Recon: AZ's $39B bid for Alexion cleared by EC; Leo taps X-Chem for derm drugs

ReconRecon | 06 July 2021 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Fauci: More than 99% of people who died from COVID-19 in June were not vaccinated (The Hill)
  • The White House is taking right approach in fighting the Covid-19 delta variant, Gottlieb says (CNBC)
  • Biden’s grand plan: ‘Blue Sky’ research to solve the biggest health problems (MedCity News)
  • As COVID Vaccinations Slow, Parts Of The U.S. Remain Far Behind 70% Goal (NPR)
  • F.D.A. Releases More of Johnson & Johnson’s Vaccine, but Baltimore Plant Remains Closed (NYT)
  • Biotech Company That Botched Vaccines Faces Investor Revolt (NYT)
  • New Research Finds J&J Vaccine Has Muscle Against Covid’s Delta Variant (KHN)
In Focus: International
  • As EU-wide health technology oversight law nears passage, industry is not pleased (MedTech Dive)
  • MHRA outlines two-year delivery plan with ‘patient first’ focus (PMLive)
  • Johnson Outlines Plan To Lift Nearly All Of England's COVID-19 Restrictions (NPR)
  • UK reports highest number of new COVID cases since Jan. 29 (Reuters)
  • EU orders nearly 40 million additional J&J COVID vaccines (Reuters)
  • EMA backs active substance scale-up at Janssen’s COVID-19 vaccine site in the Netherlands (BioPharma Reporter)
  • Chinese health authority erects new gold standard in oncology R&D (Endpoints)
  • MHRA and Health Canada release guidance to improve Development Safety Update Reports (MHRA)
  • Health Canada releases step 2 ICH S12 guidance on nonclinical biodistribution considerations for gene therapies (Health Canada)
  • Israel sees drop in Pfizer vaccine protection against infections (Reuters)
  • India's COVID death rate hit record in June after calls for better data (Reuters)
  • Japan to ship millions more COVID-19 vaccines to Taiwan, Asian neighbours this week (Reuters)
Coronavirus Pandemic
  • COVAX says it's negotiating with new vaccine suppliers (Reuters)
  • WHO recommends IL-6 receptor blockers in patients with severe or critical COVID-19 (WHO)
  • Anti-SARS-CoV-2 Repurposing Drug Database: Clinical Pharmacology Considerations (PubMed)
  • South Korea in talks to produce one billion mRNA vaccine doses (Pharmafile)
  • Bharat Biotech says its COVID-19 vaccine is 77.8% effective overall (PMLive)
  • Ocugen climbs on phase 3 COVID vaccine data, hitting back at delta variant (Fierce)
  • Mexico produces first test batch of Russia's Sputnik V vaccine, says RDIF (Reuters)
  • Should People With Immune Problems Get Third Vaccine Doses? (NYT)
  • From Money To Monsoons: Obstacles Loom For Countries Awaiting Vaccine Doses (NPR)
  • A path forward on access & IP for COVID vaccines and beyond (Biocentury)
Pharma & Biotech
  • Eli Lilly, Boehringer Ingelheim tout pivotal heart failure win for Jardiance (Endpoints)
  • The controversial approval of an Alzheimer’s drug reignites the battle over the underlying cause of the disease (WaPo)
  • If you thought the FDA’s approval of Aduhelm for Alzheimer’s was controversial, you should hear the experts' thoughts on off-label use (Endpoints)
  • Is the Alzheimer’s Association really pushing Biogen to lower its new drug’s price — or is it lip service? (STAT)
  • Innovation on hold during the pandemic? FDA says no with 29 approvals in first half of 2021 (Fierce)
  • Novartis revives inclisiran U.S. filing by sidestepping FDA's manufacturing inspection concerns (Fierce Pharma)
  • Leo taps X-Chem to discover anti-inflammatory dermatology drugs (Fierce)
  • Oxford researchers launch HIV vaccine trial (PharmaTimes)
  • Novasep secures manufacturing deal with US biotech for ADC drug candidate (BioPharma Reporter)
  • US FDA’s Novel Approval Count Hits 32 In First Half Of 2021, With More Than 40 Goal Dates Ahead (Pink Sheet)
  • Keytruda May Stay Competitive In Gastric Cancer Despite Losing Third-Line Claim (Pink Sheet)
  • Avdoralimab Phase II FORCE trial in COVID-19 misses endpoints (Pharmaletter)
  • Novartis to make Leqvio for U.S. in Austria to overcome FDA delay (Reuters)
  • FDA approves expanded indication for Keytruda in cSCC (Pharmaletter)
  • How CRISPR stacks up against more established new modalities (Biocentury)
  • Alnylam’s strategy to head off CRISPR threat (Biocentury)
  • CRISPR gene-editing treatment could reach patients ‘very, very soon’: Intellia CEO (CNBC)
  • Iterum slumps as FDA finds deficiencies in its antibiotic NDA (Pharmaletter)
  • Provention Bio slapped with FDA rejection for diabetes hopeful teplizumab (Fierce)
  • New Tx for Celiac; Blood Test for Multiple Cancers? (TTHealthWatch/MPT)
  • Medtronic's recall of unsterilized angiography guidewires labeled Class I event by FDA (MedTech Dive)
  • The most intriguing health tech deals of the year (so far) (STAT)
  • Fully implantable and bioresorbable cardiac pacemakers without leads or batteries (Nature Biotech)
  • Abbott Boosts DES Offerings with New Approvals (MD+DI)
  • If Apple takes aim at fall-prevention, will the rest of the health system hear it? (STAT)
  • Qiagen and Sysmex Team up on Cancer Companion Diagnostics (MD+DI)
  • Startup gets FDA-clearance for device to treat chronic pain (MedCity News)
  • Inside the ‘land grab’ for virtual-first care: how an unprecedented flurry of deals is shaping the new digital health landscape (STAT)
Government, Regulatory & Legal
  • 21st Century Cures 2.0 Seeks to Formalize Plans for ARPA-H (CHC)
  • FDA warns medical supply firm for sale of unapproved influenza vaccine (FDA)
  • Mayim Bialik’s Neuriva Commercials Make Questionable Claims (Science-based Medicine)
  • A Confluence of Forces Is Now Spurring Combination Product Regulatory Reform in Europe (IPQ)
  • The 402A Plot Thickens in Pennsylvania (Drug and Device Law Blog)
  • FTC Fines Kushly Industries LLC for Making Unsupported Health Claims for CBD Products (FTC)
  • Judge Rotenberg Educational Center, Inc. v. US Food and Drug Administration (US Ct of Appeals)
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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