses of remdesivir for EU (Financial Times)
  • Johnson & Johnson announced that the European Commission has granted Marketing Authorisation for its Janssen Ebola vaccine (Pharmafile) (PharmaTimes)
  • Fujifilm Partners With Dr. Reddy’s to Sell Avigan for COVID-19 (FDA News)
  • Survey: In the US, people say their use of masks may endure (McKinsey)
  • United Kingdom plans ‘office for talent’ to smooth entry for top scientists (Science Magazine)
  • Africa Union urges member countries to remove intellectual property barriers to Covid-19 vaccines (STAT)
Coronavirus Pandemic
  • New coronavirus cases in U.S. top 50,000 in one day, setting record (CBS News) (NPR)
  • A powerful law gives HHS the right to take control of remdesivir manufacturing and distribution (STAT)
  • Coronavirus Update: Oxford Racing Ahead With 8,000 Vaccinated In Phase III Trial (Scrip)
  • The coronavirus crisis is deepening (Politico)
  • The latest: What they are saying: Importance of intellectual property protections to combat COVID-19 (PhRMA)
  • Federal coronavirus contracts dodge pricing oversight, advocacy group says (BioPharma Dive)
  • NEWS
  • Further billions pledged to ensure equitable access to COVID-19 treatments (European Pharmaceutical Review)
  • Oxford offers best hope for Covid-19 vaccine this year, MPs told (The Guardian)
  • COVID-19 immunity may be more widespread than previously thought, new study suggests (Pharmafile)
  • Abivax doses first patient in phase 2b/3 COVID-19 clinical trial (PMLive)
  • Experts fear July 4 weekend will exacerbate coronavirus spread (The Hill)
  • One ART Regimen Tied to Lower COVID-19 Risk in HIV (MedPage Today)
  • Federal Officials Turn to a New Testing Strategy as Infections Surge (New York Times)
  • Does asthma increase Covid-19 risk? Emerging research suggests a complicated connection (STAT)
Pharma & Biotech
  • Takeda expands in gene therapy with $900m R&D deal (BioPharma-Reporter)
  • Akero Histology Data Could Be Best In Class For NASH (Scrip)
  • Insys Execs Can't Dodge Prison During Appeal, Seek Delay (Law360)
  • Study finds flaws in widely-used pricing model for generic drugs (Pharmaletter)
  • Sandoz views options for Erelzi, as court backs Amgen patent (Pharmaletter)
  • COVID-19 Puts Spotlight On Clinical Trial Networks: 'We Really Need Them Right Now' (Pink Sheet)
  • Two Rare Disease Focused Biotechs Raise $900 Million in Follow-on Offerings (Global Genes)
  • FDA Grants Rhythm Rare Pediatric Disease Designation for Rare Obesities Drug (Global Genes)
  • QurAlis Strengthens ALS Pipeline with Candidates from Lilly (Global Genes)
  • Novartis to pay $678M to settle claims over 'sham' doctor events (BioPharma Dive) (New York Times) (Law360)
  • Amgen prevails in high-stakes drug case against Novartis (BioPharma Dive)
  • Alexion Completes Acquisition of Portola (BusinessWire)
  • Sarepta bags drug to fully unlock DMD gene therapy opportunity (Fierce Biotech)
  • BARDA backs push for clinical-grade wearable to detect signs of COVID-19 (MedTech Dive)
  • EU Medical Device Regulation: What Should You Do During the Delay? (MD+DI)
  • UnitedHealthcare adds coverage of Tandem insulin pumps (MedTech Dive)
  • Kroger gets FDA authorization for at-home COVID test (Grocery Dive)
  • CMS proposes major market expansion in potential boost for Abbott's MitraClip (MedTechDive)
  • FTC settles false advertising suit against low-level light therapy marketer with $22 million judgment (Science-Based Medicine)
  • gets FDA clearance for its head CT scan product qER (Mobi Health News)
  • Sherlock, binx to develop point-of-care Covid-19 test using CRISPR technology (MedCity News)
  • Teva Branded Pharmaceutical Products R&D, Inc.; Withdrawal of Approval of a New Drug Application for ZECUITY (Federal Register) (FDA)
  • Chiesi Licenses Bioasis Tech to Tackle Brain Symptoms of Rare Diseases (Xconomy)
Government & Regulatory
  • Alexion Pharmaceuticals To Pay SEC $21M Over FCPA Claims (Law360)
  • Swift Pace Of Accelerated Approval Submissions Suggests Strong Constituency For US FDA Program (Pink Sheet)
  • Minnesota's Free Insulin Law Has 'Staggering' Implications, PhRMA Says (Pink Sheet)
  • US FDA Invites Warning Letter Follow-Up Inspection Alternative Proposals As Pandemic Persists (Pink Sheet)
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.

Tags: EMA, FDA, US

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