Posted 21 April 2021 | By Kari Oakes 

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.
 

 

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